Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach

About Noel ElmanPablo GurmanYitzhak Rosen

Dr. Pablo Gurman MD MSM holds a Doctor of Medicine (MD) degree from Buenos Aires University School of Medicine and a masters degree in management from Babson College. His experience spans 15 years of experience in R&D in the biotech and the pharmaceutical industry as well as more than 15 years of R&D in microsystems and nanotechnology working at MIT The University of Texas at Dallas and Argonne National Laboratory (Artificial Retina Program). His primary interests include drug development medical device development with focus on microsystems and nanotechnology biotechnology and public health.Dr. Yitzhak Rosen MD graduated from the Tel Aviv University Faculty of Medicine. He worked in the Cardiology Department at SUNY Downstate Medical Center and served as a visiting research scientist at the Institute for Soldier Nanotechnologies at MIT. Currently he is the president and CEO of Superior NanoBioSystems LLC a biomedical company. Dr. Rosen has also served as a medical officer and physician in militarily active areas with the Israel Defense Forces (IDF). He completed his medical internship at Rabin Medical Center and has worked at the Oncology Institutes of both Rabin and Sheba Medical Centers in Israel. Notably he invented a microfluidic chip platform funded by DARPA for rapid blood typing and cross-matching in mass casualty situations in collaboration with the MEMS and Nanotechnology Exchange. Additionally he has developed several medical ultrasound technologies.Noel Elman PhD is the CEO and founder of GearJump Technologies LLC a company focused on creating biotechnological solutions for public health. He is also a faculty member at the Buenos Aires Institute of Technology. Previously Dr. Elman worked at Draper Laboratory an MIT-affiliated and DoD-supported R&D center where he was a distinguished member of the technical staff. Before that he served as a research scientist and principal investigator at the Institute for Soldier Nanotechnologies at MIT leading a translational research group dedicated to developing biotech biomedical and public health technologies. Dr. Elman specializes in rapid translation from concept to experimental realization. He holds bachelor's and master's degrees in electrical engineering from Cornell University and a PhD in physical electronics from Tel Aviv University. Additionally he completed postdoctoral studies at MIT where he researched various micro- and nanodevices for therapeutics and diagnostics.