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.

Lynn Bottone

Lynn Bottone is a proven leader with 30 years of manufacturing and quality experience in the biotechnology, pharmaceutical and dietary supplement industries.
Her vast career includes experiences in Quality Control, Quality Assurance, Compliance, Project Management, and Manufacturing, specifically in the areas of drug substance, drug product formulation and aseptic filling, including inspection and packaging. She also has experience with bulk chemical, solid oral dose pharmaceuticals and dietary supplements, and liquids, creams and ointment manufacturing.

Lynn was appointment to her current position with Pfizer Inc. as Vice President of Biotech Operations on February 25, 2020. Lynn is responsible for the oversight of an integrated network of twelve large molecule manufacturing sites across ten countries producing both drug substances and drug products.

Previous to Lynn’s current role at Pfizer, she held the position of Vice President, Global Quality Assurance Vaccines at Merck from 2018 to 2020, where she was responsible for all quality assurance matters for Merck Vaccines. In addition, she was part

Peter Marks

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Pam Cheng

Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. Under her leadership, AstraZeneca Global Operations has transformed significantly driving top performance across the business while delivering value back to the enterprise.  The next phase of transformation includes the convergence of operational excellence and digital innovation, building the ‘Factory of the Future’.

Before AstraZeneca she spent 18 years in global manufacturing, supply chain, and commercial roles at Merck/MSD. As president of MSD China, she was responsible for MSD’s entire business in China—sales and marketing, commercial operations, and oversight of manufacturing and research and development. Prior to that, she was head of Global Supply Chain Management and Logistics for Merck and led the transformation of Merck supply chains across the global supply network.  Before joining the Biopharmaceutical industry, she worked in engineering and project management roles at Universal Oil Products, Union Carbide Corporation, and GAF Chemicals.

In addition to her executive role at AstraZeneca, Pam is a nonexecutive director for the board at Smiths Group plc.

Ms. Cheng holds bachelor’s and master’s degrees in chemical engineering from Stevens Institute of Technology and an MBA in marketing from Pace University.

Esteban Santos

Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain.

Prior to this role, Santos was senior vice president, Manufacturing, responsible for operations at Amgen’s commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the Netherlands and Singapore. He held various leadership roles, including vice president, Drug Product; vice president, Site Operations; vice president, Manufacturing; and vice president, Engineering. Santos joined Amgen in 2007 as executive director, Manufacturing Technologies.

Before joining Amgen, Santos was site general manager for the Johnson & Johnson (J&J) Cordis operation in Puerto Rico. Prior to J&J, Santos held several management positions in General Electric’s industrial and transportation businesses in Puerto Rico, Connecticut and Pennsylvania.

Santos holds a Bachelor of Science degree in Electrical Engineering from the University of Puerto Rico – Mayagüez, and a Master of Science in Management from the Rensselaer Polytechnic Institute, Hartford, Connecticut.

Patrick Yang

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

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.

Michael Kamarck

Michael Kamarck was the 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.

Wolfram Carius

Prof. Wolfram Carius is the EVP, Cell and Gene Therapy 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 nearly three 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 over 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.

Tim Moore

Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, 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.

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.

Andrea Goddard

Andrea Goddard (Andi) is currently the Senior Vice President and Global Head of Quality and Compliance for Roche/Genentech Pharma Technical Operations and is a member of Genentech Executive Committee. Pharma Technical Operations spans the world with sites on four continents. She is based in South San Francisco, California.

Andi is proud to work for a company focused on patient needs and in an organization that produces clinical and commercial pharmaceuticals for life threatening conditions. She fully embraces the commitment to “Doing now what patients need next.”

Andi is known as a demanding and courageous yet caring leader recognized for her ability to solve problems, her strategic agility, strength, warmth and integrity.

Andi has over 25 years of experience in the biopharmaceutical industry. Her background includes operational and leadership roles in Manufacturing, Manufacturing Science and Technology and Quality.

Chris McDonald

Chris leads the Global Manufacturing Leadership Team (GMLT), which includes the Site Operational Leaders and cross-functional partners from Quality, MSAT, IT, HR and Finance.  Chris is responsible for viral vector, clinical and commercial cell therapy operations, developing manufacturing strategy, executing site operations, ensuring cGMP compliance, establishing new capabilities, advancing process and analytical technologies, building teams and developing people.  Additionally, Chris is responsible for culture development at our sites driving an inclusive culture of safety, quality and production excellence.

