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Peter Patriarca
Independent Consultant at Immuno-Vax
Peter A. Patriarca, MD, is a highly experienced professional in the field of vaccine development and regulatory affairs. He is currently the Principal of Immuno-Vax, LLC, and a senior affiliate consultant with the Biologics Consulting Group, Inc., based in Bethesda, MD.134
Professional Background
Dr. Patriarca has an extensive career spanning various sectors of the healthcare and pharmaceutical industries:
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Government Service: He served as a Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (CDC) from 1980 to 1992 and at the U.S. Food and Drug Administration (FDA) from 1993 to 2001.1
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FDA Leadership: At the FDA, he held the position of Director of the Division of Viral Products in the Office of Vaccines Research and Review (OVRR), CBER. In this role, he oversaw laboratory-based research and review activities of more than 100 scientific staff.1
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Corporate Experience: Dr. Patriarca worked as the Corporate Head and Vice President of Worldwide Regulatory Affairs and Pharmacovigilance at MedImmune, Inc. from 2001 to 2005.1
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Consulting: For the past 14 years, he has been providing technical and regulatory consulting services for all phases of vaccine and drug development.1
Expertise and Achievements
Dr. Patriarca's expertise includes:
- Vaccine development and licensure
- Regulatory affairs
- Pharmacovigilance
- Medical epidemiology
His accomplishments include:
- Contributing to approximately 400 IND submissions and 12 successful Biologics License Applications (BLAs) or NDAs.1
- Authoring more than 100 peer-reviewed publications.12
- Serving on multiple scientific advisory bodies for organizations such as CDC, WHO, the Bill and Melinda Gates Foundation, the American Academy of Pediatrics, and the National Academy of Sciences.12
Dr. Patriarca's extensive experience and expertise make him a valuable consultant in the field of vaccine development and regulatory affairs.
