Explore the Agenda
7:45 am Check In & Coffee
8:20 am Chair’s Opening Remarks
Strategic Access Planning: Managing Exit Strategies & Reimbursement from Start to Finish
8:30 am Panel Discussion: Planning & Executing Smooth Transitions from EAP to Commercial Supply
- Anticipating patient needs and country-specific timelines to maintain uninterrupted access during program closure or handover
- Aligning internal teams, local stakeholders, and advocacy groups to address operational, regulatory, and financial challenges
- Learning from real-world multi-country cases to optimize transition planning and avoid common pitfalls
9:00 am Bridging the Gap Between Regulatory Approval & Commercial Launch: Access Strategies
- Leveraging flexible access pathways between regulatory approval and commercial launch to provide patients with access while minimising costs
- Exploring case studies of successful access strategies in Europe, highlighting how companies have navigated multiple access pathways and overcome challenges
- Identifying cost-saving opportunities in distribution, including localised distribution strategies and reducing reliance on clinical product shipments, without compromising patient access or safety
9:30 am Session Reserved for Inceptua
10:00 am Network & Learn Break: Access Insights Session
This interactive break is your chance to connect with peers, explore real-world experiences, and exchange insights shaping today’s Expanded Access landscape. Use this time to discover innovative approaches, discuss operational and regulatory learnings, and engage with colleagues advancing ethical, patient-focused access pathways. For more information or to share your work, please email info@hansonwade.com
11:00 am Rapid Fire Solutions: Building Ethical & Compliant Chargeable Access
- Skip the theory and dive straight into what works. This fast-paced practical session explores real-world approaches to chargeable access through case studies from countries piloting subscription models, tiered pricing, co-pay caps, and other innovative strategies. In interactive exercises, co-design practical access blueprints, testing pricing, eligibility, payer mixes, and ethical safeguards. Leave with actionable frameworks and tools to implement fair, sustainable, and compliant paid access programs in diverse healthcare settings.
Driving Cohesion Across Internal & External Partners for Effective EAPs
11:45 am Clarifying Regulatory & Operational Differences Between Cohort & Individual Patient Programs to Align Program Design with Target Populations
- Unpacking important distinctions between cohort and individual patient regulatory pathways and impact on program design
- Exploring cost and resource considerations, including the need for a CRO, which are required to execute cohort and individual patient programs
- Implementing the obligatory commitments of running a cohort program into the pre-existing company infrastructure
12:15 pm Operating EAPs In-House, Hybrid, or Fully Outsourced: Finding the Right Model
- Comparing the pros and cons of fully in-house, fully outsourced, and hybrid approaches to program management
- Leveraging vendor expertise for complex countries or niche therapies while maintaining control over core markets
- Learning from real-world case studies on outsourcing, internalizing, and transitioning programs smoothly
12:45 pm Lunch & Networking
1:45 pm Session Reserved for Bionical Emas
2:15 pm The Rationalization of EAPs for Small Biotech
- Profit, survival or compassionate use • Navigating the evolving Expanded Access Programs globally
- Discussing the “all-in-one” role by managing regulatory, supply, clinical, and commercial responsibilities simultaneously
- Establishing priorities and workflows when multiple functions rely on one or two team members
- Building internal awareness and educating cross-functional teams to secure cooperation and reduce bottlenecks
- Leveraging vendor partnerships strategically to supplement expertise while maintaining oversight
Advanced Modalities: Delivering Innovative Therapies Through Effective EAPs
2:45 pm Implementing Home Infusion in Early Access Programs: Lessons from a Spinal Muscular Atrophy Case Study
- Navigating unique challenges of providing infusion therapy in a home setting
- Addressing operational and regulatory hurdles, including pharmacy manuals, IRB approvals, and agency contracting
- Engaging physicians and patients while ensuring uptake, satisfaction, and preparing for commercial transition
3:15 pm Afternoon Break & Networking
3:45 pm Gene Therapies: Global Pathways to Bridge Innovation & Access
- Enabling early patient access to investigational gene therapies through global pre-approval pathways and compassionate use programs
- Supporting patient access to gene therapy treatment with managed and conditional post-approval models
- Strengthening safety, effectiveness, and global alignment by leveraging multi-stakeholder data and collaboration
4:15 pm Rare & Ultra-Rare Diseases: Designing Programs for Maximum Patient Impact
- Navigating patient advocacy pressures, ethical considerations, and access equity
- Supporting single-patient vs cohort access in a dynamic regulatory environment
- Applying concrete program design and operational solutions for rare and ultra-rare diseases