Chris is a global business leader with over 30 years of biotech and pharmaceutical operations experience across various functions within Technical Operations. Chris joined Kite in 2018 as Site Head of Cell Therapy Operations in Fredrick, MD.  Prior to that Chris was with Astra Zeneca, where he was VP & Site Head of Operations for their monoclonal antibody site.  Previously Chris spent 10 years at Novartis in positions of increased responsibility, including VP & Site Head of Vaccines Operations, and VP & Global Head of Technical Operations Strategy.  In this role Chris was responsible for product life cycle management, long range production planning and manufacturing network strategy for a network operating in eight countries. Prior to his time at Novartis, Chris held various manufacturing and engineering leadership roles at Amgen.

Chris holds a bachelor’s degree in Computer Science from Eastern Michigan University and master’s degree in business from the Fuqua School of Business at Duke University. He is also a frequent guest lecturer at Duke and North Carolina State Universities for operational excellence in biomanufacturing and biotechnology processing.

Greg Guyer

C. Greg Guyer, Ph.D, joined BioMarin in May 2020 and currently serves as Chief Technical Officer and Executive Vice President of Global Manufacturing and Technical Operations, responsible for overseeing our manufacturing, process development, quality, supply chain, engineering and analytical chemistry departments. From 2015 to 2019, Dr. Guyer served in a number of increasingly responsible positions at Bristol Myers Squibb (BMS), primarily leading all of operations and biologic development. Prior to BMS, Dr. Guyer worked for Merck & Co., Inc., from 1994 to 2015, leading various global organizations in biologic and pharmaceutical operations, quality, regulatory, emerging markets strategy and enterprise systems. He currently serves on the Board of Directors for the University of Georgia Research Foundation.

Dr. Guyer earned his Ph.D. in analytical chemistry from American University, Bachelor of Science degree in chemistry from the University of Georgia and Master of Business Administration degree from Lehigh University

Andy Ramelmeier

R. Andrew “Andy” Ramelmeier, PhD, currently serves as Executive Vice President, Technical Operations and is responsible for Technical Operations at Sangamo, including manufacturing, quality supply chain, and process and analytical development. Dr. Ramelmeier has 25 years of 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. Prior to joining Sangamo in January 2018, he served as Senior Vice President, Technical Operations at Portola Pharmaceuticals, Inc., where he was responsible for tech transfer, bulk and drug product manufacturing, technical support and supply chain of Portola’s pipeline products. From 2006 to 2014, Dr. Ramelmeier served as Vice President, Manufacturing, Process Sciences and Facilities at BioMarin, overseeing multiple commercial biologics products, clinical pipeline, and facilities in Novato, CA, and Shanbally, Ireland. Earlier in his career, he held roles of increasing responsibility at Johnson & Johnson and Merck.

Prior to joining industry, Dr. Ramelmeier conducted post-doctoral work in Germany. He received a B.S. in Chemical Engineering from Johns Hopkins and his Ph.D. in Chemical Engineering from the University of California, Berkeley.

Anders Vinther

Anders Vinther serves as VP Quality at Kronos Bio. He joined Intarcia Therapeutics in 2018 as VP Global Quality and Engagement, previous to this Anders was 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.

Melissa Seymour

Melissa Seymour is Global Head of Quality and Chief Quality Officer for Biogen Inc. In her current role Melissa leads the PO&T organization in setting the quality compliance strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality and compliance in the pharmaceutical industry. Prior to this, Melissa served as the Vice President of Global Quality Control assuming responsibility for the comprehensive strategy and implementation of Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide. Additionally, she spent several years as the Vice President of Corporate Quality with responsibility for global compliance and 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 executive MBA from Duke University. She has over 25 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline.

Melissa has been highly involved in the influencing of regulatory guidance through her participation on non-profit Boards of the Parenteral Drug Association (PDA) from 2016 to present as well as Rx-360, an international consortium focused on pharmaceutical and medical device supply chain security vis-à-vis public health concerns and patient safety.  Additionally, she has been an advocate for simplification of Post Approval change processes, participating in industry forums, writing articles, and interacting with regulators.  Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality.

Jerry Cacia

Jerry Cacia is the chief technical officer at Graphite Bio. In this role, Jerry is responsible for leading the development of the overall manufacturing strategy and technical operations in support of Graphite Bio’s gene editing programs as they advance through the clinic.

Jerry has proven experience in the development of manufacturing processes and quality control systems across multiple therapeutic modalities. During his 32-year career at Genentech and Roche, he held various senior leadership positions in technical development, manufacturing, and quality. In his most recent position, Jerry served as head of global technical development at Roche during which time he supported a pipeline that included over 80 new molecular entities and more than 100 development projects in various stages.

Harry Lam

Dr. Harry Lam currently is Chief Technology Officer and EVP at JW Therapeutics, responsible for JW’s Technical Operations functions, including process development, clinical and commercial manufacturing, manufacturing science & technology, global supply chain, engineering, and capital projects.

