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UID:2035@azbio.org
DTSTART;TZID=America/Phoenix:20260609T100000
DTEND;TZID=America/Phoenix:20260609T110000
DTSTAMP:20260501T170713Z
URL:https://www.azbio.org/events/virtual-hill-briefing-strengthening-fdas-
 biomarker-qualification-program
SUMMARY:Virtual Hill Briefing: Strengthening FDA’s Biomarker Qualificatio
 n Program -  - 9 Jun 26 10:00
DESCRIPTION:\n\n\n\nVirtual Hill Briefing: Strengthening FDA’s Biomarker 
 Qualification Program\n\n\n\n\n\n\n\n\n\nTuesday\, June 9\, 2026\n1:00PM 
 – 2:00PM ET&nbsp\; (10 AM - 11 AM in Arizona)\nLocation: Virtual\nRegist
 er Today\n&nbsp\;\n\nFriends of Cancer Research (Friends) is hosting a V
 irtual Hill Briefing exploring opportunities to strengthen the FDA’s Bio
 marker Qualification Program (BQP). Biomarkers and early endpoints have th
 e potential to modernize drug development\, but the policies and processes
  to validate\, qualify\, and support broader adoption have not kept pace w
 ith scientific progress.\n\nThe BQP was designed to support broader use of
  biomarkers across development programs\, but its impact has been limited.
  A streamlined pathway for predictable\, efficient\, and evidence-driven b
 iomarker development will yield critical tools to aid safety assessment an
 d accelerate clinical trials.\n\nMore predictable biomarker development ma
 tters for researchers\, FDA\, and ultimately for patients waiting on the n
 ext generation of precision therapies.\n\nThe briefing will highlight prac
 tical opportunities for the FDA and Congress to strengthen the regulatory 
 pathways needed to support more efficient development\, qualification\, an
 d broader adoption of biomarkers and novel endpoints. Access the agenda be
 low.\n\n&nbsp\;\nAgenda\nOpening Keynote (To Be Announced)\n\nSetting the 
 Stage: The Role of Biomarkers and the FDA’s Qualification Program\n\n 	J
 eff Allen\, Friends of Cancer Research\n\nPanel Discussion: Strengthening 
 the Biomarker Qualification Framework\n\n 	Rasika Kalamegham\, Genentech 
 –&nbsp\;Moderator\n 	Steve Hoffmann\, Foundation for the NIH\n 	Mike Mon
 talto\, Amgen\n 	Lauren Oliva\, Biogen\n 	Katy Wack\, PathAI\n 	Meeting Ad
 journed\n\nAgenda is subject to change.\n\n\n\n\n\n
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