Dr. Jonathan Sackner-Bernstein's expertise spans across medical product types (devices, drugs and biologics) as well as therapeutic areas, honed by his experiences and leadership in academics, at the FDA and in working for DARPA. In addition to his consulting practice in all matters regulatory, operational and clinical, he recently served as the Chief Medical Officer and VP, Clinical and Regulatory Affairs for Zidan Medical, focused on the development of a novel system for endobronchial tumor ablation. He previously served as Chief Medical Officer and Executive Vice President of Clinical and Regulatory Affairs at ROX Medical and recently identified a novel candidate drug therapy for Parkinson's disease (Patent Pending). Sackner-Bernstein's experience includes running clinical and regulatory affairs for a complex Phase 2 autologous cell therapy development program.
Highlights of Jonathan’s forensic skills include: identifying the efficacy signal in the Phase 2 trial of carvedilol for heart failure that reversed the sponsor’s disposition to cancel the program, identifying the means to successfully introduce carvedilol therapy in severe heart failure, unmasking the safety signal in nesiritide clinical trials that led to definitive study showing the drug to be ineffective and recognizing issues that deemed a hypertensive device as not being commercially viable prior to a $70MM+ investment.
As Associate Center Director for Technology and Innovation in the FDA’s Center for Devices and Radiological Health, Jonathan implemented safety and innovation programs, launched the FDA’s Entrepreneurs-in-Residence program (the first to be co-sponsored by the White House) and built a team that shaped a series of outward-looking initiatives to prepare the FDA for a new generation of connected, innovative medical devices. Amongst others, these initiatives led to the Breakthrough Therapy Designation and the Early Feasibility Studies programs. He led expansion of the relationship between the FDA and DARPA - largely focused on the Medical Counter-Measures program. Subsequently as consultant to DARPA, Jonathan's responsibilities ranged from regulation to commercial transition of programs/projects during the launch of the Biological Technologies Office, with a primary focus on neuroscience and big data programs.
Jonathan’s academic experience ranges from First-in-Human to international trials, as a clinical investigator and trial leader, including studies of drugs, biologics and devices, as well as extending to health care policy. Sackner-Bernstein held academic appointments in cardiology at Columbia University and North Shore LIJ Health System (Northwell) following training at Mount Sinai Medical Center. He earned his undergraduate degree in electrical engineering at the University of Pennsylvania.
Cell Therapies and
and Data Analysis
IT'S NOT TOO LATE TO MAKE A DIFFERENCE
Research shows that cognitive function doesn't reach its peak until our 30s, and is maintained well into our late 60s. As we reach into middle age, we have an obligation to use our brain power to impact those around us and the world in general.
“His deep and broad experience in medical research, government regulation, clinical practice, and business development make him a unique individual, attractive to DARPA and a perfect fit for TEDx Brussels.”