Prior to joining JW, Dr. Lam was CTO and VP of CMC Development at Affinita Biotech. Previously, he was VP & Head of Biologics Manufacturing at Sanofi; VP of Manufacturing & Technical Operations at Progenitor Cell Therapy; and VP of Manufacturing & Process Development at Shire Regenerative Medicine.

Prior to Shire, Dr. Lam spent 17 years at Genentech/Roche with increasing responsibilities in various functions in South San Francisco and Singapore, including engineering, manufacturing, manufacturing science & technology, and CMO operations. Prior to Genentech, Harry spent 11 years at Pfizer Bioprocess R&D.

Dr. Lam 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.

Rakesh Kakkar

Rakesh Kakkar is currently Vice President, Vaccine Industrial Affairs US at Sanofi. He manages vaccine operations for US sites and responsible for Manufacturing operations of drug substance and drug product, Supply chain, Quality, Strategy, Technical Services and Engineering, Project management and Manufacturing excellence areas. Prior to that he served as Head of Biologics Manufacturing and managed drug substance manufacturing. Prior to joining Sanofi in 2016, Rakesh spent 16 years at Pfizer Biotech/Wyeth in various roles of increasing responsibility. He led vaccine manufacturing operations as well as localization of vaccine manufacturing in various emerging markets. He led CMO evaluations, Transfer of Manufacturing Processes/operations, Quality Systems, Managing the Budget, Regulatory Strategy for product launches and ensuring Sustainable Manufacturing Capability. He also provided strategic direction for new technologies, analytical advancements, regulatory filings and implementation to maximize operational efficiency and conformance to regulatory requirements.

Rakesh has 23 years of experience in Biologics including, Laboratory Operations, Quality Control, Quality Assurance, Supply chain, Manufacturing for Vaccines and Therapeutic Oncology Immunoconjugates. He has demonstrated success in leading and managing multifunctional groups within US and globally including Latin America and Europe. He has served on the USP expert panel and has extensive experience interacting with FDA, EMEA and various regulatory agencies. Prior to joining Pfizer Rakesh was a Senior scientist at Chembio Diagnostic Systems, Inc., a biotechnology company involved in the development and production of Immunodiagnostics.

Rakesh received his M.S. in Clinical Pathology from University of Saskatchewan, Canada and Ph.D. in Biochemistry from Guru Nanak Dev University, India. He was a post-doctoral fellow at the College of Medicine, University of Saskatchewan, Canada prior to joining industry in 1999. He is author of more than 32 peer-reviewed publications. He is an active member of ISPE.

Gerard Greco

Dr. Greco joined Takeda as the first Global Quality Officer of the company five years ago. Since that time he has led the transformation of Global Quality at the company in the development of one Quality Management System and the establishment of one Global Quality Leadership team. His scope of responsibility covers all elements of Quality in support of Manufacturing & Supply, R&D, Vaccines, and the Commercial businesses. During 2019 he has led the ongoing integration of Takeda Quality with Shire, as Takeda has grown to a Top 10 Pharma company during this time.

Jerry has over 35 years of experience in quality leadership roles in the pharmaceutical industry. He started his career as a microbiologist at Johnson & Johnson. He spent 17 years at J&J in leadership positions in microbiology and as site quality head for two of the company’s biologics facilities. He worked at Wyeth as head of International Quality, Global Pharmaceutical Quality and later at Pfizer as head of Specialty Biotech & Vaccines Quality. Before joining Takeda in 2014 he worked at Teva as head of Quality for their Global Manufacturing plants.

Jerry is a graduate of Rutgers University where he earned a Ph.D in Microbiology & Molecular Genetics.

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.

Dennis Nsenkyire

Dennis is responsible for leading a high performing team responsible for designing, developing, and executing Janssen’s integrated end-to-end supply chain strategic roadmap in partnership with R&D, Commercial and global cross-functional teams.

Success in his current role is working with Commercial, R&D, and end-to-end Supply Chain leaders to translate customer/patient value proposition into an operational strategy and ensure the continual evolution of supply chain capability through innovation, agility, end-to-end value and people/leadership development.

Most recently, Dennis served as Vice President, Supply Chain Culture & Capability Development, where he led the development and implementation of innovative capabilities to further advance Supply Chain talent, skills, competencies, and development programs. Prior to that, Dennis held critical leadership roles responsible for J&J Supply Chain Insights, Strategy and Business Excellence where he led and shaped the development, deployment and execution of J&J Supply Chain strategy and strategic innovation programs.

Prior to joining the Supply Chain organization, Dennis led the Commercial Operations team at Ethicon (J&J Medical Device Sector), responsible for go-to-market models, sales force design and deployment, commercial analytics, planning, and operations.

