Beginning of the end of the future of medicine?
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FDA approvals for 2022 are the lowest they have been for five years[i].
What are the reasons for this decline?
This question is not easy to answer because there are multiple factors at play.
It is nonetheless useful to ask questions that help uncover the reasons and challenges behind the unexpected decline in drug approvals.
Is it just statistical variation? If there are only 1:10 drug development efforts that are successful there are likely to be lulls in the number of successful new therapies.
Have we achieved most of the easy wins? It is clear that new therapies are becoming more complex likely in response to the fact that all the drugs that can address the simpler biology, i.e small molecules, have already been developed.
Is it that the complexity of the biology that new therapies address means that new therapy development is slower than in the past? If we are now in an era of complex therapies it stands to reason that the development of new therapies will be more difficult and slower
Is precision medicine not yet sufficiently developed? One of the promises of precision medicine is that it will be faster to develop new therapies because they can be targeted to sub-populations that respond. If precision medicine was a widespread approach wouldn’t there be a steady rise in new therapy approvals.
Are multiple different stakeholders not working well enough together? Innovation in life science and healthcare is a multi-stakeholder challenge. If any of the multitude of stakeholders is either not aware or not convinced of a new therapy the likelihood that it will progress towards clinical implementation is diminished.
Is there not enough emphasis on patient centered drug development? The FDA is emphasizing patient focused drug development. Are we now seeing the effects of not being able to make drug development patient centered? Or is it still too early to see that effect.
Are regulatory frameworks not developed enough to handle new advanced therapies? Advanced therapies such as engineered cell therapy or mRNA therapeutics bring up a lot of new issues. For example the toxicity of these therapies is notoriously hard to predict with preclinical testing.
Did the effects of the pandemic slow down research? Lots of clinical trials were put on hold or limited in their recruiting during the pandemic.
Is there not enough emphasis on translational research? Are we at a tipping point where there is so much new knowledge being generated that resources are not being invested in the translational process?
Does it cost too much to develop new therapies? It can cost up to 2bn dollars to develop a new therapy. Such a high cost creates a dynamic where there is too much at stake to develop therapies for smaller patient populations or to develop more riskier therapies?
Why is it important to pose these questions? Like poverty, hunger, the climate crisis innovating in the life sciences and healthcare is somewhat of a ‘wicked problem’. Wicked problems share the characteristic that you cannot define a single cause and are therefore difficult to solve. You can only hope to make progress by bringing people and organizations together to work on the challenges that have the ability to address operating under the umbrella of the wider wicked problem.
The thing is every single one of the challenges represented by the ten questions above can be addressed and progressed if everyone commits to working more closely together incorporating the perspectives and the needs of all stakeholders. That won't happen if life science and healthcare research and innovation remain entrenched in siloed and competitive approaches that turn a blind eye to key stakeholders.
What are your thoughts?
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[i] Nature Reviews Drug Discovery (Nat Rev Drug Discov) ISSN 1474-1784 (online)
