A target product profile (TPP) captures aspirational product attributes at launch to steer the evidence generation plan, address regulatory and reimbursement requirements, aid development of strategies that reduce downstream risks and ultimately increase the probability of successful therapy adoption. It is a directional tool that must be developed from an early stage of an advanced therapy medicinal product’s (ATMPs) development.
A quality target product profile (QTPP) is a prospective summary of the quality characteristics of a drug product to ensure the desired quality, taking into account safety and efficacy. Both the TPP and QTPP are dynamic, living documents that are updated as evidence is generated during development.
The Cell and Gene Therapy Catapult have created a resource to help therapy developers create a robust TPP and QTPP. It acts as an ATMP developers guide to creating an evidence generation plan for successful therapy adoption.
The guide outlines each of the attributes included in these documents in detail, to help therapy developers navigate through the process, supporting the development of support the development of safe, effective and commercially viable products.
Click here 'Developing a Robust Target Product Profile (TPP) for Successful Therapy Adoption' to watch our webinar where the CGT Catapult’s experts in market access, regulatory affairs and non-clinical strategy discuss the resource, the value of a TPP and how to approach building one.
