Modeling and simulation’s positive impact on NDA and BLA approvals through July 1, 2018 has included first use, orphan and priority review drugs for multiple indications
Certara Software or Services Supported 95% of the US FDA Novel Drug Approvals in First Half of 2018
Ellen Leinfuss, 609-216-9586
Chief Commercial Officer
Rana Healthcare Solutions
Lisa Osborne, 206-992-5245
Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today reported that 95% of novel new drug approvals by the US Food and Drug Administration (FDA) in the first half of 2018 were supported by Certara software or services. Those results emphasize how much modeling and simulation has become an integral part of regulatory submissions and highlight Certara’s leadership role in the field.
“Certara congratulates all of the biopharmaceutical companies that have achieved this hard-earned regulatory milestone and thanks them for giving us the opportunity to contribute to this success,” said Certara’s CEO Dr. Edmundo Muniz. “Our mission is to revolutionize the drug development paradigm by leveraging modern quantitative approaches such as modeling and simulation and real-world evidence solutions to optimize R&D productivity, commercial value and patient outcomes. These technologies’ positive impact is evident in the accelerated development cycles for these approved drugs and the innovation adoption by the FDA.”
FDA has been a leader promoting modeling and simulation as an integral part of drug development and review, highlighting it specifically in the 21st Century Cures Act, PDUFA VI and GDUFA II. Further illustrating that point, FDA Commissioner Scott Gottlieb, MD, cited “the more widespread use of modeling and simulation, the greater use of real-world evidence in the pre- and post-market setting, and the adoption of better tools for collecting and evaluating more real-time safety information after products are approved” among the new scientific domains that have been introduced into the development and review process in a recent statement.
Among the 2018 novel drug approvals for which Certara’s modeling and simulation technology-enabled services were leveraged, the following examples are illustrative of innovation:
Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
Disclaimer: If you have any questions regarding information in this press release please contact the company added in the press release. Please do not contact pr-inside. We will not be able to assist you. PR-inside disclaims the content included in this release.