Mike McDermott

As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities.

Mike and the Pfizer Global Supply (PGS) team work to ensure uninterrupted supply for Pfizer’s entire product portfolio, which includes hundreds of medicines and vaccines – more than 38 billion doses each year.  The PGS network includes approximately 30,000 colleagues and contractors and more than 40 Pfizer global manufacturing sites.

Recent highlights include the rapid ramp-up of manufacturing and global distribution of the Pfizer-BioNTech COVID-19 vaccine; ongoing efforts to enhance COVID-19 vaccine production and distribution processes; and the expedited production of Pfizer’s novel COVID-19 oral antiviral.

Mike has more than 30 years of experience in the pharmaceutical industry and has held positions in all aspects of supply operations as well as in Marketing and Finance.  He joined Wyeth in 1989 as a Project Engineer in Pearl River, New York.  Mike returned to Pearl River in 2003 as the site’s Managing Director for Vaccines manufacturing and was elevated to the role of Vice President of Site Operations in 2007.

With Pfizer’s acquisition of Wyeth in 2009, Mike became leader of the Consumer Healthcare Operating Unit and then was named Vice President of the Biotechnology Unit in 2012.  In 2014, Mike became Vice President of Global Supply Chain, overseeing internal and external supply as well as distribution.  He was named President of PGS in 2018 and assumed his current role in January 2022.

A passionate advocate for Diversity, Equity and Inclusion, Mike served on the Board of People to People, a non-profit organization that helps under-served people, for 10 years, and has enacted impactful changes to increase diversity within PGS.  Mike, his wife Katie and their five daughters, of whom Mike is incredibly proud, are all committed to community engagement and social action.

Mike has Bachelor of Science and Master of Science degrees in Industrial Engineering from the New Jersey Institute of Technology (NJIT) in Newark, New Jersey.  He has been an adjunct professor at NJIT and was named a distinguished alumnus.  Mike serves on the Executive Committee of the National Association of Manufacturers and is a member of the Pharmaceutical Manufacturers Forum as well.

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.

Susanne Hundsbaek-Pedersen

Susanne is the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries.

Susanne has been leading the transformation of Procurement and Supply Chain management functions reaching more than 170 countries. Under her leadership as SVP of Global Supply Chain Management, the organization was recognized as one of Top 25 Supply Chain by Gartner. More recently she has in her role as SVP of Product Supply Diabetes Products been heading manufacturing facilities across the globe at Novo Nordisk, the world’s leading Diabetes care company. In her role in manufacturing, she has been orchestrating a technological transformation that was recognized by the World Economic Forum as a global lighthouse in Advanced Manufacturing.

Susanne holds a Diploma in Industrial Engineering from Copenhagen University College of Engineering and an MBA from IMD, Lausanne Switzerland.

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.

Edgardo Hernandez

Edgardo Hernandez is senior vice president at Eli Lilly and Company and president of manufacturing operations.

Ed served as senior vice president of global parenteral drug product, delivery devices and regional manufacturing from 2018 until 2021. In this role, he was responsible for global parenteral manufacturing, emerging markets manufacturing, drug-product contract manufacturing, packaging, and distribution operations. Ed provided oversight for manufacturing sites in 12 countries across North America, South America, Europe, and Asia; that manufacture the final parenteral product (non-oral) formulations of Lilly medicines.

Previously, Ed was vice president of Fegersheim Operations for Lilly’s manufacturing site located in France. Before that, he served as site head for two other Lilly manufacturing sites: Indianapolis Active Pharmaceutical Ingredient manufacturing from 2014 until 2016, and PR06 in Puerto Rico from 2012 until 2014. Ed joined Lilly in 2005 as an engineering services leader for Lilly del Caribe in Puerto Rico, after working for several years in positions for Pfizer and Pharmacia.

Ed is a native of Puerto Rico and holds bachelor’s and master’s degrees in chemical engineering from the University of Puerto Rico and North Carolina State University, respectively.

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.

Ann Lee

Ann Lee, PhD, is the Chief Technical Officer of Prime Medicine. Ann is an accomplished biotech executive with extensive experience and accomplishments in vaccines, biologics, small molecules and cell therapy development and manufacturing. She brings a passion for helping patients, innovating new technologies, and developing employees. Over the course of her career, she has contributed to the licensure and commercialization of 25 new vaccines and medicines, with the most recent being two CAR T cell therapies.

Ann recently worked at BMS, which acquired Celgene and Juno Therapeutics. Ann joined Juno Therapeutics in 2017 as Executive VP of Technical Operations to work in the new field of cell and gene therapy. She built the global Cell Therapy Development and Operations organization responsible for developing new manufacturing processes and technologies, manufacturing, quality assurance, designing new facilities, and creating the global supply chain network and digital systems to deliver these autologous products.

