Bob Seevers
Regulatory Consultant Ex-FDA Independant
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
