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 Fireside Chat: Advancing Managed Access, A Global Call to Collaborate
Synopsis
The global Managed Access community is at a pivotal moment. Join this discussion to explore opportunities, initiatives, and milestones shaping the journey toward advancing the landscape. We'll highlight collaborative actions, stakeholder dialogue, and frameworks that resonate globally and regionally. This discussion is a call to action for the community to share best practices, foster strategic relationships, and work together toward a more harmonized Managed Access environment
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
Navigating Post-Trial Access in Europe: Ethical Imperatives & Practical Barriers
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
- Utilising 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
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 Market Trends- Optimizing Post-Trial Access (PTA): Why the Pharmaceutical Industry is Streamlining PTA Processes
Synopsis
- Continuing the treatment after the closure of the clinical trial is more than a regulatory requirement- it’s a lifeline for patients who depend on investigational treatments. By streamlining PTA processes, pharmaceutical companies can deliver faster access to therapies, improve patient outcomes, and enhance operational efficiency
- Despite its importance, PTA remains underutilized. Many companies still rely on openlabel extensions and protocol extensions to ensure treatment continuity, often due to various challenges and limitations. However, in recent years, the industry has seen a growing shift toward broader adoption of PTA options
- In this session, we’ll explore why organizations of all sizes are increasingly considering PTA strategies and examine the key obstacles they face in implementing these programs effectively
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?
Enhancing Early Access Program Success by Bridging Patient, HCP & Advocacy Group Priorities
2:30 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
3:00 pm Fireside chat: Why an Expanded Access Management Platform Makes a Difference
Synopsis
- Empowering Physicians by discovering how simplified submissions and real-time patient tracking create a smoother, more transparent experience for healthcare professionals
- Optimizing Operations by learning how automated workflows and streamlined processes reduce manual effort, speed up delivery, and ensure compliance with audit-ready systems
- Driving Strategic Impact by exploring how value can be delivered through improved data visibility, stakeholder alignment, and downstream operational efficiencies
3:30 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
4:00 pm Afternoon Break & Networking
Driving Early Access Success in Diverse Global Markets
4:45 pm Free-of-charge Donations Programme – A Multi-Asset Technical Solution
Synopsis
- Exploring the transition from a legacy in-house system to a bespoke, automated solution for managing complex Early Access and free-of-charge donations across multiple assets
- Highlighting how the platform was designed to reduce manual processes, enhance efficiency, ensure compliance, and improve traceability while enabling greater scalability
- Sharing key implementation challenges, outcomes, and practical lessons learned
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
6:15 pm Chair’s Closing Remarks
6:30 pm Operationalise: Early Access Programmes’ Drinks Reception!
Synopsis
Join our dedicated drinks reception to further connect and network with like-minded experts!