Dennis joined Johnson and Johnson in 2002 at McNeil Consumer and Specialty Pharmaceuticals, where he held several leadership positions in Process Excellence and Business Strategy and Insights. Dennis also worked at J&J Vision Care, where he was responsible for market insights, sales force deployment, sales force compensation, CRM, territory management, and business analytics. Prior to Johnson and Johnson, Dennis held various leadership roles in Marketing,

Process Excellence and Engineering at Honeywell International and Therma Tru Corporation.

Dennis holds a master’s degree in Electrical Engineering from Arizona State University, an Executive MBA from Drexel University (Lebow College of Business) and is a Certified Process Excellence Master Blackbelt.

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.

Stan Russell

Stan Russell is a 32+ year veteran of the Life Science Industry, with experience in Biotechnology, Pharmaceuticals, and Medical Devices.  His background spans a broad spectrum of dosage forms and therapeutic areas, as well as roles in Engineering, Product/Process Development, Supply Chain, Operations, IT, and Quality.  As an employee, consultant, and joint-venture partner; Stan has worked with over thirty companies including small virtual/startup organizations and Fortune 20 enterprises.  He is passionate about helping people beat cancer, and currently serves as the Vice President of Quality for TCR² Therapeutics in Cambridge, MA.  Stan holds a Bachelor of Science in Chemical Engineering from Northwestern University’s McCormick School of Engineering, and a Master of Business Administration from Northwestern’s Kellogg School of Management.  A Midwesterner transplanted in New England, Stan enjoys outdoor activities and volunteering; and currently serves on two non-profit boards.

Nuno Fontes

Eric Hacherl

Eric Hacherl, Ph.D. is the VP of Manufacturing. He Holds a Ph.D. in Chemical Engineering from Rutgers University. As the Head of Manufacturing, he is responsible for Internal and External Manufacturing, Materials Management, Shipping & Receiving and Manufacturing Science & Technology. Eric joined Spark in September 2020 and reports to Cynthia Pussinen, Chief Technology Officer. Eric has over 20 years of experience in the pharmaceutical industry. His functional expertise lies in Operations, Supply Chain and Manufacturing Science & Technology. His focus has been primarily on vaccines and large molecule manufacturing. Prior to joining Spark, he was the Site General Manager and VP of Operations for Catalent Gene Therapy in Baltimore, MD.

Eileen Higham

Claus Weisemann

Claus Weisemann joined NGM Biopharmaceuticals in September 2019 as VP of Quality, developing and implementing  science- and risk-based Quality Systems for all GxP areas in a small clinical stage Biotech company.  He brings more than 30 years of experience in R&D, development and commercial Quality functions in large, mid-size and small pharma and biotech companies. He started his career with BAYER in Germany in R&D, Analytical Development and CMC Quality. After his transfer to the United States, he served in BAYER’s Biological business unit in various Quality functions of increasing responsibility before continuing his career with Watson Pharmaceuticals, Grifols, Alexion, Luitpold (a Daiichi Sankyo company) and Dynavax. In a VP or Senior VP role since 2008, he improved Quality systems, remediated critical compliance situations, led large groups over several locations, and also built Quality teams from scratch.

Dr. Weisemann received an advanced degree in Chemistry with a focus on Analytical Chemistry and a Ph.D in Organic Chemistry with additional education in Pharmacology and Toxicology from the University of Ulm, Germany.

Jeff Ranney

Jeff leads Amgen Engineering’s Process System team within the Engineering Technical Authority Department (ETA). This team provides operational engineering support for the Amgen network and leads the design for process systems and equipment for major projects across Amgen. This includes design leadership for Amgen’s expansion projects at Amgen New Albany (Final Drug Product facility and new site) and Amgen North Carolina (Drug Substance facility and new site).

Jeff led the integration of the ETA Process Systems group. Jeff and his team were responsible for the design of critical projects across the network including the new Rhode Island Manufacturing Drug Substance facility and major expansion projects at Amgen Thousand Oaks. Jeff also led launch of Engineering’s standard design program which enables alignment across our network.

Jeff joined Amgen in 2004, holding positions of increasing responsibilities in the areas of Engineering, Project Management and Manufacturing support. Jeff led the Site Project Management and Site Engineering teams at the Amgen Washington location before joining the ETA as part of the establishment of the department.

Jeff holds an BS in Chemical Engineering from the Colorado School of Mines and a MS and PhD in Chemical Engineering from the University of Michigan.

