I have a broad background in biostatistics pertaining to theory and methods, preclinical and clinical trials, and epidemiology. Since 2006, in my current position, I have written protocols and grants, analyzed data, and co-authored manuscripts arising from clinical studies in surgery, emergency medicine, cancer, and pediatrics. From 1992 to 2005 I was Principal Investigator of the Air Force Health Study, a 20-year prospective epidemiological study of veterans who sprayed Agent Orange and other herbicides in Vietnam; while in that position, I authored or co-authored papers on statistical methods, pharmacokinetics, survival analysis, and epidemiology and presented results to the National Academy of Sciences and the United States Congress. My research interests include Bayesian methods in the design and analysis of clinical studies. I am currently active at the Mays Cancer Center (MCC) as a member of the Protocol Review Committee; additionally I provide statistical guidance and co-authorship on MCC investigator-initiated grants and protocols.
Funding Agency DoD Title W81XWH-17-1-0560 (Jiang) Antibody Therapies for Breast Cancer Status Active Period 9/2017 - 9/2021 Role Co-Investigator Grant Detail Development of Hemichannel-Targeting Antibody Therapies for Breast Cancer Bone Metastasis
Breast Cancer Breakthrough Award Level 3
The major objective of this grant is to develop a therapeutic antibody that targets connexin hemichannel and can be used to treat breast cancer bone metastasis. Funding Agency NIH/NCI Title P30 Cancer Center Support Grant at the University of Texas Health Science Center at San Antonio. Status Active Period 8/2009 - 7/2018 Role Co-Investigator Grant Detail This is a P30 Cancer Center Support Grant at the University of Texas Health Science Center at San Antonio. This grant provides funding for the conduct of cancer clinical trials, prevention studies and assistance with statistical design and analysis of translational cancer research projects. Specifically, this is for support of the biostatistics and medical informatics core which has the following aims: provide flexible, cost-efficient services to CTRC basic, clinical and translational researchers; provides services to aid in the administration of the CTRC including monitoring and reporting functions for compliance with local and Federal regulatory requirements, quality assurance review, preparation of reports and analyses for administrative meetings; to provide informatics components for the Protocol Review Committee, the Data Safety Monitoring Committee and to provide statistical assistance with the development and conduct of clinical protocol-based research. Funding Agency Audie Murphy Mem Vets Hospital Title CAP Project 5 (344-19) Status Active Period 6/2016 - 5/2018 Role Co-Investigator Grant Detail The overarching goals of the STRONG STAR Consortium to Alleviate PTSD (STRONG STAR-CAP) are to improve the psychological and physical health and well-being of Service Members (active duty, National Guard, and Reserve) and Veterans who have deployed in support of OEF/OIF/OND by developing and evaluating the most effective diagnostic, prognostic, preventive, treatment, and rehabilitative strategies for combat-related PTSD and comorbid conditions. The STRONG STAR Consortium to Alleviate PTSD will support projects funded by VA-ORD and DoD. This mobility assignment is funded by the Veterans Administration to support this initiative. Funding Agency NIH/NIA Title Primary Fibroblast Resiliency as a Predictor of Health and Lifespan in Mice Status Active Period 9/2017 - 5/2018 Role Co-Investigator Grant Detail There has been considerable effort to understand the relationship between cellular resiliency (largely defined in these studies as stress resistance) and longevity. However, prior studies have largely focused on this relationship within populations of animals; that is, addressing whether modifying longevity has a similar effect on stress resistance (or vice versa). This study expands on these prior studies with 3 innovations: 1) we will demonstrate for the first time whether patterns of resiliency in the cells of individual mice may be predictive of the lifespan or cause of death of an individual mouse. 