Department of Medicine

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Additional Information

Contact Us

Health Science Campus
Ruppert Health Center
Room # 0012
Phone: 419.383.3685
Fax: 419.383.6244 webmaster@utoledo.edu

Pulmonary Lab

Dr. James C. Willey, M.D.Dr. James C. Willey, M.D.

Principal Investigator, Pulmonary Lab
Professor of Medicine and Pathology

George Isaac Chair In Cancer Research
Email: james.willey2@utoledo.edu
PubMed Bibliography

ACTIVITIES IN SPOTLIGHT

Research:

  • February 25, 2016; presentation to the FDA Public Workshop on Next-Generation Sequencing-Based Oncology Panels White Oak, MD
    • Slides 177-184 (PDF)
    • Video of presentation: Go here, select Webcast archive Part 4 and go to the 10 minute to 16 minute interval.
  • 2014; Nat Biotechnol. 903-14, Sep;32(9):2014. A comprehensive assessment of RNA-seq accuracy, reproducibility and information content by the Sequencing Quality Control Consortium, SEQC/MAQC-III Consortium.
  • 2013; Nature Methods "Technology Feature" (PDF) highlighting work of Willey lab

Clinical:

  • June, 2015; CT Screening for Lung Cancer: Nonsolid Nodules in Baseline and Annual Repeat Rounds, Yankelevitz DF et al and I-ELCAP Investigators Group (see below citation)
  • Nov. 2015; Public interest presentation on Lung Cancer Screening
  • March, 2016; Presentation on Lung Cancer Screening to University of Toledo Board of Trustees; see attached.
 


Research Interests

  • Determining molecular genetic basis of cancer risk 
  • Development of molecular diagnostic tests for better diagnosis and more optimized, individualized treatment of cancer
  • Gene regulation in normal and malignant human lung cells
  • The Development of standardized, quantitative gene expression measurement technologies, including standardized RT-PCR and standardized immunoPCR.  These novel technologies are protected by patents owned by the University of Toledo and licensed to Accugenomics, Inc. (see below)

    These research efforts have been funded by the National Institutes of Health (National Cancer Institute, National Heart Lung and Blood Institute, and National Institute of Environmental Health Sciences), the Third Frontier Fund of the State of Ohio, and the George Isaac Cancer Research Fund

Education

University of Vermont, Burlington, VT   B.A., 1974, Zoology
Medical College of Ohio, Toledo, OH  M.D., 1978, Medicine

Training

1978–1981 Resident - Internal Medicine
Georgetown-VA Internal Medicine Residency Program
VA-Hospital and Georgetown University; Washington, D.C.

National Cancer Institute Post-Doctoral Fellowships

1981-1984- Medical Staff Fellow National Cancer Institute; Laboratory of Human Carcinogenesis (C.C. Harris)
1984-1986- Senior Staff Fellow National Heart Lung and Blood Institute: Pulmonary Branch (R.G. Crystal)
1986-1990- Biotechnology Fellow and Expert National Cancer Institute

Pulmonary Training

1984-1986- Senior Staff Fellow National Heart Lung and Blood Institute: Pulmonary Branch (R.G. Crystal)
1993-1994- Strong Memorial Hospital, University of Rochester (Richard Hyde/Mark Utell)

Academic Appointments

2002-Present  Professor of Medicine and Pathology, Pulmonary and Critical Care Division, Dept. of Medicine, University of Toledo (previously Medical College of Ohio).
2001-Present Professor of Medicine, Pulmonary and Critical Care Division, Dept. of Medicine, University of Toledo.
2000-Present George Isaac Professor for Cancer Research, University of Toledo.
1994-2000 Associate Professor of Medicine, Pulmonary and Critical Care Division, Dept. of Medicine, University of Toledo.
1990-1994 Assistant Professor of Biophysics and Medicine, Department of Environmental Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY
1988-1990 Expert, National Cancer Institute, Laboratory of Human Carcinogenesis, Bethesda, MD
1986-1988 Biotechnology Fellow, National Cancer Institute (NCI), Laboratory of Human Carcinogenesis,  Bethesda, MD
1984-1986 Senior Staff Fellow, National Heart Lung Blood Institute, Pulmonary Branch, Bethesda, MD
1981-1984 Medical Staff Fellow, NCI, Laboratory of Human Carcinogenesis, Bethesda, MD
1979-1981 Resident, Internal Medicine, VA-Georgetown ( Georgetown University and Veterans Administration Hospitals, Administered by VA Hospital), Washington, DC 

