| | October 2019 8OPINIONIN MYIncreasingly, Biotech companies are taking drugs through to regulatory approval and commercialization rather than divesting during development to large Pharma. This reflects the increased funding available ($29b in 2018, $10b higher than in 2017) to pay for the expensive costs in the latter stages of development but also a maturing pharmaceutical services sector that enables Biotech to progress development by accessing expertise and global capability, whilst remaining agile and lean in terms of their own fixed costs.Regardless, drug development remains expensive and is getting more rather than less so. To the wider industry's chagrin, advances such as electronic data capture, data standardization and risk based monitoring have not translated to lower costs with the cost of developing a new drug now estimated to be circa $1.4b. There is, of course, the context of working in a highly regulated industry that is becoming more complex by the year, but a cautionary approach has created an industry mind-set that adds, without ever taking away. Research from Tufts shows that from 2001-05 to 2011-15, the distinct number of procedures (blood draws, biopsies, scans, rating scale completion, etc.) in a typical Phase III study increased by 59 percent. The number of eligibility criteria per study increased by 61 percent (directly narrowing the patient funnel), the number of scientific endpoints used to judge success increased by 86 percent while the number of planned patient visits increased by 25 percent. It is not hard to imagine how this increased burden on patients and investigators has acted as a disincentive such that finding the right sites with the right patients continues to be the number one development challenge facing the industry. Indeed, over Project teams need to be challenged constantly to justify the study procedures and eligibility criteria they are proposing, with each procedure and criteria truly earning its place in the study protocolIntricacies of Precision MedicineBy Andrew Garrett, PhD, Executive Vice President, Scientific Operations, ICON Clinical Research [NASDAQ: ICLR]
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