Knut Zellerhoff, 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.

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

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

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

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

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Joyce Reyes

Lana Pauls, MPH

Michael Sharp, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Gabrielle Wiederkehr, MSc

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

Lana Pauls, MPH

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Joyce Reyes

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

Rob Walsh, MD

 

 QA/QC

Joshua Sharlin, Ph.D

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

Lynn Schaich

Robert Kaster, RPh., ASQ-CQA

 

Medical Writing/Electronic Submissions

Brandon Jones

Dahlia Sperling

Russ Neubauer, Ph.D

Sandor Bernath, Ph.D, MBA

 

Process & Innovation Management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercializing and Business & Corporate Strategy

Lisa Jansa, MBA

Martin Lafontaine

Stephen Casey, MBA

Thomas Seoh

 

Kinexum Associate

Jennifer Zhao

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA