Jonathan Sackner-Bernstein
Jonathan Sackner-Bernstein | |
|---|---|
 Sackner-Bernstein in 2019 | |
| Born | January 27, 1961 |
| Nationality | American |
| Alma mater | Miami Beach Senior High School University of Pennsylvania Moore School of Electrical Engineering Jefferson Medical College |
| Occupation | Cardiologist |
| Organization(s) | Mt. Sinai Hospital Columbia University Food and Drug Administration DARPA ExVivos |
| Known for | Biotech, Medtech, Clinical Research |
| Spouse | 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.[1] 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.[2]
Education
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.[3] 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.[4]
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).[5]
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.[6][7][8] While nesiritide was projected to generate $1 billion in sales in 2006,[9] these studies triggered controversy[10] that eventually led to markedly lower use by physicians.[11]
Other frequently cited articles include work on Carvedilol [12] and cardiac hypertrophy.[13]
He is also the author of a book on heart disease, Before It Happens To You.[14]
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.[15] As the Center's first Associate Center Director for Technology and Innovation, Sackner-Bernstein launched the Innovation Initiative in 2011, [16] 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),[17] then serving as architect for the initial Entrepreneurs-in-Residence Program. sponsored by the White House Office of Science and Technology Policy (OSTP) [18]
Commercial projects
From late 2018 to mid 2019, Sackner-Bernstein served as Chief Medical Officer and EVP, Clinical and Regulatory Affairs for ROX Medical.[19]
References
- ^ "jonathan sackner bernstein - Google Scholar".
- ^ 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
- ^ https://www.signup4.net/Upload/BOOZ12A/CTSA37E/File%208_Speaker%20Biographies.pdf
- ^ "ROX Medical, Inc. Hires Dr. Sackner-Bernstein as CMO and Executive VP of Clinical and Regulatory Affairs".