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About This Webinar
Discover how to align your trial strategy with FDA’s Project Optimus, from understanding the initiative to implementing smart trial designs and effective data analysis. Get the insights you need to stay ahead in oncology drug development.
Agenda
- What is Project Optimus? An overview of the FDA’s initiative to modernize dose selection in oncology trials.
- Why Project Optimus for Dose Optimization? Understand the shift toward evidence-based, patient-focused dosing strategies.
- Trial Design Strategies for Implementation - Learn how to design trials that meet Project Optimus expectations, including dose-finding and adaptive approaches.
- How to Carry Out Data Analysis - Key insights on analyzing and presenting data to support dose selection for regulatory review.
When:
Wednesday, May 7, 2025 · 4:00 p.m. · Jerusalem
Duration: 1 hour
Language:
English
Who can attend? Everyone
Dial-in available?
(listen only): No
Featured Presenters
MD PhD, Executive Director, Cogitars UK
Miguel is a former physician turned statistician. He holds an MSc in Biostatistics and PhD in Bayesian Statistics applied to epidemiology from Imperial College London. Miguel joined Cogitars in 2021 and, in 2023, opened Cogitars UK, the United Kingdom branch of Cogitars.
In his 10+ years of experience in pharma, biotech and medical devices, Miguel has worked as a consultant with UCB, Astrazeneca and the WHO, among others. He has designed and led several Bayesian trials, including the development of novel Bayesian methodology.
In his 10+ years of experience in pharma, biotech and medical devices, Miguel has worked as a consultant with UCB, Astrazeneca and the WHO, among others. He has designed and led several Bayesian trials, including the development of novel Bayesian methodology.
VP of Biostatistics, Bioforum The Data Masters
Paul is a research professional with more than 20 years of experience in planning and executing clinical trials, study designs, statistical analysis and reporting, functional oversight and Good Clinical Practice. He joined Bioforum 4 years ago from IQVIA, where he served as Country Manager for the Biostatistics and Statistical Programmer groups in South Africa. In addition, Paul has experience as customer and operational oversight for a major FSP partnership spanning more than 200 FTEsAs the Vice President of Biostatistics, Paul drives the growth and expansion of Bioforum’s biostatistics capabilities and expertise, responsible for the FSP division and Bioforum Academy in the areas of biometrics and biostatistics. Paul holds an M.Com. in Statistics and is a member of the South African Statistical Association.
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