(if applicable) The Ohio State University, Columbus, OH MAS 12/1988 Statistics The University of Pittsburgh, Pittsburgh, PA

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1 NAME: Wisniewski, Stephen R. BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. era COMMONS USER NAME (credential, e.g., agency login): WISNIEWSKI POSITION TITLE: Professor, Associate Vice Provost for Planning EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION The Pennsylvania State University, State College, PA DEGREE (if applicable) Completion Date MM/YYYY BS 05/1987 Mathematics The Ohio State University, Columbus, OH MAS 12/1988 Statistics The University of Pittsburgh, Pittsburgh, PA PhD 04/1994 Epidemiology FIELD OF STUDY A. Personal Statement Dr. Wisniewski is a Professor of Epidemiology, Psychiatry and Clinical Sciences at the University of Pittsburgh, the Associate Vice Provost for Planning and a Co-Director of the Epidemiology Data Center. Dr. Wisniewski has a long history of designing and conducting clinical trials. Dr. Wisniewski is currently a co-pi of the Genomics and Informatics Center (GIC) for the Genomic Research in AAT-Deficiency and Sarcoidosis Study (GRADS) and Approaches and Decisions in Acute Pediatric TBI (ADAPT) Trial. He is also the Core Director for the Design, Biostatistics and Epidemiology Core of the University of Pittsburgh s CTSA Award. He has served as the lead for the data coordinating center for three multi-center pancreatitis studies, SNAP, NAPS2-CV and NAPS2-AA. Dr. Wisniewski s primary area of interest is in the design and analysis of multi-center trials. Specifically the implementation of novel study designs to address important clinical questions as well as the organizational and communication challenges associated with multi-center studies. 1. Wisniewski SR, Leon AC, Otto MW, Trivedi MH. Prevention of Missing Data in Clinical Research Studies. Biological Psychiatry, 2006;59: PMID Wisniewski SR, Eng H, Meloro L, Gatt R, Ritz L, Stegman D, Trivedi M, Biggs MM, Friedman E, Shores-Wilson K, Warden D, Bartolowits D, Martin JP and Rush AJ. Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project. Clinical Trials, 2004;1: PMID Warden D, Rush AJ, Trivedi M, Ritz L, Stegman D, Wisniewski SR. Quality improvement methods as applied to a multicenter effectiveness trial STAR*D. Contemporary Clinical Trials, 2005;26: PMID Lavori PW, Rush AJ, Wisniewski SR, Alpert J, Fava M. Kupfer DJ, Nierenberg A., Quitkin FM, Sacheim HA, Thase ME, Trivedi M for the STAR*D Group. Strengthening Clinical Effectiveness Trials: Equipoise-Stratified Randomization. Biological Psychiatry, : PMID B. Positions and Honors Positions and Employment Research Associate, Department of Epidemiology, Graduate School of Public Health, University Assistant Professor, Department of Epidemiology, Graduate School of Public Health, University

2 Assistant Professor, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania Associate Professor, Department of Epidemiology, Graduate School of Public Health, University Associate Professor, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania Associate Dean for Research, Graduate School of Public Health, University of Pittsburgh 2009 Associate Professor of Clinical Sciences, University Professor, Departments of Epidemiology, Psychiatry and Clinical and Translational Sciences, University Senior Associate Dean, Graduate School of Public Health, University of Pittsburgh 2015 Associate Vice Provost for Planning, University of Pittsburgh C. Contribution to Science (from over 350 publications) Endophthalmitis Endophthalmitis is a serious eye infection that can occur after cataract surgery. Two treatment options were available (tap, biopsy). The literature was not clear on the superiority of either treatment. In addition, those with the infection received IV antibiotics, without established efficacy. The Endophthalmitis Vitrectomy Study was conducted to evaluate these treatments. Results showed that there was not difference in surgical approach and that IV antibiotics were not necessary. Secondary analyses showed the impact of these findings on costs and important subgroup findings were there were treatment effects. 