Sean Khozin, MD, MPH
Global Head of Data Strategy; Janssen R&D, Johnson & Johnson
Research Affiliate: MIT
Previously:
[Opinions my own]
Research Affiliate: MIT
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
- "INFORMED is a new initiative at the FDA to incubate new ideas in applying big data to boost the scientific, economic and social returns from the regulation of drugs and medical devices" In Vivo Magazine
- Clinical Investigator: National Cancer Insititue
- Cofounder, Hello Health
- Founder & Chief Medical Officer, SKMD: High-tech and high-touch patient-centered healthcare delivery network seamlessly incorporating telemedicine, remote motoring, and advanced analytics into clinical workflows. Dubbed by Health Affairs "an emblem of modern medicine."
[Opinions my own]
Select Publications
Status Update on Data Required to Build a Learning Health System.
Bertagnolli MM, Anderson B, Norsworthy K, Piantadosi S, Quina A, Schilsky RL, Miller RS, Khozin S.
J Clin Oncol. 2020 May 10;38(14):1602-1607. doi: 10.1200/JCO.19.03094. Epub 2020 Mar 25.
PMID: 32209005
"A Letter in Support of Real-World RECIST".
Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA.
Adv Ther. 2020 Apr;37(4):1691-1693. doi: 10.1007/s12325-020-01246-9. Epub 2020 Feb 13.
PMID: 32056085
Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer.
Parikh RB, Adamson BJS, Khozin S, Galsky MD, Baxi SS, Cohen A, Mamtani R.
JAMA. 2019 Sep 24;322(12):1209-1211. doi: 10.1001/jama.2019.10650.
PMID: 31550019
Machine-Learning and Stochastic Tumor Growth Models for Predicting Outcomes in Patients With Advanced Non-Small-Cell Lung Cancer.
Siah KW, Khozin S, Wong CH, Lo AW.
JCO Clin Cancer Inform. 2019 Sep;3:1-11. doi: 10.1200/CCI.19.00046.
PMID: 31539267
Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non-Small-Cell Lung Cancer Data Set.
Griffith SD, Miksad RA, Calkins G, You P, Lipitz NG, Bourla AB, Williams E, George DJ, Schrag D, Khozin S, Capra WB, Taylor MD, Abernethy AP.
JCO Clin Cancer Inform. 2019 Aug;3:1-13. doi: 10.1200/CCI.19.00013.
PMID: 31403818
Real-world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non-small cell lung cancer.
Khozin S, Miksad RA, Adami J, Boyd M, Brown NR, Gossai A, Kaganman I, Kuk D, Rockland JM, Pazdur R, Torres AZ, Zhi J, Abernethy AP.
Cancer. 2019 Nov 15;125(22):4019-4032. doi: 10.1002/cncr.32383. Epub 2019 Aug 5.
PMID: 31381142 Clinical Trial.
Artificial intelligence and machine learning in clinical development: a translational perspective.
Shah P, Kendall F, Khozin S, Goosen R, Hu J, Laramie J, Ringel M, Schork N.
NPJ Digit Med. 2019 Jul 26;2:69. doi: 10.1038/s41746-019-0148-3. eCollection 2019.
PMID: 31372505 Review.
An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non-Small-Cell Lung Cancer.
Stewart M, Norden AD, Dreyer N, Henk HJ, Abernethy AP, Chrischilles E, Kushi L, Mansfield AS, Khozin S, Sharon E, Arunajadai S, Carnahan R, Christian JB, Miksad RA, Sakoda LC, Torres AZ, Valice E, Allen J.
JCO Clin Cancer Inform. 2019 Jul;3:1-15. doi: 10.1200/CCI.18.00155.
PMID: 31335166
Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer.
Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA.
Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.
PMID: 31140124
Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations.
Khozin S, Coravos A.
Clin Pharmacol Ther. 2019 Jul;106(1):25-27. doi: 10.1002/cpt.1441. Epub 2019 Apr 23.
PMID: 31013350
Developing and adopting safe and effective digital biomarkers to improve patient outcomes.
Coravos A, Khozin S, Mandl KD.
Version 2. NPJ Digit Med. 2019;2(1):14. doi: 10.1038/s41746-019-0090-4. Epub 2019 Mar 11.
PMID: 30868107
Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.
Blumenthal GM, Gong Y, Kehl K, Mishra-Kalyani P, Goldberg KB, Khozin S, Kluetz PG, Oxnard GR, Pazdur R.