Gargi Seth

Dr. Gargi Seth is a Director in Global Technical Development Project and Portfolio Management group. In this role, Dr. Seth and her team partner with TDTs and stakeholders to drive the progression of CMC projects to deliver the pipeline, develop tools to support decision making, support continuous improvement of TDT business processes, define methodologies for cross-project learning and generate insights for strategy development and implementation. In her current role, Dr. Seth has been leading cross-functional efforts at an organizational level within Roche Pharma Technical (PT) to assess readiness to deliver on future demand scenarios of patient-centric flexible care solutions, has served as Technical Development Lead for a late stage large molecule and has successfully implemented strategic innovation experiments to improve governance and decision-making effectiveness.

Through her experiences in both established biotech, and emerging market start-up companies, Dr. Seth brings business and strategic acumen, in-depth scientific knowledge, product and process development expertise, direct people management and cross-functional team leadership experience.

Prior to Genentech, Dr. Seth was part of the Senior Management Team as Head of Technology Management at Cipla Biotec in India where she was responsible for building and leading a technical management department to identify, develop, implement and transfer bioprocess and analytical technologies.  Prior to Cipla, Dr. Seth was Senior General Manager and Associate Vice President of R&D at Intas Pharmaceuticals in India, leading process and product development functions to develop recombinant therapeutics.

Dr. Seth was formerly a group leader at Genentech in Technical Development function where she led several cross-functional teams to gain fundamental insights into protein production processes.

Dr. Seth earned her Ph.D. in Chemical Engineering from the University of Minnesota and is an active member of the biotechnology community.

John Higgins

John Higgins is a Director who serves as Product Champion in Global Technical Operations at AstraZeneca, and is the CMC lead for commercial biologics at AstraZeneca.

John has a passion for excellence in CMC and biologics manufacturing and has committed 20 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 more than 11 products that are now marketed including Enhertu®, Saphnelo®, Uplizna®, 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 a number of organizations including Wyeth (now Pfizer), Johnson & Johnson, Novavax 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.

Babita Parekh

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 Executive Vice President and President of Global Product Development and Supply (GPS), Lou oversees the worldwide product development, manufacturing and supply chain arms for Bristol-Myers Squibb (BMS). His organization leads the development, launch and commercial lifecycle of an innovative portfolio of products that accelerate science and deliver hope to patients through life-changing medicines.

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.

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.

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.

Pam Cheng

Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. Under her leadership, AstraZeneca Global Operations has transformed significantly driving top performance across the business while delivering value back to the enterprise.  The next phase of transformation includes the convergence of operational excellence and digital innovation, building the ‘Factory of the Future’.

Before AstraZeneca she spent 18 years in global manufacturing, supply chain, and commercial roles at Merck/MSD. As president of MSD China, she was responsible for MSD’s entire business in China—sales and marketing, commercial operations, and oversight of manufacturing and research and development. Prior to that, she was head of Global Supply Chain Management and Logistics for Merck and led the transformation of Merck supply chains across the global supply network.  Before joining the Biopharmaceutical industry, she worked in engineering and project management roles at Universal Oil Products, Union Carbide Corporation, and GAF Chemicals.

In addition to her executive role at AstraZeneca, Pam is a nonexecutive director for the board at Smiths Group plc.

Ms. Cheng holds bachelor’s and master’s degrees in chemical engineering from Stevens Institute of Technology and an MBA in marketing from Pace University.

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).

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.

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.

Arleen Paulino

Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing and technology transfer, as well as plant manager for the cell culture facility.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette University.

Jens Vogel

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

Charlene Banard

Charlene Banard serves as the Head of Technical Operations for the Cell & Gene Therapy platform at Novartis, a role which is accountable for the multi-national network of manufacturing facilities producing innovative CAR-T cell therapies for patients around the world.

Charlene has extensive experience in the biopharmaceutical industry having held roles focused on development and operations in support of innovative treatments. Over the course of her career she has held senior positions managing product lifecycle, quality, and technical operations, for multiple technical platforms. Prior to joining Novartis in 2020, Charlene was the SVP of Global Quality for Shire and previously worked at Gilead, Cell Genesys and Chiron. She holds an MBA in Trans-Global Business from Saint Mary’s College in California and a Bachelor of Science degree from the University of California at Davis. Her personal mission is to help people live their best lives.

Craig Kennedy

Mr. Craig Kennedy is Senior Vice President of Transformation and Supply Chain Management.  Craig has a proven track record of driving change and operations improvement at Merck.  Craig will enable our transformational efforts focused on Fortify Plant to Patient integrating financial planning, MMD’s Digital strategy, accelerating Merck Production System, Merck for Mothers, Enterprise Resiliency Modernization and Enterprise Risk Management positioning Merck for the long term.

Since joining Merck in 1996, Craig’s Merck experience has broadly encompassed Regional operations management, plant management and direct manufacturing operations, change management functions, SAP implementation, Supply Chain and inventory management, capacity management and materials management.

