Cardiac Safety Early Career Seminar Series – Carlos Serna, US FDA

The Cardiac Safety Steering Team is proud to present the first webinar in the 2025 Early Career Seminar Series.

This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment.

Three awardees were selected for the 2025 Seminar Series:

• Dr. Carlos Serna, US FDA, September 26th, 2025 at 10:00 am EDT
• Dr. K. Ashley Fetterman, AbbVie, October 3rd, 2025 at 10:00 am EDT
• Dr. Leto Luana Riebel, Oxford University, October 24th, 2025 at 10:00 am EDT

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

Talk Title: Leveraging New Approach Methodologies (NAMs) to Assess Safety and Efficacy of Drug Combinations

Speaker: Dr. Carlos Serna, US FDA

Carlos Serna III serves as a Research Scientist in the Complex in vitro Models Laboratory at the Center for Drug Evaluation and Research (CDER). In this role, he investigates new approach methodologies (NAMs) including the integration of human induced pluripotent stem cell derived neurons and astrocytes with multielectrode array (MEA) platforms for evaluating electrophysiological effects of CNS active compounds, including opioids and those with potential seizurogenic liability. Dr. Serna also assesses cardiotoxicity using hiPSC-cardiomyocytes on MEA as a highly predictive model for identifying drug-induced QT prolongation. Dr. Serna is an accomplished biomedical engineer with extensive experience in microphysiological systems, bioprinting, 3D cell culture, and regulatory science research. His expertise spans neural engineering, medical device development, drug delivery, and hemocompatibility assessment. Before his current position, he served as an ORISE Postdoctoral Fellow in FDA's Blood Damage Assessment Laboratory at the Center for Devices and Radiological Health (CDRH), where he developed innovative in vitro thrombogenicity test methods to improve FDA review efficiency for medical devices. His work included establishing new methodologies for identifying biological markers of platelet, leukocyte, coagulation, and complement activation. Prior to joining FDA, Dr. Serna conducted postdoctoral research at Northwestern University's Feinberg School of Medicine and the Shirley Ryan AbilityLab, focusing on 3D bioprinting applications for volumetric muscle loss treatment and developing co-culture systems on microfluidic chips to examine pyramidal motor circuits. Dr. Serna received his PhD in Biomedical Engineering from the University of Texas at El Paso and his Bachelor of Science in Physics from The Ohio State University. He has authored multiple peer-reviewed publications in a variety of biomedical fields and has presented his research at numerous national conferences. Dr. Serna's research interests include microphysiological systems based on excitatory cells, neuroscience, material science, pharmacokinetics, drug delivery, and the advancement of regulatory science-based decision-making at the FDA.