A review article, published in Frontiers in Medicine and written by Dr Magda Papadaki, head of manufacturing innovation at the Association of the British Pharmaceutical Industry (ABPI), states that collaboration between the pharma industry, patients and health regulators will be a ‘game changer’ in delivering cell and gene therapies to patients.
Game changer
“By looking at the growing number of public–private partnerships and open innovation projects, as well as emerging accelerated development schemes, this review attempts to define the new business and organisational standards needed to ensure patients get new innovative treatments faster,” said Papadaki. “As decision-making from lab bench to the clinic becomes more coordinated, it is imperative that ATMP developers redefine how they operate in this uncharted territory and build new ‘fit-for-purpose’ business models that capitalise on the evolving partnerships between the industry and the NHS — including with shared clinical and data infrastructures — for the benefit of patients.”
The ABPI reported in a press announcement that despite new cell and gene therapies emerging for the long-term management or cure of certain rare diseases and immune-oncology, delays in patient access to these treatments are still encountered. Papadaki highlights the need for a shift towards continual, long-term monitoring of the benefits and risks of medicines to ensure therapies live up to their potential, otherwise patients may miss out of face delays in accessing novel therapeutics in this field.
She added: “The paradigm shift in the way therapeutic products are developed and assessed will rest on an unparalleled level of early and continuous collaboration between unfamiliar bedfellows; from industry and regulators, to payers and patients.”
This review, ‘Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advance Therapies to Patients’, aims to initiate a future roadmap in the advancement of therapeutic development, approval and adoption within the innovative field of cell and gene therapies.