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Clinical
Research
Experience
FDA
Approvals
Consulting
Projects
Publications
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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
http://rss.netwiz.net/clinicalresearch
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
in 1993 providing consulting services in clinical research
to the pharmaceutical and biotechnology industries.
FOCUS OF CONSULTING: Clinical Research - Biotechnology
and pharmaceutical drug development
PHARMACEUTICAL/BIOTECHNOLOGY EXPERIENCE
- 1993 - Present: Clinical Research Consultant,
Biotechnology and Pharmaceutical Development
- 1992 - 1993: Axion Pharmaceuticals, South San
Francisco, California - Vice President, Clinical Research
- 1979 - 1992: Bayer AG, Miles Inc., Cutter Biological, 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
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- Oncology
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- Infectious Diseases
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- Coagulation
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- Hemophilia
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- Bone Marrow Transplantation
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- Allergy
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- Immunology
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- Autoimmune Disease
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- Breast Cancer
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- Pulmonary Medicine
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- Neurology
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- AIDS
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- Pediatrics
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- Burns
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- Surgery
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- Malignant Melanoma
- Multiple myeloma
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- Acute/Chronic Leukemia (AML, CML, CLL, ALL)
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- Hematologic malignancies
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- Myelodysplastic Syndrome (MDS)
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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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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 - 2024, Richard S. Schwartz, M.D. All
rights reserved.
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