Tag: target product profile

Consulting

Driving Product Development and Finding the Fast Track in Early-Phase Oncology Programs

Small- to mid-sized biotech and pharma companies face many challenges when planning and executing an early-phase oncology trial, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints. Sponsors of first-in-human trials of novel oncology compounds face significant challenges. Beyond the typical circumstances of limited budget,...

Clinical Research: Phase 1 - Phase 4

Target Product Profiles: Turning Discoveries into Companies

One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments. Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has an...

Consulting

4 Ways a Target Product Profile Enhances the Medical Device Development Process

A target product profile (TPP) is a strategic process tool that streamlines medical device development through cross-functional strategic alignment. It’s a living document that defines the value proposition and key differentiators of an intended commercial product while assisting in product development strategy. A TPP may take a lot of time and resources to craft, but it’s a strategy that promises a major...

Clinical Research: Phase 1 - Phase 4

The 5 Components of an Effective Target Product Profile

A target product profile is a document that presents a polished explanation and aggregation of all relevant information needed in validating product development. This common template can be used for all products across a company portfolio to guide and align regulatory, preclinical, clinical, marketing, and health economic outcomes and reimbursement strategies. The concept of the TPP was originally developed...