How to engage with BARDA & FDA

Šeila Selimović, PhD, serves as a Branch Chief in the Biomedical Advanced Research and Development Authority (BARDA) at the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR). Her work at BARDA focuses on de-risking enabling technologies on their path to commercialization, in areas ranging from digital health and wearables to biosensors and point-of-care diagnostics, to tissue engineering and life support technologies.

Prior to BARDA, Šeila was a Program Director at the NIH’s National Institute of Biomedical Imaging and Bioengineering and an AAAS Science and Technology Policy Fellow at the US Department of State. She completed her PhD in Condensed Matter Physics at Brandeis University and a postdoctoral fellowship at Harvard Medical School / Brigham & Women’s Hospital. Dr. Selimović has authored over 60 research articles and editorials and edited two scientific books.

The Biomedical Advanced Research and Development Authority (BARDA) develops and makes available medical countermeasures by forming unique public-private partnerships to drive innovation off the bench to the patient to save lives. Within BARDA, the Division of Research, Innovation, and Ventures (DRIVe) partners with companies and teams offering solutions to a broad range of national health security threats. This presentation will highlight how DRIVe propels innovation and commercialization, in particular in medical diagnostics.

 

Jessica Paulsen is the Associate Director for Digital Health in the Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health (CDRH) at the FDA. She provides executive leadership and strategic oversight of OPEQ’s digital health review practices and policy implementation. She also leads the Center’s Digital Health Focal Point Program which aims to promote communication, collaboration, and consistency in digital health product reviews across CDRH.  She previously served as the Director for the Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices in CDRH. She earned her B.E. in Biomedical Engineering and Engineering Management from Vanderbilt University.

FDA’s Center for Devices and Radiological Health is responsible for protecting and promoting the public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices. We facilitate medical device innovation by advancing regulatory science, providing industry and developers with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States. This presentation will include an overview of the regulatory review process, including mechanisms and best practices for early engagement with FDA.