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biopharmaceuticals

Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances
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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

Sanat Chattopadhyay is responsible for the company’s (approx. $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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FUTURE READY: Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, Data & (High) Yields
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FUTURE READY: Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, Data & (High) Yields

Jerry Murry, is Senior Vice President of Process Development at Amgen. Jerry started his career at Amgen in 2006 as Executive Director, Process Development within the Translational Sciences organization in R&D, and was promoted to Vice President, Process Development in 2010. In 2012, Jerry joined the Amgen Full Potential Transformation team as lead of the initiative “Transforming Process Development at Amgen”(AFP3).

In 2014, as part of the integration and reorganization of a new single, global process development team, Jerry was named the head of CMC Lifecycle management with responsibility for Operations Commercialization activities including regulatory filings and launches.

In 2016, Jerry became head of Drug Product Technologies with responsibility for all formulation and product and process development.
In 2018, Jerry was promoted to Senior Vice President Process Development at Amgen with responsibilities for all global Process Development activities.

Prior to joining Amgen, Jerry spent 8 years at Pfizer Central Research and 6 years at Merck Research Laboratories in Process Development.

Jerry earned BA/BS in Biology and Chemistry at Texas Lutheran University, a PhD in Chemistry from University of Utah and was an NIGMS NIH Fellow at Harvard University.

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Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche
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Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Tongtong joined Genentech in 2018 as the head of Pharmaceutical Technical Development for US Biologics, and was named global head of Pharma Technical Development in April 2021. Prior to her role at Genentech, Tongtong held several scientific, managerial and strategic roles at Eli Lilly, with increasing responsibilities in the Bioproduct Research and Development organisation. Tongtong also worked at Corixa Corporation, a biotech company, where she gained valuable experiences both as a discovery scientist and as a CMC leader in support of therapeutic antibody and cancer vaccine platforms.

Tongtong received her B. Sc. in Molecular Biology from University of Science and Technology of China, a doctorate in Biology from Syracuse University, and completed her postdoctoral training in cell biology and yeast genetics at Cornell University.

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Authentic Leadership
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Authentic Leadership

As Chief Global Supply Officer, Executive Vice President, Mike McDermott leads 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. This includes hundreds of medicines and vaccines provided to more than 185 countries worldwide. The PGS network, which includes more than 30 global manufacturing sites and approximately 31,000 colleagues, also works with more than 300 contract manufacturers to produce 50 billion doses of medicines and vaccines each year.

Mike has more than 30 years of industry experience, having joined Pfizer in 1989, by way of Wyeth, after starting as a Project Engineer in Pearl River, New York. He has held many roles, including Plant Manager and Operational Vice President of multiple divisions, including Consumer Healthcare, Biotechnology and Supply Chain, as well as roles in Finance and Marketing.

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 has enacted impactful changes to increase diversity within PGS and was recently named Executive Sponsor of Pfizer’s Women’s Resource Group, the company’s largest Colleague Resource Group.

In addition to ambitious goals related to product supply at launch and manufacturing cycle times, Mike and PGS support Pfizer’s Net Zero strategy, which includes delivering Greenhouse Gas reductions.

Mike, his wife Katie and their five daughters – of whom he is incredibly proud – are committed to community engagement and social action. An active volunteer himself, Mike was a Board Member for People to People, a non-profit organization which helps under-served communities, for 10 years.

Mike holds Bachelor of Science and Master of Science degrees in Industrial Engineering from the New Jersey Institute of Technology (NJIT), where he has been an adjunct professor. He was named an NJIT Distinguished Alumnus and is the recipient of the 2023 Newark College of Engineering Outstanding Alumnus Award.

Mike serves on the Executive Committee of the National Association of Manufacturers and is a member of the Pharmaceutical Manufacturers Forum.

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Empowering A Culture of Operational Excellence For Sustainable Growth
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Empowering A Culture of Operational Excellence For Sustainable Growth

Tina Self is a dynamic leader with over 20 years of experience in the biotech and pharmaceutical industries, specializing in quality and manufacturing. Currently, she serves as the Senior Vice President of Global Biologics Manufacturing and Berkeley Site Head at Bayer. Tina has been with Bayer for over eight years, where she has held several key leadership roles, including Vice President of Manufacturing Operations and Vice President of Quality. She is recognized for her strategic oversight of manufacturing processes, commitment to quality assurance, and her ability to drive continuous improvement. Tina holds an MS in Biotechnology from The Johns Hopkins University and an MBA in International Business from Florida Atlantic University.

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Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing
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Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments

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Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future
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Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future

Discussing the most important new technologies in biomanufacturing today, with a special emphasis on what we want to do as our industry matures
Debating how talent and workforce development in our industry is changing, and what we should do about it
Listing the current factors affecting speed of development and efficient manufacturing. How do we continue to improve in a changing business landscape with special reference to IRA and the BIOSECURE Acts?
Understanding the current Regulatory environment with an eye for how things are going to evolve into the future
How can we improve the access of biologic medicines?