Ann Oncol. 2019 May 1;30(5):830-838. doi: 10.1093/annonc/mdz060.
PMID: 30796424
Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.
Khozin S, Carson KR, Zhi J, Tucker M, Lee SE, Light DE, Curtis MD, Bralic M, Kaganman I, Gossai A, Hofmeister P, Torres AZ, Miksad RA, Blumenthal GM, Pazdur R, Abernethy AP.
Oncologist. 2019 May;24(5):648-656. doi: 10.1634/theoncologist.2018-0307. Epub 2018 Dec 27.
PMID: 30591549
Assessing function of electronic health records for real-world data generation.
Guinn D, Wilhelm EE, Lieberman G, Khozin S.
BMJ Evid Based Med. 2019 Jun;24(3):95-98. doi: 10.1136/bmjebm-2018-111111. Epub 2018 Nov 26.
PMID: 30478146
Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study.
Agarwala V, Khozin S, Singal G, O'Connell C, Kuk D, Li G, Gossai A, Miller V, Abernethy AP.
Health Aff (Millwood). 2018 May;37(5):765-772. doi: 10.1377/hlthaff.2017.1579.
PMID: 29733723 Review.
INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.
Khozin S, Pazdur R, Shah A.
Nat Rev Drug Discov. 2018 Aug;17(8):529-530. doi: 10.1038/nrd.2018.34. Epub 2018 Apr 6.
PMID: 29622786
Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
Khozin S, Abernethy AP, Nussbaum NC, Zhi J, Curtis MD, Tucker M, Lee SE, Light DE, Gossai A, Sorg RA, Torres AZ, Patel P, Blumenthal GM, Pazdur R.
Oncologist. 2018 Mar;23(3):328-336. doi: 10.1634/theoncologist.2017-0353. Epub 2018 Jan 9.
PMID: 29317551 Free PMC article. Clinical Trial.
Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.
Conley RB, Dickson D, Zenklusen JC, Al Naber J, Messner DA, Atasoy A, Chaihorsky L, Collyar D, Compton C, Ferguson M, Khozin S, Klein RD, Kotte S, Kurzrock R, Lin CJ, Liu F, Marino I, McDonough R, McNeal A, Miller V, Schilsky RL, Wang LI.
Cell. 2017 Nov 16;171(5):982-986. doi: 10.1016/j.cell.2017.10.032.
PMID: 29149611
Real-world Data for Clinical Evidence Generation in Oncology.
Khozin S, Blumenthal GM, Pazdur R.
J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187.
PMID: 29059439
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Arnerić SP, Cedarbaum JM, Khozin S, Papapetropoulos S, Hill DL, Ropacki M, Rhodes J, Dacks PA, Hudson LD, Gordon MF, Kern VD, Romero K, Vradenburg G, Au R, Karlin DR, Facheris MF, Fitzer-Attas CJ, Vitolo OV, Wang J, Miller BM, Kaye JA.
Nat Rev Drug Discov. 2017 Oct;16(10):736. doi: 10.1038/nrd.2017.153. Epub 2017 Sep 22.
PMID: 28935908
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.
Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.
JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.
PMID: 28617920
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Weinstock C, Khozin S, Suzman D, Zhang L, Tang S, Wahby S, Goldberg KB, Kim G, Pazdur R.
Clin Cancer Res. 2017 Aug 15;23(16):4534-4539. doi: 10.1158/1078-0432.CCR-17-0540. Epub 2017 Jun 13.
PMID: 28611199
Data-Sharing Models.
Bertagnoll MM, Khozin S, Murphy MJ.
N Engl J Med. 2017 Jun 8;376(23):2305-2306. doi: 10.1056/NEJMc1705477.
PMID: 28591539
Advantages of a Truly Open-Access Data-Sharing Model.
Bertagnolli MM, Sartor O, Chabner BA, Rothenberg ML, Khozin S, Hugh-Jones C, Reese DM, Murphy MJ.
N Engl J Med. 2017 Mar 23;376(12):1178-1181. doi: 10.1056/NEJMsb1702054.
PMID: 28328337
From big data to smart data: FDA's INFORMED initiative.
Khozin S, Kim G, Pazdur R.
Nat Rev Drug Discov. 2017 May;16(5):306. doi: 10.1038/nrd.2017.26. Epub 2017 Feb 24.
PMID: 28232724 Review.
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.
