Charles Glaus
Senior Director, Oncology Precision Medicine, Early Clinical Development Bayer
Seminars
Thursday 25th February 2027
Fireside Chat: How Much Preclinical Evidence Is Enough?: Defining a Fit-for-Purpose Preclinical Package to Progress RLTs Towards IND
10:00 am
- Benchmark contrasting approaches to preclinical development to determine the level of evidence required to progress confidently towards the clinic
- Determine which studies generate decision-critical evidence versus where additional data adds time, cost, & complexity without strengthening the development case
- Balance toxicology, biodistribution, dosimetry, pharmacology, & model selection to build a robust package proportionate to the candidate and development stage
- Leverage early FDA engagement to clarify expectations, ask the right scientific questions, & establish a more predictable path towards IND
Thursday 25th February 2027
Integrating Dosimetry, PK & Biodistribution to Improve Human Dose Prediction & Inform Clinical Progression
3:00 pm
- Combining imaging-derived kinetics, PK & biodistribution data to build more robust human dose predictions
- Accounting for species differences in distribution, clearance, & organ kinetics to improve extrapolation from animals to humans
- Quantifying uncertainty in predicted tumor & organ doses to determine when estimates are reliable enough to support clinical progression
