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 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
9:30 am Building a Global RWD Strategy: From Fragmented Data to Decision-Grade Evidence
In this fireside chat, industry leaders will examine these questions from different
perspectives:
- What does a biopharma team need to consider when selecting data to support a global evidence strategy?
- How can federated access and harmonization enable research across markets and datasets with different structures and standards?
- How should researchers assess whether those data are fit for a particular strategic, regulatory or market-access decision?
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 Needle in the Haystack: Accelerating Rare Disease Diagnosis with Genetic Real World Data and Machine Learning Models
- Discover how linking genetic data with other real-world data can strengthen patient identification and trial feasibility tactics.
- Explore a case study showing how machine learning models can influence clinical and commercial strategies.
- Examine incremental benefit of more robust real world data during model training, and the impacts on business decisions.
12:30 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 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
12:00 pm Verified Intelligence: The foundation for decision grade evidence
- Transform healthcare data into trusted intelligence through documented provenance, rigorous quality controls, and continuous validation
- Harness AI to curate, validate, and monitor real-world data while preserving scientific rigor and transparency
- Convert verified intelligence into regulatory-grade evidence that supports regulatory and clinical decisions with confidence
12:30 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
1:00 pm Lunch Break
Data Quality, Governance & Evidence Credibility
2:00 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
2:30 pm EHR-Embedded Technology to Accelerate Prospective Evidence Generation
- Embedding AI-powered research workflows directly within the EHR to identify eligible patients and streamline study execution.
- Scaling prospective evidence generation through an integrated platform that connects technology, providers, and research operations.
- Reducing operational burden while expanding access to research opportunities across community practices, academic centers and health systems
- Case study: Accelerating enrollment and prospective evidence generation in a multicenter cancer clinical trial
3:00 pm Session Reserved for Partner
- 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
2:00 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
2:30 pm If It Doesn’t Matter to the Patient, What Are We Measuring?
- Confront an uncomfortable question: does what we measure in trials and RWE studies actually matter to the people living with the disease, and what does it cost us when it doesn't? Studies can be well conducted and still tell payers, prescribers, patients, and your own commercial team almost nothing about whether life got better
- Understand where the gap between measured and experienced burden actually opens up, and how to spot it in your own program. When patients and caregivers are enabled to track what is important to them, they consistently select domains that established endpoints and RWE sources may not cover
- Learn a prospective real-world data collection method for discovering what matters to patients, and see what it changes for launch, access, and differentiation. Real programs have used it to establish a condition's unmet need and to build the burden baseline a new therapy gets measured against
3:00 pm Session reserved for Partner
- 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
3:10 pm Afternoon Break & Poster Session
Witness some of the latest and greatest research in the RWE field in this spotlight poster session! Visit the website for T&Cs.
3:40 pm Building RWD foundations That Deliver on the True Promise of A
- Sourcing more expansive RWD that reveals hidden patients and HCPs
- Generating previously undetected signal that produces new insights
- Avoiding fragmented/synthetic patient cohorts that hallucinate results
- Attaining outcomes that redefine the new normal for RWE
4:10 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
4:40 pm Real-World Evidence & Artificial Intelligence: Entering a New Era of Evidence Generation
With the rapid advancement of large language models, AI is transforming every stage of the Real World Evidence life cycle, from planning and study design to generation and dissemination. This presentation explores emerging trends in the adoption of AI agents across RWE workflows and the measurable impact they are beginning to deliver. It highlights high value use cases, capability gaps, and operating model shifts required as organizations transition to AI enabled evidence generation.
5:10 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?
5:30 pm Chair’s Closing Remarks
5:35 pm Drinks Reception
Enjoy drinks with industry peers thanks to our partner Integral Technologies!