Sackner-Bernstein in 2019
|Alma mater||Miami Beach Senior High School|
University of Pennsylvania
Moore School of Electrical Engineering
Jefferson Medical College
|Organization||Mt. Sinai Hospital|
Food and Drug Administration
|Known for||Biotech, Medtech, Clinical Research|
|Spouse(s)||Audrey S. Bernstein|
Jonathan Sackner-Bernstein (born 27 January 1961) is an American physician. He has published more than 80 scientific articles, which have been cited more than 4,000 times. His research has ranged from cardiac care to the efficacy of drugs. His research led to increased scrutiny of Nesiritide, a widely marketed drug, which led to its decline in its use.
Sackner-Bernstein graduated from the University of Pennsylvania's Moore School of Electrical Engineering in 1983 (BSEE),. He completed his MD from Jefferson Medical College, during which he moonlit writing code. He completed a residency in internal medicine and subsequently cardiology at Mount Sinai Hospital in New York. In addition, Sackner-Bernstein completed a research fellowship in heart failure under Milton Packer at Mount Sinai.
Academic, clinical and research experience
Sackner-Bernstein joined the Columbia University faculty in 1993 in the Division of Circulatory Physiology, where he established its clinical research program. He accumulated a large experience with the beta-blocker carvedilol prior to the application by its developer (GlaxoSmithKline) to the US Food and Drug Administration (FDA).
His most cited research focused on whether the newly marketed heart failure drug nesiritide (hr-BNP, Natrecor) was safe and effective, with a call for large-scale clinical trials prior to widespread use. While nesiritide was projected to generate $1 billion in sales in 2006, these studies triggered controversy that eventually led to markedly lower use by physicians.
He is also the author of a book on heart disease, Before It Happens To You.
US government projects
Sackner-Bernstein joined the FDA in 2008 as Associate Center Director, leading Post Market Operations as well as Technology and Innovation programs. As the Center's first Associate Center Director for Technology and Innovation, Sackner-Bernstein launched the Innovation Initiative in 2011,  which subsequently led to the Early Feasibility Program and laid the foundation for the Breakthrough Device Program.
He also helped establish a formal relationship between FDA and DARPA (Defense Advanced Research Projects Agency), then serving as architect for the initial Entrepreneurs-in-Residence Program. sponsored by the White House Office of Science and Technology Policy (OSTP) 
From late 2018 to mid 2019, Sackner-Bernstein served as Chief Medical Officer and EVP, Clinical and Regulatory Affairs for ROX Medical.
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- Saul, Stephanie (2005-05-17). "The Marketing and Success of Natrecor". The New York Times.
- Creative Computing Magazine (December 1983) Volume 09 Number 12. December 1983.
- "Medscape: Medscape Access".
- European Heart Journal (abstract P1651): http://eurheartj.oxfordjournals.org/content/ehj/21/Abstract_Supplement/1.full.pdf
- Sackner-Bernstein, JD; Skopicki, HA; Aaronson, KD (Mar 2005). "Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure". Circulation. 111 (12): 1487–91. doi:10.1161/01.CIR.0000159340.93220.E4. PMID 15781736.
- Sackner-Bernstein, JD; Kowalski, M; Fox, M; Aaronson, K (2005). "Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials". JAMA. 293 (15): 1900–5. doi:10.1001/jama.293.15.1900. PMID 15840865.
- Aaronson, KD; Sackner-Bernstein, J (2006). "Risk of death associated with nesiritide in patients with acutely decompensated heart failure". JAMA. 296 (12): 1465–6. doi:10.1001/jama.296.12.1465. PMID 17003394.
- "Heart drug's usage causes concern among some doctors".
- NY Times May 4, 2005: https://www.nytimes.com/2005/05/04/health/heart-clinic-may-end-or-curtail-use-of-a-drug.html?_r=0 and 17, 2005: https://www.nytimes.com/2005/05/17/business/the-marketing-and-success-of-natrecor.html?_r=0
- Hauptman, PJ; Schnitzler, MA; Swindle, J; Burroughs, TE (Oct 2006). "Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure". JAMA. 296 (15): 1877–84. doi:10.1001/jama.296.15.1877. PMC 2840641. PMID 17047218.
- Wilson S. Colucci (1996). "Carvedilol Inhibits Clinical Progression in Patients With Mild Symptoms of Heart Failure". Circulation. 94 (11): 2800–2806. doi:10.1161/01.CIR.94.11.2800. PMID 8941105.
- Thomas M. Behr (2001). "Hypertensive End-Organ Damage and Premature Mortality Are p38 Mitogen-Activated Protein Kinase–Dependent in a Rat Model of Cardiac Hypertrophy and Dysfunction". Circulation. 104 (11): 1292–1298. doi:10.1161/hc3601.094275. PMID 11551882.
- "Nonfiction Book Review: Before It Happens to You: A Breakthrough Program for Reversing or Preventing Heart Disease by Jonathan Sackner-Bernstein". PublishersWeekly.com.
- http://www.medscape.com/viewarticle/790276, October 16, 2008
- http://www.raps.org/WorkArea/DownloadAsset.aspx?id=3379, accessed December 11, 2017
- Dec 2010: https://www.gpo.gov/fdsys/pkg/FR-2010-12-20/html/2010-31811.htm
- "ROX Medical, Inc. Hires Dr. Sackner-Bernstein as CMO and Executive VP of Clinical and Regulatory Affairs".