Vaccine Manufacturing 101

Meet the Panelists From – Moderna, the Coalition for Epidemic Preparedness Innovations, and former FDA and Sanofi-Pasteur officials.

Moderator: Alan Liss is the Founder of GXP farma, LLC, which provides strategic mentoring and consulting, including auditing, compliance programs & regulatory strategy development for successful interactions with global regulatory agencies for biotech and pharmaceutical companies. He is a subject matter expert for project management and drug and biologics development and regulatory approval. Formally Alan was the Director of MCMI PHSAT (medical countermeasures) at US FDA, Office of Counterterrorism and Emerging Threats, and former Deputy Director of the Regulatory and Quality Affairs Group in Biomedical Advanced Research and Development Authority in HHS

Wellington Sun is Head of Vaccine Strategy and Regulatory Affairs at Moderna Therapeutics. Dr. Sun came to Moderna from the U.S. Food and Drug Administration (FDA), where he was Director of the Division of Vaccines and Related Product Applications at the Center for Biologics Evaluation and Research (CBER). He is an infectious disease physician-scientist with diverse expertise in medicine, science, clinical research, and FDA regulation of infectious disease vaccines and other biotherapeutics.

Amy Shertleff holds a Ph.D. in Viral Pathogenesis and is a Senior Scientist in Preclinical Models at the Coalition for Epidemic Preparedness Innovations (CEPI), where she administers research programs for vaccine testing in preclinical infection models. She has served as the lead research investigator and study director for programs testing DNA vaccines, the Ebola vaccine ERVEBO, and other novel vaccine platforms through a long tenure at the United States Army Research Institute for Infectious Diseases. She has also served as an annual instructor in the UTMB/FDA joint course ‘Achieving Data Quality and Integrity in Maximum Containment Laboratories’. She has 20 years of hands-on experience in the design, development, and preclinical testing of antiviral vaccines and therapeutics under high biocontainment with pathogens such as influenza, arenaviruses, hantaviruses, ebolaviruses, and coronaviruses.

Raafat Fahim holds a Ph.D in Biochemistry and is the President of REFF Consulting. He has 35 years of experience in the Vaccines, Biologics, and Biotechnology industries. He is currently consulting for several organizations including the Coalition for Epidemic Preparedness Innovations (CEPI) where he is a Senior Vaccines Development and manufacturing consultant. Previously, he was the President and Chief Executive of Nabi Pharmaceuticals, a Biopharmaceutical Company specialized in Vaccines and Plasma products.   Prior to joining Nabi Biopharmaceuticals, Dr. Fahim was the Vice President of late-stage Development and Manufacturing at Sanofi-Pasteur where he was instrumental in developing several essential vaccines from early research to regulatory approval and commercialization