UK life sciences meeting agrees adaptive licensing is a golden opportunity

Adaptive licensing is a “golden opportunity” to demonstrate the strength of life sciences in the UK, according to speakers at an event hosted by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) yesterday.

The workshop focused on adaptive licensing, giving medicines developers across the life sciences sector the opportunity to further enhance their understanding of how they can engage with this important initiative. Earl Howe, Parliamentary Under Secretary of State for Quality, said that if used successfully it will demonstrate that regulation is “not a noose which stifles but rather a safety mechanism which can release medicines to patients in need.”

To date, 14 companies have submitted applications for the adaptive licensing pilot, and the European Medicines Agency will communicate shortly which of these will be taken forward. The opportunity to submit live assets for consideration remains open until further notice. Key topics of discussion included the fact that this pilot involves a “coalition of the willing” including regulators, payers, industry and patients in a discussion in a safe harbour environment. There was great emphasis on the need for trust and open and honest dialogue between all involved. It was recognised that this approach now allows an adaptive mindset, using multiple data sources to help patients. This recognises a shift from a blockbuster development strategy to one that considers smaller patient populations from the outset.

Welcomes pilot scheme

Bina Rawal, ABPI’s Research, Medical and Innovation Director, said: “The ABPI has long called for a more agile and flexible licensing approach and we welcome the EMA pilot, which will explore the adaptive licensing approach with real medicines in development. Once we have addressed some of the outstanding challenges, the ABPI expects adaptive licensing to help support the development of medicines where there is high unmet need, such as novel antibiotics and medicines for dementias and rare diseases. Scientific progress and innovation are a continuum, requiring a progressive approach from medicines developers, regulators, NHS, NICE and patients in the best interests of all of us.”

Steve Bates, BIA chief executive, added:  “We are delighted that a number of our member companies are already considering participating in the adaptive licensing pilot, and hope that by explaining the detail today more companies will fully understand the opportunities offered by this pathway. We hope as a result of this meeting, we will see more engagement from all stakeholders to speed the delivery of new innovative therapies to patients.”