Regulatory Concerns Surrounding Automation

The FDA doesn’t love surprises. So, to what degree should you engage with the FDA when it comes to adopting automation into your operations? In this segment from the Cell & Gene Live event Considerations For Investing In Your Gene Therapy’s Automation Framework, TJ Cradick, Ph.D., CSO of Excision BioTherapeutics, and Matt Humes, head of lab automation at Beam Therapeutics, weigh in on how to best engage with regulators when it comes to using automation. As with anything, good documentation is important to support the use of new technologies.