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 Why Enterprise Evidence Strategies Still Fail at Scale & What It Takes to Make Them Deliver
- Reframing how RWE, epidemiology, and advanced analytics should be integrated across the full R&D lifecycle to move from fragmented studies to coordinated, decision driven evidence strategies
- Understanding why many enterprise RWE and AI investments fail to influence key development, regulatory, and access decisions despite significant scale, and what differentiates organizations that consistently deliver impact
- Building the infrastructure, partnerships, and governance models required to connect global data, real world evidence, and AI insights into a cohesive system that supports faster, more confident decision making
9:05 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?
9:50 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
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 Morning Break
Clinical Track
RWE & Epidemiology for Early Development Strategy & Decision Science
11:00 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
11:30 am Accelerating Decisions with Epidemiology When Uncertainty Limits Development Confidence
- Identifying the right patient populations and geographies early to reduce uncertainty and enable faster, more confident clinical trial decisions
- Exploring how epidemiology and real-world evidence can support expansion beyond initial indications to unlock broader patient access and long term value
- Helping leadership make confident investment decisions by translating epidemiological insight into clear, decision‑relevant evidence that reduces risk and accelerates alignment
Market Access & HEOR Track
From AI-Driven Evidence to Real-World Access Decisions
11:00 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
11:30 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
12:30 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
2:30 pm Networking Roundtable Discussion: Designing RWE That Actually Influences Clinical Development Decisions, Not Just Outputs
Across organizations, RWE is increasingly used to describe patient journeys, support exploratory analyses, or generate publications but its real influence on clinical decision‑making remains inconsistent. This roundtable focuses on the non‑technical barriers that prevent RWE from shaping trial design, safety strategy, and development priorities – including timing, study framing, internal trust, and cross‑functional alignment.
Networking Discussion Questions:
- At what point in the clinical development lifecycle does RWE currently have the greatest potential to influence decisions – and where is that opportunity most often missed?
- What distinguishes RWE that genuinely informs clinical decisions from RWE that remains descriptive or retrospective?
- How do timing and sequencing affect whether RWE is acted upon or sidelined by clinical teams?
- Where do breakdowns in trust or communication most often occur between clinical development, epidemiology, and RWE teams – and how are organizations overcoming them?
HEOR Strategy, Value & Organizational Influence
1:30 pm Re‑Articulating the Strategic Value of HEOR Beyond ‘Supporting’ Clinical Evidence
- Re-articulating the strategic value of HEOR beyond ‘supporting’ clinical evidence
- Demonstrating ROI when studies take 12–24 months but decisions demand speed
- Building stronger 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 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?
3:00 pm Afternoon Break & Poster Winner Announcement
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
3:30 pm Roundtable Discussion: Are We Ready for Continuous Trial Oversight? From Retrospective Evidence to Real-Time Decisions
- How real-time clinical trial monitoring could transform regulatory decision-making, reducing ‘dead time’ and accelerating approvals while maintaining scientific rigor
- What infrastructure, data pipelines, and governance models are required to enable continuous data flow between sponsors, sites, and regulators without compromising privacy or control
- Where real-time oversight creates new risks, including misinterpretation of interim signals, bias, or overreaction to early data trends
- How organizations must rethink evidence generation, moving from static submissions to dynamic, continuously evolving evidence strategies across the clinical and post‑marketing lifecycle