NEW YORK – Syapse said Tuesday that it has expanded its existing research collaboration with the U.S. Food and Drug Administration's Oncology Center of Excellence to include, among other things, research into the impact of COVID-19 on cancer care.
San Francisco-based Syapse has been helping the FDA's Oncology Center for Excellence incorporate real-world evidence into regulatory decision-making. The partners have been investigating ways to derive real-world data from multiple sources, including electronic health records, genomic tests, and cancer registries, and well as to understand how patients respond to therapies outside of the context of clinical trials.
"One of our goals is to reduce the burden of lengthy clinical trials on cancer patients and clinical researchers, and we are optimistic that the use of real-world data will help us address important questions more rapidly today, and increasingly so in the future," FDA Principal Deputy Commissioner Amy Abernethy said in a statement. Abernethy added that the agency is "learning quickly how sophisticated analyses of real-world data can provide rapid insights into COVID-19."
Syapse CMO Thomas Brown highlighted the importance of patient history in determining the efficacy of drugs. "Understanding how a patient’s medical history influences their treatment outcomes in a real-world setting is critical for clinicians, researchers, and regulatory agencies to appropriately weigh the risk-benefit profile of a drug for a given patient," he said.
Syapse earlier this year raised $30 million in new equity investments to support its collaborations and its application of precision medicine in guiding real-world outcomes.