Wednesday, September 24
For the most up-to-date agenda, please download the full event guide.
7:30 am Check In, Coffee & Light Breakfast
8:25 am Chair’s Opening Remarks
EMBEDDING MARKET ACCESS ACROSS THE CNS DEVELOPMENT LIFECYCLE
8:30 am Panel Discussion: Starting with the End in Mind: Strategic Access Planning at the Earliest Stages for CNS Therapeutics
Synopsis
- CNS drugs face uniquely complex access hurdles: diagnostic ambiguity, subjective endpoints, societal stigma, infrastructure gaps, and payer scepticism toward psychiatric or neurodegenerative indications
- Market access strategy cannot wait until Phase 3 – strategy and decisions need to be made at the earliest stages of development to lock in value later
Key Questions:
- Why is it essential to begin market access planning before clinical proof of concept, particularly for CNS assets?
- How do you define and stress-test a Target Product Profile (TPP) at the pre–Phase 2 stage to align with future payer and HTA expectations?
- What is different about market access planning in CNS vs. other therapeutic areas at this stage?
9:00 am Designing for Access: Embedding Market Access Strategy into CNS Evidence Generation from Phase II Onward
Synopsis
- Integrating market access strategy, education and networking early into clinical infrastructure to prevent post-approval access hurdles
- Aligning pivotal trial design and package insert content with downstream payer expectations
- Using advisory boards, consultants, and early payer engagement to shape evidence generation
- Embedding market access considerations into Phase IIb–III decisions without disrupting regulatory-first priorities
9:30 am Speed Networking
Synopsis
A prime chance to make the most of in-person networking and forge new connections as new companies enter and existing ones broaden their presence within the CNS therapeutics space. This is designed to maximize your exposure to a wide range of new individuals and serve as a catalyst for ongoing discussions throughout the Summit.
10:30 am Morning Break & Refreshments
BREAKING BARRIERS ACROSS THE LIFESPAN: ADVANCING ACCESS AND EMPATHY IN NEUROPSYCHIATRIC CARE
11:00 am Perspectives From Healthcare Professionals: Roadblocks to Patient Access with Low Motivation & Aging Patient Populations
Synopsis
- Discuss how REMS certifications, product-specific dosing protocols, and prolonged in-clinic observation times discourage uptake, even when treatments are clinically appropriate
- Real-world challenges of initiating and maintaining treatment in aging or low motivation patient populations
- Strategies for simplifying care models (e.g., co-located services, enhanced patient support programs)
- Exploring strategies and tools to help healthcare professionals maintain empathy when patients do not respond to clinically appropriate therapeutic interventions
11:30 am Session Reserved for Click Therapeutics
12:00 pm Lunch & Networking Break
ACCESS INFRASTRUCTURE: DISTRIBUTION, DELIVERY & SCALABILITY FOR MODERN CNS THERAPEUTICS
1:00 pm Roundtable Discussion: Specialty vs. Retail Pharmacies in CNS Therapeutics – Navigating Access, Margins, & Patient Support
Synopsis
- How shrinking margins, generics, and store closures have impacted retail’s role in CNS therapy access, and why it’s becoming less viable for novel treatments
- The growing importance of specialty pharmacies for large-molecule and complex CNS drugs, and their role in delivering enhanced services like prior authorization and assignment of benefits
- Strategic considerations for manufacturers in choosing the right distribution model early, balancing prescriber burden, payer requirements, and patient logistics
1:30 pm Panel Discussion: From Policy to Practice – Bridging the Gap Between Payer Access & Clinical Reality
Synopsis
- Explore how mismatches between labelled indication and payer policy (e.g., differing “line of therapy” requirements across insurers and states) create treatment denial risks and force patients or physicians into appeal processes, especially for time-sensitive psychiatric interventions
- The gap between contracted payer coverage and real-world access: address claim denials, administrative friction, and the need for improved payer-provider alignment
- Address the difficulty clinicians face in staying current with plan-specific formularies and access criteria, especially across multiple insurers, plan tiers, and evolving coverage decisions, and discuss where education, digital tools, or standardization could help
2:00 pm Afternoon Break & Refreshments
INTERACTIVE WORKSHOP
2:30 pm From Trial to Treatment: Navigating Formulary Access, Package Insert Constraints, and Payer Expectations in CNS Therapeutics
Synopsis
This workshop explores the complex relationship between clinical trial design, package insert language, and payer formularies, focusing on the real-world implications for CNS access strategy. Drawing from front-line payer insights, attendees will learn how trial inclusion criteria and risk stratification data lock in downstream access barriers or enablers. The session will also cover the evolving role of medical science liaisons (MSLs) in bridging clinical, commercial, and payer priorities, ensuring launch strategies don’t stall in reimbursement bottlenecks.
Key Questions Addressed:
- How do payer formularies interpret and enforce narrow inclusion criteria from clinical trials via package inserts?
- What role do early payer engagements and MSLs play in reshaping access parameters for novel CNS drugs?
- How can access teams anticipate and counteract payer “cost containment” tactics like delayed reimbursement or formulary exclusion?
- How can clinical development teams better design trials to anticipate payer-driven access restrictions post-launch?
- What are the risks and opportunities of post-launch PI revisions in shaping ongoing access and reimbursement outcomes?