Day One

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.

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.

Brand-New Practical Session

• 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

• 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

Join our speed networking session, tailored for Early Access experts, like yourself, to connect with fellow industry peers to facilitate rapid yet meaningful exchange of insights and expertise. Elevate your networking experience during this session designed for impactful connecting within the space.

• 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

• 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

• 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

• 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

• 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?

• 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

• 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

• 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

• 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 open-label 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.

• 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

• Outlining key factors in establishing home health programmes
• Overcoming obstacles encountered by hospitals and patients
• Unveiling advantages of creating and implementing a home health programme

Join our dedicated drinks reception to further connect and network with like-minded experts!