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Day 2

7th Expanded Access Programmes World Congress 2024 Americas

Strategies and Considerations in Launching an Expanded Access Programmes
Boston, MA, USA

Day 2 - Friday 28th June 2024

Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

ACCESS & COMMERCIALIZATION

  • What are the possible scientific and regulatory approaches to facilitate development?
  • How to enable early access to treat Rare disease patients
  • Ways to guarantee that patient safety, efficacy, and product quality are not compromised
  • A discussion of experiences to date from early access approaches.

Moderator:

Panelist:
Emily Parks, Founder, POP!

Lee Sutton, Vice President, Business Development, EAP, WEP Clinical

  • How important is engaging patient early at the earliest stage in research and development
  • The need for a continuous meaningful dialogue between stakeholders to establish an effective working relationship
  • What are the best practices and ethics behind a successful early access programme?
  • Sustaining purposeful patient engagement across the lifecycle of medicines

Alan J. Balch, Chief Executive Officer, Patient Advocate Foundation

  • Building your EAP with a ‘site-first’ approach
  • Educating sites on their roles and responsibilities in an EAP
  • Ensuring a clear communication plan to support sites in an expedited manner (people to people versus technology)
  • Case study demonstrating the importance of site management
  • The importance of patient advocacy in providing much-needed information on EAP’s available for patients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups’ importance in working with health authorities to advance policies that accelerate patient access to investigational medicine
  • Creating a state of the art payer engagement strategies to address challenges in pricing and reimbursement

Moderator:

Panelist:
Amber Bifolck Fisher, Clinical Research Manager, Kura Oncology, Inc.
Alan J. Balch, Chief Executive Officer, Patient Advocate Foundation
Chisa Nosamiefan, Co-founder, The Labalaba Foundation for Lupus

MULTI-STAKEHOLDER APPROACH & COLLABORATION

  • Ideal Accelerated Pathway
  • Problems of Excluding Some Disease
  • Brainstorming: Removing the Barriers
  • What’s the Long Game?: Rethinking the Regulatory Rules

Monica L Weldon, President/CEO/Founder, SYNGAP1 Foundation

  • The importance of patient advocacy in providing much-needed information on EAP’s available for patients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups’ importance in working with health authorities to advance policies that accelerate patient access to investigational medicines
  • Creating a state of the art payer engagement strategies to address challenges in pricing and reimbursement

Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

  • Value of patient engagement in Early Access Programmes at the earliest stage in research and development
  • Continuous meaningful dialogue between stakeholders to establish an effective working relationship
  • What are the best practices and ethics behind a successful early access programme?
  • Knowing what motivates the stakeholders within early access
  • Sustaining purposeful patient engagement across the lifecycle of medicines

END OF CONFERENCE

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