Khozin S, Weinstock C, Blumenthal GM, Cheng J, He K, Zhuang L, Zhao H, Charlab R, Fan I, Keegan P, Pazdur R.
Clin Cancer Res. 2017 May 1;23(9):2131-2135. doi: 10.1158/1078-0432.CCR-16-1773. Epub 2016 Dec 6.
PMID: 27923840 Clinical Trial.
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R.
Ther Innov Regul Sci. 2016 Nov;50(6):705-709. doi: 10.1177/2168479016656030.
PMID: 27917324
Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.
Khozin S, Chuk M, Kim T, Kim G, Pazdur R, De S, Sahoo S.
Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1. doi: 10.1038/nrd.2016.189.
PMID: 27681787
Clinician Perspectives on Current Issues in Lung Cancer Drug Development.
Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM.
J Thorac Oncol. 2016 Sep;11(9):1387-96. doi: 10.1016/j.jtho.2016.05.009. Epub 2016 Jul 9.
PMID: 27401214 Review.
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer.
Carter CA, Rajan A, Keen C, Szabo E, Khozin S, Thomas A, Brzezniak C, Guha U, Doyle LA, Steinberg SM, Xi L, Raffeld M, Tomita Y, Lee MJ, Lee S, Trepel JB, Reckamp KL, Koehler S, Gitlitz B, Salgia R, Gandara D, Vokes E, Giaccone G.
Ann Oncol. 2016 Apr;27(4):693-9. doi: 10.1093/annonc/mdw008. Epub 2016 Jan 22.
PMID: 26802155
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Jarow JP, Casak S, Chuk M, Ehrlich LA, Khozin S.
Clin Cancer Res. 2016 May 1;22(9):2111-3. doi: 10.1158/1078-0432.CCR-15-2082. Epub 2016 Jan 18.
PMID: 26783289
Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.
Kazandjian D, Khozin S, Blumenthal G, Zhang L, Tang S, Libeg M, Kluetz P, Sridhara R, Keegan P, Pazdur R.
JAMA Oncol. 2016 Jan;2(1):118-22. doi: 10.1001/jamaoncol.2015.3934.
PMID: 26470053 Clinical Trial.
Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
Khozin S, Liu K, Jarow JP, Pazdur R.
Nat Rev Drug Discov. 2015 Jul;14(7):450-1. doi: 10.1038/nrd4651. Epub 2015 May 22.
PMID: 26000722
FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.
Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P, Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R.
Clin Cancer Res. 2015 Jun 1;21(11):2436-9. doi: 10.1158/1078-0432.CCR-14-3157. Epub 2015 Mar 9.
PMID: 25754348 Clinical Trial.
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.
Blumenthal GM, Karuri SW, Zhang H, Zhang L, Khozin S, Kazandjian D, Tang S, Sridhara R, Keegan P, Pazdur R.
J Clin Oncol. 2015 Mar 20;33(9):1008-14. doi: 10.1200/JCO.2014.59.0489. Epub 2015 Feb 9.
PMID: 25667291
U.S. Food and Drug Administration approval summary: 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.
Khozin S, Blumenthal GM, Jiang X, He K, Boyd K, Murgo A, Justice R, Keegan P, Pazdur R.
Oncologist. 2014 Jul;19(7):774-9. doi: 10.1634/theoncologist.2014-0089. Epub 2014 May 27.
PMID: 24868098Clinical Trial.
Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial.
Rajan A, Carter CA, Berman A, Cao L, Kelly RJ, Thomas A, Khozin S, Chavez AL, Bergagnini I, Scepura B, Szabo E, Lee MJ, Trepel JB, Browne SK, Rosen LB, Yu Y, Steinberg SM, Chen HX, Riely GJ, Giaccone G.
Lancet Oncol. 2014 Feb;15(2):191-200. doi: 10.1016/S1470-2045(13)70596-5. Epub 2014 Jan 15.
PMID: 24439931 Clinical Trial.
A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Kelly RJ, Thomas A, Rajan A, Chun G, Lopez-Chavez A, Szabo E, Spencer S, Carter CA, Guha U, Khozin S, Poondru S, Van Sant C, Keating A, Steinberg SM, Figg W, Giaccone G.
Ann Oncol. 2013 Oct;24(10):2601-6. doi: 10.1093/annonc/mdt249. Epub 2013 Jul 14.
PMID: 23857959 Clinical Trial.
