Leadership

Rashmi Shah, MB, FRCP

Dr. Shah is qualified in medicine in 1970 from the St Mary's Hospital Medical School in London and is a Fellow of the Royal College of Physicians, Edinburgh and a Fellow of the Faculty of Pharmaceutical Medicine of Royal Colleges of Physicians of the UK. He retired as an Examiner for the Faculty in 2011 after serving for 15 years.

He was a Senior Clinical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) from June 1987 until his retirement in November 2004. He has a wide experience in evaluation of new drugs and reviewing drug safety as well as in the European regulatory procedures. Rashmi has represented the UK on a number of committees including the Committee for Orphan Medicinal Products (COMP) and CPMP Scientific Advice Working Party. He was the principal author of the CPMP Points to consider strategy on drug-induced QT interval prolongation and a co-author of the guideline on drug-drug interactions. He was the EU Topic leader for ICH E14 guidance on drug-induced QT interval prolongation.

Rashmi was a member of the team that first characterised CYP2D6 and has authored a number of papers on pharmacogenetics and has represented the UK at CPMP Pharmacogenetics Working Group, CIOMS Working Group on Pharmacogenetics and the OECD Steering Group on Pharmacogenetics.
Rashmi has authored a number of papers on pharmacogenetics and drug-induced QT interval prolongation. His other special interests include drug interactions, chirality, hepatotoxicity and mechanisms of drug toxicity on which he has also authored a number of papers and chapters.

Since his retirement in 2004, Rashmi functions a pharmaceutical consultant, advising a number of large and small pharmaceutical companies on their drug development programmes, serving as a member of data safety monitoring boards and regulatory advisory panels and acting as an independent Expert Witness in a number of product liability cases.

Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

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.