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How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.

Learning Objectives

Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
Samantha Roberts, PhD


Speakers
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

North America Lead, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

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