Risk mitigation in academic drug discovery

There is a global trend toward an increasing proportion of early stage drug discovery taking place within specialized centers located in the academic and not-for-profit research sector. However, it is clear that for academic drug discovery to successfully contribute toward the identification of new therapies, scientific and technical excellences alone are not sufficient. They must also be a deep understanding of the many risks and associated pitfalls involved and adequate strategies should be put in place by practitioners to fully evaluate such risks and then adequately mitigate against them. After surveying some of the variety of academic drug discovery initiatives, we seek to identify key risks these groups face and the mitigation approaches which are being used. [1] In the United States of America, the National Institutes of Health (NIH) funding of programs such as the Molecular Libraries Roadmap Initiative (MLRI) and more recently the National Centre for Advancing Translational Sciences (NCAT) have led to a buildup of deep expertise within host academic institutions in the core drug discovery skills of medicinal chemistry, toxicological assessment, assay development, and screening. In Europe, transnational programs such as the Framework, Horizon 2020 Health and the associated Innovative Medicine Initiative public private partnerships (IMI) have led to the funding of literally 100s of research programs involving academic drug discovery aspects. Budgets can be substantial, in the case of IMI2 it is 3.27 billion Euros over a 10-year period from 2014. From 2016 onwards, more European initiatives addressing personalized medicine, healthy ageing, and infectious disease are all in the pipeline, and again much of these efforts will be realized by expertises and infrastructures positioned within the academic sector. In both Europe and the USA, we have also seen a parallel reduction in Pharma industry investment in their inhouse early stage drug discovery. The global market for overall Pharmaceutical industry outsourcing at the discovery stage is predicted to rise from 14.5 billion dollars in 2014 to 24.5 billion in 2018. [2] The inevitable reorganizations associated with such changes saw the top 10 Pharma industries collectively lay off an average of 30,000 employees per annum between 2010 and 2013. [3] This development, however, has perhaps an unintended consequence of a new cohort of seasoned industry discovery scientists finding themselves new roles in the academic drug sector where they are using their knowledge to help professionalize existing operations and increase the chances of successful project outcomes through improved risk management. The measures of success in academic drug discovery may be somewhat more wide ranging than those commonly employed by industry which operates under the watchful eyes of private owners or shareholders who are intrinsically orientated toward achieving maximal returns on their investments. [4] Within academic drug discovery, metrics for success may also encompass development of useful tool compounds, better understanding of the underlying biology of a disease, or licensing of compounds at the lead stage when ongoing risk is effectively shared with external partners, as evidenced by the business models of several leading academic drug discovery organizations. [5] The American Association of University Technology Managers reported that technology transfer activities in general resulted by 2014 in an increase of 11% in issued patents and 17% in the number of licensed patents. These numbers demonstrate the growing interest in the realization of commercial value of academic research activities, especially in light of waning governmental research support, such as the reduction in funding seen since 2004 for NIH grants (if inflation is adjusted for). [6] Adopting appropriate risk mitigation strategies is crucial for academic drug discovery practitioners, when considering their limited resources and underlying organizational constraints. The main risks facing academic drug discovery can be divided into the scientific, technical, organizational, and financial in origin.