The UK is home to the second-biggest cell and gene therapy (CGT) cluster in the world after the USA, with over 60 specialist companies operating in this sector. More than 15 of these are based in the CGT cluster at the Stevenage Bioscience Catalyst which also plays host to the rapidly expanding Cell & Gene Therapy Catapult manufacturing centre. £5.2m has also been invested into projects at the CGT Catapult in the last year, with £400m raised by companies in the Stevenage CGT cluster.
The industry is continuing to grow at a pace: production capacity in the manufacturing sector has grown by 60%, with employment in this area also increasing by 30% in 2018. By 2035, it is predicted that the CGT industry could be worth £10bn and provide 18,000 jobs. So how can this growth be sustained?
Speaking at our inaugural Bio Integrates conference in May, Matthew Durdy, Chief Business Officer at the CGT Catapult highlighted the importance of collaboration between biotechs, investors, policy makers, public and private bodies and patients, saying it must be “in their DNA”. The UK BioIndustry Association and Alliance for Regenerative Medicine co-authored report agrees. The report details the UK’s Advanced Therapy Medicinal Product Landscape and calls for the following to maintain the UK’s leading position in this sector:
- Key stakeholders to support scientific research;
- Development of a skilled workforce;
- A positive regulatory environment, including fostering accelerated pathways to patients;
- UK-wide collaboration between NICE and its devolved counterparts to ensure health technology assessments are able to address the long-term value provided by cell and gene therapies; and
- Industry, NHS and other public/private bodies to collaborate to develop innovative financing models.
The increase in the number of clinical trials is another key step in accelerating cell and gene therapies to market: clinical trials and preclinical studies have grown by 37% and 20% year-on-year, respectively, mainly in oncology. And whilst there are currently hundreds of patients receiving this type of treatment, the goal is to treat 10,000 patients per year by 2028 as an integrated part of the healthcare system.
Recently, cell and gene therapy breakthroughs are showing promise for patients with rare and hard to treat diseases: a study involving a form of gene editing that hunts the HIV virus down and removes it from the DNA in cells could move to human trials within a year; a bowel and blood cancer study showed blocking a specific protein that fuels tumours kills them off; earlier this year, a British woman became the first person in the world to have gene therapy to try to halt her age-related macular degeneration and in July, the FDA gave priority review to an approval application from Novartis for a drug to treat sickle cell disease.
With the establishment of three advanced therapy centres in the UK this year and 85 clinical trials like the ones above ongoing, the next 5-10 years looks to see an improvement in the number and accuracy of therapeutic treatments currently available as the pace of innovation continues. What will be the rate-limiting step? Our panel of experts at Bio Integrates were unanimous in their response: “supply chains”.
At our Pharma Integrates conference in November we will be addressing the supply chain need for advanced medicines. We will also be discussing how we can develop the skill sets, recruit and retain the key talent to enable this area to achieve its full potential and ensure advanced therapies reach patients rapidly. See you there!
Want to hear more? Audio from all the roundtable discussions, breakout sessions and keynote presentations at Bio Integrates is available here.