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.

Manisha Desai, a seasoned pharmaceutical executive and strategic leader, currently serves as the Senior Vice President of Product Development within Global Product Development and Supply (GPS) at Bristol Myers Squibb (BMS).  Throughout her 25-plus-year career at BMS, Manisha has developed extensive expertise in the biopharma industry, with a focus on end-to-end CMC development. This includes the design & development, scale-up, and technology transfer for both oral and parenteral drug products for BMS’s small and large molecule portfolio, as well as combination products, to manufacturing sites. In addition to her technical expertise, Manisha has excelled in developing and executing organizational strategy, leading strategic partnerships, building high-performing teams, managing large global organizations, shaping organizational culture, and guiding teams through change.

Manisha earned her bachelor’s and Masters degree in Pharmaceutical Sciences from the University of Mumbai, India; her Ph.D. in Pharmaceutical Sciences from the University of Michigan; and her MBA from the NYU Stern School of Business.

Outside of work, Manisha enjoys spending time with her family and friends, traveling, engaging in charity work, and watching shows on Broadway.

Aine’s career in the biomanufacturing sector spans roles in the UK, Ireland, and the US, with a strong focus on developing innovative solutions to expedite the delivery of medicines to patients. Aine Hanly has recently rejoined Amgen as Vice President, Quality. In this role, Aine will lead a global team accountable for all aspects of quality oversight for Amgen’s products, from early product and process design to manufacturing and product supply to ensure that quality standards are met and in compliance with applicable regulatory requirements.

Prior to her return to Amgen, Aine spent the past 4 years with Vir Biotechnology, an immunology-based biopharmaceutical company developing medicines for infectious diseases and other serious conditions. Aine was the Chief Technology Officer (CTO) and EVP Technical Operations, leading the company’s technical operations function, which included responsibility for end-to end GxP Quality and Data Strategy.

Prior to Vir, in her almost decade-long tenure at Amgen, Aine led teams across several Amgen sites (ACO, AML, AMA and ATO) including oversight of clinical manufacturing and clinical supply (MCS). Her leadership roles in Process development supported the commercialization of Amgen’s pipeline products and technical support for ongoing manufacturing operations. As the site head at Amgen’s Cambridge facility, Aine also led the site’s transformation and staff expansion.

Prior to joining Amgen in 2012, Aine held roles of increasing responsibility in Pfizer (formerly Wyeth) Process Development, Product Supply and Quality including site head of Quality for Pfizer’s Grange Castle Manufacturing site in Ireland.

Aine earned her bachelor’s degree in biological chemistry and her Ph.D. in physical organic chemistry from the University of Ulster in Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining Yale University and CuraGen Corporation as a lead scientist, where she focused on gene isolation and validation using various molecular biology techniques.

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.

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.