MICHR Works Collaboratively to Transform Expanded Access to Maximize Support Through TEAMSS Grant
Since MICHR was awarded the TEAMSS (Transforming Expanded Access to Maximize Support and Study) grant two years ago, the consortium of universities involved in TEAMSS has worked to develop and test infrastructure, best practices, and reduce burdensome data collection for expanded access that will allow other academic medical centers to become more effective and efficient in supporting these requests.
With the arrival of COVID-19, there is a more pressing need than ever to get treatments to patients as quickly as possible. “Many of the COVID-19 patients in greatest need are those who don’t qualify for clinical trials because they don’t meet the requirements or they are already too sick,” explained Misty Gravelin, co-investigator on the grant and MICHR project manager. “With Expanded Access, physicians are able to request the treatment use of investigational drugs and devices outside of a clinical trial for specific patients.”
Because of this, the TEAMSS study team members and the resources TEAMSS has developed have been put to use in service of both our local patients and patients at other institutions.
At Michigan Medicine, this has allowed U-M’s physicians to request remdesivir for critically ill patients before the clinical trial was open, for patients who were too young to qualify for the trial, and now through the Emergency Use Authorization. Remdesivir, an investigational antiviral drug, is theorized to have efficacy against SARS-CoV2, the type of coronavirus that causes COVID-19.
Thanks to TEAMSS staff, physicians can stay focused on the care of their sick patients, rather than spending multiple hours of their time navigating the requirements to obtain the drug.
Adam Lauring, MD, PhD, Associate Professor of Internal Medicine, Associate Professor of Microbiology and Immunology, U-M Medical School, said he connected with TEAMSS staff early on in the COVID-19 pandemic to obtain remdesivir for some of Michigan Medicine’s first patients.
“The expanded access process is pretty complicated, requiring communications with the FDA, the University institutional review board, the pharmaceutical company, and lots of documentation,” explained Lauring. “All I had to do was decide on the drug and they pretty much took care of the rest.”
TEAMSS has also worked closely with the blood bank to open a site for convalescent plasma as part of an Expanded Access Program run by the Mayo Clinic. Convalescent plasma is plasma (the liquid part of blood) that has been donated by people who were sick with COVID-19 and have since recovered. That plasma is theorized to contain antibodies to the SARS-CoV2 virus, which can then be transfused into sick patients in an effort to help their bodies clear the virus faster.
In addition to this important work on COVID-related programs, TEAMSS are also assisting our physicians with a number of single-patient emergency use requests for investigational products targeted to that patient’s specific infection and sequelae.
TEAMSS has served as a national example to other sites to provide guidance, templates, and answer questions as medical centers around the country are trying to make these treatments available for their patients.
MORE ABOUT TEAMSS
The TEAMSS (Transforming Expanded Access to Maximize Support and Study) U01 Collaborative Innovation Grant was awarded to MICHR in partnership with Duke University, the University of Texas Southwestern Medical Center, and the University of Rochester, in an effort to build a national framework to help more patients gain access to experimental drugs, devices and biologics. It is funded by the National Center for Advancing Translational Science (NCATS), part of the National Institutes of Health (NIH). The lead principal investigator of this grant is MICHR Director George Mashour; MICHR Managing Director Kevin Weatherwax is the co-principal investigator and MICHR Project Manager Misty Gravelin is co-investigator.
For more information, please visit MICHR’s expanded access page.