Leadership

James Loewenstein, Ph.D.

Dr. Loewenstein has close to 25 years of biopharmaceutical industry experience. He has a M.Sc. in biochemistry from the University of Amsterdam, The Netherlands, and obtained his Ph.D. from Tel Aviv University, Israel. Dr. Loewenstein's research experience includes tumor immunology, cell line development and creation of recombinant antibodies, performed at the Weizmann Institute (Rehovoth, Israel), the Hebrew University (Jerusalem, Israel), and Oncogen/Bristol Meyers Squibb (Seattle, WA.). For the last 20 years Dr. Loewenstein has been engaged in regulatory affairs and in clinical study design and management, assisting numerous companies, among those Teva, Interpharm, Dexxon, Kamada, Yissum, Synagile, and Varinel. As a regulatory and clinical study specialist, Dr. Loewenstein has been involved in the development of diverse drugs, of drug delivery systems, and of medical devices, at various stages of their development and spanning a broad therapeutic area. He has advised drug companies with regard to the regulatory aspects of their drug candidate's development, has successfully designed, managed and audited clinical studies, and has comprehensive experience in regulatory submissions including to the Israel Ministry of Health and the FDA. The geographic area of Dr. Loewenstein's professional activities has included Israel, Europe and the USA.

Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

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.