FDA’s record-breaking year for approvals affirms high value provided by model-informed drug development
PRINCETON, NJ – Jan. 15, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2018 were supported by Certara software or services. 2018 was a record-breaking year for FDA; the Agency approved 59 innovative new therapies, including many first use, orphan and priority review drugs.
“The group of novel drugs approved in 2018 affirms the significant impact that modeling and simulation has had on modern drug development,” said Certara’s CEO Dr. Edmundo Muniz. “Certara’s scientists and technologies supported new treatments in a wide range of therapeutic areas, including oncology, respiratory, central nervous system, and rare diseases. Our work, which integrates model-informed drug development, regulatory science and real-world evidence is leveraged to optimize decision-making. The Certara team provides value across the pharma lifecycle—from translational science, dose optimization, and safety and efficacy analyses—to comparative analysis, product labeling, and market access. We congratulate the developers of the entire class of 2018 on their outstanding achievements, which will help to relieve suffering and improve quality of life for patients globally.”
In her FDA Voices blog post, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, referred to 2018 as “a year of innovation, efficiency, and new advances in drug therapy for the American public.” Dr. Woodcock pointed out that 73% of the 2018 novel drug approvals were designated in one or more of the agency’s expedited review categories (Fast Track, Breakthrough, Accelerated Approval, and Priority Review).1 These innovative approval methods help to bring new therapies to patients months or even years sooner than if their application went through the standard review process.
FDA has encouraged the use of modeling and simulation as an integral part of drug development, as codified in the current PDUFA and GDUFA, as well as the 21st Century Cures Act. FDA Commissioner Dr. Scott Gottlieb has repeatedly commented on this topic. For example, he stated that FDA is using more advanced computing tools, and more sophisticated statistical and computational methodologies, as part of the drug development and the drug review process. In fact, he reported, “Almost 100 percent of all new drug applications for new molecular entities have components of modeling and simulation.”2
- 2018: A Year of Innovation, Efficiency, and New Advances in Drug Therapy for the American Public. FDA Voices. https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm629275.htm
- Dr. Gottlieb’s speech to the Regulatory Affairs Professionals Society (RAPS) Regulatory Conference. https://www.fda.gov/NewsEvents/Speeches/ucm575400.htm
Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions 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.
Ellen Leinfuss, 609-216-9586
Chief Commercial Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions