Track 5: Patient Impact on Product Development
This track represents the fusion of the patient-focused drug development and value and access tracks, emphasizing the critical intersection of patient-centric approaches and value-driven healthcare. It focuses on the integration of patient-centric methods in medical product development and the evolving landscape of value-based care and healthcare access. The track aims to address meaningful patient engagement (PE) throughout the product lifecycle and tackle the complex issues surrounding value assessment and market access. Attendees will explore how patient outcomes and value-driven healthcare can guide R&D strategies. This track brings together global regulators, industry leaders, academics, patients, and payers to discuss and address critical questions for all stakeholders. Patient-Guided Medical Product Development:
- How do we meaningfully engage patients and incorporate their voices into decision-making throughout the medical product lifecycle?
- How do we operationalize patient-centric approaches in our day-to-day work?
- How do we measure the value of efforts
- What have we learned that can be used to drive more meaningful patient engagement?
- How do stakeholders best work together to leverage their collective power and expertise to promote meaningful involvement of patients?
Value and Access in Healthcare:
- What information and evidence are being used to define value?
- What are the ethical considerations when determining access to medical products?
- Do strategies that increase diversity and inclusion in clinical trial research improve access to medicines? Who is making or influencing access decisions?
- How can real-world data be leveraged to improve access to medicines?
- What are the regulatory and legal considerations?
DIA recommends this track and associated sessions to professionals involved in patient affairs, advocacy, or support services; clinical trial design and optimization; regulatory affairs/agencies; corporate and government affairs; health economists; outcomes researchers; epidemiologists, Health Technology Assessment (HTA) staff; payers; bioethicists, and data scientists.
Included Topic Areas
Patient engagement (PE): Meaningful collaboration, best practices, and tools; Patient-centric development: Patient-guided drug creation and fostering a patient-first culture; Diverse patient partnerships: Engaging diverse populations and building collaborative relationships; Operationalizing PE: Implementing strategies, metrics, and resources; Patient advocacy: Insights and outcomes from effective advocacy; Comparative effectiveness: Research and real-world outcomes; Inclusion and Ethics: Diversity, equity, inclusion, and ethical clinical research; Healthcare evaluation: Health Technology Assessment (HTA) and value-based care; Economic considerations: Drug pricing, reimbursement, access, commercialization, and lifecycle management.
Priority Topics
- Sustainable and Quantifiable Clinical Trial Diversity and Inclusion Approaches
- Value Impact of Patient Engagement in Drug Development
- Effective Collaboration from the Patient Advocate’s Perspective
- Democratizing Patient Experience Data (PED) through AI and Digital Innovations
- Overcoming Barriers to Patient Engagement Across Organizations
- Drug Shortages
- CMS’ National Coverage Determination for Alzheimer’s Disease
- The EU’s General Pharmaceutical Legislation/GPL and Joint EMA HTA Assessment