Juan Andres

As Chief Technical Operations and Quality Officer, Juan Andres is responsible for the supply of product required for Moderna’s preclinical and clinical development programs, as well as scaling the CMC (chemistry, manufacturing and controls) processes across Moderna’s portfolio. Mr. Andres also will lead all CMC late-stage development and future commercialization activities.

Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of Novartis’ manufacturing sites, and related support functions and technologies worldwide, overseeing small molecules drug substance and drug product, as well as biologics drug substance, drug product and technical development. Mr. Andres’ previous roles at Novartis included Group Novartis Quality Head, Global Head of Technical Research and Development, and Global Pharmaceutical Operations Head. Prior to Novartis, Mr. Andres worked at Eli Lilly & Co. for 18 years in a variety of manufacturing, production and quality roles in the United States, Puerto Rico, UK and Spain, most recently serving as Vice President, Pharmaceutical Manufacturing.

Mr. Andres holds a Master degree in Pharmacy from Alcala de Henares University in Madrid and completed an advanced development program at the London Business School.

Patrick Yang

Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech, Roche, and Juno Therapeutics.

He was Executive Vice President and Global Head of Roche Pharmaceuticals Technical Operations based in Basel, Switzerland from January 2010 to March 2013. In this role, he was accountable for Roche’s pharmaceutical and biotech manufacturing operations, and process development. He and as previously Executive Vice President of Product Operations of Genentech, based in South San Francisco. Dr. Yang worked for Genentech for 10 years, from 2003 until his retirement in October 2013.

Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Co. in various leadership positions including Vice President, Supply Chain Management, and Vice President, Asia/Pacific Operations.

Before joining Merck in 1992, Dr. Yang spent 12 years at General Electric (1980-1992), serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Dr. Yang holds a Ph.D. degree in engineering from Ohio State University, Columbus, Ohio.

He a member of Board of Directors of Tesoro Corporation, Codexis, Celladon, Amyris, and PharmaEssentia.

Lou Schmukler

As senior vice president and president of Global Product Development and Supply (GPS), Lou oversees worldwide product development and manufacturing for Bristol-Myers Squibb (BMS).  GPS develops and produces active ingredients and drug products, and delivers the company’s medicines throughout the world. The GPS team achieves this mission through a relentless focus on innovation, quality, safety and agility.

“In GPS we turn molecules into life-changing medicines,” said Lou. “Everyone in the organization is dedicated to deliver them in the right way, at the right time, every time for the patients we serve.”

Lou joined BMS in 2011 as president of Technical Operations. Prior to joining BMS, he led Pfizer’s worldwide biotech manufacturing operations as senior vice president of the Specialty-Biotechnology Operating Unit.  Previously he was responsible for global pharmaceutical manufacturing for Wyeth and Vice President of quality for Hoffman-LaRoche. Earlier in his career he also held leadership roles at Marion Merrell Dow, Mallinckrodt and Novartis-Sandoz.

Lou is an active member and has held leadership positions in several industry organizations including the Pharmaceutical Research and Manufacturers of America (PhRMA), International Society of Pharmaceutical Engineering (ISPE) and National Association of Manufacturers (NAM).

He holds a bachelor’s degree in pharmacy from Temple University and a master’s in management from Webster University.

Michael Kamarck

Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars business.

Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing responsibility in Biotechnology and Vaccines Operations at Wyeth, including leading the development of the global biotechnology network with $3.5 billion of capital investment. While at Wyeth, he also was responsible for global technical operations for all of the Company’s businesses. Dr. Kamarck began his career in biotechnology and pharmaceutical research at Bayer AG.

Dr. Kamarck graduated from Oberlin College where he currently serves as a Trustee. He received his Ph.D. in biochemistry from the Massachusetts Institute of Technology and is the author of more than 50 peer-reviewed publications and 20 issued patents. He also holds an Honorary Doctorate of Science from University College Dublin.

Alison Moore

Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Tim Moore

Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Mr. Moore is current the President and Chief Technical Officer at PACT Pharma. Prior to joining PACT, he served as Executive Vice President, Technical Operations at Kite, a Gilead Company, since March of 2016. During this time Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. In addition, Mr. Moore globally expanded the biopharmaceutical operations to serve and support the US, EU, as well as key partners in Asia.

Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of ISPE, PDA and has been a part of the Executive Committee of BioPhorum and serves as a Board member for Cerus. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Hari Pujar

Hari Pujar, Ph.D., serves as Chief Technology Officer of Spark Therapeutics, leading the technical operations, process and technology development and quality assurance organizations. He is responsible for growing and scaling the company’s cutting-edge technology capabilities for an expanding development pipeline.

Prior to joining Spark, Hari was most recently vice president, Technical Development & Manufacturing, at Moderna Therapeutics. There he built and led the technology and early manufacturing organizations that delivered on supply for more than a dozen clinical programs in a brand-new technology area. Previously, he held a variety of scientific and cross-functional leadership positions during 18 years at Merck & Co in the company’s commercial, R&D and manufacturing divisions.

Hari has a Ph.D. in Chemical Engineering from the University of Delaware and an MBA from the Wharton School at the University of Pennsylvania.

Wolfram Carius

Prof. Wolfram Carius is the Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices) at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for two years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Brendan O’Callaghan

Brendan O’Callaghan is responsible for over 5000 colleagues across several global manufacturing sites who are committed to bringing life-changing biologics based medicines to help improve the lives of patients everywhere.

In his role, Brendan collaborates transversally with expert teams from across Commercial, R&D and IA to help advance our capabilities and capacities to develop, launch and supply our exciting pipeline of Biologics therapies for SANOFI and the patients we serve. A key focus for Brendan is in supporting our many skilled colleagues as we build the expertise and capabilities we need to achieve our ambition to become a top tier player in Biologics, with a clear focus on Product Technology and Development, Flawless Launch and Reliable, Competitive Commercial Supply, Quality, MSAT, Supply Chain, Engineering, Manufacturing Excellence and other related areas of global support.

Derek Adams

Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial process development function and supply chain for clinical studies and drove strategy for product development. Prior to his time at Evelo, he served as Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, where his responsibilities included developing and supporting all manufacturing processes globally as well as global clinical supply chain.  His Alexion career also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing facility and head of upstream process development.  Derek began his career in process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

Yuan Xu

Dr Xu has been the Chief Executive Officer since February, 2018. Before joining Legend Biotech, Dr Xu was Senior Vice President at Merck where she led teams in biologics and vaccines discovery, development, and commercialization. Prior to Merck, Dr Xu held positions at Gilead, Novartis, Amgen, Chiron, GlaxoSmithKline, and Genentech.

With more than 25 years of biologic, biosimilar, vaccine and cell therapy discovery, development, commercialization, and life-cycle-management experience, Dr Xu has contributed to the successful commercial launch of nearly 25 products.

Dr Xu received her Bachelor of Science in biochemistry from Nanjing University, China, her Doctor of Philosophy in biochemistry from the University of Maryland at College Park in College Park, Maryland, USA, and completed her post-degree training in virology and gene therapy at the University of California, San Diego in San Diego, California, USA.

Stacey Ma

Stacey is currently the Executive Vice President of Technical Operations at Sana Biotechnology. In this role, she is a member of the Sana Executive Team, and oversees process, pharmaceutical and analytical development, supply chain, quality, CMC regulatory, CMC portfolio and global manufacturing operations.

Prior to joining Sana in March 2019, Stacey was the Global Head of Innovation, Manufacturing Science and Technology in Genentech/Roche’s Pharma Technical Operations, responsible for driving technology and innovation in the manufacturing and testing network for all pharma products. Over her 23-year career there, she has had various leadership roles within Genentech/Roche, in both South San Francisco and Basel locations, in diverse areas such as analytical development, pharmaceutical development, quality, technical product management and supply chain.

Stacey is an internationally recognized expert in analytical sciences for biopharmaceuticals. She is a fellow of AIMBE and has co-chaired many international scientific conferences and workshops related to CMC development strategies, including several co-sponsored by FDA, EMA, and Chinese FDA. Stacey has a BS in Chemical Engineering from University of Minnesota, and a Ph.D. in Chemical Engineering from Yale University.

Prentice Curry

Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. He has expertise in the management of quality assurance and quality control laboratories, corporate quality functions, validation, construction, and manufacturing along with international assignments in Europe and Asia. He has spent the last five years at Kite Pharma building out the technical operations functions in manufacturing, supply chain, and quality.

Juan Torres

Dr. Juan Torres has worldwide responsibility over Corporate Quality, Quality Control, and Quality Operations at all Biogen production sites. He has been with Biogen for the last sixteen years. Dr. Torres has over 20 years of industrial experience in the area of biological manufacturing and holds a Ph.D. in Biochemistry and Toxicology from North Carolina State University. He also has Post-Doctoral experience in the Chemical Engineering department at NC State University, where he studied novel techniques for large-scale protein purification, and a Masters of Science degree in Organic Chemistry. Prior to joining Biogen, Dr. Torres was Director in the Process Sciences department at Centocor, Inc. and, before that, held positions of increasing responsibility over an eight-year period for Bayer Biological Products.

John Pinion

John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across Asia, Europe and the Americas. His expertise and leadership spans engineering, quality, manufacturing and translational sciences. He joined Ultragenyx in July 2015 and currently holds the role of EVP, Translational Sciences and Chief Quality Operations Officer. Mr. Pinion provides leadership for Ultragenyx’s translational sciences functions to include Pharmacology and Toxicology, Research and Bioanalytical Development, as well as GxP Quality and Compliance and CMC Analytical Development and QC.

As a key member of Ultragenyx’s executive leadership team reporting directly to the organization’s CEO, he also contributes to ongoing business development, clinical development, commercial and strategic planning activities.

In the ten years prior to joining Ultragenyx, Mr. Pinion held roles of increasing responsibility at Genentech (subsequently Roche post Genentech acquisition), departing the organization as Senior Vice President and Global Head of Quality and Compliance for Pharma Technical Operations based in Basel, Switzerland.

Previous to Genentech, Mr. Pinion spent 17 years in operational and senior leadership roles in Baxter International’s Renal, Bioscience, Parenterals and Device divisions.

John currently sits on the Board of Directors and has served as the Chair of the Audit and Risk Committee of Aroa Biosurgery Ltd, a soft tissue repair company commercializing regenerative tissue substitutes based in Auckland, New Zealand. He holds a B.S. in Mechanical Engineering from West Virginia University and lives in Northern California with his wife and two sons.

Greg Russotti

Greg Russotti is the Chief Technology Officer at Century Therapeutics, a company developing iPSC-derived, allogeneic immune cell therapy products for hematology/oncology indications. Before joining Century in January 2020, Greg was Vice President of Cell Therapy Development and Operations at Celgene. During his 13 year tenure at Celgene, he guided CMC efforts for five different cell therapy products to IND and clinical stage development. Greg was also a leader in establishing in-house clinical manufacturing at Celgene and in building Celgene’s first commercial CAR T manufacturing facility. Prior to Celgene, Greg held various leadership roles at Merck Research Laboratories, developing vaccines and monoclonal antibodies for clinical and commercial manufacturing. Greg received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his Ph.D. in Chemical and Biochemical Engineering from Rutgers University.

Susan Abu-Absi

Susan Abu-Absi, Ph.D. is Senior Vice President of Pharmaceutical Development & Technology at bluebird bio, a gene therapy company located in Cambridge, MA. The integrated product platforms at bluebird bio encompass gene therapy, cancer immunotherapy and gene editing – providing the potential to treat a broad range of serious diseases. She leads the teams that develop the CMC strategy and deliver and support the manufacturing processes and analytical methods required to advance therapies through clinical stages to commercial products and throughout the lifecycle. Bluebird bio’s first product, ZYNTEGLO™, received conditional MAA approval in June of 2019.

Susan has over 20 years of experience in biologics process development and manufacturing. Prior to joining bluebird bio, she spent more than ten years in the Manufacturing Sciences & Technology organization at Bristol-Myers Squibb. During her tenure at BMS, she supported clinical and commercial biologics drug substance manufacturing at internal sites and at contract manufacturers. She led teams of scientists, engineers and statisticians tasked with improving process robustness and yields and introducing new technologies into manufacturing. As a leader at BMS, Susan contributed to the successful development and commercial supply of several products, including the launches of Opdivo®, Empliciti®, Yervoy®, and Nulojix®.  Before her tenure at BMS, Susan was a member of the Process Sciences team at Bayer Healthcare in Berkeley, CA.

Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota in the laboratory of Professor Wei-Shou Hu and a B.S. in Chemical Engineering from the University of Toledo (Toledo, OH).

Harry Lam

Dr. Harry Lam is currently EVP, Technical Operations at JW Therapeutics. Previously, he was Head of Therapeutics Technical Operation at 23andMe, previous to that he was VP, Biologics Manufacturing at Sanofi; and VP, Manufacturing and Technical Operations, Progenitor Cell Therapy (PCT), A Subsidiary of Hitachi Chemical Advanced Therapeutics Solutions.

Dr. Lam also spent 17 years at Genentech, where he held a variety of positions with increasing responsibilities, including Director of Manufacturing & Technology, Genentech Singapore Pte Ltd; Senior Director, Global Head of Biologics Drug Substance Manufacturing Science & Technology; and Roche Global Head of Contract Manufacturing Operations, Commercial Drug Substance.

Harry received his B.S. in Chemical Engineering from the University of Birmingham, UK and his Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute, NY.

Charlene Banard

Erich Hahn

Eric is the SVP & Head of Takeda’s Global Biologics Operating Unit. He joined Takeda in 2014 as Head of Global Engineering for the Vaccines Business Division and transitioned to Takeda’s Global Manufacturing and Supply Organization in 2016.

Eric has 20+ years of experience working in the pharmaceutical and biotech industry. Prior to joining Takeda, Eric held several increasingly senior level leadership roles in engineering and operations for Aventis Behring, Hospira and Leica Biosystems.

Eric holds a Bachelor of Science degree in Mechanical Engineering Technology from Southern Illinois University and a Master of Science degree in Biotechnology from the University of Wisconsin-Madison.

Patrick Yang

Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech, Roche, and Juno Therapeutics.

He was Executive Vice President and Global Head of Roche Pharmaceuticals Technical Operations based in Basel, Switzerland from January 2010 to March 2013. In this role, he was accountable for Roche’s pharmaceutical and biotech manufacturing operations, and process development. He and as previously Executive Vice President of Product Operations of Genentech, based in South San Francisco. Dr. Yang worked for Genentech for 10 years, from 2003 until his retirement in October 2013.

Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Co. in various leadership positions including Vice President, Supply Chain Management, and Vice President, Asia/Pacific Operations.

Before joining Merck in 1992, Dr. Yang spent 12 years at General Electric (1980-1992), serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Dr. Yang holds a Ph.D. degree in engineering from Ohio State University, Columbus, Ohio.

He a member of Board of Directors of Tesoro Corporation, Codexis, Celladon, Amyris, and PharmaEssentia.

Michael Kamarck

Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars business.

Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing responsibility in Biotechnology and Vaccines Operations at Wyeth, including leading the development of the global biotechnology network with $3.5 billion of capital investment. While at Wyeth, he also was responsible for global technical operations for all of the Company’s businesses. Dr. Kamarck began his career in biotechnology and pharmaceutical research at Bayer AG.

Dr. Kamarck graduated from Oberlin College where he currently serves as a Trustee. He received his Ph.D. in biochemistry from the Massachusetts Institute of Technology and is the author of more than 50 peer-reviewed publications and 20 issued patents. He also holds an Honorary Doctorate of Science from University College Dublin.

Joseph Tarnowski

Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D.  Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the Technical Operations division of Bristol-Myers Squibb Co.  in New Brunswick, NJ.  Joe was responsible for building the manufacturing capabilities needed to supply the company’s biologic medicines to worldwide markets, including the construction of the company’s new $750 million large-scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts, and the integration of Medarex, Inc. He has spent over 35 years in the pharmaceutical industry focused primarily on the research, development, registration and commercialization of biopharmaceutical products made using recombinant DNA technology.  He holds 13 patents and has several patent applications pending for biologic products.

Joe earned a B.S. degree in Chemistry from Southeast Missouri State University and a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences.  After receiving his Ph.D., Joe was awarded a post-doctoral fellowship in Molecular Biology at the prestigious Roche Institute of Molecular Biology, in Nutley, NJ.  Following his fellowship, Joe was hired to be a senior scientist to develop the large-scale protein purification processes necessary for the manufacture of Recombinant Protein Therapeutics.   Interferon Sciences, Inc. recruited Joe from Hoffman-LaRoche, and he later held senior positions at Scios (acquired by Johnson & Johnson), CellPro, Inc. (cell therapeutics company), and ImClone Systems Incorporated (acquired by Eli Lilly). While at ImClone Systems, he grew the company’s Branchburg, NJ Campus from one building on six acres to seven buildings on nearly 50 acres.  After the completion of its second manufacturing plant in 2005, ImClone Systems was one the world’s largest mammalian cell culture manufacturers.

Joe has held critical roles in the manufacturing, process development, registration, and launch of several FDA and internationally approved human therapeutic products, including Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® Orencia®, Yervoy®, Nulojix®, Eperzan®/Tanzeum®, Nucala®, and Strimvelis^™. He has a thorough understanding of the biologics drug registration process and has had extensive experience in developing the Chemistry, Manufacturing and Controls (CMC) sections for many Investigational New Drug and Biologics License Applications.

Wolfram Carius

Prof. Wolfram Carius is the Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices) at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for two years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Derek Adams

Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial process development function and supply chain for clinical studies and drove strategy for product development. Prior to his time at Evelo, he served as Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, where his responsibilities included developing and supporting all manufacturing processes globally as well as global clinical supply chain.  His Alexion career also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing facility and head of upstream process development.  Derek began his career in process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

Tim Moore

Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Mr. Moore is current the President and Chief Technical Officer at PACT Pharma. Prior to joining PACT, he served as Executive Vice President, Technical Operations at Kite, a Gilead Company, since March of 2016. During this time Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. In addition, Mr. Moore globally expanded the biopharmaceutical operations to serve and support the US, EU, as well as key partners in Asia.

Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of ISPE, PDA and has been a part of the Executive Committee of BioPhorum and serves as a Board member for Cerus. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Alison Moore

Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Jerry Cacia

Jerry is responsible for Roche’s Global Technical Development organization.  This scope includes responsibility for developing manufacturing processes and control systems for Roche’s development pipeline.  This pipeline consists of over 70 New Molecular entities and over 100 development projects in pre-clinical through licensure phases of development.   Jerry has been with Roche/Genentech for 30 years.  He has held a number of senior leadership positions in Technical Development, Manufacturing, MSAT, and Quality prior to becoming the head of Global Technical Development in 2018.

Jens Vogel

Dr. Jens Vogel is President and CEO of Boehringer Ingelheim Fremont Inc., the US arm of Boehringer Ingelheims Biopharmaceuticals Unit. Jens has 20 years of experience in all aspects of biopharmaceutical development and manufacturing, through senior leadership roles in process & technology development, GMP manufacturing and global program leadership in the US, Germany and the UK.

Prior to his current role, Jens was Global Head of CMC Strategy & TechRA, covering CMC development and global regulatory strategy for the entire portfolio of innovative BI biologics, Biosimilars, as well as, all contract development and manufacturing projects.

Before he joined Boehringer Ingelheim, Jens was part of Bayer’s Global Biologics Development Leadership Team in Berkeley.

To date, Jens and his teams contributed to the successful licensure and post launch support of multiple commercial biologics, as well as, more than 60 INDs/IMPDs.

Jens’ interests include reliable supply of biologic therapies to patients, disruptive innovation in technology and business models, and strategic collaborations to maximize value generation for all stakeholders. He is very active in the industry community and was voted as one of the 100 most influential people in drug development and manufacture (The Medicine Maker Power List 2015).

Stephen Hill

Stephen Hill is the Chief Technical Officer of Lyell Immunopharma. Prior to this role he was Head of Global Biologics Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical portfolio for Biologics that includes oversight of six manufacturing sites across the US and Europe and five commercial products. His focus is on driving network performance, reliability and supply while developing a robust management system.

As Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center, Stephen was responsible for the largest biologics manufacturing facility within the company’s global network. The site consists of a licensed, large-scale cell culture production facility and recently commissioned small-scale clinical and commercial facility.

Prior to AstraZeneca, Stephen served as Vice President Bulk Manufacturing at Amgen’s Puerto Rico facility and as Executive Director leading commercial formulation and filling and commercial drug substance operations. In these roles he drove Lean Transformation resulting in significant operational efficiencies and successful new product introductions.

Stephen also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement while increasing output to deliver multiple pipeline new product introductions annually.

Stephen joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. Stephen started his career at Immunex Corporation as an operator manufacturing Enbrel.

Stephen holds a Master in Business Administration (MBA) and Bachelor’s in Microbiology (BS) and Political Science (BA) from the University of Washington.

Charles L. Cooney

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Jun Huang

Dr. Jun Huang is Director/Team Leader, with the Process Monitoring, Automation and Control group, part of Pfizer Global Technology & Engineering, based in NJ. He leads a team responsible for the development and implementation of Advanced Analytics, AI/ML, Advanced Process Control (APC), IIoT and digital solutions to drive improved manufacturing visibility, productivity and quality. He has been a major contributor to a number of key manufacturing initiatives, e.g. digitalization, involved in both strategy development and operationalization. He co-leads the Pfizer Global Supply’s IIoT program. Previously, he worked for GSK and PerkinElmer.

