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.