Concurrent molecular alterations in tumors with germ line epidermal growth factor receptor T790M mutations.
Thomas A, Xi L, Carter CA, Rajan A, Khozin S, Szabo E, Dennis PA, Giaccone G, Raffeld M.
Clin Lung Cancer. 2013 Jul;14(4):452-6. doi: 10.1016/j.cllc.2013.01.005. Epub 2013 Mar 26.
PMID: 23540867
18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumors.
Thomas A, Mena E, Kurdziel K, Venzon D, Khozin S, Berman AW, Choyke P, Szabo E, Rajan A, Giaccone G.
Clin Cancer Res. 2013 Mar 15;19(6):1487-93. doi: 10.1158/1078-0432.CCR-12-2929. Epub 2013 Feb 4.
PMID: 23382114
Hepatoid carcinoma of the lung with anaplastic lymphoma kinase gene rearrangement.
Khozin S, Roth MJ, Rajan A, Smith K, Thomas A, Berman A, Giaccone G.
J Thorac Oncol. 2012 Nov;7(11):e29-31. doi: 10.1097/JTO.0b013e3182697a23.
PMID: 23070248
Response to crizotinib in ROS1-rearranged non-small-cell lung cancer.
Komiya T, Thomas A, Khozin S, Rajan A, Wang Y, Giaccone G.
J Clin Oncol. 2012 Sep 20;30(27):3425-6; author reply 3426. doi: 10.1200/JCO.2012.42.4556. Epub 2012 Aug 13.
PMID: 22891268
Using the hierarchy of control technologies to improve healthcare facility infection control: lessons from severe acute respiratory syndrome.
Thorne CD, Khozin S, McDiarmid MA.
J Occup Environ Med. 2004 Jul;46(7):613-22. doi: 10.1097/01.jom.0000134191.92225.f2.
PMID: 15247800 Review.
The effects of adrenalectomy and aldosterone replacement in transgenic mice expressing antisense RNA to the type 2 glucocorticoid receptor.
Castonguay TW, Beaulieu S, Eskay RL, Barden N, Kamara K, Khozin S, Lustberg L, Brown L.
Physiol Behav. 2002 Nov;77(2-3):417-23. doi: 10.1016/s0031-9384(02)00881-8.
PMID: 12419418
Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effects.
Yang YA, Dukhanina O, Tang B, Mamura M, Letterio JJ, MacGregor J, Patel SC, Khozin S, Liu ZY, Green J, Anver MR, Merlino G, Wakefield LM.
J Clin Invest. 2002 Jun;109(12):1607-15. doi: 10.1172/JCI15333.
PMID: 12070308
Bertagnolli MM, Anderson B, Norsworthy K, Piantadosi S, Quina A, Schilsky RL, Miller RS, Khozin S.
J Clin Oncol. 2020 May 10;38(14):1602-1607. doi: 10.1200/JCO.19.03094. Epub 2020 Mar 25.
PMID: 32209005
"A Letter in Support of Real-World RECIST".
Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA.
Adv Ther. 2020 Apr;37(4):1691-1693. doi: 10.1007/s12325-020-01246-9. Epub 2020 Feb 13.
PMID: 32056085
Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer.
Parikh RB, Adamson BJS, Khozin S, Galsky MD, Baxi SS, Cohen A, Mamtani R.
JAMA. 2019 Sep 24;322(12):1209-1211. doi: 10.1001/jama.2019.10650.
PMID: 31550019
Machine-Learning and Stochastic Tumor Growth Models for Predicting Outcomes in Patients With Advanced Non-Small-Cell Lung Cancer.
Siah KW, Khozin S, Wong CH, Lo AW.
JCO Clin Cancer Inform. 2019 Sep;3:1-11. doi: 10.1200/CCI.19.00046.
PMID: 31539267
Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non-Small-Cell Lung Cancer Data Set.
Griffith SD, Miksad RA, Calkins G, You P, Lipitz NG, Bourla AB, Williams E, George DJ, Schrag D, Khozin S, Capra WB, Taylor MD, Abernethy AP.
JCO Clin Cancer Inform. 2019 Aug;3:1-13. doi: 10.1200/CCI.19.00013.
PMID: 31403818
Real-world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non-small cell lung cancer.
Khozin S, Miksad RA, Adami J, Boyd M, Brown NR, Gossai A, Kaganman I, Kuk D, Rockland JM, Pazdur R, Torres AZ, Zhi J, Abernethy AP.
