NAMHC Drug Development Workgroup Charge

| Roster |

Background

The Drug Development Workgroup will advise the National Advisory Mental Health Council on future directions in drug development for the treatment of mental disorders.  NIMH has an ambitious program in experimental therapeutics, which attempts to foster a mechanism-focused approach to drug development for psychiatry. While the experimental therapeutics approach, which requires target engagement in the context of clinical trials, has been successful in many ways, there remain (perceived or actual) obstacles in obtaining funding for clinical trials in psychopharmacology. We see this in both the number and success rates for clinical trials of novel pharmaceutical agents, in contrast to psychosocial interventions and devices which have been relatively more successful.

Workgroup Charge

The Workgroup will address the state of and future directions of drug development for mental disorders at NIMH through a series of questions:

• What should constitute “target engagement” for medications? Are hypothesis-based readouts sufficiently mechanistic? Are we communicating this priority effectively?
• How do we approach special populations from an experimental therapeutics perspective?
• Should we restart or revamp Fast Fail (contract-based) efforts to explore novel drugs? How else do might we encourage rapid testing of mechanisms?
• Should NIMH consider confirmatory efficacy trials for medications? If so under what conditions?
• Do we have the workforce and/or what are the obstacles to developing and maintaining an adequate psychopharmacology research workforce?

This Workgroup is in process of developing recommendations.