Tuesday, June 25 • 2:00pm - 3:15pm
#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.

Learning Objectives

Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.


Lawrence Eugene Liberti, PhD, RPh, RAC


Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Maria Isabel Manley, LLM

Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc

Patient Perspective
Julie Eller

avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Julie Eller

Julie Eller

Manager, Grassroots Advocacy, Arthritis Foundation
Julie leads a patient network of more than 100,000 patient Advocates as they share their story to effect change. Julie has had arthritis since she was seven years old and the Arthritis Foundation has helped her foster a passion for translating the patient experience into advocacy... Read More →

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)

Tuesday June 25, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA