In early 2006 David Barlow, CEO of Molecular Insight Pharmaceuticals, Inc. (MIP), a development stage biopharmaceutical company, faced a set of challenges in bringing its lead product to market and in progressing its second product into the clinical trial stage. MIP researched, developed and commercialized molecular imaging pharmaceuticals and targeted radiotherapeutics to meaningfully improve patient diagnosis and care. An emerging company in the late research and development phase, MIP focused on applying its proprietary platform technologies to develop product candidates that targeted markets with significant unmet needs in the areas of cardiology, oncology and neurology. Zemiva, the company's lead cardiology product candidate for the rapid diagnosis of cardiac ischemia, had completed Phase 2b clinical trials. Azedra was a preclinical stage oncology product designed to treat a rare form of cancer—neuroendocrine tumors. In addition to developing these two products, Barlow was preparing MIP for its Initial Public Offering (IPO).This case considers the integration of market and nonmarket components in MIP's strategy for intellectual property protection, manufacturing, sales and financing product development. The case focuses on the approach MIP takes in its interactions with the Food and Drug Administration (FDA) and Congress; the Centers for Medicare and Medicaid Services (CMS); the American Medical Association (AMA) and other medical societies; and patient advocacy groups in order to garner support, obtain regulatory approval and stimulate demand for its products.
