Originally aired April 1, 2021
COVID-19 vaccines were developed at record pace — but how? Were any testing corners cut, safety standards compromised, or vaccines rushed into distribution? In the second webinar of a public health series co-hosted with the American Public Health Association, Milken Institute, and MDB, vaccine research, manufacturing, and regulatory experts answer these questions and provide essential insights into the science and engineering behind vaccinology.
Alan Liss (Moderator)
Founder, GXP Farma, LLC; Former Director, MCMI PHSAT, U.S. FDAAlan Liss is the Founder of GXP Farma, LLC, which provides strategic mentoring, auditing, compliance programs, and regulatory strategy for biotech and pharmaceutical companies. He previously served as Director of MCMI PHSAT (medical countermeasures) at the U.S. FDA’s Office of Counterterrorism and Emerging Threats, and as former Deputy Director of the Regulatory and Quality Affairs Group at BARDA in HHS.
Wellington Sun
Head of Vaccine Strategy and Regulatory Affairs, Moderna Therapeutics; Former Director, FDA Center for Biologics Evaluation and Research (CBER)Dr. Wellington Sun is Head of Vaccine Strategy and Regulatory Affairs at Moderna Therapeutics. He came to Moderna from the U.S. Food and Drug Administration, where he was Director of the Division of Vaccines and Related Product Applications at CBER. An infectious disease physician-scientist, he brings diverse expertise in medicine, clinical research, and FDA regulation of infectious disease vaccines and biotherapeutics.
Amy Shertleff, PhD
Senior Scientist, Preclinical Models, Coalition for Epidemic Preparedness Innovations (CEPI)Dr. Amy Shertleff holds a PhD in Viral Pathogenesis and is a Senior Scientist in Preclinical Models at CEPI, where she administers research programs for vaccine testing in preclinical infection models. She has served as lead research investigator and study director for programs testing DNA vaccines, the Ebola vaccine ERVEBO, and other novel vaccine platforms through her work with the U.S. Army.
Raafat Fahim, PhD
President, REFF Consulting; Senior Vaccines Development and Manufacturing Consultant, CEPI; Former President & CEO, Nabi PharmaceuticalsDr. Raafat Fahim holds a PhD in Biochemistry and brings 35 years of experience in vaccines, biologics, and biotechnology. He is President of REFF Consulting and a Senior Vaccines Development and Manufacturing Consultant at CEPI. Previously, he was President and CEO of Nabi Pharmaceuticals and Vice President of Late-Stage Development and Manufacturing at Sanofi-Pasteur, where he led development of multiple essential vaccines from early research through regulatory approval and commercialization.
