Certara®, the global leader in model-informed drug development, announced today that it has launched the COVID-19 Pharmacology Resource Center (the Center) to help advance therapeutics for COVID-19. The Center is an online resource that unites experts across the globe in accelerating efforts in the fight against COVID-19 by providing pharmacology simulation tools and a forum for scientific exchange. The Center emphasizes the importance of incorporating clinical pharmacology and translational medicine principles to optimize dosing in clinical studies.
The Center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. Dosing is a critical decision in testing potential therapeutics for COVID-19 because drugs affect patients differently. The dose has to be high enough to be effective but low enough to avoid toxic side effects and not waste critically needed drugs. The Center features computer simulation tools that are updated with emerging data and include patient factors such as body mass index and lung tissue concentration. Using these tools to help determine the optimal dose will lead to faster, more efficient clinical trials in the search for COVID-19 therapies.
“We are facing an unprecedented, global, public-health crisis which traditional drug development cannot combat fast enough,” said Dr. Craig Rayner, president, integrated drug development at Certara. “In order to go faster, we have to work smarter. By integrating science, technology and worldwide collaboration, we can design more efficient clinical trials that accelerate the development of therapeutics for COVID-19.”
The Center also provides a platform to facilitate the exchange of current and emerging information to help design well-controlled clinical trials. The Center invites companies, academic institutions, healthcare organizations, governments, and nonprofits to join in its mission, collaborate in the development of computer models and participate in scientific discourse – asking questions, finding answers, and generating ideas in the global, life-sciences community.
“The COVID-19 Pharmacology Resource Center will contribute to more efficient drug development through platform tools, collaboration and coordination, which are critical elements in the challenges we face today,” said Dan Hartman, director, integrated development, at the Bill & Melinda Gates Foundation. “Through the COVID-19 Therapeutics Accelerator, which provides fast and flexible funding for research, and this Center, we are building out the ecosystem to move forward scientifically-proven drugs as fast as possible.”
In addition to launching the COVID-19 Pharmacology Resource Center, Certara is also participating in the COVID-19 Therapeutics Accelerator, funded by the Gates Foundation, Wellcome, Mastercard and the Chan Zuckerberg Initiative to address the COVID-19 pandemic on a worldwide scale. Certara is applying its expertise in clinical pharmacology and regulatory strategy to support stage-gate decisions, development strategies, trial designs and dosing optimization for COVID-19.
For more information, please visit the COVID-19 Pharmacology Resource Center.
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.