Dr. Huang holds a PhD in chemometrics from the Norwegian University of Science and Technology in Norway, an MBA in Finance and Supply Chain Management from Rutgers University in the USA.

Ronan Farrell

Ronan Farrell is the Head of Quality and Compliance for Roche/Genentech based in Basel, Switzerland.  With over 25 years of experience in the pharmaceutical industry, he is a pharmacist with a PhD in pharmaceutical chemistry from Trinity College Dublin, Ireland. Prior to Roche, Ronan worked with Novartis in various Quality roles including Head of Quality Animal Health and Head of Quality Pharma.  Previously, Ronan held various manufacturing site roles with Pfizer in Ireland.

Nick Page

Nick joined Oxford BioMedica in April 2018. Prior to joining he has held a number of senior operational leadership positions in the pharmaceutical industry, most recently as Platform Head of Anti-infectives within Novartis. His 35+ years of industry experience include API, Solid oral dose, Sterile, and Radiopharmaceutical manufacturing in various organisations encompassing innovative, generic and contract manufacturing. During his career he has spent several years working in China and India as well as in Global roles. He originally qualified as a Chartered Chemist and also has an MBA from The Open University.

Ryan Bartock

Ryan Bartock has over 17 years of experience in manufacturing, supply chain, technical operations and strategy across Merck, GSK and Spark Therapeutics.

He joined Spark as Head of Supply Chain and Network Strategy in 2017 where he developed the supply chain, commercialization strategy and launched the first ever FDA approved Gene Therapy, LUXTURNA^TM. In his current role, Ryan leads Spark’s Supply Chain and CMC Program Management functions.

He joined Spark from GlaxoSmithKline (GSK) where he was Sr. Director – Strategy, Ops and Planning for the Biopharm R&D unit. Prior to this, Ryan was the Sr. Director of Biopharm Supply Chain and Network Strategy where he was responsible for late stage clinical, launch and lifecycle supply for GSK’s Biopharm portfolio and global Manufacturing Sites. He delivered 2 commercial launches, supported the integration of Human Genome Sciences and was responsible for working across Development and Manufacturing divisions to design a novel flexible cell culture manufacturing platform and facility for commercial supply. Ryan held a number of earlier roles of increasing responsibility at both GSK and Merck spanning Fast-Moving Consumer Goods, Biopharms, and Vaccines. Ryan holds a degree in Industrial Engineering from Drexel University and is a member of CellandGene.com’s editorial Board.

Tina Larson

Tina M. Larson is Chief Operating Officer at Recursion Pharmaceuticals.  Recursion is re-imagining drug discovery using automation and artificial intelligence.  Before joining Recursion she was Senior Vice President of Technical Operations at Achaogen, where she built Achaogen’s Technical Operations organization in support of late stage development and commercial launch of the company’s first product.  Prior to Achaogen, she spent 20 years at Genentech and Roche, holding leadership positions in Technical Development, Manufacturing and Engineering.  Ms. Larson worked on every commercial biopharmaceutical product launched from Genentech, and many clinical programs as well. In 2012, she was selected by the Genentech Executive Committee to be nationally recognized as their Healthcare Businesswomen’s Association Rising Star.  Ms. Larson has a Bachelor of Science in Chemical Engineering from Colorado State University and currently serves on the Dean’s Advisory Board for the Walter Scott, Jr. College of Engineering.

Ran Zheng

Ran Zheng is Chief Technical Officer at Orchard Therapeutics, overseeing multiple functions within technical operations including process development, manufacturing, quality, facilities and engineering, supply chain, and CMC program management. Ran has over 20 years of experience in biopharmaceutical industry. Prior to Orchard, Ran held various leadership positions in process development, manufacturing, quality and supply chain at Amgen, Genzyme and Diosynth.

Kim K. Burson, PhD

Kim K. Burson, Ph.D. is the Head of Quality Assurance and Quality Control at Denali Therapeutics which is dedicated to defeating neurodegenerative diseases. She has over 20 years of quality experience in diversified product platforms including small molecules, biologics, peptides, enzymes, and medical devices.

Kim’s global background includes both clinical and commercial quality product oversight at large, small and virtual companies.  Prior to Denali, she has held management positions at Achaogen, Genentech, Roche in Switzerland, Millennium Pharmaceuticals and two medical device companies.  Her areas of expertise include Quality Assurance, Quality Control, global inspection management, internal and external auditing, the Pharmaceutical Quality System, Contract Manufacturing Organization (CMO) oversight, and analytical method development and validation.

Kim received her Ph.D. in Chemistry from Stanford University.

Kathrin Jinivizian

As Head of External Manufacturing & CMC Strategic Operations, Kathrin Jinivizian is responsible for successful execution of CMO activities, including manufacturing & filling of clinical trial material. In addition, in her role as Head of CMC Strategic Operations, Kathrin facilitates the development and operationalization of the long range manufacturing strategy as well as the overall CMC governance & reporting.

Prior to joining Moderna in February 2018, Kathrin worked for 14 years at Novartis in various Manufacturing & Quality roles in Germany, Switzerland, and the United States. Upon completion of the Novartis  Accelerated Quality Management Program, Kathrin assumed the roles of the Director of MS&T and later Manufacturing for CAR-T (Kymriah™) in Morris Plains, NJ. Later, Kathrin transitioned to Executive Directors of Operations, overseeing a team of ~140 employees for manufacturing of generic semi-solids.

Kathrin holds a Bachelor of Science for molecular Biology from Johannes Gutenberg University of Mainz, Germany.

Manny Otero

Dr. Otero has 15 years of experience in the biopharmaceutical industry, including in bioprocess development, manufacturing, CMC of vaccines and complex biologics. Prior to Turnstone, he was vice president of bioprocess development and manufacturing at Seres Therapeutics, Inc., where he was the corporate team leader for the first synthetic microbiome therapeutic to enter Phase I clinical studies in the United States. Prior to Seres Therapeutics, Dr. Otero was director of engineering at Merck & Co.’s manufacturing division. In that role, he supported development programs for the Varivax™, Zostavax™, ProQuad™ and MMRII™ franchises. Dr. Otero has authored more than 20 peer-reviewed publications. He received a Ph.D. in chemical and biological engineering from Chalmers University of Technology in Gothenburg, Sweden, and an M.Eng. in biomedical engineering and B.S. in chemical engineering from the Massachusetts Institute of Technology.

Abhinav Shukla

Abhinav A. Shukla is Vice President and Head for Manufacturing at CRISPR Therapeutics. Most recently, Abhinav was Vice President and Head for Biologics Process Development at Shire leading a multi-site team responsible for process development for all biologics ranging from early-stage to commercial launch. Prior to Shire, Abhinav was Senior Vice President for Process Development & Manufacturing at KBI Biopharma, a rapidly growing CDMO organization. At KBI, Abhinav grew the Process Development and Manufacturing teams practically from inception and established an ecosystem for execution of multiple early stage through commercial launch for a range of clients. Prior to KBI, Abhinav created and led the MS&T team at Bristol-Myers Squibb where his contributions included the successful commercialization of Yervoy®, Nulojix® and Orencia®. He also made numerous technical contributions at Amgen including the creation of an organization wide platform for mAbs and Fc fusion proteins. Abhinav is a known industry expert in biopharmaceutical development and manufacturing with over 20 years of experience in the field, a track record of establishing new paradigms in industry and over 40 publications in this area. He serves on the editorial boards of several journals including Biotechnology and Applied Biochemistry and Bioprocess International. He has a Ph.D. in Chemical and Biochemical Engineering from Rensselaer and Undergraduate and Masters degrees in Biochemical Engineering from the Indian Institute of Technology, Delhi.

Wen Bo Wang

Dr. Wen Bo Wang is Senior Vice President, Technical Operations at Fate Therapeutics, overseeing the company’s manufacturing strategies for its pipeline of off-the-shelf cell-based cancer immunotherapy candidates and scaling the Company’s induced pluripotent stem cell iPSC platform to support late-stage clinical and commercial operations. She was formerly Senior Vice President Cell Therapy R&D at Fujifilm Cellular Dynamics Inc (FCDI), where she was responsible for developing the cell therapy R&D strategy and the iPSC based pipeline products and led the next generation production technology development efforts. Previously, she was VP Process Sciences, and directed scale up and scale out platform process development for iPSC based iCell products and MyCell products including automation and bioreactor work. Prior to joining FCDI in 2008, Dr. Wang was Group Leader, Process Sciences, at Geron Corporation, Menlo Park, CA working with embryonic stem cell derived cell therapies and dendritic cell cancer vaccine. From 2001 to 2005, Dr Wang held a number of positions at ViaCell, Boston, MA including Associate Scientific Director, ViaCord Human Umbilical Cord Blood Bank (a subdivision of ViaCell). Dr. Wang serves on the board of directors for Standards Coordinating Body and as US expert at the US Technical Advisory Group (US TAG) for ISO TC/276 Biotechnology. Dr. Wang earned a B.S. in Biology from Ocean University of Qingdao, P.R. China and received her Ph.D. in Biology from Newcastle University, United Kingdom. She conducted post-doctoral training in Cryobiology at Biosciences Research Laboratory, USDA/Agricultural Research Service, Fargo, N.D.

Tina Self

Tina Self is Vice President of Quality at Bayer, Berkeley, California. She is the proud leader of a fantastic team focused on ensuring product quality and patient safety of recombinant human factor VIII products which serve the hemophilic community.  Prior to this role, Tina was Sr. Director, Quality at Sanofi Genzyme where she led the Quality organization overseeing enzyme replacement therapies for rare disease patients.  Tina has over 20 years of experience with diverse product platforms including small molecule, autologous drug therapy, enzyme replacement, tMABs and recombinant proteins in both clinical and commercial environments.  She holds a Bachelor of Science in Biology from Georgia Southwestern State University, a Master in Business Administration from Florida Atlantic University and a Master in Biotechnology from Johns Hopkins University.  In her spare time she enjoys spending time with her family and playing Scrabble.

Murali Bilikallahalli

Murali, currently at Acceleron Pharma overseeing the Technical Operations division that develops, manufactures and supplies finished products to clinical and commercial. Murali is an accomplished Senior Executive with more than 20 years of success across the higher education, pharmaceutical, and biotechnology industries. Leveraging extensive experience in biologics & vaccines development, manufacturing operations and acquisition/merger deals. He serves on the editorial boards of reputed journals Drug Discovery Today and mAbs. He served on the advisory boards of USP and various international conference

His broad areas of expertise include all aspects of Biologics Discovery, Development and Commercialization; Operational excellence, competitive landscape, portfolio prioritization, and logistics of business acquisitions and mergers. He and his team successfully developed, manufactured, and launched six commercial protein & vaccine products (Flumist®, Elelyso®, Xiapex®, Trumenba®, Imfinzi®, and Crysvita®).

Throughout his executive career, Murali has held leadership positions with Acceleron Pharma, Ultragenyx Pharmaceutical Inc., AstraZeneca Biologics, Pfizer Biotherapeutics and Univ of Texas Medical Branch.

Mihaela Simianu

Dr. Simianu is Head of Sterile Liquids Commercialization within Global Vaccines and Biologics Commercialization member of Merck Manufacturing Division. She leads biologics, vaccines and sterile pharmaceuticals product development and commercialization and supports in-line sterile product life cycle management.

Prior to this role she was Director of Regulatory Compliance at with Pharmatech Associates consulting group and Executive Director in Process Development with Amgen where she was accountable for advancing company’s portfolio of innovative drug products and management of organization’s assets.

Dr. Simianu was for 17 years with Eli Lilly and Company in technical and leadership roles with increasing responsibility as part of Lilly Research Laboratory and Manufacturing Science and Technology organization.

Dr. Simianu holds a Doctorate Degree in Chemistry from Marquette University, Milwaukee, WI.  She was a Postdoctoral Fellow in Biochemistry at Center for Biotechnology and Genetic Materials, Lincoln, NE. She has a MS/BS degree in Chemical Engineering and Pharmaceutical Technology from University of Cluj-Napoca (Romania).

Nick Timmins

Nick is an experienced Cell and Gene Therapy Executive, innovator, and people leader. He has over 15 years’ experience developing an assortment cell and gene based therapies and associated technologies, including leadership roles at BlueRock Therapeutics, the Center for Commercialization of Regenerative Medicine (CCRM), and the Center for Advanced Therapeutic Cell Technologies. Nicks global experience includes time living and working in Canada, Switzerland, Australia, and New Zealand, engaging with a diverse assortment of partners, clients, and colleagues from industry and academia.

Jim Green

Jim Green is the Single Use Technology (SUT) platform lead in the Bayer Biotechnology division. In this role, Jim leads an engineering team that is responsible for defining, deploying and supporting Bayer SUT process equipment. Jim’s current areas of focus are investments in clinical manufacturing facilities in Europe and the United States as well as the recently announced Cell Culture Technology Center being constructed in Berkeley, CA. Prior to this role, Jim held project management and engineering leadership roles in commercial launch projects for Bayer Hemophilia A products Kovaltry^® and Jivi^®.

Jim holds a PhD in Chemical Engineering from Northeastern University and a BS in Chemical Engineering from the University of Connecticut.

Dave DiGiusto

David is the Chief Technical Officer for Semma Therapeutics. He has over 28 years of experience in the scientific, clinical and regulatory aspects of cells as therapeutic agents including the isolation, characterization and genetic modification of hematopoietic stem cells and T-cells for clinical applications. He has been instrumental in the creation of six GMP compliant biologics manufacturing facilities and associated quality systems, production and QC testing programs. Under his direction, plasmid DNA, CAR-T-cells, regulatory T-cells, engineered stem cell grafts and gene modified hematopoietic stem cell products have been manufactured and released for use in Phase I/II clinical trials. David is a major contributor to first in human studies for Cancer and HIV Gene Therapy and has developed methods for assessing ex-vivo stem cell manipulations using in vitro and in vivo models. David is a member of the NIH recombinant DNA advisory committee (RAC).

Rob Piperno

Rob Piperno is the Director of CGT Quality Assurance in the Global Pharma QA organization.  In this role he is responsible for providing the global quality oversight and management of internal and external activities supporting clinical and commercial Cell and Gene Therapy Products, including the approval of STRIMVELIS™ by EMA.  Rob joined GSK in 2009 as part of the Corporate Audit and Assurance function and transitioned to R&D QA in 2012, and to CGT QA in 2014.  He has over 20 years of experience in the pharmaceutical industry and prior to GSK he was employed at Johnson & Johnson for 9 years holding positions including, site quality operations and leading a corporate team supporting the management of external partners and CMOs.  Rob has a Bachelor’s and Master’s degree in Biology from Rutgers University and an MBA in Pharmaceutical Management from St. Joseph’s University.

Prentice Curry

Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. He has expertise in the management of quality assurance and quality control laboratories, corporate quality functions, validation, construction, and manufacturing along with international assignments in Europe and Asia. He has spent the last five years at Kite Pharma building out the technical operations functions in manufacturing, supply chain, and quality.

Jian Irish

Jian Irish has held various leadership roles over 25 years in the biopharma industry with the responsibilities for product development, launch, supply, and lifecycle management. Jian has served executive leadership roles in launching the cell therapy at Kite Pharma as the Senior Vice President of Supply Chain and Global Head of Manufacturing. Prior to Kite Pharma, she held Vice President Responsibility for Biologics Supply, Sourcing, Partnerships and Biologics Product Development at Sanofi. Jian also served executive leadership roles at Amgen in the JAPAC regional operations, Supply Chain, Manufacturing, and oncology CMC development.

Jian Irish earned her BS in Chemical Engineering from East China University of Science and Technology in China, MS and Ph.D. in Pharmaceutical Sciences from Chiba University in Japan, and MBA from the Anderson School of Management at University of California, Los Angeles.

José Eduardo Vidal

Dr. José Eduardo Vidal joined Atara Biotherapeutics in August 2018 and as SVP, Quality Assurance and Process Sciences. Prior to Atara, Dr. Vidal served as Vice President, Drug Substance Operations at Amgen where he oversaw 1,200 employees and managed a $500 million budget across their global drug substance manufacturing network. Previously at Amgen he was Executive Director, Process Development, where he collaborated closely with manufacturing and quality to accelerate the delivery of a product portfolio comprised of over ten Phase 3 products.

José also held several senior roles at Pfizer, where he was responsible for leading Quality Operations across multiple sterile manufacturing plants, as well as at Wyeth and Biovail in local and global technology, manufacturing and quality operations.

José received his bachelor’s degree in molecular biology, master’s degree in molecular endocrinology and biochemistry and his doctorate in biochemistry and cellular molecular biology all from the University of Puerto Rico, Rio Piedras.

Karin Shanahan

Karin is SVP, Global Biologics and Sterile Operations at Merck Pharmaceutical where she holds operational responsibility for manufacturing Keytruda and Gardasil in addition to other in-line and pipeline products. She has over 22 years experience in the pharmaceutical industry, beginning her career in pharma with Bristol-Myers Squibb in their global supply chain organization. Since leaving BMS, she has held global operations roles in Becton Dickenson, Catalent Pharmaceuticals and Teva Pharmaceutical. During her career, Karin has led global operations with as many as 24 sites and 7,000+ employees across Canada, US and Europe. Through 22+ years, she has gained experience in many technologies, from radiopharmaceuticals to oral solid dose, but always finds her way back to biologics and sterile operations. Prior to joining the pharma industry, she held supply chain roles at Daimler Benz and the U.S. military in her home town of Berlin, Germany. She holds a BA in Political Science & International Relations from Rutgers University and currently resides in New Jersey with her family.

Denise Steckel

Denise Steckel has over 20 years of experience at Genentech in Operations Support, Quality and External Collaborations.   Currently Denise is the Head of the Clinical Collaborations Management group.  In this role Denise and her team ensure alignment of all CMC deliverables, including product supply, for Investigational Medicinal Products (IMP) and/or commercial material supply alignment with the QA strategy, Clinical Development plans, and the associated Clinical Collaboration Agreements.

Denise has a BA in Business from St. Mary’s College and an MBA from Arizona State.

Carin Huibers

Since Jan 2016 Carin is responsible for the pharma sites producing the LM Products.

Between October 2014 and December 2015 Carin led the Supply chain/Tiger team to produce the Ebola Vaccines. Tiger Team was a cross functional team to produce these regimens for emergency use. She built the supply chain for long-term supply and also built the supply network in Sierra Leone. This included contracting a transport company, supported renting a vaccination clinic and built a storage location in Sierra Leone.

Carin Huibers was General Manager for Janssen Biologics from June 2011 until October 2014, leading one of the largest manufacturing facilities for J&J and manufacturer of a range of biotechnological products. She provides strategic direction to the operation activities, engineering, maintenance, EHS and warehousing, and develops and sustains a highly compliant GMP organization.

Carin joined Johnson & Johnson in 1997, as Director Quality Assurance and Qualified Person for API and final products for all Biologics and became Senior Director Biotech Operations of the Leiden API manufacturing site in 2006. In 2011 she was appointed as General Manager and Board Member.

Prior to joining J&J, she built up extensive experience in Quality Assurance and Clinical Manufacturing serving for Organon International in the Netherlands, an innovative pharmaceutical company producing parenterals, tablets, liquids and creams.

Carin holds a Pharm. D from the Leiden University, the Netherlands

Christina Yi

With more than 20 years of industry experience, Christina has a proven track record of success across various aspects of pharmaceutical operations. Leveraging modern operational approaches and data to deliver consistent, high-impact results, she has successfully brought innovative products to market through strategic planning, efficient process design and regulatory compliance. At Dendreon, Christina is responsible for manufacturing, quality, sourcing and procurement, technical operations, apheresis operations and project management.

John Higgins

John Higgins is a Director who serves as Product Champion in Global Technical Operations at AstraZeneca, and is the CMC lead for IMFINZI^® and Trastuzumab Deruxtecan, which is partnered with Daiichi Sankyo.

John has a passion for excellence in CMC and biologics manufacturing and has committed 18 years in development and manufacturing across vaccines, monoclonal antibodies, recombinants, antibody drug conjugates and small molecule adjuvants. John’s experience stretches across the full lifecycle of products and has various contributions to several products now marketed including Synagis^®, IMFINZI^®, Fasenra^®, Lumoxiti^®, Blincyto^®, Stelara^®, and Simponi^®.

John has significant accomplishments in scale up, tech transfer, process engineering, facility start up, process validation and commercial support over his career at several major pharma companies including Wyeth (now Pfizer), Johnson & Johnson and MedImmune/AstraZeneca. In addition, John has been an active leader in the scientific and professional community in various positions at AAPS, ACS and PDA.

Stacey Ma

Stacey is currently the Executive Vice President of Technical Operations at Sana Biotechnology. In this role, she is a member of the Sana Executive Team, and oversees process, pharmaceutical and analytical development, supply chain, quality, CMC regulatory, CMC portfolio and global manufacturing operations.

Prior to joining Sana in March 2019, Stacey was the Global Head of Innovation, Manufacturing Science and Technology in Genentech/Roche’s Pharma Technical Operations, responsible for driving technology and innovation in the manufacturing and testing network for all pharma products. Over her 23-year career there, she has had various leadership roles within Genentech/Roche, in both South San Francisco and Basel locations, in diverse areas such as analytical development, pharmaceutical development, quality, technical product management and supply chain.

