In the final session of the workshop, four presenters described pathways toward effective collaborations: Deborah Dunsire of Millennium Pharmaceuticals, Inc.; Victor Dzau of Duke University and Duke University Health System; Margaret Hamburg of the FDA; and Kathy Hudson of the NIH. This chapter summarizes their remarks along with those of other workshop participants who addressed the broad issues associated with collaborative strategies for the development of personalized medicine.

THE NEED FOR COLLABORATION

Translating genomic discoveries into patient benefits is a “team sport,” Dunsire said. No one organization has all the capabilities and resources needed to realize the promise of personalized medicine. Only through partnerships can success be achieved.

This collaboration needs to extend from the research laboratory to the clinic, Dunsire added. As such, collaborations can involve a very wide range of stakeholders, including industry, academia, regulators, health care providers, and patient organizations. A particularly important set of stakeholders that should be part of these collaboration efforts, Dzau said, consists of the various payers, such as the Centers for Medicare & Medicaid Services (CMS). Payers should be eager for evidence that a particular approach would save money. “That conversation has to occur,” Dzau said.

Austin emphasized that a successful collaboration requires a shared vision. In the collaboration among NCATS, the University of Kansas, and the Leukemia & Lymphoma Society, all of the partners had experience with drug development and shared knowledge of the process. In addition, the project used management practices standard in industry, with project managers in each of the three institutions who worked closely together to ensure that the project met its timelines.

Each party to a collaboration needs to benefit, even though each has different capabilities, Frueh said. “You need to look at what everybody brings to the table and really define the benefit to each entity, to each party, that participates.” On this issue, Pacanowski pointed to the importance of clear deliverables. “Knowing what to expect as a product that would benefit all of the [partners] is probably the most critical piece.” Finally, Capone observed that the vision must be not only shared but compelling in order to motivate and align the partners.

Frueh made the point that a balance needs to be drawn between less formal and more formal arrangements to reduce the demands on the members of a collaboration. In addition, the larger any group gets, the more complex it gets. Davies observed that companies need to focus on what they do well. “Are we spreading ourselves too thin?” he asked. “Is there an area where we can have more impact than other areas?”



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