Center for Research Innovation in Biotechnology
Last updated on September 15, 2021
Amid a global pandemic, the US Food and Drug Administration (FDA) remained relatively active, approving 55novel molecular entities (NMEs) in 2020, the third highest annual rate recorded. Orphan approvals also surged, capturing 60% of NMEs introduced during 2020, as did the number of NMEs approved using a priority review. The pandemic did appear to impact one recent trend, and in a paradoxically encouraging way. Escalating rates of consolidation slowed in 2020, with only 102 companies lost, down by two-thirds over the rate in 2019. This leaves 2000 extant clinical-stage pharmaceutical companies. When limiting this analysis to companies contributing to the research and development (R&D) of an approved drug, eight were lost, leaving 144 extant.
We analyzed therapeutic areas most commonly targeted by academia since 2001, finding a domination of certain oncology and infectious diseases. These findings raise important questions about whether this trend reflects an expanded opportunity arising from academic research or a troubling sign of an industry struggling with the challenges of innovation.
An assessment of inventors of US Food and Drug Administration (FDA)-approved medicines reveals a growing role for academic entrepreneurship in general and National Institutes of Health (NIH)-supported investigators in particular. For all small-molecule therapeutics approved between 2001 and 2019 (383 in total), 8.3% listed an academic inventor in the Orange Book. Remarkably, an additional 23.8% listed an inventor from a company founded by an NIH-funded academic inventor. Over time, the relative inventive contributions from academia has progressively increased, including nearly one-third of medicines approved since 2017. These findings suggest a surging role for academic inventors and founders, perhaps in combination with a faltering of traditional private sector dominance of drug discovery.
The COVID-19 pandemic has been humbling for the biomedical community, pointing out as much about what we do not know as what we do. Among these learnings are lessons about immune-based measures to prevent or treat a new biothreat. This article summarizes lessons learned from two experimental approaches for passive immunity, convalescent plasma and monoclonal antibody therapy. Two early reports of outcomes, both of which appeared within hours of one another, reveal the importance of blending past learning with a forward-looking approach. These also present cautionary lessons as the world looks to new vaccines to help eradicate this deadly scourge.
Kinch MS. Drug Discov Today. 2017 Apr;22(4):620-624. doi: 10.1016/j.drudis.2015.06.004. Epub 2015 Jun 19.
Kinch MS, Kinch GA, Griesenauer RH. Drug Discov Today. 2018 Sep 14. pii: S1359-6446(18)30266-6. doi: 10.1016/j.drudis.2018.09.006
Kinch MS, Griesenauer RH. Drug Discov Today. 2018 Aug;23(8):1469-1473. doi: 10.1016/j.drudis.2018.05.011. Epub 2018 May 8.
Griesenauer RH, Kinch MS. Expert Rev Vaccines. 2017 Dec;16(12):1253-1266. doi: 10.1080/14760584.2017.1383159. Epub 2017 Sep 25.
Griesenauer RH, Kinch MS. Drug Discov Today. 2017 Nov;22(11):1593-1597. doi: 10.1016/j.drudis.2017.06.011. Epub 2017 Jul 4.
Kinch MS, Woodard PK. Drug Discov Today. 2017 Jul;22(7):1077-1083. doi: 10.1016/j.drudis.2017.03.006. Epub 2017 Mar 21.
Kinch MS. Drug Discov Today. 2016 Jul;21(7):1046-50. doi: 10.1016/j.drudis.2016.04.008. Epub 2016 Apr 19.
Kinch MS, Moore R. Cell Chem Biol. 2016 Jun 23;23(6):644-53. doi: 10.1016/j.chembiol.2016.05.013. Review.
Patridge E, Gareiss P, Kinch MS, Hoyer D. Drug Discov Today. 2016 Feb;21(2):204-7. doi: 10.1016/j.drudis.2015.01.009. Epub 2015 Jan 21.
Kinch MS, Surovtseva Y, Hoyer D. Drug Discov Today. 2016 Jan;21(1):1-4. doi: 10.1016/j.drudis.2014.09.001. Epub 2014 Sep 15.
Kinch MS, Flath R. Drug Discov Today. 2015 Nov;20(11):1288-92. doi: 10.1016/j.drudis.2014.12.008. Epub 2014 Dec 17.
Patridge EV, Gareiss PC, Kinch MS, Hoyer DW. Drug Discov Today. 2015 Oct;20(10):1182-7. doi: 10.1016/j.drudis.2015.06.006. Epub 2015 Jun 22.
Kinch MS, Merkel J. Drug Discov Today. 2015 Aug;20(8):920-3. doi: 10.1016/j.drudis.2015.02.006. Epub 2015 Feb 17.
Kinch MS, Hoyer D, Patridge E, Plummer M. Drug Discov Today. 2015 Jul;20(7):784-9. doi: 10.1016/j.drudis.2014.11.001. Epub 2014 Nov 11.
Kinch MS, Umlauf S, Plummer M. Drug Discov Today. 2015 Jun;20(6):648-51. doi: 10.1016/j.drudis.2015.02.002. Epub 2015 Feb 11.
Kinch MS, Raffo J. Drug Discov Today. 2015 May;20(5):500-4. doi: 10.1016/j.drudis.2014.12.002. Epub 2014 Dec 9.
Kinch MS. Drug Discov Today. 2015 Apr;20(4):393-8. doi: 10.1016/j.drudis.2014.09.003. Epub 2014 Sep 16.
Kinch MS, Patridge E. Drug Discov Today. 2015 Mar;20(3):292-5. doi: 10.1016/j.drudis.2014.08.013. Epub 2014 Sep 6.
Kinch MS. Drug Discov Today. 2015 Feb;20(2):170-4. doi: 10.1016/j.drudis.2014.10.013. Epub 2014 Nov 4.
Kinch MS. Drug Discov Today. 2015 Jan;20(1):3-6. doi: 10.1016/j.drudis.2014.09.002. Epub 2014 Sep 15.
Kinch MS. Drug Discov Today. 2014 Dec;19(12):1831-5. doi: 10.1016/j.drudis.2014.08.007. Epub 2014 Aug 27.
Kinch MS. Drug Discov Today. 2014 Nov;19(11):1686-1690. doi: 10.1016/j.drudis.2014.04.006. Epub 2014 Apr 18.
Kinch MS, Merkel J, Umlauf S. Drug Discov Today. 2014 Nov;19(11):1682-1685. doi: 10.1016/j.drudis.2014.05.021. Epub 2014 May 29.
Kinch MS, Patridge E. Drug Discov Today. 2014 Oct;19(10):1510-3. doi: 10.1016/j.drudis.2014.05.012. Epub 2014 May 28.
Kinch MS, Patridge E, Plummer M, Hoyer D. Drug Discov Today. 2014 Sep;19(9):1283-7. doi: 10.1016/j.drudis.2014.07.005. Epub 2014 Jul 17.
Kinch MS, Haynesworth A, Kinch SL, Hoyer D. Drug Discov Today. 2014 Aug;19(8):1033-9. doi: 10.1016/j.drudis.2014.03.018. Epub 2014 Mar 26.