Stacey is an internationally recognized expert in analytical sciences for biopharmaceuticals. She is a fellow of AIMBE and has co-chaired many international scientific conferences and workshops related to CMC development strategies, including several co-sponsored by FDA, EMA, and Chinese FDA. Stacey has a BS in Chemical Engineering from University of Minnesota, and a Ph.D. in Chemical Engineering from Yale University.

Lisa Wyman

Lisa Wyman is Vice President of Technical Operations, overseeing manufacturing, quality, supply chain, process development, and engineering.

She joined Acceleron in January 2019 from Shire, where she held global roles with increasing responsibility leading more than 30 pipeline development programs from preclinical to launch and lifecycle management of more than 40 commercial assets. Prior to her work at Shire, she held positions in manufacturing, engineering and quality at Boston Scientific, Wyeth, and Lonza.

Lisa is an accomplished leader with a strong history of transforming programs, improving regulatory compliance, and driving exponential growth. Recognized as an expert in the industry, she has been honored with an Engineering Leader award by Plant Engineering, Mentor of the Year Award for Advancement of Women in Compliance, and was a Boston Business Journal Top 40 Under 40 award recipient.

Lisa received a BS in Biology from Ithaca College and an MS in Engineering Management from Tufts University.

Merrick Endejann

Mr. Merrick Endejann has 17 years of biotechnology and pharmaceutical experience and holds a BS in Industrial Engineering from the University of Cincinnati. Mr. Endejann’s role at Cellectis Biologics is to spearhead the Validation program; he is accountable for the qualification and validation of all systems and processes that are being introduced to the new facility. Previously he led Catalent Pharma Solutions’ Validation and Operations Technology departments and led the site’s Data Integrity efforts, including strategy development. His efforts included the completion of CQV activities to support facility renovation and commercial product introduction to support a combination product. Additionally, Merrick established the CQV program for Argos Therapeutics, which supported clinical trial manufacturing processes for their autologous immunotherapy products. Mr. Endejann currently resides in Chapel Hill, North Carolina, with his wife, Melissa, and their sons, Merrick and Maelen.

Philip Lee

Dr. Lee is an entrepreneur and technology platform builder specializing in cellular systems. He has over a decade of life science leadership experience spanning product development, technical operations, marketing management, and innovation. He was the co-founder and CEO of CellASIC, which was acquired by Merck KGaA, and served as the former Head of Cell Culture Systems at Merck KGaA. He received his PhD in Bioengineering from UC Berkeley/UCSF and B.S. degrees in Chemical Engineering and Biology from the Massachusetts Institute of Technology.

Tanya Warnecke

Tanya is the CTO and COO at ArtisanBio and has a unique combination of experiences including technical, operational, and business leadership. Ventures include cell engineering startups with a variety of applications (cell therapies, biofuels, and biochemicals) and life sciences tools including instrumentation, reagent development, and software engineering. Prior to Artisan, Tanya was the co-Founder, CTO, and VP of Applications at INSCRIPTA and Director of Technology at OPXbio.

Raja Srinivas

Raja Srinivas is co-founder of Asimov, a mammalian that creates products for advanced cellular design. Asimov programs living cells with integrated genetic engineering, computer-aided design, and artificial intelligence. Asimov is currently pursuing applications across the CGT stack, from manufacturing to advanced gene payload design. Raja is responsible for the company’s corporate strategy and business development. Prior to Asimov, Raja got his PhD at MIT in the department of Biological Engineering where he focused on computational engineering of proteins and drugs using all-atom simulations. Raja got his bachelors in Biomedical Engineering and Applied Mathematics from the Johns Hopkins University

Antonio Ubiera

Antonio’s 15-year career in R&D has focused on the development and optimization of processes for clinical and commercial manufacture of biotherapeutics. He is currently Senior Director of Process Development, within the Biopharmaceutical Product Development & Supply organization at GSK R&D (King of Prussia, PA). In this role, he leads a department of scientists and engineers in development, scale-up, and transfer of manufacturing processes for both early- and late-stage programs. Antonio’s leadership experiences include roles in GMP Manufacturing and Operations, where he most recently led the Process Technology department within GSK’s clinical pilot plant, delivering on new technology introduction, process transfer, scale-up, facility scheduling, and GMP-supporting activities for the manufacture of a wide range of monoclonal antibodies and other therapeutic proteins. Alongside development and operations responsibilities, he has also held cross-functional matrix team leadership roles, responsible for end-to-end CMC activities for biopharmaceutical supply-chain delivery. Antonio received a B.S. degree in Chemical Engineering from North Carolina State University, and M.S. and Ph.D. degrees in Chemical Engineering from the University of Virginia.

Nick Keener

Nick has 15 years of experience in technical and leadership positions in the biotechnology industry. What drives him is the opportunities to apply his talent, experience and leadership skills to the endeavor of bringing life-changing medicines to patients. Nick has led multiple functional areas at multiple sites within Process Development at Amgen and more specifically within multiple disciplines in drug substance development and manufacturing support. This broad leadership experience has given Nick a fundamental understanding of the spectrum of complex, interdependent activities required to bring life-changing medicines to patients. As a leader Nick values and promotes teamwork, collaboration, communication, innovation, transparency, strategic thinking, strategy execution, and disciplined adherence to scientific and business fundamentals.

Therese Choquette

Therese Choquette is the Analytical Project Leader for tisagenlecleucel in Novartis Cell and Gene Therapy Development and Manufacturing working with CART cells. She received her M.S. in Medical Science in Biomedicine and holds a Ph.D. in Rheumatology from the Karolinska Institute in Stockholm, Sweden. With an interest in immunology and immune responses she did her postdoc investigating effects of hyperglycemia on host defense in tuberculosis in the lab of Dr. Kornfeld at University of Massachusetts Medical School in Worcester, MA. Prior to joining Novartis in 2014 she was leading one of the R&D Applied Research teams at Organogenesis Inc. in Canton, MA.

Joe Maguire

Joseph Maguire Senior Director, IT at Atara Biotherapeutics. Joe started this role in 2016, prior to Atara he worked in various roles in manufacturing, engineering and IT with Bristol Myers-Squibb and Shire (now Takeda).

Chris Stevens

Chris Stevens joined Spark Therapeutics as Head of Manufacturing in February 2017 where he leads the internal/external Drug Substance and Drug Product Manufacturing, Manufacturing Sciences and Technology and Materials Management organizations. He joined Spark from GlaxoSmithKline (GSK) where he was Sr. Director – Strategy, Ops and Planning for the Biopharma and Cell/Gene Therapy R&D units. Prior to this, Chris was responsible for the GMP clinical manufacturing operations at GSK including manufacturing, supply chain, process transfer and cell banking. Before GSK, he held roles of increasing responsibility at Bristol-Myers Squibb (BMS) in Manufacturing and Supply Chain at the BMS facility in Devens, MA. While at BMS, Chris also led efforts in operations management and the implementation of advanced Manufacturing Execution Systems (MES) and process modeling technologies at sites in Indiana and Puerto Rico. Chris received his M.S. in Industrial Management from the University of Southern Indiana and a B.S. in Chemical Engineering from Purdue University.

Snehal Patel

Snehal has been at Juno Therapeutics a Company of Celgene since 2018. Snehal is the Site Head for Juno’s Cell Therapy Manufacturing Plant in Bothell, Washington. Prior to joining Juno, Snehal spent 18 years at Genentech/Roche in roles of Internal and External Manufacturing, and Quality.

Sanat Chattopadhyay

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada.

Sanat oversees a network of 50 pharmaceuticals, vaccines, biologics/therapeutic proteins and animal health manufacturing, commercialization and distribution sites with approximately 20,000 staff in over 20 countries around the world producing annually 17.5 billion tablets, 700M injectables, 1 billion packs, and 90 billion animal health vaccines doses in 22,000 product finishes. He also serves on Merck’s Executive Committee.

In his current role, he has successfully launched a new strategy for the manufacturing and supply organization, restructured the organization into four independent, interconnected business units, and further integrated supply planning and operations across the company.

He has a 30-year track record of success in commercialization, manufacturing and supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals for Hoechst, Aventis, Wyeth and Merck.

Before joining Merck in November 2009, Sanat worked for Wyeth Pharmaceuticals as Senior Vice President, New Products & Process Development. A graduate Chemical Engineer and a post-graduate Industrial Engineer from India, Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments in 5 countries across 3 continents, rising to the level of Senior Vice President, Product Development & Supply at Aventis where he led global supply chain, including new product commercialization, technology and engineering.

Outside Merck, Sanat serves on the Board of Directors of Hilleman Laboratories, an equal joint-venture partnership formed between Merck and the Wellcome Trust, a global charitable foundation dedicated to human and animal health.  He is also a member of the Advisory Board of the USA-India Chamber of Commerce.

Wolfram Carius

Prof. Wolfram Carius is the Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices) at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for two years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Anders Vinther

Anders is VP Global Quality & Engagement at Intarcia Therapeutics, Inc.

Prior to that he was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

At Roche and Genentech he held various senior leadership positions including VP Biologics Quality and VP Global Quality System and Processes

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 25+ years of business and biopharmaceutical experience and is a thought leader in quality leadership.

Alison Moore

Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development, Operations and R&D organizations (Amgen). Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Greg Guyer

Dr. C. Greg Guyer is the Global Head of Operations at BMS. Prior to this he was SVP, Biologics Development & Operations and responsible for overseeing biologics development and operations sites. Greg joined the company in November of 2015. Previously Dr. Guyer spent 21 years in various leadership roles in Merck. His last role was Sr. Vice President, Biologics/Therapeutic Proteins & Sterile Line of Business at Merck. He was responsible for overseeing manufacturing operations for Biologics, Therapeutic Proteins and Sterile Manufacturing Sites. Greg joined the Company in 1994 as Senior Director, Worldwide Regulatory CMC, Merck Research Laboratories. He then held positions of increasing responsibility within the Merck Manufacturing Division (MMD), specifically in the Quality Operations area, Global Quality Assurance and Asia Pacific Operations, until 2005 when he took on the unique role of leading the COMET (Global SAP) Program, a strategic initiative of Merck’s “Plan-to-Win”. He then served as VP, Emerging Markets for MMD leading the development of the Emerging Markets Strategy with his counterparts in Global Human Health and Merck Research Laboratories. Prior to his current role, he was Sr. Vice President, Global Quality overseeing all Quality Operations, Quality Assurance & Research and Commercialization Quality for all lines of our business. Greg is a graduate of the University of Georgia, with advanced degrees from The American University in Washington, DC and Lehigh University. Prior to joining Merck, Greg served in varied capacities over ten years, at the FDA in the Center for Drug Evaluation & Research and also in the Center for Veterinary Medicine.

Joanne Beck

Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations, Engineering and Quality.  Prior to Celgene, she was SVP of Pharmaceutical Development at Shire.  Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions.  Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.

Loren Wagner

Loren recently joined Celgene as the Head of CAR T Manufacturing Operations.  In this role, Loren is responsible for the commercialization of Celgene’s CAR T assets, including the startup of their new commercial manufacturing facility in Summit, NJ.  Prior to Celgene, Loren was the Associate VP of Manufacturing Sciences at Allergan, where he was responsible for clinical manufacturing and quality assurance globally since 2006.

Derek Adams

Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial process development function and supply chain for clinical studies and drove strategy for product development. Prior to his time at Evelo, he served as Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, where his responsibilities included developing and supporting all manufacturing processes globally as well as global clinical supply chain.  His Alexion career also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing facility and head of upstream process development.  Derek began his career in process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

Andy Ramelmeier

Dr. R. Andrew “Andy” Ramelmeier is Senior Vice President, Chief Manufacturing and Quality Officer, at Sangamo Therapeutics, a leading gene therapy/editing company.   Andy has 25 years experience in the Biopharmaceutical industry, developing and transferring biological processes, designing and building manufacturing facilities, and directing contract manufacturers as well as internal manufacturing operations.  In a prior role at Portola Pharmaceuticals, Inc., Andy was SVP, Technical Operations, where he was responsible for tech transfer, manufacturing (bulk and drug product), technical support, and supply chain of Portola’s pipeline products. Prior to Portola, Andy was Vice President, Manufacturing, Process Sciences and Facilities at BioMarin Pharmaceuticals, overseeing multiple commercial biologics products, a clinical pipeline, and facilities in Novato, CA, and Shanbally, Ireland.  Before joining BioMarin, he was Vice President, Process Sciences, J&J Global Biologics Supply Chain, and held roles of increasing responsibility in Centocor R&D (J&J) and BioProcess R&D at Merck & Co.  Prior to his employment, he conducted post-doctoral work in Germany and received his Ph.D. in Chemical Engineering at University of California, Berkeley, and a B.S. in Chemical Engineering from Johns Hopkins.

Diane Blumenthal

Diane I Blumenthal is currently Head of Technical Operations at Spark Therapeutics. Her responsibilities include: Manufacturing, Quality Control, cGMP and Scientific Facilities, Supply Chain and Network Strategy.  She responsible for leading the CMC efforts that led to the first US approval of a gene therapy product which included the approval of the first US manufacturing facility to produce a gene therapy product.   Diane has more than 30 years of experience in the use of recombinant DNA technology for the expression and manufacture of biotechnology products. Throughout her career, Diane has played a key role in the development and commercialization of multiple pharmaceutical products, including Erbitux® and Cyramza® and now Luxturna®.   Prior to joining Spark Therapeutics, she served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, following the acquisition of ImClone Systems.  While in this role, Diane was responsible for leading a multi-disciplinary team of scientists, statisticians and engineers tasked with providing technical support to manufacturing, development, quality control, quality assurance and regulatory teams.  During her time at ImClone Systems, Diane and her team were responsible for the implementation of novel methodologies used for the demonstration process and product comparability.  Diane has extensive experience in the transfer and scale-up of processes from the laboratory bench to commercial scale manufacturing with expertise in both microbial and mammalian cell culture expression systems and the corresponding downstream purification processes.  Prior to her time at Lilly, Diane served as a scientific and manufacturing consultant to multiple start-up biotechnology companies and held scientific leadership positions at Zymquest, Inc., Scios, Inc. (formally California Biotechnology) and the Eastman Kodak Company.  She received her M.S.E. in Chemical Engineering from Lehigh University and a B.S.E. in Bioengineering at the University of Pennsylvania.

Jayant Aphale

Dr. Jayant Aphale serves as executive vice president of technical operations at Gritstone Oncology overseeing process development, analytical development, clinical manufacturing and supply chain operations for their immuno-oncology portfolio with a focus on quality and operational efficiencies.  Dr. Aphale brings more than 25 years of manufacturing and technical operations experience within the vaccines, biologics and oligonucleotide space.  In addition to developing long term manufacturing strategies and leading CMC related interactions with regulatory agencies, Dr. Aphale has extensive experience in project & portfolio management, in selecting and managing global third-party manufacturing partners, as well experiences in facility design, start up and registration.  Most recently, he was Vice President of Technical Operations at Sarepta Therapeutics, leading the technical operations team for internal process development, drug manufacturing and global supply chain activities across its drug candidate portfolio. He participated directly in launching Sarepta’s first commercial product, ExonDys51, an antisense oligonucleotide, by developing and scaling manufacturing processes from Phase 1 through launch and commercialization. Dr. Aphale’s previous experience includes senior manufacturing and technical operations roles at GSK Vaccines, Enobia Pharma, Acambis Vaccines, Wyeth Vaccines, Diosynth and Roche Diagnostics. Dr. Aphale received his Ph.D. in microbiology from Ohio State University and an MBA in finance and strategy from The University of North Carolina.

Bob Miller

Bob Miller, Ph.D. is the Senior Vice President, Quality Assurance in PDM and has more than 25 years of experience in the Pharmaceutical and Biotechnology industry. Prior to joining Gilead Sciences he was President of his own company Quality Compliance Management, LLC., VP Compliance at Johnson & Johnson, VP QA Consumer Sector at Johnson & Johnson, VP, Quality Assurance, VP Quality US and PR at Pfizer. Bob held various positions of increasing levels of responsibility within Warner Lambert, Bayer, and Lerderle Laboratories.

Dr. Miller received his Ph.D. in Pharmaceutical Chemistry from Rutgers University College of Pharmacy, New Brunswick, NJ and B.S. in Pharmacy, Rutgers University College of Pharmacy, New Brunswick, NJ.

Karen Walker

Karen Walker is Vice President of Global Quality for Seattle Genetics. She brings 30 years’ experience in the biotech industry, holding positions in development, validation, Regulatory Affairs and Quality. She has worked in a number of companies including Novartis, Amgen, Abgenix, Bayer, Bristol-Myers Squibb and several other small to mid-sized biotech companies. Most recently, she held the role of VP and Global Head of Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit.

Jerry Cacia

Jerry Cacia, Sr Vice President of Technical Development, Roche Pharma

Jerry is responsible for Roche’s Global Technical Development organization.  This scope includes responsibility for developing manufacturing processes and control systems for Roche’s development pipeline.  This pipeline consists of over 70 New Molecular entities and over 100 development projects in pre-clinical through licensure phases of development.   Jerry has been with Roche/Genentech for 30 years.  He has held a number of senior leadership positions in Technical Development, Manufacturing, MSAT, and Quality prior to becoming the head of Global Technical Development in 2018

Patrick Swann

Patrick Swann is Vice President of Quality Sciences and Technology (QS&T) at Amgen.  QS&T encompasses multiple Quality functions including oversight of commercial specifications, stability programs, comparability strategy, annual product review, data sciences, nonconformance investigations, inspection preparation and QC/QA for products manufactured at Amgen’s Thousand Oaks facility.  Previously, he held positions at Biogen including leadership of the Global Regulatory CMC group and the Analytical Development group.  Patrick also served for 15 years at the U.S. FDA including roles as the Deputy Director of the Division of Monoclonal Antibodies and deputy topic lead for FDA on the ICH Q11 Expert Working Group.  He has presented at numerous international conferences on topics including Quality by Design, process validation, and bioanalytical method development/validation.

Randy J. Maddux

Mr. Maddux leads the Quality, Process Development, Analytical Development and Formulation, Engineering and Facilities, and Supply Chain functions for the company. Prior to joining Aptevo Therapeutics in 2016, he spent 4 years as VP and Site Director at GSK, where he led the largest biopharmaceutical development and manufacturing site within the GSK manufacturing network. Prior to GSK, Mr. Maddux spent 9 years at Human Genome Sciences as VP Quality and Operations and 8 years at Biogen in positions of increasing responsibility within the Quality organization. During his 20+ years in biotech, he served in key roles supporting the licensure and launch of several successful products including Avonex, Tysabri, Benlysta, and Raxibacumab. Mr. Maddux is a past member of the Life Sciences Foundation Board at Montgomery College in Maryland.

Henrik Friese

Henrik is Corporate Vice President at Novo Nordisk A/S and has the responsibility for Quality intelligence and authority inspections at Novo Nordisk A/S. Henrik is member of the Novo Nordisk Quality leadership team and is Superior Qualified Person for Novo Nordisk.

Henrik has worked at Novo Nordisk for 23+ years. Prior to his current role, he has been heading up several production sites at Novo Nordisk. Henrik has been Quality Vice President for a Production Site in Denmark and for many years been heading up Manufacturing Development at Novo Nordisk which included responsibility for establishment of new production sites in Brazil and China and the introduction of new products in commercial production.

In his current role Henrik and his team is directly involved in all GMP inspections at Novo Nordisk and at the same time responsible for capturing and securing implementation of new GMP regulations and trends.

Henrik hold a Master of Pharmacy from the Royal Danish Pharmacy University.

Søren Thuesen Pedersen

Søren Is Chemical Engineer by education and has been working 25 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratory and CMC Manufacturing Development. He has been one of the founding fathers of the Novo Nordisk External Requirements’ Process; How does Novo Nordisk ensure compliance of new external requirements? Mr. Pedersen is responsible for the External Representation of Novo Nordisk out of the GMP area and represents Novo Nordisk in ISPE, EFPIA, IFPMA and BIO. He has furthermore been member of the Novo Nordisk Board of Directors for 12 years as elected employee representative. The spare time interests include Danish and EU Politics.

Uwe Buecheler

Uwe Buecheler, joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH) in 1991. During his time at Boehringer Ingelheim he held different positions in Biopharmaceuticals in Regulatory Affairs, Biological Safety and Quality. 2006 he was appointed site head for the Boehringer Ingelheim site in Biberach, Germany and thereafter 2010 got responsible for global Biopharmaceuticals Operations including sites in Germany, Austria, USA and China. In July 2016 he took over the responsibility for the new Biopharma Business Unit responsible for the growing BioXcellenceTM contract manufacturing business as well as supplies of Biopharmaceuticals to Boehinger Ingelheim Human Pharma.
Uwe Buecheler, has conducted his Ph.D. in Molecular Biology at the University of Heidelberg and the Cancer research Center in Heidelberg. Prior joining Boehringer Ingelheim he worked at Roche (former Boehringer Mannheim site in Penzberg). He has been awarded Professor h.c. at the University of Ulm and is member of various Advisory boards and (Bio-) Pharmaceutical Industry Associations

Steve Doares

Steve leads the Global Manufacturing Sciences team at Biogen, with accountability for technology transfer into GMP manufacturing of processes from clinical through commercialization stages for Biogen’s therapeutic product portfolio, both internally and externally.  His teams also provide scientific expertise for process troubleshooting and lifecycle improvements; process monitoring, advanced modeling, and PAT implementation; and technical and vendor management expertise for raw materials and SUS/disposables.  The Global Manufacturing Sciences team oversees both drug substance/API and drug product processes, for biologics and pharmaceuticals.  Steve has been at Biogen since 2010, and before that spent 15 years at Wyeth/Pfizer in glycoconjugate vaccine process development and technology transfer, clinical trials material drug substance production, and quality assurance supporting a vaccine drug substance plant.

