In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.
Timestamps
- 00:00 Introduction and Welcome
- 00:26 Meet Marta: CEO of Radius Research
- 00:58 Understanding Target Product Profiles (TPPs)
- 01:44 The Importance of TPPs in Drug Development
- 01:59 Defining a TPP
- 03:22 TPP as a Strategic Document
- 05:28 TPP in Preclinical and Clinical Stages
- 07:09 Challenges and Misconceptions in TPP Development
- 14:27 Regulatory Considerations for TPPs
- 14:53 Sections of a TPP
- 39:07 Understanding Toxicology Evaluations
- 39:34 FDA Requirements for Pre-IND Talks
- 39:51 TPP and Toxicity Thresholds
- 41:41 Go/No-Go Criteria in TPP
- 42:50 PKPD and Drug Distribution
- 45:40 Drug Formulation and Quality Attributes
- 46:36 Regulatory Strategy and 505(b)(2) Pathway
- 52:34 Differentiation and Risk Assessment
- 01:03:42 Transition from Discovery to Development
- 01:07:48 Combination Products and Delivery Systems
- 01:09:35 Conclusion and Contact Information
Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at mnew@radyusresearch.com