Ann was at Genentech in 2005 as VP of Process R&D and became SVP and Head of Global Technical Development at Roche in 2009. She was responsible for delivering Roche’s global R&D pipeline, as well as tech transfer and technical support for all commercial products. She was a member of corporate strategic portfolio governance committees and worked extensively cross-functionally as well as with external partners across the globe.

Prior to Genentech, Ann joined Merck Research Laboratories, where she advanced through several leadership positions in vaccine development over 14 years. She then became Vice President of Chemical Technology and Engineering in the Manufacturing Division at Merck, overseeing process engineering and technical operations at 10 chemical sites around the world.

Ann is a member of the National Academy of Engineering, a Fellow of the American Academy of Arts and Sciences, and a Fellow of the American Institute of Medical and Biological Engineering. She is the recipient of many scientific and engineering awards and has served on several professional, academic and company boards. She holds a B.S. in chemical engineering from Cornell University, and a Ph.D. in biochemical engineering from Yale University.

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.

Karin Shanahan

Karin Shanahan oversees worldwide product development, manufacturing and supply for Bristol Myers Squibb as executive vice president, Global Product Development & Supply (GPS). 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.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the pharmaceutical industry. Though I’ve worn many hats in the industry since then, I was drawn back to Bristol Myers Squibb because of its unwavering dedication to quality and delivering innovative medicines to patients in need,” says Karin. “I am honored to help lead the integral GPS team as we navigate an everchanging landscape.”

Karin began her career in the pharmaceutical industry at Bristol Myers Squibb in corporate procurement, global supply chain, and global quality. Karin moved into manufacturing operations, leading two manufacturing sites in Billerica, MA, and Latina, Italy. After almost 14 years with Bristol Myers Squibb, Karin joined Becton-Dickenson as a leader of global operations,  followed by Catalent Pharmaceuticals where she led global Biologics operations. In 2013, Karin joined Teva Pharmaceuticals as senior vice president and chief operating officer of global operations, where she led global Manufacturing Science & Technology (MS&T) and Network Strategy and a network of 25 sites across Europe and the Americas. Most recently, Karin served as senior vice president of Global Biologics & Sterile Operations at Merck.

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 Operating  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, Cognate Bioservices, and is an Advisor to Cellares, a Cell Therapy Technology company. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

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.

Aine Hanly

Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her career in the biomanufacturing industry, which has spanned roles in the UK, Ireland and the US, has been dedicated to advancing innovative solutions to accelerate the delivery of medicines to patients.

Prior to joining Vir, Dr. Hanly served as the Vice President of Process Development for Amgen, accountable for clinical manufacturing and global supply of clinical trial materials. During her nearly decade-long tenure, she led teams enabling the commercialization of Amgen’s pipeline products as well as providing technical support for ongoing commercial manufacturing operations. Additionally, as site head at Amgen’s Cambridge facility, Dr. Hanly led the site’s transformation and staff growth, and together with the research and development team, greatly increased Amgen’s partnerships and presence within the local Cambridge ecosystem. She also worked for more than 10 years at Pfizer (formerly, Wyeth), where she held roles of increasing responsibility in analytical R&D, process development, quality and product supply strategy.

Dr. Hanly received her bachelor’s degree in biological chemistry and a Ph.D. in physical organic chemistry, from the University of Ulster, Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining the collaborative research wing at Yale University and CuraGen Corporation as lead scientist studying gene isolation and subsequent confirmation using a variety of molecular biology techniques.

Cynthia Pussinen

Cynthia Pussinen is the Chief Technical Officer (CTO) for Spark Therapeutics, Inc., — a member of the Roche Group which is the world’s largest biotech company.

As CTO, Pussinen has overall responsibility for Spark’s technology and technical strategy. She leads all facets of pipeline technical and process development, preclinical and clinical manufacturing and the commercial manufacturing and distribution of LUXTURNA® (voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European Union.

Pussinen also has responsibility for Spark’s fully integrated supply chain and operations, quality assurance, analytical and quality control, engineering and scientific facilities, capital projects, corporate facilities and real estate, information technology and environmental, health, safety and sustainability.

With more than 25 years’ experience leading global organizations and high performing teams in the life sciences industry, Pussinen’s expertise spans the drug development continuum from research through commercialization. She has led the development, licensure and commercialization of more than fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant), Porcine Sequence), Eraxis® (anidulafungin) and ZMAX® (azithromycin).

Prior to joining Spark in 2021, Pussinen served as the Global Vice President and General Manager, Life Sciences and Specialty Chemicals for Honeywell International, Inc. It was there she developed and executed comprehensive product development and commercialization strategies for significant, sustained growth and innovation across multiple verticals including process automation and artificial intelligence (AI).