Andrew Chang

Dr. Andrew Chang has more than twenty years of experience in the development, regulation and quality of biologics and pharmaceuticals. At his current capacity as a Vice President, Quality and Regulatory Compliance, Quality Intelligence and Inspection, Novo Nordisk A/S, he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspection preparation. Since 2013, Andrew has represented Novo Nordisk at several work groups in industry trade organizations, e.g., PhRMA, BIO to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the regulatory authorities. He is also a member of PhRMA and BIO’s ICH Work Groups, and representing PhRMA as an expert to ICH Q12 Expert Working Group for developing guideline on Pharmaceutical Products Lifecycle Management.

Prior to Novo Nordisk, Andrew served more than eleven years at US FDA, most recently as an Associate Director for Policy and Regulation, Acting Deputy Director and Senior Regulatory Scientist in the Division of Hematology, Center for Biologics Evaluation and Research (CBER). During his tenure, Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy development. These include, but are not limited to FDA Commissioner’s Special Citation for successfully completing FDA’s initiative on product quality regulation and CBER’s Public Health Achievement Award for outstanding regulatory review performance
that resulted in averting a crisis in product availability. In 2002, the FDA recognized Andrew as the FDA regulatory expert in the regulation of new and novel recombinant products as well as naturally‐derived biological products.

Andrew’s formal scientific training includes post‐doctor in immunology from the National Institutes of Health, Ph.D. in Biochemistry from the State University of New York, and B.S. in Pharmaceutical Chemistry from the China Pharmaceutical University. He has published numerus peer reviewed scientific papers in JAMA, J.Exp.Med., Blood, J.Immunol., Dev. Immunol. Thromb Haemost., Haemophilia, Pharmaceutical Engineering etc., and has been a frequent speaker at national and international conferences.

Scott Liu

Dr. Scott Liu is the Co-founder, President and CEO at Shanghai Henlius Biotech Inc., a global biopharmaceutical company focusing on the development, production and commercialization of high-quality and affordable biosimilar, biobetter and novel therapeutic monoclonal antibodies. Under his leadership, Henlius has become a leader of therapeutic monoclonal antibodies to treat a range of chronic and life-threatening diseases in China.Dr. Liu has more than 25 years of experience in biopharmaceutical R&D, manufacturing and quality management. Prior to joining Fosun Group in 2010, he has previously served several executive positions such as Vice President of R&D at United Biomedical, the Founding Director of the Biologics QC Department at Bristol-Myers Squibb (Syracuse, USA), and the Director of QAL (QC) at Amgen (Fremont, USA). Because of his extensive knowledge in quality and control of biologics, Dr. Liu had provided assistance to the CDE of CFDA in developing and implementing quality standards for biosimilars and novel biologics in China. Furthermore, Dr. Liu led the promotion of industry-wide adoption of single-use manufacturing technology to support the production of clinical and commercial monoclonal antibody therapeutics, and actively participated in the development of《Technical Guidelines of Biosimilar Development and Evaluation》to promote the innovation and globalization of the biopharmaceutical industry in China.Dr. Liu was the recipient of the the Bristol-Myers Squibb“Technical Operations Presidential Award”in 2004 and was recognized in 2013 as an expert of the “Thousand Talents Plan of Shanghai”. Dr. Liu received his Ph.D. degree in Biology from the Purdue University with postdoctoral training in Biology at Stanford University and studied business administration (iMBA courses) at the Syracuse University.

Bradley Glover

Brad Glover is the Vice President and Head of the Strategy and Business Operations group within Technical Operations.  He leads a team that drives strategic planning, portfolio management, efficiency and productivity, CMC program management, alliance management and Kite facilities and engineering.

Dr. Glover has been with Kite for over 2 years and joined the company from Genentech / Roche where he held several senior leadership roles in Alliance Management, Strategy, Finance, and was the head of the business and supply chain operation at the Oceanside biologics facility.  Dr. Glover held positions based both in the US and at the Roche Headquarters in Basel Switzerland.  Prior to joining Genentech, Dr. Glover worked in a number of professional roles with increasing responsibility at Biosite, Amgen Ventures and Illumina in business development, venture capital and marketing analytics.

Dr. Glover holds a BS degree in biochemistry from the University of California San Diego, a PhD from the University of Colorado in biochemistry and molecular genetics and an MBA from the Rady School of Management at UCSD.  He was also a Jane Coffin Childs Medical Research Fellow in the laboratory of Robert Tjian at the University of California Berkeley.

Jill A. Myers

Before joining TG Therapeutics, Dr. Jill Myers was the VP of Biologics CMC at Fortress Biotech where she led a team responsible for product development, technology transfer and management of CMC activities for various Fortress Biotech and affiliated companies.  She has more than 30 years’ experience in the biotechnology industry.  Before Fortress, she was  a consultant assisting clients in a variety of areas of biologics process development, strategic planning, CMO management, manufacturing, and various CMC activities.  Myers  has also held positions of increasing responsibility at Abbott Laboratories, Repligen, Biogen (where she led the Process Biochemistry group), Applied Molecular Evolution (where she built the Process Sciences and Manufacturing Group, prior to an acquisition by Eli Lilly) and Momenta Pharmaceuticals.  Myers received her Ph.D. in Biochemistry from UCLA and did a postdoctoral fellowship at Harvard Medical School. She is a member of the Board of the Recovery of Biological Products Conference Series, and has served on a variety of industry committees, including PDA and IBC Scientific Advisory Boards and an MIT Industrial Advisory Board.

Diana Hoganson

Diana Hoganson is currently a CMC Lead overseeing commercial programs in the Technical Services Product Stewardship group at Shire (Lexington, MA). As CMC Lead, Diana is responsible to develop and execute plans to achieve the business strategy, ensure technical and regulatory support to the product including post-marketing commitments, and define and implement lifecycle initiatives. While at Shire, she spent time in process development and commerical technical support, overseeing lab functions and leading both PD teams and development and commercial CMC teams. As upstream development scientist, she held positions at Eli Lilly, Biomedica, and Selective Genetics. Diana received her BA from the University of Minnesota-Morris in chemistry and her PhD from the University of South Carolina in pharmaceutical sciences. She completed a post-doctoral fellowship at the University of North Carolina, Chapel Hill.

Elsie DiBella

Elsie DiBella is an agile technical leader with 20 years of experience in biotechnology including process development, technology transfer, commercial manufacturing support, technical leadership of CMC teams, and CMC regulatory submissions for programs at all stages, early clinical through BLA/MAA licensure and post-approval changes.  She is currently the Vice President of Bioprocess and CMC Development at Momenta Pharmaceuticals.  She has previously held positions within Process Development and Manufacturing Sciences at Shire, Centocor, and Bristol Myers Squibb.  She holds a Ph.D. in Biophysical Chemistry from Cornell University.  She is an avid runner and cyclist, who enjoys competing against herself more than the field.

Jeff Davis

Jeff Davis is the Head of Operations and Engineering for Roche/Genentech’s US Biologics Process Development organization. In this capacity, he oversees Drug Substance and Drug Product pilot manufacturing operations and facilities, manufacturing technology development, business and resource planning, and Lean/continuous improvement. He has 18 years of experience in the Biopharmaceutical industry, spanning GMP Manufacturing, Supply Chain, Operations Strategy, Manufacturing Science and Technology, and Process Development. Prior to his current role, Jeff was Head of Manufacturing Science and Technology for Genentech’s South San Francisco Drug Substance manufacturing facility. He holds BS and MS degrees in Chemical Engineering from Stanford University.

Lisa Wyman

Lisa is a biotechnology and medical device industry executive with more than 18 years of diverse leadership roles in engineering, manufacturing, and quality. Lisa is the Executive Director of Quality at Mersana Therapeutics in Cambridge, Massachusetts where she is responsible for GLP, GCP, GMP compliance and quality assurance for the development and commercialization of novel antibody drug conjugates. Prior to her current role, Lisa was Senior Director of Quality Compliance and Risk Management at Shire and held positions in manufacturing, engineering and quality at Boston Scientific, Biogen, Wyeth and Lonza.

Lisa is an accomplished leader who has a strong history of transforming programs and teams, improving regulatory compliance, and driving exponential growth. She was selected as one of Boston Business Journal’s 40 under 40 and recognized by Plant Engineering as a 2016 Engineering Leader.

Chris Stevens

Chris Stevens joined Spark Therapeutics as Head of Manufacturing in February 2017 where he leads the internal/external Drug Substance and Drug Product Manufacturing, Manufacturing Sciences and Technology and Materials Management organizations.  He joined Spark from GlaxoSmithKline (GSK) where he was Sr. Director – Strategy, Ops and Planning for the Biopharm and Cell/Gene Therapy R&D units.  Prior to this, Chris was responsible for the GMP clinical manufacturing operations at GSK including manufacturing, supply chain, process transfer and cell banking.  Before GSK, he held roles of increasing responsibility at Bristol-Myers Squibb (BMS) in Manufacturing and Supply Chain at the BMS facility in Devens, MA.  While at BMS, Chris also led efforts in operations management and the implementation of advanced Manufacturing Execution Systems (MES) and process modeling technologies at sites in Indiana and Puerto Rico.  Chris received his M.S. in Industrial Management from the University of Southern Indiana and a B.S. in Chemical Engineering from Purdue University.

George Skillin

George Skillin is the Senior Director of Pfizer Global Engineering, where he manages a team of 35 engineering professionals in the Process, Equipment, Automation Engineering disciplines and manages the Global Serialization and Industrial Control System Cyber Security Programs for Pfizer. George joined Pfizer in 2002 taking on a 2+ year international assignment as a member of the Site Leadership Team in conjunction with the design, construction, and start-up of the Grange Castle Biotechnology Campus in Dublin, Ireland. Upon returning to the US, George led the Enterprise System Program at the Andover site, joined the Biotechnology Engineering Leadership Team and has been leading numerous teams and global programs including Process Engineering, Automation Engineering, Manufacturing Informatics, Communications, and Knowledge Management. George was appointed to the Pfizer Global Engineering Leadership team in December of 2009. Over the past 9 years, George has held numerous diverse leadership roles across Pfizer Global Engineering giving him broad experience across Pfizer’ Global Supply network of 65 manufacturing sites. George has worked at Eastman Kodak, Merck, Ernst & Young and has over 30 years in the Life Sciences manufacturing industry. He has a Bachelors of Science in Chemical Engineering from the University of Maine and an M.B.A. from the University of Rochester’s Simon School of Management in Finance and Cost Accounting.

Christine Moore

Dr. Christine Moore is Global Head and Executive Director, GRACS CMC – Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA, including Acting Office Director of the Office of New Drug Quality Assessment and of the Office of Process and Facilities. In those positions, she had oversight of quality assessment of INDs, NDAs, ANDAs, and supplements, as well as for providing strategic and organizational direction. Prior to moving into the regulatory CMC area, she spent 10 years at Pfizer and Searle/Pharmacia in API process development, process analytical technologies, scale-up, and technology transfer. She holds a BS in Chemical Engineering from Northwestern University and a PhD in Chemical Engineering from MIT.

Throughout her career, Christine has focused on the development of scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies, modernizing regulatory guidance, and progressing international harmonization.  She has been a thought leader in progressive regulatory approaches to pharmaceutical manufacturing in the areas of Quality by Design, process analytical technology, and continuous pharmaceutical manufacturing. Christine has given over 100 invited and keynote presentations and has served on multiple ICH working groups.  She is a member of the PhRMA Global Quality and Manufacturing Work Group and is a director on the ISPE International Board of Directors.

Rob Piperno

Rob Piperno is a credible leader and Quality Assurance professional with significant experience in Cell & Gene Therapy and pharmaceutical drug product development. Rob has over 15 years experience in international cross-functional matrix team leadership delivering drug products from clinical development to commercial manufacturing.

Andrew Mica

Andrew Mica is the Senior Director Gene Therapy Manufacturing Operations at Biogen responsible for collaborating internally and externally to support innovative new cell and gene therapies. Prior to this role, he was Senior Director, North America Supply Chain at Biogen overseeing product lifecycle management, manufacturing planning and logistics, and commercial product distribution centers. He directed new product launch and network strategy initiatives including a global assessment of Biogen’s distribution network and operating model aimed at modernizing current capabilities and preparing for the future portfolio. Prior to joining Biogen in 2014, Andrew worked with Amgen, in various commercial and clinical supply chain roles with leadership roles in Commercial Supply Chain organizational transformation and Supply Chain Segmentation initiatives. Andrew began his career with GSK in plant support, process improvement and new product introduction roles both domestically and abroad.

Andrew served in the US Marine Corps, has a Bachelor of Science degree in Environmental Engineering from North Carolina State University and an MBA from California State University. He is a licensed Professional Engineer and certified Lean Six Sigma Master Black Belt.

Jeff Yant

Jeff Yant has >19 years of experience in the design, characterization, implementation, and support of biotherapeutic manufacturing processes.  He graduated in 1992 from the University of California, Santa Cruz with a B.A. in Biology.

Jeff then worked as a graduate student at the University of London (UK), and subsequently as a post-doctoral researcher at the Salk Institute (San Diego, CA) on aspects of developmental biology.  After completing his post-doc in 1999, Jeff joined Amgen (Thousand Oaks, CA) as a Process Development Scientist and group leader. He later served as the Global Operations Leader for multiple clinical and commercial monoclonal antibody products.

In 2010, Jeff moved to Amgen’s Rhode Island site to lead its Process Sciences organization.  During this time, he also served as an Adjunct Professor in the College of Pharmacy at the University of Rhode Island.  Jeff currently oversees the Process Development and Operations groups within Amgen’s Biosimilars Business Unit (Thousand Oaks,  CA) where he is responsible for the similarity and CMC strategies across nine biosimilar assets.

Nuno Fontes

Nuno Fontes is the Executive Director of Process Science at Boehringer Ingelheim, in Fremont, USA, providing vision, strategic direction and functional leadership to a group of 100 scientists and engineers organized into six functional sub-groups: Cell Culture, Purification, Analytical Science, Integrated Bioprocessing Engineering, Manufacturing Science & Technology, and Single-Use GMP Clinical Operations. His group is responsible for all early and late-stage process development, tech transfer, pilot plant operations, manufacturing science support to operations, and single-use clinical supply GMP operations onsite.

Ryan Burke

Ryan is a Senior Production Scheduler for BMS, where he is responsible for capacity management, finite scheduling, and implementing the BioG scheduling tool at the Devens, MA facility. In this role Ryan adds value to the biologics manufacturing plant through the planning, scheduling, and MES integration of routine and non-routine tasks to provide real-time scheduling conflicts and opportunities. Ryan collates this information into elegant visual management platforms, providing actionable opportunities for continuous improvement and plant de-bottlenecking.

Prior to joining BMS in 2015, Ryan held a range of roles within Manufacturing & Supply Chain at Shire, where he streamlined operations in raw material planning & inventory control.

Ryan holds a BS in Biochemistry from the University of New Hampshire and an MS in Engineering Management from Tufts University.

Piper Trelstad

Dr. Piper Trelstad has 18 years of experience in vaccine manufacturing and supply chain. She leads the Strategy and Project Management team for Takeda Pharmaceuticals’ Vaccine Operations, where she is focused on digital innovation, lifecycle management and mid-long term global commercial manufacturing readiness.  Prior to her current role, Piper led the Life Cycle Management group within Vaccine Operations. Piper joined Takeda from Merck, where she most recently served as Vaccine Product Leader.  Earlier in her career, she held a number of leadership roles within the Merck Manufacturing Division, including capital project team leader, startup leader and potency investigation leader, as well as positions within vaccine technical operations.  Piper holds a PhD in Chemical Engineering from the University of California at Berkeley.  She has an undergraduate degree from Yale University in English Literature and another from the University of Maryland at College Park in Chemical Engineering.

Ryan Bartock

Ryan Bartock joined Spark Therapeutics as Head of Supply Chain and Network Strategy in September 2017 where he leads the Supply Chain, Network Strategy and CMC Project Management Organizations.

He joined Spark from GlaxoSmithKline (GSK) where he was Sr. Director – Strategy, Ops and Planning for the Biopharm and Cell/Gene Therapy R&D units.

Prior to this, Ryan was the Sr. Director of Biopharm Supply Chain and Network Strategy where he led the development of a new flexible cell culture facility for commercial supply in addition to defining lifecycle and supply strategies across each of GSK’s therapeutic franchises.

Ryan has held operational, strategic and commercial roles at GSK and Merck & Co, Inc. in vaccines, biopharms, and fast-moving consumer goods.  He received his B.Sc. in Industrial Engineering from Drexel University and is a certified LeanSigma Black Belt.

Matthew Shields

Matt Shields is the Global Head of operations for Specialty Care Operations (SCO) within Sanofi’s Biologics Platform. He is responsible for the global network of the SCO Biologics operations plants across US and Europe. Matt is responsible for providing leadership to ensure delivery of SCO strategic priorities including uninterrupted global supply of Specialty Care medicines, flawless launches of new products and implementation of next generation manufacturing.

Matt has over 17 years of experience in Biologics industrial operations. Prior to joining Sanofi, Matt most recently was an Executive Director and Plant Manager at Amgen where he was responsible for the design and delivery of Amgen’s next generation manufacturing facility located in Singapore. He has also held various leadership roles in Supply Chain, Manufacturing and Engineering.

Matt holds an MBA from Bryant University, and a Bachelor of Science degree in Chemical and Material Science engineering from the University of Connecticut.

Paulien Groll

Paulien Groll has 26 years of experience in pharmaceutical manufacturing in roles of increasing responsibility with Genentech, Baxter, Baxalta, and Shire. In her current role as Head of Global Quality Compliance & Risk Management, Paulien oversees and is accountable for regulatory compliance, the internal audit program, the Supplier Quality Audit program, inspection readiness, risk management execution, regulatory intelligence, maintaining the Quality Manual and Quality Standards, Quality Management Review, and Product Quality reviews. Paulien has a strong passion to improve patient lives while maintaining a strong quality perspective. She accomplishes this by supporting inspired teams and innovation, while staying engaged with the world around her.

Sarah Kennett

Sarah Kennett, Ph.D., joined Roche/Genentech at the end of 2017 as a Principle Regulatory Program Director for Biologics in Pharma Technical Regulatory.  She was previously the Review Chief for the US FDA Office of Biotechnology Products (OBP) Division of Biotechnology Review and Research I.  Sarah joined OBP as a reviewer in 2007 and held positions of increasing responsibility, with a promotion to Review Chief in 2013.  While in OBP, Sarah oversaw the CMC review of a wide variety of antibody-related and other therapeutic protein products throughout their lifecycles and was involved with numerous manufacturing facility inspections.  She has experience with divergent product issues, such as those related to breakthrough products, biosimilars, compounding, and counterfeiting, and was recently the OBP contact for FDA’s biological product representative for ICH Q12.  Sarah joined FDA in 2005 as a Fellow in the Office of Cellular, Tissue, and Gene Therapies. She obtained her Ph.D. in Molecular Cancer Biology at Duke University and followed that with postdoctoral training in the NIH Laboratory of Molecular Carcinogenesis.  Sarah received a B.S. degree in Molecular and Cell Biology (Microbiology minor) from the Pennsylvania State University.

Jennifer McGee

Jennifer McGee is a quality director with more than 18 years of experience in pharmaceutical manfuacturing. For the last twelve years she has held roles of increasing seniority within the Quality Culture of GSK. Jennifer has a Bachelor’s Degree in Biology and Biological Sciences from Ursinus College and a Master of Science, Quality Assurance and Regualtory Affairs from Temple University.

Todd Renshaw

Todd Renshaw has 30 years of experience in the pharmaceutical industry in roles of increasing responsibility with Merck, PRTM, Genentech, Roche, and now Vir Biotechnology. Todd has a Bachelor of Science in Chemical Engineering from MIT and an MBA from Harvard Business School.

Alison Moore

Dr. Alison Moore is senior vice president, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Wolfram Carius

Prof. Wolfram Carius is the Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices) at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for two years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Anders Vinther

Anders is the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of Biologics Quality which included operational quality leadership for 10 Biologics Roche and Genentech manufacturing sites and all outsourced manufacturing for biologics products. Previous to that role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS), Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors. Additionally over the past 20 years in PDA he has been Chairman of the Board of Directors, Treasurer, Board of Directors member, task force and conference planning committee leader and member, and author of numerous articles.

Johna Norton

Johna Norton is senior vice president, global quality for Eli Lilly and Company.

Johna joined Lilly in 1990 as an analytical chemist and went on to hold positions in quality assurance and quality control, supporting manufacturing and process development at Lilly facilities and with Lilly external manufacturing partners. She has held roles at sites in Indianapolis and Clinton, Indiana, and also spent four years in Kinsale, Ireland, and more than two years in Puerto Rico.

Prior to taking her current role, Johna was vice president, quality, for API, Puerto Rico and product research and development.  In this capacity, she was responsible for providing quality oversight and direction for Lilly’s API manufacturing network and the product research and development organization.

