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Tuesday June 16, 2026 1:45pm - 3:00pm EDT
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-579-L04-P; CME 1.25; RN 1.25

This roundtable will discuss innovations in drug review, including real-time review, AI-enabled dossier analysis, cloud data exchange, mid-cycle communications, and cross-disciplinary review, and how modern tools create a dynamic review environment.

Learning Objectives

Examine drug review practices, and highlight key PDUFA VIII enhancements; Describe the evolving role of technology (AI, cloud) in drug evaluation; Explain drug review practices globally.

Chair

Cartier Esham, PHD, MSC

Speaker

Panelist
Max Wegner, PHARMD, RPH

Panelist
Donna Boyce, MS, RAC

Panelist
Brittany Avin McKelvey, PHD


Speakers
avatar for Donna Boyce

Donna Boyce

Senior Vice President & Head, Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Cartier Esham

Cartier Esham

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), United States
Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which... Read More →
RH

Rhonda Hearns-Stewart

Senior Physician, FDA, United States
Rhonda Hearns-Stewart, MD, is a Senior Physician. She joined the FDA as a Medical Officer in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) in 2013. As a senior clinical reviewer in the Division of Bone, Reproductive, and Urologic Products... Read More →
avatar for Brittany McKelvey

Brittany McKelvey

Senior Director, Regulatory Policy, LUNGevity Foundation, United States
Brittany McKelvey is the Senior Director of Regulatory Policy at the LUNGevity Foundation. In her role, she leads the organization in advancing lung cancer policy, clinical trial reform, and regulatory initiatives. Brittany directs the Transforming Clinical Trials Initiative, fostering... Read More →
avatar for Max Wegner

Max Wegner

Senior Vice President,Head Regulatory Affairs, Bayer, Germany
A global leader in regulatory science, Max Wegner is Senior Vice President and Head of Regulatory Affairs at Bayer, overseeing all regulatory activities for the Pharmaceuticals division. He began his career in pharmacy at the University of Bonn, continued his pharmacology PhD at Bayer... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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