Scott Stibitz

Scott Stibitz

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Scott Stibitz

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Use of controlled human infection models (CHIMs) to support vaccine development: US regulatory considerations.

Vaccine 2019 Jul 21;37(31):4256-4261. Epub 2019 Jun 21.

Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States. Electronic address:

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http://dx.doi.org/10.1016/j.vaccine.2019.06.009DOI Listing
July 2019

Gene Essentiality and Metabolism in Bordetella pertussis.

mSphere 2019 05 22;4(3). Epub 2019 May 22.

Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia, USA

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http://msphere.asm.org/lookup/doi/10.1128/mSphere.00694-18
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http://dx.doi.org/10.1128/mSphere.00694-18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6531889PMC
May 2019

The BvgASR virulence regulon of Bordetella pertussis.

Curr Opin Microbiol 2019 02 11;47:74-81. Epub 2019 Mar 11.

Center for Biologics Evaluation and Research, FDA, Silver Spring, MD, United States. Electronic address:

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http://dx.doi.org/10.1016/j.mib.2019.01.002DOI Listing
February 2019

Corynebacterium pseudodiphtheriticum Exploits Staphylococcus aureus Virulence Components in a Novel Polymicrobial Defense Strategy.

mBio 2019 01 8;10(1). Epub 2019 Jan 8.

F. Edward Hébert School of Medicine, Department of Microbiology and Immunology, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA

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http://mbio.asm.org/lookup/doi/10.1128/mBio.02491-18
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http://dx.doi.org/10.1128/mBio.02491-18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325251PMC
January 2019

A Novel Bvg-Repressed Promoter Causes -Like Transcription of but Does Not Result in the Production of Serotype 3 Fimbriae in Bvg Mode Bordetella pertussis.

J Bacteriol 2018 10 24;200(20). Epub 2018 Sep 24.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1128/JB.00175-18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153668PMC
October 2018

Stable Chromosomal Expression of Shigella flexneri 2a and 3a O-Antigens in the Live Salmonella Oral Vaccine Vector Ty21a.

Clin Vaccine Immunol 2017 Dec 5;24(12). Epub 2017 Dec 5.

Laboratory of Mucosal Pathogens and Cellular Immunology, U.S. FDA-Center for Biologics Evaluation and Research, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1128/CVI.00181-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5717188PMC
December 2017

Activation of Bvg-Repressed Genes in Bordetella pertussis by RisA Requires Cross Talk from Noncooperonic Histidine Kinase RisK.

J Bacteriol 2017 11 17;199(22). Epub 2017 Oct 17.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA, Silver Spring, Maryland, USA.

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http://jb.asm.org/lookup/doi/10.1128/JB.00475-17
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http://dx.doi.org/10.1128/JB.00475-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5648863PMC
November 2017

Staphylococcus aureus Epicutaneous Exposure Drives Skin Inflammation via IL-36-Mediated T Cell Responses.

Cell Host Microbe 2017 Nov;22(5):653-666.e5

Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Materials Science and Engineering, Johns Hopkins University, Baltimore, MD 21218, USA. Electronic address:

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http://dx.doi.org/10.1016/j.chom.2017.10.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774218PMC
November 2017

U.S. Regulatory Considerations for Development of Live Biotherapeutic Products as Drugs.

Microbiol Spectr 2017 10;5(5)

Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993.

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http://dx.doi.org/10.1128/microbiolspec.BAD-0017-2017DOI Listing
October 2017

The BvgAS Regulon of .

mBio 2017 10 10;8(5). Epub 2017 Oct 10.

Gene Expression and Regulation Section, Laboratory of Cell and Molecular Biology, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA

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http://dx.doi.org/10.1128/mBio.01526-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5635692PMC
October 2017

A simplified mycobacterial growth inhibition assay (MGIA) using direct infection of mouse splenocytes and the MGIT system.

J Microbiol Methods 2016 12 17;131:7-9. Epub 2016 Sep 17.

Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1016/j.mimet.2016.09.010DOI Listing
December 2016

Stable expression of Shigella dysenteriae serotype 1 O-antigen genes integrated into the chromosome of live Salmonella oral vaccine vector Ty21a.

Pathog Dis 2016 11 20;74(8). Epub 2016 Sep 20.

Laboratory of Mucosal Pathogens and Cellular Immunology, U.S. FDA-Center for Biologics Evaluation and Research, New Hampshire Avenue, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1093/femspd/ftw098DOI Listing
November 2016

The multifaceted RisA regulon of Bordetella pertussis.

Sci Rep 2016 09 13;6:32774. Epub 2016 Sep 13.

Institut Pasteur de Lille, Center for Infection and Immunity of Lille, Lille, France.

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http://dx.doi.org/10.1038/srep32774DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020355PMC
September 2016

Development of an Acid-Resistant Salmonella Typhi Ty21a Attenuated Vector For Improved Oral Vaccine Delivery.

