Drug Development Informed with TACT

Published on Tue, 12/11/2018

TREAT-NMD Background

The TREAT-NMD network has been responsible for significant infrastructure projects to advance the diagnosis, treatment, and care of patients with neuromuscular diseases. Among its ongoing projects is the TREAT-NMD Advisory Committee for Therapeutics (TACT). TACT provides non-conflicted, thorough, and expert reviews of therapy development projects independent of funding. The goal is to optimize the development of drugs and biologics for neuromuscular disease indications. One need only review the sample TACT application form to see the depth and breadth of the review process.

Availability of TACT Review Process

TACT reviews therapy development projects for academic researchers and biotechnology/pharmaceutical companies. The next TACT review meeting will be held in Glasgow, UK between 12th-13th April 2019 and will review up to four applications.

TACT has received a number of applications so far for this review cycle but would like to encourage additional applications from stakeholders across the neuromuscular community, involved in therapy development whether they be academic-led groups or from industry. TACT's goal is to provide advice on the position of potential therapies along a realistic pathway to clinical trials and registration by evaluating preclinical data as well as drug development considerations that are crucial for the conduct of studies that generate meaningful data. TACT has reviewed more than 50 applications since 2009. Further details about the committee of experts, process and the benefits of a TACT review can be found on the TREAT-NMD website.

Later in 2019, there will be a second review cycle with a meeting on 2-3 November (location to be confirmed) and we welcome applications for this meeting as well.

TACT provided this comment from Fulcrum Therapeutics on the review of their candidate therapeutic for FSHD:

"On behalf of Fulcrum, and patients, thank you for the thoughtful review of Fulcrum's proposal on the development of FTX-1821. We appreciate the time and effort that the TACT invested into considering our proposal and making suggestions that we believe will strengthen our proposition. The review was exceptionally well written with clear recommendations and reflects well on the mission of TACT. Thank you." Robert Gould, President and CEO, Fulcrum Therapeutics, 2018

Connecting with TACT

MDF encourages the DM community to take advantage of the opportunity offered by TACT. If you would like to submit a proposal for this meeting or require further details, please contact Cathy Turner (catherine.turner@newcastle.ac.uk) for more information.