NIH Study Section Service as Grant Reviewer (Last 2 years):

  • 02/06/2014 at NCI: LUNG SPORE Meeting 2014/05 ZCA1-RPRB-C-M1 SRO: BIANCO
  • 06/04/2014 at NCI: LUNG SPORE Meeting 2014/10 ZCA1-RPRB-7-O1 SRO: LOPACZYNSKI
  • 10/06/2014 at NCI: LUNG SPORE Meeting 2015/01 ZCA1-RPRB-7-J1 SRO: LOPACZYNSKI
  • 02/03/2015 at NCI: LUNG SPORE Meeting 2015/05 ZCA1-RPRB-7-M1 SRO: LOPACZYNSKI
  • 04/13/2015 at NCI: LUNG SPORE Meeting 2015/05 ZCA1-RPRB-M-M1 SRO: Lyman
  • 06/08/2015 at NCI:LUNG SPORE Meeting 2015/10 ZCA1-RPRB-C-O1 SRO: BIANCO
  • 02/02/2016-02/03/2016 at NCI: NCI Program Project Meeting II (P01)2016/05 ZCA1 RPRB-C (M1) SRO: BIANCO

Professional Affiliations and Activities

Present Laboratory Personnel

  • Erin Crawford, M.S., Laboratory Supervisor
  • Jiyoun Yeo, Post-Doctoral Fellow, 07/01/2014-Present
  • Xiaolu Zhang, Ph.D. Candidate (scheduled to defend 02/2016)
  • Rose Zolondek, Ph.D., graduate student
  • Daniel Craig, Ph.D., graduate student
  • Diego Morales, M.S. graduate student in Bioinformatics
  • Maggie Reilly, M.S.B.S., graduate student
  • Inchul Yang, Ph.D., Visiting Professor (on Sabbatical): Center Head/Principal Research Scientist, Center for Bioanalysis, Korea Research Institute of Standards and Science
  • James Willey, M.D., Laboratory Director

Graduated Former Students

M.D/Ph.D and Ph.D. Major Research Advisor
Lauren Stanoszek, M.D./Ph.D. (Willey, Major Advisor)
06/07-06/15; MD/PhD Program, College of Medicine, University of Toledo
07/15-06/19; Pathology Resident, University of Michigan

Jiyoun Yeo, Ph.D. (Willey, Major Advisor)
06/09-06/14; PhD Program, College of Medicine, University of Toledo
07/14-present; Post-Doctoral Fellow (Willey laboratory), College of Medicine, University of Toledo

Thomas Blomquist, M.D./Ph.D. (Willey, Major Advisor)
6/05 – 6/2012; MD/PhD Program College of Medicine, University of Toledo
06/12-06/2013: Research Assistant Professor, Dept. of Medicine, University of Toledo COM.
07/13-present; Pathology Resident, University of Toledo Medical Center.
07/01/17; Scheduled to begin as UTMC Director, Molecular Diagnostics, in July, 2017.

D'Anna Mullins, M.D., Ph.D. (Willey, Major Advisor)
6/02 – 06/08; MD/PhD Program; College of Medicine, University of Toledo
07/08-06/2011; Internal Medicine Residency, Ohio State University Medical Center (OSUMC)
07/01/2011-06/30/13; Hematology/Oncology Fellowship, OSUMC
06/30/13-present; Hematologist/Oncologist, Licking Memorial Hospital, OH
Clinical Fellow, Hematology/Oncology, 2011-present
The Ohio State University Medical Center

Timothy Graves, Ph.D.
6/1/00 – 5-31-06; Ph.D. Program,School of Medicine, Medical College of Ohio (now College of Medicine, University of Toledo). Graduated 2006
Post-Doctoral Fellowship with St. Jude's Hospital in Memphis, 2006-2007
Consultant, IMS Health 2007-2014
Presently: Executive Director, SAI MedPartners, LLC

Michael Harr, Ph.D.
8/02 – 8/06; Ph.D. program, School of Medicine, Medical College of Ohio
08/06-01/10; Post-Doctoral Fellow Case Western Reserve University School of Medicine, Cleveland, OH.
01/10-2012; Post-Doctoral Fellow Memorial Sloan Kettering, NYC
2012-present; AgencyLx, LLCGraduated 2006

Masters Program Major Research Advisor
Yasser Aldhamen, M.S.
Graduated 2007
Ph.D. Graduate School, Michigan State University, 2007-present

Ding Wu, M.S.
Graduated 2000
Sr. Research Technician
University of Chicago

Ronald Brown, M.S. graduate student 08/09-08/10
Master's program successfully completed; Boston University
Completed Master's thesis lab work in my laboratory
09/10-2014; Medical School, Wright State Medical School, Dayton, OH.