Cancer. 2019 Nov 15;125(22):4019-4032. doi: 10.1002/cncr.32383. Epub 2019 Aug 5.
PMID: 31381142 Clinical Trial.
Artificial intelligence and machine learning in clinical development: a translational perspective.
Shah P, Kendall F, Khozin S, Goosen R, Hu J, Laramie J, Ringel M, Schork N.
NPJ Digit Med. 2019 Jul 26;2:69. doi: 10.1038/s41746-019-0148-3. eCollection 2019.
PMID: 31372505 Review.
An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non-Small-Cell Lung Cancer.
Stewart M, Norden AD, Dreyer N, Henk HJ, Abernethy AP, Chrischilles E, Kushi L, Mansfield AS, Khozin S, Sharon E, Arunajadai S, Carnahan R, Christian JB, Miksad RA, Sakoda LC, Torres AZ, Valice E, Allen J.
JCO Clin Cancer Inform. 2019 Jul;3:1-15. doi: 10.1200/CCI.18.00155.
PMID: 31335166
Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer.
Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA.
Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.
PMID: 31140124
Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations.
Khozin S, Coravos A.
Clin Pharmacol Ther. 2019 Jul;106(1):25-27. doi: 10.1002/cpt.1441. Epub 2019 Apr 23.
PMID: 31013350
Developing and adopting safe and effective digital biomarkers to improve patient outcomes.
Coravos A, Khozin S, Mandl KD.
Version 2. NPJ Digit Med. 2019;2(1):14. doi: 10.1038/s41746-019-0090-4. Epub 2019 Mar 11.
PMID: 30868107
Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.
Blumenthal GM, Gong Y, Kehl K, Mishra-Kalyani P, Goldberg KB, Khozin S, Kluetz PG, Oxnard GR, Pazdur R.
Ann Oncol. 2019 May 1;30(5):830-838. doi: 10.1093/annonc/mdz060.
PMID: 30796424
Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.
Khozin S, Carson KR, Zhi J, Tucker M, Lee SE, Light DE, Curtis MD, Bralic M, Kaganman I, Gossai A, Hofmeister P, Torres AZ, Miksad RA, Blumenthal GM, Pazdur R, Abernethy AP.
Oncologist. 2019 May;24(5):648-656. doi: 10.1634/theoncologist.2018-0307. Epub 2018 Dec 27.
PMID: 30591549
Assessing function of electronic health records for real-world data generation.
Guinn D, Wilhelm EE, Lieberman G, Khozin S.
BMJ Evid Based Med. 2019 Jun;24(3):95-98. doi: 10.1136/bmjebm-2018-111111. Epub 2018 Nov 26.
PMID: 30478146
Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study.
Agarwala V, Khozin S, Singal G, O'Connell C, Kuk D, Li G, Gossai A, Miller V, Abernethy AP.
Health Aff (Millwood). 2018 May;37(5):765-772. doi: 10.1377/hlthaff.2017.1579.
PMID: 29733723 Review.
INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.
Khozin S, Pazdur R, Shah A.
Nat Rev Drug Discov. 2018 Aug;17(8):529-530. doi: 10.1038/nrd.2018.34. Epub 2018 Apr 6.
PMID: 29622786
Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
Khozin S, Abernethy AP, Nussbaum NC, Zhi J, Curtis MD, Tucker M, Lee SE, Light DE, Gossai A, Sorg RA, Torres AZ, Patel P, Blumenthal GM, Pazdur R.
Oncologist. 2018 Mar;23(3):328-336. doi: 10.1634/theoncologist.2017-0353. Epub 2018 Jan 9.
PMID: 29317551 Free PMC article. Clinical Trial.
Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.
Conley RB, Dickson D, Zenklusen JC, Al Naber J, Messner DA, Atasoy A, Chaihorsky L, Collyar D, Compton C, Ferguson M, Khozin S, Klein RD, Kotte S, Kurzrock R, Lin CJ, Liu F, Marino I, McDonough R, McNeal A, Miller V, Schilsky RL, Wang LI.
Cell. 2017 Nov 16;171(5):982-986. doi: 10.1016/j.cell.2017.10.032.
PMID: 29149611
Real-world Data for Clinical Evidence Generation in Oncology.
Khozin S, Blumenthal GM, Pazdur R.
J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187.
