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Monday, June 28 • 2:30pm - 3:30pm
#128 SL: FDA Science Strategies: Purposeful Scientific Leadership to Advance Innovation and Improve Patient Outcomes

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-535-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide an overview of FDA CDER’s Science Strategies Program. It will also provide an opportunity for stakeholders, including patients and drug developers, to share their experiences, perspectives and priorities to inform FDA’s efforts.

Learning Objectives

Describe FDA Center for Drug Evaluation and Research’s Office of New Drugs' efforts to enhance therapeutic-specific strategic planning and scientific leadership; Discuss the opportunities for key stakeholders including, patients, academia, drug developers, health care providers, and payers, to help advance FDA’s therapeutic-specific science strategies.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Klaus Romero, MD, MS

Panelist
Jeffrey Siegel, MD

Panelist
Michelle Campbell, PhD

Panelist
Meaghan Malley



Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Science Strategies, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Meaghan Malley

Meaghan Malley

Senior Project Associate, Kidney Health Initiative, ASN Alliance for Kidney Health, United States
Meaghan Malley is the Senior Project Associate for the Kidney Health Initiative (KHI) at the ASN Alliance for Kidney Health (ASN). KHI is a public-private partnership between ASN, the U.S. Food and Drug Administration and over 100 member companies and organizations focused on fostering... Read More →
KR

Klaus Romero

Chief Scientific Officer, Critical Path Institute (C-Path), United States
Klaus Romero MD, MS, FCP is a clinical pharmacologist and epidemiologist by training, with 15 years combined experience in academic clinical research. Dr. Romero has been with C-Path since December of 2007, and during his tenure, he has helped lead clinical pharmacology, pharmacoepidemiology... Read More →
JS

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, Office of New Drugs, CDER, FDA, United States
Jeffrey Siegel is the director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum