Biomanufacturing World Summit

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.

Hilary Marston, M.D., M.P.H. is a Principal at Canal Row Advisors, a regulatory strategy consulting firm. Prior to this, Dr. Marston served as the Chief Medical Officer of the FDA. She oversaw clinical matters that involved multiple product development centers, including financial incentives for rare disease product development, combination product jurisdiction and research participant protection policy. She also led Agency response to health crises, including epidemics and shortages.

Dr. Marston previously served as Senior Advisor for Global COVID-19 Response on the White House COVID Team, Director for Medical Biopreparedness and Response at the National Security Council, and Policy Advisor for Pandemic Preparedness at the National Institutes of Health.

Dr. Marston trained in Internal Medicine at Brigham & Women’s Hospital.

Scott Gottlieb, MD, is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. He is currently a senior fellow at the American Enterprise Institute for Public Policy Research and a partner at the venture capital firm New Enterprise Associates.

Under his leadership, the FDA advanced new frameworks for the modern oversight of gene therapies, cell-based medicines, and digital health devices. The agency implemented new reforms to standardize drug reviews and made historic improvements in post-market data collection and the use of real-world evidence. He promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises. The agency’s prolific advances in new policy distinguished his tenure as FDA Commissioner, along with a record-setting number of approvals for novel drugs, medical devices, and generic medicines.

Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. He is the author of the New York Times bestselling book “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic” and is a regular contributor to CNBC and CBS News’ Face the Nation. Dr. Gottlieb serves on the board of directors of publicly traded companies Pfizer, Inc., Illumina, Inc., and TempusAI.

Dr. Gottlieb is an elected member of the National Academy of Medicine and completed medical school and a residency in internal medicine at the Mount Sinai School of Medicine, where he currently serves on the executive committee of the Mount Sinai Health System’s board of directors and co-chairs the board’s education committee. He graduated from Wesleyan University, where he majored in economics, and currently serves on the university’s board of directors. Dr. Gottlieb lives in Connecticut with his wife and three daughters.

Kimberly has achieved several first-in-industry achievements throughout her career within life sciences. Currently at Johnson & Johnson Innovative Medicine, she shapes the long-term vision, strategic direction and execution of end-to-end supply chains and global manufacturing networks for emerging new modalities, including cell & gene therapy and radio pharmaceuticals.

Before joining J&J, Kimberly served as SVP, Global Supply Chain at Bristol Myers Squibb, where she oversaw plan, deliver, digital excellence and integrated product strategies for all commercial products in addition to plan for all clinical supplies. Under Kimberly’s leadership, the global supply team successfully launched more than nine new products, including several within hours of FDA approval,
and BMS was recognized on the annual ‘Supply Chain Top 25’ list by Gartner. Both achievements were firsts in the company’s history.

Earlier in her career at Novartis, Kimberly led the supply chain teams that achieved FDA approval and launch for the world’s first CD-19 CAR-T therapy and launched the first FDA-approved biosimilar.
Kimberly received her M.B.A. from the Wharton School, University of Pennsylvania and her B.S in Chemical Engineering from Northwestern University. She has been recognized as one of the Fierce Pharma’s ’20 Fiercest Women in Life Sciences’.

Kimberly serves on the Advisory Board of the Department of Chemical and Biological Engineering at Northwestern University and is passionate about mentoring tomorrow’s workforce to excel in STEM careers.

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.

As the Senior Vice President for Specialty Care Manufacturing & Supply at Sanofi in Paris, Daniela Ottini oversees the global Manufacturing Network for Specialty Care products. With extensive experience spanning over a decade at AbbVie,  she has held leadership positions such as Vice President of External and Contract Manufacturing in Rome, Italy, and Vice President of Biologics Manufacturing in Dublin, Ireland. Her career highlights include managing diverse portfolios and leading strategic initiatives like the integration of AbbVie-Allergan for Operations. Previously, at Abbott, Daniela held various roles over 16 years, including Manufacturing Director in Italy and Regional Purchasing Manager in the UK.  She holds a degree in Chemical Engineering from Sapienza Università di Roma and a Master’s in Business Engineering from the University of Rome Tor Vergata.

Paul was appointed Chief Quality Officer at Bristol Myers Squibb in September 2024.  Prior to that he served as Vice President, Head of R&D Quality at BMS since 2023. A dynamic and strategic leader with more than 27 years of good practice (GxP) quality and compliance experience, Paul has demonstrated an ability to foster a culture of quality excellence. Most notably, he has helped shape the Quality strategy with a focus on proactive, risk-based and scientific principles, leveraging innovation to enable end-to-end, sustainable quality performance.

