Lynn Schaich

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.

 

 

 

 

 

 

 

 

 

 

 

 

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, PhD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

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

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, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, PhD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

Gabrielle Wiederkehr, MSc

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

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

Rob Walsh, MD

 

QA/QC

Christopher Kotsopulos, MS

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/Regulatory Submissions

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Business Strategy & Management Support

Lisa Jansa, MBA

Martin Lafontaine

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA