Carolyn Hiller, MBA

Senior Advisor for Innovation and Strategic Partnerships

Carolyn Hiller joins the Reagan-Udall Foundation for the FDA as a Senior Advisor for Innovation and Strategic Partnerships. Drawing on diverse experiences, she has achieved success at leading virtual teams that are often comprised of members from competing organizations. Ms. Hiller works at the intersection of the medical device industry, federal agencies, and non-profit groups to bring innovative technology to patients faster, safer, and more cost effectively by contributing regulatory science tools, standards, and methods, for both the IVD development process and the review process. She brings a decade of executive non-profit leadership experience including national organizations representing patients, researchers, physicians, and clinical facilities.

In 2015, Ms. Hiller joined the Medical Device Innovation Consortium to launch the Clinical Diagnostics program, working with volunteers six regulatory science tools were developed. These include Surrogate Samples Framework, Surrogate Samples Harmonized Education modules, IVD Clinical Evidence Framework, IVD Real World Evidence Framework, Fingerstick Capillary Blood Specimens Blueprint, and Somatic Reference Sample Landscape Analysis. In addition to releasing these tools, the Clinical Laboratory and Standards Institute (CLSI) requested the Surrogate Samples work to create an international standard, in November 2021 they released the EP39 – A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests. On December 20, 2021, the FDA recognized EP39 as a complete standard.

In 2017, FDA requested Ms. Hiller to lead the Somatic Reference Standards (SRS) initiative, nearly 30 organizations collaborated to scope the project. This translational research project will arc from CRISPR technology, NIST validation, and into the clinical setting within a timeframe of less than 24 months. The resulting physical samples will transform diagnostic validation for test developers, regulators, and payers. The corresponding sequenced datasets created from NIST’s validation will greatly enhance research as they will be publicly available on PrecisionFDA and NIH websites. She raised $3.5 million to support the pilot that launched in January 2022.

Ms. Hiller has an MBA from the University of St. Thomas, St. Paul, Minnesota, as well as a BA in Marketing from Metropolitan State University, and an AAS in Animal Health Technology from the University of Minnesota.