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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

CLINICAL RESEARCH EXPERIENCE

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 to provide consulting services in clinical research to the pharmaceutical and biotechnology industries.

My formal training is as a board certified hematologist, oncologist, and internist. However, I have had considerable research interests in multiple areas including hematology, oncology, immunology, infectious diseases, bone marrow transplantation, autoimmune disorders, AIDS, neurology, and pulmonary diseases among others. Having been associated with the pharmaceutical and biotechnology industry for more than 25 years, incoluding as a Vice President and Director of Clinical Research and acting Chief Medical Officer, I have been responsible for directing many of the clinical research programs of both a large pharmaceutical company and more recently a small start-up company. In this capacity, I have had the principal responsibility for development of the clinical programs which have led to the successful licensure of a number of new products and IND filings for multiple products including intravenous gammaglobulin, antithrombin III (orphan drug), alpha1-proteinase inhibitor (orphan drug), factor IX complex, treatment of inhibitors, recombinant factor VIII, multiple clinical studies for treatment of autoimmune disorders, and an IND for a new cancer chemotherapeutic agent among many others.

I also was a member of the New Products Planning Committee at Miles Inc. for 13 years and have extensive experience in evaluating new pharmaceutical and biotechnology products. I have continued with these activities and have evaluated potential new product acquisitions and clinical protocol proposals for several biotechnology companies.

Over the past 25+ years, I have had extensive interaction with numerous investigators worldwide, many of them heads of their departments, in the fields of hematology, oncology, allergy, immunology, infectious diseases, pulmonary medicine, neurology, AIDS research, hemophilia, pediatrics, burns, surgery, and internal medicine and have worked with a number of division heads of the NIH on clinical research studies. I have an excellent reputation at the FDA, having made presentations to three Advisory Panels and having been a member of the NHLBI Alpha1-Antitrypsin Deficiency Steering Committee as well as the Steering Committees for both the NICHD and NIAID Intravenous Gamma Globulin Pediatric/Adult AIDS Studies. I have worked with and knows many leading investigators in all of the above fields on a first-name basis.