Prior to joining BMS, Paul held several senior-level Quality positions at Johnson & Johnson, most recently serving as the Head of BioResearch QA where he led risk-based quality and compliance oversight spanning preclinical, clinical and pharmacovigilance disciplines. During that time, he partnered with internal and external stakeholders to develop and implement innovative quality oversight, leveraging data analytics and technology solutions to deliver more effective, efficient and value-based quality outcomes. Prior to Johnson & Johnson, Paul held positions at Pfizer and Warner Lambert both in R&D and Manufacturing Quality. He holds a Bachelor’s in Biochemistry from the University of Scranton, an M.S. in Quality Engineering from Lehigh University and an MBA from St. John’s University.

Chris Crowell leads the Global Manufacturing team at Kite, overseeing the four-site commercial network that delivers industry-leading turnaround times for the company’s primary cell therapy, receives regulatory approvals from multiple jurisdictions, and is launching clinical trial production for a promising new asset.

Most recently, Chris served as the Site Head of Kite’s T-cell therapy commercial manufacturing facility in Amsterdam, managing a sitewide staff of approximately 1,000 employees and serving patients from throughout Europe and the Middle East. He joined Kite initially in 2021 as Vice President of Manufacturing and Site Head of Kite’s Research, Development & Manufacturing Center located in Santa Monica, California, bringing years of pharmaceutical manufacturing and operations expertise to Kite’s clinical site.

Prior to Kite, Chris served as the Executive Director and Plant Manager of Amgen’s Drug Substance manufacturing facility in Thousand Oaks, California that was responsible for manufacturing the company’s oncology pipeline products. He began his 28-year career at Amgen in their Analytical Development function within Quality and advanced in roles that spanned all phases of Chemistry, Manufacturing and Controls (CMC) commercialization – including Global Operations and Process Development. That comprehensive experience led to his recruitment by Kite.

Chris holds a bachelor’s degree in biological sciences from the University of California, Santa Barbara, and a Doctor of Philosophy in pharmaceutical sciences from the University of Colorado’s Anshutz Medical Campus. Born and raised on the East Coast, his dissertation focused on elucidating the relationship of changes in gene expression with changes in phenotypes of protein therapeutics impacted by cell culture media conditions.

Nitin Rathore, Ph.D., is currently the Vice President of Drug Product Technologies, Process Development at Amgen Inc., Thousand Oaks, California. Dr. Rathore has over 20 years of experience in process development and leads the Drug Product organization at Amgen encompassing both biologics and synthetics portfolio across all phases of development.

His organization focusses on commercialization of Amgen’s multi-modality portfolio covering molecule assessment, formulation development, process design, technology transfer, regulatory filings, and new product launches. His team also provides support to drug product manufacturing sites including both new product introductions as well as ongoing support to ensure supply of 40 commercial products. Dr. Rathore has experience in advancing next-gen technologies both in development space (automation and high throughput), and in the area of drug product filling, lyophilization and automated visual inspection. He is currently a member of Board of Directors for the IQ consortium and has been an active member of various other professional societies. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug product development and innovation in biomanufacturing.

Prior to Amgen, he worked in the process optimization group at Novozymes, North America. Dr. Rathore received his Ph.D. degree in Chemical and Biological Engineering from University of Wisconsin-Madison, Madison, WI.

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.

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ – the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

Mike has 35 years of experience in the BioPharma industry, having spent 16 years in R&D and 17 years in manufacturing; retiring as a senior vice president from Merck & Co. (MSD) in March of 2022 and recently becoming Head, Pharmaceutical Sciences in R&D at Takeda Pharmaceuticals in September 2022.  During his 33 years at Merck, Mike led process development/new product introduction, operations, facility construction/start-up and divisional strategy/transformation/culture.  Under his leadership, Mike’s areas have introduced manufacturing products which have changed medical paradigms for treatment.  This includes the medically significant CRIXIVAN (the first effective AIDS therapy) and ERVEBO (the only vaccine for ebola), as well as large market drugs like JANUVIA (for Type II diabetes – $6BB/yr in revenue) and KEYTRUDA (for cancer – ~$20BB/yr in revenue) and has overseen more than 50 new product introductions.

In addition, he has led the timely delivery and start-up of over $8 BB in new manufacturing facilities for vaccines and biologics.  He has successfully led 3 major transformation projects and large segments of 2 company integrations.  Mike now heads the Pharm Sciences group in Takeda R&D and is responsible for product definition and process and method development and characterization from the Research interface through introduction to manufacturing.

Mike received his PhD from MIT, his BS from Caltech.  He chairs a hospital board, sits on two Boards of Directors (including the board of Ireland’s NIBRT), and has been a member or chaired academic visiting committees for MIT, UTexas, Tufts, Johns Hopkins and U Delaware.  He currently lives in Westfield, New Jersey.