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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-05-10
- Length: 50m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/084---Drug-Discovery--Candidate-Selection--Pre-Clinical-Development--IND-Submissions--Administration-Route-Selection--TPP-and-Toxicology-with-Marta-New-e23jmfo

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=0) Introduction: The Challenge of Animal Models and Standard of Care
- [1:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=97) Pre-Clinical Planning: TPP and PDP Documents
- [5:14](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=314) Academic Spinouts and Team Composition
- [8:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=505) The Biotech Funnel: From Academia to Pharma
- [13:32](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=812) Administration Route Selection and Formulation
- [18:45](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=1125) Candidate Selection and Animal Models
- [28:40](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=1720) The Pre-IND Meeting with the FDA
- [44:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions#t=2640) IND Submissions and Clinical Trial Initiation

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Radyus Research (company)
- FDA (other)
- PDX models (other)
- CRO (other)

## Related episodes from other shows

- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [Preparing Your Pre-Submission with the Content FDA Wants to See](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see) (Global Medical Device Podcast)
- [#338: Site Selection for Clinical Trials](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-06-338-site-selection-for-clinical-trials) (Global Medical Device Podcast)
- [How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus) (Global Medical Device Podcast)
- [5 Actionable Lessons Learned from the RADx Initiative by NIH](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-27-5-actionable-lessons-learned-from-the-radx-initiative-by-nih) (Global Medical Device Podcast)

## Citing this page

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