Dave Edwards, PhD

Dave Edwards, Ph.D

Dave is a greatly experienced professional with over 30 years’ experience in the Pharmaceutical world in the fields of Toxicology and Drug Development working for pharmaceutical companies along with major Contract Research Organizations. Most recently, Dave served as Vice President for Early Development for a small pharma company developing novel small molecules for the treatment of inflammatory diseases such as atherosclerosis, arthritis, asthma and, latterly, diabetes. In this role, he was responsible for transitioning all new compounds from Discovery into Development and from there to the Clinic, Reporting to him were Toxicology, Drug Metabolism, Pharmacokinetics, Drug Manufacturing, Analytical Chemistry, Formulation and Clinical Supplies. Comfortable in relationships with both clients and regulatory agencies worldwide, Dave advises on all preclinical issues and partakes in the preparation and submission of regulatory documents such as INDs and NDAs.

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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, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, 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

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Lana Pauls

Michael Sharp, 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.

Lana Pauls

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

David Bergstrom, Ph.D

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

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

Dahlia Sperling

Russ Neubauer, Ph.D

Sandor Bernath, Ph.D, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Formulation Development

David Bergstrom, Ph.D

 

Business Strategy & Management Support

Stephen Casey, MBA

Lisa Jansa, MBA

Martin Lafontaine

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA