Jonathan Sackner-Bernstein

Change agent, Connector, Doctor, Engineer, Entrepreneur, Scientist, Startup

I am an expert in drug/device development, clinical operations and regulatory processes. I served as a member of CDER’s advisory committees prior to his recruitment to the FDA as Associate Center Director in the Center for Devices and Radiological Health with a portfolio extended from establishing post-market safety systems to leading the launch of the Center’s Innovation Initiative. In that role, I led working groups that included the Centers for Medicare and Medicaid Services, the Veteran’s Administration and DARPA leadership and also led the design and launch of the White House’s first Entrepreneurs-in-Residence program. Following service at the FDA, I guided DARPA’s launch of its Biological Technologies Office with focus on neurosciences and commercial transition of its programs. I published and lectured extensively as an internationally recognized cardiologist, holding academic appointments at Columbia College of Physicians and Surgeons and North Shore LIJ Health System following training in cardiology and internal medicine at Mount Sinai Medical Center in New York, obtaining my MD degree at Jefferson Medical College and earning my undergraduate degree in electrical engineering at the University of Pennsylvania.

... asking questions, finding answers and sharing the lessons, particularly when doing so impacts the lives of others.

If you are over 35, 40 or 50 years of age, it is not too late to make a difference. In fact, scientific data show that more advanced age is the optimal time for success, not during one's youth. So those of us who were told we needed to do great things by 30 or not at all (see Einstein) can not use that as an excuse, because Einstein was wrong. Those of us duped into believing that the 10,000 hour rule means we can't be great (see Gladwell) need to see the data that show the 10,000 hour rule is not relevant. In my TEDx talk from Brussels (www.jhsbmd.com), I show why those of us with age have an advantage when it comes to doing stuff that matters, and because of that advantage, those of us over 35 or 40 have an obligation to take action to make a difference.

Biotech, Diet & Nutrition, FDA, Med Device, Medicine, regulatory affairs (medical devices), Statistics & Data Analysis

After studying engineering & practicing cardiology for ~15 years, I was able to see the possibilities of science and tech much more clearly after serving in a senior position at the US FDA. In addition to the core work in medical device tech and regulation, I established the collaboration between the FDA and DARPA that continues today, and which enabled me to hone my operational skills and to imagine attainable possibilities. In addition to working as consultant to DARPA, I'm launching and helping to launch several innovative products and programs. My goal is to help others unleash their intellectual restlessness and act upon it - the path towards making a difference, much in the way of Tesla, Edison and many TEDsters.

... being a government regulator. At the FDA I learned that some of the greatest opportunities for innovators are within the government.