Over the last few decades we have all witnessed the industrialization of biologics manufacturing, as well as continuous progress in complex medicines such as Cell and Gene Therapy. In this panel we will reflect on where we started, where we are now, and what our future holds. We dedicate this conversation to Mike Kamarck, an exceptional leader of our era whose legacy includes everything we plan to discuss:
- Achievements – What we did, and what we have learned from the rapid rise of biologics manufacturing industrialization
- Encore – Exploring what comes next in the industrialization for the complex medicines manufacturing so that curable medicines can be made upon approval for all patients
- Reflections – How leaders like Mike have championed the technology development, talent development, and industry-wide leadership beyond any one company
- Winning Over Diseases – Demonstrating the importance of technology, manufacturing, talent development and leadership as we march forward together
- Carrying On – Discussing how we will continue the mission Mike championed, and have fun with a contagious big smile as we do it
Dr. Alison Moore is a CMC Executive who most recently served as the 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.
Prof. Wolfram Carius is the EVP Pharmaceuticals 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.
Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus,
and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT (Massachusetts Institute of Technology)
Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.
EVP, President, Merck Manufacturing Division
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.
EVP, Chief Global Supply Officer
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 39 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.
Vice Chairman & Co-Founder
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.
EVP, Manufacturing and Supply
Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of Sanofi’s diverse pipeline, to build world-class standards of manufacturing and supply chain excellence and to future proof Sanofi’s manufacturing network, leveraging the latest digital, process and technology solutions, to ensure the continued reliable supply of essential, high-quality medicines to patients worldwide.
Brendan joined Sanofi in 2015 and was previously our Global Head of Biologics and Manufacturing and Supply head of the Specialty Care portfolio. He has played a key role in supporting our transformation to a fully integrated BioPharma company and advancing the digital transformation of our manufacturing network, notably the Framingham site in the US, which was awarded the prestigious International Society for Pharmaceutical Engineering Factory of the Future and Facility of the Year Awards in 2020. Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck / MSD as Head of Biologics and later Vice President of its Europe, Middle East and Africa Operations. Brendan graduated in chemical engineering from the University College of Dublin, where he currently serves as an honorary adjunct Professor of Chemical and Biochemical Engineering. He is married with four sons. A keen sports enthusiast, Brendan is a UEFA qualified soccer coach, with a specialization in Goalkeepers.
Chief Technology Officer
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.
Michael Kamarck (In Memoriam)
BioPharma Advisor & Board of Directors: Passage Bio, VaxCyte
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.