PMID: 29059439
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Arnerić SP, Cedarbaum JM, Khozin S, Papapetropoulos S, Hill DL, Ropacki M, Rhodes J, Dacks PA, Hudson LD, Gordon MF, Kern VD, Romero K, Vradenburg G, Au R, Karlin DR, Facheris MF, Fitzer-Attas CJ, Vitolo OV, Wang J, Miller BM, Kaye JA.
Nat Rev Drug Discov. 2017 Oct;16(10):736. doi: 10.1038/nrd.2017.153. Epub 2017 Sep 22.
PMID: 28935908
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.
Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.
JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.
PMID: 28617920
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Weinstock C, Khozin S, Suzman D, Zhang L, Tang S, Wahby S, Goldberg KB, Kim G, Pazdur R.
Clin Cancer Res. 2017 Aug 15;23(16):4534-4539. doi: 10.1158/1078-0432.CCR-17-0540. Epub 2017 Jun 13.
PMID: 28611199
Data-Sharing Models.
Bertagnoll MM, Khozin S, Murphy MJ.
N Engl J Med. 2017 Jun 8;376(23):2305-2306. doi: 10.1056/NEJMc1705477.
PMID: 28591539
Advantages of a Truly Open-Access Data-Sharing Model.
Bertagnolli MM, Sartor O, Chabner BA, Rothenberg ML, Khozin S, Hugh-Jones C, Reese DM, Murphy MJ.
N Engl J Med. 2017 Mar 23;376(12):1178-1181. doi: 10.1056/NEJMsb1702054.
PMID: 28328337
From big data to smart data: FDA's INFORMED initiative.
Khozin S, Kim G, Pazdur R.
Nat Rev Drug Discov. 2017 May;16(5):306. doi: 10.1038/nrd.2017.26. Epub 2017 Feb 24.
PMID: 28232724 Review.
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.
Khozin S, Weinstock C, Blumenthal GM, Cheng J, He K, Zhuang L, Zhao H, Charlab R, Fan I, Keegan P, Pazdur R.
Clin Cancer Res. 2017 May 1;23(9):2131-2135. doi: 10.1158/1078-0432.CCR-16-1773. Epub 2016 Dec 6.
PMID: 27923840 Clinical Trial.
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R.
Ther Innov Regul Sci. 2016 Nov;50(6):705-709. doi: 10.1177/2168479016656030.
PMID: 27917324
Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.
Khozin S, Chuk M, Kim T, Kim G, Pazdur R, De S, Sahoo S.
Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1. doi: 10.1038/nrd.2016.189.
PMID: 27681787
Clinician Perspectives on Current Issues in Lung Cancer Drug Development.
Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM.
J Thorac Oncol. 2016 Sep;11(9):1387-96. doi: 10.1016/j.jtho.2016.05.009. Epub 2016 Jul 9.
PMID: 27401214 Review.
Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer.
Carter CA, Rajan A, Keen C, Szabo E, Khozin S, Thomas A, Brzezniak C, Guha U, Doyle LA, Steinberg SM, Xi L, Raffeld M, Tomita Y, Lee MJ, Lee S, Trepel JB, Reckamp KL, Koehler S, Gitlitz B, Salgia R, Gandara D, Vokes E, Giaccone G.
Ann Oncol. 2016 Apr;27(4):693-9. doi: 10.1093/annonc/mdw008. Epub 2016 Jan 22.
PMID: 26802155
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Jarow JP, Casak S, Chuk M, Ehrlich LA, Khozin S.
Clin Cancer Res. 2016 May 1;22(9):2111-3. doi: 10.1158/1078-0432.CCR-15-2082. Epub 2016 Jan 18.
PMID: 26783289
Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.
Kazandjian D, Khozin S, Blumenthal G, Zhang L, Tang S, Libeg M, Kluetz P, Sridhara R, Keegan P, Pazdur R.
JAMA Oncol. 2016 Jan;2(1):118-22. doi: 10.1001/jamaoncol.2015.3934.
PMID: 26470053 Clinical Trial.
Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
Khozin S, Liu K, Jarow JP, Pazdur R.
Nat Rev Drug Discov. 2015 Jul;14(7):450-1. doi: 10.1038/nrd4651. Epub 2015 May 22.
PMID: 26000722
FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.
Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P, Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R.
Clin Cancer Res. 2015 Jun 1;21(11):2436-9. doi: 10.1158/1078-0432.CCR-14-3157. Epub 2015 Mar 9.
PMID: 25754348 Clinical Trial.
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.
