All Timing Below in EST - for CET See Full Event Guide

8:30 am

Morning Registration and Virtual Networking

8:45 am Chair’s Opening Remarks

  • Christine MacCracken Director, Patient Strategies & Solutions, Office of the Chief Medical Officer, Janssen

The Right Data at the Right Time: Using RWE in Your Program

9:00 am Key Limitations on Data Capture

9:25 am Incorporating Technology: Building a Digital Platform for Patient Access Programs to Streamline Processes and Collect Patient Data

  • Philipp Schlatter Community of Practice Leader Post Trial Access & Drug Supply, Roche

9:50 am Morning Q&A – Ask the Speakers Your Questions

10:00 am Challenges and Solutions in Real World Data Collection through EAP

  • Graham Sidorowicz Vice President Business Development, Bionical Emas EAP
  • Rakesh Davda Head of Real World Data and Market Access, Bionical Emas EAP
  • Hayley Belli Assistant Professor- Biostatistics Division, Department of Population Health//Co-Chair of the Ethics and Real World Evidence Subgroup, NYU School of Medicine//NYU Working Group on Compassionate Use and Preapproval Access (CUPA)
  • Edith Eby Vice President, Global Medical Operations, Governance and Community
, Pfizer Worldwide Medical & Safety

Synopsis

  • Biostatistical considerations
  • Considerations of the patient and Healthcare Provider
  • Maximizing Real World Data uptake

10:30 am

Speed Networking

Funding, Structure, Commercial Objectives

10:50 am Morning Break

11:00 am Expanded: Access Programs for Mutual Benefit: Drawing up a Collaborative Resource Council

  • Erika Segear Associate Director of Regulatory Affairs, Duke University
  • Richard Klein Director, Expanded Access Programs & Policy, GE2P2 Global Foundation
  • Lea Ann Browning-McNee Director of Communication & Engagement, Reagan-Udall Foundation
  • Jeff Waldron Managing Director, Sherborn Consulting
  • Andrew G. Shuman Associate Professor in the Department of Otolaryngology, University of Michigan Medical School

11:40 am Closing Out: The Move to Commercialization

  • Dawn Sullivan Sr. Program Manager, Department Lead, UltraPrograms, Ultragenyx Pharmaceutical

12:10 pm Lunch & Virtual Networking

The Patient, Clinician and Therapy Site

1:10 pm Building Patient Trust: Our Journey to “Radical” Transparency in Compassionate Use

  • Christine MacCracken Director, Patient Strategies & Solutions, Office of the Chief Medical Officer, Janssen

1:35 pm Expanded Access with a Clear Conscience: The Case Study of an Independent Ethics Advisory Panel

  • Lisa Kearns Senior Researcher, NYU Grossman School of Medicine

2:00 pm Reducing the Burden: Automation in Setting Up an Expanded Access Program

  • Erika Segear Associate Director of Regulatory Affairs, Duke University

2:25 pm CureDuchenne’s Experience with EAP Operationalizing: An investigation into Beneficial Patient- Pharma Interactions

  • Debra Miller Chief Executive Officer/Founder , CureDuchenne

2:45 pm FInal Q&A – Ask the Speakers Your Questions

  • Lisa Kearns Senior Researcher, NYU Grossman School of Medicine
  • Christine MacCracken Director, Patient Strategies & Solutions, Office of the Chief Medical Officer, Janssen
  • Erika Segear Associate Director of Regulatory Affairs, Duke University
  • Debra Miller Chief Executive Officer/Founder , CureDuchenne

3:05 pm Key Patient Focused Considerations to Operationalize a Successful EAP

3:45 pm Chair’s Closing Remarks

  • Christine MacCracken Director, Patient Strategies & Solutions, Office of the Chief Medical Officer, Janssen

3:55 pm Day 2 Debrief- your chance to join the conversation

4:25 pm

End of conference