Pussinen was the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium Pharmaceuticals, Inc and spent many years with Ipsen Biomeasure and Ipsen Biosciences, the U.S. subsidiaries of Ipsen. There she served as President, leading all of Ipsen’s support functions, R&D, clinical and technical development and operations. Prior to that she served as Ipsen’s Vice President of Technical Operations & Development. Early in her career Pussinen spent more than 18 years at Pfizer in a variety of increasingly responsible leadership roles including portfolio and project management, global logistics and supply chain, pharmaceutical sciences and as a scientist in medicinal chemistry discovery.

She earned a Master of Science in R&D management from Rensselaer Polytechnic Institute and a Bachelor of Science in chemistry, with a minor in engineering from the University of Connecticut. Pussinen is lean/six sigma certified, is recognized as a mentor through the Healthcare Businesswomen’s Association (HBA) and was honored by WEST (Women in the Enterprise of Science and Technology) as a recipient of their Giving Back award.

Ann Lee-Karlon

Dr. Ann Lee-Karlon is Chief Operating Officer of Altos Labs and leads scientific and business operations for the company. She was previously Senior Vice President at Genentech, leading portfolio strategy and operations with oversight for over 35 drug development teams in the pipeline. She also led the anti-CD20 immunology team, including development of Ocrevus® for multiple sclerosis. Dr. Ann Lee-Karlon holds a BS in bioengineering from UC Berkeley, MBA from Stanford, and PhD in bioengineering from UCSD, and completed her postdoc at University College London as a National Science Foundation Fellow. She serves on the Dean’s boards for UC Berkeley and UCSD schools of engineering. Dr. Lee-Karlon was elected Fellow of the American Institute of Medical and Biological Engineering and is a Fellow of the Aspen Institute.

Charles Calderaro

Chuck Calderaro joined Kite in 2019 as Global Head of Technical Operations.

Prior to Kite, he served as the Senior Vice President of Global Manufacturing for BioMarin, where he was accountable for a diverse international operations network which utilized gene therapy, biological, small molecule, medical device, and packaging technologies to deliver innovative clinical and commercial products to patients. His more than 30 years of experience at Genentech/Roche, Aventis-Behring, Alcon Labs, and Johnson & Johnson spans all aspects of technical operations in positions of increasing responsibility and includes a four-year global assignment in Switzerland. He also served as a commissioned naval officer and nuclear engineer with the US Navy.

Chuck holds a bachelor’s degree in electrical engineering from the University of Notre Dame, a master’s degree in nuclear engineering from the US Naval Nuclear Power School, and an MBA from Texas Christian University.

Jens Vogel

Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs. Before rejoining Bayer in March 2020, he was President and CEO of Boehringer Ingelheim Fremont and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Jens held various roles of increasing responsibility in Biologics Development at Bayer in Berkeley. He holds a PhD in Biochemical Engineering.

About the Company

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group reported operations in 83 countries, employed about 100,000 people and had sales of 41.4 billion euros. For more information: www.bayer.com.

The Pharmaceuticals division focuses on researching, developing and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology and ophthalmology. The company is pursuing completely new therapeutic approaches to diseases, strengthening its position in the highly promising area of cell and gene therapy discovery, development and manufacturing.

Bradley Glover

Bradley Glover is the Executive Vice President and Chief Technology Officer at Celularity. He is responsible for a clinically- and commercially-focused cell therapy and degenerative disease products organization managing all aspects of Global Program and Portfolio Management, Technical Operations, Enterprise Facilities and Engineering, and Enterprise IT.

Prior to joining Celularity, Brad was at Kite Pharma where he held several executive roles in Corporate Development and Technical Operations and was responsible for the strategic oversight and leadership of corporate strategy, corporate program and portfolio management, technical operations strategy, CMC program management and business operations.  Prior to this, he held several roles of increasing responsibility at Genentech and Roche in the areas of finance, strategy, supply chain operations and alliance management.

Brad 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 at the University of California Berkeley.

Peter Olagunju

Peter Olagunju serves as the Chief Technical Officer of TCR².  He brings over 20 years of experience in cell and gene therapy, clinical development, program management, manufacturing and technical operations. Prior to joining the Company, he was Senior Vice President of Technical Operations at FerGene Inc., where he led the technical operations function for the commercialization of a gene therapy for bladder cancer. Before that, Mr. Olagunju was Vice President of Global Patient Operations at bluebird bio, Inc., where he held several roles of increasing responsibility and was the program lead and functional head of manufacturing supporting the European approval for ZYNTEGLO®, a transformational gene therapy for Transfusion dependent Thalassemia. Earlier in his career, he held senior positions in Commercial Technical Operations and served as the Head of Quality at Dendreon Corp. and ZymoGenetics, Inc. Mr. Olagunju holds an M.B.A. from the University of Washington and a B.S. in Biology from the University of Illinois at Urbana-Champaign.

