Is Academia the Light at the End of the Tunnel for New Drug Development?
Drug discovery has always been a complex and expensive process, but one which provided potentially high rewards in exchange. However the burn-rate for pharmaceutical development costs has become difficult to sustain as the pipeline for new chemical entities (NCEs) and “blockbuster drugs” has significantly dried up, and the risk-to-reward ratio becomes tipped much less favourably.
A number of the biggest blockbuster drugs came off patent in 2011-2013, including Lipitor, Plavix, Oxycontin and Viagra, paving the way for reduced-price generics to flood the market and hit the parent company profits. In 2014-2016 the trend continues, with Nexium (2014) Celecoxib (2014), Gleevec (2015) and Crestor (2016) all due to come off patent – to name just a handful. This will significantly dent the profits of some of the world’s largest pharma, including many of the well known faces such as Eisai Inc, Janssen Pharmaceuticals, Novartis, Genetech, Roche, Astrazeneca, Eli Lilly, Pfizer, Teva Pharmaceuticals, Boehringer Ingelheim, GSK, and Daiichi Sankyo.
Large pharma are forced to evolve and change their business models as a consequence. Many companies are now looking at emerging markets and branded generics, or identifying drug repurposing/repositioning opportunities to help boost their profits. New strategies have emerged, such as focussing on developing biologics, polypharmacology, phenotypic screening or translational approaches, and increasing the in-licensing of early clinical stage drug candidates is also being heavily explored to help boost the pipelines and resurrect sales.
Academic research and collaboration is a further critical area being explored and touted as the potential solution to fill the gap in drug discovery. These research groups have significant in-depth disease knowledge, have traditionally been less profit driven/focussed and therefore had a greater remit to experiment and innovate without the risk of failure that would block the path in a traditional pharma R&D environment.
A recent survey reviewing the state of academic drug discovery in the UK, published in Nature Reviews Drug Discovery , was supported and implemented by Thomson Reuters Scientific. This survey was compared to a similar survey run in 2011 reviewing the US academic drug discovery . Both the UK and US research groups were shown to still be heavily focussed on meeting their traditional academic objectives, advancing science through publication and the delivery of new medicines, rather than solely targeting profit and intellectual property.
Interestingly, both the UK and the US academic teams demonstrated that a large portion of their drug discovery group members have some (>1yr) industry experience, with more than a quarter of UK researchers having over 10 years, and >50% of US researchers having “significant” industry experience. This is to be expected with the ongoing loss of pharma R&D jobs. These groups are therefore becoming less lifetime-academic compiled and are acquiring industry know-how, which can only help support/accelerate the collaboration and commercialisation of their innovations with pharma partners.
There are however challenges that remain and if academic drug discovery is to fill the void and help drive new drugs to the market, then they will need better funding structures, and support in areas where these smaller groups do not have the same experience or diversity of skills as pharma.
These two articles demonstrated that within these drug discovery groups in both the US and UK, only approx 6% of funding currently comes from industry partnerships, which may explain why a large percentage of both the UK and US candidates are still in preclinical stages.
Furthermore in addition to funding, academic groups can benefit from the resources, technology, information, and insight (such as delivered by Thomson Reuters) that their industry colleagues have been exploiting for years. As the economic trends force pharma to cut spending in R&D, they also challenge the traditional funding structure in academia where there is now more pressure to demonstrate commercial viability of their research proposals. These intelligence and decision-making tools commonly employed in pharma are still relatively new to academia but as they face these commercial challenges, academia can equally benefit from these resources to submit more powerful funding applications and to identify potential industry collaborators.
“The challenges for academia are significant. Funding schemes are not aligned enough to drug discovery goals and on the whole academics don’t have all the required skills and capabilities internally. The development of strong mutually beneficial collaborations between academia, government, CRO’s and patient/ disease focused groups together with appropriate funding is essential. Academia is proving that it is an essential part of the drug discovery eco-system”
Cathy Tralau-Stewart, independent academia-industry drug discovery consultant
Tools such as Thomson Reuters Cortellis and Thomson Reuters Integrity have helped pharma identify the most valuable opportunities in which to invest, and have aided project decision-makers to demonstrate the commercial goals of their research streams to justify that investment. Academic groups now have to demonstrate the same commercial viability to secure funding from government and industry to continue their research, and in addition, they need to identify potential industry collaborators who could support their research. These are new challenges, which traditional academics have not previously faced, and which commercial intelligence tools can play a strong role.
What is clear about this evolution though is that both academia and industry can benefit from this relationship, and one would hope that the blend of traditional academic innovation/focus, combined with the industry experience and funding, will lead to a strong blend for the future of drug discovery and innovation.
- Cathy Tralau-Stewart, Caroline Low and Nicola Marlin, Nature Reviews Drug Discovery, 13 (Jan 2014)
- Stephen Frye, Nature Reviews Drug Discovery, 11 (May 2012)