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Day 1

7th Expanded Access Progammes World Congress 2024 Americas

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

Day 1 - Thursday 27th June 2024

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

MACRO OUTLOOK & CURRENT TRENDS

  • Understanding the challenges in planning and implementing a global EAP
  • Country specific framework and requirements to access investigational drugs
  • Scientific elements and regulatory tools available to address the challenges and explore the flexibility within the current regulatory systems
  • Significant degree of administrative effort required to initiate the programme for a timely access
  • How far are we from establishing a harmonised guidelines across Americas?

Moderator:
Monica L Weldon, President/CEO/Founde, SYNGAP1 Foundation

Panelist:
Rachel Harrison, Associate Director, Early Access Program, Apellis Pharmaceuticals
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

Amber Bifolck Fisher, Clinical Research Manager, Kura Oncology, Inc.

Wyndi Phillips, Vice President, Project Management, WEP Clinical 

Annmarie Galli, Head, Global Medical Affairs Research and Compassionate Use / Managed Access Programs
Oncology, GSK

  • 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.

Jennifer M. Joe, Global Medical Strategy & Population Health Director, AstraZeneca
Bhaskar Dutta, Head, Digital Health & Medical Affairs Technologies, Alexion
Norah Xiao, Director, Digital Health Partnership, Astrazeneca
Isabelle Lousada, CEO and President, Amyloidosis Research Consortium

  • Country Specific Regulatory Pathways
  • Practical Challenges and Solutions in PTA
  • Unique Operational Considerations for PTA

Graham Sidorowicz, EVP Commercial, Bionical Emas

  • Challenges & Opportunities of a company-wide roll-out of Early Access Programme
  • Strategies & consideration for a successful implementation
  • Established responsibilities from everyone involved to ensure smooth delivery to patients in need

Rachel Harisson, Associate Director, Pre-Approval Access Programs, argenx

CHALLENGES & POTENTIALS

  • Setting up objectives of an EAP within the Asset Plan
  • Importance of Early Conversations & cross-functional collaboration of internal stakeholders
  • Managing the expectations of External Stakeholders
  • Mitigating difficult conversations while setting up an EAP

Siddharth Jain, Medical Director –LSDs & HAE, Global Medical Affairs, Takeda

  • Is an Open Label Extension feasible?
  • Is Expanded Access/Compassionate Use the perfect plan?
  • Regulatory Variations and Challenges
  • Lessons Learned

Donna Cowan, Associate Director, EAP & Registry, Stealth Biotherapeutics
Amber Bifolck Fisher, Clinical Research Manager, Kura Oncology, Inc.

  • Advancing Equity
  • Inclusive Communication
  • Culturally Effective Decision Making
  • Voices of Diversity

Chisa Nosamiefan, Co-founder, The Labalaba Foundation for Lupus

  • Deep-dive into the reality of healthcare access around the world
  • Streamlining the process and navigating early access regulations globally
  • What does the future of health access look like? The interconnected ecosystem where all healthcare stakeholders work together

Moderator:

Panelists:

Jennifer E. Miller, PhD, Associate Professor , Yale School of Medicine
Monica L Weldon, President/CEO/Founder, SYNGAP1 Foundation

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