CNS Drug Development In Japan
Doug Berger, M.D., Ph.D. and Associates, CNS Clinical Development and Pharmaceutical Consultants: Scientific, Business, and Management Consultancy for pharmaceuticals in Japan
Dr. Berger is an American physician specializing in CNS clinical research and development as well as business development & licensing strategy for the pharmaceutical industry in Tokyo, Japan.
Dr. Berger has extensive CNS-related clinical development project management experience in Japan including the design and planning of bridging studies, interaction with the arms of the regulatory agency: the MHLW (Japanese Ministry of Health, Labor, and Welfare), and the PMDA (Pharmaceuticals and Medical Device Agency), subject and facility registration/contracting, data interpretation and NDA submissions for CNS compounds, evaluation of safety reports, and licensing negotiations. Strategy is based on the medical environment in Japan, the Japan Pharmaceutical Regulatory Guidelines, ICH, and GCP in Japan.
Dr. Berger has worked in Japan directly on the development of a wide variety of CNS compounds (anti-depressants, antipsychotics, anti-Alzheimer's, soporifics, medications for vigilance, etc.), anti-hypertensives, analgesics, antiemetics, allergy medications, biologics including growth factors and erythropoietin products, oncology chemotherapeutics, and contrast media for imaging; and indirectly on a wide-range of therapeutics through his experience as a Portfolio Review Committee member and Clinical Scientist. Dr. Berger has published papers related to drug development in Japan (see below), including an article in SCIENCE magazine on psychiatric drug development in Japan; and he has also authored a number of project development plans, position papers, and a manual on the clinical evaluation of adverse events focusing on CNS.
Dr. Berger graduated Magna Cum Laude from the University of Connecticut with an undergraduate double major in biology and pathobiology, and a minor in anthropology. He then obtained his M.D. from New York Medical College with Alpha Omega Alpha honors, completed a 4-year residency program in psychiatry at the New York Medical College Department of Psychiatry, and is an American Board-Certified Psychiatrist. Now based in Tokyo, Dr. Berger had been on the Faculty of the Albert Einstein College of Medicine Department of Psychiatry in New York as an Assistant Professor of Psychiatry. He has done research at a number of Japanese Universities and has a Ph.D. in Neuropsychiatry from the University of Tokyo School of Medicine. He is bilingual in both spoken and written Japanese. Dr. Berger has also completed an intensive MBA preview course at the General Business and Management Division of Temple University Japan. A detailed curriculum vitae can be provided upon request to appropriate inquiries.
Selected Medical Papers
Papers in English and/or Japanese can be read by clicking on the highlighted paper title. The journals' home pages can be accessed by clicking on the highlighted journal names. Dr. Berger's full bibliography can be seen on the Research Projects & Medical Papers page.- Berger D DOUBLE-BLINDING AND BIAS IN MEDICATION AND COGNITIVE-BEHAVIORAL THERAPY TRIALS FOR MAJOR DEPRESSIVE DISORDER, F1000 Research 2015, 4:638 (doi: 10.12688/f1000research.6953.1)
- Berger D, Ruano P, Eames, D: PMDA CONSULTATION FOR CLINICAL DRUG DEVELOPMENT IN JAPAN, Pharma Japan, 2186; 14-15. April 26, 2010.
- Berger D, Ruano P, Eames, D: HOW NOT TO LICENSE A DRUG INTO JAPAN, Pharma Japan, 2159; 16-17. October 12, 2009.
- Berger D: PHARMACEUTICAL PARTNERSHIPS IN JAPAN FOR REGULATORY AND COMMERCIAL SUCCESS, Pharma Japan, 2096; 16-17. June 30, 2008.
- Berger D: METHODOLOGIC ISSUES IN THE CLINICAL TRIAL STUDY OF DEPRESSION, Pharma Japan, 2083; 18-19. March 24, 2008.
- Berger D: ANTIDEPRESSANT DRUG DEVELOPENT IN JAPAN: CURRENT PERSPECTIVES AND FUTURE HORIZONS, Clinical Research Focus, 16:7, 32-35, Sept 2005.
- Berger D, Fukunishi I: PSYCHIATRIC DRUG DEVELOPMENT IN JAPAN, Science, 273 (July 19), 318-319;1996.
- Berger D, Nezu S, Iga T, Hosaka T, Nakamura S: INFORMATION PROCESSING EFFECT ON SACCADIC REACTION TIME IN SCHIZOPHRENIA, Neuropsychiatry, Neuropsychology & Behavioral Neurology, 3:2, 80-97;1990.
Contact Information
Telephone : 03-3716-6624 (from within Japan) or +81-3-3716-6624 (from outside of Japan). Although you will almost always get the answering machine, most calls are returned within a few hours. Also, please note that as your call may be forwarded to a mobile phone, you may need to wait a few seconds for transfer, and because of this there is no fax function.
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