Anjali Tapadia, M.S./M.D. graduate student 01/10- 08/10
College of Medicine, University of Toledo
Completed Master's thesis work in my laboratory
09/10-06/14; Medical School, University of Toledo College of Medicine

Former Post-Doctoral Fellows
Annas Renno, M.D.; 01/2013-06/2013
Presently: Internal Medicine Resident

Aaron Baugh, M.D., 01/2014—6/2014
Presently: Internal Medicine Resident

Fadi Safi, M.D.
07/12-06/14; Pulmonary Fellow
Research training in my laboratory

Anthony Boulos;
07/13-06/15; Pulmonary Fellow
Research training in my laboratoryDavid Weaver, Ph.D., D.D.S., 1995-2002
Director of Genomics Facility, UTMC, 2002-present

Dawn-Alita Hernandez, M.D.
8/02 – 9/06; Residency and Pulmonary Training; School of Medicine, Medical College of Ohio
Presently: Assistant Professor of Pulmonary and Critical Care Medicine
University of Toledo

Kristy Warner, Ph.D., 2000-2003
Research Laboratory Specialist Lead
University of Michigan School of Dentistry, 2003-present

Clara Jackson, M.D./Ph.D.1996-1997
Medical School, 1997-2001
Medicine/Pediatric Residency, 2001-2005
Internal Medicine/Pediatric Practice Fremont, Ohio, 2006-present
Wolfgang Schuermann, M.D. Post-doctoral Fellow 5/91 - 12/91
School of Medicine, University of Rochester
Presently: Pulmonary Medicine and Research, Hanover, Germany

Michael Apostolakos, M.D. Post-doctoral Fellow 7/91 - 1/93
School of Medicine, University of Rochester
Presently: Director, Critical Care Unit, Strong Memorial Hospital, Rochester, N.Y.

Former MS and BS Lab Members
Charles Knight, M.S., 2002-2005
Gene Express, Inc., Toledo, 2005-2007

Bradley Austermiller, B.S., 2003-2005
Gene Express, Inc., Toledo, 2005-present

Jeff Demuth, M.S., 1995-1998
Proctor and Gamble, Cincinnati, 1998-present
Vrushalee Palsule, M.S., Technician
Presently: University of Florida

Summer Undergraduate Interns (last two years)
2014
Karan Padda, Swarthmore College; Currently: Second year, Emery University School of Medicine
Taylor Arend, Denison College; Currently: First year, University of Toledo College of Medicine

2015
Paige Willey, Swarthmore College; Currently: Senior, Swarthmore College
Thad Woodard, Johns Hopkins University; Currently: Sophomore, Johns Hopkins University


Current NIH Grant

Project Number  Project Title Contact PI/Project Leader Organization FY Admin IC Funding IC FY Total Cost by IC Similar Projects 
1R01HL108016-01 INHERITED GENETIC RISK FACTORS COMMON TO COPD AND LUNG CANCER WILLEY, JAMES C UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS 2011-2016 NHLBI NHLBI  $551,872 Click Here

Recently Completed NIH Grants

Project Number  Project Title Contact PI/Project Leader Organization FY Admin IC Funding IC FY Total Cost by IC Similar Projects 
7R21CA132806-03 STANDARDIZED NANOARRAY PCR FOR GENE EXPRESSION PROFILING OF LUNG CANCER   WILLEY, JAMES C  UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS   2009-2014 NCI  NCI   $153,845  Click Here
5R21CA138397-02 IMPLEMENTATION OF INNOVATIVE RNA SAMPLE QUALITY CONTROL METHODS WILLEY, JAMES C UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS 2011-2014 NCI NCI $190,982 Click Here
5RC2CA148572-02 VALIDATION OF A MULTI-GENE TEST FOR LUNG CANCER RISK WILLEY, JAMES C UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS 2010-2014 NCI NCI $850,365 Click Here

Patent Activity

Patent citations: 222

Patents Awarded (12 since 1992)

United States Patent # 08,981,068   Issued: 2015:
Inventor: Willey, James C.
Compositions of standardized mixtures for determining an amount of a nucleic acid

United States Patent # 8,771,947   Issued: 2014
Inventor: Willey, James C.
Cancer risk biomarkers