2) Because we can establish cell lines throughout the life of the animal, we will determine whether these cell resiliency patterns change with age and determine at what age may be the most predictive marker. 3) We will discover whether interventions known to affect aging alter these patterns of cellular resiliency as a means to adapt this assay as a screen for potential novel interventions to extend longevity. Funding Agency NIH/NIA Title Metformin for Preventing Frailty in High Risk Older Status Active Period 6/2017 - 4/2018 Role Consultant Grant Detail The research described in this proposal will test a pharmacological intervention that could potentially be used to delay/reduce the development of frailty in older adults. In this initial study we will enroll glucose intolerant subjects, a population which encompasses approximately 1/3rd of older adults and is most likely to benefit from metformin. Because of the enormous costs associated with frailty (both personal and economic), an intervention that prevents or delays frailty, even in a sub-population of older adults, would have a major positive impact in our society. To our knowledge, this research will be the first to study a potential intervention targeted toward central pathogenic processes (inflammation and insulin resistance) involved in the etiology of frailty in humans. Funding Agency NIH/NTI Title A National Coordinating Center for Trauma Research/The PROspective Observational Vascular Injury Trial Status Active Period 12/2015 - 11/2017 Role Consultant Grant Detail NTI-NTRR15-11/W81XWH-15-2-0089
The objective of this grant is to establish a prospective, multicenter, observational study through the AAST Multicenter Trials Committee. This study, referred to as PROspective Observational Vascular Injury Trial or PROOVIT, aims to capture key elements of vascular trauma presentation, diagnosis, management, outcomes from leading trauma institutions in the US.
Funding Agency CTRC Title Phase 2 Study of Th-302 for the Treatment of Glioblastoma Status Active Period 7/2017 - 6/2018 Role Consultant Grant Detail One of the most exciting and promising aspects of modern cancer drug development is the potential to personalize treatments by developing drugs that inhibit specific molecular targets. While this potential has come to fruition somewhat, overall this has been limited . Success stories of personalized cancer treatments include erlotinib for anti?epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors for non small-cell lung cancer with modest improvements in survival, anti?human epidermal growth factor receptor 2 (HER2) for breast cancer, and more recently BRAF inhibitors for patients with melanoma whose tumors carried the V600E BRAF mutation. The key to developing such targeted therapies lies in identifying responsive patient populations and tumor characteristics. Due to the molecular heterogeneity of most tumors, however, this has proven extremely challenging. In this application, we take a novel approach in targeting the metabolic state of the tumor, an approach that has not yet been significantly described in the literature. Just as novel is the pairing of an imaging agent and a therapeutic agent whose uptake mechanisms are identical to identify those patients with the highest probability of response. Finally, we integrate the least invasive and potentially simplest means of identifying these patients, through the use of emerging biomarkers of hypoxia.
Funding Agency National Center for Adv Translational Science Title ISG: Inst for Integration of Med Status Active Period 5/2015 - 4/2018 Role Co-Investigator Grant Detail The objective of the Biomedical Informatics Program (BMIP) is to transform our clinical and translational research enterprise by providing access to and promoting the use of an interconnected set of data resources and informatics tools. We will re-engineer our informatics infrastructure in order to optimize the development of innovative methods to solve increasingly complex multidisciplinary research problems and to integrate genotypic, phenotypic, clinical, and public health data sources. In doing so, the BMIP will provide a valuable resource that promotes the overall goals of the Institute for Integration of Medicine and Science (IIMS).