Before coming to Merck, Craig worked for a consulting firm, Professional Systems Development, as a project manager and consultant specializing in computer systems and operations improvement supporting companies located in Asia Pacific, the Middle East, Africa, Western and Eastern Europe and the U.S.

Craig graduated from the University of Sydney, Australia with a degree in computer science and pure mathematics.

Craig has lived and worked in many different countries and cultures around the world, and lives with his family in Princeton, NJ.

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.

LeAnn Pipkins

LeAnn Pipkins joined Gilead in 2019 as Vice President of Global Supply Chain and has been focused on leading Gilead’s transformation in integrated planning.

Before Gilead, LeAnn spent 20 years in the biopharmaceutical industry in roles of increasing responsibility at Pharmacia/Pfizer and Genentech/Roche. She has worked in global operations in supply chain, strategy and regulatory. Prior to joining the biopharmaceutical industry, LeAnn worked in the fine chemical industry as a process improvement engineer for Eastman Chemical.

LeAnn holds bachelor’s degrees in Economics and Chemical Engineering from Texas A&M University and an MBA from the University of Chicago.

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).

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.

Eric 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.

Hari Pujar

Hari Pujar, Ph.D., serves as Operating Partner, at Flagship Pioneering, helping create breakthroughs in human health and build life science companies.  Previously he was Chief Technology Officer of Spark Therapeutics, a pioneer and leader in AAV gene therapy. He led technical operations, process and technology development and quality assurance organizations. He was responsible for growing and scaling the company’s cutting-edge technology capabilities for an expanding development pipeline.

Prior to Spark, Hari was Head, Technical Development & Manufacturing, at Moderna, where 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 of mRNA.

Before Moderna, he spent 18 years at Merck & Co in the company’s R&D, manufacturing, and commercial divisions focused on vaccines and biologics, culminating in the E2E leadership of a third of the vaccine portfolio, comprising of pediatric and adult vaccines, representing nearly $2b in annual revenue.

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.

Stephen Hardt

Stephen Hardt is the Vice President Supply Chain and External Manufacturing for Allogene Therapeutics, overseeing a broad network of contract manufacturers and suppliers and leading Allogene’s planning, logistics and distribution functions. Stephen has over 25 years of experience in technical operations, supply chain strategy, manufacturing and portfolio management. Prior to joining Allogene, he worked for Genentech where he held various global leadership roles most recently as the Vice President of Technical Product Management and Network Strategy. In this role, Stephen developed and executed product strategies for a portfolio of over 40 products, led the biologic and small molecule CMC team system and his team oversaw numerous global product launches including Tecentriqâ, Ocrevusâ and Hemlibraâ. At Genentech, Stephen was also the Global Head of Contract Manufacturing Operations, providing leadership for an extensive external network of drug substance, drug product and clinical manufacturing sites. Prior to joining Genentech, Steve held various senior roles across the biotech and diagnostic industries. Steve holds a bachelor’s degree in biology from the University of California, San Diego.

Som Chattopadhyay

Som Chattopadhyay serves as Vice President, Global Supply Chain Organization. Reporting to Executive Vice-President of Operations, primary responsibilities include supply of medicines to patients in a safe, compliant, and efficient manner. Activities covered included network optimization, cost of sales management, capacity management, corporate and regional planning, operations strategic planning (long range plan), trade, regional supply chains which include demand management, customer service, distribution, logistics and regional manufacturing, product launches and governance of transformation initiatives. Som is currently responsible for Operations data analytics transformation initiative.

Prior to this role, Som was Vice President of Results Delivery Office reporting to Executive Vice President of Corporate Transformation. He led a selected team to identify, envision, and install improvements to reduce costs and increase operational efficiency. These business cases containing improved strategy, structure, and processes resulted in creation of initiatives which delivered between 2014-2018 >$1.5B cost savings; 15 ppt operating income rise.

Som joined Amgen in 2002 and over the last 16 years has held positions of increasing responsibilities in engineering, strategic planning, results delivery office (finance), and supply chain. Som has worked in Rhode Island, Ireland, and Thousand Oaks.

Prior to joining Amgen, Som worked across the Semiconductor Capital Expansion value chain involved in multiple billion $+ capital expansion projects around the world.

Som has over 30 years of experience in Biotechnology and Semiconductor industry. Som holds a degree in Production and Industrial engineering from MNNIT (Motilal Nehru National Institute of Technology), Allahabad, India and is Professional Engineer -Mechanical in the State of California.

Kim Burson

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.

Shannon Holmes

Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a global team responsible for quality oversight and strategy of all products and devices in clinical development as well as lifecycle management of commercial programs. Prior to this role, Shannon was a member of the Regulatory Affairs CMC team at Biogen and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. While at Biogen, Shannon has led successful submissions for clinical, licensed, and post-marketing regulatory applications for biological and combination products. Shannon is an active member of the PhRMA Global Quality and Manufacturing Work Group. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.

