Explore the Agenda
7:30 am Morning Check-In & Coffee
8:30 am Chair’s Opening Remarks
Global Evidence, Local Decisions on Why Strong Global RWE Still Breaks Down at Country‑Level Access, Organizational Design, & Rare Disease Patient Journeys
8:35 am Understanding the Invisible Patient & Mapping Rare Disease Journeys Beyond Diagnosed Populations
- Addressing undiagnosed and misdiagnosed patients that remain invisible in traditional RWD
- Using epidemiology to inform earlier diagnosis and targeted outreach strategies
- Balancing methodological rigor and operational feasibility in rare disease evidence generation
9:05 am Beyond Point Solutions: Building Trusted, End-to-End Agentic AI for Real-World Evidence
- Explore how end-to-end agentic workflows can address distinct challenges across the RWE lifecycle, rather than accelerating isolated tasks without connecting them to a broader evidence-generation process
- Examine why coordinating specialized agents within an integrated workflow can make AI easier to adopt, embed into existing processes, and govern than a collection of disconnected point solutions
- Identify what makes a purpose-built RWE agent more trustworthy than a general-purpose LLM, including domain-specific expertise, transparent and traceable methods, rigorous evaluation, and appropriate human oversight by subject-matter experts
9:35 am Panel Discussion: How RWE & AI Are Actually Shaping Research & Development & Evidence Strategy Today From Methodology to Impact
- How is real‑world evidence being used across the full development and post‑launch lifecycle, and how should organizations integrate RWE earlier while leveraging AI and other methods to enhance decision‑making at each stage?
- How is real‑world evidence being used in practice to inform R&D and lifecycle decisions beyond methodological decisions?
- What does real‑world AI adoption look like beyond pilots, and what has been required to move from experimentation to scalable, trusted impact?
- Where are the real credibility risks when integrating AI and RWE into regulated evidence generation, and how are leading organizations managing them?
- How should companies balance speed, innovation, and scientific defensibility as AI becomes embedded across evidence generation workflows?
- What strategic and governance capabilities will distinguish evidence leaders over the next 3–5 years?
10:20 am From Real-World Evidence to Real-World Impact: Closing the Gap Between Insight and Action in Life Sciences
- Describe key limitations of traditional real-world evidence approaches, including gaps in understanding patient pathways, provider decision-making, and treatment variation
- Explain how integrating longitudinal data sources can improve visibility into patient identification, treatment patterns, and real-world care dynamics
- Identify approaches for translating real-world evidence into action, including strategies to support provider engagement and improve alignment between evidence and real-world practice
10:30 am AI‑Enabled RWE at a Crossroads, From Risk Prediction to Decision Grade Evidence
- Applying AI and machine learning to real‑world data to improve risk prediction, safety signal detection, and benefit– risk assessment across development and post‑marketing
- Understanding why AI‑driven analyses often fail to translate into trusted evidence, particularly when uncertainty, bias, or poor contextualization limit interpretation in regulatory and safety settings
- Aligning AI‑enabled RWE with epidemiological principles and regulatory expectations to ensure outputs are interpretable, credible, and decision‑relevant
11:00 am Morning Break
Clinical Track
RWE & Epidemiology for Early Development Strategy & Decision Science
11:30 am From Rare Data to Real Impact Translating Real World Evidence Into Clinical Decisions in Rare Disease
- Translating real world evidence into clinically meaningful insights in rare disease settings where data is limited and uncertainty is high
- Bridging real world evidence and medical affairs to ensure evidence is understood trusted and applied by clinicians and stakeholders globally
- Overcoming challenges of small populations fragmented datasets and lack of standardized endpoints to ensure evidence influences real world treatment decisions
12:00 pm Unlocking Novel Evidence Generation via Point of Care Integration in the Real World
- Evidence generation learnings from a large scale nationwide primary and specialty care physician network
- An intelligent model to unlock participation and engagement of the “lay HCP” in pragmatic studies
- Combining direct longitudinal clinic relationships and point of care EHR integration to answer novel real world research questions
- Specific tactical guidance on standing up prospective research protocols leveraging a decentralized, virtual site model in complex conditions
12:30 pm Transforming Clinical Development & Commercial Strategy With Real-World Diagnostic Data
- Key drivers of value for insight generation, including structured, curated and up-to-date diagnostic data, clinical and technical expertise, and direct access to the source of testing
