Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Sixth Consecutive Year

Certara®, the global model-informed drug development and decision support leader, today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or consulting services. This result affirms the pharmaceutical industry's dedication to employing model-informed drug development approaches for informing key clinical testing decisions, resulting in reduced cost and increased speed in bringing new drugs to patients.

"We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA," said Certara's CEO Dr. William Feehery. "Certara's Simcyp®, Phoenix® and Global Submittm software platforms have been widely used by both the FDA and the biopharmaceutical industry during the past several years for drug development and regulatory review. In addition to the use of our technology, our expert consulting services teams supported the development of therapies for patients with cancer, central nervous system diseases, infectious diseases, and rare diseases in the class of 2019."

During her speech at the Breakthroughs in Medicine conference in Rancho Palos Verdes, CA last September, Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research (CDER) spoke of the Agency's commitment to innovation in drug development. Certara's mission is closely aligned with that commitment, which was outlined by the Agency in its Congressional testimony on implementing the 21^st Century Cures Act:

"As part of FDA's broader innovation initiative, we are encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations to allow an evaluation of a product's safety and effectiveness...CDER and FDA's Center for Biologics Evaluation and Research (CBER) are currently deploying these tools to help predict clinical outcomes, inform trial design, support evidence of effectiveness, and evaluate potential adverse event mechanisms."

Certara's innovations have had a profound impact on accelerating and improving the efficiency of drug development. During the past six years, Certara's technology and/or consulting services have been used to inform and expedite the development of about 250 novel therapies. In 2019 alone, Certara provided technology, consulting and/or regulatory writing and submission support for 11 oncology drugs, 12 drugs for orphan diseases, and 16 drugs that received priority or accelerated review. Certara's quantitative and integrated approach to drug development has enabled sponsors to reduce the size and duration of clinical trials, develop dosing strategies for special populations, such as pediatrics, evaluate alternative formulations, seek expedited regulatory pathways, and leverage in silico models in lieu of conducting clinical trials.

About Certara

Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past six years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.