Dearmond DT, Das, NA, Restrepo, CS, Katona, MA, Johnson, SB, Hernandez, BS, Michalek JE. Intra-pleural impedance sensor real-time tracking of pneumothorax in a porcine model of air leak Seminars in Thoracic and Cardiovascular Surgery 2019 Oct;:1-8. Veronica J. Lai, Joel E. Michalek, Qianqian Liu, Brian L. Mealey. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial J Periodontol 2019 Jul;2019(1-8):1-8. Ochoa O, Garza R 3rd, Pisano S, Chrysopoulo M, Ledoux P, Arishita G, Ketchum N, Michalek JE, Nastala C. Prospective Longitudinal Patient-Reported Satisfaction and Health-Related Quality of Life following DIEP Flap Breast Reconstruction: Relationship with Body Mass Index Plastic Reconstructive Surgery 2019 Jun;143(6):1589-1600. Garcia, M, Hernandez, B, Ellington, TG, Kapadia, A, Michalek JE, Fisher-Hoch, S, McCormick, J, Prasad, A. A Lack of Decline in Major Nontraumatic Amputations, and Impact of Revascularization Diabetes Care 2019 Apr;42(4). Feldman MD, Michalek JE. Chronic total occlusions-Is true lumen wire passage preferred to subintimal dissection re-entry? Catheter Cardiovasc Interv 2019 Apr;93:1057-1058. Wu S, Liu Y, Michalek JE, Mesa RA, Parma DL, Rodriguez R, Mansour AM, Svatek R, Tucker TC, Ramirez AG. Carotenoid Intake and Circulating Carotenoids Are Inversely Associated with the Risk of Bladder Cancer: A Dose-Response Meta-analysis Adv Nutr 2019 Apr;. Svatek R. S., Niannian J., de Leon E., Mukherjee N. Z., Kabra A., Hurez V., Nicolas M., Michalek JE, Javors M., Wheeler K., Sharp Z. D., Livi C. B., Shu Z.J., Henkes D., Curiel T. J. Rapamycin Prevents Surgery-Induced Immune Dysfunction in Patients with Bladder Cancer Cancer Immunology Research 2019 Mar;7(3):466-476. Schmitz, G, Rosenblatt, L, Salerno, N, Odette, J, Ren, R, Emanuel,T, Michalek JE, Liu, Q, Du, L, Jahangir, K, Olson, AS. Treatment data using a topical povidone-iodine antiseptic in patients with superficial skin abscesses Data in brief 2019 Mar;. Espinoza SE, Musi N, Wang CP, Michalek JE, Orsak B, Romo T, Powers B, Conde A, Moris M, Blair-Kelps D, Li Y, Ganapathy V, Jergensen TE, Kelly LC, Jiwani R. Rationale and study design of a randomized clinical trial of Metformin to prevent frailty in older adults with diabetes J Gernontol A Biol Sci Med Sci 2019 Mar;. Kaushik D, Wang H, Michalek JE, Liss M, Liu Q, Jha RP, Svatek RS, Mansour AM. Chemoradiation vs radical cystectomy for muscle-invasive bladder cancer;a propensity score-weighted comparative analysis using the National Cancer Database Urology 2019 Jan;:1-11. Bharathy N., Berlow N. E., Wang E., Abraham J., Settelmeyer T. P., Hooper J. E., Svalina M. N., Bajwa Z., Goros M. W., Hernandez B. S., Wolff J. E., Pal R., Davies A. M., Ashok A., Bushby D., Mancini M., Noakes C., Goodwin N. C., Ordentlich P., Keck J., Hawkins D. S., Rudzinski E. R., Mansoor A., Perkins T. J., Vakoc C. R., Michalek JE, Keller C. Preclinical rationale for entinostat embryonal rhabdomyosarcoma Skeletal Muscle 2019 Jan;9. Berlow N E, Rikhi R, Geltzeiler M, Abraham J, Svalina M N, Davis L E, Wise E, Mancini M, Noujaim J, Mansoor A, Quist M J, Matlock K L, Goros