Kathleen Munster

Kathleen Munster is SVP, Enabling Functions (Quality, Facilities, and IT) at 2seventy bio.  2seventy bio is a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer.  Kathleen joined bluebird bio in October 2020 and transitioned to oncology spin-off 2seventy bio in November 2021.  She has over 20 years of experience in clinical and commercial manufacturing in site-based and global roles spanning multiple product types and biopharma companies.  She has expertise in Health Authority inspection management and has supported numerous product approvals/launches.  Prior to bluebird/2seventy, Kathleen was responsible for a global network of sites as VP, Biologics, Cell & Gene Therapy Quality at Catalent Pharma Solutions. Before this, she led Quality at the Devens, MA site for Bristol-Myers Squibb after holding a number of leadership roles in Quality, IT, and Supply Chain during her tenure at BMS.  Kathleen started her career at Merck & Co., Inc. and holds degrees in Chemistry and German from Lafayette College and an MBA from Rutgers University.

Pratik Ahuja

Pratik Ahuja is Vice President of Supply Chain at Urovant Sciences. He is a visionary executive and leader who has successfully built, led, and transformed large teams in the biopharmaceutical industry across process development, supply chain and finance.

Pratik is responsible for building out Urovant’s Global Supply Chain, Strategic Sourcing and External planning function. Pratik also ensures excellence for commercial manufacturing, life cycle management and CMC development activities across Urovant’s global manufacturing network.

Prior to this role, Pratik served as the Director of Supply Chain at Amgen where he was responsible for supply planning, scheduling, capacity management, risk management as well as raw materials planning and procurement for 10 manufacturing plants enabling 70+ products and programs across all development phases – pre-clinical, clinical, and commercial.

Pratik held several positions of increasing responsibilities across process development, external manufacturing, and corporate strategy at Amgen.

Before joining Amgen, Pratik was a consultant for Biologics Process Development at Allergan, Irvine.

Pratik holds a Master of Bioscience from Keck Graduate Institute of Applied Lifesciences – Claremont Colleges and a Bachelor of Engineering degree in Biotechnology from University of Mumbai.

Steve Goodman

Steve Goodman is Executive Director, AAV CMC, at Vertex Cell and Gene Therapies. In this role, Steve oversees internal and external process and analytical development, as well as manufacturing, for AAV programs. Prior to this, Steve was the head of drug product manufacturing at bluebird bio, where he oversaw production of cellular therapies across their portfolio of products and is accountable for the long-term technology strategy to expand access of these treatments to serve global patient requirements. Before joining bluebird in January 2018, Steve was at GSK where he held a number of roles across research, development, manufacturing and supply chain. As Director of Manufacturing and Strategy for GSK’s CGT unit, he was responsible for the external manufacturing of the entire value chain to support GSK’s cellular therapies, and for defining and executing the vector manufacturing strategy. Steve joined GSK in 2002 following a Ph.D. and post-doctoral fellowship in organic synthetic chemistry at Harvard University.

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.

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.

Pouria Motevalian

As Director of Process Development, Pouria Motevalian leads process characterization, optimization and scale up for viral vectors at Thermo Fisher Scientific. Additionally, he oversees process modeling/simulation and knowledge management activities. Prior to joining Thermo Fisher Scientific, Pouria led early and late-stage process development of biologics, conjugate/mRNA vaccines, at Pfizer. Furthermore, he played an integral part in deploying new technologies focused on digital enablement in bioprocess research and development.

Pouria received his Ph.D. in Chemical Engineering with minor in Computational Science from the Pennsylvania State University. He has been an active contributor to the professional and scientific community in ACS, AIChE and AAPS.

Jose Caraballo-Oramas

Jose Caraballo-Oramas is a Biotech/biopharma executive with extensive quality, development, and manufacturing expertise. As VP of Corporate Quality, he directs and oversees global compliance, quality systems, and quality engineering functions for Kite Pharma, a Gilead company. Previous roles include Head of Bayer’s Corporate Quality Audit and Inspections – Audit Program Management for Americas, Quality Lead for Bayer’s Cell Culture Technology Center, Biotech Product Steward, Director of Global Quality Biotech, and Director of Validation. In addition, he is experienced in Global Team Leadership, MSAT, Quality Operations, Quality Systems, Process Optimization, Manufacturing, Technology Transfers, Facility Start-ups, Validation, GxP Compliance, and Regulatory Submissions from multiple roles in development, quality, and manufacturing at Kite, Bayer, Amgen, and Abbott Laboratories.

