Explore the Agenda
8:00 am Morning Check-In & Coffee
8:55 am Chair’s Opening Remarks
Turning Real World Evidence Into Decisions That Drive Development Access & Commercial Impact
9:00 am Why Real-World Evidence Has Reached a Tipping Point & Bridging Expectations to Outcomes?
- Reframe where RWE truly creates value today across development, access, and lifecycle decision making and where expectations still exceed reality
- Highlight the structural challenges holding RWE back, including data quality, timing, organizational alignment, and over reliance on tools without decision context
- Explore the emerging capabilities and strategic shifts that will unlock RWE’s full potential
9:30 am Designing Enterprise Evidence Systems That Deliver Decision Impact Across the Lifecycle
- Building integrated evidence planning frameworks that align RWE, HEOR, and clinical data across global teams and pipeline assets
- Connecting evidence generation, synthesis, and decisionmaking across functions to move beyond fragmented studies toward coordinated enterprise insight
- Embedding evidence into organizational workflows to support both internal development decisions and external stakeholder value demonstration
10:00 am Why Strong Evidence Still Isn’t Enough & What It Takes to Secure Access, Pricing & Reimbursement in Today’s Market
- Understanding why robust clinical and real-world evidence still fails to translate into payer approval and favorable access outcomes
- Navigating the realities of pricing, policy, and reimbursement frameworks that influence decisions beyond the strength of the data
- Aligning evidence generation with payer expectations early to avoid delays, restrictions, and lost commercial value
10:30 am Morning Break & Speed Networking
As the RWE community reconnects, this valuable session will ensure you get the chance to reconnect with peers and make brand new connections! This structured networking opportunity will pair you with fellow attendees for several 3-minute introductions, ensuring you have the opportunity to meet and network with your industry colleagues.
Clinical Track
RWD Strategy, Data Foundations & Sustainable
11:30 am From Data to Decision Advantage: Building Enterprise-Ready RWE That Scales
- Scaling real-world evidence from isolated analyses to enterprise systems
- Bridging data science, policy, and evidence strategy to ensure RWE outputs are interpretable, credible, and decision-relevant
- Embedding AI, automation, and digital tools into evidence workflows without compromising trust and transparency
12:00 pm What It Actually Takes to Scale AI in RWE From Experimental Success to Organizational Reality
- Why AI initiatives often succeed technically but stall organizationally once real studies and stakeholders are involved
- Overcoming friction between data science, epidemiology, RWE, and evidence leadership when scaling AI workflows
- Reframing AI as a decision-support enabler rather than a workforce replacement to unlock sustainable adoption
Market Access & HEOR Track
Evidence Quality, Reimbursement Risk, & AI Governance for Decision Grade Evidence
11:30 am Understand Why Evidence That Follows Guidance Still Fails to Deliver Predictable Regulatory & HTA Outcomes
- Understand why aligning regulatory requirements for safety and efficacy with HTA expectations for value and cost remains inherently challenging, even with integrated evidence planning
- Identify how subjectivity, interpretation, and uncertainty in HTA committee decision-making drive divergence between published RWE guidance and real-world acceptance
- Design evidence strategies that realistically manage where alignment is possible, where divergence is unavoidable, and how predictability can be improved across markets and decision bodies
12:00 pm From Experimentation to Real Impact: Making RWD and AI Work in Practice
- Identifying where real world evidence generation can benefit most from AI, and why it usually falls short despite technical sophistication
- Translating complex real-world datasets into usable, decision‑relevant insights rather than fragmented or non‑actionable outputs
- Scaling AI beyond promising pilots by embedding it into real workflows, systems, and decision-making processes across evidence generation
12:30 pm Lunch Break
Data Quality, Governance & Evidence Credibility
1:30 pm Choosing the Right Data: Navigating a Crowded RWD Marketplace Without Sacrificing Credibility
- Compare datasets beyond surface‑level metrics and patient counts
- Balance data quality, coverage, and cost across therapeutic areas
- Build internal confidence in investment and ROI decisions
2:00 pm Session Reserved for Integral Privacy Technologies
2:30 pm Building Scalable RWD Assets Through Tokenization
- Move beyond study-by-study data buying toward reusable, enterprise RWD assets
- Leverage tokenization to integrate labs, outcomes and behavioral data to support Real World Evidence use cases
- Improve consistency and confidence across development teams
Regulatory‑Grade RWE – Data Quality, Scale & Credibility Under Scrutiny
1:30 pm Current Status of RWD/E Use in Regulatory Decision Making: Lessons Learned, Ongoing Challenges, and Future Directions
- Review FDA use cases where RWE has supported regulatory submissions and decisions
- Explore therapeutic-area differences in feasibility, fit-for-purpose data, and evidentiary expectations
- Discuss key challenges, lower hanging opportunities, and future directions for RWD/E in regulatory decision-making
2:00 pm Session reserved for Truveta
2:30 pm Comparing FDA Guidance With Reality & Why Real‑World Evidence Still Cannot Stand Alone
- Understanding why best practice RWE guidance does not guarantee acceptance in practice
- Identifying sources of subjectivity and uncertainty in HTA committee decision making
- Designing RWE strategies that improve predictability across markets and bodies
3:00 pm Poster Competition & Afternoon Break
Witness some of the latest and greatest research in the RWE field in this spotlight poster session!
Visit the website for T&Cs. Results announced in the afternoon of Conference Day 2.
4:00 pm Session Reserved for HealthVerity
4:30 pm Panel Discussion: Breaking Down Organizational Silos Between Strategy, Science & Execution for RWE With AI
- Why do AI‑driven RWE initiatives so often succeed technically but fail organizationally, and where do most companies get stuck?
- How can RWE/HEOR leaders better align data scientists, analysts, and medical experts around shared goals, methodologies, and accountability?
- What practical approaches are teams using to validate AI outputs without slowing delivery or undermining confidence in the evidence?
- How should organizations address cultural resistance and skills anxiety when AI drastically changes timelines, roles, and workflows?
- Who ultimately owns AI‑generated evidence and what governance models support innovation while protecting scientific and regulatory credibility?