Johna holds a bachelor’s degree in chemistry from Gannon University and a master’s degree in analytical chemistry from Miami University.

R. Ananth

R. Ananth (Raghunathan Ananthanarayanan) has more than 30 years of experience in the global pharmaceutical industry as a senior leader specializing in business development, R&D, manufacturing, regulatory affairs, sales and marketing, strategic sourcing, and mergers and acquisitions. Since December 2014, Ananth has been President and Chief Executive Officer of Teva Active Pharmaceutical Ingredients (TAPI), and was additionally appointed head of the company’s Biologics Operations in July 2016.

Prior to joining Teva, Ananth was a member of the management council at Dr. Reddy’s Laboratories Ltd., where he was President of Pharmaceutical Services and Active Ingredients. Ananth previously was a management committee member at Piramal Healthcare as the President of Pharma Solutions for APIs and Finished Dosage.

Earlier in his career, Ananth held several senior-level positions across multiple geographies at Galpharm International Ltd., Zydus Cadila Healthcare Ltd., Wockhardt Ltd., and Rhone-Poulenc Rorer.

Ananth earned a doctorate in Pharmaceutical Technology from the University of Mumbai in India.

Kimball Hall

Kimball Hall serves as the Senior Vice President and Head of Drug Substance Biologics Manufacturing and is a member of the Genentech Executive Committee (GEC). Prior to joining Genentech in 2016, she previously worked at Amgen in a variety of leadership positions, most recently as the Vice President for Manufacturing of the Future, where she established advanced manufacturing facilities in Singapore that utilize disposable upstream technology.

Kimball’s organization is responsible for managing the biologics drug substance supply – the active ingredient that gets filled at the drug product sites before delivery of the medicines to our patients.  The biologics network is comprised of six sites in North America, Europe and Asia.

Kimball received her Bachelor of Science in Microbiology from the University of Washington and is based in South San Francisco.  She received the University of Rhode Island, College of Environmental Sciences “Distinguished Achievement” award and was also honored with the “Magic Circle” award from the Big Sisters of Rhode Island for her philanthropy.

At Genentech, she sponsors the Operational Development Rotational Program and is an advisor to the Genentech Women’s Professional Group.

Juan Andres

Juan Andres is Senior Vice President of Late Stage Technical Development and Manufacturing at Moderna. Prior to joining Moderna he was the Head of Global Novartis Manufacturing (Novartis Technical Operations) based in Basel, Switzerland.

His responsibilities include small molecules Drug Substance and Drug Product manufacturing, Biologics Technical Development and Manufacturing Operations and Supply Chain management.

During his career at Novartis, Juan Andres  also served as Head of Novartis Pharma Manufacturing, Group Quality, Global Head of Technical Research and Development (TRD) and Head of Pharmaceutical Manufacturing Operations.

Prior to joining Novartis, Juan Andres worked for Eli Lilly & Co. for

18 years in a variety of manufacturing, production and quality roles in the US, Puerto Rico, UK and Spain, including Vice President Pharmaceutical Manufacturing & Devices.

Juan is a pharmacist from Alcala de Henares University in Madrid.

Maria Nieradka

Maria Nieradka is Senior Vice President, Global Supply Chain at Biogen, a Biotechnology company.  Her responsibilities include global procurement, planning, end to end small molecule manufacturing, drug product and finished goods manufacturing for biologics, and distribution for clinical and commercial supply chains, along with supply chain strategy.  Maria holds Bachelors Degrees in Industrial Engineering and English from Rutgers College of Engineering and Douglass College and an MBA in Pharmaceutical Studies from Fairleigh Dickinson University.  Maria has over 30 years of Supply Chain experience in the pharmaceutical and consumer healthcare industry.   Over the past 10 years, Maria has been Vice President of Supply Chain and Logistics organizations at Merck, Johnson and Johnson and Bristol-Myers Squibb. She has a proven track record in leading large complex organizations, aligning customer and supply chain priorities, implementing change, and delivering significant results. Her lifelong passion for art and engineering inspired her to combine the two in her approach for building people, process, and technology. This creative approach led to many successes, including several major drug launches and major system implementations. Her focus on strategy and organization design expertise helped facilitate successful acquisitions in multiple organizations throughout her career. Committed to developing leaders that deliver results, Maria sponsors Diversity and Inclusion initiatives, as well as Women’s Leadership initiatives where her focus is to provide growth opportunities for women in the field of technology.

Jacks Lee

Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines.  His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing.  He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations.

Jacks joined Merck in 2007 as head of Global Technology & Engineering.  Prior to that, he was with Sanofi and its predecessor companies in varying capacities including serving as heads of US Biological Operations and Global Pharmaceutical Products Division.  He is a member of the Vaccines Advisory Board, and was previously nominated and served on the United States Pharmacopia (USP) Expert Committee of Biostatistics.

Daniel Palmacci

Daniel Palmacci is Vice President of a Drug Product Network and Site Head Schaftenau at Novartis. He is based in Austria and in Basel, Switzerland. Daniel has nearly 20 years of leadership experience in Biologics in the area of Manufacturing, Technical development, Supply Chain and Operations Management.

He is a member of Novartis Biologics Leadership Team and is Technical Operations Head of Austria’s Country Executive Committee.

In his previous role he was the Head of Biologics External Supplier Organization that manages all Contract Manufacturers (CMO) for the cross divisional network of Novartis, Sandoz and Alcon. Scope of Contract Manufacturers cover Biologic Drug Substance, Aseptic Drug Product, Packaging and Devices.

Daniel was also responsible for Technical Development Project Management organization. The group of Project Managers is accountable for Biologic Drug Substance, Drug Product, Medical Devices and Packaging. Technical development scope is starting from early phase for Biosimilars through the Launch. The organization is also responsible for the Products Life Cycle Management and commercialization in close collaboration with Marketing and Sales.

As a Member of Sandoz Biologics Executive Committee he managed all TechOps activities (end to end) by coordinating internal and external manufacturing and supply chain to ensure supply of commercial Biosimilars.

Prior to joining Novartis Daniel worked for BayerHealthCare for several years in positions with progressively senior roles in leading cross-functional teams responsible for Production, Manufacturing Science, Technical development, Operational Excellence, Supply Chain, Quality Assurance and Engineering.

In his more than 20 years in the international pharmaceutical industry he has worked in Germany, Italy, India, Brazil, France and the US.

Daniel holds a Master of Chemistry and Process Engineering, High Honors, at Technical University Berlin, Germany.

Christie Bielinski

Christie Bielinski is Vice President of Product Quality Management for Janssen Pharmaceuticals. Christie leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product.

In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.

Prior to joining J&J in 2006, Christie worked for Baxter Healthcare, Inc. There she held roles of increasing responsibility in quality across the Renal, Medication Delivery and Transfusion Therapies business units.

Christie is an accomplished leader, who in her 20-plus-year career has cultivated a proven reputation for her ability to successfully develop and implement strategies for quality improvement in turn-around situations.

Christie holds a Bachelor’s of Science Degree in Animal Science from Purdue University, West Lafayette, IN. She is an ASQ Certified Quality Auditor and an ASQ Certified Quality Manager. She is a wife and mother to four VERY busy boys who aim to leave their own indelible mark upon the world.

Paul J. Staid

Paul leads the Biologics Product Strategy and Operations organization within BMS Biologics Development and Operations (BDO).   He is responsible for the supply strategy and lifecycle management of biologics brands, global network strategy, and the BDO PMO and performance management processes.

Prior to his current role, Paul was Head of GMS Strategy & Business Operations where he played a lead role in the diabetes divestiture as well as developing GMS restructuring plans as part of a company wide Diversified Specialty BioPharma Operating Model initiative.

Paul joined BMS in November 2009 as Head of Global R&D, Biologics, and GMS Sourcing within BMS Global Procurement.

Prior to joining BMS, Paul held the role of Senior Director of Biotech Strategic Sourcing for Wyeth Pharmaceuticals.   Prior to Wyeth he held a range of roles in supply chain, manufacturing, and engineering  functions with increasing responsibility in  high tech electronics, strategy consulting, and industrial equipment industries.

Paul holds a BS in Mechanical & Aerospace Engineering and an MBA from Cornell University.

Laurent Boer

Laurent J. Boer is General Manager of  the Allston plant for Sanofi Genzyme. He is responsible for the commercial bio-manufacturing of Cerezyme® and previously was responsible for the Massachusetts Raw Material Platform supporting Sanofi Genzyme manufacturing, global trade and logistics as well as label and packaging for US and non-EU markets at Sanofi Genzyme’s Northborough plant.

He previously worked in supply chain roles in UCB (Belgium), Biogen Idec (USA and Netherlands) and UPS (Europe and USA). He holds a Master of Science from Erasmus University Rotterdam, The Netherlands. He majored in Operations Research. He brings more than 25 years of experience in Supply Chain roles and General Management.
He received a M.S. degree from Erasmus University in Rotterdam, Netherlands and a Masters Certificate in Project Management from George Washington University.

Li Malmberg

Dr. Li Malmberg is VP Biologics Development and Manufacturing at Celgene where she oversees the CMC Development and Manufacturing for Biologics Products.  Prior to joining Celgene, Li Malmberg spent over 23 years with AbbVie and Abbott with increasing roles and responsibilities in pharmaceutical development with broad experiences in fermentation, small molecule pharmaceutical development, and biologics development.  Most recently, she was head of process and analytical development for biologics from preclinical to commercial launch.  Prior to this role, Li was head of Manufacturing Sciences responsible for technical support for commercial biologics manufacturing. During her 13 year tenure in biologics at the Worcester site, she was involved in launching four commercial biologics and advancing over 25 clinical biologics programs with multiple scaling up and site transfers.  In addition, she recently received AbbVie Chairman Award for her efforts in leading the teams with multiple granted manufacturing patents for Humira.

Li holds a Ph.D. in Chemical Engineering from the University of Minnesota-Twin Cities, a MS degree in Chemical Engineering from University of Wisconsin-Madison, and a B.S. in Chemical Engineering from University of Illinois at Champaign-Urbana.

Mayo Pujols

Mayo Pujols is currently VP Global Head Car-T Operations and Technology at Celgene located in Summit, New Jersey. Prior to Celgene, he was the SVP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey.  He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management.  Prior to this role, he was Advaxis’s VP of Technical Operations. Prior to that role he was Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises.  Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.  He holds a B.S. degree in Chemical Engineering from Stevens Institute of Technology and a M.S. degree in Chemical Engineering from Columbia University.  He also trained on operations and finance at the University of Virginia Darden School of Business.

Rohini Deshpande

Rohini joined Amgen in 1997 as a scientist in R&D.  At present, she is Vice President Process Development and Head of Attribute Sciences. Attribute Sciences is a multi-modality global group across six Amgen sites.  The scope spans preclinical to commercial.  Previously, Rohini was Executive Director of Drug Substance group for Amgen Thousand Oaks.  Her team developed production cell lines and processes for many Amgen biologics products.

Prior to her 20 years at Amgen, Rohini did her post-doctoral work in antibody structure function at UCLA, before that she worked as a post-doctoral fellow establishing a Yeast two hybrid system at University of Michigan, Ann Arbor, and prior to that she did her Ph.D. in Biology with an emphasis on Immuno endocrinology at SUNY Binghamton.

Tina Larson

Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections.  Ms. Larson is accountable for Process Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices.  Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science and Technology, Process Development, and Global Business Operations.  Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe.  She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star.  Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

Darren Dasburg

Darren currently serves as VP & Head, Learning and Development Global Operation at AstraZeneca. Bringing over 30 years of professional experience in a variety of settings, he was appointed Vice President-Site Head for the Boulder Manufacturing Center in September 2015 when AstraZeneca/MedImmune acquired the former Amgen biologics production facility. Previously, Darren held the position of Vice President of Capacity Utilization with MedImmune where he led capacity sharing arrangement to support bio-manufacturing efforts. Prior to that, he was a Founding Partner of Cinteger LLC where he provided executive management consulting in the areas of construction, facilities operations, project engineering, service-provider outsourcing, real estate and business management. Darren also served as Vice President of Corporate Engineering with GlaxoSmithKline. He is a licensed Professional Engineer and certified Outsourcing Professional, being the first person to obtain that certification.

Cathryn Shaw-Reid

Dr. Cathryn Shaw-Reid is executive director, Process Development at Amgen where she currently serves in a change management leadership role responsible for transforming the governance framework to enable more effective decision-making across the Operations global network.

Cathryn has built a variety of clinical and commercial teams at Amgen, including product team leadership in Process Development and Global Operations functions.  She transitioned to Puerto Rico in 2010 to seize the exciting opportunity to serve as the first Plant Manager for Amgen’s new solid dosage form facility where she led the team in validation and licensure of Sensipar^®/Mimpara^® drug product and tablet production, and then she completed manufacturing roles in both clinical and commercial drug substance plants.  She also led the Strategic Planning and Operations Risk Management organization focused on executive decision-making.

Prior to Amgen, Dr. Shaw-Reid led a biochemistry team at Merck Research Labs in West Point, Pennsylvania in the discovery of novel HIV small molecule inhibitors.

Cathryn holds a B.A. (liberal arts) and B.S. (chemical engineering) from Columbia University in New York and a Ph.D. in biochemical engineering from the Massachusetts Institute of Technology (MIT).  She completed a post-doctoral fellowship at Harvard Medical School in the field of enzymology.

Lisa Wyman

Lisa Wyman is Senior Director, Quality Compliance and Risk Management at Shire, based in Lexington, MA. Lisa leads a global organization accountable for quality compliance and quality risk management of a diverse product portfolio including plasma-derived proteins, small molecules, biologics and combination products. The scope of her responsibilities include the deployment of global quality manual & global quality standards, GMP/GDP auditing, product & material lifecycle, supplier quality management,  quality governance, annual product quality review, quality risk management, regulatory intelligence, quality business operations, and a center of excellence for regulatory compliance.

Prior to her current role, Lisa was Senior Director of QA Engineering at Shire and held positions in manufacturing, engineering and quality at Boston Scientific, Biogen, AstraZeneca, Wyeth and Genetics Institute.

She is an accomplished leader who has a strong history of transforming programs and teams, improving regulatory compliance, and driving exponential growth. Lisa was selected as one of Boston Business Journal’s 40 under 40 and recognized by Plant Engineering as a 2016 Engineering Leader.

Lisa received her Bachelors of Science from Ithaca College and her Master’s Degree in Engineering from Tufts University.

She also serves on the board of Lean In Boston and is the founder of Lean In Shire, a women’s business resource group.

Jerry Murry

Jerry obtained his Ph.D. at the University of Utah and was an NIH fellow at Harvard University before starting his industrial career at Pfizer Central Research. Prior to joining Amgen in 2006, Jerry was Sr. Director of Process Development at Merck Research Laboratories, where he led several PST level cross-functional teams. In August 2013, Jerry joined the Amgen Full Potential Initiative and led the AFP#3 team, Redesign Process Development through Business Case and into Implementation planning. In August 2014, Jerry became VP CMC Lifecycle Management within the Process Development organization.

Karen Walker

Karen Walker is Vice President of Global Quality for Seattle Genetics. She brings 30 years’ experience in the biotech industry, holding positions in development, validation, Regulatory Affairs and Quality. She has worked in a number of companies including Novartis, Amgen, Abgenix, Bayer, Bristol-Myers Squibb and several other small to mid-sized biotech companies. Most recently, she held the role of VP and Global Head of Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit.

Søren Thuesen Pedersen

Mr. Pedersen, a chemical engineer by education, has been working in the pharmaceutical industry for 30 years in both specialist and managerial positions within parenterals and solids manufacturing

In his current job Mr. Pedersen is responsible for the External Requirements process which is a core element in the Novo Nordisk QMS. This includes the responsibility for the external representation of Novo Nordisk within in the GMP area.

As a member of the BIO Manufacturing and Quality group as well as the EFPIA Supply Chain working group, the area of pharmaceutical manufacturing has been at the core of his competencies.

He serves as EA to the Head of Quality in his roles in the GPMLF and the ISPE Board of Directors.

Finally, He has been member of the Novo Nordisk Board of Directors since 2006.

Heidi Hoffmann

Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead at Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics.  Directly after receiving her Ph.D. from University of California, Berkeley, Dr. Hoffmann began her career at Aviron, where she worked on process development and production of vaccines for EBV, PIV, and influenza (FluMist).  She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy.  In 2002, Dr. Hoffmann returned to vaccine work by joining VaxGen, where she was responsible for process development and manufacturing of anthrax vaccine.  Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia (abatacept) into the Celltrion manufacturing facility in South Korea.  After the completion of that project, Dr. Hoffmann joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and manufacture of HIV vaccines.  Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs produced using Sutro’s proprietary cell-free protein expression system.

Andrew Jones

Andrew is the Head of Product Quality for Biopharm and Sterile Products at GlaxoSmithKline. His duties are to support the submission, approval, and launch of New Products as they transition from R&D into the Global Manufacturing space at GSK. He is responsible for the Central Testing Lab and the analytical strategy for Biopharm and Sterile Products. He is the key interface between commercial manufacturing and R&D. He is also responsible for the external manufacturing of new and existing Biopharm and Sterile Products. Previously, Andrew was the Head of Quality for the Biopharm Supply Chain at GSK. In his roles at GSK and Janssen, he was a leader in Quality and Compliance supporting the submission, approval, and launch of Stellara, Simponi, Tanzeum, Nucala, and the recent Benlysta Subcutaneous at home use product.

Ashraf Amanullah

Ashraf is currently Vice President of Biologics Process Development and Manufacturing at aTyr Pharma. He is a drug development and manufacturing executive with more than 20 years of demonstrated leadership experience in global pharma and biotechnology organizations, with expertise in process development, technical operations, cGMP clinical manufacturing, commercialization and life cycle management of antibody therapeutics, vaccines, gene therapy, cell-based therapeutics and recombinant proteins. Prior to joining aTyr Pharma, Ashraf was Senior Director at Gilead Sciences where he built a world class CMC organization, Director of CMC Development at Genentech. Prior to Genentech, Ashraf held various positions at Merck & Co. Inc. over nine year tenure, with responsibility for process development, cGMP manufacturing, and technology transfer and commercialization of vaccines.  He is the author of 55 peer-reviewed publications, and his work has been presented at over 90 conferences. Ashraf received his Ph.D. in Chemical Engineering from The University of Birmingham (UK) and conducted post-doctoral studies with The University of Birmingham, Novo Nordisk, Merck & Co. Inc. and University College London.

Ryan Burke

Ryan is a Senior Production Scheduler for BMS, where he is responsible for capacity management, finite scheduling, and implementing the BioG scheduling tool at the Devens, MA facility. In this role Ryan adds value to the biologics manufacturing plant through the planning, scheduling, and MES integration of routine and non-routine tasks to provide real-time scheduling conflicts and opportunities. Ryan collates this information into elegant visual management platforms, providing actionable opportunities for continuous improvement and plant de-bottlenecking.

Prior to joining BMS in 2015, Ryan held a range of roles within Manufacturing & Supply Chain at Shire, where he streamlined operations in raw material planning & inventory control.

Ryan holds a BS in Biochemistry from the University of New Hampshire and an MS in Engineering Management from Tufts University.

Manny Otero

Dr. Otero has 15 years of experience in the biopharmaceutical industry, including in bioprocess development, manufacturing, CMC of vaccines and complex biologics. Prior to Turnstone, he was vice president of bioprocess development and manufacturing at Seres Therapeutics, Inc., where he was the corporate team leader for the first synthetic microbiome therapeutic to enter Phase I clinical studies in the United States. Prior to Seres Therapeutics, Dr. Otero was director of engineering at Merck & Co.’s manufacturing division. In that role, he supported development programs for the Varivax™, Zostavax™, ProQuad™ and MMRII™ franchises. Dr. Otero has authored more than 20 peer-reviewed publications. He received a Ph.D. in chemical and biological engineering from Chalmers University of Technology in Gothenburg, Sweden, and an M.Eng. in biomedical engineering and B.S. in chemical engineering from the Massachusetts Institute of Technology.

Arun Tholudur

Arun Tholudur has broad experience in end-to-end biopharmaceutical process development and commercialization. He is currently Executive Director of Process Development at Amgen with responsibilities for global packaging development for all of Amgen’s clinical and commercial products, equipment design for device assembly, labeling, and packaging, and cold-chain transportation solutions. Prior to this role, Arun was the Global Operations Leader directing all Operations/CMC activities leading to successful licensure of IMLYGIC, the world’s first commercially approved oncolytic virus, in the US, EU, Switzerland, and Australia. Previously Arun led the Process Engineering team at Amgen’s Colorado site providing technical direction and support for scale-up, technology transfer, and late stage clinical and commercial manufacturing support for products manufactured at the Colorado facilities. Prior to Amgen, Arun held positions of increasing responsibility in upstream process development at Diosynth Biotechnology. Arun received his MS and PhD in Chemical Engineering from the University of Colorado at Boulder.

Lisa McClintock

Lisa holds a Bachelor of Arts in Microbiology from University of California, Santa Barbara. She recently joined BMS and is responsible for all manufacturing operations at the Syracuse site including cell bank, inoculum, cell culture and purification as well as the supporting system critical for the success of manufacturing.  Before joining BMS Lisa was the Vice President, Head of Manufacturing for St. Renatus LLC in Ft. Collins, CO.  Prior to St. Renatus she held various positions of increasing responsibility, up to the Director, Global Operations & Planning at Amgen, Thousand Oaks, CA.