David Maraldo

Dave Maraldo leads Global Biologics Operations within the Merck Manufacturing Division (MMD).   In this role, he oversees manufacturing and supply of Merck’s Biologic portfolio of products.   Dave has been part of Merck for over 20 years. Over his career, Dave has supported all of Merck’s current vaccines and biologics franchises at various stages of their life-cycle, including multiple roles in process development, commercialization, operations, and manufacturing science & technology.  Previously, Dave served as the Co-Chair of Merck’s Development and Commercialization Review Committee responsible for cross-functional pharmaceutical development and manufacturing strategy across biologics, vaccines and small molecules.  He also has recently joined the Board of Advisors of the School of Engineering at Widener University.  Dave holds a Ph.D. in Chemical Engineering from Drexel University and an MBA degree from Lehigh University.

Aaron Vernon

Parinaz Rajaii

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 over 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 appointed to her current position with Pfizer Inc. as Vice President of Biotech Operations in February 2020. Lynn is responsible for leading an integrated network of 10,000 colleagues across nine large molecule and aseptic manufacturing sites located in seven countries producing starting materials, drug substances and drug products.

Previously, Lynn held the position of Vice President, Global Quality Assurance Vaccines at Merck from 2018 to 2020, where she was responsible for all quality operations matters for Merck Vaccines.

Prior to her role at Merck, Lynn spent 30 years at Pfizer (legacy Wyeth, Lederle Laboratories) in roles with increasing responsibilities in quality operations and compliance as well manufacturing. Lynn’s last role at Pfizer was as the Site Leader of the Sanford, NC manufacturing facility where she was responsible for all aspects of plant operations including commercial and clinical manufacture of vaccine intermediate and drug substances.  Prior to Sanford, Lynn was at the Pearl River, NY facility where her last role was as Site Quality Operations Lead. She was also responsible for oversight of Consent Decree remediation during her tenure at the Pearl River site.

Lynn has been instrumental in her career in driving balanced operational efficiencies and significant culture changes and has built extensive expertise in manufacturing and quality and compliance.

She holds a Bachelor of Science degree in Chemistry from the State University of New York, College at Purchase.

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.

Rahul Singhvi

Rahul Singhvi is a global leader in the Life Sciences industry and serves as the Chief Executive Officer of National Resilience, Inc.

Most recently, Rahul was an Operating Partner at Flagship Pioneering, a Boston-based life sciences innovation firm where he was responsible for founding and operating companies launched from Flagship’s innovation foundry, Flagship labs. Before joining Flagship, Rahul was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he was responsible for worldwide vaccine CMC and manufacturing operations. During his six-year tenure at Takeda, the vaccine business grew to over 500 employees and created an industry leading late-stage pipeline of vaccine candidates against dengue, norovirus, and zika. Before Takeda, Rahul was President and CEO of Novavax, Inc. (Nasdaq: NVAX) where he transformed the company from a specialty pharmaceutical business to a vaccine development company with vaccine candidates against influenza (funded by BARDA) and respiratory syncytial virus (RSV). Rahul’s professional career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing.

Rahul serves on the Executive Advisory Board of the Leonard Davis Institute (LDI) of Health Economics at the University of Pennsylvania and on the Scientific Advisory Board of the anti-microbial resistance research group at the Singapore MIT Advance Research and Technology program. He is a mentor instructor in the Undergraduate Projects Opportunity Program (UPOP) at MIT and is a visiting lecturer at the University College London (UCL).

Dr. Singhvi graduated as the top ranked chemical engineer from the Indian Institute of Technology, Kanpur, India and obtained both his M.S. and Sc.D. chemical engineering degrees from MIT. He received an MBA from the Wharton School of the University of Pennsylvania, where he graduated as a Palmer Scholar.

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.

Aine Hanly

Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her career in the biomanufacturing industry, which has spanned roles in the UK, Ireland and the US, has been dedicated to advancing innovative solutions to accelerate the delivery of medicines to patients.

Prior to joining Vir, Dr. Hanly served as the Vice President of Process Development for Amgen, accountable for clinical manufacturing and global supply of clinical trial materials. During her nearly decade-long tenure, she led teams enabling the commercialization of Amgen’s pipeline products as well as providing technical support for ongoing commercial manufacturing operations. Additionally, as site head at Amgen’s Cambridge facility, Dr. Hanly led the site’s transformation and staff growth, and together with the research and development team, greatly increased Amgen’s partnerships and presence within the local Cambridge ecosystem. She also worked for more than 10 years at Pfizer (formerly, Wyeth), where she held roles of increasing responsibility in analytical R&D, process development, quality and product supply strategy.

