from bench to bedside and, subsequently, the drug is expected to be on the market 6 years after signing.

Brooks summarized the message to the Colten Foundation this way:

We are all part of the same spectrum. If NIH funding doesn’t continue … then the pipeline doesn’t continue strong. If the FDA doesn’t have the expertise … we’re not going to get products through. If industry does not remain incentivized, it’s only going to slow things down, because industry can go make money someplace else. The people that lose are the patients.

The major points discussed during session four are summarized below (Box 4-2).

BOX 4-2

Key Points: Partnerships, Data Sharing, and Intellectual Property

  • Coordinated teamwork, whether formal or informal, and organization are critical.

  • Philanthropic organizations and the NIH are not competing entities; rather, they can be tremendously complementary.

  • Partnership with the NIH and industry in the research process is critical.

  • Clearly lay out the process for drug discovery with all partners so that everyone is on the same page.

  • Try to remove as much risk as possible within your partnerships.

  • Realize that your role as a true expert in a disease space will provide tremendous value to your partnerships with for-profit companies.

  • Find common ground when working with the medical community and patients once a treatment is commercialized.

  • Bear in mind that your direct connection with a patient population is an invaluable perspective that a patient group brings to a partnership.

  • Be keenly aware of the myriad ethical issues that may arise as your program develops and you begin to venture into areas such as biobanking and registries.

  • Consider the merits of public–private partnerships and product development partnerships as you move forward.



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