PLoS One 2016;11(9):e0163511. Epub 2016 Sep 27.

Laboratory of Mucosal Pathogens and Cellular Immunology, Food and Drug Administration-Center for Biologics Evaluation and Research, New Hampshire Avenue, Silver Spring, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0163511PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5046385PMC
September 2016

Improvements to a Markerless Allelic Exchange System for Bacillus anthracis.

PLoS One 2015 1;10(12):e0142758. Epub 2015 Dec 1.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0142758PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4666636PMC
June 2016

Development of Phage Lysin LysA2 for Use in Improved Purity Assays for Live Biotherapeutic Products.

Viruses 2015 Dec 16;7(12):6675-88. Epub 2015 Dec 16.

Office of Vaccines Research and Review, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.3390/v7122965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690888PMC
December 2015

Bordetella pertussis fim3 gene regulation by BvgA: phosphorylation controls the formation of inactive vs. active transcription complexes.

Proc Natl Acad Sci U S A 2015 Feb 26;112(6):E526-35. Epub 2015 Jan 26.

Gene Expression and Regulation Section, Laboratory of Cell and Molecular Biology, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892;

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http://dx.doi.org/10.1073/pnas.1421045112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330726PMC
February 2015

Strong inhibition of fimbrial 3 subunit gene transcription by a novel downstream repressive element in Bordetella pertussis.

Mol Microbiol 2014 Aug 13;93(4):748-58. Epub 2014 Jul 13.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA, Bethesda, MD, 20892, USA.

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http://dx.doi.org/10.1111/mmi.12690DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4669884PMC
August 2014

Pertussis pathogenesis--what we know and what we don't know.

J Infect Dis 2014 Apr;209(7):982-5

Departments of Medicine and Microbiology, Immunology and Cancer Biology, University of Virginia School of Medicine, Charlottesville, Virginia.

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http://dx.doi.org/10.1093/infdis/jit639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3952676PMC
April 2014

Stably luminescent Staphylococcus aureus clinical strains for use in bioluminescent imaging.

PLoS One 2013 12;8(3):e59232. Epub 2013 Mar 12.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0059232PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3595258PMC
September 2013

Epicutaneous model of community-acquired Staphylococcus aureus skin infections.

Infect Immun 2013 Apr 4;81(4):1306-15. Epub 2013 Feb 4.

Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1128/IAI.01304-12DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639601PMC
April 2013

In vivo phosphorylation dynamics of the Bordetella pertussis virulence-controlling response regulator BvgA.

Mol Microbiol 2013 Apr 14;88(1):156-72. Epub 2013 Mar 14.

Gene Expression and Regulation Section, Laboratory of Cell and Molecular Biology, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1111/mmi.12177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3608721PMC
April 2013

Dissemination bottleneck in a murine model of inhalational anthrax.

Infect Immun 2012 Sep 2;80(9):3189-93. Epub 2012 Jul 2.

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1128/IAI.00515-12DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418736PMC
September 2012

Bacillus anthracis protease InhA regulates BslA-mediated adhesion in human endothelial cells.

Cell Microbiol 2012 Aug 17;14(8):1219-30. Epub 2012 Apr 17.

Department of Biosciences and Biomedical Research Laboratory, George Mason University, 10650 Pyramid Place, Manassas, Virginia 20110, USA.

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http://dx.doi.org/10.1111/j.1462-5822.2012.01791.xDOI Listing
August 2012

The Bordetella pertussis model of exquisite gene control by the global transcription factor BvgA.

Microbiology 2012 Jul 24;158(Pt 7):1665-1676. Epub 2012 May 24.

Gene Expression and Regulation Section, Laboratory of Cell and Molecular Biology, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1099/mic.0.058941-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542142PMC
July 2012

Identification of the bacterial protein FtsX as a unique target of chemokine-mediated antimicrobial activity against Bacillus anthracis.

Proc Natl Acad Sci U S A 2011 Oct 26;108(41):17159-64. Epub 2011 Sep 26.

Department of Medicine, Division of Infectious Diseases, University of Virginia, Charlottesville, VA 22908, USA.

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http://dx.doi.org/10.1073/pnas.1108495108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193227PMC
October 2011

Different requirements for σ Region 4 in BvgA activation of the Bordetella pertussis promoters P(fim3) and P(fhaB).

J Mol Biol 2011 Jun 22;409(5):692-709. Epub 2011 Apr 22.

Gene Expression and Regulation Section, Laboratory of Molecular and Cellular Biology, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

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https://linkinghub.elsevier.com/retrieve/pii/S00222836110043
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http://dx.doi.org/10.1016/j.jmb.2011.04.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3141349PMC
June 2011

Novel architectural features of Bordetella pertussis fimbrial subunit promoters and their activation by the global virulence regulator BvgA.