Dr. Hanly received her bachelor’s degree in biological chemistry and a Ph.D. in physical organic chemistry, from the University of Ulster, Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining the collaborative research wing at Yale University and CuraGen Corporation as lead scientist studying gene isolation and subsequent confirmation using a variety of molecular biology techniques.

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. Mr. Moore is current the President and Chief Operating  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, Cognate Bioservices, and is an Advisor to Cellares, a Cell Therapy Technology company. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Karen Walker

Karen Walker, Chief Technology Officer, Kyverna Therapeutics.  Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several other small to mid-sized biotech companies.

Her experience with Cell and Gene Therapies includes serving in the role of Senior Advisor for Cell and Gene Therapy at Roche/Genentech from 2019- Aug 2021 at which time she joined Kyvernta Therapeutics.  As Sr. Advisor, Karen advised the RGNE community on aspects of development and industrialization of cell-base and gene-based therapies (ATMPs) across the development lifecycle including topics important for patient engagement, supply management, control strategy development and linking the data across the different areas of research, clinical development and CMC to gain insight into how the products perform with respect to safety, efficacy and durability of benefit.  Prior experience included serving as VP and Global Head of Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit where she led the CMC teams through the formation of the strategies and the execution of those strategies to develop Kymriah through the pivotal trial stage and to filing of the first CAR-T BLA in Pediatric ALL.

Karen’s years of experience in Biopharma Technical Development, Quality, Regulatory CMC, and Manufacturing (including Cell and Gene Therapy), both within the US and Europe have contributed to honing a mind-set and approach that is strategic, forward looking and adaptive.  The challenges that are present in the development of ATMPs, including shortened development time (4 years faster than traditional pharmaceutical or biopharmaceutical products), complex supply chains including supply security for single patient delivery, largely poorly characterized and poorly understood product mechanism of action, rapidly evolving technology and changes to the way we work, are all inspiring and energizing as the field of ATMPs emerges and evolves.

A strong focus of Karen in this emerging field has been active external engagement with industry/trade organizations and dialogue with Health Authorities and Standards bodies to influence the regulatory framework for these products and advocating for stronger harmonization across regions.

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 CMC 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.

Mihaela Simianu

Dr. Simianu is currently member of Merck’s Global Vaccines Technical Operations accountable for Global Drug Product and Analytical Technology Operations. Prior to this role she served as head of Merck’s Sterile Products Commercialization. She advanced a portfolio of > 35 new pipeline products with complex and diverse modalities designed as vaccines, immune-oncologic and anti-infectious agents. She integrated Manufacturing Science and Technology along the clinical and commercial process design, characterization and qualification leading to successful market approval of 3 new products. She contributed to commercial manufacturing expansion at sites internal and external to Merck.

Prior to Merck she holt different technical and leadership positions with at Eli Lilly and Co, Amgen, and Pharmatech Associates. She has a diverse and deep expertise in development, commercialization and international manufacturing of complex biopharmaceuticals used in the treatment of multiple forms of cancer and diseases associated with endocrine, cardiovascular, neurological, infectious diseases, and immunological disorders. Dr. Simianu holds a MS/BS in Chemical Engineering and Pharmaceutical Technology and a Doctorate Degree in Chemistry.

Dushyant Varshney

Dr. Dushyant B. Varshney, Ph.D., is the Executive Vice President & Chief Technology Officer at Arcturus Therapeutics. He is responsible for Global CMC, Technical Operations, Supply & Quality, including technology innovation, product development, manufacturing, technology transfer and commercialization of Drug Substance and Finished Drug Products.

Dr. Varshney has over 25 years of experience at global bio-pharma organizations, leading the entire product life-cycle of diverse biotech modalities including mRNA therapeutics, gene & cell-based therapy, biologics, vaccines and sterile injectables. He has made significant contributions towards 30+ launches, 75+ INDs, BLA, PAS submissions, and ensured supply of more than 7B+ doses, $20B+ revenues at companies including Gilead, Pfizer, Novartis and Sanofi.

Before joining Arcturus, Dr. Varshney was the Global Head of Manufacturing, Science & Technology at Gilead-Kite, where he led and contributed to rapid commercialization strategy for successful technology transfers, launch & patient access of Yescarta®, Tecartus®, viral vectors and clinical products. Prior to that, he served as the Vice President, Global Head of Technical Services, Operations & Supply at Jubilant, and as the Head of Manufacturing, Science & Technology at Pfizer. At Novartis, contributed to commercial technology transfer, qualification, manufacturing of Flucelvax® (first US cell-based influenza vaccine) Trivalent & Quadrivalent and Pre-Pandemic Vaccine stockpiles (bird & swine-flu, H5N1, H3N2, H7N9).

