This is a Related Course of the MOT program.
The focus of this course will be on business development in biotechnology, and in particular on the strategic and other issues inherent in partnering the research, development and commercialization of human healthcare products. Experience has shown that biotechnology companies almost inevitably enter into joint ventures, partnerships and other collaborations in order to develop one or more of their products or technologies. We will explore the strategic rationale for such partnerships, both from the perspective of smaller development stage biotechnology companies, and from the perspective of larger biotech or pharmaceutical companies. We will also explore in depth the complex management, financial and other issues which must be considered both when entering into such a partnership, and in managing such a relationship over the relatively long period associated with the development and commercialization of healthcare products. We will begin with a brief discussion of the biotechnology industry and the process by which products move from research through clinical development and the FDA approval process to commercialization. With this background, we will then explore biotech partnering in detail. Topics will include the role of patents and other intellectual property; determining the scope of a collaboration; the significance of manufacturing rights; co-promotion, co-marketing and other commercial arrangements; key financial terms (including upfront fees, milestone payments, royalties, profit sharing, transfer pricing, loans and equity investments); and management of a collaboration, including in particular how decisions are made when the partners cannot agree. Following our consideration of biotech partnering, we will move on to a discussion of mergers and acquisitions. Smaller biotech companies often articulate a business development plan which aims at becoming a “fully integrated pharmaceutical company” through mergers and acquisitions. We will explore product acquisitions (the purchase of a single product line or group of related products being divested by another company) as well as corporate mergers and acquisitions (the purchase of an entire company). The focus will be on issues specific to biotech M&A, and in particular on the valuation, timing and other issues associated with consideration by the board of directors of a potential purchase (growth strategy) - or sale (exit strategy) - of a product or company.
Course Description (pdf)
Course Syllabus (pdf)
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