Jeffrey Bornstein
Seminars
Tuesday 18th November 2025
Using Biomarkers to Support a Precision Medicine Approach to Antifibrotic Drug Development
2:30 pm
- Demonstrating target engagement early in your program
- Exploring the impact of engaging your target in downstream biomarkers
- Applying the observed effect of downstream biomarkers to select the patient population for late-stage clinical development
Wednesday 19th November 2025
Panel Discussion: How Early Clinical Learnings Can Inform Smarter Preclinical Strategy for Antifibrotic Drug Development
10:00 am
As more antifibrotics enter early-phase clinical trials, translating bedside learnings back into the lab has never been more important. This panel gathers experts in early clinical development to examine how clinical signals, can be mined to refine target selection, guide biomarker validation, and improve preclinical model design.
- How Phase 2 outcomes including responder subtypes are informing updates to preclinical models for improved translational relevance to refine preclinical models with clinical feedback
- Uncover strategies across disease areas to incorporate biomarkers, imaging, and functional readouts into preclinical studies that mirror clinical endpoints and support future regulatory alignment to embed clinically meaningful endpoints earlier
- Exploring how best to apply Phase 2 learnings to strengthen preclinical data packages, optimizing dosing, toxicology thresholds, and study design to de-risk early development for smarter IND enabling packages
- Using insights from heterogenous patient responses to refine hypotheses, select more predictive models, and prioritize mechanisms likely to succeed in defined populations
