Heather Myler

Heather Myler

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Heather Myler

Heather Myler

Publications by authors named "Heather Myler"

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Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing.

Bioanalysis 2019 Jun 18. Epub 2019 Jun 18.

Bioanalytical Sciences, Bristol-Myers Squibb Co., Princeton, NJ 08543, USA.

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http://dx.doi.org/10.4155/bio-2018-0107DOI Listing
June 2019

Report on the AAPS Immunogenicity Guidance Forum.

AAPS J 2019 Apr 16;21(4):55. Epub 2019 Apr 16.

Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.

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http://link.springer.com/10.1208/s12248-019-0328-8
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http://dx.doi.org/10.1208/s12248-019-0328-8DOI Listing
April 2019

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Bioanalysis 2018 Nov 29. Epub 2018 Nov 29.

Amador Bioscience, Pleasanton, CA, USA (formerly of OncoMed, Redwood City, CA, USA).

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http://dx.doi.org/10.4155/bio-2018-0287DOI Listing
November 2018

Generic Anti-PEG Antibody Assay on ProterixBio's (Formerly BioScale) ViBE Platform Shows Poor Reproducibility.

AAPS J 2018 04 24;20(3):65. Epub 2018 Apr 24.

Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, New Jersey, USA.

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http://dx.doi.org/10.1208/s12248-018-0228-3DOI Listing
April 2018

Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.

AAPS J 2017 09 6;19(5):1461-1468. Epub 2017 Jun 6.

Analytical and Bioanalytical Operations, Bristol-Myers Squibb, Princeton, New Jersey, USA.

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http://dx.doi.org/10.1208/s12248-017-0105-5DOI Listing
September 2017

Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples.

Bioanalysis 2015 ;7(15):1869-83

Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.

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http://dx.doi.org/10.4155/bio.15.112DOI Listing
May 2016

Recommendations for the development and validation of confirmatory anti-drug antibody assays.

Bioanalysis 2015 ;7(13):1619-31

Covance, Inc., 3635 Concorde Parkway, Suite 100 Chantilly, VA 20151, USA.

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http://dx.doi.org/10.4155/bio.15.96DOI Listing
April 2016

Biotransformation and stability of antibody-drug conjugates: payload metabolism and linker cleavage delineation.

Bioanalysis 2015 ;7(11):1319-23

Biologics Discovery California, Bristol-Myers Squibb, Redwood City, CA 94063, USA.

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http://dx.doi.org/10.4155/bio.15.50DOI Listing
March 2016

Quantitative bioanalysis of antibody-conjugated payload in monkey plasma using a hybrid immuno-capture LC-MS/MS approach: Assay development, validation, and a case study.

J Chromatogr B Analyt Technol Biomed Life Sci 2015 Oct 12;1002:54-62. Epub 2015 Aug 12.

Analytical and Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

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http://dx.doi.org/10.1016/j.jchromb.2015.08.007DOI Listing
October 2015

New FDA draft guidance on immunogenicity.

AAPS J 2014 May 29;16(3):499-503. Epub 2014 Mar 29.

Mercer University, 3001 Mercer University Drive, Atlanta, Georgia, 30341, USA,

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http://dx.doi.org/10.1208/s12248-014-9587-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4012054PMC
May 2014

Measuring biotherapeutics with endogenous counterparts and pre-existing antibodies: an interferon case study.

Bioanalysis 2014 Apr;6(8):1113-22

Bristol-Myers Squibb, Route 206 & Province Line Rd, Princeton, NJ 08543, USA.

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http://www.future-science.com/doi/10.4155/bio.14.37
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http://dx.doi.org/10.4155/bio.14.37DOI Listing
April 2014

Biotherapeutic bioanalysis: a multi-indication case study review.

Bioanalysis 2011 Mar;3(6):623-43

Bristol-Myers Squibb, Route 206 & Province Line Rd., Princeton, NJ 08540, USA.

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http://www.future-science.com/doi/10.4155/bio.11.33
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http://dx.doi.org/10.4155/bio.11.33DOI Listing
March 2011

Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients.

J Pharmacol Toxicol Methods 2010 Mar-Apr;61(2):92-7. Epub 2010 Jan 4.

Ambrx, Inc., 10975 North Torrey Pines Road, La Jolla, California 92037, USA.

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http://dx.doi.org/10.1016/j.vascn.2009.12.004DOI Listing
June 2010

Novel heparanase-inhibiting antibody reduces neointima formation.

J Biochem 2006 Mar;139(3):339-45

Department of Biochemistry and Cell Biology, Rice University, Houston, Texas 77005, USA.

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http://academic.oup.com/jb/article/139/3/339/1043596/Novel-H
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http://dx.doi.org/10.1093/jb/mvj061DOI Listing
March 2006

Nitric oxide-generating hydrogels inhibit neointima formation.

J Biomater Sci Polym Ed 2005 ;16(5):659-72

Department of Chemical Engineering, Rice University, Houston, TX 77005-1892, USA.

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January 2006

Heparanase and platelet factor-4 induce smooth muscle cell proliferation and migration via bFGF release from the ECM.

J Biochem 2002 Jun;131(6):913-22

Department of Biochemistry and Cell Biology, Rice University, P.O. Box MS-Houston, Texas 77251, USA.

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http://dx.doi.org/10.1093/oxfordjournals.jbchem.a003182DOI Listing
June 2002