While the life sciences sector within the United Kingdom (UK) represents what is actually one of the most thriving, concentrated industry clusters worldwide, a growing problem exists pairing investment to drug development pipeline to maximize potential. Namely due to risks of drug development (e.g. time, probability of failure, expense) there isn’t enough targeted investment in early clinical stage biotech companies, and despite potential promise to improve quality of life and save lives, most new therapy advances never make it past Phase 1.
Recently published in a UK-based pharma news site called PharmiWeb.com, Andrew Boyle, founder of a successful London-based investment house called LGB& Co. first introduces the tremendous British influence on the world’s drug development sector. After all, with Oxford, Cambridge and UCL, England has three of the top ten universities in the medical research field. Add in biotech clusters in other English cities and Mr. Boyle summarizes the influence of the UK in PharmiWeb.com: “12% of all life sciences academic citations worldwide” with almost 20% of the top 1% of these citations.
The UK does well with life science startups as well, reports Mr. Boyle. Commenting that about 40% of UK biotech firms are actually the result of academic spin-outs, the UK’s research centers are globally known for their contribution to the new drugs, diagnostics and devices.
Problems in the Pipeline
But problems commence when there is the need for bigger checks. What Mr. Boyle via PharmiWeb calls “the 8% problem,” he offers the oncology example in the UK: of the oncology-based investigational products in the drug development pipeline, only 8% actually make it out of Phase 1 successfully to Phase 2 or Phase 3. He reports that other therapeutic areas report similar performance.
How to Address
Boyle suggests this problem centers on study design. After all, failure today is costly (and frequent), often paring down the available investor pool for Phase 1 to Phase 2 in the UK for example. Clinical trials must be designed “so that failures happen quickly and cheaply,” suggests Mr. Boyle. Such design offers a risk mitigation measure given “investors will be able to limit their losses and spread their investments rather than be tied to companies limping through trials for 10-15 years.”
Boyle suggests Cliff Holloway, CEO of Scancell Holdings, plc, favors the concept as the ‘Adaptive Trial Design” as a way to offer more flexibility in the process, thereby mitigating risk for investors. These trials “use accumulating data to modify the ongoing trial without undermining its integrity and validity.” With more “flexibility and efficiency,” they have the potential to bolster “study power” while “reducing sample sizes” therefore also total cost.
Mr. Boyle suggests that more precision-based, targeted patient recruitment, virtual trials and greater collaboration will contribute to the lowering of cost, bolstering flexibility while overall reducing the costs of studies: fertile terrain for greater investment assuming the right science, focus and technology involved.