Rashmi Shah, MB, FRCP

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
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

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

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

 

EU Regulatory

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

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA