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.

Pam was appointed Executive Vice-President, Operations & Information Technology in June 2015 and assumed additional responsibility for the AstraZeneca Sustainability strategy and function in January 2023. Pam joined AstraZeneca after having spent 18 years with Merck/MSD in Global Manufacturing and Supply Chain and Commercial roles. Pam was the Head of Global Supply Chain Management & Logistics for Merck and led the transformation of Merck supply chains across the global supply network. Pam also held the role of President of MSD China, responsible for MSD’s entire business in China. Prior to joining Merck, Pam held various engineering and project management positions at Universal Oil Products, Union Carbide Corporation and GAF Chemicals. Pam holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology in New Jersey and an MBA in marketing from Pace University in New York.

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, 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 radiopharmaceuticals.
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.

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.

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

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

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

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

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

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

Alison Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an extensive background in biomanufacturing. She is former Chief Technical Officer of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR-T therapies. Prior to Allogene she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and including roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and Regulatory Affairs. Dr. Moore holds a bachelor’s degree in Pharmacology with Honors and a Ph.D. in Cell Biology from Manchester University, England.

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.

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.

She leads a global, multicultural team across North & Latin America, Europe, and Asia responsible for all aspects of Supply Chain Operations and Value Chain Management (Product and Manufacturing strategies) at Merck. Her team is responsible for the supply chain management of Merck’s Human Health portfolio covering Small Molecules, Biologics, and Vaccines.

Bala started her career as an intern at Amazon.com, followed by start-up experiences and pivoting to Pharmaceutical Manufacturing. She began as a shop floor Technical Operations Engineer and, over the last 20 years, held roles of increasing responsibilities across the value chain in Manufacturing, Technical Operations, Engineering, LEAN/Six Sigma, and Supply Chain Management. Having led significant transformation and digital initiatives, she is also a D&I champion in the company and a champion for Merck’s ESG efforts to create sustainable and accessible supply chains.

Bala has a bachelor’s degree from the University of Madras, India, a master’s degree in electrical engineering from Southern Illinois University in Carbondale, and Executive education from Harvard Business School. Bala lives in Doylestown, Pennsylvania, with her husband and three kids (2 humans and a pug).