VISFO teams up with Oncology Access Solutions to offer insights on CAR T-cell therapies

VISFO’s VP and Senior Director of Strategic Intelligence, Dr Louise Street-Docherty and Dr Fran Pearson have partnered with Dr Clare Hague (Managing Director of Oncology Access Solutions) to offer insights to those in the global R&D community who are working to establish a competitive position in the CAR T-cell therapy market.
Since their arrival on the therapeutic landscape, chimeric antigen T-cell (CAR-T) therapies have given hope to thousands of blood cancer patients and are now also showing incredible promise in another key area of interest for VISFO, autoimmunity. In recent trials in systemic lupus erythematosus (SLE) some patients have demonstrated signs of remission that have persisted for several years. As CAR-T development continues to expand, with global predicted revenues of US$29 billion by 2029, the need for strategic planning becomes ever more important. The complexity of manufacture and high cost-of-goods in an increasingly competitive landscape mean that adoption of strategic planning tools is imperative to mitigate the high risk of a new therapy not making it to market.
Thought leadership
In the recent publication, which features in the journal Cell and Gene Therapy Insights, we put forward critical considerations for strategic planning of new CAR-T cell therapies for oncology. We recommend a modified and dynamic approach to writing a Target Product Profile (TPP) tailored to the unique complexities of CAR-T therapy development. Considering the new EU Joint Clinical Assessment process launched last week (a topic on which Clare has previously published), having a well-constructed TPP as your ‘north star’ is now more critical than ever.
In the article we emphasize that:
· A TPP should be assembled early in clinical development to guide discussions with regulators, HTA agencies, payers, and patients
· Activity should be led by a multidisciplinary and cross-functional TPP team working seamlessly with stakeholders
· Early engagement with patient groups is critical for insight gathering and external validation processes
· Commercial aspects such as pricing and reimbursement should form a key part of assessing market attractiveness
· Optimal (rather than minimal) benchmarks should be set as standard to most effectively guide go/no-go decisions.
A TPP design service with a difference
VISFO’s TPP design service aims to guide life sciences and pharmaceutical industry clients through the process of developing a robust and well-informed TPP early in the product development cycle. Critically, we help you design a TPP that can adapt to the evolving competitor and existing therapeutic environments throughout the development process, for the highest likelihood of market launch and positioning.
Key points of value:
· Provides a structure to assist with identifying opportunities for differentiation
· Delivers an opportunity for proactive development programs designed to meet market needs from the outset
· Reduces the likelihood of late-stage trial failures due to misalignment with clinical endpoints or safety profiles
· Identifies and sets expectations for productive conversations with regulators and payers
Contact us to find out more about how VISFO can help you to design a TPP that will align your clinical development programs with strategic objectives, regulatory expectations and market needs, ultimately enhancing the likelihood of your therapy’s success.
