The ATTC network in collaboration with EuroGCT launch new resources demonstrating the strategic advantage of PPE for ATMP developers. 

PPIE should be recognised not only for its ethical value, but as an upstream strategic investment in better decision-making under uncertainty. Introduced early and used meaningfully, it can improve protocol quality, strengthen recruitment and retention, support more realistic participant-centred trial designs, and reduce avoidable protocol modifications, delays, and operational inefficiencies. 

The financial value of PPIE is difficult to quantify precisely, but published estimates suggest that it may be substantial. A CTII model suggested that an investment of US$100,000 (£74,000; €86,400) in patient engagement could generate a return exceeding 500-fold, equivalent to accelerating a pre-phase 2 product launch by 2.5 years, or pre-phase 3 launch by 1.5 years. While these estimates are based on assumptions and should be interpreted with caution, they underline a broader point: earlier, better-informed decisions on trial design can create major downstream value. 

That logic is particularly compelling in a development environment where delays may cost around US$40,000 (£30,000; €35,000) per day in direct trial costs and US$500,000 (£370,000; €432,000) per day in lost commercial sales. Against this, the cost of meaningful PPIE is usually negligible within the overall trial budget. Even modest improvements in feasibility, enrolment, retention, or protocol design can therefore produce significant returns. 

The ATTC network and EuroGCT have collaborated to develop a new suite of resources showcasing how meaningful PPIE can strengthen ATMP development. The resources include a review article and two real-world case studies that move the conversation beyond ethics and compliance, highlighting how early patient involvement can improve study design, reduce inefficiencies, support regulatory preparedness and create value throughout the development pathway.  

A central theme of this work is that early patient involvement is not only good practice, but a strategic advantage for ATMP developers. The review article, PPIE Beyond Ethics: A Business Case for ATMP Developers, explores the growing evidence that PPIE can help de-risk development programmes, improve decision-making and support progress towards patient access. Complementing this are two case studies featuring Accession Therapeutics and Rinri Therapeutics, demonstrating how patient insights have informed development activities and delivered tangible benefits in practice.  

Commissioned by the ATTC network and developed in collaboration with EuroGCT, these resources reflect a highly collaborative effort involving industry partners from across the cell and gene therapy sector. Together they show how meaningful PPIE can support timely, patient-centred ATMP development by helping to minimise avoidable delays within the clinical development pathway. 

View the resources here.