M W, Hernandez B S, Doung Y C, Thway K, Tsukahara T, Nishio J, Huang E T, Airhart S, Bult C J, Gandour-Edwards R, Maki R, Jones R L, Michalek JE, Milovancev M, Ghosh S, Pal R, Keller C. Probabilistic modeling of personalized drug combinations from integrated chemical screen and molecular data in sarcoma BMC Cancer 2019 Jan;19(593):1-23. Prasad A, Hughtston H, Michalek J, Trevino A, Gupta K, Martinez JP, Hoang DT, Wu PB, Banerjee S, Masoomi R. Acute kidney injury in patients undergoing endovascular therapy for critical limb ischemia Catheter Cardiovascular Intervention 2018 Nov;:636-641. Choi B, Wang CP, Michalek JE, Gelfond JA. Power comparison for propensity score methods Computational Statistics 2018 Nov;. Bharathy, N, Berlow, NE, Wang, E, Abraham, J, Settelmeyer, TP, Hooper, JE, Svalina, MN, Ishikawa, Y, Zientek, K, Bajwa, Z, Goros, MW, Hernandez, BS, Wolff, JE, Rudek, MA, Linping, X, Anders, NM, Ranadip, P, Harrold, AP, Davies, AM, Ashok, A, Bushby, D, Mancini, M, Noakes, C, Goodwin, NC, Ordentlich, P, Keck, J, Hawkins, DS, Rudzinski, ER, Chatterjee, B, Bachinger,HP, Barr, FG, Liddle, J, Garcia, BA, Mansoor, A, Perkins, TJ, Vakoc, CR, Michalek JE, Keller, C. The HDAC3-SMARCA4-miR-27a axis promotes expression of the PAX3:FOXO1 fusion oncogene in rhabdomyosarcoma Science Signaling 2018 Nov;11(557). McGinity M, Granhi R, Michalek JE, Rodriguez J, Trevino A, McGinity A, Seifi A. The impact of tackle football injuries on the American healthcare system with a neurological focus Public Library of Science 2018 May;13(5). DeArmon DT, Das NA, Restrepo CS, Johnson S, Michalek JE, Hernandez B. Pleural electrical impedance is a sensitive, real-time indicator of pneumothorax Journal of Surgical Research 2018 May;231:15-23. Yang X, Leesar M, Ahmed H, Lendel V, Rodriguez G, Mutlu D, Cawich I, Prasad, A, Oglesby M, Marmagkiolis, K, Phillips N, Jouke D, Michalek J, Liu Q, Milner T, McElroy A, Hoyt, T, Feldman MD, Cilingiroglu M. Impact of Ticagrelor and Aspirin versus Clopidogrel and Aspirin in Symptomatic Patients with Peripheral Arterial Disease: Thrombus Burden Assessed by Optical Coherence Tomography Cardiovascular Revascularization 2018 Feb;. Bandyopadhyay A, Farours E, Phelps DA, Pozo VD, Ghilu A, Kurmashev D, Michalek JE, Trevino A, Guttridge D, London C, Hirotani K, Zhang L, Kurmaseva RT, Houghton PJ. Evaluation of patritumab with or without erlotinib in combination with standard cytotoxis agents against pediatric sarcoma xenograft models Pediatric Blood Cancer 2018 Feb;65(2). Hui SH, Folsom R, Killewich LA, Michalek JE, Davies MG, Pounds LL. A comparison of preoperative and intraoperative vein mapping sizes for arteriovenous fistula creation J Vasc Surg 2018 Feb;. Haines DE, Wong W, Canby R, Jewell C, Houmsse M, Pederson D, Sugeng L, Porterfield J, Kottam A, Pearce J, Valvano J, Michalek JE, Trevino A, Sagar S, Feldman MD. Validation of a defibrillation lead ventricular volume measurement compared to three dimensional echocardiography Heart Rhythm Society 2017 Oct;14(10):1515-1522. Ramirez AG, Munoz E, Parma DL, Michalek JE, Holden AE, Phillips TD, Pollock