Download BIOGRAPHICAL SKETCH Leslie A. Kalish, ScD

BIOGRAPHICAL SKETCH
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NAME
POSITION TITLE
Leslie A. Kalish, ScD
Associate Professor of Pediatrics / Principal
Biostatistician
eRA COMMONS USER NAME
lkalish
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
Bucknell University, Lewisburg, PA
Pennsylvania State Univ., University Park, PA
Harvard School of Public Health, Boston, MA
DEGREE
(if applicable)
YEAR(s)
BA
MA
ScD
1976
1978
1986
FIELD OF STUDY
Mathematics
Statistics
Biostatistics
A. PROFESSIONAL POSITIONS
1976-1978
Graduate Assistant, Pennsylvania State University, University Park, PA
1978-1980
Associate Statistician, Desmatics, Inc., State College, PA
1980-1993
Biostatistician, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA
1986-1987
Postdoctoral Research Fellow, Biostatistics, Harvard School of Public Health, Boston, MA
1987-1993
Assistant Professor, Biostatistics, Harvard School of Public Health, Boston, MA
1993
Associate Professor, Biostatistics, Harvard School of Public Health, Boston, MA
1993-2001
Senior Research Scientist, New England Research Institutes, Watertown, MA
2001-2003
Principal Research Scientist, New England Research Institutes, Watertown, MA
2003Principal Biostatistician, Clinical Research Program, Children’s Hospital, Boston, MA
2003Associate Scientific Staff, Department of Medicine, Children’s Hospital, Boston, MA
2003Associate Professor of Pediatrics, Harvard Medical School, Boston, MA
AWARDS AND HONORS
1976
Pi Mu Epsilon, Phi Beta Kappa, Magna Cum Laude
1982-1983
National Research Service Award - Traineeship
1985
Robert Reed Award in Biostatistical Science
1986
Society for Clinical Trials Student Scholarship
1987
National Research Service Award - Fellowship
1989-1990
Mellon Foundation Faculty Development Grant
B. PEER-REVIEWED PUBLICATIONS (all 2008-2010 and selected previous, from >100 papers)
Kalish LA, Begg CB. Treatment allocation methods in clinical trials: a review. Stat Med 1985;4:129-144.
Kalish LA. Matching on a non-risk factor in the design of case-control studies does not always result in an
efficiency loss. Am J Epidemiol 1986;123:551-554.
Kalish LA, Begg CB. The impact of treatment allocation procedures on nominal significance levels and bias.
Controlled Clin Trials 1987;8:121-135.
Kalish LA. Efficient design for estimation of median lethal dose and quantal dose-response curves. Biometrics
1990;46:737-748.
Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C,
Zorilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of
perinatal transmission. N Engl J Med 1999;341:394-402
Kalish LA, McIntosh K, Read JS, Diaz C, Landesman SH, Pitt J, Rich KC, Shearer WT, Davenny K, Lew JF.
Evaluation of human immunodeficiency virus (HIV) type 1 load, CD4 T cell level, and clinical class as timefixed and time-varying markers of disease progression in HIV-1infected children. J Infect Dis. 1999;180:15141520 [Erratum. J Infect Dis 2000;181:408].
Kalish LA, Collier AC, Flanigan TP, Kumar PN. Plasma human immunodeficiency virus type 1 (HIV-1) RNA
load in men and women with advanced HIV-1 disease. J Infect Dis 2000;182:603-606.
Collier AC, Kalish LA, Busch MP, Gernsheimer T, Assmann SF, Lane TA, Asmuth DM, Lederman MM,
Murphy EL, Kumar P, Kelley M, Flanigan TP, McMahon DK, Sacks HS, Kennedy MS, Holland PV.
Leukocyte-reduced red blood cell transfusions in patients with anemia and human immunodeficiency virus
infection. The Viral Activation Transfusion Study: a randomized controlled trial. JAMA 2001;285:1592-1601.
Murphy EL, Collier AC, Kalish LA, Assmann SF, Para MF, Flanigan TP, Kumar PN, Mintz L, Wallach FR,
Nemo GJ. Highly active antiretroviral therapy decreases mortality and morbidity in patients with advanced
HIV disease. Ann Int Med 2001;135:17-26.
Kalish LA, Riester KA, Pocock SJ. Accounting for non-independent observations in 22 tables, with
application to correcting for family clustering in exposure-risk relationship studies. J Modern Appl Stat
Methods 2002;1:379-386.
Kalish LA, Buczynski B, Connell P, Gemmel A, Goertz C, Macklin EA, Pian-Smith M, Stevens S, Thompson J,
Valaskatgis P, Wayne P, Zusman RM. Stop Hypertension with the Acupuncture Research Program (SHARP):
clinical trial design and screening results. Controlled Clin Trials 2004;25:76-103.
Pocock SJ, Collier T, Dandreo KJ, de Stavola BL, Goldman MB, Kalish LA, Kasten LE, McCormack VA.
