RELEASE: FAST Announces $5 Million Donation for Rare Neurodevelopmental Disorders Clinical Trials

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RELEASE: FAST Announces $5 Million Donation for Rare Neurodevelopmental Disorders Clinical Trials

(Information sent by the signatory company)

-Foundation for Angelman Syndrome Therapeutics (FAST) Announces $5 Million Grant to Advance Clinical Trials for Rare Neurodevelopmental Disorders

The Rush University Center will be led by Dr. Elizabeth Berry-Kravis

MIAMI, Dec. 2, 2022 /PRNewswire/ -- The Foundation for Angelman Syndrome Therapeutics (FAST) today announced a $5 million grant to establish the new clinical trial and translational research for rare neurodevelopmental disorders, a emblematic center, the first of its kind, which will be directed by Dr. Elizabeth Berry-Kravis. Under the name Rush F.A.S.T. Center for Translational Research, will be the global headquarters for training individuals to conduct neurogenetic clinical trials and deliver innovative intervention therapies that require novel delivery methods and specialized care.

Many of the clinicians working in neurogenetic disorders run excellent general and specialty care clinics for specific subsets of disorders, but are not trained in the ins and outs of setting up, running, and reporting clinical trials, which means they the lack of specific training for the rapid execution of the trials is significantly limiting the capacity to enroll in them.

"It's the dawn of a new era. There are now more than 25 therapeutic programs in development for Angelman syndrome, most of them funded by FAST," said Dr. Allyson Berent, chief scientific officer at FAST. "We're at an inflection point, where we're ready for many of these programs to reach human patients for early human clinical trials, but most hospitals don't have the bandwidth to follow the rhythm of this explosive need."

To address this need, the new center - under the direction of Dr. Berry-Kravis, who has been leading clinical trials for more than 20 years - will be the first training program organized for individuals focused on clinical trial execution and administration. of novel drugs for rare neurogenetic disorders. By establishing a formal fellowship program for national and international candidates, physicians will be trained in: understanding the steps required to embark on a prospective clinical trial; the regulatory hurdles needed to go through contracts and ethics approvals; the challenges in creating the infrastructure for patient testing, and creating the specialized clinical teams needed for these trials (for example, anesthesia, trial coordinators, trained neuropsychologists, neurologists/epileptologists, neurosurgeons, and any other specialists relevant to a specific trial), and more. In addition, this program will support the infrastructure and construction necessary to create a state-of-the-art facility in Rush, with clinical trial space built around the needs of this unique patient population.

This FAST trial site will bring all of these pieces under one roof as a model for how to most efficiently and effectively run a clinical trial, allowing Dr. Berry-Kravis to formally share her expertise with others and help increase the capabilities of dozens of additional centers around the world. When a FAST fellow completes her training, she will be able to take this experience to other institutions around the world. To this end, FAST is committed to financially supporting the upgrading of current clinical trial sites and the creation of new ones, to tree this experience and ensure that the capacities of many sites can meet the enormous demand.

FAST Fellows will receive hands-on training and embed at the Center for a full year, focusing entirely on conducting clinical trials for NDDs. In addition to the fellows, the Rush F.A.S.T. Center will also train externs in shorter terms to learn drug delivery, advance their own skills, and gain proficiency training to bring back to their own institutions so they can better deliver interventional therapy to more patients in the most safe and efficient.

"We are on the cusp of many vital advances, so it is an honor to be named director of the Rush F.A.S.T. Center at such a critical time," said Dr. Elizabeth Berry-Kravis. "This is going to help a lot of people, and I look forward to working with the brightest minds in the industry to deliver tomorrow's medical breakthroughs."

Media Contact:Eric

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