Conference Day One | Wednesday 8th October
7:00 am Registration & Morning Coffee
7:50 am Chair’s Opening Remarks
Driving Faster Access: Shaping Policy & Navigating Regulations to Accelerate Early Access in Europe
8:00 am Roundtable Discussion: A Complex Regulatory Environment: Navigating Early Access Challenges in the EU for Better, More Timely Patient Support
Synopsis
• Navigating the complexities of the EU’s regulatory framework for early access: Key challenges and opportunities
• Identifying regulatory bottlenecks and how they affect the speed of patient access in the EU
• Practical strategies for aligning early access programmes with regional and national regulations while maintaining compliance across borders
• Discussing how the evolving regulatory landscape in the EU influences future early access strategies and industry collaboration
8:30 am Rapid Fire Solutions: Tackling Real-World EAP Challenges
Synopsis
From patient burden to last-minute formulation changes, this fast-paced session delivers practical, on-the-ground solutions to common EAP challenges. Featuring a series of concise, ten-minute spotlights from leading biopharma, each presentation highlights a single innovation or tactic that helped unlock access, streamline processes, or support patient continuity. Designed to fuel actionable discussion, this session goes beyond the theory – focusing on what’s actually working, and where we go next.
9:00 am Navigating the Landscape of Patient Access & Support Pathways
Synopsis
• Establishing clear criteria and governance for diverse patient access pathways, including pre-approval, post-trial, and commercial import requests
• Lessons learned from creating and refining policies to close gaps and support patients
• Strategies for ensuring the longevity and scalability of managed access programmes while adapting to internal and external challenges
9:30 am Post-Trial To Launch: Powering Your Early Access Programmes by Design
Synopsis
- Successfully managing Last Patient Last Visit (LPLV) and post-trial activities
- Navigating the transition from complex clinical trial designs to Early Access Programmes
- Utilizing post-trial real-world data to drive informed decision-making
- Addressing regulatory requirements to ensure smooth approval and access
- Supporting patients beyond trial completion , continuing the care journey
10:00 am Speed Networking
Synopsis
Join our speed networking session, tailored for Early Access experts like yourself, to connect with fellow industry peers to facilitate a rapid yet meaningful exchange of insights and expertise. Elevate your networking experience during this session designed for impactful connecting within the space.
10:30 am Morning Break
Navigating Post-Trial Access in Europe: Ethical Imperatives & Practical Barriers
11:00 am Regulatory Feasibility of Post-Trial Access: Meeting Legal & Ethical Obligations
Synopsis
• Clarifying EU-specific regulatory expectations and legal requirements for post-trial access across member states
• Evaluating feasibility and compliance challenges under GDPR, national regulations, and EMA guidance
• Addressing ethical responsibilities and patient care obligations in the absence of harmonised EU-wide post-trial access policies
11:30 am Defining Overall strategic Roadmap for Post-Trial Access implementation & Evolution
Synopsis
• Collaborating with internal stakeholders at early stages of programme development
• Developing PTA strategies considering disease severity and country-specific regulatory pathways and launch readiness
• Set-up, conduct PTA programmes following internal processes and adapt programmes according to unplanned events
12:00 pm Session Reserved for Inceptua
12:30 pm Post-Trial Access: Making it Work Through EAP Mechanisms
Synopsis
• EAP vs. OLE: Choosing the Optimal Pathway to Ensure Patient Continuity and Minimise Operational Burden
• Adapting PTA Operations to Evolving Global Regulations, Internal Readiness & Real-World Complexity
1:00 pm Lunch & Networking
2:00 pm Why Early Access is so important to Rare Disease families: A Parents Perspective
Synopsis
- A window into a rare disease parent’s journey to diagnosis, access to investigational medicine, reimbursement, and more.
- What does the industry need to know before designing Early Access Programmes for rare diseases?
2:30 pm Session Reserved for Marken
Enhancing Early Access Program Success by Bridging Patient, HCP & Advocacy Group Priorities
2:40 pm Building Internal Readiness: Defining Roles & Responsibilities Without a Dedicated EAP Team
Synopsis
• Navigating early access planning in the absence of a centralised or dedicated EAP function
• Exploring lessons learned from Teva’s evolving operating model and Centre of Excellence approach
• Creating a cross-functional matrix that works: aligning stakeholders across R&D
3:10 pm Session Reserved for myTomorrows
3:40 pm Achieving Stakeholder Alignment in Early Access Programmes: Strategies for Clarity, Consent & Collaboration
Synopsis
• Mapping key stakeholder roles and identifying potential conflicts of interest or misalignment early in programme development
• Practical steps to ensure clear, transparent communication with patients, HCPs, and advocacy groups to manage expectations and ethical concerns
• Case examples of how stakeholder alignment improved operational efficiency, patient enrolment, and long-term treatment outcomes in rare and non-rare diseases
4:10 pm Afternoon Break & Networking
Driving Early Access Success in Diverse Global Markets
4:45 pm Session Reserved for WEP
5:15 pm Providing Sustainable Access to Medicines in Low- & Middle-Income Countries
Synopsis
• Exploring the challenges and solutions for providing sustainable access to medicines in LMICs, with a focus on rare diseases
• Sharing insights from the Africa Roadmap project and its impact on connecting countries to early access programmes
• Discussing how innovative approaches, including data sharing and registries, can improve access and support rare disease treatments in resource-constrained regions
5:45 pm The Future is Home: Innovations in Chronic Therapies for Rare Disease Patients
Synopsis
• Outlining key factors in establishing home health programmes
• Overcoming obstacles encountered by hospitals and patients
• Unveiling the advantages of creating and implementing a home health programme