John Lunger

John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for commercialization.

Previously, John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Merrimack’s first commercial product launched in October of 2015.  Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer, and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he held a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine followed by strategic consulting with Accenture.

John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.

Professor. Mazen Hassanain

Prof. Mazen Hassanain, King Saud University Professor of Surgery, Canadian College of Surgery Association Fellow with expertise in Transplantation, Immunology, and Oncology, has founded a number of companies in the healthcare and biotechnology sectors. SaudiVax is his most recent startup, which was founded at the end of 2016. Prof. Hassanain was the Director-General for the Saudi Ministry of Health Research Department, and he founded King Saud University vaccine research program.

Shishir Gadam

Shishir is currently a Vice President of Cell Therapy Global Manufacturing Science and Technology at BMS. He was previously at Genentech/Roche where he held various leadership roles: Senior Director of Biologics commercial CMC management; Head of Product Technical Leaders; Head of Drug Product GMS&T; and Director of site MS&T at Genentech’s drug substance manufacturing site at Vacaville. Prior to joining Genentech, Shishir worked at Merck, in West Point, PA, on vaccine bioprocess development and biologics clinical manufacturing. He has a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute, Troy, NY, an M.S. in Chemical Engineering from West Virginia University in Morgantown, WV, and a B.S. in Chemical Engineering from Indian Institute of Chemical Technology, Mumbai. In 2017, Shishir was inducted to American Institute for Medical and Biological Engineering (AIMBE) College of Fellows for his outstanding contributions to developing, scaling-up, designing and starting-up manufacturing processes and facilities, and defining product technology lifecycle strategies for biologics.

Ezequiel Zylberberg

Ezequiel Zylberberg, Ph.D. is Vice President of Product Development and Planning at Akron Biotechnology, a manufacturer of cGMP-compliant ancillary materials to enable the development and commercialization of advanced therapies. Ezequiel manages Akron’s supply chain and product development pipeline, with a focus on developing and delivering high quality, automation-ready, industrial scale solutions to drive industry growth. He is a Research Affiliate at MIT’s Industrial Performance Center (IPC), and received his PhD from the University of Oxford’s Saïd Business School.

Derrick Fournier

Derrick is an executive focused on helping organizations drive value through the power of analytics. He currently leads the manufacturing and supply chain Business Insights and Analytics (BIA) team at Bristol-Myers Squibb (BMS). Derrick also led strategy and operations for the Commercial BIA team at BMS. Prior to joining BMS, Derrick worked as a Strategy Consultant at Accenture where he helped clients design analytics focused operating models and organizations. Derrick is a Professional Engineer and holds an MBA from the Richard Ivey School of Business and a Bachelor’s Degree in Electrical Engineering from the University of Western Ontario, both located in London, Canada.

Sam MacHour

Prior to joining Samsung Biologics in 2019, Sam spent more than 32 years supporting large MedTech, Bioscience and Biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Compliance, Regulatory, Operations and product commercialization. Sam’s experience covers all dosage forms, including small and large molecules, cell & gene and medical devices. In his career, Sam served in a variety of roles of increased scope and held senior and global leadership roles at Lonza, Becton Dickinson, Pfizer, J&J, Boehringer Ingelheim and GSK. Sam holds a Master’s degree from Concordia University in Physics, is a graduate of Harvard’s General Management Program and is an Alumni of and frequent contributor to the Harvard’s Kennedy School of Government and the Harvard’s Healthcare Initiative.

Paul Jorjorian

As the VP of Biologics Paul oversees a global Biologics Drug Substance manufacturing and development network for Thermo Fisher Scientific’s Pharma Services.

Paul has held multiple leadership roles in process development, technology transfer and operations. In his career Paul has developed, transferred or manufactured over 75 biotherapeutic proteins at various clinical phases, including multiple commercial products. Experience includes business strategy development, operations management, technology transfer, process development, process characterization and process validation.

Prior to joining Thermo Fisher Paul worked for Bristol Myers Squibb and GE Plastics (now SABIC). Paul holds a B.S. in Chemical Engineering and Management from Purdue University, West Lafayette, IN and a Masters in Chemical Engineering from Cornell University, Ithaca, NY.

Pascal Bécotte

Dr. Pascal Bécotte leads the firm’s Canadian operations and co-leads the firm’s global Corporate Officers practice which includes the Finance, Human Resources, Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs practices. Pascal is also a member of the firm’s Global Executive Committee as well as a member of the Healthcare and Industrial teams, where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. He splits his time between the Toronto and New York offices.

