Expert Profile
Edward O Connor
Individual Consultant, HJJ
Dr. Edward O’Connor has varied and extensive experience within both experimental and CLIA, GLP, GCP and GMP regulated laboratories. Dr. O’Connor is an recognized expert in both instrumental (LC-MS, LC-EC, LC-PDA) and ligand binding (MSD, ELISA, FLOW) and cell based assays. Molecules include small molecules, peptides, proteins, antibodies, aptamers and both DNA and RNA nucleotides. Dr. O’Connor is also experienced in allometric pharmacokinetics, and the design of in vivo and in vitro bioanalytical assays to reveal mechanism of action, efficacy and toxicity as related to animal and human studies for developing and evaluating pharmaceutical products. Dr. O’Connor uses and teaches the use of in silico techniques and programs (ACD, BLAST, etc.) in the design of both ligand binding assays and LC-MS approaches to accelerate the development of capture and detect moieties as well as chromatographic and mass spectrographic conditions to optimize assay performance.
Dr. O’Connor is a member of the emerging technologies and real time analysis committees of AAPS and has published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. O’Connor has also streamlined vendor selection and management processes, as well as implemented “DOWNTIME” practices to improve efficiency in Bioanalytical labs. Another facet is Dr. O’Connor’s application of statistics to predict cut points (receiver operator curve-ROC) for cell based and neutralization assays.
Dr. O’Connor has been working as an independent consultant in bioanalysis since 2017. A detailed description of his expertise and the services he provides may be obtained from the website www.aegisbioconsult.com.
Trainings by Expert
Bioanalytical Methods Validation
Category:
Clinical Research
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Biotechnology
,
Laboratory Compliance
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Testing and Validation
,
Quality and Safety
,
Laboratory
,
Quality & Safety
,
Life Sciences
HPLC Method Development and Validation
Category:
Laboratory Compliance
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Testing and Validation
,
Quality and Safety
,
Laboratory
,
Life Sciences
Worksheets that Capture SOP Details and Are Compliant
Category:
Clinical Research
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Biotechnology
,
Laboratory Compliance
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All FDA Regulated Industry
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Documentation and IT
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Quality and Safety
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Laboratory
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Clinical Laboratory
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Analytical Laboratory
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GCP & Other Best Practices
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Risk Management & Controls
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All FDA Regulated Functions
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Audit & Inspection-Role
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Lab Audit
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Life sciences QA/QC
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Regulations & Guidances
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Best Practices & GXPs
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Life Sciences
,
Regulatory Affairs
,
QA/QC
Applying Six Sigma Downtime to Analytical and Bioanalytical Labs
Category:
Clinical Research
Good Clinical Practice (GCP) - As Applied To The Regulated Bioanalytical Lab
Category:
Clinical Research
Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements
Category:
Laboratory Compliance
