David Bergstrom, Ph.D

David Bergstrom, Ph.D

 

David has been a pharmaceutical product development scientist and leader for more than 30 years.  He has been involved in the technical aspects of moving compounds for the research bench, into early development, full development, Regulatory approval and eventual commercial launch and manufacturing.  His experience has been in large, small, semi-virtual pharmaceutical companies as well as the CRO/CDMO industry segment.

He began his career in the pharmaceutical industry as a bench solid dosage form formulator for conventional as well as advanced drug delivery systems.  Over the years he gained direct experience in almost all dosage forms as well as other CMC related functional areas and commercial manufacturing.

David earned his Ph.D. in Pharmaceutics from the University of Utah under the direction of Distinguished Professor William I. Higuchi.  He also has a M.S. degree in Pharmaceutical Chemistry from The University of Michigan and a B.S. in Pharmacy from Ferris State University.

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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

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.