With 7000 medicines in the global pipeline, the life sciences industry is on the brink of some major innovations. Now, a General Election and Brexit loom. We look to current and future Government to continue to support the life sciences: the industrial and academic researchers who fail, succeed and keep moving forward.
Recent days have revealed a number of surprises in the press. One that might have been missed was the announcement that Circassia’s pursuit of novel allergy treatments were at an end.
The announcement came with the confirmed failure of its latest candidate for an immunotherapy treatment of allergy to dust mites, following the results of its investigational IIb clinical study which showed no statistically significant improvement over placebo.(1)
The conclusion to wind down their allergy R&D surely wasn't a quick decision. It follows a previous failure to meet clinical endpoints for another immunotherapy candidate for cat allergy in June 2016. Journalists are enjoying a number of allergy- related quips in the headlines, but the summaries all the same – it's a failure.
But what do we really mean by "failure" in science? In our work in drug discovery and development (as in all frontier science), we are still charting unknown terrain, both in terms of human biology and the biology of disease. Any new information is surely a gain. Other industrial and academic researchers will be reviewing the results of the Circassia work carefully to learn what we can from the studies.
After all, these candidates and the immunotherapy approach demonstrated a positive impact in earlier phases of the research; sometimes retracing our steps can help us eventually move forward more adroitly. This complex and frustrating pattern of scientific progress has been the norm for our industry; a quick and direct path to breakthrough is our version of a "black swan". We will continue to improve our efficiency in R&D, as demonstrated in the improving probabilities of a candidate medicine reaching approval to be available for patients.(2)
However, achieving breakthroughs and new treatments requires more than investment and effort. If that were all that were needed, we could have expected some new treatments for dementia, for example, by now. ABPI's sister association in the US, PhRMA, noted in 2015 that over 123 candidate medicines for Alzheimer's Disease had failed since 1998 (3), but our investments continue.
This dogged commitment to continue the pursuit for new treatments to address these challenging areas of disease and health limitations shouldn't be confused with "brute force and ignorance". We learn from failure and we apply these learnings. However, sometimes breakthroughs in our work are linked to breakthroughs in other scientific disciplines, for example in artificial intelligence, in advanced instrumentation for analytics and study, in manufacturing and in nanotechnologies (this is a short list).
A coincidence of these breakthroughs is exactly that – a coincidence and not orchestrated; but we can encourage convergence through interdisciplinary research and collaboration.
We have encouraged the UK Government to support greater cross-disciplinarity in research accordingly and we are looking forward to hearing from Sir Mark Walport, the Chief Executive of UKRI, at our ABPI Annual Conference next week. But the pace by which these breakthroughs occur is not predictable nor it is easily shaped; it's what we can refer to as the "speed of science".
When working at the "speed of science", the real challenge is persistence. This is usually what challenges continued efforts to explore a given line of inquiry or development.
The CEO of Circassia, Steve Harris, sets this out very well in his press statement: "We remain convinced that the technology has biologic activity, but we also believe the difficulty in overcoming the placebo effect using the field study designs required by regulators represents a significant hurdle, and consequently we will make no further investment in our allergy portfolio." (1)
We hope to continue to explore the technology that Circassia has pursued, along with many other areas of technology and scientific discovery for medicines. We can even hope to see parallel developments in regulatory science to help us to better establish evidentiary requirements to confirm the benefits and risks of medicines for the benefit of patients.
But we need persistence in our investments as industry, as charities, as healthcare systems and as Government, because the speed of science can be slower and more variable than we plan.
As we approach a General Election in the UK and Brexit, we look to the current and future Government to be persistent in their support of the life sciences, supporting the industrial and academic researchers who fail, succeed and keep moving forward.
Circassia press release, April 17, 2017. http://www.circassia.com/media/press-releases/circassia-announces-top-line-results-from-house-dust-mite-allergy-field-study/
ABPI Open for Innovation: The UK Biopharma R&D Sourcebook 2016, 5.13, p. 31; Data from 2016 CMR Factbook from Clarivate Analytics; Drawn from the Global R&D Performance Metrics Programme and reproduced with permission.