CMSU Tapped for ALS Clinical Trial Initiative

The Clinical Materials Services Unit (CMSU) has been awarded the contract to provide drug supply and distribution services to the for a new clinical research initiative that seeks to rapidly evaluate new drug candidates for Amyotrophic Lateral Sclerosis (ALS).

The HEALEY ALS Platform Trial – which will be conducted by the Sean M. Healey & AMG Center at Massachusetts General Hospital – is a new clinical trial initiative in which studies of investigational ALS treatments are tested and evaluated simultaneously.  New treatments can be added to the study as they become available.  This approach has already proven successful in the cancer field and will greatly accelerate therapy development by allowing investigators to test more drugs, increase patient access to trials, and reduce the cost by quickly and efficiently evaluating the effectiveness of multiple therapies.

Three drugs developed by Biohaven Pharmaceuticals, RA Pharma, and Clene Nanomedicine will be the first to participate in the platform trial.  CMSU will be responsible for providing clinical supply chain management, packaging, labeling, distribution, and return services for all the drugs used in the platform study.

CMSU is led by senior research associate Cornelia Kamp, M.B.A., and director of Clinical and Business Affairs Patrick Bolger, R.Ph., M.B.A., and is a core research unit of the Center for Health + Technology (CHeT).  Over the past 11 years CMSU has provided clinical supply services to 60 multi-center clinical trials conducted in the US, Canada, New Zealand and Australia supported with funding from the NINDS, NCCAMS, NICHD, NEI, Michael J. Fox Foundation, DOD, FDA, and numerous pharmaceutical and biotech companies.  At any given time, CMSU supports between 15-20 clinical trials.   CMSU recently moved to its new location at 150 Metro Park in Rochester.