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Dr. Brad Worthington, surgeon and anesthesiologist, has created BKK, a nonopioid surgical pain reliever. A combination of three FDA-approved drugs, BKK has beneficial properties beyond those of the individual medications of which it is made. Having obtained a patent for BKK, Worthington and his business partner, Thurman Ballard, are evaluating three paths to market, each with its own risks, costs, timelines, and possible outcomes: 1) seek venture capital investment to fund a New Drug Application for FDA approval; 2) partner with a compounding pharmacy that can manufacture and distribute the drug wholesale; or 3) develop a relationship with a manufacturer that can produce convenience kits containing all three drugs, bottled separately, with directions for mixing and administering them. This case provides a close look into the barriers to entry for new drug commercialization for an individual or small business. Innovations in healthcare delivery, medical technology, and even new drug development or new uses for existing drugs are often generated by those closest to patient care—nurses, doctors, and other medical personnel. But without significant resources, even the most ingenious new ideas require entrepreneurial thinking to bring them to market. Students have the opportunity to build a decision tree and explore the qualitative and quantitative data presented to justify all three options. Which should Worthington and Ballard choose?
1. To explore challenges to bringing a new product to market. 2. To understand the FDA process for new drug approval. 3. To use a decision tree to evaluate three investment options.