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Monday, June 24 • 2:15pm - 3:15pm
#139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an opportunity for stakeholders to hear about FDA’s effort to advance the development of a publicly available core set(s) of clinical outcomes assessment measures and endpoints.

Learning Objectives

Describe FDA efforts, including plans and progress on an anticipated new FDA extramural grants program, to advance the development of a publicly available core set(s) of clinical outcomes assessment (COA) measures and endpoints for specific disease indications; Discuss the opportunities for key stakeholders including, academia, Health Technology Assessors, payers, health care providers, and regulated industry.

Chair

Meghana Chalasani, MHA

Speaker

FDA Update
Theresa Mullin, PhD

FDA Update
Laura Lee Johnson, PhD

FDA Update
Elektra Johanna Papadopoulos, MD, MPH

Industry Update
Tara Symonds, PhD

Industry Update
Anton Hoos, MD, PhD, MBA



Speakers
avatar for Anton Hoos

Anton Hoos

Executive Team, Patient Focused Medicine Development
Tony is a founding member of the non-profit, multi-stakeholder alliance ‘Patient Focused Medicines Development’ (www.pfmd.org); members include many patient groups, industry and others; Tony currently serves on PFMD’s executive team. He has 30 years of professional experience... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA
Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →
LL

Laura Lee Johnson

Director Division III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
EP

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →
avatar for Tara Symonds

Tara Symonds

Chief Science Officer, Clinical Outcomes Solutions
Tara Symonds is Strategic Lead at Clinical Outcomes Solutions providing advice on COA strategy from development to dissemination. Tara has 25+ years of experience in the COA field both negotiating labelling and in disseminating results effectively with payers. She has worked in numerous... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session