James Loewenstein, Ph.D.

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
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

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, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

 

EU Regulatory

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.

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, Rph., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

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

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA