ChemDiv chemistry of cures

San Diego, Biocom

Out-sourcing of drug discovery and development processes by integrated and specialty pharmaceutical companies is now well-established. Large Pharma can effectively resource and deploy R&D managers to operate development programs on a global scale. Outsourcing is also growing among startup and established biotechs in response to the challenges of scarce capital for early stage discovery and development and the need to advance and validate ideas and hypotheses in more rapid and cost-effective ways. However, for many small biotech companies, managing geographically dispersed R&D efforts can be challenging. These trends raise critical issues for early stage biotech entrepreneurs; questions such as what to focus on, what strategies to pursue for seed funding; and require decisions about what to manage, what to build, and what to outsource. In response to these pressures, contract research organizations have sprung up in the San Diego and southern California region. Their regional presence makes outsourcing of R&D by small and startup biotechs feasible.

This workshop will examine these issues and explore several approaches to funding and executing discovery research and early stage development.

Some of the topics we intend to explore in this workshop are:

* Identifying the core competencies of your organization. How to make distinctions between key versus non-key functions. How to identify functions and processes that can be effectively outsourced and making contractor versus employee decisions.

* What are some stage-specific strategies and opportunities for outsourcing? How to manage execution risk through task distribution and multiple partners.

* What are realistic expectations and internal capacity for supervision of outsource partners? How to define expectations, expertise, and requirements for tasks and deliverables. Making resource allocation decisions relating to cost, timeliness, and quality.

* What kinds of financial models are available/appropriate to different stages of the discovery and development process? Are collaborative and alternative development strategies- SBIR/STTR grants, milestone-based payments, risk-sharing possibilities - feasible?

* How to evaluate the track record of prospective service providers.