Blumenthal GM, Karuri SW, Zhang H, Zhang L, Khozin S, Kazandjian D, Tang S, Sridhara R, Keegan P, Pazdur R.
J Clin Oncol. 2015 Mar 20;33(9):1008-14. doi: 10.1200/JCO.2014.59.0489. Epub 2015 Feb 9.
PMID: 25667291
U.S. Food and Drug Administration approval summary: 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.
Khozin S, Blumenthal GM, Jiang X, He K, Boyd K, Murgo A, Justice R, Keegan P, Pazdur R.
Oncologist. 2014 Jul;19(7):774-9. doi: 10.1634/theoncologist.2014-0089. Epub 2014 May 27.
PMID: 24868098Clinical Trial.
Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial.
Rajan A, Carter CA, Berman A, Cao L, Kelly RJ, Thomas A, Khozin S, Chavez AL, Bergagnini I, Scepura B, Szabo E, Lee MJ, Trepel JB, Browne SK, Rosen LB, Yu Y, Steinberg SM, Chen HX, Riely GJ, Giaccone G.
Lancet Oncol. 2014 Feb;15(2):191-200. doi: 10.1016/S1470-2045(13)70596-5. Epub 2014 Jan 15.
PMID: 24439931 Clinical Trial.
A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Kelly RJ, Thomas A, Rajan A, Chun G, Lopez-Chavez A, Szabo E, Spencer S, Carter CA, Guha U, Khozin S, Poondru S, Van Sant C, Keating A, Steinberg SM, Figg W, Giaccone G.
Ann Oncol. 2013 Oct;24(10):2601-6. doi: 10.1093/annonc/mdt249. Epub 2013 Jul 14.
PMID: 23857959 Clinical Trial.
Concurrent molecular alterations in tumors with germ line epidermal growth factor receptor T790M mutations.
Thomas A, Xi L, Carter CA, Rajan A, Khozin S, Szabo E, Dennis PA, Giaccone G, Raffeld M.
Clin Lung Cancer. 2013 Jul;14(4):452-6. doi: 10.1016/j.cllc.2013.01.005. Epub 2013 Mar 26.
PMID: 23540867
18F-fluorodeoxyglucose positron emission tomography in the management of patients with thymic epithelial tumors.
Thomas A, Mena E, Kurdziel K, Venzon D, Khozin S, Berman AW, Choyke P, Szabo E, Rajan A, Giaccone G.
Clin Cancer Res. 2013 Mar 15;19(6):1487-93. doi: 10.1158/1078-0432.CCR-12-2929. Epub 2013 Feb 4.
PMID: 23382114
Hepatoid carcinoma of the lung with anaplastic lymphoma kinase gene rearrangement.
Khozin S, Roth MJ, Rajan A, Smith K, Thomas A, Berman A, Giaccone G.
J Thorac Oncol. 2012 Nov;7(11):e29-31. doi: 10.1097/JTO.0b013e3182697a23.
PMID: 23070248
Response to crizotinib in ROS1-rearranged non-small-cell lung cancer.
Komiya T, Thomas A, Khozin S, Rajan A, Wang Y, Giaccone G.
J Clin Oncol. 2012 Sep 20;30(27):3425-6; author reply 3426. doi: 10.1200/JCO.2012.42.4556. Epub 2012 Aug 13.
PMID: 22891268
Using the hierarchy of control technologies to improve healthcare facility infection control: lessons from severe acute respiratory syndrome.
Thorne CD, Khozin S, McDiarmid MA.
J Occup Environ Med. 2004 Jul;46(7):613-22. doi: 10.1097/01.jom.0000134191.92225.f2.
PMID: 15247800 Review.
The effects of adrenalectomy and aldosterone replacement in transgenic mice expressing antisense RNA to the type 2 glucocorticoid receptor.
Castonguay TW, Beaulieu S, Eskay RL, Barden N, Kamara K, Khozin S, Lustberg L, Brown L.
Physiol Behav. 2002 Nov;77(2-3):417-23. doi: 10.1016/s0031-9384(02)00881-8.
PMID: 12419418
Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effects.
Yang YA, Dukhanina O, Tang B, Mamura M, Letterio JJ, MacGregor J, Patel SC, Khozin S, Liu ZY, Green J, Anver MR, Merlino G, Wakefield LM.
J Clin Invest. 2002 Jun;109(12):1607-15. doi: 10.1172/JCI15333.
PMID: 12070308
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