Steven M. Weisman, Ph.D. HEAD OF CLINICAL AND REGULATORY SUPPORT

Dr. Weisman knows how to bridge the gap between science and marketing. As head of ISS’s Clinical and Regulatory Support practice, he focuses on the development of scientific and regulatory approaches that increase a product’s market potential. He’s an invaluable resource for scientific litigation support for products in crisis and, under his guidance, ISS has encouraged firms to proactively monitor the safety and effectiveness of their products and develop systems that reduce liability claims.

Dr. Weisman has over 20 years of experience in pharmacology, toxicology, pharmaceutical product development, clinical and regulatory affairs, and marketing evaluation and communication.

He played a leading role in the pharmaceutical industry’s response to the removal of PPA (phenylpropanolamine) from over-the-counter products. He’s worked extensively on management initiatives for opiate safety, antibiotic drug resistance, and emergency contraceptives. He’s even credited with establishing the safety and continued marketing of artificial fingernail products.

Dr. Weisman is a leading authority on the switch of prescription-only products to over-the-counter status and is widely published in these areas. His development and support work includes shepherding the analgesic, Aleve, from a prescription-only product to its popular over-the-counter form, and promoting the cardiovascular uses of aspirin for heart attack and stroke prevention. He is also recognized for effective regulatory strategies that maximize the global market potential of regulated products. His expertise in claim substantiation has helped clients successfully defend against challenges to their marketing initiatives and saved them millions of dollars.

Prior to founding ISS he ran the Pharmaceutical and Food practices at a major scientific consulting firm in Washington, DC. Before that, he served as Global Director of Medical and Clinical Affairs at Bayer, Director of Strategic Research at Sterling Winthrop, and held similar positions at Hoffman La Roche and Procter & Gamble. He has organized and presented at numerous symposia, FDA advisory committee meetings, and other regulatory venues, worldwide. He manages the FDA advisory committee process for many of the largest pharmaceutical concerns and represents companies before regulatory authorities in major markets around the world.

Dr. Weisman received his PhD in Pharmacology from Cornell University Medical College and completed his postdoctoral training in Immunopharmacology at the Roche Institute of Molecular Biology.