Brian E. Harvey, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Brian E. Harvey, MD, PhD is a physician and biochemist with academic research, clinical practice, U.S. FDA regulatory, bio-pharmaceutical industry and non-profit experience.  He currently is the Executive Vice President, Scientific and Regulatory Affairs at the non-profit Global Liver Institute (www.globalliver.org) based in Washington, DC and also serves as a regulatory consultant.  Other volunteer activities include work with World Vets (http://worldvets.org/), as a Veterinary Husband and Assistant.  This past year, he spent a week in Nicaragua on an Equine mission, where he and the team cared for over 400 horses during their trip. 

Prior to his current activities, Dr. Harvey held positions as Vice President of U.S. Regulatory Strategy at Pfizer and Vice President of U.S. Regulatory Policy at Sanofi-Aventis, including during the period of the Genzyme merger.

Dr. Harvey also held several senior roles at FDA, serving in the medical device (CDRH), biologic (CBER) and drug (CDER) Center from 1995 to 2007.  As Director of CDER Division of Gastroenterology Products Office of New Drugs (OND), he headed the regulatory review teams for NDA and BLA submissions and chaired FDA meetings with regulated industry on a regular basis.  As Director, he created the Inborn Errors of Metabolism Team within the GI division to focus on rare disease product approvals.  Prior to this, he served as Deputy Director for the Office of Drug Evaluation 5 (CDER) and CBER Associate Director for Policy, Office of Therapeutics Research and Review (OTRR).  In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow and worked with the health staffs of the Senate Finance, Health Education Labor & Pensions (HELP) and Judiciary Committees.  During his entire federal service, he also worked as a medical hospitalist, caring for patients on evenings, weekends and holidays at Anne Arundel Medical Center in Annapolis, MD as an “Outside Activity” (HHS-520 Approved).

Brian graduated with honors from Middlebury College in Vermont.  After college, he completed his PhD in biochemistry and then enrolled into the MD program at the University of Connecticut.  In his last year of medical school, he began post-doctoral research on colorectal cancer and the role of sialic acid in site-specific metastasis at Harvard University.  He completed his internship and residency in internal medicine at Harvard’s Beth Israel Hospital, which included clinical rotations at Dana-Farber Cancer Institute, West Roxbury Veterans Hospital, clinical research at Brigham and Women’s Hospital and the Harvard School of Public Health.  His bench research activities resulted in several publications in peer reviewed journals.  This was followed by a three year gastroenterology fellowship at Johns Hopkins Hospital, Baltimore, MD, which included hepatology training and being a member of the Liver Transplant Service.

Experts

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

Michael Trautmann, MD

Mustafa A. Noor, MD, FACP

Peter Damsbo, MD

Ramachandra (Ram) G. Naik, M.D.

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

Regulatory Strategy and Operations

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Susan Manley, MS

Biostatistics

Alan Fisher, DrPH

Regulatory Science & Innovation; Biomedical Advanced R&D

Carol Linden, PhD

EU Regulatory

Catherine Bernard, Ph.D

Gabrielle Wiederkehr, MSc

Michael Trautmann, MD

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun, B.S.

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Susan Manley, MS

Health Policy Development

Steven Grossman, JD

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Michael B. Zemel, Ph.D.

CMC, Formulation/Process Development & Sourcing

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Medical Device

Eric Kolb

Melissa Thompson

Paul Goode, Ph.D

QA/QC

Brian Oscherwitz, MBA, PMP

Jennifer Zhao, B.S.

 Medical Writing/Electronic Submissions

Jennifer Zhao, B.S.

Kristi Hultberg, B.S.

Sandor Bernath, Ph.D, MBA

Botanicals

Jinhui Dou, Ph.D.

Government Relations and Public Affairs

Scot Faulkner, MPA

Steven Grossman, JD

Defense & National Security Practice

Dean E.Calcagni, MD

Steven Grossman, JD

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.

Kinexum Associates

Elijah Abass

Brontë Jenkins