Given the decline in therapeutic development for nervous system disorders an ad hoc planning committee will plan and host a two-day public workshop to explore opportunities to foster private sector innovation by supporting new investments directed toward the development of novel therapeutics to meet unmet needs for nervous system disorders. The workshop will bring together key stakeholders to explore these opportunities, and presentations and discussions will be designed to:

• Examine opportunities and barriers to increasing investments for the development of novel therapeutics to support unmet medical needs for nervous system disorders.

• Explore potential incentives that might lead to a significant re-investment in research and development (R&D) within the neuroscience sector, while considering the resources needed for implementation. For example,
  • Explore how extending intellectual property (IP) protection and patent life exclusivity might promote R&D.
  • Discuss regulatory changes, such as increased use of intermediate endpoints and conditional approval pathways for therapeutics targeting specific diseases (e.g., Alzheimer’s disease, stroke, and schizophrenia).

• Discuss specific considerations for combination therapies and disease modifying treatments that may require extensive long-term prevention trials.

• Consider the impact of potential policy changes on patients.
  • Discuss how potential changes in policy may benefit patient outcomes (e.g., access to therapeutics that may delay or prevent the onset of a disorder).
  • Consider the negative implications of such policy changes to patients (e.g., higher out-of-pocket expenses due to the delay of generics).

The committee will plan and organize the workshop, select and invite speakers and discussants, and moderate the discussions. An individually authored summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.