• About Me

      Wikipedia

      It's Not Too Late To Make A Difference

      TEDx Brussels

      Academic & Policy Publications

      Google Scholar

    • LEADERSHIP

      Dr. Jonathan Sackner-Bernstein is a widely-sought consultant in FDA regulatory processes - based on his insider knowledge coupled with clinical, operational, analytic and leadership expertise. Together, his experiences and skills across medical product (drugs, biologics and medical devices) and therapeutic areas (cardiology, neuroscience, sleep medicine, hematology, gastroenterology, diabetes etc.) allows him to apply insights and lessons to product development in creative and effective ways.

       

      Following a renowned career as an academic cardiologist and serving in a senior role at US FDA, Sackner-Bernstein led operations for clinical development of a cell therapy, then designed an architecture for cyber-secure medical devices, while also serving as a consultant to DARPA.

       

      As Associate Center Director for Technology and Innovation in the FDA’s Center for Devices and Radiological Health, Sackner-Bernstein 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. As consultant to DARPA, Sackner-Bernstein responsibilities ranged from regulation to commercial transition of programs/projects during the launch of the Biological Technologies Office, with focus on neuroscience and big data programs.

       

      Sackner-Bernstein recently served as Chief Medical Officer and Executive Vice President of Clinical and Regulatory Affairs at ROX Medical. In this role, Sackner-Bernstein led the strategic and tactical aspects of the development of the ROX implant for uncontrolled hypertension. His recognition and disclosure of a previously unrecognized risk of the device led to the end of the development program, and represented another example of Sackner-Bernstein's unique ability to see trends in data that aren't readily apparent to others. Similar insights were published that changed the use of nesiritide for heart failure, rescued carvedilol during the phase 2 clinical trials and later, to identify means to successfully develop carvedilol for severe heart failure. These types of insights underscore his value in due diligence for investors/funds.

       

      Sackner-Bernstein’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 (each in metro New York). He earned his undergraduate degree in electrical engineering at the University of Pennsylvania.

    • Portfolio

      Pharmaceuticals

      • FDA Center for Drugs Advisory Committee member
      • Participated for Sponsor at Advisory Committee meetings (cardiovascular and neurological)
      • Operations leadership roles in multiple cardiovascular outcomes clinical trials (global)

      Medical Devices

      • Associate Center Director, FDA Center for Devices; led initiatives ranging from assuring safety of marketed devices to more efficient engagement with innovators
      • FDA Center for Devices Advisory Committee member
      • Established collaboration between FDA and DARPA

      Cell Therapies and

      Tissue Engineering

      • Supported work that led to DARPA's investment in tissue engineering for drug development
      • Led clinical operations and regulatory teams for 60+ center stem cell intervention clinical trial

      Technology

      and Data Analysis

      • Designed hack-resistant medical device architecture and tools for secure remote software update 
      • Performed traditional meta-analyses and Bayesian analyses to challenge clinical practice paradigms
    • 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.”

      [TEDxBrussels 2014]