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Tuesday, June 18 • 3:15pm - 4:15pm
#264: Advancing Innovation in Clinical Trial Design and Conduct

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will provide an overview of FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities and an opportunity for stakeholders to share their experiences, perspectives, and priorities to inform FDA’s efforts.

Learning Objectives

Discuss key challenges or barriers that hinder the implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Patient Perspective
Ella Balasa


Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Advisory Committees, 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 Ella Balasa

Ella Balasa

Patient Advocate and Engagement Consultant, United States
A chronic disease patient who advocates research and advisory boards, optimizing clinical trial designs and reviewing protocols, composing lay clinical summaries and op-eds, collaborating on white paper development, moderating patient and industry panel discussions, as well as sharing... Read More →
avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum