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Mar 22, 2021 9:50 AM - Mar 24, 2021 2:30 PM

(Eastern Standard Time)

Medical Affairs and Scientific Communications Forum

Session 8 Track 2: Applying Learning from Rare Disease to Support Diversity in Clinical Trials

Session Chair(s)

Diane  Cleverley, PhD

Diane Cleverley, PhD

Senior Regulatory Writer

Certara, United States

With the advent of patient-focused drug development guidance from the FDA, medical writers can have a hand in crafting protocols and clinical trial materials to include patient advocacy input. The writer will learn how to incorporate advocates’ suggestions to enhance patient’s ability to enroll and continue to sustain participation in clinical studies, and their quality of experience. Also, to understand how patient input might further benefit special population considerations (cultural, elderly, non-communicative, pediatric, rare-disease, or comorbidities). With a focus on rare disease and application to other special populations based on what we have learned in the rare disease community.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the impact of the patient-focused drug development guidance from the FDA on regulatory medical writing
  • Identify special populations that might benefit from patient input
  • Apply learnings from rare disease to other special populations for clinical trial registrations


Wesley  Michael, MBA

Rare Patient Voice

Wesley Michael, MBA

Rare Patient Voice, LLC, United States


Emily  Lemiska

Patient Input Through Advocacy Groups for Use in Clinical Trials

Emily Lemiska

US Pain Foundation, United States

Director of Communications and Educational Programming

Scott  Schliebner, MPH


Scott Schliebner, MPH

TFS Health Science, United States

Senior Vice President, Clinical Development Services

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