My interest has long lain with therapeutics. The promise of new treatments to improve lives and alleviate suffering captivated me as an undergrad and I made for the nearest pharmacology department. Subsequently, I was lucky enough to have the opportunity to work discovering new treatments of affective disorders as part of an SFI funded cluster and in a university spinout.
Over the past four years I’ve worked in Enterprise Ireland supporting TTOs and academic inventors commercialise promising therapeutic candidates in the hope that this activity would lead to jobs and wealth creation through licences and spinouts. With the recent relaunch of the Commercialisation Fund, I feel it might be timely to take stock of some of the issues in taking early stage candidates from the lab towards the patient. As a disclaimer, what follows are my own thoughts/concerns and I refer to applied development of therapeutics not basic research and discovery.
What has driven my pause for thought is the observation that there appears to be a critical mismatch in terms of numbers of therapeutic licences and spinouts in comparison to the amount devoted to university research in this area. What all too often happens is that potential treatments to diseases languish after initial discovery on a shelf because the grant funding runway has been exhausted and the attempt to move therapeutic candidates out of the university somehow fails. There is an element of this in all technology areas – not every piece of applied research can yield a winner. However, the problem seems especially acute with respect to therapeutics. Licence to established companies does not appear to be a viable route based on the observation that none has happened of late (though I’d be happy to be corrected on this). Startups appear a more viable route by the simple expedient that there are some in existence, though they (with few notable exceptions) appear to have a torrid time in surviving never mind growing.
I certainly don’t feel this state of affairs has anything to do with the quality of the research but, rather, to do with challenges I outline below. These stem from three interlocking factors that need to be addressed in parallel in order for any spinout to gain momentum – people, assets and funding.
People: Putting together the right mix of people that will both execute on the development plan and be credible to funders and prospective partners is crucial. Yet, building a team to develop new drugs is surprising difficult in Ireland. Whilst over 50% of GNP comes from the export of pharmaceuticals, the available skillsets are in manufacturing not drug development.
Assets: In the case of new therapeutics arising from universities, they are likely to mostly be “early stage” considering the very high costs of appreciably developing them are beyond most/all funding available at third level.
Funding: It’s almost an axiom to say that developing new drugs is the most expensive and risky of startup types. These qualities make it especially difficult to raise monies sufficient to reach a value inflection point. A first port of call is often the local VC community and they, it seems to me, add the lack of a credible team and the usually early stage nature of the molecule to the the risk/cost feature and pass on the opportunity to invest. Non-dilutive financing in the forms of grants and awards are a partial answer. However, the long timelines to obtaining these, their narrow programmatical uses and low application success rate limit their utility.
I’m not sure what the solutions to the above challenges are beyond calling for more resources, though I do have some thoughts that might comprise later entries. In the meantime, however, some form of debate would be welcomed. Otherwise, a scenario may arise where the following question is posed – should development of therapeutics in the university be abandoned as they are unlikely to be given adequate chance of progression out of academia and into the clinic?