Sean Khozin, MD, MPH
Global Head of Data Strategy; Janssen R&D, Johnson & Johnson
Research Affiliate: MIT
Composer and Instrumentalist: wel.kins
Previously:
[Opinions my own]
Research Affiliate: MIT
Composer and Instrumentalist: wel.kins
Previously:
- Associate Director: FDA Oncology Center of Excellence
- Founding Director: Information Exchange and Data Transformation (INFORMED), an incubator for driving innovations in agile technology, digital health, and data science to advance public health
- Cofounder, Hello Health
- Founder & Chief Medical Officer, SKMD: High-tech and high-touch patient-centered healthcare delivery network in New York City seamlessly incorporating telemedicine, remote motoring, and advanced analytics into clinical workflows. Dubbed by Health Affairs "an emblem of modern medicine."
[Opinions my own]
Selected Publications
Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study.
Health Aff (Millwood). 2018 May;37(5):765-772.
INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.
Nat Rev Drug Discov. 2018 Apr 6. doi: 10.1038/nrd.2018.34.
Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
Oncologist. 2018 Jan 9. pii: theoncologist.2017-0353
Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.
Cell , Volume 171 , Issue 5 , 982 - 986
Real-world Data for Clinical Evidence Generation in Oncology.
J Natl Cancer Inst. 2017 Nov 1;109(11).
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Nat Rev Drug Discov. 2017 Oct;16(10):736.
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.
JAMA Oncol. 2017 Jun 15:e171029.
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Clin Cancer Res. 2017 Jun 13. pii: clincanres.0540.2017.
Data-Sharing Models.
N Engl J Med. 2017 Jun 8;376(23):2305-2306.
Advantages of a Truly Open-Access Data-Sharing Model
N Engl J Med. 2017 Mar 23;376(12):1178-1181.
From big data to smart data: FDA's INFORMED initiative
Nat Rev Drug Discov. 2017 Feb 24. doi: 10.1038/nrd.2017.26
Osimertinib for the Treatment of Metastatic Epidermal Growth Factor T970M Positive Non-Small Cell Lung Cancer
Clin Cancer Res. 2016 Dec 6. pii: clincanres.1773.2016
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period
Ther Innov Regul Sci. 2016 Nov;50(6):705-709.
Evaluating the potential for digital submission of expedited premarket safety reports to the FDA
Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1.
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer
Ann Oncol. 2016 Apr;27(4):693-9.
Clinician Perspectives on Current Issues in Lung Cancer Drug Development
J Thorac Oncol. 2016 Sep;11(9):1387-96.
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Clin Cancer Res. 2016 Jan 18
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced non-small cell lung cancerBenefit-Risk Summary of Nivolumab for Patients With Metastatic
Ann Oncol. 2016 Jan 22.
Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.
JAMA Oncol. 2016 Jan 1;2(1):118-22.
Why do oncology drugs fail to gain US regulatory approval?
Nat Rev Drug Discov. 2015 May 22.
Ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.
Clin Cancer Res. 2015 Jun 1;21(11):2436-9
Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.
J Clin Oncol. 2015 Mar 20;33(9)
Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations.
Oncologist. 2014 Jul;19(7):774-9
Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial.
Lancet Oncol. 2014 Feb;15(2):191-200
A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung Cancer
Ann Oncol. 2013 Oct;24(10):2601-6
Concurrent molecular alterations in tumors with germ line epidermal growth factor receptor T790M mutations.
Clin Lung Cancer. 2013 Jul;14(4):452-6
18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumors.
Clin Cancer Res. 2013 Mar 15;19(6):1487-93
Hepatoid carcinoma of the lung with anaplastic lymphoma kinase gene rearrangement
J Thorac Oncol. 2012 Nov;7(11):e29-31
Response to crizotinib in ROS1-rearranged non-small-cell lung cancer.
J Clin Oncol. 2012 Sep 20;30(27):3425-6; author reply 3426
Integrating a Physical Office with an Online Platform to Improve Continuity of Care and Expand Patient-Physician Communication.
J Participat Med. 2011 Jan 12; 3:e5.
