Thursday, September 25
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
INTERACTIVE WORKSHOP
8:30 am Diagnostic Utility in Action: Advancing Reimbursement and Integration for CNS Biomarkers
Synopsis
This workshop dives into the clinical and economic challenges of integrating diagnostics into CNS care pathways. With fluid and imaging biomarkers redefining eligibility for high-cost therapies, pharma and diagnostics teams must co-develop evidence plans that demonstrate payer-valued clinical utility. The session highlights how to align biomarker evidence generation with diagnostic commercialization timelines, clarify regulatory vs. payer hurdles, and build sustainable collaborations across pharma, diagnostics, and lab networks.
Key Questions Addressed:
- What level of clinical utility and economic evidence do payers require to reimburse emerging CNS diagnostics?
- How can pharma and diagnostics collaborate earlier to align biomarker development with therapeutic value demonstration?
- What infrastructure and standardization gaps must be addressed to ensure scalable diagnostic access across CNS indications?
- What types of evidence are most impactful in demonstrating diagnostic value to both clinicians and payers, and how early should this evidence be generated?
- What lessons from oncology biomarker integration can be adapted to accelerate CNS diagnostic adoption and coverage?
11:30 am Morning Break & Refreshments
ACCESS INFRASTRUCTURE: SCALABILITY FOR MODERN CNS THERAPEUTICS
12:00 pm Scaling CNS Therapeutics: Rethinking Diagnosis, Delivery & Reimbursement in the Future of a Fragmented System
Synopsis
- Why underdiagnosis, long wait times, and neurologist shortages restrict access and how CNS therapeutics include the reliance on costly measurement devices (e.g. MRI / PET scans) and the lack of access to such devices at many clinical sites
- What a scalable CNS care model must include: new clinical networks, broader education efforts, and the crucial role of non-profits and patient advocacy groups
12:30 pm Roundtable Discussion: Mechanism of Action Discrepancies Hindering Clarity in Physician Treatment Plans
Synopsis
- How ambiguity around disease mechanisms of action (e.g., in Alzheimer’s/psychosis) and therapeutic modes of action creates hesitancy in physician decision-making and payer endorsement – what is needed to prove clinical necessity?
- Payer exclusions
- Exploring how divergent advisory board perspectives and inconsistent trial interpretations impact clinical consensus and market uptake
- Navigating the nationwide and state level market access treatment protocol requirements
1:30 pm Lunch & Networking Break
ALIGNING MARKET ACCESS CONSIDERATIONS WITH EVOLVING CLINICAL INNOVATION
2:30 pm Case Study: Unlocking Market Access for CNS Digital Therapeutics: Leveraging Claims Analysis for Strategic Payer Engagement
Synopsis
- Strategic Positioning with Payers: Learn how to craft a compelling value proposition for a digital therapeutic by aligning with payer priorities – replacing costly, less effective treatments and addressing broader cost burdens (e.g., side effects of antipsychotic augmentation)
- Harnessing Claims and Actuarial Analysis: Discover how analyzing medical claims data with actuarial support reveals high-cost treatment pathways and enables evidence-based arguments for coverage and reimbursement
- Practical Engagement Tactics: Explore actionable approaches for payer engagement, such as timing of roundtables, access strategies for CMOs, and translating clinical and economic value into payer-relevant language
3:00 pm Beyond Advocacy: The Strategic Role of Nonprofits in CNS Market Access
Synopsis
- How non-profit organizations support patient identification, education, and engagement in underserved or complex CNS indications
- Collaborating with non-profits to strengthen real-world data capture, enhance public awareness, and expand therapeutic access
- Exploring the influence of patient advocacy groups in shaping payer policy, supporting trial recruitment, and amplifying the voice of the CNS patient community in market access strategies
3:30 pm Afternoon Break & Refreshments
4:00 pm Umbrella Trials & Combination Therapy as a Route to Accelerating Commercialisation of CNS Therapeutics
Synopsis
- How umbrella trials streamline timelines and reduce duplication – key benefits for CNS programs facing long development cycles
- Leveraging umbrella trials to test multiple indications and mechanisms, supporting differentiated value propositions and early payer engagement
- How umbrella frameworks allow iterative learning without restarting full trials, enabling earlier, more confident steps toward commercialization
4:30 pm Roundtable Discussion: Industry vs. Clinicians on Umbrella vs. Extended Trials
Synopsis
- From an R&D and clinician standpoint, how can umbrella trials improve clinical efficiency without compromising the rigor needed for regulatory approval and payer confidence, especially when endpoints vary across CNS indications?
- What are the trade-offs between broad, parallel umbrella trial designs and the trend toward deep patient stratification using biomarkers for precision therapeutics?
- How do clinicians and trial sponsors navigate the real-world complexity of identifying, enrolling, and following narrowly defined CNS patient populations across multiple indications in a single umbrella trial?