PR99083

MIAMI, Dec. 3, 2022 /PRNewswire=KYODO JBN/ --

-- The Center at Rush University Will Be Directed By Dr. Elizabeth Berry-Kravis

The Foundation for Angelman Syndrome Therapeutics (FAST) announced today a $5

million gift to establish the new clinical trial and translational research

effort for rare neurodevelopmental disorders, a first-of-its-kind flagship

center to be directed by Dr. Elizabeth Berry-Kravis. Named the Rush F.A.S.T.

Center for Translational Research, it will be the global headquarters for

training individuals in how to run neurogenetic clinical trials and deliver

innovative interventional therapies that require novel delivery methods and

specialized care.

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Many of the doctors working on neurogenetic disorders are running excellent

general and specialized care clinics for specific subsets of disorders, but are

not trained in the intricacies of setting up, running, and reporting on

clinical trials—which means the absence of specific training to expeditiously

execute trials is significantly limiting trial enrollment capabilities.

"This is the dawn of a new era. Today there are over 25 therapeutic programs in

the development pipeline for Angelman syndrome, with a majority robustly funded

by FAST," said Dr. Allyson Berent, chief science officer at FAST. "We are at a

turning point, where we are ready for many of these programs to reach human

patients for early stage first-in-human clinical trials, but most hospital

centers don't have the bandwidth to keep up with this exploding need."

To answer this need, the new center—under the leadership of Dr. Berry-Kravis,

who has been leading clinical trials for over 20 years—will be the first

organized training program for individuals focusing on clinical trial execution

and novel drug delivery for rare neurogenetic disorders. By establishing a

formal fellowship program for both national and international candidates,

physicians will be trained in: understanding the steps it takes to onboard a

prospective clinical trial; the regulatory hurdles required to get through

contracts and ethics approvals; challenges in setting up infrastructure for

patient testing, and putting together the specialized clinical teams required

for these trials (e.g. 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 buildout needed to create a

state-of-the-art facility at Rush, with clinical trial space built around the

needs of this unique patient population.

This FAST trials center will put all these pieces under one roof as a model of

how to most efficiently and effectively execute a clinical trial—enabling Dr.

Berry-Kravis to formally share her expertise with others, and to help to grow

the capabilities at dozens of additional centers globally. When a FAST fellow

completes their training, they will be able to bring this expertise to other

institutions around the world. To support this, FAST is committing to

financially support the upgrading of current, and the establishment of new,

clinical trial centers, to arborize this expertise to ensure the capabilities

of numerous centers can meet the huge demand.

FAST fellows will have hands-on training and be integrated into the Center for

a full year, focusing entirely on running clinical trials for NDDs. In addition

to the fellows, the Rush F.A.S.T. Center will also train externs in shorter

stints to learn about drug delivery, advance their own skill sets, and train in

efficiencies to bring back to their own institutions to better deliver

interventional therapeutics to more patients in the safest and most efficient

ways.

"We are on the cusp of so many vital breakthroughs, which is why it is an honor

to be named director of the Rush F.A.S.T. Center at such a critical time," Dr.

Elizabeth Berry-Kravis. "This is going to help so many people, and I am looking

forward to working with the brightest minds in the field to generate the

medical breakthroughs of tomorrow."

Media Contact:

Eric Koch

617-733-6891

ericdkoch@gmail.com

SOURCE Foundation for Angelman Syndrome Therapeutics