Nidan, from what I've read, the ACTC will be a facilitative support organization similar to the Cancer Center of Excellence (see below). The precision medicine trial architecture will still be driven by the FDA's CDER where Dr Woodcock is driving her people to assist drug companies to design targeted precision trials. Their stated goal is to get safe, effective drugs to the public faster. It's my belief that this collaborative effort between CDER and Anavex is going on right now with the RS IND submission. I think we have a leg up with Drs Fadiran and Aisen working and advising us. I think we will see IND approval and trial start up for Rett Syndrome shortly with a possible Master Protocol "basket trial" aspect. Also. think there is a good chance to conduct our AZ P3 as one of the initial candidates supported by the ACTC. thus being one of the first "lead the force" targeted precision medicine AZ trials. Definitely Biogen is watching this very closely (as well as several other Pharma's).
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A cutting-edge consortium
The ACTC is a “next-generation” infrastructure designed to harness best practices and latest methods to address the timeframe, complexity, and expense of recruitment and site activation for Alzheimer’s trials. For example, ACTC will centralize key functions such as tissue banking, imaging, biostatistics, and data management, as well as implementing a centralized Institutional Review Board. Also, the consortium and trials are funded separately—having dedicated funding means that the trial sites within the consortium can maintain consistent quality standards and staffing which are independent of trial activities.
The ACTC consists of 35 sites plus a coordinating center and 10 units staffed with teams to manage areas such as biomarkers, clinical operations, informatics, magnetic resonance imaging, positron emission tomography, and recruitment. As part of its recruitment unit, the ACTC is establishing a new Minority Outreach and Recruitment Team, which will use innovations in recruitment to support both central and local partnerships with diverse communities.
With scientific input from the NIA, the ACTC is led jointly by Dr. Paul Stephen Aisen, of the University of Southern California, San Diego; Dr. Reisa A. Sperling, of Brigham and Women’s Hospital and Harvard Medical School, Boston; and Dr. Ronald C. Petersen, of the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
AI
