MPN Pathways: Empowered Voices in Research (Session 4) - FDA 101

Explore FDA processes and patient empowerment in this MPN webinar. Hosted by MPN Advocates Network. Learn more on WebinarCafe

Research Webinar Benefits

This session will provide a comprehensive introduction to the U.S. Food and Drug Administration (FDA), its history, key responsibilities, and how it regulates drugs. Participants will gain insights into the regulatory pathways for drug approval and how the FDA exercises flexibility to support novel treatments. Importantly, this session will highlight ways MPN (myeloproliferative neoplasm) patients and caregivers can actively engage in the regulatory process to ensure their voices are heard. 

Key Learning Objectives:

• Gain an overview of the FDA’s history, responsibilities, and common misconceptions.

• Understand the regulatory framework governing drug approvals, including safety and efficacy considerations.

• Explore the different regulatory pathways available for drug approvals.

• Learn how the FDA applies regulatory flexibility to accommodate innovative treatments.

• Discover opportunities for MPN patients and caregivers to contribute to the regulatory decision-making process.

Meet our expert speaker:

Sarah Wicks is an associate at Hyman, Phelps & McNamara, P.C. where she advises drug and biologics companies on a wide range of FDA regulatory and compliance matters throughout the product development and commercialization process. She helps clients navigate human subject protections, clinical trial conduct, product strategies, and interactions with the FDA. She also provides guidance on advertising, promotion, and labeling, ensuring compliance with FDA regulations, and offers expertise in managing internal investigations, responding to FDA inspection observations, and defending against enforcement actions. A strong advocate for the patient voice in drug development, Sarah is dedicated to incorporating patient perspectives into the regulatory process. She plays a key role in planning externally-led patient-focused drug development meetings and works with patient organizations to organize patient listening sessions and adjunct scientific workshops. Her efforts bridge the gap between regulatory frameworks and the needs of the patient community, ensuring that drug development aligns with patient priorities and experiences. By combining her regulatory knowledge with a commitment to patient-centered approaches, Sarah helps clients navigate the complex landscape of drug development while advocating for meaningful patient engagement.