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James J. Cappola, MD, PhD, is a licensed internist specializing in microbiology and immunology. He received his MD from Instituto de Ciencias Biomedicas, Universidad Autonoma de Cd. Juarez, Mexico, and his PhD from The Waksman Institute of Microbiology at Rutgers University, where he held an NIH Research Fellowship for his pioneering work in immunodeficiency diseases. There, he published his thesis entitled: "The cellular basis for acquired immunological tolerance". He has worked in the pharmaceutical and biotechnology industries since 1973 and has focused on the clinical development of medical devices, drugs and biologics for the past 25 years. Dr Cappola has been instrumental in the development of protocols for multi-center clinical trials as well as in successful regulatory submission for FDA-approved drugs and biologics in multiple therapeutic areas.n As Senior Vice President at Medeva PLC, he directed the clinical trials for Metadate, a once-daily formulation of methylphenidate for the treatment of ADHD in children, resulting in FDA approval in April 2001. Also at Medeva, he directed clinical trials in support of the European approval of Hepagene, a recombinant vaccine used to control chronic hepatitis B. Further, as Vice President, Medical Affairs for Knoll BASF, Dr. Cappola directed the clinical development programs in the United States and Canada for Isoptin SR for the treatment of hypertension and gained FDA approval for the use of Rythmol in controlling paroxysmal atrial fibrillation and sudden arrhythmic attacks. At Bristol Myers Products, Dr. Cappola was a member of the medical team that gained FDA OTC approval for the use of aspirin once daily for the prevention of heart attack, a study that involved 10,000 patients and was coordinated at the Harvard School of Public Health. While Vice President and Trustee of the American Academy of Pharmaceutical Physicians [AAPP] from 1997-2001, Dr. Cappola developed that organization's first physician training program. This program has been expanded by the AAPP, and is currently being offered to physicians to update and extend their skills in pharmaceutical medicine, and to award grants certification to pharmaceutical physicians. Dr. Cappola is an active member of the American Medical Association, the Drug Information Association, the Royal Society of Medicine, the American Society for Clinical Pharmacology and Therapeutics and the American Academy of Pharmaceutical Physicians. | 