Joy Cavagnaro, PhD

Brian E. Harvey, MD, Ph.D

 

 

Dr. Harvey most recently served as VP of US Regulatory for Pfizer. Previously, from 2007-2012, he was VP of US Regulatory Policy for Sanofi-Aventis, including the merger with Genzyme. Dr. Harvey was Director of the Division of Gastroenterology Products at the CDER, FDA until April of 2007. His previous positions include Deputy Director of the Office of Drug Evaluation and Acting Director of the Division of Anti-Inflammatory, Analgesic & Ophthalmologic Drug Products at the CDER, FDA, Associate Director Regulatory Policy at the Office of Therapeutics Research & Opthamology; Review at the CBER, FDA, American Political Science Association (APSA) Congressional Fellow, and Medical Officer at CDRH, FDA. Dr. Harvey has over 11 years of FDA experience in the Centers for Drugs, Biologics and Devices in both medical officer review and management positions. He has experience in drug, biologic product, medical device and combination product pre-market regulatory evaluation. His special interests include Biosimilars,  Functional GI Disorders, IBS, gastroparesis, constipation, Crohn's & Ulcerative Colitis, RA, Gout, Inborn Errors of Metabolism, Orphan Products, FDA policy development, healthcare policy and risk communication. Dr. Harvey received his PhD in biochemistry and MD from the University of Connecticut, did postdoctoral research at New England Deaconess Hospital in Boston, completed an internal medicine internship and residency at Beth Israel Hospital/Harvard, and completed a 3 year gastroenterology fellowship at Johns Hopkins Hospital.  During his time at FDA and Sanofi, he worked as a part time Medical Hospitalist at Anne Arundel Medical Center, MD.

 

 

 

 

 

 

 

 

 

 

 

 

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

John K. Whisnant, Jr, MD

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

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Susan Manley, MS

 Biostatistics

Alan Fisher, DrPH

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

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.

Virgil Whitehurst, Ph.D

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

Medical Device

Michael Sharp, 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

Defense & National Security Practice

Dean E.Calcagni, MD

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.