- Use cases where diagnostic data and closed claims are uniquely placed to support clinical development and commercial strategy, including key success criteria and strategic implications
- Approaches to expanding access to AI-enabled tools that empower individuals to generate rapid, self-service insights
Market Access & HEOR Track
From AI-Driven Evidence to Real-World Access Decisions
11:30 am Why Demonstrated Value Is Not Enough Securing Access in a Constrained Pricing Environment
- Understanding how payer dynamics, account structures, and reimbursement pathways shape access outcomes beyond the strength of clinical and real-world evidence
- Navigating negotiation realities including contracting, channel dynamics, and policy constraints that influence pricing decisions even when value is clearly demonstrated
- Adapting market access strategy to focus on high-impact moments that improve coverage and uptake, while balancing evidence generation with commercial and payer expectations
12:00 pm Session Reserved for Novellia
12:30 pm Session Reserved for PSP Corporation
12:40 pm Lunch Break
Understanding Why RWE Still Fails to Translate Into Decisions From Early Evidence to Real Access
1:30 pm Designing Fit for Purpose RWE in Early Development Using Symptom Level Data to Inform Decision Making
- Working in therapeutic areas like mental health where structured diagnoses are often missing and exploring how symptom level and unstructured data can be used to better define patient populations and unmet needs
- Applying epidemiological thinking in early development to navigate bias, confounding, and data gaps when informing trial design and early decision making
- Sharing practical case examples that show how real-world symptom data can support cohort identification, endpoint selection, and reduce risk earlier in the pipeline
2:00 pm From Linked Data to Lost Decisions: Why Integrated RWD Still Fails at Payer Review
- Examining why technically strong real-world datasets and evidence still fail to translate into payer approval and real patient access
- Identifying where data integration improves insight but does not address payer concerns, operational barriers, or patient access challenges
- Aligning evidence strategies with how access decisions are made and implemented, including patient pathways, support programs, and real-world constraint
HEOR Strategy, Value & Organizational Influence
1:30 pm HEOR: More Than a Support Function – A Strategic Value Driver
- Reframing the strategic value of HEOR beyond a purely supportive role to clinical evidence
- Demonstrating ROI in a landscape where research timelines take 12–24 months, lagging behind rapid decision-making needs
- Strengthening leadership advocacy and communication skills within HEOR leadership
2:00 pm Realigning Cross-Functional Teams on What Real World Evidence Really Is: From Data to Decision-Grade Evidence
- Aligning clinical, RWE, HEOR, and access teams around what constitutes decision‑grade evidence across the product lifecycle
- Bridging the gap between data generation and value demonstration by ensuring study design, methods, and timelines are aligned with regulatory and payer expectations
- Strengthening internal decision-making by improving how evidence is framed, communicated, and translated into compelling value narratives
2:30 pm Afternoon Break
The winning poster will be announced at this time. The winner will receive their award, and have their poster showcased on our website as a downloadable file.
Translating Integrated Data Into Payer Decisions
3:00 pm Fit-for-Purpose RWE: A Practical Framework for Matching Methodological Rigor to Decision Risk
- Starting RWE generation from the decision context to ensure that both the data and the analytic approach are fit-for-purpose
- Unpacking the drivers of evidence quality, from (first and foremost) target trial emulation fidelity to (secondly) analytic methodology, which can mitigate but not overcome data and design limitations
- Understanding the range of RWE methodology available, from descriptive benchmarking to external control arms, and matching corresponding levels of evidence rigor (and sensitivity analyses) to the decision risk
4:00 pm Networking Roundtable Discussion: From Evidence Generation to Evidence That Gets Accepted: Where RWE Loses Credibility Before Payer Review
Many RWE strategies fail long before formal payer or HTA review – due to poor framing, mis‑sequencing, unclear research questions, and false assumptions about what counts as ‘decision-relevant evidence’. This roundtable helps attendees stress‑test their evidence strategies against real access expectations.
Networking Discussion Questions:
- At what point in your organization does RWE most often become misaligned with payer or HTA decision needs – and why?
- How are teams distinguishing between evidence that is ‘interesting’, ‘publishable’ and ‘payable’?
- What are the most common misconceptions stakeholders still have about what payers and HTA bodies will accept from RWE and AI-enabled studies?
- If you were forced to cut half of your current RWE or HEOR activity, what would you keep because it truly influences access decisions?