About Me
EDUCATION:
PhD Biochemistry University of Minnesota 1987
WORK EXPERIENCE:
Pfizer – Director of Bioanalytical
08/07/2017 – 02/12/2024
Led a team of scientists in a regulated laboratory environment within the PDM group in the BioMedicines Design Department (BMD) of Pfizer.
Provided expert leadership in the development and execution of large-molecule PK, ADA, and nAb assays supporting projects from IND enabling toxicology through clinical development of novel protein therapeutics. Spearheaded the establishment of bioanalytical support for Gene Therapy, including immunogenicity assays for AAV vectors and gene products, and PCR for biodistribution studies. Responsible for the Department’s Business and Quality Management Team, with focus on Compliance and Outsourcing.
Eurofins Bioanalytical Services / Millipore – Scientific Director
06/21/2012 – 07/28/2017
Develop client scientific and business relationships. Provide guidance and oversight for regulatory and scientific integrity of the bioanalytical studies to ensure that studies are performed in a compliant manner. Define scope of work, focus of the project and consultation to the client. Management of Scientific Development staff (Scientific Directors and/or Principal Investigators). Led the New Technology and Service initiative to identify, evaluate and implement new services to the Company’s offerings.
Covance – Associate Director
01/18/2010 – 06/15/2012
Direct the Principal Investigator staff responsible for the scientific conduct of immunochemistry projects. Ensure the scientific quality and expertise of the department, consult with clients on drug discovery or development needs and establish appropriate immunochemistry assays or programs. Develop department capabilities and resources to meet both present and future needs.
Eli Lilly and Company – Research Advisor
06/18/2000 – 01/15/2010
Oversee the development, validation and implementation of bioanalytical methods for therapeutic macromolecules. Represent ADME on cross-functional project teams to providre scientific consultation including recommendation on selection of drug candidates for development and preparation of regulatory submissions. Serve as Principal Investigator for GLP studies and Contributing Scientist for clinical studies. Liaison with contract laboratories, managing method transfers and study sample analysis.
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My Publications
Immunogenicity assessment of AAV-based gene therapies: An IQ Consortium White Paper. Mol Ther Methods Clin Dev 26:471-494
Kavita, et al. 2023
PK/PD and bioanalytical considerations of AAV-based gene therapies: An IQ Consortium White Paper. AAPS Journal 25 (5): 28
Hersey et al. 2022
White Paper on recent issues in bioanalysis. Bioanalysis 14 (10): 627-692
Ablamunits V, Basak, Lawrence-Henderson, Ciazzo and Kamerud. 2021
A competitive ligand binding assay to detect neutralizing antibodies to a bispecific drug using a multiplex MesoScale Discovery platform. Bioanalysis 13 (22): 1659-1669
Jiang Z, Kamerud, You, Basak, Seletskaia, Steeno and Gorovits. 2021
Feasibility of singlicate-based analysis in bridging ADA assay on MesoScale Discovery platform; comparison with duplicate analysis.
Bioanalysis 13 (14): 1123-1134
Corsaro, et al. 2021
White Paper on recent issues in bioanalysis. Bioanalysis 13 (6): 415-463
Tan C, Steeno, You, Gaitonde, Cai, Kamerud, Gorovits and Baltrukonis. 2020
Criteria to re-evaluate anti-drug antibody assay cut point suitability in the target population. AAPS Journal 22(2): 19
Jiang Z, Kamerud, Zhang, Ruiz, Guadiz, Fichtner and Gorovits. 2020
Strategies to develop highly drug-tolerant cell-based neutralizing antibody assays: neutralizing antidrug antibody extraction and drug depletion.
Bioanalysis 12(18): 1279-1293
Gorovits B, Wang, Araya, Zhu, Kamerud and Lepsy. 2019
Antidrug antibody assay conditions significantly impact assay screen and confirmatory cut points. AAPS Journal 21 (4): 71
Booth B, et al 2019
White Paper on recent issues in bioanalysis. Bioanalysis 11 (23): 2099-2132
Stevenson et al. 2018
White Paper on recent issues in bioanalysis. Bioanalysis 10
Xiang et al. 2018
Approaches to resolve false reporting in neutralizing antibody assays caused by reagent leaching from affinity capture elution solid phase.
AAPS Journal 21 (1): 4
Xiang et al. 2018
A simple approach to determine a curve-fitting model with correct weighting function for calibration curves in quantitative ligand binding assays.
AAPS Journal 20 (3): 45
Azadeh et al. 2017
Calibration curves in ligand binding assays: recommendations and best practices for preparation, design and editing of calibration curves.
AAPS Journal 20 (1): 22
Gupta et al. 2017
White paper on recent issues in bioanalysis. Bioanalysis 9 (24): 1697-1996
Richards et al. 2016
White Paper on recent issues in bioanalysis. Bioanalysis 8 (23): 2475-2496
Kelley M, Ahene, Gorovits, Kamerud, King, MacIntosh and Yang. 2013
Theoretical considerations and practical approaches to address the effect of antidrug antibody (ADA) on quantification of biotherapeutics in circulation.
AAPS Journal 15: 646-658
Lowes et al. 2011
Recommendations on IS criteria, stability, ISR and recent 483s by the Global CRO Council. Bioanalysis 3 (12): 1323-1332
Lee et al. 2011
White Paper: Bioanalytical approaches to quantify total and free therapeutic antibodies and their targets. Technical challenges and PK/PD applications over the course of drug development. AAPS Journal 13:99-110
Viswanathan et al. 2007
Conference Report - quantitative bioanalytical method validation and implementation: best practices for chromatographic and ligand binding assays. AAPS Journal Vol 9 article 4
Kamerud JQ. 2005
Outsourcing of ligand binding assays: the Sponsor's perspective. American Pharmaceutical Outsourcing 6: 16-21
Benecky M, McKinney, Peterson and Kamerud. 1998
Simultaneous detection of multiple analytes using Copalis technology: a reduction to practice. Clin Chem 44: 2052-2054
Hollis BW, Kamerud, Kurkowski, Beaulieu and Napoli. 1996
Quantitation of circulating 1,25 dihydroxyvitamin D by radioimmunoassay with a 125I-labelled tracer. Clin Chem 42: 586-592
Hollis BW, Kamerud, Selvaag and Napoli. 1993
Determination of Vitamin D status using a radioimmunoassay with a 125I-labelled tracer. Clin Chem 39: 529-532
Kamerud JQ. 1992
New methods for quantitation of vitamin D metabolites. Eur Clin Chem: Nov/Dec 1992