Issues in the reporting of epidemiologal studies: a survey of recent practice. BMJ 2004;329:883-887. (Print
version is abridged. Full version appears online at http://bmj.bmjjournals.com/cgi/content/full/329/7471/883)
Guinan EC, Kalish LA, Berry WS, McDaniel S, Lehmann LE, Diller LR. A novel pattern of transaminase
elevation associated with autologous transplant for neuroblastoma. Pediatr Transplant 2006;10:669-676.
Kalish LA, Waltz DA, Dovey M, Potter-Bynoe G, McAdam AJ, LiPuma JJ, Gerard C, Goldmann D. Impact of
Burkholderia dolosa on lung function and survival in cystic fibrosis. Am J Respir Crit Care Med
2006;173:421-425.
Paltiel HJ, Kalish LA, Susaeta RA, Frauscher F, O’Kane PL, Freitas-Filho LG. Pulse-inversion US imaging of
testicular ischemia: quantitative and qualitative analysis in a rabbit model. Radiology 2006;239:718-729.
Levy H, Kalish LA, Huntington I, Weller N, Gerard C, Silverman EK, Celedon JC, Pier GB, Weiss ST.
Inflammatory markers of lung disease in adult patients with cystic fibrosis. Pediatr Pulmonol 2007;42:256-62.
Limperopoulos C, Bassan H, Kalish LA, Ringer SA, Eichenwald EC, Walter G, Moore M, Vanasse M, DiSalvo
DN, Soul JS, Volpe JJ, du Plessis AJ. Current definitions of hypotension do not predict cranial ultrasound
abnormalities in premature infants. Pediatrics Pediatrics 2007;120:966-77.
Gryllos I, Grifantini R, Colaprico A, Cary ME, Hakansson A, Carey DW, Suarez-Chavez M, Kalish LA, Mitchell
PD, White GL, Wessels MR. PerR confers phagocytic killing resistance and allows pharyngeal colonization
of group A Streptococcus. PLoS Pathog 2008;4(9):e1000145.
Kalish LA. Methodological weaknesses in concluding that “small for gestational age” is an independent risk
factor for parenteral nutrition-associated cholestasis. [letter] J Pediatr 2008;153(1):149.
LeBovidge JS, Timmons K, Rich C, Rosenstock A, Fowler K, Strauch H, Kalish LA, Schneider LC.
Evaluation of a group intervention for children with food allergy and their parents. Ann Allergy Asthma
Immunol 2008;101:160-165.
Levy H, Kalish LA, Cannon CL, Asher D, Gerard C, Goldmann D, Pier GB, Weiss ST. Predictors of mucoid
Pseudomonas colonization in cystic fibrosis patients. Pediatr Pulmonol 2008;43:463-471.
Moss RL, Kalish LA, Duggan C, Johnston P, Brandt ML, Dunn JCY, Ehrenkranz RA, Jaksic T, Nobuhara K,
Simpson BJ, McCarthy MC, Sylvester KG. Clinical parameters do not adequately predict outcome in
necrotizing enterocolitis: a multi-institutional study. J Perinatol 2008;28(10):665-674.
Porter SC, Kaushal R, Forbes PW, Goldmann D, Kalish LA. Impact of a patient-centered technology on
medication errors during pediatric emergency care. Ambul Pediatr 2008;8(5):329-335.
Reller ME, Tauxe RV, Kalish LA, Mølbak K. Excess salmonellosis in women in the United States: 1968-2000.
Epidemiol Infect 2008;136:1109-1117.
Fine AM, Kalish LA, Forbes P, Goldmann D, Mandl KD, Porter SC. Parent-driven technology for decision
support in pediatric emergency care. Jt Comm J Qual Patient Saf 2009;35(6):307-315.
Morrissey LK*, Shea JO*, Kalish LA, Weiner DL, Branowicki P, Heeney MM. Clinical practice guideline
improves the treatment of sickle cell disease vasoocclusive pain. Pediatr Blood Cancer 2009;52(3):369-372.
(*co-first authors)
LeBovidge JS, Strauch H, Kalish LA, Schneider LC. Assessment of psychological distress among children
and adolescents with food allergy. J Allergy Clin Immunol 2009(6);124:1282-1288.
Duro D, Kalish LA, Johnston P, Jaksic T, McCarthy M, Martin C, Dunn JC, Brandt M, Nobuhara KK, Sylvester
KG, Moss RL, Duggan C. Risk factors for intestinal failure in infants with necrotizing enterocolitis: a Glaser
Pediatric Research Network study. J Pediatr (in press).
Porter SC, Forbes P, Manzi S, Kalish LA. Patients providing the answers: narrowing the gap in data quality
for emergency care. Qual Saf Health Care (in press).
Harney K, McCabe M, Branowicki P, Kalish LA, Neufeld E. Observational cohort study of pediatric inpatients
with central venous catheters at “intermediate risk” of thrombosis and eligible for anticoagulant prophylaxis. J
Pediatr Oncol Nurs (in press).
C. Research Support
CURRENT:
K12 HL87164 (E. Neufeld)
10/01/06-06/30/11
NIH/NHLBI
Clinical Hematology Research Career Development Program
Role: Program mentor and Advisory Committee member for biostatistical and training resources.
