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President Urges breaking down.pdf


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Consistency Challenge
is intended to prompt the research community to employ
the new precisionFDA
electronic portal to develop DNA quality standards and
test results to advance personalized medicine.
The precisionFDA portal was launched at the end of last year to give researchers
access to information to personalize treatments to patient needs and help regulate
next-generation sequencing tests. Stakeholders in the diagnostics space are
especially interested in how the platform can be used to aggregate genomic data to
support development of new next-generation sequencing tests. (See "A Sharing
Tool For Next-Gen Sequencing: FDA Launches precisionFDA" — "The Gray
Sheet," Dec. 17, 2015.)
The White House summit was also the first public appearance of Robert Califf as
the agency's new commissioner. While he did not make a public speech during the
meeting, several speakers including National Institutes of Health Director Francis
Collins and President Obama congratulated him on his confirmation and noted
FDA's key role in moving the Precision Medicine Initiative forward.
Collins noted FDA is developing a regulatory framework for reviewing genomic
technologies that will take advantage of existing and evolving standards and is
using researcher crowdsourcing such as the precisionFDA project to identify the
most accurate genetic testing tools.
"We will work to the highest standards of data quality, working with our colleagues
at the FDA," Collins said. "I am also thrilled that the commissioner is here with us
this morning because he's been such a leader in thinking through the ways we can
be sure … the information people receive about themselves is meaningful and
clinically valid."

NIH Seeks A Million Volunteers
Collins also announced several additional new initiatives for NIH. In particular, the
agency is supporting a pilot program that will be launched by Vanderbilt University
in Nashville, Tenn., in conjunction with the Google health-focused spinoff Verily to
start enrolling volunteers for "the first phase of the Precision Medicine Initiative
Cohort" as a first step to collecting genomic and other data from a million
Americans.
NIH also says it will collaborate with the Health Resources and Services
Administration to work with community health centers to help enroll underserved
and underrepresented volunteers into the cohort.
NIH will also work with the Office of the National Coordinator for Health IT on a
project called "Sync for Science" to develop open standards with multiple electronic
health records companies.
Collins also announced that the NIH has established a central institutional review
board to oversee how the Precision Medicine Initiative is conducted and to protect
the rights of its participants.
The NIH director said this is the fastest he has seen any such project progress in
his more than 20 years in government. By the summer, the remaining parts of the
Precision Medicine Initiative will go into effect, Collins said, including establishing a
coordinating center, developing a network of health care providers to engage and

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/president-urges-break... 2/26/2016