In early 2006, David Barlow, CEO of Molecular Insight Pharmaceuticals, Inc (MIP), a biopharmaceutical development stage company, faced a lot of problems, resulting in its leading product on the market and in an advanced product in its second phase of clinical trials. MIP researched, developed and commercially molecular imaging and targeted radiotherapy pharmaceutical meaningfully improve patient diagnosis and care.
The new company at the end of the research and development phase, MIP focused on applying proprietary technology platform for the development of product candidates that target markets with significant unmet needs in cardiology, oncology and neurology. Zemiva, lead cardiology product of a candidate for the rapid diagnosis of coronary heart disease, completed Phase 2b clinical trials. Azedra a preclinical stage oncology product is intended to treat a rare form of cancer of neuroendocrine tumors. In addition to the development of these two products, Barlow MIP preparing for an initial public offering (IPO). This case is the integration of market and non-market components in MIP strategies to protect intellectual property, production, sales and financing for development of the product. The case focuses on the MIP approach takes in its interaction with the Food and Drug Administration (FDA) and the 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 gain support to obtain regulatory approvals and to stimulate demand for their products. "Hide
by David P. Baron, Aneesha Capur Source: Stanford Graduate School of Business 10 pages. Publication Date: 05 May 2008. Prod. #: P51-PDF-ENG