Explore the Agenda
9:00 am Registration & Coffee
9:30 am Choosing the Right Indication When Aging isn’t a Disease: Navigating Regulatory Complexities, Optimizing Trial Design, & Identifying Appropriate Indications to Accelerate the Development of Aging Therapies
The aging therapeutics field faces a fundamental challenge: aging itself is not classified as a disease, complicating drug development pathways and regulatory approval. Identifying appropriate indications linked to aging that offer clear, measurable endpoints and feasible regulatory routes is crucial to advancing effective therapies. In this 3-hour workshop, we will explore strategic methods on selecting target populations and indications that optimize trial success:
- Identifying age-associated diseases with fast regulatory paths and measurable clinical endpoints by focusing on functional outcomes that enable accelerated approval
- Selecting target populations that show early biomarker shifts, even with modest symptom improvement to demonstrate efficacy within shorter trial durations
- Avoiding the pitfalls of overgeneralizing ‘aging’ in regulatory strategy by tailoring indications and endpoints to specific disease contexts
12:30 pm Lunch Break
1:30 pm Bridging Stakeholders in Aging Therapeutics: Overcoming Translational Challenges, Aligning Investors & Regulators, & Driving Cross-Sector Innovation to Accelerate Therapy Development
The development of aging therapeutics requires unprecedented collaboration across investors, regulators, pharma, and biotech leaders. Long timelines, complex endpoints, and regulatory uncertainty create significant hurdles to advancing safe, effective, and commercially viable drugs. Aligning early on regulatory frameworks, validating biomarkers, mitigating risks, and fostering partnerships will be critical to accelerating
progress in this space.
In this 3-hour workshop, we will explore strategies to overcome translational bottlenecks and build stronger cross-sector alignment:
- Navigating uncertain returns during long timelines to meet demands for clearer early efficacy markers in aging drug portfolios
- Balancing rigorous safety standards with flexible frameworks to accommodate novel aging biomarkers and functional endpoints
- Overcoming challenges in patient recruitment and endpoint validation through digital health and real-world data integration
- Addressing funding constraints and translational bottlenecks to strategically align with investors and regulatory bodies early on