BH. Lifestyle and clinical correlates of hepatocellular carcinoma in South Texas: a matched case-control study Clinical Gastroenterology and Hepatology 2017 Mar;3565(17). Elliott, RJS, Godoy, DA, Michalek JE, Behrouz, R, Elsehety, MA, Hafeez, S, Rios, D, Seifi, A. The effect of morbid obesity on subarachnoid hemorrage prognosis in the United States World Neurosurgery 2017 Jan;105:732-736. Churnin, I, Michalek JE, Seifi A. Association of Resident Duty Hour Restrictions on Mortality of Nervous System Disease and Disorder Journal of Graduate Medical Education 2016 Oct;8(4):576-580. Carr KR, Rodriguez M, Ottesen A, Michalek J, Son C, Patel V, Jimenez D, Seifi A. Association Between Relative Anemia and Early Functional Recovery After Severe Traumatic Brain Injury (TBI) Journal of Neuro Critical Care 2016 Oct;. Patel S, Hurez V, Nawrocki ST, Goros M, Michalek JE, Sarantopoulos J, Curiel T, Mahalingam D. Vorinostat and hydroxychloroquine improve immunity and inhibit autophagy in metastatic colorectal cancer Oncotarget 2016 Jul;7(37):59087-59097. Phipps JE, Hoyt T, Vela D, Wang T, Michalek JE, Buja LM, Jang IK, Milner TE, Feldman MD. Diagnosis of Thin-Capped Fibroatheromas in Intravascular Optical Coherence Tomography Images: Effects of Light Scattering Circulation: Cardiovascular Interventions 2016 Jul;9(7):1-12. Dengler BA, Mendez-Gomez P, Chavez A, Avila L, Michalek J, Hernandez B, Grandhi R,Seifi A. Safety of Chemical DVT Prophylaxis in Severe Traumatic Brain Injury with Invasive Monitoring Devices Neuro critical care 2016 Jun;:1-9. Svalina MN, Kikuchi K, Abraham J, Lal S, Davare MA, Settelmeyer TP, Young MC, Peckham JL, Cho YJ, Michalek JE, Hernandez BS, Berlow NE, Jackson M, Guillaume DJ, Selden NR, Bigner DD, Nazemi KJ, Green SC, Corless CL, Gultekin S, Mansoor A, Rubin BP, Woltjer R, Keller C. IGF1R as a Key Target in High Risk, Metastatic Medulloblastoma Scientific Reports 2016 Jun;. Ha CS, Michalek JE, Elledge R, Kelley KR, Ganapathy S, Su H, Jenkins CA, Agiris A, Swords R, Eng TY, Karnad A, Crownover RL, Swanson GP, Goros M, Pollock BH, Yuan Z. p53-based strategy to reduce hematological toxicity of chemotherapy: A proof of principle study Molecular Oncology 2016 Jan;10(1):148-56. Simpson CB, Lee CT, Hatcher JL, Michalek JE. Botulinum toxin treatment of false vocal folds in adductor spasmodic dysphonia: Functional outcomes Laryngoscope 2016 Jan;126(1):118-121. Landgren, O, Shim, Y, Michalek JE, Costello, R, Burton, D, Ketchum, N, Calvo, K, Caporaso, N, Raveche, E, Middleton, D, Marti, G, Vogt, R. Agent Orange Exposure and Monoclonal Gammopathy of Undetermined Significance. An Operation Ranch Hand Veteran Cohort Study JAMA Oncology 2015 Sep;:E1-E8. Strandberg G, Larsson A, Lipcsey M, Michalek JE, Eriksson M. Intraosseous and intravenous administration of antibiotics yields comparable plasma concentrations during experimental septic shock Acta Anaesthesiol Scan 2015 Jan;. Bartanusz Viktor, Jezova Daniela, Sordo Salvador, Gildea Marianne, Michalek JE, Stewart Ronald M, Corneille Michael G. Diurnal Salivary Cortisol Levels in Acute Trauma Patients at the