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:
Biomedical gerontology, as a field, was the expert response to the realisation that combating aging one disease at a time was impractical, being ultimately a game of whack-a-mole. However, the search for a unitary “theory of aging” leading to a single “Holy Grail” anti-aging therapy has proven equally quixotic. This century, the field has increasingly converged on a middle ground, in which dividing aging into a manageable number of sub-problems has facilitated the identification of corresponding solutions. As more and more of those solutions progress from concept to proof of concept and thence to the clinic, the time is right to analyse our approach and to do our best to foresee future obstacles.
The Controversy and Possibilities of Young Blood:
Mammalian tissue aging is reversible by changing the composition of the old systemic milieu, but parabiosis is not clinically applicable. The benefits of young blood or plasma infused into old people is not without controversy, and is fraught with side effects. What would be the rational way toward extended health span? There are many changes that manifest with Aging. However, we uncovered that multiple age-imposed changes arise from alterations in key signalling networks regulating tissue maintenance and repair. And it is likely that blood heterochronicity acts through re-calibration of these pathways (perhaps, not entirely, but at least, to a significant degree). Developing paradigm of simultaneously calibrating to health/youth two key signalling pathways that change with age in opposite directions (up vs. down) we demonstrate a reversal of multi-tissue attrition: enhanced tissue maintenance, decrease in fibrosis and inflammation, and improved cognitive performance in old mammals. This novel defined pharmacology has clinical capabilities to treat, prevent and possibly reverse degenerative and metabolic age-associated diseases, as a class.
Workshop A Leaders:
SENS Research Foundation
Professor of Bioengineering
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:
Chief Commercial & Strategy Officer
Vice President Program Development
Co-Founder & CEO
Co-Founder and CEO