Katherine Donigan

Katherine Donigan has extensive experience in the field of science and regulatory policy. Katherine is currently serving as the Senior Director of Science and Regulatory Policy at Sarepta Therapeutics since November 2022. Prior to this, they held the role of Senior Director of Science and Regulatory at the Biotechnology Innovation Organization from November 2021 to November 2022.

Before transitioning to industry roles, Katherine worked at the FDA for several years. Katherine started in November 2014 and held various positions, including Senior Scientific Advisor at the CDER/Office of New Drug Policy, Division of Clinical Policy, where they provided scientific expertise and policy guidance in areas such as personalized medicine and molecular genetics. Katherine also served as the Director of Personalized Medicine and Molecular Genetics, Deputy Office Director (acting) at CDRH/OIR, where they directed the Personalized Medicine Policy staff and provided leadership in developing regulatory policies for emerging technologies in personalized medicine. Additionally, they managed the Personalized Medicine Policy team and led efforts related to diagnostic regulatory reform at CDRH/OIR.

Before joining the FDA, Katherine gained experience as a Genetics & Public Policy Fellow at the American Society of Human Genetics and the National Human Genome Research Institute. Katherine also worked as a Postdoctoral Fellow at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

In their previous role as a Congressional Fellow at the United States Senate, Office of Senator Elizabeth Warren, Katherine engaged with stakeholders and constituents to address healthcare, public health, and research issues. Katherine conducted research, analyzed legislative issues, and developed legislative proposals for the Senator's policy decisions.

Throughout their career, Katherine Donigan has demonstrated expertise in areas such as personalized medicine, molecular genetics, in vitro diagnostics, regulatory policies, and healthcare legislation. Their work experience spans both the public and private sectors, highlighting their knowledge and contributions to science and regulatory policy.

Katherine Donigan earned a Bachelor of Science degree in Molecular Biology from Lehigh University in 2005. Katherine then pursued a Master of Philosophy degree in Genetics at Yale University from 2005 to 2008. Subsequently, they continued their education at Yale University, obtaining a Doctor of Philosophy degree in Genetics from 2008 to 2011.