Our Mission

Innovative Science Solutions is a team of skilled scientific and regulatory consultants that deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, ISS integrates strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.

About Us

Since its inception in 2000, ISS has offered comprehensive consulting services ranging from the development of strategies for product defense, to guiding the collaborative work of leading medical service organizations, to successfully navigating FDA advisory committee meetings.

Our dedicated scientific and regulatory consultants have extensive experience serving both industry and counsel on issues related to a diverse array of regulated products — including pharmaceuticals, medical devices, chemicals, cosmetics, foods, and dietary supplements. Our services span the entire product lifecycle — from technology identification and development to approval and post-market stewardship.

ISS professionals work hand-in-glove with the world's thought leaders and utilize strategic alliances with multiple organizations to provide a wide breadth of services. We're committed to the constant evolution of medical and chemical business environment — keeping our clients ahead of the pace.

The ISS Founders

Steven M. Weisman, Ph.D.

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.

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David H. Schwartz, Ph.D.

David H. Schwartz, Ph.D. Head of Scientific Support to Counsel

A "scientific detective," Dr. Schwartz excels at analyzing how science and law interact. As head of ISS' Support to Counsel practice, he helps clients defend and support pharmaceuticals, industrial chemicals, medical devices, foods, and dietary supplements in the courts, the regulatory arena, and the market place. With a talent for communicating complex scientific information, Dr. Schwartz has become a go-to for lawyers, business professionals, and financial and investment firms. Dr. Schwartz specializes in providing strategic and tactical support to counsel in legal cases involving complex scientific issues. He has played a lead role in winning multi-billion dollar legal cases for clients. With the sheer weight of the scientific data he's able to collect, evaluate, and present as evidence, he's helped counsel win cases before going to trial, saving ISS clients time and money.

Dr. Schwartz counts Daubert hearings among his biggest successes. His expertise guides the ISS team across all disciplines related to the health sciences: toxicology, epidemiology, environmental health and safety, biostatistics, pharmacology, and regulatory affairs.

He has pioneered programs to critically review the scientific foundation of an adversary's case and provided persuasive, evidence-based responses. For 20 years, he has worked with the legal community evaluating product safety and defending a host of products and exposures, including the following: welding rods, cellular phones, ionizing and non-ionizing radiation, hydraulic fracturing and other drilling technologies, breast implants, wound care products, dietary supplements, general healthcare products, and a host of over-the-counter and prescription pharmaceutical agents (including: antidepressants, dermatologics, anti-malarials, anxiolytics, antipsychotics, and diet drugs).

Prior to founding ISS, Dr. Schwartz served as the Director of Scientific Litigation Support for the law firm McCarter and English, where he played a principal role in the safety evaluation of Prozac. Since then, he has guided clients using scientific principles to defend products before, during, and after launch.

Dr. Schwartz received a Ph.D. in Neuroscience from Princeton University and postdoctoral training in Neuropharmacology and Neurophysiology from the Center for Molecular and Behavioral Neuroscience at Rutgers University.

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