Dushyant received his Ph.D. in Chemistry from University of Iowa, M. Pharm from Institute of Chemical Technology, Mumbai, and B. Pharm from University of Pune in India. He is a Stephen Covey Leadership Coach, Master Black-Belt in Operational Excellence, made 120+ conference presentations, published 40+ articles, chapters and edited the book “Lyophilized Biologics & Vaccines” published by Springer.

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.

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.

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.

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.

Søren Thuesen Pedersen

Søren Is Chemical Engineer by education (1994) and has been working 27 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratories 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 with new external requirements? Mr. Pedersen is responsible for the Advocacy and 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.

Murali Muralidhara

Murali Muralidhara, PhD, Chief Manufacturing Officer at RVAC Medicines, heads up Global CMC, MSAT and SC functions based out of  Singapore-Boston & Shanghai.  He has over  20 years of technical and leadership experience  in Product Development, Manufacturing, and Commercialization Protein Biologics, Vaccines  & Gene Therapy products in large & mid-size pharma set-up.  Murali has contributed to product development, module-3 preparation, investigation and approval of eight biologic & vaccine products ( Flumist®, Elelyso®, Xiapex®, Trumenba®, Imfinzi®,  Crysvita®, and Reblozyl® ) and  over 20 INDs/IMPDs for clinical development as an  individual contributor, team leader and Function head . He has deep leadership expertise in organizational design, value creation, leading multi-site/multi-country operations, CDMO operations, talent development & retention, and implementation of continuous improvement programs.  He has published 50 research papers & reviews, made over 40 industry podium presentations and serves on journal editorial boards of Drug Discovery Today, mAbs, and Vaccines & Vaccination.

RJ Doornbos

As the Head of Global Quality Systems, RJ serves as a key member of the Global Quality Leadership (GQLT) team. The primary function of this role is to ensure that an effective Quality System is in place for R&D and GPS organizations to ensure that work is conducted to the highest standards of quality and in compliance with applicable regulatory requirements. The Quality Systems organization also supports site operations in GPS, as well as functions performing GxP regulated activities in R&D. This includes establishing and maintaining an integrated GxP Quality System Framework to assure that GxP research and development activities as well as biopharmaceutical manufacturing activities are conducted in accordance with Company requirements, worldwide health authority regulations, and evolving regulatory expectations. The maintenance of this integrated quality system will include measuring and monitoring the operational performance of system elements. To ensure that the global quality system for BMS is designed and maintained according with evolving regulatory expectations, the quality systems department will contain centers of excellence (CoEs) for key systems such as devices, Change Management, Investigations, Complaints and Systems Ownership. The Head of Global Quality Systems oversees systematic implementation of programs to assure compliance with all principles of current Good Laboratory Practices, Good Clinical Practices, Good Pharmacovigilance Practices, and Good Manufacturing Practices to ensure patient safety and the highest standards of quality.

She joined BMS in December of 2017 from Teva, where she was Executive Director of North East Cluster, Quality Operations overseeing four manufacturing and packaging sites supporting human health products for the North America Human Health Business. Prior to that, RJ spent the majority of her career in the Schering-Plough Research Institute and the Merck Manufacturing Division with roles of increasing scope and complexity in the areas of Regulatory Affairs, Pharmaceutical Sciences, and R&D Commercialization Quality. Her experience spans the entire product lifecycle in both Quality Operations (R&D and Commercial) and in designing and implementing small and large scale Quality Systems including successful execution of US FDA Consent Decree. She has her BS in Pharmacy from Rutgers University, 1992.

Nuno Fontes

Nuno is the SVP, Head of Global Biologics Development at Bayer Pharmaceuticals, leading the group responsible for all process development and clinical manufacturing of cell therapy, gene therapy and recombinant protein therapeutics in both Berkeley, CA, USA and in Wuppertal, Germany. With over 20 years of experience in the Biotech Industry, prior to joining Bayer in January 2021, Nuno had been in key leadership roles in Biotech including: Executive Vice-President of Technical Development at Coherus Biosciences, Executive Director of Process Science at Boheringer-Ingelheim and CMC Team Leader and group leader at Genentech (Roche). Nuno has a PhD. in Biochemical Engineering and an MBA in commercialization of science and technology.

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.

