Cristina Csimma (Virdante Pharmaceuticals Inc), as TACT chair, is leading this exciting initiative with the support of the TACT core, nominated committee members and the TREAT-NMD secretariat. TREAT-NMD is confident that the breadth and calibre of the international TACT experts will ensure the quality of the output.
The aim of TACT is to provide transparent and consistent guidance and advice to the neuromuscular community, in an educational and directional context, on the readiness of drugs and/or therapeutic targets for trials in neuromuscular diseases.
The remit of the committee is to evaluate the therapeutic potential of drugs based on preclinical data, thereby assisting TREAT-NMD in prioritising clinical trials to be run via the network. TACT advice will be helpful for preparing funding applications and investigational drug applications, and serve as an unbiased appraisal to be published for the wider neuromuscular community. We hope that this process would be endorsed by the major funders.
In addition to the expert analysis of preclinical data TACT will also address issues of drug formulation, bioavailability and toxicology as well as possible regulatory requirements and marketing considerations. In close collaboration with the TREAT-NMD clinical trials coordination centre in Freiburg TACT is also dedicated to providing information on rational and economical trial design. The ultimate goal of TACT is to help pave the pathway for successful drug registration by providing professional and independent advice.
The TACT appraisal process of potential therapeutics for clinical trials will take a maximum of 6 months. TACT will consider more than one drug at a time and therefore will have panels of experts, selected from the TACT members below, reviewing the drugs concurrently, with the same chair and core committee for continuity.
Applications for the second round of reviews which will take place on 5th & 6th June 2010 have now been accepted.
The applications are:
Is it same as the molecular Band-Aid which was discovered by University of Minnesota and was recently in news. I guess Dr. Joseph Metzger was involved into that paper.
But I think that poloxymer(by Phrixus) is in news for quite sometime. I think even PPMD and ActionDuchenne had earlier funded this also.
Are both same? Is this getting done by University of Minnesota and Phrixus together? Any idea on what stage it is in currently?