the core strategic framework that serves to define and align commercial, clinical, medical, manufacturing, safety, and regulatory requirements. This group of key stakeholders all have an equal voice in the creation of a TPP. When this group functions as a team, it can create a framework that:
Evolves as the product moves through development
- Articulates the unmet needs of patients, physicians and payers
- Differentiates and positions a product—what, why, how, when
The purpose of this checklist is to help you navigate the development of a TPP. A strong TPP can help you better navigate the product development equation of risk multiplied by cost multiplied by time equals R&D success.