Say "Goodbye" to the Worry and Uncertainty of Setting Up and Managing an Expanded Access Program

This inaugural Operationalize: Expanded Access Programs digital event is here to bring you solutions.

Dealing with a diverse and confusing global regulatory landscape - on top of an increasing number of access requests from patients - is no easy feat for people working in expanded access programs. As operational obstacles can arise at any time - from set up to close out - all stakeholders must equip themselves with the knowledge and tools to overcome these challenges.

By bringing together the world’s leading Expanded Access Programs thinkers, this exclusive platform will clarify the complex issues through end-to-end Managed Access/Compassionate Use program operationalization. Through open discussion, sharing best-practice case studies, and removing hypotheticals: this event provides an unrivalled opportunity to solve your challenges across the entire timeline.

Whether it's Expanded Access Programs, Early Access, Managed Access, Compassionate Use, Named Patient Programs or even Post-Trial Access: Ensure you aren’t repeating past mistakes by hearing global leaders recall their experience with a shared goal of providing you with pragmatic solutions to solve these complex hurdles.

Expert Speaker Faculty

Paul Aliu

Head of Global Governance, Chief Medical Office (CMO)

Novartis

Erika Segear

Associate Director of Regulatory Affairs

Duke University

Georges van Baelen

Founder & CEO

Arctiryon

Lisa Kearns

Senior Researcher

NYU Grossman School of Medicine

Dawn Sullivan

Sr. Program Manager, Department Lead, UltraPrograms

Ultragenyx Pharmaceutical

Jessa Ford Depew

Regional Medical Director

Santhera Pharmaceuticals

Jodi Wolff

Head of Patient Advocacy, U.S

Santhera Pharmaceuticals

Donna Cowan

Expanded Access and Clinical Program Manager

Stealth BioTherapeutics

Philipp Schlatter

Community of Practice Leader Post Trial Access & Drug Supply

Roche

Greg Tuyteleers

Global Operations Head - Managed Access,

Janssen

Ramona Reichenbach

Head of Managed Access Center of Excellence (MACoE)

Novartis

Paula Singer

Global Medical Affairs, Senior Manager Early Access Programs

Alnylam Pharmaceuticals

Gretchen Randlett

Advisor, Expanded & Continued Access & CT Sourcing

Eli Lilly

Samantha Nunes-Radimerski

Global Medical Governance Lead – Managed Access Programs (MAPs)

Novartis

Richard Klein

Director, Expanded Access Programs & Policy

GE2P2 Global Foundation

Operationalize: Expanded Access Programs is Proud to Partner With:

Expertise Partners

Hosting Partners