- How has working through a global pandemic impacted the way we do business?
- Taking stock of how we changed and why we changed. What are some of the net positives? What are some of the things where we do want to return to how things used to be?
- Reviewing where our organizations were five years ago and where we planned to be today, how much has COVID-19 changed the trajectory of our journeys?
- What are some of the lessons learned that we plan to take with us into the future?
- Is the community of biopharmaceutical manufacturers stronger for this experience? Where do we go from here?
Jerry Cacia is the chief technical officer at Graphite Bio. In this role, Jerry is responsible for leading the development of the overall manufacturing strategy and CMC technical operations in support of Graphite Bio’s gene editing programs as they advance through the clinic.
Jerry has proven experience in the development of manufacturing processes and quality control systems across multiple therapeutic modalities. During his 32-year career at Genentech and Roche, he held various senior leadership positions in technical development, manufacturing, and quality. In his most recent position, Jerry served as head of global technical development at Roche during which time he supported a pipeline that included over 80 new molecular entities and more than 100 development projects in various stages.
Stephen Hill is the Chief Technical Officer of Lyell Immunopharma. Prior to this role he was Head of Global Biologics Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical portfolio for Biologics that includes oversight of six manufacturing sites across the US and Europe and five commercial products. His focus is on driving network performance, reliability and supply while developing a robust management system.
As Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center, Stephen was responsible for the largest biologics manufacturing facility within the company’s global network. The site consists of a licensed, large-scale cell culture production facility and recently commissioned small-scale clinical and commercial facility.
Prior to AstraZeneca, Stephen served as Vice President Bulk Manufacturing at Amgen’s Puerto Rico facility and as Executive Director leading commercial formulation and filling and commercial drug substance operations. In these roles he drove Lean Transformation resulting in significant operational efficiencies and successful new product introductions.
Stephen also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement while increasing output to deliver multiple pipeline new product introductions annually.
Stephen joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. Stephen started his career at Immunex Corporation as an operator manufacturing Enbrel.
Stephen holds a Master in Business Administration (MBA) and Bachelor’s in Microbiology (BS) and Political Science (BA) from the University of Washington.
Rahul Singhvi is a global leader in the Life Sciences industry and serves as the Chief Executive Officer of National Resilience, Inc.
Most recently, Rahul was an Operating Partner at Flagship Pioneering, a Boston-based life sciences innovation firm where he was responsible for founding and operating companies launched from Flagship’s innovation foundry, Flagship labs. Before joining Flagship, Rahul was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he was responsible for worldwide vaccine CMC and manufacturing operations. During his six-year tenure at Takeda, the vaccine business grew to over 500 employees and created an industry leading late-stage pipeline of vaccine candidates against dengue, norovirus, and zika. Before Takeda, Rahul was President and CEO of Novavax, Inc. (Nasdaq: NVAX) where he transformed the company from a specialty pharmaceutical business to a vaccine development company with vaccine candidates against influenza (funded by BARDA) and respiratory syncytial virus (RSV). Rahul’s professional career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing.
Rahul serves on the Executive Advisory Board of the Leonard Davis Institute (LDI) of Health Economics at the University of Pennsylvania and on the Scientific Advisory Board of the anti-microbial resistance research group at the Singapore MIT Advance Research and Technology program. He is a mentor instructor in the Undergraduate Projects Opportunity Program (UPOP) at MIT and is a visiting lecturer at the University College London (UCL).
Dr. Singhvi graduated as the top ranked chemical engineer from the Indian Institute of Technology, Kanpur, India and obtained both his M.S. and Sc.D. chemical engineering degrees from MIT. He received an MBA from the Wharton School of the University of Pennsylvania, where he graduated as a Palmer Scholar.
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 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.