The ASAP Guide to Biopharmaceutical Partnering
The ASAP Guide to Biopharmaceutical Partnering is a supplement and update to The ASAP Handbook of Alliance Management, and represents the latest and most advanced thinking on leading, managing, guiding, and deriving revenue from alliances in every stage of the biopharma asset life cycle and across the biopharma ecosystem.
Building on the shared insights, published research, and real-world, in-the-trenches experiences of numerous ASAP members and the broader community of biopharma alliance management practitioners, The ASAP Guide to Biopharmaceutical Partnering explores the complexities of the evolving biopharma landscape, providing a deep dive into such critical areas as:
- Biopharma alliances and the Alliance Life Cycle
- Managing alliances from the deal to execution—and beyond
- Governance, alignment, and “influencing without authority”
- Alliance wind-down, termination, and divestiture
- Integration of alliances acquired via M&A activity
- Alliances involving academia, pharma, biotech, digital health, and more
- Discovery, development, and commercialization alliances
“From a business [risk] standpoint, we need to understand all the therapeutic areas, need to have a depth of experience in the science so we understand what risks may arise from our partnerships. Legal risk: we’re expected to know and understand the contract, inside and out, so we can support teams to manage legal issues that surface in partnerships or agreements that need to evolve. And then obviously the human risk is the most fun, because you bring two companies together...[it's about] really knowing how people interact and collaborate, deal with conflict, and so forth. [Alliance management] should be a one-stop shop for all things human, business, and legal risk associated with partnerships.”
Three Types of Risk
Encompassing all three risks—business, human, and legal risk or uncertainty—is what might be called “regulatory risk,” or the risk associated with the all-important effort in development alliances to achieve the goal of registering a drug with the FDA (US), EMA (EU), NICE (UK), or other regulatory bodies around the world. In any asset-based product alliance, there is nothing more critical than achieving the goal of drug registration, so anything that hinders or delays the achievement of that goal becomes a risk: in time, cost (billions of dollars), and otherwise. Minimizing these risks means that both parties in an alliance must work together and work with regulatory authorities at all times, staying focused on the goal of drug registration. Otherwise, alliance failure—and failure to come out with a registered drug—can be the result.
Click here to see an overview of the supplement.
The ASAP Guide to Biopharmaceutical Partnering features frameworks, checklists, examples of dashboards and other tools; key questions for alliance managers at important decision points; fillable online worksheets and forms; and a glossary and suggestions for further reading. This supplement should be required reading for anyone who is embarking on or transitioning into an alliance management role in biopharma, and contains numerous insights that will aid more experienced practitioners as well.