Pharmaceutical Consultant in Japan and China: Clinical Drug Development, R&D, and Pharmaceutical Business & Drug Licensing Consulting for pharmaceuticals in Japan and China. Medical Monitor China, Japan and Asia. China and Japan Pharmaceutical Regulatory Guidelines, Market Analysis, ICH, GCP, Biotechnology Partnering, licensing and Business Strategy Specialists, Pharma Consultant in China and Japan. Doug Berger, M.D., Ph.D. & Associates, Pharmaceutical Specialists in China and Japan.



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Pharmaceutical Consulting in China & Japan: Pharmaceutical Clinical Trials, R&D (Drug Research and Development), and Pharmaceutical Partnering, Licensing & Business Consultants in Japan and China. Japan Pharmaceutical Regulatory Guidelines, Market Analysis, ICH, GCP, licensing and Business Strategy Pharma Consultant in Japan. Licensing-in and Licensing-out for Japan, and medical monitoring for Asia and Japan.

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

Japanese Page:日本語の製薬コンサルティングページ

【Click on the image above to contact Dr. Berger】

Dr. Berger is an American physician consulting on clinical research and development as well as business development & licensing strategy for the pharmaceutical industry in Tokyo, Japan and China. 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 and China.

Dr. Berger has many years of pharmaceutical experience in Japan in positions including Director of Clinical Development, Project Manager for Clinical Development, and Medical Director Asia-Pacific Region, and he has served for a number of years on the R&D Portfolio Review Board of a for a multinational pharmaceutical corporation's Japan office. Detailed corporate experience can be provided on request.

Dr. Berger is native-level proficient in Japanese with medical experience in Japan beginning in 1985 and has written a number of articles related to the pharmaceutical industry in Japan. He and his staff of China-educated physicians also provide China-related pharmaceutical consultation and medical monitoring for China, Japan, and Asia.

A sample of selected articles can be seen here:

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Drug Licensing Into Japan .............................. Pharma Partnering In Japan ................... PMDA Consultation

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Antidepressant Development In Japan .... Psychiatric Drug Development 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 and his associates are also seeking license-in candidate compounds for a venture capital pharmaceutical company in japan (See this page).

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 CNS, cardiovascular, oncology, respiratory, immunology, dermatology, and others. He is considered a pharmaceutical expert in Japan.

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. He is also Director of a Mental Health Clinic in Japan, the Tokyo Meguro Counseling Center. A detailed curriculum vitae can be provided upon request to appropriate inquiries.

The following consulting categories are available through Dr. Berger and his extended network of associates. Consultation is available for China as well through Dr. Berger's staff.

    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
  • Business development for CRO business 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 Pharmaceutical 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.

  1. Berger D, Ruano P, Eames, D: PMDA CONSULTATION FOR CLINICAL DRUG DEVELOPMENT IN JAPAN, Pharma Japan, 2186; 14-15. April 26, 2010.

  2. Berger D, Ruano P, Eames, D: HOW NOT TO LICENSE A DRUG INTO JAPAN, Pharma Japan, 2159; 16-17. October 12, 2009.

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

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

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

  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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