Libby (Elizabeth) Barksdale, PhD, is the Senior Director, Science and Regulatory Affairs, at BIO, where she manages and advocates for regulatory policies of importance to the biotechnology industry. Her wide-ranging portfolio covers pediatrics, RWE, clinical trial diversity, FDA Advisory Committee reform, FDA-sponsor meeting best practices, cell and gene therapy (nonclinical), and more. As Senior Director, Libby is responsible for developing and proactively advancing BIO regulatory policy initiatives to promote a public policy environment that spurs biomedical innovation. Previously, Libby was the Senior Director of Regulatory Affairs and Scientific Policy for LUNGevity Foundation, a lung cancer patient advocacy group. In her role she guided the development and execution of LUNGevity’s regulatory strategy as well as the organization’s Transforming Clinical Trials Initiative, a multi-stakeholder effort to streamline clinical trials and make them more patient-centric. Libby also spent time on the regulatory science and policy team at the American Association for Cancer Research, where she led efforts aimed at increasing understanding of the regulatory ecosystem and enhancing the development of oncology products, and at the Federation of American Societies for Experimental Biology, where she focused on clinical research and biomedical research training. Libby received her BS in Biology from Hope College and PhD in Molecular Medicine from The George Washington University. She sought out experiences in science policy while conducting postdoctoral research at the National Institute of Child Health and Human Development.