Vaccine development in the COVID-19 era: regulatory challenges & innovation

How have regulators evolved to meet the need for rapid vaccine development during the pandemic – and what does that mean for the regulatory landscape going forward? Here, four experts who have played key roles in the regulatory response to COVID-19 come together to discuss the key issues.

Peter Marks joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016. He has been Acting Director for OVRR since 2021. He is board-certified in internal medicine, hematology, and medical oncology, and before joining the FDA, he held a variety of leadership roles in academic medicine and the pharmaceutical industry – most recently as the leader of Yale University’s Adult Leukaemia Service and Chief Clinical Officer of Smilow Cancer Hospital.

Marco Cavaleri is the Chair of the EMA COVID-19 Task Force and responsible for EMA activities for emergent pathogens, vaccines, and antimicrobial resistance. Marco is a pharmacologist who spent several years in industry R&D, mainly in preclinical and clinical development of anti-infectives, before the EMA in 2005. In 2009 he was appointed Head of Section for Anti-infectives and Vaccines in the Safety & Efficacy Sector, Human Medicines Development and Evaluation Unit.

Carla Vinals has been in the pharmaceutical industry for 26 years, and her career has been devoted to vaccine development. Carla joined Moderna in 2020, as the company was preparing for Phase 3 trials of its COVID-19 vaccine. Carla and her team are now supporting two large multinational Phase 3 studies for RSV and CMV vaccines, and ongoing programs targeting respiratory viruses, latent viruses, and pandemic preparedness.

Adam Hacker is the Head of Global Regulatory Affairs, Coalition of Epidemic Preparedness Innovations (CEPI). As part of his role at CEPI, Adam co-chairs the COVAX Regulatory Advisory Group, consisting of thirteen regulatory authorities, where regulatory issues related to COVID-19 vaccine development are discussed. He has more than 20 years of pharmaceutical industry experience in leadership roles extending from Regulatory Affairs to Quality and Medical Affairs, including 10 years at Janssen.

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