Conference Day One
Tuesday, October 28
7:00 Check-In & Coffee
7:50 Chair’s Opening Remarks
Strategies to Seamlessly Integrate Artificial Intelligence Across Real-World Evidence Studies to Improve Efficiency & Accuracy
8:00 Real-World Evidence in the US & Europe: Trial Optimization, Digital Health & Artificial Intelligence
Synopsis
- Describe methods for target clinical trial emulation and optimization using RWE
- Share best practices on digital applications where RWD and RWE can be captured
- Envision the applications of AI/ML/GenAI to advance biopharmaceutical and healthcare
8:30 Optimizing the Potential of Artificial Intelligence in Improving Real-World Data & Real-World Evidence for Enhanced Evidence-Based Decision Making
Synopsis
- Leverage AI algorithms in predictive analytics to demonstrate how clinical trial findings translate to real-world clinical settings
- Identify how AI can improve data quality: data generation, data pipeline automation, and data augmentation
- Discuss the role of AI in insight generation: patient stratification, data summarization and stories, and trial emulation
- Highlight applications of generative AI in potential and promising areas
9:00 Leveraging Artificial Intelligence & Machine Learning for Patient Identification in Rare Disease Research
Synopsis
- Utilize AI-driven algorithms to analyze diverse data sources, improving the identification of rare disease patients and reducing diagnostic delays
- Apply machine learning models to uncover hidden patterns in RWD, enhancing early detection and recruitment for clinical trials
- Ensure regulatory and ethical compliance in AI-based patient identification by addressing biases, data privacy concerns, and transparency in model validation
9:30 Strategies to Utilize Artificial Intelligence to Analyze Existing Datasets to Navigate Data Quality Challenges for Real-World Evidence Studies
Synopsis
- Use AI-driven data harmonization techniques to identify and correct inconsistencies, improving RWD reliability at scale
- Leverage generative AI to approach data standardization tasks from EHR and other sources for comprehensive analysis
- Apply ML/DL models to fill data gaps, enhance completeness, and generate high-quality datasets for RWE studies
10:00 Morning Break & Speed Networking
Synopsis
Join our speed networking session tailored for RWE stakeholders, like yourselves, to connect with industry peers and facilitate meaningful exchanges of insight and expertise.
Real-World Evidence in Clinical Research Chair: Alexander Cole, Executive Director & Head of Epidemiology
11:00 Overcoming Tokenization Challenges in Real-World Evidence to Improve Real-World Data Quality
Synopsis
- Address data linkage limitations by implementing advanced privacy-preserving techniques to securely connect disparate real-world datasets without compromising patient confidentiality
- Standardize tokenization methods across data sources to ensure consistency, interoperability, and improved data utility for regulatory and payer decision making
- Balance privacy and usability by adopting innovative encryption and de-identification strategies that maintain data integrity while meeting compliance requirements
11:30 Extending Clinical Trial Follow-Up Through Tokenized Real-World Data Integration
Synopsis
- Leverage tokenization to securely link clinical trial participants with longitudinal RWD for extended outcome tracking
- Enhance evidence generation beyond trial endpoints by capturing long-term safety, effectiveness, and healthcare utilization
- Support regulatory and payer discussions with robust post-trial insights anchored in real-world clinical practice.