Kim Fellows-Peake

Kim Fellows-Peake has been in the Biotech Operations field for 20 years, primarily in Manufacturing and Quality. Kim recently took on a new role in Strategy Realization, where she is responsible for creating and executing a strategy to achieve desired 2022 results within Technical Operations at BioMarin Pharmaceuticals.

Erik Fouts

Erik Fouts is the Vice President responsible for the manufacturing, facilities, engineering, and technical support functions associated with the manufacture of three marketed biologics products and several clinical candidates. The role requires the management of 300+ staff in three commercial and clinical manufacturing facilities located in Novato, California. Erik joined BioMarin as a member of the Protein Purification Process Development group in 2000, and since then has taken on positions of increasing responsibility within Technical Operations.  Erik was performing gene expression research at Lawrence Berkeley National Laboratory prior to coming to BioMarin.  He holds a B.A. in Biochemistry and Cell Biology from U.C. San Diego and a Ph.D. in Molecular and Cell Biology from U.C. Berkeley.

Sid Advant

Sid Advant is Executive Director, Biologics Manufacturing at Celgene Corporation, where he oversees Clinical and Commercial Manufacturing of Celgene’s biologics portfolio. This role includes the selection as well as technical & operational management of Drug Substance and Drug Product CMO’s, as well oversight of the internal clinical manufacturing facility.  Prior to joining Celgene, Sid spent over 23 years in a variety of roles with increasing responsibility within Biologics Process Development, Operations and Portfolio Management at Protein Design Labs, Fujifilm Diosynth, ImClone/Lilly and Kemwell BioPharma, and has been involved in the development and commercialization of multiple biologics.  Sid holds a Ph.D. in Pharmaceutical Sciences from University of Connecticut and B.S. in Pharmacy from India.

Marc Lampron

Marc brings 30+ years experience in engineering/construction/procurement/turn-over and maintenance of manufacturing facilities, with the majority of his experience focused on biopharmaceutical manufacturing (small molecule, sterile fill-finish, vaccines, bulk biotech drug substance), domestically as well as internationally.

Marc is a member of Roche’s Global Engineering Team since 2015, and holds the position of Program Director for the Vacaville and Kentucky Distribution Center Capex program.  He is actively engaged in the oversight of project definition, planning and execution of the Capex projects, including the synchronization of the required capital investments/refurbishments associated with product tech transfers. Marc is a standing member of the Americas-region Global Engineering Leadership team.

Prior to his current role in the Global Engineering, Marc was the Global Lead for Roche’s Biologics Drug Substance procurement group, responsible for sourcing and procurement all direct materials for Roche’s Bio-DS manufacturing plants.  Prior to Roche’s acquisition of Genentech, he was the Senior Director for Technical Operations Procurement, covering all procurement aspects related to GMP direct materials, facilities and business operations, as well CAPEX investments.

Prior to his current employment at Genentech/Roche, Marc was employed as Amgen’s Executive Director – Strategic Sourcing (Facilities and Capital), where his responsibilities included leading and aligning remote manufacturing sites’ procurement organizations and overseeing the rapid build-up of the sourcing, procurement and contracting for Amgen’s global capital expansion program.  Before Amgen, Marc was employed for many years at Merck & Co., holding positions of increasing responsibility in the manufacturing and operations division, including site maintenance, site procurement, global procurement category management and CAPEX project management.   Prior to Merck, Marc worked as a project manager in the construction industry in Montreal, Quebec.

Marc holds a Bachelor of Science (Civil Engineering) from Queen’s University, Ontario (Canada).

Craig Beasley

Marisa Bookman

Marisa Bookman has over 20 years of experience in the pharmaceutical and biotech industry directing operations and improving manufacturing efficiency.  She has a proven track record in designing supply chain infrastructure, S&OP development and leadership, commercial product/device launches, manufacturing site commercial readiness, technology transfers, demand & supply management, and commercial key accounts management.  Marisa has leadership experience managing cross functional teams in various geographic regions driving strategy, efficiency, profitability, and integration from design to implementation.  She is passionate about the industry, supply chain and most importantly how the work we do makes a difference in patients’ lives.

Marisa relocated to Boston from California in mid-2016 has been in her current role at Biogen for over a year where she is the head of U.S. Commercial Supply Chain which encompasses Finished Goods Planning, New Product Launches, Logistics & Distribution, and Artwork Services.

Marisa took on the Biogen role following a decade spent at Amgen where she held various global leadership roles and directed multiple corporate transformation initiatives within Supply Chain and Operations.  Marisa shares a couple of rewarding career experiences that are top of mind for her:

• The 1^st being her role at Amgen Ireland to design and implement the organizational structure for site supply chain including directing the operational framework for technology transfer of all products into Amgen Ireland.
• The 2^nd being her role as Regional Operations Leader where she directed a global cross functional team to bring new therapies in record time to market; specifically partnering closely with medical institutions and primary care physicians and specialists to truly understand patients’ needs.

Marisa loves traveling, meeting new people, and enjoys experiencing new adventures with her husband.  She loves to hike, run, swim, and plays the piano.

Anders Vinther

Anders is the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of Biologics Quality which included operational quality leadership for 10 Biologics Roche and Genentech manufacturing sites and all outsourced manufacturing for biologics products. Previous to that role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS), Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors. Additionally over the past 20 years in PDA he has been Chairman of the Board of Directors, Treasurer, Board of Directors member, task force and conference planning committee leader and member, and author of numerous articles.

Tim Moore

Mr. Moore joins Kite Pharma from Genentech, a member of the Roche Group, where he served most recently as Senior Vice President and Global Head of Pharmaceutical Technical Operations Biologics and a member of the Genentech Executive Committee. In this position, he oversaw global manufacturing and end-to-end quality supply performance of more than 20 biological product families totaling more than $28 billion in sales, across 150 countries, 7,500 professionals and 10 internal manufacturing sites. Mr. Moore’s previous roles at Genentech include Senior Vice President, Global Supply Chain, Vice President, South San Francisco Manufacturing, and Vice President, Corporate Engineering.  Prior to joining Genentech, he served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). Mr. Moore has also held engineering positions at Merck & Co. He holds a BS in chemical engineering from the University of Tulsa, and an MS in engineering management from Northwestern University.

Alison Moore

Dr. Alison Moore is senior vice president, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.
Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Peter Moesta

Peter has more than 30 years of experience in the biopharmaceutical industry and a strong understanding of manufacturing and launching complex biologics. Before joining TPI, he was senior vice president of Biologics Manufacturing at Bristol-Myers Squibb, where he oversaw the development, production and worldwide launch of numerous significant biologics, including oncology products Yervoy and Opdivo. Previous to this role, Peter held various leadership positions in biologics development and manufacturing at Abbott Laboratories and BASF AG.

Pierre-Alain Ruffieux

Pierre-Alain Ruffieux is Global Head of Quality and Compliance for Roche Pharma Technical Operations responsible for all Pharmaceutical Quality and GMP compliance activities. He was most recently Head of Quality for the Pharmaceuticals division and a member of the Pharma Executive Committee at Novartis. In this capacity, he was responsible for leading and managing quality across the division including technical operations, product development and commercial activities in more than 100 countries. He brings more than 20 years of experience in technical development, manufacturing and quality.

Anil Sawant

Anil Sawant, PhD, has more than 25 years of experience in the pharmaceutical industry in Quality & Compliance, Pharmaceutical Microbiology, Business Ethics and Compliance, Auditing and R&D functions. He has worked on various dosage forms from injectables to topical, and various product types of drugs, vaccines, medical devices, and consumer products. Currently, Anil is Vice President, Global Quality Management Systems and External Affairs at Merck, with responsibility for ensuring effectiveness of Quality Management Systems at all Human and Animal Health supply chain sites worldwide. Prior to joining Merck, Anil served in executive positions at Johnson & Johnson and Wyeth Pharmaceuticals (now Pfizer). A PDA Member and volunteer since 1992, Anil currently serves on PDA’s Regulatory Affairs and Quality Advisory Board. He was the lead for PDA Technical Report No. 55 on musty odor taints of pharmaceutical products and co- lead for the PDA Technical Report No. 67 on objectionable microorganisms. He currently leads PDA’s Task Force on Particulate Matter in Oral Dosage forms, is the Co-Lead for the Task Force on Data Integrity and is a member of the Quality Metrics Task Force. Anil is a frequent speaker at PDA conferences and local chapter meetings. He holds a BSc Honors and an MSc Honors Degree in Microbiology & Biochemistry from Panjab University, India, and a PhD in Microbial and Biochemical Sciences from Georgia State University. He is recipient of the GSU Distinguished Alumni Achievement Award and serves on the Board of Directors of GSU Alumni Association.

Charlene Banard

Charlene is accountable for the global Quality function at Shire, a global biotechnology company focused on meeting unmet medical needs of patients with rare diseases and specialty conditions.  In partnership with her colleagues at Shire, Charlene and her team provide a safe and ready supply of quality products and services to our patients and healthcare providers.

Charlene has more than 25 years in the biopharmaceutical industry bringing new products and technologies to fruition through robust team partnerships.  Prior to joining Shire, she held leadership positions at Gilead Sciences, Cell Genesys and Chiron Corporation.  She holds a Bachelor of Science degree in Biochemistry from the University of California, Davis and a Masters in International Business from Saint Mary’s College in Moraga, California.

Daniela Ottini

Daniela joined AbbVie in 1994 as a Quality Engineer.  She has held several positions at AbbVie, including Process Engineer, Purchasing Manager for the Italian affiliate and Regional Purchasing Manager for Europe and Asia. She then led the Chemical Manufacturing Plant in Italy and worked as Site Director for three years before assuming the role of Plant Director for the Singapore Site. She is now the VP for Biologics Manufacturing in charge of the sites in Singapore, Worcester and Puerto Rico.

Daniela attended ‘Università degl Studi La Sapienza’ in Rome and received her Degree in Engineering and a Master in Business Administration at ‘Università di Tor Vergata’ in Rome.

Joanne Beck

Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations, Engineering and Quality.  Prior to Celgene, she was SVP of Pharmaceutical Development at Shire.  Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions.  Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.

Karen Walker

Karen Walker is Vice President and Global Head of Quality for Novartis’ Cell and Gene Therapies Unit. She has 25+ years in the biotech industry, holding positions in development, validation, Regulatory Affairs and Quality. She has worked in a number of companies including Amgen, Abgenix, Bayer, Bristol-Myers Squibb and several other small to mid-sized biotech companies.
In her current role, she is responsible for the Quality Unit of the Cell and Gene Therapies Unit of Novartis, covering all aspects of quality for the development and commercialization of Cell, Gene or combination Cell and Gene therapies, both internally and externally. Establishing and ensuring compliance to appropriate GxP standards for these products and clinical trials, and engaging in the development of these standards at a global level, with Health Authorities and recognized industry leaders.
As a consequence of the type of product in focus for the Novartis CGTU, Karen and her team have had to grapple with the complexity and challenges of managing starting material and raw material supply and quality.

Andy Ramelmeier

Dr. R. Andrew “Andy” Ramelmeier has served as senior vice president of biologics technical operations since October 2014. He has 20 years of experience and a strong foundation in the development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines, enzymes and other therapeutic proteins. Dr. Ramelmeier was responsible for the licensure of several commercial products, process improvements to several more commercial products, and the design, construction and operation of 6 biologics production facilities, totaling over $400MM in investment. His technical expertise spans from cell culture and fermentation through purification, formulation and parenteral fill/finish. Prior to joining Portola, Dr. Ramelmeier served as vice president, global manufacturing and facilities, at BioMarin Pharmaceutical, a biotechnology company specializing in enzyme replacement therapies. In that position, he was responsible for bulk manufacturing of three commercial biologics products, clinical manufacturing of pipeline product candidates, and facilities maintenance and engineering. Previously, Dr. Ramelmeier was vice president, process sciences at Centocor /J&J, where he was responsible for technical support of J&J’s BioPharm manufacturing plants. He held roles of increasing responsibility in R&D at Centocor and in BioProcess R&D at Merck & Co. Dr. Ramelmeier received a B.S. in chemical engineering from Johns Hopkins University and a Ph.D. in chemical engineering from the University of California, Berkeley. He conducted post-doctoral work at the Institute for Enzyme Technology in Germany.

Kimball Hall

Kimball Hall joined Roche in 2016 as Vice President and Head of Drug Substance Biologics Manufacturing, and is based at Genentech in South San Francisco. Her organization is focused on reliably manufacturing high-quality commercial drug substance as well as some clinical and launch products. The global DS network is comprised of six sites: Basel, Oceanside, Penzberg, Singapore, South San Francisco and Vacaville. Previously she worked for Amgen in various leadership positions, most recently as Vice President for Manufacturing of the Future, where she led the establishment of advanced manufacturing facilities in Singapore that utilize disposable upstream technology. She attended the University of Washington in Seattle earning her Bachelor of Science in Microbiology.

Val Romberg

Val Romberg is responsible for CSL Behring’s state-of-the-art global manufacturing and plasma collection operations with sites in Germany, Australia, Switzerland and the USA where the company’s lifesaving biotherapies are produced. He is also accountable for Planning.

Mr. Romberg has more than 30 years of experience in the pharmaceutical industry. In 1998, Mr. Romberg joined Centeon, a predecessor company of CSL Behring, as a project manager in King of Prussia, Pennsylvania. In this role, he was involved in the development of several products, both recombinant and plasma derived. In 2003, he assumed the role of Senior Director, Technical Operations in Kankakee, Illinois in manufacturing for Aventis Behring. In July 2006, he became Senior Director, Research & Development, in Bern, Switzerland, focusing on the development of immunoglobulins. Then in 2008 he became SVP, Global R&D, CSL Behring. In 2011, R&D was integrated into a single global integration and Mr. Romberg took the role of SVP, Plasma Product R&D. He is currently based in King of Prussia. During his R&D tenure, R&D had more than 25 product or indication approvals in the US, EU, or Japan.

Mr. Romberg has a Bachelor’s degree in chemistry from the University of Michigan.

Juan Torres

Dr. Juan Torres is Senior Vice-President of Global Quality for Biogen, Inc. In this capacity he has worldwide responsibility over Corporate Quality, Quality Control, and Quality Operations at all Biogen production sites. He has been with Biogen for the last twelve years. Dr. Torres has over 20 years of industrial experience in the area of biological manufacturing and holds a Ph.D. in Biochemistry and Toxicology from North Carolina State University. His doctoral research was in the area of protein chemistry. He also has Post-Doctoral experience in the Chemical Engineering department at NC State University, where he studied novel techniques for large-scale protein purification, and a Masters of Science degree in Organic Chemistry.  Prior to joining Biogen, Dr. Torres was Director in the Process Sciences department at Centocor, Inc. and, before that, held positions of increasing responsibility over an eight-year period for Bayer Biological Products in Analytical Development, Quality Control, and Quality Assurance. Dr. Torres was born in Seville, Spain and grew up in Puerto Rico. His wife is also Puerto Rican and they have three children. During the last 20 years, Dr. Torres and his wife have been heavily involved in providing medical care to under-served communities in the developing world.

Paul Marshall

Paul G. Marshall joined Heron Therapeutics as Senior Vice President of Technical Operations in November 2013. Mr. Marshall has 27 years of experience in the development and commercialization of pharmaceutical products, including manufacturing and supply chain responsibility for 14 approved drugs and biologics, three of which achieved blockbuster (sales >$1B) status. Since 2006, Mr. Marshall held ascending executive positions within Amylin Pharmaceuticals, Inc., including Senior Vice President of Operations. Prior to Amylin, Mr. Marshall held executive manufacturing positions at Amgen, Inc. and Baxter International. He has held management positions at Creative BioMolecules, Welgen Manufacturing Partnership (now Amgen, Rhode Island), Repligen Corporation and Damon Biotech. Mr. Marshall received his B.S. and M.S. degrees in biology from the University of Massachusetts at Dartmouth and completed three years of post-graduate work concentrating in hematology and coagulation research at Brown University.

George Avgerinos

George has 35 years of experience in biotechnology CMC/operations.  He is currently at Fortress Biotech, a company dedicated to acquiring, developing and commercializing products thru the creation of subsidiaries (Fortress Companies).  In his current role, George is creating a centralized team to manage a diverse portfolio ranging from branded generics to antibodies, vaccines and CAR-T therapies.  Prior to joining Fortress, George spent 23 years at BASF Bioresearch/Abbott and Abbvie and led CMC activities for the launch and growth of Humira.  George started his career at Biogen in 1981 and subsequently joined Collaborative Research while serving as Adjunct Professor of BioChemical Engineering at Tufts University.  He received a B.A. in Biophysics from the UCONN and a Ph.D. in Biochemical Engineering from MIT.

Bob Miller

Bob Miller, Ph.D. is the Vice President of Quality in PDM and has more than 25 years of experience in the Pharmaceutical and Biotechnology industry. Prior to joining Gilead Sciences he was President of his own company Quality Compliance Management, LLC., VP Compliance at Johnson & Johnson, VP QA Consumer Sector at Johnson & Johnson, VP, Quality Assurance, VP Quality US and PR at Pfizer. Bob held various positions of increasing levels of responsibility within Warner Lambert, Bayer, and Lerderle Laboratories.

Dr. Miller received his Ph.D. in Pharmaceutical Chemistry from Rutgers University College of Pharmacy, New Brunswick, NJ and B.S. in Pharmacy, Rutgers University College of Pharmacy, New Brunswick, NJ.

Tina Larson

Tina M. Larson is Vice President of Technical Operations at Achaogen, accountable for Pharmaceutical Development, Manufacturing, Supply Chain and Quality. Achaogen is a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Prior to Achaogen, Ms. Larson was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science, Technology Development, Pilot Plants and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. Tina was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

Andrew McKillop

Andrew is currently Vice President PharmSci QA with responsibility for the Manufacturing (GMP) Quality of the Pfizer R＆D Portfolio.

Andrew McKillop was previously Senior Director/Team Leader of the Scientific and Laboratory Services group, Global Quality Operations with responsibility for operations in Collegeville, Groton, Kalamazoo, Parsippany, Sandwich and Singapore. SLS provides expert scientific and analytical support to PGS ＆ Global External Supply Manufacturing sites, and other customers such as WRD and Global Security.

Previously Andrew was the Quality Operations Lead for the Pharmaceutical Sciences Quality Assurance group in Groton, Connecticut responsible for the quality oversight of API, Drug Product and Packaging/Labeling production in Groton, as well as products manufactured by PGS and external manufacturers for use in clinical trials.

Andrew started his career at Pfizer in Analytical R＆D in 1996, moving to Ann Arbor in 2002, working on the development and registration of several new products. In 2005 he took on a PhSci team leader role, moving to Groton CT in2006, and led a number of early and late phase projects in development, also working in project alliances with external companies.

Andrew holds a BSc in Chemistry, PhD in analytical chemistry and an MBA.

Erik Fouts

Erik Fouts is the Vice President responsible for the manufacturing, facilities, engineering, and technical support functions associated with the manufacture of three marketed biologics products and several clinical candidates. The role requires the management of 300+ staff in three commercial and clinical manufacturing facilities located in Novato, California. Erik joined BioMarin as a member of the Protein Purification Process Development group in 2000, and since then has taken on positions of increasing responsibility within Technical Operations.  Erik was performing gene expression research at Lawrence Berkeley National Laboratory prior to coming to BioMarin.  He holds a B.A. in Biochemistry and Cell Biology from U.C. San Diego and a Ph.D. in Molecular and Cell Biology from U.C. Berkeley.

Eric Niebling

Eric Niebling is the Vice President of External Supply Integration for the Janssen Supply Chain at Johnson & Johnson.  In this role, Eric leads a global team in the sourcing and management of all external product supply for drug product and biologic API’s.  Under Eric’s leadership, Janssen Supply Chain has established a strong portfolio of CMO’s and strategic alliance partners to ensure flawless product supply and readiness for new product introductions.

Eric has spent 28 years at Johnson & Johnson in the medical device, pharmaceutical and biotech areas.  Eric’s broad business experience includes leadership roles in manufacturing, business development, acquisition integration and contract manufacturing.

Mayo Pujols

Mayo Pujols is currently VP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey.  He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management.  Prior to this role, he served as Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises.  Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.  He holds a B.S. degree in Chemical Engineering from Stevens Institute of Technology and a M.S. degree in Chemical Engineering from Columbia University.  He also trained on operations and finance at the University of Virginia Darden School of Business.

Jeffrey Trost

Jeff Trost, Ph.D.  Jeff has been accountable for the laboratory operations at Myriad Genetic Labs since September 2005.  Key areas of success have been reducing  sample processing time down 5 days from 23 and reducing rework from ~25% to <5%, introducing multiple new products and technology from Sanger Sequencing to Next Generation Sequencing.  Prior to this role, Dr. Trost spent 2 years as the Director of Reagents Product Technical Support at Ventana Medical Systems and 10 years at Amersham Biosciences, starting in research and development for molecular biology kits and enzymes and finishing as the Director of East Coast Manufacturing.  Jeff holds a Ph.D. in Chemistry from Arizona State University and a double major BS degree in Bacteriology/Biochemistry from the University of Wisconsin-Madison.

