7th Expanded Access Progammes World Congress 2024 Americas
Day 1 - Thursday 14th November 2024
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
MACRO OUTLOOK & CURRENT TRENDS
- When should companies consider the idea of Early Access Programmes?
- Understanding the challenges in running a global EAP
- Navigating country specific framework and requirements
- Addressing challenges on patients demands and supply
- Positive impact of EAP on patients with serious, immediately life-threatening, or rapidly debilitating diseases
Moderator:
Panelist:
Elsa Luna, Director, Expanded Access Operations, Pfizer
- Planning and designing for expanded access programs early can be difficult. This panel explores how pharma and biotech can work with Patient Advocacy Groups and Research Consortiums to ensure that the patient voice is part of early planning, and how digital communities can facilitate early planning and
awareness of expanded access programs.
- What is expanded access and when do we use it?
- How do we plan for expanded access?
- Who needs to be involved with expanded access and what is the key to its success?
- What are the means to get the medicine to the patient?
- Country Specific Regulatory Pathways
- Practical Challenges and Solutions in PTA
- Unique Operational Considerations for PTA
Jennifer Grigonis, Sr. Director Business Development EAP, Bionical Emas
Tori Rizk, Associate Portfolio Director, Bionical Emas
Patrick Raletz, Project Manager EAP, Bionical Emas
Juan Rosario, Project Manager EAP, Bionical Emas
- In an era where ‘real-world data’ is increasing of interest, what are the limitations?
- Data collection within early access programs in various regions
- Ethical considerations and operational challenges in conducting data collection
- Benefits of collecting RWD within early access programs
CHALLENGES & POTENTIALS
- Opening an EAP without Vendor Support
- Considering Stakeholder Expectations
- Managing Resource Limitations
Amber Bifolck Fisher, Senior Clinical Research Manager, Expanded Access, Kura Oncology
- 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
- Case study demonstrating the importance of site management
Melanie Wolf, Associate Director, Global Early Access Programs, Sarepta Therapeutics
- Introduction to EAP and their differences
- When does the implementation of the Early Access programme be considered?
- What are the numerous challenges faced in the implementation of EAPs?
- Key considerations for the successful implementation of early access program
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
- Recognizing the importance of patient-centered approaches.
- Advocating for equitable access to medications
- Prioritizing empathy and understanding in healthcare decision-making.
Chisa Nosamiefan, Co-founder, The Labalaba Foundation for Lupus
- Expanded access is often access to treatment where no other options exist
- How to build a patient centric EAP
- Will include case study on a rare pediatric programs life saving EAP
Jennifer McNary, Founder, One Rare
- Drivers of early access programmes
- Setting up a clear perspective and expectations of the programme
- Streamlining process and ensuring early access of medicinal products to patients
- How regulators and reimbursement agencies can work together to help ensure that patients are able to access life changing medicines as soon as it is safe for them to do so?
