Pre-Conference Workshop Day | Tuesday 7th October

7:00 am Check-In & Coffee

Track One: Opening Your First Early Access Programme

8:00 am Workshop A: Early Access Programmes 101: Core Principles & Practical Insights for Success

  • Catherine Singfield Senior Director & Head of Medical, Evidence Optimisation and Managed Access Programmes Team, Jazz Pharmaceuticals

Synopsis

  • Mapping the various early access programmes, including compassionate use, expanded access, and right-to-try, along with key regulatory and eligibility differences and the specific nuances to be aware of
  • Learn how to engage with critical internal and external stakeholders, from medical and regulatory teams to healthcare providers and patients, ensuring alignment throughout the programme
  • Explore the fundamental elements that determine the success of your first EAP, such as patient safety, regulatory requirements, and resource planning, laying the groundwork for future expansion

Track Two: Advanced Challenges in Early Access Programmes

8:00 am Workshop D: Implementing & Managing Paid-for Programmes in Early Access

Synopsis

  • Deciding on the appropriate approach for your programme, charged versus free of charge
  • Evaluating the pros and cons of paid-for programmes in comparison to other early access pathways
  • Exploring a detailed case study of a paid-for programme, showcasing successes, challenges and key takeaways
  • Preparing your organisation for a paid programme, understanding the financial and operational implications of paid programmes

10:00 am Morning Break & Networking

10:45 am Workshop B: Designing a Robust Structure for Your First EAP Rollout

  • Kjersten Teeter Head of Medical Operations & Strategic Planning, Blueprint Medicines
  • Bethany Bearden Associate Director, Early Access Programmes Operations, Blueprint Medicines

Synopsis

  • Building the right structure for your EAP by establishing the optimal internal team, defining roles, and determining resource needs for a successful launch
  • Ensuring compliance and documentation by understanding the legal and regulatory framework and preparing the required documentation to meet standards
  • Setting up operational oversight by putting systems in place to manage patient order

10:45 am Workshop E: Humanitarian Programmes & Health Equity in Early Access: Advanced Strategies

Synopsis

  • Aligning humanitarian efforts with early access strategies to ensure vulnerable populations receive timely treatment
  • Addressing logistical, regulatory, and political challenges to implement programmes in crisis stricken or low-resource environments
  • Partnering with NGOs, governments, and the private sector to create sustainable models for equitable access in humanitarian settings

12:45 pm Lunch Break & Networking

1:45 pm Workshop C: Transitioning to Commercial Teams for Launch

  • Rachel Harrison Director, Pre-Approval, Post-Trial Access Programmes, Medical Affairs & Evidence Generation, Argenx

Synopsis

  • Passing the baton to commercial colleagues
  • Coordinating with cross-functional internal teams on final dispatch of drug supply, informing sites of upcoming launch, notifying Regulatory Authorities of cohort programme closure
  • Introducing MSLs to the sites for a smooth transition

1:45 pm Workshop F: Governance, Scalability, & Sustainability in Early Access Programmes

Synopsis

  • Learning how to align governance, quality, and pharmacovigilance standards with the operational needs of your EAP to ensure compliance and sustainability
  • Integrating EAPs into local healthcare systems for long-term success
  • Building consistency and scalability through automated tracking and response systems

3:45 pm End of Workshop Day

EVENT GUIDE
CONFERENCE DAY ONE