Andrew Mica

Andrew Mica is the Senior Director, North America Supply Chain at Biogen overseeing product lifecycle management, manufacturing planning and logistics, and commercial product distribution centers. He is directing new product launch and network strategy initiatives including a global assessment of Biogen’s distribution network and operating model aimed at modernizing current capabilities and preparing for the future portfolio.  Prior to joining Biogen in 2014, Andrew worked with Amgen, in various commercial and clinical supply chain roles with leadership roles in Commercial Supply Chain organizational transformation and Supply Chain Segmentation initiatives.  Andrew began his career with GSK in plant support, process improvement and new product introduction roles both domestically and abroad.

Andrew served in the US Marine Corps, has a Bachelor of Science degree in Environmental Engineering from North Carolina State University and an MBA from California State University.  He is a licensed Professional Engineer and certified Lean Six Sigma Master Black Belt.

Heidi Hoffmann

Heidi Hoffmann, Senior Director, Supply Chain at Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics.  Directly after receiving her Ph.D. from University of California, Berkeley, Dr. Hoffmann began her career at Aviron, where she worked on process development and production of vaccines for EBV, PIV, and influenza (FluMist).  She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy.  In 2002, Dr. Hoffmann returned to vaccine work by joining VaxGen, where she was responsible for process development and manufacturing of anthrax vaccine.  Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia (abatacept) into the Celltrion manufacturing facility in South Korea.  After the completion of that project, Dr. Hoffmann joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and manufacture of HIV vaccines.  Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs produced using Sutro’s proprietary cell-free protein expression system.

Paul J. Staid

Paul leads the Biologics Product Strategy and Operations organization within BMS Biologics Development and Operations (BDO).   He is responsible for the supply strategy and lifecycle management of biologics brands, global network strategy, and the BDO PMO and performance management processes.

Prior to his current role, Paul was Head of GMS Strategy & Business Operations where he played a lead role in the diabetes divestiture as well as developing GMS restructuring plans as part of a company wide Diversified Specialty BioPharma Operating Model initiative.

Paul joined BMS in November 2009 as Head of Global R&D, Biologics, and GMS Sourcing within BMS Global Procurement.

Prior to joining BMS, Paul held the role of Senior Director of Biotech Strategic Sourcing for Wyeth Pharmaceuticals.   Prior to Wyeth he held a range of roles in supply chain, manufacturing, and engineering  functions with increasing responsibility in  high tech electronics, strategy consulting, and industrial equipment industries.

Paul holds a BS in Mechanical & Aerospace Engineering and an MBA from Cornell University.

Thomas Seewoester

Thomas is a leader in Amgen’s Operations organization and Plant Manager of Amgen’s Rhode Island facility. Prior to his current role he was head of Drug Product Supply and Drug Substance Supply in Thousand Oaks with responsibilities to provide global clinical supply out of two drug substance plants, a drug product plant, a device assembly and packaging plant and a small molecule API plant. In those plants Thomas and his teams have successfully matured new operations technologies for their successful commercialization and network-wide deployment. His plant teams received twice awards for being the most improved plants.

Thomas champions a culture of safety, global teamwork, operational excellence and lean manufacturing in order to generate product and data most efficiently while continuously improving the operation.

Throughout his 25 years of industrial bioprocessing experience in Process Development and Manufacturing, Thomas and his various teams have developed over 40 clinical and commercial processes and created knowledge to commercialize some of the most successful bio-therapeutics.
Thomas received a Ph.D. from the Institute for Cell Culture Technology, Germany and completed a 2-year postdoc program.

Sally Dyer

Sally Dyer joined AstraZeneca/MedImmune in 2016 as the Director of Manufacturing for the Boulder Manufacturing Center.

In her current role, Sally is accountable to build and prepare the manufacturing organization for the introduction and on-going production of biologics for the newly acquired site.

Prior to joining AstraZeneca/MedImmune, Sally spent time at Amgen, Inc. in various site and global manufacturing roles including site start-ups in Colorado, Puerto Rico and most recently at Amgen’s Next Generation manufacturing plant in Singapore.

Sally holds a B.S. Degree in Biological Science with an emphasis in Molecular Cell Biology from the University of California at Davis.

Walter Cespedes

Mr. Cespedes is a seasoned executive with over 28 years of industry Quality experience. Mr. Cespedes serves as Executive Director, Third Party and Commercial Quality Americas for Teva (Actavis).  Prior to this appointment, he served as VP Corporate Quality for Durata Therapeutics, Inc.  Mr. Cespedes has also held a position as a Senior Director of Corporate Quality Assurance for MEDA Pharmaceuticals. Prior to his work at MEDA, he held Quality Assurance roles at Pfizer, such as Quality Operations Supervisor, Senior Manager for Quality Operations, and Drug Product Assurance Team Leader. Earlier in his career, he worked for Roche Diagnostic Systems, Inc., Hoffman La-Roche, Inc, and Biocraft Laboratories, Inc. Mr. Cespedes is a graduate of Seton Hall University and earned his Masters of Science in Executive Management from the New Jersey Institute of Technology.  He now serves on the board of NJIT College of Science & Liberal Arts.

Ken Green

Head of MS&T function at Shire with responsibility for commercial product technical support and CMC lifecycle activities.

Over 18 years’ experience in the Biotech/Pharma industry with previous roles at Pfizer, Amgen, Lonza and GSK supporting manufacturing supply networks, biologics product commercialization and post-approval lifecycle management.  Experience with process development, process characterization (QbD), validation, technology transfer and commercial manufacturing. I have a passion for continuous improvement with application of six and lean sigma methodologies and strategic deployment. In addition, I also enjoy leading high performing teams and a trained facilitator and innovation coach.

Owen Murray

Owen Murray is the Head of US Technical Operations at Recordati Rare Diseases where he has responsibility for North American product development, commercial operations, supply chain and API business. Prior to joining Recordati Rare Diseases, he was the Chief Operating Officer at GLO Science, Inc. and was responsible for end-to-end development and production for new innovative oral health products as well as commercial sales and marketing activity. Prior to GLO Science, Inc. he spent five years in operations management at Lundbeck, leading cross-functional teams to deliver technology transfer initiatives and commercial operations. During his seven and half years at Cardinal Health, Inc., he held positions of increasing responsibility from research scientist through to group leader of proprietary drug delivery technologies. He is the author of multiple publications and holds numerous global patents.

Mr. Murray received his B.Sc. in Biochemistry with honors from the University of Wales. He earned his MBA with a Management concentration from Seton Hall University. He has professional certifications in Project Management and Finance from MIT.

Angela Card

Angela Card is the Executive Director for Amgen’s Trade Compliance and Supply Chain Security function.  She has ten years of experience in the biotechnology industry, including leadership roles in supply chain, new product development and commercialization.  She has led design and execution of large-scale, cross-functional/regional improvement initiatives throughout her tenure.   Angela has extensive experience in delivery of complex change programs integrating business processes, technology and governance.  Prior to Amgen, Angela held roles in the financial services and wholesale distribution industries.  She holds a BA and MBA from California Lutheran University, located in Thousand Oaks, CA.

Shou-Bai Chao

Dr. Shou-Bai Chao is currently Senior Vice President leading AstraZeneca’s BioVentures with a dedicated team to develop Biosimilars and BioBetters with leading biotech companies in China and other Asian countries for the global markets. Prior to the current responsibility, Dr. Chao served as Senior Vice President of Technical Operations and Manufacturing at Medimmune, a biological division of Astrazeneca. He was responsible for global operations of commercial and later stage clinical products (vaccines and antibodies) manufacturing and technical operations. Dr. Chao joined MedImmune in 2008 as Vice President of vaccine manufacturing, responsible for all aspects of global vaccine manufacturing and supply. He also contributed to Medimmune’s commitments to pandemic preparedness.

Prior to joining Medimmune, Dr. Chao served as Assistant Vice President, Technical Operations and Product Supply at Wyeth Biotech. He was responsible for global technical operations for the flagship vaccine, Prevnar(R) and other Biopharmaceutical Products. He brings comprehensive perspective with more than 23 years experience at Medimmune, Wyeth, Sanofi-Pasteur and Genentech in global vaccine and biopharmaceutical process and product development, manufacturing operations and quality assurance.

Dr. Chao earned his doctorate and completed his postdoctoral fellowship in Biochemical Engineering from University of Waterloo, Canada.

Mark Galbraith

Mark Galbraith has worked in the biopharmaceutical industry for 20 years, where he has gained diverse experience and knowledge in all phases of product development from pre-clinical to commercial, at small companies and large.  Mark began his career at Merck & Co, where he held positions of increasing responsibility in several functional areas related to vaccine clinical development and commercial manufacturing including analytical R&D, regulatory sciences, commercial analytical support, and quality control operations.  Mark continued to focus and develop his career in quality control management and commercial analytics by directing the quality control activities at Celldex Therapeutics, Bristol Myers-Squibb Syracuse, and Gilead Sciences’ aseptic fill facility in San Dimas, CA.  By way of this career path, Mark has gained a broad knowledge of quality control, analytics and microbiological control for vaccines, biotechnology products, sterile pharmaceuticals, and now gene therapy.  Mark is currently serving as Head of Quality Control for Spark Therapeutics Inc. in Philadelphia, PA.   Spark is a leader in the field of gene therapy, seeking to transform the lives of patients by developing potential one-time, life-altering treatments for debilitating genetic diseases.

Tim Moore

Anders Vinther

Anders is the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of Biologics Quality which included operational quality leadership for 10 Biologics Roche and Genentech manufacturing sites and all outsourced manufacturing for biologics products. Previous to that role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS), Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors. Additionally over the past 20 years in PDA he has been Chairman of the Board of Directors, Treasurer, Board of Directors member, task force and conference planning committee leader and member, and author of numerous articles.

Andrew Skibo

Andrew D. Skibo is Regional Vice President, Supply Biologics, Global Engineering and Real Estate at MedImmune/AstraZeneca Biologics where he affects changes in manufacturing operations, quality oversight, and cross-functional relations throughout the company. He is also responsible for AstraZeneca’s Global Engineering and Real Estate functions. Previously he has worked in other senior leadership roles at Amgen, Genentech, and Foster Wheeler, among others. In these roles he has been responsible for significant aspects of the companies’ operations including operations, engineering, construction, and validation for large-scale capital projects related to bio-pharmaceutical manufacturing. He is a member of the International Leadership Forum (ILF), a member of the Materials Technical Advisory Committee of the US Department of Commerce, and a member of the Editorial Advisory Board of Life Science Leader.

David Lowndes

David joined Shire in Feb 2011 as Vice President for Supply Chain Strategy and Product Commercialization in the Specialty Pharmaceuticals Division and was promoted to Senior Vice President Global Supply Chain and Quality in June of the same year. The Specialty Pharmaceuticals Supply Chain at Shire operates a fully outsourced business model. Currently Shire is undergoing a reorganization which removes the old divisional structure bringing David’s role into a Global Technical Operations organization.

Previously David has worked for Ciba-Geigy, SPIMACO, Rhone Poulenc Rorer, Eli Lilly and Genzyme with a total of 29 years of experience covering both Pharmaceutical and Biotech Manufacturing and Supply. David has experience living and working in Europe, Middle East, Japan and the USA.

David has a degree in Pharmacy from the University of Wales Institute of Science and Technology. He is on the Strategic Committee of the FDA Xavier Pharmalink Conference and is a member of the faculty of Supply Chain Management World.

Mark Paxton

Mark S. Paxton is the newly appointed CEO of RX-360, an international medical product supply chain consortium dedicated to patient safety by promoting practices to protect supply chains and distribution channels. RX-360 is based in Washington, DC. Prior to joining RX-360, Mark served as a Regulatory Counsel in the CDER Office of Compliance where he was responsible for developing supply chain security policies, both domestically and internationally, including serving as the overseer of a major global initiative under the auspices of Asia-Pacific Economic Cooperation (APEC) to establish best practices for ensuring product quality moving in international commerce. Before joining FDA, Mark served as Associate Vice-President, International Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (“PhRMA”). In that capacity, Mark established a number of on-going dialogs and work programs with drug regulatory authorities throughout China, East Asia, India, Europe and Latin America. These efforts were designed to assist regulators and constituent companies operating in emerging markets to better understand complex regulatory issues arising from the globalization of the pharmaceutical industry.

Mark is a regulatory attorney by education, experience, and training, and prior to joining PhRMA was in private practice in Lexington, Kentucky where he focused his practice on food and drug law. Mark received his B.S. (1991) and M.S. (1993) degrees in Economics from the University of Kentucky, and his J.D. from the University of Dayton School of Law in 1998.

Paul Marshall

**Advisory Board Member** Paul G. Marshall joined Heron Therapeutics as Senior Vice President of Technical Operations in November 2013. Mr. Marshall has 27 years of experience in the development and commercialization of pharmaceutical products, including manufacturing and supply chain responsibility for 14 approved drugs and biologics, three of which achieved blockbuster (sales >$1B) status. Since 2006, Mr. Marshall held ascending executive positions within Amylin Pharmaceuticals, Inc., including Senior Vice President of Operations. Prior to Amylin, Mr. Marshall held executive manufacturing positions at Amgen, Inc. and Baxter International. He has held management positions at Creative BioMolecules, Welgen Manufacturing Partnership (now Amgen, Rhode Island), Repligen Corporation and Damon Biotech. Mr. Marshall received his B.S. and M.S. degrees in biology from the University of Massachusetts at Dartmouth and completed three years of post-graduate work concentrating in hematology and coagulation research at Brown University.

Allen Harmon

Allen Harmon is the Head of Quality for Baxalta, a spinoff of Baxter BioScience. He is located at Baxter’s Westlake Village division headquarters.

Mr. Harmon joined Baxter in 1986 in the Marion, North Carolina facility as a Manufacturing Superintendent, and since then has worked in five different Baxter manufacturing facilities in both the US and Europe. Three of which he was plant manager. Prior to accepting his current role, Mr. Harmon was the Director of Operations for Baxter’s Bay area operations where he lead the development of a Contract Manufacturing business developing and manufacturing Monoclonal antibodies. Over his career, Mr. Harmon has been involved in the planning, development and deployment of Continuous Improvement activities throughout Baxter from the early days of quality circles to leveraging lean, six sigma, and DMIAC principals to drive performance in complex matrixed environments. Recently, he has championed deployment of global strategies around, Knowledge Management, QbD, Compliance Excellence and Quality System Simplification.

Responsible for the Quality Organization for the $5.6B BioScience Businesses. Includes all of the BioScience Division facilities which include LA, California/Thousand Oaks, Ca/Hayward, Ca/Milford Ma./ Brooklyn Park, MN and Covington, Ga. as well as all of our European plants in Lessines, Belgium/Neuchatel, Switzerland/Orth and Vienna, Austria/Rieti and Pisa, Italy/ and Singapore, along with an external Quality organization responsible for oversight of approximately 20 CMO engagements. In addition, he has quality responsibility of over 70 Plasma Collection facilities and Division Quality. Accountable for global regulatory compliance, product and process quality, organizational efficiencies, global quality systems and all quality related product and process development activities.

Mr. Harmon holds a Bachelor’s degree in Chemistry from The Citadel and a Master of Science in Industrial Management from Clemson University.

Steven Lee

Currently Dr. Steven Lee is Chief Executive Officer of DRL Singapore Operations, Pte Ltd, Singapore for India-based Dr. Reddy’s Labs Biologics Technical Operations (NYSE listed company), one of Asia’s leading biosimilar development and manufacturers. Joined DRL in 2012, he is responsible for global biologics technical operations and Singapore operations to manufacture commercial biologics and support biosimilars development. Dr. Lee has more than 25 years of global multinational biopharmaceutical industry experience in bioprocess development and biologics manufacturing, and more than seven years experience in emerging market (Asia) business development and commercialization including founding BioGENEXUS, LLC in 2012. Prior to his current position, Dr. Lee was the Global Head, Biologics Business of Luye Pharma Group, a China-based pharmaceutical company, which acquired A-Bio Pharma Pte Ltd, a pioneering biotech company founded by Singapore government in 2010. Dr. Lee served as A-Bio Pharma’s new CEO since 2008. Under Dr. Lee’s leadership, Luye Pharma Group enabled A-Bio to serve as the R&D center for their biologics pipeline, aiming at China’s rapidly growing biopharmaceutical market and unmet medical needs. Prior to his return to Asia, Dr. Lee was Vice-President and General Manager, Process Development and Biologics Manufacturing, Bristol-Myers Squibb Company (BMS) where he was responsible for leading the Syracuse, New York Manufacturing and Process Development team, overseeing a wide range of protein therapeutics and late stage development biologics candidates. Dr. Lee built a high performance team to establish sustainable infrastructure for the BMS biologics franchise and obtained FDA approval and launched the first BMS internally developed biologics, OrenciaTR for rheumatoid Arthritis. Prior to joining BMS in 2002, he worked for two global pharmaceutical companies including Merck & Co, Inc (USA) and Hoffmann-La Roche (USA). At Merck, Dr. Lee held several positions of increasing responsibility at both Merck Research Laboratories in Rahway, NJ, where he developed various bioprocesses for vaccines and biologically-derived therapeutics including launching antifungal agent, CancidasÒ; and Merck Manufacturing Division in West Point, PA, where he led a consolidated process, equipment engineering and technical services group to perform technical operations for all commercial biologics and introduce novel vaccines. Dr. Lee received his Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology (MIT), Cambridge, MA, USA; M.S. in Chemical Engineering from The University of Michigan, Ann Arbor, MI, USA; B.S. in Agricultural Chemistry from National University of Taiwan, Taipei, Taiwan.

Maureen Skowronek

Maureen Skowronek is the Vice President – Global Vaccine and Biological Quality Operations at Merck. In this position, mobilize and align the quality operations of the Global Vaccine and Sterile Manufacturing and Biologics portfolio of products.  Oversee 12 manufacturing facilities and approximately 2,000 staff.  Ensures the highest quality operations and analytical technology, meeting timelines and assuring patient satisfaction for key brands:  MMR, RotaTeq, Varicella family of vaccines, Primaxin, Gardasil, Remicade, Intron family of products, etc.  Support the growth of MBV pipeline.  Direct cross-site quality operating teams and subject matter experts to provide solutions specific to evolving regulations, compliance directives, and continuous improvement in business processes and quality systems.

Past Merck Positions

Vice President – Global Biological Quality Operations (Dec. 2009 –Feb. 2011)

Past Non-Merck Positions 

Wyeth Pharmaceuticals, Collegeville, PA (now Pfizer)  (1982-2009)

Vice President Global Quality, Vaccines and Biologics (2008-2009)

Vice President Global Quality and Compliance, Biotech OPU (2006-2008)

Carlos Villalobos

Carlos is a Global Operations, Manufacturing, and Engineering executive in Bio-Pharma Industry. Most recently with Actavis, Bristol Myers-Squibb and Johnson and Johnson. Extensive experience developing strategies that substantially improve product supply and company revenues. Optimized product introduction and commercialization in more than 60 countries worldwide. Results-oriented leader with solid track record of instilling passion and motivation to a large diverse work force in a highly regulated and fast-paced environment. Proven capital investment strategist. Designed and built manufacturing and R&D assets up to $1B projects. Founder of Global Operations consulting firm that provided services to Industry and Governments in the Americas and Europe.

Vijay Yabannavar

Dr. Yabannavar is currently the Senior Vice President of Manufacturing Ops. & Technical Development at Emergent Biosolutions (Baltimore, MD), which is engaged in the development and manufacturing of vaccines and therapeutics for biodefense and commercial needs. He is the Site Head of the Baltimore Facility which is a CIADM (Center for Innovation in Advanced Development and Manufacturing) center funded by BARDA. Previously, he was the Transition Head of Technical R&D in Novartis Pharmaceuticals in Emeryville, CA following Chiron acquisition. At Chiron, Dr. Yabannavar led process development and clinical product manufacturing activities for biopharmaceuticals (including antibodies) and vaccines. Prior to joining Chiron, Dr. Yabannavar was at Schering-Plough Corp. (Union, NJ), developing and commercializing processes for recombinant proteins, antibodies and antibiotics.

Dr. Yabannavar received his Ph.D. in (Bio)Chemical Engineering from MIT (Prof. Daniel Wang’s lab) in 1988. He has made 20 presentations at International conferences and published 9 papers and authored 2 patents. He was the Chair for the Biochemical Engineering XV Conference held in Quebec City (Canada) in 2007. He has served as a member of the Advisory Board for the Chemical Engineering and Materials Science Department at U. California, Davis (Davis, CA).

Matt Gray

Matt Gray is Director of QA Systems at BioMarin Pharmaceutical Inc., where he directs the groups that manage the change control, deviation, CAPA, document lifecycle, product complaints, and annual product review systems. He also leads GMP inspection readiness efforts for the Novato site and provides a key leadership role during inspections. He has been with BioMarin since 2001 and was with Alza Corporation prior to joining BioMarin. He has played a key role in the development of Quality Assurance Systems to support BioMarin’s growth from a single product in one site to multiple products in additional sites worldwide. The QA Systems group is an integral component in the GMP facility, utility, and equipment commissioning activities. Matt received his Bachelor of Science Degree in Pharmacology from UC Santa Barbara.

Melissa Seymour

Melissa Seymour is the Vice President of Corporate Quality for Biogen Idec assuming responsibility for global compliance and global quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight. Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an MBA from Duke University. She is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality Manager. She is currently the president of the Southeastern PDA and previously served on the Board of Directors for the Rx-360 Consortium. Melissa has over 20 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline.