United States Patent # 8,765,368   Issued: 2014
Inventor: Willey, James C.
Cancer risk biomarker

United States Patent # 8,722,331   Issued: 2014
Inventor: Willey, James C.
Method for selecting a treatment for non-small cell lung cancer using gene expression profiles 

United States Patent # 8,563,23Issued: 2013
Inventor: Willey, James C.
Method for quantitative measurement of gene expression for identifying individuals at risk for bronchogenic carcinoma

United States Patent # 8,304,192  Issued: 2012
Inventor: Willey, James C.
Methods and compositions for assessing nucleic acids and alleles

United States Patent # 7,527,930 Issued: 2009
Inventor: Willey, James C.
Compositions and methods of use of standardized mixtures for determining an amount of a nucleic acid

United States Patent # 7,476,502 Issued: 2009
Inventor: Willey, James C.
Methods and compositions for assaying analytes

United States Patent # 5,876,978 Issued: 1999
Inventor: Willey, James C.
Method for quantitative measurement of gene expression using multiplex competitive reverse transcriptase-polymerase chain reaction

United States Patent # 5,643,765 Issued: 1997
Inventor: Willey, James C.
Method for quantitative measurement of gene expression using multiplex competitive reverse transcriptase-polymerase chain reaction

United States Patent # 5,639,606 Issued: 1997
Inventor: Willey, James C.
Method for quantitative measurement of gene expression using multiplex competitive reverse transcriptase-polymerase chain reaction

United States Patent # 5,432,060 Issued: 1995
Inventor: Willey, James C.
Immortalized human bronchial epithelial cell line

Patents Applications Pending (Filed in last five years)

  • 2015/0292,001  Submitted: 2015 Methods for Standardized Sequencing of Nucleic Acids and Uses Thereof
  • 2015/0225,798  Submitted: 2015 Materials and Methods for Quality-Controlled Two-Color RT-QPCR Diagnostic Testing of Formalin Fixed Embedded and/or Fresh-Frozen Samples
  • 02015/0184,240  Submitted: 2015 Compositions of Standardized Mixtures and Kits Therefor
  • 02014/0287,422  Submitted: 2014 Method for Selecting a Treatment for Non-Small Cell Lung Cancer Using Gene Expression Profiles
  • 02013/0143,207  Submitted: 2013 METHODS AND COMPOSITIONS FOR IDENTIFYING BIOMARKERS USEFUL IN CHARACTERIZING BIOLOGICAL STATES
  • 02012/0322,071 Submitted: 2012  METHOD FOR QUANTITATIVE MEASUREMENT OF GENE EXPRESSION FOR INDENTIFYING INDIVIDUALS AT RISK FOR BRONCHOGENIC CARCINOMA
  • 02010/0184,029 Submitted: 2010 METHODS AND COMPOSITIONS FOR IDENTIFYING BIOMARKERS USEFUL IN CHARACTERIZING BIOLOGICAL STATES 

Representative Publications

Crawford, E.L., Levin, A., Safi, F., Lu, M., Baugh, A., Zhang, X., Yeo, J., Khuder, S. A., Boulos, A. M., Nana-Sinkam, P., Massion, P., Arenberg, D. A., Midthun, D., Mazzone, P. J., Nathan, S. D., Wainz, R., Silvestri, G., Tita, J. and Willey, J. C., Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a bio-specimen repository, BMC Pulmonary Medicine, 2016 16:16 Epub 2016 Jan 22. DOI 10.1186/s12890-016-0178-4.

Yankelevitz DF, Yip R, Smith JP, Liang M, Liu Y, Xu DM, Salvatore MM, Wolf AS, Flores RM, Henschke CI; International Early Lung Cancer Action Program Investigators Group (including Willey, J.C.), CT Screening for Lung Cancer: Nonsolid Nodules in Baseline and Annual Repeat Rounds, Radiology, 277, 555-64, 2015 doi: 10.1148/radiol.2015142554. Epub 2015 Jun 23.

Blomquist, T.A., Crawford, E. L., Yeo, J., Zhang,X., Willey, J.C., Control for stochastic sampling variation and qualitative sequencing error in next generation sequencing, Biomolecular Detection and Quantification, online on August 28, 2015.

SEQC/MAQC-III Consortium, (Willey, J.C., co-author), A comprehensive assessment of RNA-seq accuracy, reproducibility and information content by the Sequence Quality Control consortium, Nature Biotechnology, 32, 903–914, 2014.

