Jonathan discovered and is now developing a ground-breaking therapy for the treatment of Parkinson’s disease.
The approach is contrary to established standards of care – which provide little impact for patients – making the development process even more challenging. Nonetheless, Dr. Sackner-Bernstein’s successes as a contrarian prove particularly valuable for such a project.
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. These experiences include leadership roles in strategic, operational, clinical and regulatory aspects of clinical trial and development programs.
Highlights of Jonathan’s contrarian positions include: 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 $35MM+ 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 and led the 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 following training at Mount Sinai Medical Center. He earned his undergraduate degree in electrical engineering at the University of Pennsylvania.