Remo Colarusso

Remo Colarusso is the Vice President of Manufacturing & Technical Operations for the Janssen Supply Chain at Johnson & Johnson. In this role, Remo is responsible for the product supply of the entire product portfolio of Janssen across the globe through internal manufacturing sites and external manufacturing partners; the portfolio includes vaccines, biologics, and traditional small molecule pharmaceuticals. Also in his scope are the oversight of Engineering & Maintenance, which implement capital projects and support operations across the network, and Execution Systems, which implement advanced automation and data management across the enterprise. Lastly, Remo oversees the Technical Operations group which supports the ongoing manufacturing operations, conducts the technology transfer of new products from R&D and implements new manufacturing technologies evolving in the industry.

Most recently, Remo ran the Pharmaceutical Development & Manufacturing Sciences organization which drove end-to-end pharmaceutical and biologic development and clinical product supply, resulting in the generation of the CMC dossier for new pharmaceutical and biologic product applications.

Remo has 30 years of experience covering the consumer, biotech and pharmaceutical industries in the areas of supply chain and process development. He has been accountable for the plan, source, and make functions within the supply chain, as well as supporting functions such as new product introduction, engineering, project management, strategy and process excellence / Lean Six Sigma.

Remo holds a BS in Chemical Engineering and an MBA in Operations Research, both from Rutgers University. He is an active member in the International Society of Pharmaceutical Engineers and participates in the Rutgers School of Engineering and Stevens Institute of Technology Advisory Boards.

Alex Tschumakow

Alex joined Shire in 2007 as part of the team to design, build, and startup a new greenfield manufacturing facility on their campus in Lexington, MA.  This facility utilizes single use technologies to the greatest extent possible and was the first to be approved by FDA and EMA for commercial production at the 2,000 L bioreactor scale.  Alex’s current role there is Head of Upstream Manufacturing Operations.

Previously, Alex worked for Organogenesis, BioChem Pharma, and GSK with a total of 28 years of experience in the areas of Tissue Engineering, recombinant protein vaccines, egg based influenza vaccines, and recombinant protein enzyme replacement therapies.

Alex has a Bachelor of Science in Mechanical Engineering from Purdue University and has held roles in Facility Engineering, Process Engineering, Validation, and Manufacturing.  He is currently a member of the BPOG Single Use Leadership Group.

Stephen Liebowitz

Stephen Liebowitz is Vice President, Global Technical Services at Shire Pharmaceuticals.  Previously, he held the position of Vice President Global Technical Services at NPS Pharma. Prior to NPS Dr. Liebowitz held positions at Bristol-Myers Squibb and Schering-Plough in Global Regulatory Sciences, Pharmaceutical Product Development and Quality.  He has 29+ years of pharmaceutical industry experience.  Prior to joining the pharmaceutical industry he was an Assistant Professor of Medicinal Chemistry at the University of Texas, College of Pharmacy.

He has served on the PQRI WG for Process Robustness and PQRI WG for Sterile Products, and was a past Chairperson of NJPhAST (formerly the NJ Pharmaceutical Discussion Group) and the Association of Pharmaceutical Technologists.  He is a past member of the USP Committee of Experts.  He currently is a member of AAPS.

Dr. Liebowitz received his Ph.D. and B.S. in Medicinal Chemistry from the Medical College of Virginia and SUNY at Buffalo respectively.  He was a postdoctoral fellow in Medicinal Chemistry at The Ohio State University and Adria Laboratories.

Daniel Vellom

Daniel Global position providing technical support and process/technology solutions for new vaccines, product and process improvement projects and troubleshooting for existing vaccine products. Establish and manage collaborative projects exploring new technologies and innovative process solutions via Sponsored Research contracts with academic investigators (MIT). Local representative for Sanofi Pasteur Manufacturing Technology Talent Nursery, interfacing with Universities to provide undergraduate students in scientific and engineering fields the opportunity for internships or Co-ops at Sanofi Pasteur facilities in North America and Europe.

Edward Bjurstrom

Mr. Bjurstrom is the Vice President of Operations and General Manager of Gilead Sciences’ manufacturing operation in San Dimas, California. This site manufactures aseptically filled and lyophilized products as well as packaging of solid oral dose products for distribution in North America, South America and Pacific Rim countries.

Previous to his position at Gilead, Mr. Bjurstrom managed his own consulting practice for 7 years serving a number of biotechnology and pharmaceutical companies. Key clients included NovaRx Corporation, Abgenix Inc, Revalesio Corporation, Integrity BioSolutions, Tocagen, and Gilead Sciences. Mr. Bjurstrom’s responsibilities included providing organizational support; overseeing product development, registration and launch; serving as interim head of operations, guiding facility expansion and preparing for Pre-Approval Inspections.

Prior to founding his consulting practice, Mr. Bjurstrom held a variety of leadership roles during the 18 years he was at Amgen Inc. Key responsibilities included development and execution of strategic and long range planning necessary to manage the complex issues of a rapidly growing company. He successfully led negotiations with governmental agencies, including the FDA and a variety of international regulatory bodies, as well as negotiations with business partners on both sides of the contract manufacturing relationship.

Mr. Bjurstrom’s 32 years of experience in the bio-pharmaceutical industry includes broad involvement in all aspects of process operations, manufacturing, quality, engineering and capital projects across multiple global sites. In addition, Mr. Bjurstrom has had senior management responsibility for preclinical and clinical development activities for new biotech products. His extensive managerial and leadership capabilities have also been recognized for being highly effective in managing organizational change and rapid workforce growth.

Mr. Bjurstrom has a bachelor’s degree in Chemical Engineering from California State University at Long Beach and has completed the Executive Business Program at the University of Michigan.

Amy McDaniel

Amy McDaniel is a Director of Technical Operations at the Sanford, NC facility for Pfizer, where she oversees a department responsible for implementing new technologies for the manufacture of intermediates for a conjugated bacterial vaccine. Her department is also responsible for cleaning validation, process validation, process monitoring, and technology transfer for new clinical vaccines as they progress from R&D to Production Operations.  Historically, Amy has led two manufacturing departments at the Sanford facility, as well as the QC Microbiology department.  Prior to joining the Sanford team in 2009, Amy led the QC Microbial Science & Technology function and then the QC Microbiology laboratory for 9 years at the Pfizer Andover facility in Massachusetts, for a total of 16 years at Pfizer.  Prior to Pfizer she worked for a rapid microbiology vendor as an Application Specialist, and she has also worked in Clinical research for a Contract Research organization.  She holds Masters and Ph.D. degrees in Microbiology & Molecular Genetics.  She is the author of numerous presentations and book chapters on the topic of rapid and alternative methods in microbiology.

Brian Johnson

Brian Johnson is the Sr. Director Supply Chain Security at Pfizer. He is responsible for Pfizer’s corporate supply chain security program. This program was developed to combat growing supply chain threats related to product theft, product diversion, economic adulteration, and counterfeit goods. Brian has been with Pfizer for 30 years and has held a number of leadership positions in manufacturing and quality assurance. He started in the Kalamazoo manufacturing plant and held various QA leadership positions supporting sterile manufacturing. In 2000 Brian was appointed Sr. Director Quality Assurance Global External Supply responsible for global contract manufacturing. Brian also relocated to Brussels Belgium in 2000 where he added QA responsibility for several manufacturing plants in Europe. Brian returned to New Jersey in 2003 to lead the America’s Contract Manufacturing QA organization until moving into his current role in 2010. Brian has been actively involved in a number of external professional/trade organizations working on quality assurance and supply chain security initiatives including PhRMA, ISPE, PDA, and Rx360. Brian is currently Chair of Rx360. He has a Bachelor of Science degree from Central Michigan University.

Anthony Hurley

Anthony Hurley is Vice President and Head of External Manufacturing – Biologics for Roche/Genentech based in South San Francisco, CA. He is responsible for Biologics CMO network operations globally. In this role he manages the relationships with approximately 40 different CMO’s around the world. He joined Genentech in 2005 where he was responsible for the biologics manufacturing operations in South San Francisco prior to assuming his role leading the Roche Biologics Quality Operations for the Drug Product network in 2010. In June of 2013, he assumed his current role leading the biologics CMO network. Prior to Roche/Genentech, Anthony worked for GlaxoSmithKline for 17 years, primarily in Manufacturing, including 5 years as Site Director of Upper Merion Operations, in PA. Anthony holds a B.Sc. in Chemical Engineering from CIT, Ireland and a M.Sc. in Industrial Engineering from Rutgers, The State University, NJ.

David Allen

Dr. David Allen is currently the Senior Directory of Technical Services/Manufacturing Sciences for the Indianapolis Parenteral Operations for Eli Lilly and Company.  David joined Eli Lilly and Company in 1994 from The Upjohn Company of Kalamazoo, Michigan.  His tenure in industry has spanned 27 years in total and for the first 11 years focused on protein therapeutic R&D with an emphasis on products on the pre-clinical to Phase II development activities.  For the past 16 years David has focused on manufacturing science and technology issues that has ranged from large scale protein purification of recombinant DNA proteins (Insulin), facility design and commissioning, process validation, parenteral drug product manufacturing and currently focusing on technical transfer and drug product commercialization.  David obtained his Ph.D. in Chemistry from Purdue University in 1988 and his B.S. in Biochemistry from University of Pittsburgh in 1982.

Christopher Stevens

Chris Stevens is Director of Manufacturing Operations at GlaxoSmithKline where he leads manufacturing, supply chain, process transfer and cell banking operations.  Prior to GSK, he was Associate Director, Manufacturing at Bristol-Myers Squibb’s (BMS) facility in Devens, MA responsible for downstream operations.  While at BMS-Devens, he held roles in Supply Chain and Manufacturing  focused on operations management and the implementation of advanced MES and process modeling technologies.  Prior to this, Chris held roles of increasing responsibilities with BMS in Indiana and Puerto Rico.  Chris received his M.S. in Industrial Management from the University of Southern Indiana and a B.S. in Chemical Engineering from Purdue University.

Shane A. Yount

Shane A. Yount is a nationally recognized author, consultant, and principal of Competitive Solutions, Inc., an international Business Transformation consulting and software firm. Shane’s team pioneered the acclaimed organizational governance system known as Process Based Leadership® (PBL) – A robust governance methodology designed to create a sustainable cadence of clarity, connectivity, and consistency through the use of a dynamic people and software solution. Shane’s ability to diagnose inefficient governance models and quickly design and deploy solutions that accelerate and amplify team performance, has made him and his firm long term partners with such organizations as Genentech, Pfizer, Alcon, Roche, GSK, Meridian Medical Technologies, and many others. Since 1991, Shane has led the offices of Competitive Solutions, Inc. while publishing three best-selling business novels. His latest novel, Leading Your Business Forward is required reading within many leadership development curriculums being taught within industry today.

Lance Minor

Lance Minor has over 20 years of design and deployment of business strategies and operations experience. Currently at Astra Zeneca – Global Biologics Operations, he drives network strategy, clinical and commercial supply planning from its internal and CMO network, business metrics, and the Biologics PMO team. In addition, to the commercial supply planning for Synagis and FluMist/Fluenz, his team focuses on ensuring end-to-end supply of post-PV new product launches.

Previous roles include appointments at Novartis Vaccines and Pfizer/Wyeth Pharmaceuticals supporting its Biologics and Vaccines Business Units.

Gary Barrera

Gary Barrera has almost 20 years of experience in Quality and Operations. Currently at Theravance Biopharma Antibiotics Inc., he is the Head of Quality where he drives quality strategy, governance, oversight and operations for commercial programs executed through a CMO network.  In addition to ensuring the commercial supply of VIBATIV, his team focuses on ensuring the quality of development and clinical programs for Theravance Biopharma Antibiotics Inc., rich pipeline.

Gary’s previous roles include operational and Quality roles at Bayer, Genentech, and Boehringer Ingelheim.

Jon Coffman

Dr. Jon Coffman is Director, Bioprocess Engineering & Technology & Innovation Manager in Boehringer Ingelheim at Fremont, California. Jon and his team are instrumental in driving the implementation of BI’s bioprocessing innovation vision.

Jon is an internationally recognized expert in bioprocess and technology development.  Jon has more than 20 years of industry experience, mostly from his work at Genetics Institute/Wyeth and Pfizer, and now at Boehringer Ingelheim . Prior to 2009 Jon led a team in the area of downstream purification development, as well as CMC drug development teams. From 2009 on, as Associate Research Fellow, he coordinated Technology and Innovation for Bioprocess R&D, and led Pfizer’s monoclonal on demand team, developing concepts for faster, lower cost antibody process development.  Jon now leads Boehringer Ingelheim’s development of continuous processing for early and late stage manufacturing.

Diane Petitti

Diane Petitti currently serves as Vice President and Head of Biologics Quality for Bristol-Myers Squibb (BMS) with overall accountability for assuring GMP quality and compliance of BMS’ internal and external manufacturing and testing activities supporting bulk drug substance (clinical and commercial) and commercial drug and combination products. She has additional responsibility for US supply chain quality. Petitti is a proven leader with over 25 years diverse technical and Quality management experience in the biopharmaceutical / pharmaceutical industry. Before joining BMS in 2011, Petitti was Vice President and Head of Quality for Amylin Pharmaceuticals, Inc (San Diego, CA) where she lead the design and implementation of a comprehensive GXP Quality System that successfully supported regulatory approval of two back-to-back, first-in-class diabetes products. In addition, Petitti lead the quality and validation oversight of the design, commissioning, qualification and regulatory approval of Amylin’s commercial Quality Control Laboratory (San Diego, CA) and their state-of-the-art manufacturing site (West Chester, OH). Petitti began her career at SmithKline & French Labs (Swedeland, PA) and Merck & Co (West Point, PA) holding various positions of increasing technical and management responsibility supporting development and manufacturing of biological and vaccine products. Petitti served on the inaugural Board of Directors for Rx-360, an international pharmaceutical consortium focused on assuring patient safety throughout the supply chain (2009-2012). She is an accomplished technical writer having several published works on topics such as quality systems for contract service users and practical considerations for validation and transfer of analytical methodologies (PDA and Davis Hardwood International Publishing, Ltd). Areas of technical and compliance expertise include complex investigation management (root cause analysis, product quality impact assessment and CAPA), global regulatory Health Authority inspection preparedness, management and response writing, and quality and compliance oversight of internal and third party manufacturing and testing sites.

Joseph Fuhr

Dr. Joseph P. Fuhr Jr. is a professor of economics at Widener University and currently serves as a senior fellow with The American Consumer Institute and Ambassador for the Internet Innovation Alliance. Dr. Fuhr received his M.A. and Ph.D. from Temple University and his B.A. from LaSalle University.  His primary research areas are antitrust, health economics, pharmacoeconomics, telecommunications, and sports economics. In health care, he has written on hospital mergers, specialty hospitals, exclusive arrangements, health insurance, bundling and doctor’s fees. In pharmacoeconomics, he has written on cost benefit analysis, biosimilars and predictive modeling. He has published over sixty journal articles of which ten are on biosimilars. Professor Fuhr has been an expert witness on various cases and has worked on various consulting projects.

Lucy Medeiros Cabral

Lucy has twenty four years of experience at Genentech and Roche in the Quality Assurance, Compliance, and Quality Control groups as part of the plant quality functions.

Lucy has extensive experience managing commercial and clinical contract manufacturers and material suppliers operating in the US, Europe, and Asia.

Lucy holds a Bachelor of Arts in Biology ad she is an expert in auditing raw material suppliers.

Currently Lucy is the Head of Supplier Quality Management, for the Roche Pharma worldwide responsible for the management of materials (chemicals and components).  The team is responsible for qualifying and monitoring Roche suppliers worldwide of clinical and commercial material for biologics and small molecule products and for Material Specifications lifecycle management used globally.

Lucy is also responsible for the expiry date assignment of Roche products.

Nick Keener

Nick leads the Drug Substance Process Engineering team at Amgen’s manufacturing site in Juncos, Puerto Rico.  The team’s responsibilities include Process Development commercial support, technology transfer, regulatory inspection support, process monitoring, and process validation.  The team supports upstream and downstream drug substance manufacturing processes involving microbial fermemtation, protein pegylation, oxidative refolding, fed-batch mammalian cell culture, and perfusion of mammalian cell culture.  The team supports a wide range of protein modalities: monoclonal antibodies, fusion proteins, and erythropoiesis stimulating agents.  Nick has been at Amgen throughout his career, starting in 2003 at the Thousand Oaks site, and working in the early and late-stage Process Development group prior to transferring to Amgen’s Puerto Rico site.  Nick received his PhD in Chemical Engineering from the University of Virginia in 2003.

Jeff Ranney

Jeff Ranney is a Director of Engineering in the Amgen Corporate Engineering Group.   In this role he is responsible for the Amgen’s corporate equipment engineering group in support of manufacturing systems.  His team leads a series of Amgen technical engineering networks focused on equipment design, operations and life cycle optimization of process systems across Drug Substance and Drug Product manufacturing.  Jeff is also leading the establishment and maintenance of a Standardize Design program at Amgen intended to improve the efficiency of equipment design and delivery, to reduce risk and improve flexibility in the manufacturing network.

Jeff joined Amgen in 2004 as an Engineering Project Manager, and has held various leadership roles at Amgen on both site and corporate engineering and project delivery teams.   He has a Bachelor of Chemical and Petroleum Engineering from the Colorado School of Mines and a Ph.D. in Chemical Engineering from the University of Michigan.

Bernd Eichenmueller

Bernd is currently Vice President, US Operations, for the Animal Health subsidiary of Boehringer Ingelheim in the US. He manages two sites in St. Joseph, MO and Fort Dodge, IA with 1100 employees. Main business activity is vaccine production (viral, bacterial, subunit) for veterinary vaccines. In addition, Bernd is managing a network of CMOs for veterinary pharmaceutical drug manufacturing.

Peter Carbone

Peter Carbone is VP, Global Head External Relations, Group Quality since April 2014. Prior to joining Novartis, Peter worked for Allergan for 7 years in a variety of senior quality leadership roles including Vice President Biologics. During his career, Peter has lead engineering and quality teams for several major pharmaceutical companies supporting operational excellence, quality improvement, and compliance initiatives in complex biotechnology, pharmaceutical, and medical device manufacturing environments. Peter holds a degree in Chemical Engineering from Rensselaer Polytechnic Institute.

Joerg Heidrich

A recognized leader in the field of Bio-manufacturing, Mr. Heidrich has dedicated nearly 30 years of his professional career to the management of various manufacturing operations within the global Bayer Group. He currently heads the Global Product Supply Biotech organization overseeing the manufacturing and distribution of Bayer’s $3 billion biotechnology product portfolio. Mr. Heidrich is known for his passion on leadership, process orientation and operational excellence which led to numerous outstanding financial achievements and international speaker requests.

Joerg is responsible for all pharmaceutical biotech manufacturing and supply within Bayer worldwide. This is the cornerstone of Bayer’s Specialty Pharma business, focusing on treatments for severe diseases and acute abnormalities, involving for example, oncology, hematology and multiple scleroses.

He is also a member of the Worldwide Bayer HealthCare Product Supply Executive Team; Board of Bayer US Country Council; Board of Directors of San Francisco BayArea Council; Board Member of UC Berkeley Biotech Automation Council

Work areas include: 12 years USA, 4 years Mexico, 5 years East Germany and 6 years West Germany with project assignments throughout Europe, Japan, Hong Kong and China.

Patrick Yang

Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech and Roche.

He was Executive Vice President and Global Head of Roche Pharmaceuticals Technical Operations based in Basel, Switzerland from January 2010 to March 2013. In this role, he was accountable for Roche’s pharmaceutical and biotech manufacturing operations, and process development. He and as previously Executive Vice President of Product Operations of Genentech, based in South San Francisco. Dr. Yang worked for Genentech for 10 years, from 2003 until his retirement in October 2013.

Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Co. in various leadership positions including Vice President, Supply Chain Management, and Vice President, Asia/Pacific Operations.

Before joining Merck in 1992, Dr. Yang spent 12 years at General Electric (1980-1992), serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Dr. Yang holds a Ph.D. degree in engineering from Ohio State University, Columbus, Ohio.

He a member of Board of Directors of Tesoro Corporation, Codexis, Celladon, Amyris, and PharmaEssentia.

Greg Guyer

Dr. C. Greg Guyer is currently Sr. Vice President, Biologics/Therapeutic Proteins & Sterile Line of Business at Merck. He is responsible for overseeing manufacturing operations for Biologics, Therapeutic Proteins and Sterile Manufacturing Sites. Greg joined the Company in 1994 as Senior Director, Worldwide Regulatory CMC, Merck Research Laboratories. He then held positions of increasing responsibility within the Merck Manufacturing Division (MMD), specifically in the Quality Operations area, Global Quality Assurance and Asia Pacific Operations, until 2005 when he took on the unique role of leading the COMET (Global SAP) Program, a strategic initiative of Merck’s “Plan-to-Win”. He then served as VP, Emerging Markets for MMD leading the development of the Emerging Markets Strategy with his counterparts in Global Human Health and Merck Research Laboratories. Prior to his current role, he was Sr. Vice President, Global Quality overseeing all Quality Operations, Quality Assurance & Research and Commercialization Quality for all lines of our business.

Greg is a graduate of the University of Georgia, with advanced degrees from The American University in Washington, DC and Lehigh University. Prior to joining Merck, Greg served in varied capacities over ten years, at the FDA in the Center for Drug Evaluation & Research and also in the Center for Veterinary Medicine.