Conference Day One

Tuesday 17th October 2023

8:00 am Conference Registration & Welcome Coffee

8:50 am Chair’s Opening Remarks

Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP

9:00 am The Evolution of Early Access Data Lifecycle


  • Understanding the challenges faced by physicians in applying and participating in EAPs
  • Designing strategies for engaging with patients & physicians and incorporating their feedback
  • Incorporating considerations for local ethics committees and internal hospital approvals during EAP design and implementation

9:30 am Panel Discussion: Enhancing Patient Engagement in Before, During & After Managed Access Programs


  • Displaying the positive societal impact of compassionate use for healthcare systems
  • Collaborating with patient groups to increase awareness and understanding of managed access programs
  • Increasing patient engagement increased sessions and collaboration with patient advocacy groups

10:15 am Speed Networking


Bump elbows with your fellow EAP leaders! This is your opportunity to network and forge new contacts with peers in the industry. Join speed networking to meet a broad spectrum of attendees at the summit, and exchange details to catch up later in the event.

10:45 am Morning Break

11:15 am Panel Discussion: Navigating Country-Specific Pathways for EAPs

  • Annie O’Keefe Martin Global Medical Governance Managed Access Programs, Sanofi
  • Pedro Franco Director Europe for Global Regulatory & Scientific Policy, Merck Serono
  • Hannah Kurth Former Global Pipeline Lead, International, Horizon Therapeutics


  • Understanding country-specific regulatory pathways for EAPs
  • Devising strategies for manage inspections from different health agencies
  • Meeting the requirements of each country in which EAPs are ran 

12:00 pm Launching an EAP in Germany


  • Understanding the operational considerations for the set-up of an EAP 
  • Outlining insights and lessons learned
  • Leveraging strategic rational and key takeaways

12:30 pm Lunch Break & Networking

1:30 pm Outlining Current Attempts in Harmonising Compassionate Use In Europe

  • Dr. Philipp Schlatter Community of Practice Leader Patient Access Programs & Drug Supply Global Medical Affairs, Roche
  • Pedro Franco Director Europe for Global Regulatory & Scientific Policy, Merck Serono


  • Overviewing pain points in offering compassionate multi use in the EU
  • Understanding how to navigate in a complex stakeholder environment
  • Sharing experience and methods applied to remaining complaint while running EAPs in Europe

Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP

2:15 pm Considerations for Post-Trial Access Approach and Policy

  • Annie Drelles Director, EAP and Clinical Operations Lead GOMA Clinical Trial Management and Resources, Daiichi Sankyo
  • Tom Watson Chief Executive Officer, Bionical Emas


  • Ethical approach to Post Trial Access, ensuring continued access to patients benefiting from treatment
  • Regulatory considerations and country specific case studies
  • Learnings for company policy development and operational approach 

3:00 pm Afternoon Break & Networking

Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP

3:30 pm Panel Discussion: Moving Quickly After a Request for a Compassionate Use Programme


  • Strategies for efficiently managing and prioritising urgent patient requests
  • Developing a streamlined process for handling exceptional cases
  • Collaborating with stakeholders to facilitate rapid decision-making and access to treatment

4:00 pm Effectively Implementing a Programme: Small Biotech’s Best Practices and Strategies


  • Carefully planning the programme’s scope, objectives, stakeholders, and project plan with timelines and milestones.
  • Balancing cost, expertise, capacity, and control when deciding whether to develop the programme in-house or outsource it to a vendor.
  • Allocating the necessary resources, including personnel, technology, and funding, and identifies effective strategies for allocation.

4:15 pm Revolutionising Early Access Programs: The Power of a Patient-Centric Approach


Fit-for-Patient Home Healthcare: Delving into the transformative potential of patient-centric strategies in home healthcare and amplifying effect on early access programs 


Real Success Studies & Actionable Solutions: Actual case studies and success narratives to extract insights and effective strategies for home-based, patient-centric early access approaches 


Forecasting the Future: Anticipating challenges and trends influencing patient-centricity in upcoming early access trials 

4:45 pm Maximising the Benefits of Access Programs for Patients and Stakeholders


  • How to define the objectives of the program and ensure they align with the overall goals of the organisation.
  • Design to meet the needs of all stakeholders including patients.
  • Monitoring programme outcomes and how to deal with remaining uncertainties

5:15 pm Chair’s Closing Remarks and End of Conference Day 1

5:30 pm
Drinks Reception