Bart Borek
Associate Director - Clinical & Quantitative Pharmacology Vertex Pharmaceuticals
Bart is an Associate Director at Vertex Pharmaceuticals, where they lead quantitative pharmacology initiatives supporting rare disease research and development, from target selection through Phase IV Studies. With extensive expertise in integrative biology, pharmacometrics, and regulatory science they have contributed to the approval of transformative therapies including TRIKAFTA and CASGEVY, applying data-driven approaches to guide study design and development decisions.
Seminars
- Combining clinical, mechanistic, biomarker, and historical datasets to support modelinformed decision-making in rare disease programmes
- Designing development strategies when untreated baseline data is unavailable
- Building modelling frameworks that connect study design, analysis, and reporting to improve confidence in dose selection decisions
A moderated panel drawing on speakers from across both conference days to share honest retrospective experience of MIDD implementation.
- Where has MIDD genuinely changed a development decision, and where has it been used to validate a decision that had already been made?
- What has been the hardest internal sell for MIDD, and what argument finally worked?
- Where have you seen the field overclaim what modelling can do, and what are the consequences of that for regulatory trust?