Hardware Podcasts

084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New

Let's Combinate · 10 May 2023 · 50m

What this episode covers

Marta New, CEO of Radyus Research, explains the rigorous pre-clinical development process for drug candidates, emphasizing the critical role of Target Product Profiles (TPP) and Product Development Plans (PDP) in de-risking programs before IND submission. She details the iterative selection of animal models, such as PDX models for oncology, and the strategic importance of pre-IND meetings with the FDA to align on toxicology studies and manufacturing plans. New highlights the high failure rate of academic spinouts and early-stage biotechs, noting that only a small fraction of molecules successfully navigate the funnel to clinical trials due to poor planning or lack of competitive advantage against standard of care.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Radyus Research
Also
FDA, PDX models, CRO

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