Event
CHBE Seminar: Dr. Robert Elder, FDA
Friday, October 18, 2024
11:00 a.m.
Room 2108 Chemical and Nuclear Engineering Building
Patricia Lorenzana
301-405-1935
plorenza@umd.edu
Estimating solute diffusivity in polymers for predicting patient exposure to medical device leachables
Abstract: Medical devices often include polymeric components, which contain additives or contaminants that may leach into patients and pose a health risk. Device biocompatibility is typically addressed, in part, using analytical chemistry testing, wherein small molecules are extracted from the device under harsh conditions that exaggerate the amount released relative to clinical conditions. These amounts are then used to estimate patient exposure and toxicological risk. This approach does produce worst-case estimates of patient exposure, but it may be excessively conservative in some cases. I will provide an overview of our efforts to develop physics-based mass transport models that provide more clinically relevant exposure estimates. These models require the diffusion coefficients (D) of solutes in polymers to be specified. D can be measured experimentally but this is often too time-consuming. I will discuss my work on estimating D using various non-experimental approaches, like atomistic molecular dynamics simulations and machine learning. I will also give an overview of what the FDA does and my career path to FDA.
Bio: Dr. Robert Elder received his BS in Chemical Engineering from Oregon State University (2009) and his PhD in Chemical Engineering from the University of Colorado-Boulder (2014). He went on to postdoctoral and staff positions at the Army Research Laboratory before joining the Food & Drug Administration’s Center for Devices and Radiological Health in 2019. He has extensive expertise in polymer physics, materials science, data science, and modeling & simulation of polymers and biomolecules, with over 30 peer-reviewed publications. He also led the development of an FDA guidance document on the chemical characterization of medical devices.
