# 165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-12-04
- Length: 1h 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/165---Anatomy-of-a-Target-Product-ProfileTPP-All-10-Sections-EXPLAINED-with-Marta-New-e2rq6pp

## Summary

Marta New, CEO of Radyus Research, explains the anatomy of a Target Product Profile (TPP), a strategic document that aligns clinical, regulatory, and commercial goals early in drug development. She details the 10 critical sections of a TPP, including target indication, efficacy benchmarks, safety/toxicology thresholds, and go/no-go criteria, emphasizing that it serves as a roadmap from discovery to development. New highlights how integrating these elements early prevents costly failures and ensures that manufacturing, quality, and regulatory strategies are aligned with the final product's label.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=0) Introduction: Subhi Sadeh and Marta New
- [2:03](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=123) Defining the Target Product Profile (TPP) as a Roadmap
- [7:09](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=429) Preclinical Misconceptions and the Cost of Delay
- [14:23](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=863) Regulatory Strategy and Global Market Alignment
- [19:25](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=1165) Target Indication, Modality, and Efficacy Benchmarks
- [38:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=2312) Safety, Toxicology, and PKPD Considerations
- [46:37](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=2797) Drug Formulation, 505(b)(2) Pathway, and Differentiation
- [54:48](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=3288) Risk Assessment and Go/No-Go Criteria
- [1:03:42](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta#t=3822) Stakeholder Collaboration and Combination Products

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Radyus Research (company)
- FDA (other)
- EMA (other)
- 505(b)(2) (other)
- IND (other)
- Phase 2 (other)

## Related episodes from other shows

- [How to Construct an Effective Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy) (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)
- [#364: Building a Partnership with your Regulatory Consultant](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant) (Global Medical Device Podcast)
- [IDology #9 - NASAs TRL scale in product development](https://hardwarepodcasts.com/podcast/idology/2023-02-28-idology-9-nasas-trl-scale-in-product-development) (IDology)
- [We're launching Founders & Formulators - Here's Why](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2026-06-18-were-launching-founders-formulators-heres-why) (The Startup CPG Podcast)

## Citing this page

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