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Wednesday June 17, 2026 1:45pm - 2:45pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00

Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.

Learning Objectives

Examine the dynamic collaboration between Regulatory Affairs, Medical Affairs, and Market Access to effectively address current regulatory and payor requirements; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.

Chair

Alison Maloney, MBA, MS

Speaker

An Academic Perspective
Sean D. Sullivan, PHD

A Medical Perspective
Emma Lee

A Regulatory Perspective
Todd Paporello, PHARMD, MBA


Speakers
EL

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
SS

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   04: MedAffairs-SciComm, Session

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