Pascal has more than 18 years of executive search experience, most recently with a leading global executive search firm where he was Managing Partner for the Montreal office. Immediately prior to joining Russell Reynolds Associates, Pascal worked for Target, where he was Group Vice President for Stores and Officers in Canada. Earlier in his career, he was President of a boutique recruiting and consulting firm specialized in sales and marketing. Pascal began his career as National Sales Manager for a sportswear manufacturing company.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and was trained as an aerospace engineer with the Royal Canadian Air Force. He also earned Master’s and Doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

Eric Good

Dr. Eric Good is an energetic, award-winning leader with extensive U.S. and international experience in Fortune 500 companies. Dr. Good has worked in aseptic manufacturing, project management, and Quality Assurance under Consent Decree conditions. He has been with ProPharma Group for 6 years and prior to that spent 25 years in Pharma and Biotech Manufacturing operations.  He has spoken both domestically and internationally about Quality Compliance and related topics.

Daniel J. Littlefield

Daniel Littlefield has established Modality Solutions as an innovator in cold chain validation practices. Dan exemplified this leadership during Modality Solutions’ recent clinical trial operations work in the Democratic Republic of the Congo (DRC), along with its earlier work in Sierra Leone, Liberia, and Guinea. Since 2015 Dan has spearheaded Modality Solutions’ NIH / CDC-sponsored clinical trial operations support for Ebola vaccine and treatments. In 2019, Dan and Modality Solutions engineers supported an Ebola clinical trial in the war-torn North Kivu Province of the DRC that resulted in a 90% survival rate for those treated with antibody-based drugs after injection.

Gary Hutchinson

Gary Hutchinson is president of Modality Solutions and has led our organization since its founding in 2011. Over the last two decades, he has designed and managed biopharmaceutical cold chains for best-in-class organizations. His professional focus is on environmentally-controlled logistics management: shock, vibration, pressure, humidity and temperature-sensitive biologics, medical devices, including tissue heart valves and perfusion systems, and pharmaceuticals.

Gary is an industry leader in cold chain optimization and a regulatory submission expert in the global biopharmaceutical industry. In 2019, he was invited and admitted to the prestigious Forbes Technology Council.

Zinaid Dzinovic

Zinaid Dzinovic is Director Principal Consulting & Client Advisory at Körber Pharma (formerly Werum IT Solutions). Before taking on his current position, for over 5 years Zinaid has worked at Novartis AG in Switzerland. His core responsibility areas were MES and vertical integration program management such as global MES process harmonization for sterile Novartis sites. In addition, as a Digital Product Owner, he was driving a complex lighthouse project under the Digital transformation agenda to create full visibility at the production level.

Stephen McCarthy

Steve McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve provides domain expertise and serves as an industry evangelist and customer advocate for Sparta. In this role, Steve works closely with Sparta’s customers to help them define and execute their quality management and digital transformations. He heads Sparta’s strategic thought-leadership and customer coalition programs, partnering with industry, regulators and analysts to shape the fast-approaching future of quality management systems for life-sciences in service of the health and wellness of the global population. Steve has nearly three decades of experience as a quality and supply chain leader within the healthcare industry. Prior to joining Sparta, he held several high-profile positions within Johnson & Johnson, the most recent of which was as VP of Quality Systems Shared Services for their Pharmaceuticals, Medical Devices and Consumer sectors. There he implemented several complex quality system and process transformations across the enterprise. His earlier career was spent in virology research at the University Hospital St. Thomas’ in London. Steve holds a BSc in Medical & Industrial Biology from Cardiff University in Wales, UK. He is a certified six-sigma process excellence black-belt as well as a certified 3rd degree black-belt karate instructor.

Anne Marie O’Halloran

Anne Marie O’Halloran is a Managing Director in Accenture’s Products Operating Group, where she leads Accenture’s Industry X.0 & Supply Chain practice for the Life Sciences sector.  This practice brings together services across innovation, product development, manufacturing and digital operations, and supply chain optimization to help our clients achieve a new level of innovation and efficiency across their operations and value chain. In 20+ years with Accenture, Anne Marie has worked globally across North America, Europe and Asia focusing on supporting biopharma and medical technology clients in transforming their supply chain and manufacturing capabilities. She has successfully led complex IT delivery and digital transformation programs from enterprise resource planning (ERP) to IIoT to supporting site commercialization.  Anne Marie holds a Bachelor’s degree from Cornell University and resides in New York City.

Barry Heavey

Barry has 20 years of experience in the pharmaceutical industry, working in areas such as immunology,  bio manufacturing  and stem cell research. He has a PhD in Genetics from University of Vienna and an MBA from Edinburgh University

George Siu