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Tuesday, June 20 • 2:00pm - 3:15pm
#253: Regulatory Challenges with Next Generation Sequencing

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The high interest and rapid uptake of next-generation sequencing in the clinic speaks to the promise of this technology as a valuable adjunct for optimizing therapeutic treatment, yet much of this promise remains untapped. The challenge associated with establishing a regulatory framework stems from the lack of available standards to help establish the safety and effectiveness of this technology, and from the lack of high quality, public databases with data curated from validated methods for use in clinical decision making

Learning Objectives

Explain recent efforts by regulatory bodies, academia, and regulated industry to curate data from this technology and use it for regulatory decision making.

Chair

Kim Tyrrell-Knott, JD

Speaker

What's Next for Next Gen Sequencing
Kim Tyrrell-Knott, JD

FDA Perspective
Laura Koontz, PhD

Panelist
Ingo Chakravarty

Panelist
Kelli Lynn Tanzella, PhD, MS


Moderators
avatar for Kim Tyrrell-Knott

Kim Tyrrell-Knott

Partner, Epstein Becker & Green, P.C.
KIM TYRRELL-KNOTT* is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC, and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on a... Read More →

Speakers
avatar for Ingo Chakravarty

Ingo Chakravarty

President and Chief Executive Officer, NAVICAN, An Intermountain Healthcare Company
Ingo Chakravarty, President and CEO of NAVICAN, joined Intermountain Healthcare in June 2016, spinning off NAVICAN in October 2016. He previously served in senior roles at Genmark Diagnostics, Gen-Probe, Roche Diagnostics, and Ventana Medical Systems here in the United States and... Read More →
LK

Laura Koontz

Office of InVitro Diagnostics and Radiological Health (OIR), CDRH, FDA
Laura M. Koontz, PhD, is a member of the Personalized Medicine Staff at the Food and Drug Administration in the Center for Devices and Radiological Health. Prior to joining the FDA, she was the Director of Policy for the Ovarian Cancer National Alliance. She also was an ASHG-NHGRI... Read More →
avatar for Kelli Tanzella

Kelli Tanzella

Senior Director, Regulatory Affair, Clinical and Compliance Life Sciences Soluti, Thermo Fisher Scientific
Kelli Tanzella, Sr. Director Global Regulatory Affairs, Clinical, & Compliance in the Life Sciences Group at Thermo Fisher Scientific has over 25 years’ experience in the pharmaceutical and medical device industries. She is responsible for development and implementation of regulatory... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Session