Jinhui Doug, Ph.D.

Jinhui Dou, Ph.D.

After receiving his BS (Pharmacy) and MS (Pharmacognosy) degrees, Jinhui Dou became a faculty member at Beijing University of Chinese Medicine and taught pharmacy classes for 4 years.

He accepted a graduate assistantship from the Pharmacognosy Department at the University of Mississippi and received a PhD degree in 1996 from Dr. James McChesney, a distinguished professor of pharmacognosy. After working at the University of Kansas as a post-doc associate, he became a Natural Product Scientist at NaPro BioTherapeutics in December 1996. He led a group of chemists and engineers in the reduction of paclitaxel manufacturing costs and in the establishment of a library of related-substance reference standards to support the CMC, pharmacology, and toxicology sections of paclitaxel NDA and ANDA filings.

Dr. Dou joined the FDA in 2002 as a pharmacologist reviewer in the Center for Drug Evaluation and Research (CDER). He was an FDA expert pharmacologist and pharmacognosist specialized in chemical and botanical drug review.  He reviewed over 500 INDs/NDAs in nearly all the divisions in the Office of New Drugs, such as anti-infective and anti-inflammatory chemical-drug and botanical drugs from all over the world.  Dr. Dou received numerous awards from CDER, FDA, and HHS for his distinguished contributions to the development of new guidances, policies, and regulations and his scientific reviews of new drugs.

After more than 15 years at the FDA, Dr. Dou, in 2017, joined Yiling Pharmaceutical, headquartered in Shijiazhuang, China, as a Vice Dean of the Yiling Research Institute. He now works as an independent consultant advising the pharmaceutical industry on new product develop for unmet public health needs.

Dr. Dou is a member of American Society of Pharmacognosy (ASP) and the NIH/NCI PDQ Integrative, Alternative, and Complementary Therapies (IACT) editorial board. His publications on lupin alkaloids, green tea, quassinoinds, proanthocyanidins and Artemisia/Artemisinin are from his research activities or new drug review experience.

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.