TACT : TREAT-NMD Advisory Committee for Therapeutics

The need for TACT

Of the many promising research results presented at conferences, published in journals and hailed as the basis for possible future treatments and cures, few progress into clinical trial. Evaluating the therapeutic potential of drugs seemingly ready for this step is a challenge not only for the patients who build hope on preclinical results and for the potential funders and industry sponsors of the research, but also for the researchers themselves.

TACT is:

• TACT, the TREAT-NMD Advisory Committee for Therapeutics, is an expert multidisciplinary body that provides the neuromuscular community (clinicians, researchers, patient advocacy groups and industry) with independent and objective guidance on advancing new therapies (whether novel or repurposed) for neuromuscular diseases
  
  
• The remit of the committee is to provide applicants with transparent and consistent guidance and advice, in an educational and directional context, on the readiness of drugs and/or therapeutic targets for trial. TACT advice will be helpful for preparing funding applications and investigational drug applications, while the publication of a non-confidential summary will ensure the community receives expert feedback on the progress of the application

TACT will:

• Provide a one point in time multi-disciplinary review
• Meet 2 times per year (once every 6 months)
• Accept applications for candidate drugs targeted to any form of rare inherited neuromuscular disease
• Carry out reviews under a confidential disclosure agreement
• Review drugs that are presented as having a clear perspective within the translational process with the long-term goal of an intended clinical trial and potential registration
• Consider reviewing pre-reviewed programmes if it has substantially progressed or changed and if the committee felt that it could add further value
• Address issues of drug formulation, bioavailability and toxicology as well as possible regulatory requirements and marketing considerations
• Provide applicants with a comprehensive written review, including recommendations no later than 6 weeks following the meeting
• Publish a non-confidential summary to ensure the community receives expert feedback on the progress of the application
• Provides information about the projects reviewed and planned to be reviewed at TACT meetings and the timing of TACT’s recommendations report on the TREAT-NMD website and in TREAT-NMD newsletters

TACT will not:

• Provide on-going feedback to applicants on the development programme
• Respond to queries following the issue of the final report
• Amend or update the final report
• Engage with funding organisations on behalf of applicants
• Provide funding. TACT is not a funding organization but provides evaluation and recommendations which might facilitate development of a review into an application to a funding organization

If you wish to find out more about TACT you may want to view a video of a presentation given at the Faster Cures Conference in New York City, November 2012. View video here.

Terms of Reference