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Accelerating the Pace of Progress for Innovative Biologic Products
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Accelerating the Pace of Progress for Innovative Biologic Products

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.

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Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development
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Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients

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Leading a Technical Organization Through Uncertainty
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Leading a Technical Organization Through Uncertainty

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

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Proactivity – the Future of Quality
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Proactivity – the Future of Quality

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

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A Vision for the Future: Intellia’s Journey in in Vivo Genome Editing
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A Vision for the Future: Intellia’s Journey in in Vivo Genome Editing

Eliana Clark, PhD is Executive Vice President and Chief Technical Officer at Intellia Therapeutics, where she is responsible for Internal and External Manufacturing, Supply Chain, CMC Strategy and Operations, Process and Analytical Development, Genomics Operations, and Quality, for novel gene editing-based products, both ex-vivo cell-based therapies and in vivo therapies. Eliana joined Intellia in January of 2020. Prior to Intellia, Eliana spent nearly eight years in leadership roles at Biogen, including vice president of International Manufacturing Operations and vice president of Global Manufacturing Sciences. In her most recent role at Biogen, she led the team responsible for the CMC product strategy and lifecycle management for Biogen’s entire product portfolio including clinical and commercial products. Before Biogen, Eliana spent many years at Sanofi/Genzyme, where she held leadership roles in CMC Regulatory, Manufacturing Sciences, and Technology Development. Prior to working in industry, Eliana was a professor of Chemical and Biological Engineering at Tufts University for 14 years. She holds a B.E. and Ph.D. in Chemical Engineering from the Universidad Nacional de Litoral in Santa Fe, Argentina, and is a graduate of the Greater Boston Executive Program at MIT Sloan School of Management and the WIB Boardroom Ready Program at George Washington University.

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Emerging Trends Impacting Technical Development and Manufacturing
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Emerging Trends Impacting Technical Development and Manufacturing

Jamie Moore is currently Senior Vice President of Technical Development responsible for the CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of experience as a chemist and pharmaceutical scientist working in both large and small Biopharmaceutical companies including CytomX and Roche. At CytomX, she was Senior Vice President on the executive team leading the Protein and Process Sciences, and Manufacturing organizations. Previously she spent a significant portion of her career at Genentech/Roche where she held multiple technical and managerial leadership roles within Pharma Technical Operations including Head of Pharmaceutical Development and Global Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie is serving as the President- for the Board of Directors for CASSS, an organization that brings together industry, academic and regulatory leaders to resolve scientific challenges impacting CMC development and regulation. She has a B.S. in Chemistry and received her doctoral degree in Chemistry and Chemical Biology from UCSF.

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Advancing Cell Therapy Industrialization: Key Focus Areas
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Advancing Cell Therapy Industrialization: Key Focus Areas

Thomas has been serving as the Senior Vice President of Cell Therapy Development and Operations at BMS since August 2023. Before joining BMS, he held multiple roles with Merck & Co, where he gained experience in basic research, early and late-stage process development, capital project management, site-based technical operations, commercialization, manufacturing science and technology, and supply chain. Before that, Thomas worked for startup, GlycoFi, founded at Dartmouth College, where he conducted post-doctoral research after receiving his PhD in Bioprocess Engineering from the University of Cape Town in South Africa.

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Validating a Gene Therapy Innovation Center (GTIC)
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Validating a Gene Therapy Innovation Center (GTIC)

In his current role as the Senior Director of Validation at Spark, John leverages over 24 years of expertise in the compliance and validation of enterprise computer systems, applications, and equipment regulated by the FDA and EU. John is a compliance and validation thought leader and has a deep understanding of 21 CFR Parts 210, 211, 606, 820, 11, and Annex 11. John’s experience spans a variety of analytical systems, including HPLCs and spectrophotometers, as well as computer systems such as ERP, LIMS, EDMS, EMS, PCS, and DCS, serving major pharmaceutical, medical device, and blood management companies. Before joining Spark in May of 2015, his career included roles at Pfizer, AstraZeneca, TEVA, Smith & Nephew, GE Healthcare, DSM, Haemonetics, and the American Red Cross, where he has consistently ensured compliance with predicate rules, 21 CFR Part 11, and GAMP 5 guidance. John holds a Bachelor of Science degree in Computer Information Systems from the Florida Institute of Technology.

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Enhancing the Timely Introduction of Novel Therapies
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Enhancing the Timely Introduction of Novel Therapies

John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.

John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development. As an executive leader, he contributes to corporate strategy and portfolio management.

Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.

In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.

He holds a B.S. in Mechanical Engineering from West Virginia University.

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