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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Experts

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

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

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Susan Manley, MS

Biostatistics

Alan Fisher, DrPH

Regulatory Science & Innovation; Biomedical Advanced R&D

Carol Linden, PhD

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

Health Policy Development

Steven Grossman, JD

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.

CMC, Formulation/Process Development & Sourcing

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Medical Device

Eric Kolb

Melissa Thompson

Paul Goode, 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

Steven Grossman, JD

Defense & National Security Practice

Dean E.Calcagni, MD

Steven Grossman, JD

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.

Kinexum Associates

Elijah Abass

Brontë Jenkins