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The Digital Core in Pharma and Personalized Medicine Development

When:

May 21, 2019 7:30 amMay 21, 2019 9:00 am (PDT)

Where:

Mintz San Diego
3580 Carmel Mountain Road
San Diego, CA 92130

Please join us as we explore the key regulatory issues in personalized medicine and drug development through the use of digital health. Our panel of policy and legal professionals will discuss personalized medicine, including FDA oversight of diagnostics, an update on what is happening in the EU, recent FDA enforcement actions, and issues in genetic testing. Additionally, this program will cover the use of digital health ​in drug development, including how AI and other tools are being used and ​regulatory issues and other risks companies should be aware of. Our panel will also explore these other timely regulatory policy and legal topics:

  • The FDA’s proposed pre-certification program for digital health
  • 510(k) and De Novo modernization efforts
  • The bipartisan call to help lower prescription drug prices, including through the FDA's Drug Competition Action Plan and Biosimilars Action Plan
  • The FDA's Comprehensive Regenerative Medicine Policy framework, including activities to advance the development of gene therapy and cellular/tissue-based products
Panelists
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Bethany Hills
, Member/Chair, FDA Regulatory Practice, Mintz

User-added image
Aaron Josephson
, Senior Director, ML Strategies | Former Senior Policy Advisor, FDA's Center for Devices & Radiological, Health

Kelli Tanzella, Sr. Director, Global Regulatory Affairs, Clinical, & Compliance, ThermoFisher Scientific

Linda Marban
, CEO of Capricor Therapeutics


Register HERE