Complete insights on biologic CMC requirements enable pharma, biotech and generics organizations to accelerate innovation by bringing life-saving medicines to patients faster
LONDON, Jan. 20, 2021 /PRNewswire/ — Clarivate Plc (NYSE: CCC), a global leader in providing trusted information and insights to accelerate the pace of innovation, today announced the enhancement of Cortellis CMC Intelligence™, the world’s only organized, timely and accurate source of Chemistry, Manufacturing and Controls (CMC) regulations and local practices. The addition of new biologic CMC content and features will support pharma, biotech and generics organizations in their quest to efficiently and accurately plan and prepare their CMC regulatory dossier submissions.
During these unprecedented times, researchers across the healthcare continuum need to connect the dots across multiple data points to enable the development and distribution of life-saving therapies. Most urgently, drug developers need practical solutions to support the manufacturing and global distribution of novel COVID-19 vaccines. In this new age of expedited drug development, Cortellis CMC Intelligence is a single platform solution for efficient identification, tracking, and comparison of CMC requirements, for all drug types, across the globe.
CMC and regulatory professionals are today challenged to find all necessary requirements for successful drug filings, culling through volumes of often regionalized and siloed data and insights. Critical pieces of information can be overlooked and result in delayed drug approvals and costly re-submissions. According to recent studies, 18% of total R&D expenditure is spent on CMC activities conducted to optimize, scale-up, and validate the processes and technologies for transfer to manufacture and all Quality Assurance, Quality Control, and CMC support activities.1
CMC and regulatory professionals risk spending significant time and resources preparing dossier submissions that are potentially based on incomplete or outdated CMC requirements. Studies show 50% of drugs submitted for approval from 2009-2012 were rejected. Of those drugs, nearly 12% were rejected due to CMC issues,2 with 18% of resubmitted drug applications delayed again due to CMC issues.3 Five percent of all drugs are never approved due to unmet CMC requirements.4 These points further support the need for more confident and efficient CMC regulatory dossier planning to ensure the optimized use of resources and support the submission of timely and accurate drug filings and approvals- the first time.
Mukhtar Ahmed, President, Science Group, Clarivate, said: “There is a great deal of risk and complexity in planning CMC regulatory dossier submissions. CMC and regulatory professionals are tasked with identifying, understanding and tracking complex CMC requirements to ensure all drug development and manufacturing activities are compliant with local and regional regulations. In this new age of expedited drug development – specifically surrounding the development and manufacture of vaccines for the novel coronavirus – here is a better solution to reduce risk, avoid costly re-submission delays, and save necessary time in the regulatory process. The enhancements to Cortellis CMC Intelligence address those challenges and enable more confident dossier submissions planning with a single source of comprehensive small molecule and now biologics CMC requirements. This enhancement helps pharma, biotech and generics organizations continue to unlock hidden insights in data and accelerate innovation across the industry.”
Cortellis CMC Intelligence Small Molecules curates and tracks official CMC regulations and local practices for more than 130 countries, territories and organizations with 25+ product and related regulatory filters based on eCTD structure, 800+ source documents with citations, 170+ links to Cortellis Regulatory Intelligence, providing access to expanded detail. Cortellis CMC Intelligence Biologics will address CMC regulations for over 60 countries. The addition of biologics CMC requirements to the already robust library of small molecule content represents just one of the many investments Clarivate has made – and will continue to make – to expand and enhance the Cortellis suite of life science intelligence solutions. It is a key component of the comprehensive Cortellis suite of life science intelligence that allows pharma, biotech and generics companies to more comprehensively research and analyze critical drug development data to support the entire drug lifecycle. Additional content will be added throughout 2021 and beyond to further aid CMC and regulatory professionals CMC regulatory dossier submissions planning.
Clarivate™ is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world’s most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise. For more information, please visit clarivate.com.
This press release and oral statements included herein may contain forward-looking statements regarding Clarivate. Forward-looking statements provide Clarivate’s current expectations or forecasts of future events and may include statements regarding results, anticipated synergies and other future expectations. These statements involve risks and uncertainties, including factors outside of Clarivate’s control that may cause actual results to differ materially. Clarivate undertakes no obligation to update or revise the statements made herein, whether as a result of new information, future events or otherwise.
1 Source: Clarivate CMR International, “2020 CMR International Pharmaceutical R&D Factbook,” August 2020
2 Source: JAMA, “Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012,” https://jamanetwork.com/journals/jama/fullarticle/1817795, January 2014
3 Source: JAMA, “Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012,” https://jamanetwork.com/journals/jama/fullarticle/1817795, January 2014
4 Source: JAMA, “Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012,” https://jamanetwork.com/journals/jama/fullarticle/1817795, January 2014
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