Surgical-Neurosurgical Intensive Care Unit J Clin Neurosci 2014 Dec;21(12):2150-2154. Larson, Erik R, Porterfield, John E., Marmol-Velez, Juan, Panday, Manoj, Sagar, Sandeep, Escobedo, Daniel, Michalek JE, Ouyang, Yongjian, Valvano, Jonathan, Pearce, John A, Feldman MD. Admittance to Detect Alterations in Left Ventricular Stroke Volume Heart Rhythm 2014 Nov;11(11):2075-2083. Shi Q, Hodara V, Meng Q, Voruganti VS, Rice K, Michalek JE, Carmuzzie AG, VandeBerg JL. Early endothelial damage detected by circulating particles in baboons fed a diet high in simple carbohydrates in conjunction with saturated or unsaturated fat Am J Cardiovasc Dis 2014 Oct;4(3):123-132. Abraham J, Nunez-Alvarez Y, Hettmer S, Carrio E, Chen HI, Nishijo K, Huang ET, Prapjapati SI, Walker RL, Davis S, Rebeles J, Wiebush H, McCleish AT, Hampton ST, Bjornson CR, Brack AS, Wagers AJ, Rando TA, Capecchi MR, Marini FC, Ehler BR, Zarzabal LA, Goros MW, Michalek JE, Meltzer PS, Langenau DM, LeGallo RD, Mansool A, Chen Y, Suelves M, Rubin BP, Keller C. Lineage of origin in rhabdomyscarcoma informs pharmacological response Genes Dev 2014 Jul;25(14):1578-1591. Kilpadi KL, ElDabaje R, Schmitz JE, Ehler B, Thames TA, Joshi AP, Simmons JW, Michalek JE, Fajardo RJ. Type 2 diabetes is associated with vertebral fractures in a sample of clinic- and hospital-based Latinos J Immigr Minor Health 2014 Jun;16(3):440-449. Mahalingam D, Malik L, Beeram M, Rodon J, Sankhala K, Mita AC, Benjamin D, Ketchum N, Michalek JE, Tolcher A, Wright J, Sarantopoulos J. Phase II Study Evaluating the Effcacy, Safety, and Pharmacodynamic Correlative Study of Dual Antiangiogenic Inhibition Using Bevaciumab in Combination with Sorafenib in Patients with Advanced Malignant Melanoma Cancer Chemother Pharmacol 2014 May;. Cohn SM, DeRosa M, Kumar A, Harrison C, Dent DL, Sivam S, McCarthy MJ, Warner SC, Williams S, Michalek JE, Spinella P. Impact of the Age of Transfused Red Blood Cells in the Trauma Population: A Feasibility Study Injury 2014 Mar;45(3):605-611. Xiao Y, Haynes W, Russell IJ, Michalek JE. Elevated serum high-sensitivity c-reactive protein levels in fibromyalgia syndrome patients correlate with body mass index, interleukin-6, interleukin-8, erythrocyte sedimentation rate Rheumatol Int 2013 May;33(5):1259-1264. Cornejo A, Sahar DE, Stephenson SM, Chang S, Nguyen S, Guda T, Wenke JC, Vasquez, A, Michalek JE, Sharma R, Krishnegowda NK, Wang HT. Effect of Adipose Tissue-Derived Osteogenic and Endothelial Cells on Bone Allograft Osteogenesis and Vascularization in Critical-Sized Calvarial Defects Tissue Eng Part A 2012 May;18(15-16):1-10. Abraham J, Chua YX, Glover JM, Tyner JW, Loriaux MM, Kilcoyne A, Giles FJ, Nelon LD, Carew JS, Ouyang Y, Michalek JE, Pal R, Druker BJ, Rubin BP, Keller C. An adaptive Src-PDGFRA-Raf axis in rhabdomyosarcoma Biochem Biophys Res Commun 2012 Jan;426:363-368. Salhanick M, Higgins RA, Olson JD, Michalek JE, Harrison CR, Corneille MG, Stewart RM, Harrison C,Dent DL,. Autotransfusion of Hemothorax Blood In Trauma Patients: Is It the Same as Fresh Whole Blood? Am J Surg 2011 Dec;202(6):817-822.