Nilou Sarah Arden | AIChE

Nilou Sarah Arden

Team Lead, New Technologies and Innovation Science and Research Staff

Dr. Arden leads the New Technologies and Innovation group at FDA’s Center for Drug Evaluation and Research focusing on advanced manufacturing, analytical methods development, data science and modeling to advance public health. Her work involves engaging stakeholders in research programs impacting safety, efficacy, quality and access to medicines. Dr. Arden serves as a clinical research Institutional Review Board member and as a member of the steering committee for the FDA Centers of Excellence for Manufacturing Science and Innovation, Immunology and Infectious Diseases, and the FDA Emerging Technology Team aimed at advancing innovative technologies to promote public health. Prior to her current role, Dr. Arden served at the FDA as a CMC reviewer to assess regulatory submissions and conduct pre-approval facility inspections. She was awarded a Unit Commendation Award from the US Public Health Service for serving on the objective review panel for the FDA Emerging Manufacturing Program to enhance regulatory science for risk-based assessment.

Prior to joining the FDA, Dr. Arden co-founded a digital health technology startup that focused on transforming point-of-sale information into actionable insights for families. As a registered patent agent, she served as an IP strategy advisor to the Emerging Technology Centers incubator, a nonprofit housing 60+ early stage startup ventures. In addition, she has served a broad portfolio of businesses and government clients such as Bayer, Biogen, IBM, Pfizer, and the US Navy. 

Dr. Arden completed fellowships at the ETH Zurich, Stanford University School of Medicine and the RWTH Aachen Helmholtz Institute for Biomedical Engineering. She received a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University and a B.S. from the University of California, San Diego. Dr. Arden currently serves as a guest lecturer at Columbia University and advises students at the Johns Hopkins University Center for Leadership. Dr. Arden’s personal aim is to improve the health, safety and development of vulnerable populations through initiatives supporting the advancement of technologies, innovation and education.