Mol Microbiol 2010 Sep;77(5):1326-40

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1111/j.1365-2958.2010.07293.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2975811PMC
September 2010

Pertactin is required for Bordetella species to resist neutrophil-mediated clearance.

Infect Immun 2010 Jul 26;78(7):2901-9. Epub 2010 Apr 26.

Department of Molecular, Cellular, and Developmental Biology, University of California, Santa Barbara, Santa Barbara, California 93106-9610, USA.

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http://dx.doi.org/10.1128/IAI.00188-10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2897405PMC
July 2010

Role of anthrax toxins in dissemination, disease progression, and induction of protective adaptive immunity in the mouse aerosol challenge model.

Infect Immun 2009 Jan 27;77(1):255-65. Epub 2008 Oct 27.

Laboratory of Respiratory and Special Pathogens, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, Maryland 20892, USA.

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http://iai.asm.org/content/early/2008/10/27/IAI.00633-08.ful
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http://iai.asm.org/cgi/doi/10.1128/IAI.00633-08
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http://dx.doi.org/10.1128/IAI.00633-08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2612249PMC
January 2009

Four superoxide dismutases contribute to Bacillus anthracis virulence and provide spores with redundant protection from oxidative stress.

Infect Immun 2009 Jan 27;77(1):274-85. Epub 2008 Oct 27.

Department of Microbiology and Immunology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814-4799, USA.

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http://dx.doi.org/10.1128/IAI.00515-08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2612278PMC
January 2009

Role of the N-terminal amino acid of Bacillus anthracis lethal factor in lethal toxin cytotoxicity and its effect on the lethal toxin neutralization assay.

Clin Vaccine Immunol 2008 Nov 24;15(11):1737-41. Epub 2008 Sep 24.

Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1128/CVI.00081-08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2583523PMC
November 2008

O antigen protects Bordetella parapertussis from complement.

Infect Immun 2008 Apr 19;76(4):1774-80. Epub 2008 Feb 19.

Department of Veterinary and Biomedical Sciences, Pennsylvania State University, 115 Henning Building, University Park, PA 16802, USA.

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http://dx.doi.org/10.1128/IAI.01629-07DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2292887PMC
April 2008

Bacillus anthracis exosporium protein BclA affects spore germination, interaction with extracellular matrix proteins, and hydrophobicity.

Infect Immun 2007 Nov 20;75(11):5233-9. Epub 2007 Aug 20.

Department of Microbiology and Immunology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, USA.

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http://dx.doi.org/10.1128/IAI.00660-07DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2168272PMC
November 2007

c-di-GMP-mediated regulation of virulence and biofilm formation.

Curr Opin Microbiol 2007 Feb 8;10(1):17-23. Epub 2007 Jan 8.

Department of Molecular, Cellular, and Developmental Biology, University of California, Santa Barbara, Santa Barbara, CA 93106-9610, USA.

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http://linkinghub.elsevier.com/retrieve/pii/S136952740600192
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http://dx.doi.org/10.1016/j.mib.2006.12.006DOI Listing
February 2007

Routine markerless gene replacement in Bacillus anthracis.

Infect Immun 2006 Mar;74(3):1949-53

Division of Bacterial Products, CBER/FDA, 8800 Rockville Pike, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1128/IAI.74.3.1949-1953.2006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1418658PMC
March 2006

Role of BvgA phosphorylation and DNA binding affinity in control of Bvg-mediated phenotypic phase transition in Bordetella pertussis.

Mol Microbiol 2005 Nov;58(3):700-13

Department of Molecular, Cellular and Developmental Biology, University of California, Santa Barbara, CA 93109-9610, USA.

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http://dx.doi.org/10.1111/j.1365-2958.2005.04875.xDOI Listing
November 2005

BvgA functions as both an activator and a repressor to control Bvg phase expression of bipA in Bordetella pertussis.

Mol Microbiol 2005 Apr;56(1):175-88

Department of Molecular, Cellular and Developmental Biology, University of California, Santa Barbara, CA 93106-9610, USA.

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http://dx.doi.org/10.1111/j.1365-2958.2004.04526.xDOI Listing
April 2005

Demonstration of differential virulence gene promoter activation in vivo in Bordetella pertussis using RIVET.

Mol Microbiol 2005 Feb;55(3):788-98

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA.

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http://dx.doi.org/10.1111/j.1365-2958.2004.04418.xDOI Listing
February 2005

Analysis of bvgR expression in Bordetella pertussis.

J Bacteriol 2003 Dec;185(23):6902-12

Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC262712PMC
http://dx.doi.org/10.1128/jb.185.23.6902-6912.2003DOI Listing
December 2003

The response regulator BvgA and RNA polymerase alpha subunit C-terminal domain bind simultaneously to different faces of the same segment of promoter DNA.

Mol Cell 2003 Jan;11(1):163-73

Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1016/s1097-2765(03)00007-8DOI Listing
January 2003