1. The Endothalmitis Vitrectomy Study Group. Results of the Endophthalmitis Vitrectomy Study: A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for the Treatment of Post-Operative Bacterial Endophthalmitis. Archives of Ophthalmology, 1995; 113: Wisniewski SR, Hammer ME, Grizzard WS, Kelsey SF, Everett D, Packo KH, Yarian DL, Doft BH for the EVS Study Group. An Investigation of the Hospital Charges Related to the Treatment of Endophthalmitis in the Endophthalmitis Vitrectomy Study. Ophthalmology, 1997; 104: PMID: Doft BH, Wisniewski SR, Kelsey SF, Groer-Fitzgerald S and the Endophthalmitis Vitrectomy Study Group. Diabetes and postcataract extraction endophthalmitis. Current Opinions in Ophthamology, 2002;13: PMID: Evaluation of treatments for depression A number of treatments have been approved by the FDA for the treatment of depression. Little information was available on the relative efficacy of these treatments. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study was conducted to directly compare treatments. The study enrolled over 4,000 patients from 42 clinical centers. No significant difference in treatments were identified, though some important findings showed that those receiving treatment were not generalizable to those who are typically included in Phase 3 clinical trials. 1. Trivedi MH, Fava M, Wisniewski SR, Thase ME, Quitkin F, Warden D, Ritz L, Nierenberg A, Lebowitz BD, Biggs MM, Luther JF, Shores-Wilson K, Rush AJ for the STAR*D Study Team. A Comparison of Citalopram Augmentation with Bupropion-SR and Buspirone Following SSRI Failure for Depressed Outpatients: A STAR*D Report. New England Journal of Medicine, 2006;354: PMID: Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg A, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M for the STAR*D Team. A Comparison of Bupropion-SR, Sertraline, and Venlafaxine-XR Following SSRI Failure for Depressed Outpatients: A STAR*D Report. New England Journal of Medicine, 2006;354: PMID: Wisniewski SR, Fava M, Trivedi MH, Thase ME, Warden D, Niederehe G, Friedman ES, Biggs MM, Sackeim HA, Shores-Wilson K, McGrath PJ, Lavori PW, Miyahara S, Rush AJ. Acceptability of Second-Step Treatments to Depressed Outpatients: A STAR*D Report. American Journal of Psychiatry, 2007;164: PMID:

3 4. Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, McGrath PJ, Lavori PW, Thase ME, Fava M, Trivedi MH. Can Phase III Trial Results of Antidepressant Medications be Generalized to Clinical Practice? A STAR*D Report. American Journal of Psychiatry, 2009;166; PMID: Pediatric Traumatic Brain Injury A study was conducted to evaluate the efficacy of hypothermia as a treatment for severe traumatic brain injury in children. This study, the Cool Kids Trial, show no beneficial effect of hypothermia. Secondary data analyses showed that there was very little standard treatment of children with severe traumatic brain injury. This led to the observation that the field is not ready for randomized clinical trials and that other approaches should be implemented. This led to the funding of the ADAPT Trials, an observational cohort study of 1,000 children with severe traumatic brain injury enrolled at over 50 centers in eight countries. 1. Adelson PD, Wisniewski SR, Beca J, Brown SD, Bell M, Muizelaar JP, Okada P, Beers SR, Balasubramani GK, Hirtz D. Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial. The Lancet Neurology, 2012;75: PMID: Pancreatitis The risk factors and treatment for pancreatitis are not well understood. Three studies were conducted to attempt to evaluate risk factors as well as treatment (NAPS2-CV, NAPS2-AA, SNAP). These studies led to insight regarding potential clinical and genetic risk factors as well as approaches to feed patients during an acute episode of pancreatitis. 1. Wilcox CM, Yadav D, Ye T, Gardner TB, Gelrud A, Sandhu BS, Lewis MD, Al-Kaade S, Cote GA, Forsmark CE, Guda NM, Conwell DL, Banks PA, Muniraj T, Romangnuolo J, Brand RE, Slivka A, Sherman S, Wisniewski SR, Whitcomb DC, Anderson MA. Clinical Gastroenterology and Heptatology, 2015;13: Whitcomb DC, Larusch J, Krasinskas AM, Klei L, Smith JP, Brand RE, Neoptolemos JP, Lerch MM, Tector M, Sandhu BS, Guda NM, Orlichenko L; Alzheimer's Disease Genetics Consortium, Albert MS, Albin RL, Apostolova LG, Arnold SE, Baldwin CT, Barber R, Barnes LL, Beach TG, Beecham GW, Beekly D, Bennett DA, Bigio EH, Bird TD, Blacker D, Boxer A, Burke JR, Buxbaum JD, Cairns NJ, Cantwell LB, Cao C, Carney RM, Carroll SL, Chui HC, Clark DG, Cribbs DH, Crocco EA, Cruchaga C, Decarli C, Demirci FY, Dick M, Dickson DW, Duara R, Ertekin-Taner N, Faber KM, Fallon KB, Farlow MR, Ferris S, Foroud TM, Frosch MP, Galasko DR, Ganguli M, Gearing M, Geschwind DH, Ghetti B, Gilbert JR, Gilman S, Glass JD, Goate AM, Graff-Radford NR, Green RC, Growdon JH, Hakonarson H, Hamilton-Nelson KL, Hamilton RL, Harrell LE, Head E, Honig LS, Hulette CM, Hyman BT, Jicha GA, Jin LW, Jun G, Kamboh MI, Karydas A, Kaye JA, Kim R, Koo EH, Kowall NW, Kramer JH, Kramer P, Kukull WA, Laferla FM, Lah JJ, Leverenz JB, Levey AI, Li G, Lin CF, Lieberman AP, Lopez OL, Lunetta KL, Lyketsos CG, Mack WJ, Marson DC, Martin ER, Martiniuk F, Mash DC, Masliah E, McKee AC, Mesulam M, Miller BL, Miller CA, Miller JW, Montine TJ, Morris JC, Murrell JR, Naj AC, Olichney JM, Parisi JE, Peskind E, Petersen RC, Pierce A, Poon WW, Potter H, Quinn JF, Raj A, Raskind M, Reiman EM, Reisberg B, Reitz C, Ringman JM, Roberson ED, Rosen HJ, Rosenberg RN, Sano M, Saykin AJ, Schneider JA, Schneider LS, Seeley WW, Smith AG, Sonnen JA, Spina S, Stern RA, Tanzi RE, Trojanowski JQ, Troncoso JC, Tsuang DW, Valladares O, Van Deerlin VM, Van Eldik LJ, Vardarajan BN, Vinters HV, Vonsattel JP, Wang LS, Weintraub S, Welsh-Bohmer KA, Williamson J, Woltjer RL, Wright CB, Younkin SG, Yu CE, Yu L, Alkaade S, Amann ST, Anderson MA, Baillie J, Banks PA, Conwell D, Coté GA, Cotton PB, Disario J, Farrer LA, Forsmark CE, Johnstone M, Gardner TB, Gelrud A, Greenhalf W, Haines JL, Hartman DJ, Hawes RA, Lawrence C, Lewis M, Mayerle J, Mayeux R, Melhem NM, Money ME, Muniraj T, Papachristou GI, Pericak-Vance MA, Romagnuolo J, Schellenberg GD, Sherman S, Simon P, Singh VP, Slivka A, Stolz D, Sutton R, Weiss FU, Wilcox CM, Zarnescu NO, Wisniewski SR, O'Connell MR, Kienholz ML, Roeder K, Barmada MM, Yadav D, Devlin B. Common genetic variants in the CLND2 and PRSS1-PRSS2 loci alter risk for alcohol-related and sporadic pancreatitis. Nature Genetics 44: , PMID:

4 3. Tien Y. (Doctoral Dissertation with Wisniewski and Whitcomb) A Computational Method for the Analysis of Pain Patterns and Progression of Pancreatitis with a Large Number of Predictor Variables, 2014, Doctoral Dissertation 4. O Keefe SJ, Whitcomb DC, Cote GA. Study of Nutrition in Acute Pancreatitis (SNAP): A Randomized, Multicenter, Clinical Trial of Nasogastric vs. Distal Jejunal Feeding. Gastroenterology, 2014;146:S-800. Complete List of Published Work in MyBibliography: D. Research Support ACTIVE UL1 RR PI: STEVEN E. REIS, M.D. NIH 09/01/ /30/2015 $173, cal Clinical and Translational Science Institute DBE Core The Design, Biostatistics and Epidemiology (DBE) Core of the Clinical and Translational