Curriculum
Vitae


Clinical
Research
Experience


FDA
Approvals


Consulting
Projects


Publications

Richard S. Schwartz, M.D.
Biopharmaceutical Clinical Research Consultant
Pharmaceutical and Biotechnology Development
Burlingame, California USA
Tel: (650) 344-6260
e-mail: rss@netwiz.net

RATIONALE: Recognizing that there is a shortage of individuals with the specialized training and analytical skills to develop the clinical research programs to license new products, I began 13 years ago to provide consulting services in clinical research to the pharmaceutical and biotechnology industries.

FOCUS OF CONSULTING: Clinical Research - Biotechnology and pharmaceutical drug development

PHARMACEUTICAL/BIOTECHNOLOGY EXPERIENCE - 26 YEARS

    • 1993 - Present: Clinical Research Consultant, Biotechnology and Pharmaceutical Development
    • 1992 - 1993: Axion Pharmaceuticals, South San Francisco, California - Vice President, Clinical Research
    • 1979 - 1992: Miles Inc., Cutter Biological, Bayer AG, Berkeley, California - Director of Clinical Research, Biologicals

THE FOLLOWING SERVICES ARE OFFERED AMONG OTHERS:

    • Clinical study design and strategy
    • Preparation of study protocols
    • Preparation of investigator brochures
    • Medical monitoring
    • Case report form design and preparation
    • Identification of clinical investigators
    • Analysis of data
    • Parameters for statistical analysis
    • Technical writing
    • Manuscript and abstract preparation
    • Report preparation - IND's, PLA's, NDA's, annual reports
    • Adverse event analysis and safety reports
    • Independent review or preparation of regulatory affairs submissions
    • Advise and provide technical assistance for market analyses
    • Preparation of or suggestions for technical graphics and slides
    • New Product and due diligence evaluations
    • Market research technical assistance
    • Literature reviews
    • FDA presentations
Available for both short-term and long-term projects

EXAMPLES OF FIELDS IN WHICH CLINICAL TRIALS CONDUCTED:

  • Hematology
    		•
  • Oncology
  • Infectious Diseases
    		•
  • Coagulation
  • Hemophilia
    		•
  • Bone Marrow Transplantation
  • Allergy
    		•
  • Immunology
  • Autoimmune Disease
    		•
  • Breast Disease
  • Pulmonary Medicine
    		•
  • Neurology
  • AIDS
    		•
  • Pediatrics
  • Burns
    		•
  • Surgery

EDUCATION:

    • Postdoctoral Fellowship Training in Hematology/Oncology (Stanford)
    • NIH Fellow, American Philosophical Society Daland Fellow
    • Residency - Internal Medicine (University of Michigan)
    • M.D. - Stanford University School of Medicine
    • B.S., Chemistry, University of California, Los Angeles (Magna Cum Laude, Honors)

BOARD CERTIFICATIONS:

    • American Board of Internal Medicine
    • American Board of Internal Medicine - Hematology (Adult)
    • American Board of Internal Medicine - Oncology (Adult)
PROFESSIONAL SOCIETY MEMBERSHIPS:
    • American Society of Clinical Oncology (ASCO)
    • American Society of Hematology (ASH)
KEY WORDS:
    • Expertise in all aspects of clinical trials (Phases I-IV)
    • Author of many protocols, IND's, PLA's, and manuscripts.
    • Experience working with both small and large biotechnology/pharmaceutical companies

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Curriculum Vitae Clinical Research Experience FDA Approvals Consulting Projects Publications


For more information, contact Richard S. Schwartz, M.D. at rss@netwiz.net or call (650) 344-6260 (after 8AM Pacific Coast Time, California)


Copyright ©1998 - 2005, Richard S. Schwartz, M.D. All rights reserved.