FDA issues guidance on conduct of clinical trials during the COVID-19 pandemic
To Our Community, The impact of COVID-19 on our personal and business lives has been, and will continue to be, significant. New guidance from the FDA specifically outlines how the virus will impact clinical trials, both those that are ongoing, as well as those yet to begin (“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”). The State of Pennsylvania Department of Community and Economic Development (DCED) is making resources available to help businesses through this uncertain time through its COVID-19 Resources website. Being faced with so much unknown, this pandemic has caused disruption, stress, and fear. With the need for new vaccines and treatments, we in the life sciences are tasked with bringing the best and brightest minds together to find solutions. At the Pittsburgh Life Sciences Greenhouse, we are honored to be a part of this effort through our portfolio company, CytoAgents. CytoAgents is working on an immunotherapy that is easily administered and cost effective, increasing its ability to make a positive global impact. With their oral treatment, the inflammation response that is triggered by a virus will be controlled more effectively. And unlike anti-viral medications, there is no risk of resistance or possibility of not working as the virus mutates. This is revolutionary and exciting, and it brings a sense of hope. Please be careful, mindful of others, and adhere to the CDC guidelines. |