• FDA Regulation of Medical Devices
• Pharmaceuticals, Cosmetics, and Food
• Healthcare Economics and Reimbursement
• Litigation Support and Expert Testimony

Dr. Steven M. Weisman is a founder of Innovative Science Solutions, LLC, providing consulting services to industry and counsel on regulated healthcare products.

Dr. Weisman has 15 years of experience in pharmacology, toxicology, pharmaceutical product development, and marketing evaluation and communication. This experience includes developing regulatory strategies, product development plans, preclinical and clinical testing programs, regulatory submissions, and product defense/ communication strategies for drugs, foods, cosmetics, and dietary supplements. He has organized and presented at numerous symposia, FDA Advisory Panels and other regulatory meetings. His skills in analyzing the scientific and regulatory aspects of potential new products and the development of responses to FDA Rule-Makings are sought by numerous clients.

Dr. Weisman has been responsible for Investigational New Drug applications (INDs), New Drug Applications (NDAs), and other regulatory filings, managed clinical research efforts, and adverse event tracking systems. He is also an authority on developing new indications and claims for mature brands, and in crisis and media relations. In addition, he has extensive experience in global product development and communication strategies.

Dr. Weisman received a B.S. in Biology from Fairleigh Dickinson University and a Ph.D. in Pharmacology from Cornell University School of Medicine, and was a Postdoctoral Fellow in Immunopharmacology at the Roche Institute of Molecular Biology. See www.innovativescience.net.

Dr. David H. Schwartz is a founder of Innovative Science Solutions, LLC, providing consulting services to industry and counsel on regulated healthcare products.

Dr. Schwartz has 10 years of experience defending products in the legal and public settings. He has specific expertise in pharmacology, immunology, neuroscience, toxicology, and biocompatibility. Dr. Schwartz has utilized his expertise to defend such diverse products as silicone breast implants, appetite suppressants, class II medical devices, foods, and psychoactive drugs. In his implementation of Daubert challenges, Dr. Schwartz was able to help counsel win cases before going to trial with the sheer weight of the scientific data he was able to collect, evaluate, and present as evidence.

Dr. Schwartz received a B.S. in Psychology from Rutgers University and a Ph.D. in Psychology/Neuroscience from Princeton University, and was a Postdoctoral Fellow at the Center for Molecular and Behavioral Neuroscience at Rutgers University. See www.innovativescience.net.

Dr. Brian C. Becker is founder and President of Precision Economics, LLC. The firm provides economic expertise for litigation, regulation, and public policy.

Dr. Becker a recognized leader in the areas of transfer pricing and valuations. His skills are applied to the development of insightful solutions for the resolution of complicated economic and financial problems. He has over a decade years of experience in a broad range of economic areas, including: transfer pricing (tangible and intangible transfers, price sharing agreements, and inter-company service arrangements), valuations (limited partnerships, unprofitable subsidiaries, small company discounts, and the appropriate risk premium), securities (shareholder litigation, damage analysis, and regulatory disputes), international trade (anti-dumping), goodwill impairment (value goodwill as part of annual impairment testing as well as for purchase price allocation studies in acquisitions), intellectual property (intellectual property work for tax purposes, experts in intellectual property disputes), and economic damage estimations.

Dr. Becker is a frequent speaker at regulatory and policy forums, and publishes extensively on a variety of economic topics. Dr. Becker received his B.A. in Applied Mathematics and Economics from the Johns Hopkins University and a M.A. and Ph.D. in Applied Economics from the Wharton School of Finance at the University of Pennsylvania. See www.precisionecon.com.