Description: The purpose is to develop and evaluate a multidisciplinary career development program in nonmalignant hematology that will equip new investigators with the knowledge and skills to address complex
problems in blood diseases. The program provides training to encourage promising young physician scientists
to choose non-malignant hematology as a career path, broaden the didactic experience within hematology for
graduates of the program, provide structured training in clinical research methods, and evaluate the outcomes
of the training program.
1 UL1 RR025758 (L. Nadler)
05/19/08-04/30/13
NIH/NCRR
Harvard Clinical and Translational Science Center (CTSC)
Role: Associate Director for Children’s Hospital Boston site within the Harvard CTSC
The Harvard CTSC is designed to: enhance the ability of investigators to identify information and access
resources and tools necessary to conceive and successfully complete clinical and translational (C/T)
experiments; engage experts from many diverse areas to address challenging questions in C/T research;
involve academic disciplines not traditionally engaged in C/T research; provide novel advisory and facilitative
human resources to lower the barriers to performing innovative, collaborative, and cross-institutional C/T
experiments; educate the broader Harvard research community as to the opportunities, challenges, and goals
of C/T research; improve the impact of C/T research on underserved populations and communities; and ensure
that opportunities in C/T research are equally afforded to all.
H34 MC10575 (S. Chung)
09/01/08-8/31/11
NIH/HRSA
REUNITE: A Novel Imaging System for Children Separated During Disaster
Role: Biostatistician
The REUNITE project addresses the difficulty of reuniting unidentified children who are separated from their
caretakers after a public health emergency. The system will be developed to provide the functionalities of
digital imaging, indexing, archiving, and retrieval of images of the victims of the disaster, with emulation
features (digital reconstruction of facial trauma). REUNITE will then be tested in field tests of simulated
disasters.
R01 GM085421 (A. Schachter)
10/01/08-09/30/12
NIH/NIGMS
Preclinical predictive markers of post-approval drug safety
Role: Biostatistician
The aims are identify preclinical dose-effect indicators of post- approval drug safety and to build and distribute
preclinical indicator machine-learning models that predict post-approval drug safety.
1RC1DK086486-01 (M. Fleming)
09/21/09-07/31/11
NIH/NIDDK
Hepcidin-based screening for infantile iron deficiency
Role: Biostatistician
The goal of this study is to test the utility of a new, potentially more accurate blood screening test for iron
deficiency in infants, and to begin to determine if there is a genetic susceptibility to iron deficiency in infancy.
RECENTLY COMPLETED:
1R21 HL089659-01A1 (E. Guinan)
04/01/08-03/31/10
NIH/NIAID
rBPI21 & Endotoxin-directed Innate Immunity in Stem Cell Transplantation
Role: Biostatistician
In Specific Aim 1, we will determine the tolerability and pharmacokinetics of rBPI21 in BPI-deficient HSCT
recipients in order to establish an understanding of the dose and schedule that will effectively block LPS
mediated toxicity. The effects of rBPI21 infusion on the endotoxin-modulating activity of plasma will be
investigated in Specific Aim 2. Specific Aim 3 will focus on determining the effect of rBPI21 infusion on the
functional expression of the endotoxin receptor composed of MD-2, TLR4, and mCD14.
Glaser Pediatric Research Network (L. Kalish)
12/01/02-12/31/09
Necrotizing Enterocolitis (NEC) Surgical Database
Role and Description: PI and Senior Biostatistician for Data Analysis Coordinating Center of a multicenter
prospective data collection process for necrotizing enterocolitis in order to provide accurate data regarding
practice of treatment and variability of care between different centers.
Dana Foundation (O. Levy)
01/01/07-12/31/09
Endotoxin-related Innate Immunity in Patients Undergoing Hematopoietic Stem Cell Transplantation
Role and Description: Biostatistician for a pilot clinical trial of rBPI21 administered to patients undergoing
myeloablative allogeneic hematopoietic stem cell transplantation (HSCT). HSCT is often complicated by acute
graft versus host disease (aGVHD) which is triggered by penetration of endotoxin from the intestines into the
bloodstream. The protein rBPI21 is an endotoxin-neutralizing agent. This study will investigate the presence of
endotoxin and how rBPI21 might alter the body’s inflammatory response to it.
NIH/NCRR M01 RR02172 (J. Mandell)
04/01/04-05/31/08
General Clinical Research Center
Role and Description: Senior Biostatistician for the Children’s Hospital Boston GCRC, one of a national
network of 78 centers that provide optimal settings for medical investigators to conduct safe, controlled, stateof-the-art, in-patient and out-patient studies of both children and adults
Cystic Fibrosis Foundation (D. Ericson)
07/01/06-06/30/08
A Six Month Open Label Study of Amiloride Solution for Inhalation and Tobramycin Solution for
Inhalation for the Eradication of Burkholderia dolosa in Patients with Cystic Fibrosis
Role and Description: Statistician for clinical trial, the primary goal of which is to determine the ability of
multiple doses of amiloride solution for inhalation (ASI) and tobramycin solution for inhalation (TSI) to eradicate
Burkholderia dolosa respiratory tract infection in patients with cystic fibrosis.