Using the hierarchy of control technologies to improve healthcare facility infection control: lessons from severe acute respiratory syndrome.
J Occup Environ Med. 2004 Jul;46(7):613-22
The effects of adrenalectomy and aldosterone replacement in transgenic mice expressing antisense RNA to the type 2 glucocorticoid receptor.
Physiol Behav. 2002 Nov;77(2-3):417-23
Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effects.
J Clin Invest. 2002 Jun;109(12):1607-15
Health Aff (Millwood). 2018 May;37(5):765-772.
INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.
Nat Rev Drug Discov. 2018 Apr 6. doi: 10.1038/nrd.2018.34.
Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
Oncologist. 2018 Jan 9. pii: theoncologist.2017-0353
Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.
Cell , Volume 171 , Issue 5 , 982 - 986
Real-world Data for Clinical Evidence Generation in Oncology.
J Natl Cancer Inst. 2017 Nov 1;109(11).
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Nat Rev Drug Discov. 2017 Oct;16(10):736.
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.
JAMA Oncol. 2017 Jun 15:e171029.
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Clin Cancer Res. 2017 Jun 13. pii: clincanres.0540.2017.
Data-Sharing Models.
N Engl J Med. 2017 Jun 8;376(23):2305-2306.
Advantages of a Truly Open-Access Data-Sharing Model
N Engl J Med. 2017 Mar 23;376(12):1178-1181.
From big data to smart data: FDA's INFORMED initiative
Nat Rev Drug Discov. 2017 Feb 24. doi: 10.1038/nrd.2017.26
Osimertinib for the Treatment of Metastatic Epidermal Growth Factor T970M Positive Non-Small Cell Lung Cancer
Clin Cancer Res. 2016 Dec 6. pii: clincanres.1773.2016
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period
Ther Innov Regul Sci. 2016 Nov;50(6):705-709.
Evaluating the potential for digital submission of expedited premarket safety reports to the FDA
Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1.
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer
Ann Oncol. 2016 Apr;27(4):693-9.
Clinician Perspectives on Current Issues in Lung Cancer Drug Development
J Thorac Oncol. 2016 Sep;11(9):1387-96.
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Clin Cancer Res. 2016 Jan 18
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced non-small cell lung cancerBenefit-Risk Summary of Nivolumab for Patients With Metastatic
Ann Oncol. 2016 Jan 22.
Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.
JAMA Oncol. 2016 Jan 1;2(1):118-22.
Why do oncology drugs fail to gain US regulatory approval?
Nat Rev Drug Discov. 2015 May 22.
Ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.
Clin Cancer Res. 2015 Jun 1;21(11):2436-9
Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.
J Clin Oncol. 2015 Mar 20;33(9)
Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations.
Oncologist. 2014 Jul;19(7):774-9
Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial.
Lancet Oncol. 2014 Feb;15(2):191-200
A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung Cancer
Ann Oncol. 2013 Oct;24(10):2601-6
Concurrent molecular alterations in tumors with germ line epidermal growth factor receptor T790M mutations.
Clin Lung Cancer. 2013 Jul;14(4):452-6
18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumors.
Clin Cancer Res. 2013 Mar 15;19(6):1487-93
Hepatoid carcinoma of the lung with anaplastic lymphoma kinase gene rearrangement
J Thorac Oncol. 2012 Nov;7(11):e29-31
Response to crizotinib in ROS1-rearranged non-small-cell lung cancer.
J Clin Oncol. 2012 Sep 20;30(27):3425-6; author reply 3426
Integrating a Physical Office with an Online Platform to Improve Continuity of Care and Expand Patient-Physician Communication.
J Participat Med. 2011 Jan 12; 3:e5.
Using the hierarchy of control technologies to improve healthcare facility infection control: lessons from severe acute respiratory syndrome.
J Occup Environ Med. 2004 Jul;46(7):613-22
The effects of adrenalectomy and aldosterone replacement in transgenic mice expressing antisense RNA to the type 2 glucocorticoid receptor.
Physiol Behav. 2002 Nov;77(2-3):417-23
Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effects.
J Clin Invest. 2002 Jun;109(12):1607-15
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