Global Summit:

mRNA’s Path Forward

Harmonizing the Regulatory Pathway for mRNA Vaccines and Therapeutics

April 4, 2024
Washington, D.C., USA

About the event

The Alliance for mRNA Medicines invites you to participate in a global summit focused on the most pressing regulatory issues impacting mRNA technologies.

At this summit, regulatory, industry, and academic leaders will present and discuss the
opportunities for harmonizing the regulatory framework for mRNA. The leaders will detail the
specific opportunities involving:

Vaccines
Therapeutics
Manufacturing

Why attend?

The summit offers a unique opportunity for meaningful knowledge exchange, discussion, and interaction between regulators and attendees on timely and relevant issues. Attendees will:

Learn more from regulators about the areas most ripe for harmonization
Better understand the viewpoints of industry and academic leaders working through the same issues
Lay the groundwork for continued collaboration in this critical area

Speakers

Marco Cavaleri

Head of Biological Health Threats and Vaccines Strategy
European Medicines Agency

Peter Marks M.D., PhD.

Director
Center for Biologics Evaluation and Research (CBER)

Alison Niewiarowska, PhD.

Head of Biological Products
UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Andrew Pengilley

Senior Medical Advisor, Pre-Market Assessment Branch
Australia Therapeutic Goods Administration

Ka-Wai Wan, PhD

Senior Pharmaceutical Assessor
UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Michael Wall

Biologist/Evaluator
Health Canada

About AMM

The Alliance for mRNA Medicines (AMM) is the leading global organization dedicated to advancing and advocating for mRNA and next-generation encoding RNA therapeutics and vaccines for the benefit of patients, public health, and society. Our mission is to propel the future of mRNA medicine, improve patients’ lives, and advance scientific knowledge by convening and empowering the mRNA community, including industry leaders, innovators, scientists, and other key stakeholders.

April 4: Draft Agenda

8:00 AM – 8:30 AM ET

Networking Breakfast

8:30 AM – 8:45 AM ET

Welcome and Agenda Review

8:45 AM – 9:30 AM ET

Opening Fireside Chat: Setting the Stage

9:30 – 11:15 AM ET

Panel Discussion 1: Regulator Perspectives

11:15 AM – 11:30 AM

Coffee break

11:30 AM – 12:30 PM

Panel Discussion 2: Harmonization opportunities for mRNA as a platform

12:30 PM – 1:15 PM

Lunch

1:15 PM – 2:15 PM

Panel Discussion 3: Harmonization opportunities: mRNA Chemistry, Manufacturing and Controls

2:15 PM – 2:30 PM

Break

2:30 PM – 3:30 PM

Panel Discussion 4: Harmonization opportunities: mRNA delivery systems

3:30 PM – 4:00 PM

Reflections, Wrap Up, and Next Steps

4:00 PM

Reception