5th Expanded Access Programmes World Congress 2023 Americas
Day 2 - Friday 17th November 2023
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
Wyndi Phillips, Vice President, Project Management, WEP Clinical
- 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
TBC
Roberta Smith, President , Alagille Syndrome Alliance
- 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