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.
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
