Background
Companies large and small face enormous risks during the crucial early drug development stages. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), major pharmaceutical and biotechnology companies spent $10.5 billion or 22% of total annual R&D costs on non-clinical research in 2011 — more than the total amount spent on Phase I and II activity combined.i While the failure rate tends to diff er for small molecules and biologics, the majority of development eff orts fail, with the rate generally falling between 60 and 90%. With the new technologies and services available to Sponsors, the traditional path to drug development is no longer the best solution. With the right planning and tools, the studies conducted in the preclinical and early clinical stages can lay a foundation that will reduce risk and maximize the investment in future stages.
Focus on De-Risking a Molecule: The Rise of Translational Medicine
Companies large and small face enormous risks during the crucial early drug development stages. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), major pharmaceutical and biotechnology companies spent $10.5 billion or 22% of total annual R&D costs on non-clinical research in 2011 — more than the total amount spent on Phase I and II activity combined.i While the failure rate tends to diff er for small molecules and biologics, the majority of development eff orts fail, with the rate generally falling between 60 and 90%. With the new technologies and services available to Sponsors, the traditional path to drug development is no longer the best solution. With the right planning and tools, the studies conducted in the preclinical and early clinical stages can lay a foundation that will reduce risk and maximize the investment in future stages.
Focus on De-Risking a Molecule: The Rise of Translational Medicine
Facing rising R&D costs and increasing pressure
to appease investors, companies must discover
early on if a potential drug is too risky to pursue.
There are many risks in early drug development,
which can be grouped into three main categories:
safety, efficacy, and time to market. To mitigate the
risk in the latter category, companies must move
with insightful speed — performing the right
studies to obtain the best data — to stay ahead of
competitors. The knowledge that a potential drug
carries too much risk can save millions, and it also
builds trust with stakeholders who see that there
are sound decision-making processes in place, and
that resources are being carefully allocated.
No comments:
Post a Comment