Jason Murphy

Dr. Murphy joined Moderna in 2018 and leads Technical Development of DNA, Enzymes and mRNA related to Moderna’s mRNA platform technology.  Dr. Murphy also leads Applied Technologies which houses Moderna High Throughput Development and Automation Engineering teams.   Prior to joining Moderna, Dr. Murphy was at Elanco (a division of Eli Lilly and Company) for 3 years leading fermentation and strain development as well as Biopharmaceutical Technical Services and spent 14 years at Merck & Co. in various roles within Merck Research Labs and the Merck Manufacturing Division.  Dr. Murphy is a Chemical Engineer by training with a Ph.D. and M.S. degree from the University of Houston and a B.S. degree from University of California at Berkeley.

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.

Babita Parekh

Currently, Babita Parekh is the Vice President of Analytical Sciences and Global Bioassay Steward at Eli Lilly & company. She has obtained an M.S and a Ph.D. in Microbiology/Biochemistry from the M. S. University of Baroda, India. Babita began her post-doctoral career at United States Department of Agriculture, Maryland and postdoctoral fellowship at NYU medical Center.

Babita joined Lilly NJ in 1996 and started her career in Quality Control. She has provided leadership to the BioAnalytical Sciences and is responsible for the strategic direction and organizational capability. She was involved throughout the development and regulatory submission/commercialization for four monoclonal antibodies. Her group is responsible for managing analytical methods through all phases of product development, for studying correlation between structure/function, bioassay stewardship and regulatory filing support.

Eileen Higham

Eileen Higham, Ph.D. has more than 20 years of experience leveraging deep technical, strategic, and operational expertise to develop innovative cell therapies, gene therapies, and biologics to transform human health.

Eileen is currently Senior Vice President, Head of Technical Operations at Intergalactic Therapeutics, a recently unveiled non-viral gene therapy company. Prior to Intergalactic, Eileen was Vice President, Head of Analytical & Process Development at Sana Biotechnology, where she led a team developing best-in-class manufacturing processes and analytical packages for production of next generation cell and gene therapies. Prior to Sana, Eileen was Senior Director, Head of Analytical & Process Development at Juno Therapeutics (Celgene/Bristol Myers Squibb), where she provided technical, strategic, and operational leadership for development of best-in-class manufacturing processes and analytical packages for production of autologous T cell therapies. In this role, she built and led an organization of 100+ scientists and engineers developing strategies to enable robust, well-controlled, scalable, and well-characterized Drug Product process design and associated analytical packages.  Prior to Juno, Eileen served as Product Development Team Leader – Adoptive Cellular Therapy at MedImmune/AstraZeneca, with joint appointments in Biopharmaceutical Development (BPD) and the Oncology Innovative Medicines Unit (iMED). Eileen started her career in industry at Merck as a Biochemical Engineer.

Eileen received a Bachelor of Science in Engineering in Chemical Engineering from Princeton University and a Doctorate in Biological Engineering from the Massachusetts Institute of Technology.

Ruby Casareno

Ruby Casareno, Ph.D., serves as Senior Vice President, Technical Operations at Allakos Inc, leading the biologics drug substance and drug product process development and analytical development, CMC strategy & project management, quality control, and supply chain & packaging organizations. Her team also oversees the contract manufacturing sites. She is responsible for building and scaling the Technical Operations organization to commercialize lirentelimab and expand the development pipeline. Prior to joining Allakos in 2017, Ruby served as Director of Outsourced Manufacturing and Manufacturing Sciences & Technology at Portola (now AstraZeneca) and supported the commercialization of Andexanet in the US and Europe. Prior to Portola, she was responsible for clinical development of 9 biologics as Director of Process Development & Manufacturing at Oncomed Pharmaceuticals (now Mereo BioPharma). Ruby held various scientific and cross-functional leadership positions at Seagen, Maxygen, Johnson &Johnson (Scios), Xoma and Bio-Rad Laboratories. Ruby has a Ph.D. in Biological Chemistry from the Ohio State University.

Sid Advant

Siddharth (Sid) J. Advant has 25+ years of experience in the Biopharmaceutical Industry in the area of pharmaceutical development, technical operations and CMC leadership.

Sid is currently employed at GSK, leading a GMP Operations organization (Cell banking, Technology transfer, Manufacturing, Engineering, Validation) responsible for delivering Drug substance and Drug product in support of Tox, Phase I-III clinical studies (for mammalian, microbial & gene therapy products). His group is also responsible for oversight of manufacturing at select CDMO’s to supplement internal capacity, or in support of established supply chains.

Prior to GSK, Sid worked at Celgene/Bristol Myers Squibb (through the acquisition of Celgene in 2019). At Celgene, Sid lead the development & implementation of a Biologics Manufacturing Strategy (Internal & External), wherein his group was responsible for oversight of all Biologics Manufacturing, encompassing external Drug Substance & Drug Product manufacturing for clinical & commercial assets, including the approval of Reblozyl in 2019 as well as internal manufacturing (building

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.

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