Japan Pharmaceutical Consulting: Doug Berger, M.D., Ph.D. & Associates, Clinical Drug Development/Drug Discovery and Pharmaceutical Business & Licensing Consulting in Tokyo Japan. Japan Pharmaceutical Regulatory Guidelines, Pharmaceutical Development, Market Analysis, ICH, GCP, Biotechnology Partnering, and Business Strategy Pharma Consultant Japan.



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Japan Pharmaceutical Consulting

Pharma Consultant in Japan: Pharmaceutical Clinical Trials, Drug Research and Development, and Pharmaceutical Licensing & Business Consultants in Japan. Pharmaceutical Partnering in Japan, Japan Pharmaceutical Regulatory Guidelines, Market Analysis, ICH, GCP, licensing and Business Strategy Specialists.

Doug Berger, M.D., Ph.D. and Associates, Clinical Development and Pharmaceutical Consultants: Scientific, Business, and Management Consultancy in Tokyo, Japan

Japanese Page:日本語の製薬コンサルティングページ

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Dr. Berger is an American physician consulting on clinical research and development as well as business development & licensing strategy for the pharmaceutical industry in Japan. A wide range of R&D and business related Japan-specific consultations are available through Dr. Berger and his extended network of associates in Japan. Dr. Berger has extensive 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-formerly called the Kiko Advisory Board), subject and facility registration/contracting, data interpretation and NDA submissions, the medical 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 also has experience in market analysis (peak-sales and market penetration simulations), pricing negotiation strategy, pre-launch marketing, and licensing activities for pharmaceuticals 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. Along with his extended network of associates, Dr. Berger is able to provide consultation service in a wide-range of therapeutic areas including CSN, cardiovascular, oncology, respiratory, immunology, dermatology, and others.

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 experience as the Director of Clinical Development for a mid-size multinational pharmaceutical corporation's Japan office, and has served for a number of years on the R&D Portfolio Review Board of a large multinational pharmaceutical corporation in Japan. He has consulted in Japan privately on a number of issues and projects for both generic as well as new drugs, and keeps an up to date knowledge base and an extended network of talented associates with in-depth pharmaceutical industry experience in Japan in order to deliver the highest quality consultation service. Dr. Berger has also completed an intensive MBA preview course at the General Business and Management section of Temple University Japan in order to support his business related activities.

The following consulting categories are available thru Dr. Berger and his extended network of associates.

    Clinical Development Consultations:

  • Regulatory strategy and planning based on ICH and GCP in Japan
  • PMDA consultation advice, preparation, and execution
  • Requests for and interface with the MHLW for prior NDA dossiers
  • Clinical trial/bridging study design in Japan
  • Local development scenarios and costs in Japan
  • Co-development/partnering tie-ups in Japan
  • Summaries of the development of marketed compounds in Japan
  • Safety report evaluations and post-marketing strategies in Japan
  • Data interpretation and NDA submissions for Japan
  • Translation and medical writing

    Business Development Consultations:

  • Pharmaceutical partnering in Japan
  • Pharmaceutical licensing negotiations in Japan
  • Opinion-leader introductions for R&D or marketing in Japan
  • Marketing strategy and competitor environment evaluations in Japan
  • Business case estimations (NPV, Peak Sales, Pricing Simulations, etc.) in Japan
  • Local office set-up and incorporation in Japan
  • Staffing introductions and HR consultancy for pharmaceuticals in Japan


Dr. Berger also has a private practice of counseling and psychotherapy in Tokyo, the details of which can be obtained by linking to the Psychiatric Practice Home Page (the focus of the psychotherapy pages is only on Dr. Berger's psychiatric work and does not include information on his pharmaceutical industry experience).

Dr. Berger also sponsors the Douglas M. Berger Psychopharmacology Research Fellowship in Japan for foreign psychiatry residents or Ph.D. candidates to study a clinical psychopharmacology topic in collaboration with a Japanese host scientist; and donates a portion of his income to support the Rockefeller University Neuroscience Research Department in New York City.


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.

  1. Berger D: PHARMACEUTICAL PARTNERSHIPS IN JAPAN FOR REGULATORY AND COMMERCIAL SUCCESS, Pharma Japan, 2096; 16-17. June 30, 2008.

  2. Berger D: METHODOLOGIC ISSUES IN THE CLINICAL TRIAL STUDY OF DEPRESSION, Pharma Japan, 2083; 18-19. March 24, 2008.

  3. Berger D: ANTIDEPRESSANT DRUG DEVELOPENT IN JAPAN: CURRENT PERSPECTIVES AND FUTURE HORIZONS, Clinical Research Focus, 16:7, 32-35, Sept 2005.

  4. Berger D: ADDITIONAL ECNP DATA (Letter), Psychiatric Times, 21:9, August, p.14; 2004.

  5. Berger D: PSYCHOTHERAPY PERSPECTIVES IN MEDICATION MANAGEMENT: SSRI INDUCED APATHY (Letter), Psychiatric Times, 16:8, August, p.7; 1999.

  6. Berger D, Fukunishi I: PSYCHIATRIC DRUG DEVELOPMENT IN JAPAN, Science, 273 (July 19), 318-319; 1996.

  7. 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

phone 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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