Anavex Life Sciences Corp (AVXL)

[Talon38]

This is what the ACTC would provide for us while working with FDA/CDER and their new guidelines for accomplishing expedited precision medicine trials:

"The ACTC experts and infrastructure will support the design and conduct of trials across the full spectrum of Alzheimer’s and related dementias, from prevention initiatives to combination trials for advanced symptomatic stages. Specific objectives of the consortium include:

Creating infrastructure with expert leadership to streamline implementation of trials
Developing innovative trial design methods, outcomes and analysis strategies
Maintaining trial site quality standards during and between trials
Developing and implementing cutting-edge participant recruitment and retention strategies, especially in diverse populations
Using a centralized Institutional Review Board
Developing and running capture systems for data pertinent to the ACTC
Securing centralized tissue banking for specimens
Providing centralized imaging, biostatistics, bioinformatics and data management and analysis support
Facilitating and managing public-private partnerships

Trials would be conducted harnessing guidance from ACTC leaders, an executive committee and an external advisory board, which will include a patient advocate. The Principal Investigators for the project are:

Paul Stephen Aisen, M.D., director of the ATRI at the Keck School of Medicine of USC, San Diego (and ANAVEX SAB member)
Reisa A. Sperling, M.D., director of the Center for Alzheimer Research and Treatment at the Brigham and Women’s Hospital, professor of Neurology, Harvard Medical School, Boston
Ronald C. Petersen, M.D., Ph.D., director of the Mayo Clinic Alzheimer’s Disease Research Center, professor of Neurology at Mayo Clinic College of Medicine and Science, Rochester, Minnesota"