Virgil Whitehurst, PhD

Virgil Whitehurst, PhD

Dr. Whitehurst's career as a Pharmacologist / Toxicologist at the Food and Drug Administration (FDA) spans 37 years. While at the FDA, Dr. Whitehurst provided critical review, interpretation, evaluation, and recommendation for numerous INDs and NDAs. He has conducted nonclinical and pharmacology studies in pulmonary and cardiovascular areas as well as other scientific studies in dental, dietary, and smoking cessation as part of a multidisciplinary research team for 25 years. In addition, he has served as an expert witness before FDA Advisory Committees, Commission, and Directorate. Prior to joining the FDA, Dr. Whitehurst was an Associate Professor of Biochemistry at both Howard University's Medical and Dental School. As a researcher, he designed and conducted studies in microbiology, pharmacology, toxicology, and biochemistry. He also designed, performed, analyzed scientific data, and appeared as an expert witness on behalf of various pharmaceutical companies. Dr. Whitehurst holds a BA in Chemistry from Anderson University, an MA in Education from Butler University, and a PhD in Pharmacology/Toxicology from Indiana University at Bloomington. He has published 35 scientific articles/abstracts on pulmonary and cardiovascular drug products. Dr. Whitehurst is a subject-matter expert in reproductive, immunologic, neurologic, pulmonary and cardiovascular toxicology as well as with carcinogenicity assessment. Dr. Whitehurst has expertise to critically review, evaluate, and interpret current scientific literature, research data and investigative reports, medical findings, and proposed or existing standards criteria. His expertise and extensive experience also enable evaluation of exposure and adverse chronic and acute health effects resulting from consumer products.

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