Clarivate Analytics Launches Cortellis CMC Intelligence to Expand Drug Availability in Low and Middle Income Countries
New database provides access to comprehensive “Chemistry, Manufacturing and Controls” regulatory requirements for 73 regions and countries
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.”