Investment Considerations for Pharmaceutical Product Portfolios
Pharmaceutical executives with varying backgrounds and expertise are increasingly being asked to provide input on complex strategies related to portfolios of products, including regulatory and commercial competitive intelligence. Given the appropriate expertise – including preclinical, clinical pharmacology, clinical, regulatory affairs, CMC (Chemistry, Manufacturing and Controls)/supply chain, commercial, and patent law – they may be asked to help estimate the probabilities of achieving clinical milestones such as regulatory approval in a market of interest. They may also be asked to comment on product development even earlier in the development cycle, taking into account commercial insights, payer perspectives and quality-of-life issues. This chapter discusses investment decisions based on the author’s experience in investing in portfolios of pharmaceutical products, such as how much one can invest, and the palatability of the proposed return structure. The chapter breaks down many facets of this complex process to give insights into business decisions related to portfolios. Differences in portfolio strategy between big pharma and biotech companies are discussed, along with portfolio management, innovative partnering strategies and commercial perspectives
KeywordsCompetitive intelligence Due diligence Clinical development milestones Investment return structures Pharmaceutical product portfolio strategy Partnering
Special thanks go to Drs. Michael O’Kelly, Senior Director in Quintiles Center for Statistical Drug Development, Kamali Chance, Senior Director and Head, Global Biosimilars Regulatory Strategy, Global Biosimilar Unit, Quintiles, and Tony Abruzzini, Vice President of the Center for Integrated Drug Development, Quintiles, for their editorial reviews, and the Regulatory Affairs Professionals Society, which previously published key concepts elaborated upon in this chapter.
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