Science Institute (CTSI) provides services to funded and unfunded researchers, with a focus on junior faculty, fellows and graduate students in the areas of grant application, development, study design consultation, and statistical analysis. U01 HL PI: STEPHEN R. WISNIEWSKI, PH.D. NHLBI 05/01/ /30/2015 $1,827, cal Sarcoidosis and A1AT Genomics & Informatics Center This project aims to learn more about the causes and progression of two potentially deadly yet under-studied lung diseases, alpha-1 antitrypsin deficiency and sarcoidosis to help identify new treatments and explore the relationship between the bacteria that live in the lungs, gene activation patterns and disease progression. U01 NS PI: MICHAEL J. BELL, M.D. NIH 07/01/ /30/2018 $625, cal ADAPT Trial Approaches and Decisions in Acute Pediatric TBI The Epidemiology Data Center participates in this observational cohort study of children with severe Traumatic Brain Injury (TBI) to compare the effectiveness of pediatric TBI therapies within an international consortium testing a total of six TBI therapies. UM1 HL PI: STEPHEN R. WISNIEWSKI, PH.D. U Vermont 09/30/ /30/2018 $700, cal Analysis and Characterization of Trauma-Induced Coagulopathy This is a subcontract for participation in data coordination for the Trans-Agency Research Consortium for Trauma-Induced Coagulopathy (TACTIC). The Epidemiology Data Center will oversee network coordination, data management and analysis, sample collection reimbursement systems, and manuscript preparation. W81XWH PI: STEPHEN R. WISNIEWSKI, PH.D. UCSF 09/30/ /29/2019 $186, cal TBI Endpoints Development (TED) Under this subaward, the University of Pittsburgh with will be responsible for data curation during all phases of the project in support of the Consensus and Implementation Conferences and Validation studies within the TBI Endpoints Development (TED) project. This will include collecting data from a variety of studies as well as the study documentation and harmonizing the data sets. The harmonization process will include the standardization of the coding of variables across the studies, giving identical variables across studies similar variable names within the database and documenting differences on how data were collected across study. In addition, Dr. Wisniewski will serve on the TED Executive and Steering Committees. He will lead the

5 Biostatistics Core and will serve in a leadership role in the Consensus Conferences providing expertise in informatics and biostatistics. HL PI: STEPHEN R. WISNIEWSKI, PH.D. NIH 04/01/ /31/2020 $252, cal Vitamin D to Prevent Severe Asthma Exacerbations in High-Risk Children PENDING -- The primary aim of this clinical trial is determine whether high-dose vitamin D3 supplementation (2,000 IU/day) is superior to control vitamin D3 supplementation (200 IU/day) in preventing severe asthma exacerbations in high-risk school-aged children who have vitamin D insufficiency and who are on ICS for mild to moderate persistent asthma. The Epidemiology Data Center will serve as the Data Coordinating Center for the trial. PENDING HL PI: STEPHEN R. WISNIEWSKI, PH.D. NHLBI 07/01/ /30/2020 $3,313, cal Network Management Core (NEMO) for the Pulmonary Trials Cooperative PENDING -- The Epidemiology Data Center will coordinate the Network Management Core (NEMO) of the Pulmonary Trials Cooperative (PTC). The NEMO will have primary responsibility for organizing and operating this multi-center cooperative which conducts multiple simple clinical trials in both inpatient and outpatient settings in adults with a variety of chronic pulmonary diseases, including but not limited to interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea, but excluding asthma and acute lung injury and critical care. OVERLAP There is no overlap.