Fireside Chat: How Much Preclinical Evidence Is Enough?: Defining a Fit-for-Purpose Preclinical Package to Progress RLTs Towards IND

• 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

Speakers:

Anneli Savinainen

Vice President & Head of Preclinical Development

Mariana Oncology

Charles Glaus

Senior Director, Oncology Precision Medicine, Early Clinical Development

Bayer

Bob Seevers

Regulatory Consultant Ex-FDA

Independant