12:00 Optimizing Early Pipeline Decisions Through Strategic Real-World Data Integration
Synopsis
- Apply RWD to uncover unmet medical needs and shape target product profiles at the earliest stages
- Inform trial feasibility and site selection by analyzing real-world treatment landscapes and patient journeys
- Use early RWE signals to align development milestones with regulatory and market access expectations
Real-World Evidence in Value & Access Chair: G. Rhys Williams, Vice President – Integrative Evidence Gene
11:00 Presentation Reserved for Truveta
11:30 Building Capabilities of Linking Different Data Sets to Support Access & Align Business Needs
Synopsis
- Develop scalable frameworks for integrating diverse RWD sources to unlock comprehensive patient insights
- Align data linkage strategies with evolving market access requirements and evidence generation goals
- Foster cross-functional collaboration to ensure data capabilities support both scientific and commercial objectives
12:00 Democratizing Your Real-World Data for Internal Impact & Insights Generation for Value & Evidence Teams
Synopsis
- Enable cross-functional access to RWD to drive evidence-based decision-making
- Streamline internal workflows by making data more accessible, interpretable, and actionable
- Empower value and evidence teams with timely insights to support market access and strategic planning
12:30 Lunch & Networking Break
1:30 Implementing Tokenization to Link Real-World Data & Enable Longitudinal Patient Insights
Synopsis
- Break down how tokenization is applied to link patient data across EHR, claims, and lab systems in real-world research
- Tackle common implementation hurdles such as data mismatches, interoperability issues, and token persistence
- Explore a real life case where tokenization enabled long-term patient tracking in a post-marketing study while preserving privacy
2:00 Leveraging Real-World Evidence in ECA Planning: Bullet-Proofing Statistical Methods for Co-Founder Control, Sensitivity Analysis & Trial Emulation Frameworks
Synopsis
- Apply advanced statistical techniques, such as propensity score matching and inverse probability weighting, to mitigate confounding and strengthen causal inference in RWE studies
- Conduct rigorous sensitivity analysis to test the robustness of findings, ensuring transparency and credibility in regulatory and payer evaluations
- Utilize trial emulation frameworks to replicate randomized clinical trial conditions, enhancing the reliability and real-world applicability of RWE insights
1:30 Integrating Real-World Evidence into Health Technology Assessments to Address Data Gaps & Drive Market Access Success
Synopsis
- Standardize RWE data collection and reporting methods to reduce inconsistencies and improve the credibility of submissions to HTA bodies
- Use RWE to supplement clinical trial data, providing a more comprehensive view of a treatment’s real-world effectiveness, safety, and cost-effectiveness
- Foster collaboration between clinical, regulatory, and market access teams to ensure RWE aligns with HTA criteria and accelerates market access decisions
2:00 Leveraging Real-World Data to Accelerate Clinical Development from Pre- to Post-Market Access, Across the Entire Life Cycle
Synopsis
- Explore how RWD can accelerate clinical timelines across early development, trial design, and post-market expansion to inform key decisions and optimize outcomes
- Unpack common barriers to RWD integration, including data access, quality, regulatory expectations, and cross-functional alignment
- Learn from real-world case studies showcasing RWD applications in early-phase strategy, external comparators, and evidence packages for regulators and payers
2:30 Afternoon Break & Poster Session
Synopsis
Witness some of the latest research in the RWE and evidence generation field by pharma, biotech, and service providers in this spotlight poster session! For more information or to submit your abstract, please email info@hansonwade.com
Optimizing Cross-Functional Collaboration to Streamline Real-World Evidence Studies
3:30 Presentation Reserved for OM1
4:00 Achieving Cross-Functional Alignment Through Integrated Evidence Planning to Enhance Decision-Making Across Stakeholders
Synopsis
- Develop a centralized evidence strategy that aligns medical, clinical, regulatory, market access, and commercial teams to ensure consistent objectives and efficient data generation
- Use integrated evidence planning to identify key data gaps and ensure that evidence is generated early, reducing silos and improving decision-making across functions
- Foster continuous collaboration and communication between teams to adapt to evolving stakeholder needs, ensuring a unified approach to RWE generation and use
4:30 Panel Reserved for PointClickCare
5:00 Effective Strategies for Communicating the Value of Real-World Evidence to Internal Stakeholders & Driving Cross-Functional Buy-In
Synopsis
- Tailor RWE communication to highlight its impact on regulatory approvals, market access, and patient outcomes, making it relevant to each internal stakeholder
- Use compelling case studies and data-driven insights to demonstrate how RWE supports decision making and enhances overall business objectives
- Establish a cross-functional working group to align on RWE goals, ensuring buy-in from all teams and fostering a culture of collaboration around evidence generation