Yeo, J., M.S., Crawford, E.L., M.S., Blomquist, T.M., Stanoszek, L.M., Dannemiller, R.E.,  Jordan, L., Zyrek-Betts, J., M.D., de la Casas, L., Willey, J.C., Use of two-color fluorometric real-time PCR to develop molecular diagnostic tests with intrinsic quality control, PLos ONE, 9 (2),  e89395, 2014.

Blomquist, T.M., Crawford, E.L., Lovett, J.L., Yeo, J., Stanoszek, L.M., Levin, A., Li, J., Lu, M., Shi, L., Muldrew, K., Willey, J.C., Targeted RNA-sequencing with competitive amplicon libraries increases reproducibility and reduces data complexity and cost, PLos ONE, 8 (11): e79120, doi:10.1371/journal.pone.0079120, 2013

Pierce, L.R., Willey, J.C., Palsule, V.V., Yeo, J., Shepherd, B.S., Crawford, E.L., Stepien, Accurate Detection and Quantification of the Fish Viral Hemorrhagic Septicemia virus (VHSv) with a Two-Color Fluorometric Real-Time PCR Assay, C.A., PLoS ONE 8(8): e71851. doi:10.1371/journal.pone.0071851

Cis-acting genetic variation contributes to CCAAT/enhancer binding protein gamma (CEBPG) expression variation in human bronchial epithelial cells, Blomquist, T.M., Brown, R.D., Crawford, E.L., de la Serna, I., Williams, K., Yoon. Y., Hernandez, D-A., and Willey, J.C., Gene Regulation and Systems Biology, Gene Regulation and Systems Biology 2013:7 125-138, 2013.

Pierce, L.R., Willey, J.C., Crawford, E.L., Palsulea, V.V., Leaman, D.W., Faisal, M., Kim, R.K., Shepherd, B.S., Stanoszek, L.M., Stepien, C.A.,*A new StaRT-PCR approach to detect and quantify fish Viral Hemorrhagic Septicemia virus (VHSv): Enhanced quality control with internal standards, Journal of Virological Methods, 189, 129-142, 2013.

Stanoszek, L.M., Crawford, E.L., Blomquist, T.M., Willey, P.F.S., Willey, J.C., RNA quality control methods for optimal BCR-ABL clinical testing in human whole blood samples, Journal of Molecular Pathology, 15, 391-400, 2013

MAQC Consortium, The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models, Nature Biotechnology, 28, 827-838, 2010.

Blomquist T., Crawford, E. L. and Willey, J.C., Genetic variation at E2F1/YY1 and P53 consensus sites is associated with altered allele-specific expression of ERCC5 (XPG) transcript in normal human bronchial epithelium, Carcinogenesis, 31, 1242-1250, 2010.

Blomquist, T. Crawford, E.L., Mullins, D., Yoon, Y., Hernandez, D., Khuder, S., Ruppel, P.L., Peters, E., Oldfield, D.J., Austermiller, B., Anders, J.C., and Willey, J.C., Pattern of antioxidant and DNA repair gene expression in normal airway epithelium associated with lung cancer diagnosis, Cancer Research, 69, 8629-8635, 2009.

Shi LM, Jones WD, Jensen RV, et al., The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies. BMC Bioinformatics, 9, Suppl. 9:S10, 2008.

Sudo, H., Li-Sucholeiki, X.-C., Marcelino, L.A., Gruhl, A.N., Herrero-Jimenez, P., Zarbl, H., Willey, J.C., Furth, E.E., Coller, H,A., Kurzweil, R.l. Ekstrom, P.O., Morgenthaler, S., Gostjeva, E.V., Thilly, W.G., Fetal-juvenile origins of point mutation clusters in the adult human tracheal-bronchial epithelium: absence of effects of age, gender or smoking status, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, 646, 25-40, 2008.

Crawford EL, Blomquist T, Mullins DN, Yoon Y, Hernandez DR, Al-Bagdhadi M, Ruiz J, Hammersley J, Willey JC., CEBPG regulates ERCC5/XPG expression in Human Bronchial Epithelial Cells and this regulation is modified by E2F1/YY1 interactions, Carcinogenesis, 28, 2552-2559, 2007.

Harr, MW and Willey, JC, The interactive transcript abundance index [c-myc*p73•]/[p21*Bcl-2] correlates with baseline level of apoptosis and response to CPT-11 in human bronchogenic carcinoma cell lines, International Journal of Cancer, 30, 1553-60, 2007.

Last Updated: 6/9/16