New database provides access to comprehensive “Chemistry, Manufacturing and Controls” regulatory requirements for 73 regions and countries
PHILADELPHIA, USA, October 15, 2018 – Today Clarivate Analytics announced the launch of Cortellis CMC Intelligence, a unique database developed to simplify the drug submission process and increase the chances of an approval, with a focus on the areas of greatest medical need in Low and Middle Income countries (LMICs). Cortellis CMC Intelligence was funded in part by a grant from the Bill & Melinda Gates Foundation.
In 2017 Clarivate Analytics acquired a product prototype from the Gates Foundation to provide its Product Development Partners (PDPs), who work to advance drugs, vaccines, and diagnostics focused on neglected diseases that disproportionately impact people in LMICs with reliable chemistry, manufacturing and control (CMC) regulatory information. Clarivate has since transformed this tool into a fully productized and scalable solution available to drug developers and manufacturers globally.
In an industry in which it can take up to ten years and $2.7 billion to progress a drug from discovery to market, it is imperative to mitigate risks that have the potential to increase development time and cost. According to the U.S. FDA, 50% of new drug applications filed between 2000 and 2012 were rejected, 11.3% of which were due to CMC issues. With as much as 15% of total R&D expenditures spent on CMC activities, these issues can have a significant negative financial impact — and in some instances, may result in incorrect termination of promising drug development programs.1
Mukhtar Ahmed, President, Life Sciences, Clarivate Analytics, said:
“The efficient and speedy introduction of new drugs to underserved patient populations continues to be a priority for drug developers, but historically has been difficult to achieve. Understanding CMC requirements is uniquely challenging as the information must be compiled for individual countries with differing requirements and relies on highly-specific expertise to interpret. Cortellis CMC Intelligence provides access to high quality, comprehensive, and verified data for the countries where reliable, up-to-date regulatory information is hard to find. As a result, regulatory professionals can complete a faster, more efficient process to submit CMC applications just once —whether for one country or many.”
With Cortellis CMC Intelligence, regulatory professionals will be able to:
- Understand the regulatory requirements for 73 LMICs, including the Caribbean, EMEA, Latin America, Asia-Pacific, and Commonwealth of Independent States (CIS)
- Compare requirements in new markets against those countries where a product is already approved to determine optimal expansion strategies and market entry sequence
- Identify markets with similar or more stringent requirements to determine approval criteria that must be met to enable simultaneous application submission in multiple markets
Clarivate Analytics plans to expand the Cortellis CMC Intelligence database beyond LMICs to include regulatory requirements for 140 countries across the globe by 2020.
Find out more here: https://clarivate.com/products/cortellis-cmc-intelligence/
Join the online conversation using #CMCCortellis
1 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme
Cortellis delivers the unique insights needed to reduce risk and increase success across the drug development lifecycle from early discovery to commercialization and beyond. The Cortellis suite of solutions serves the needs of life science professionals with unmatched content, intelligent search, best-in-class analytics and insightful visualization tools. For more information, visit www.clarivate.com/cortellis
About Clarivate Analytics:
Clarivate Analytics is the global leader in providing trusted insights and analytics to accelerate the pace of innovation. Building on a heritage going back more than a century and a half, we have built some of the most trusted brands across the innovation lifecycle, including Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor, and Techstreet. Today, Clarivate Analytics is a new and independent company on a bold entrepreneurial mission to help our clients radically reduce the time from new ideas to life-changing innovations. For more information, please visit www.clarivate.com