Workshop A: Deep Dive into the Hallmarks of Aging
28th January - 9.00-12.00
Aging consists of a set of well-characterized cellular and molecular changes or ‘hallmarks of aging’. In this workshop session we delve deeper into these hallmarks to explore their history, present interaction with each other and future, through talks, in-depth Q&A and group discussions.
- A Divide-and-Conquer Approach to Combating Aging: A Concept with a Chequered History
- The Controversy and Possibilities of Young Blood
Workshop A Leaders:
Workshop B: Progressing your Pipeline into the Clinic
28th January 13.00-16.00
Elevian share their framework for Indication selection when targeting
aging, following a careful analysis of scientific data, regulatory pathway and commercial opportunity.
Alkahest will provide a brief glimpse into the realities of a clinical stage company. The presentation will focus on mid-stage drug development: the point once you have identified a druggable therapeutic and have turned your attention to clinical proof of efficacy and safety.
Topics will include:
• Indication selection and tradeoffs
• Aging a targetable disease
• Creation of a development plan
• Engaging your internal and external teams, vendors, and advisors
• Executing against your clinical plans
• The importance of quality and compliance
The session will conclude with a dialogue on the impact of clinical operations on corporate strategy, from fundraising and partnering to early commercial planning and the special complexities of the aging field.
Retrotope Share Observations in Reaching Phase 2/3 Clinical Trials:
• Developing PoC/drug effect size using expanded access (better be a big drug effect!)
• Leveraging the special consideration by FDA for treating orphan and ultra orphan diseases (rare pediatric disease vouchers)
• Challenges in filing for IND with a limited PK/PD, safety data set /overcoming CMC hurdles / role of consultants
• Reaching agreement with FDA in early pre-IND meetings
Workshop B Leaders: