David Clapham Email & Phone Number

Olathe, Kansas, US

• Responsible for all client communication related to study conduct (e.g., scientific data, timelines, and budgetary matters).
• Ensure compliance of study activities with pertinent portions of study protocol, SOPs, and regulatory requirements.
• Maintain expert knowledge of scientific trends as well as regulatory requirements and changes.
• Ensure laboratory investigations, deviations, validations, and reports are initiated and completed as required.
• Maintain final authority for sample identification, including discrepancies with clinical sites and/or Sponsor.
• Responsible for timeline adherence and communication of status to Sponsors and management.

Tampa, Florida, US

• Regulatory and scientific oversight of regulated and non-regulated bioanalytical studies (i.e., PK, ADA, nAB, Biomarkers).
• Analysis, interpretation, and approval of study data.
• Primary point of contact for Sponsor and/or Study Director
• Preparation and/or review of Sample Analysis Plans (SAP) and validation plans, and ensure studies are followed according to the plans and applicable SOPs.
• New project initiation including but not limited to; setting up Sponsor/study specific files, Watson LIMS study design, Sponsor meetings and updates to Master Schedule.
• Preparation and creation of analytical batches, data reduction, data review and preparation of final analytical reports that are written according to SOPs and ready for QC/QAU review.

Tampa, Florida, US

• Support regulated (e.g., GLP, GCP) and non-regulated bioanalytical studies to ensure they meet all requirements of the study protocol, SOPs, and appropriate regulations.
• Ensure the scientific integrity of study documentation, data, and reports.
• Prepare and/or review bioanalytical (sample analysis and validation) plans, SOPs, and protocol deviation documentation.
• Sponsor interactions including leading Sponsor meetings, maintenance of meeting minutes, critical Sponsor communication documentation, and timely transfer of data and records.
• Primarily responsible for conduct of studies from start to finish for development, validation, sample analysis, and method transfer projects - including PK, ADA, and biomarkers.
• Collaborate with other internal groups relating to study conduct, including laboratory analysts, Quality Control, Quality Assurance, and Sample Control.

Tampa, Florida, US

• Develop and validate assays including on the Genalyte Maverick platform.
• ADA Assay development and validation for the MSD platform.
• PK assay development and validations.
• Biotinylation and sulfo-tag (ruthenium) labeling of proteins.
• Protein/conjugate analysis and characterization using GE Äkta pure FPLC and ForteBio Octet systems.

• Develop and validate immunoassays (ELISA, Western Blot) for infectious diseases.
• Optimize assay conditions, troubleshoot protocols, manage clinical samples, analyze and present data.
• Perform polymerization/conjugations of peptides with Streptavidin, HRP, and BSA through maleimide/thiol reactions.
• Conduct conjugations of Anthrax PA and Streptavidin/HRP through thioether (maleimide/thiol) bonding.
• Develop and perform Failure Mode Analysis testing of conjugation syntheses.
• Develop lyophilization procedures for various assay components (peptide mixtures, plate coatings, diluents)

• Develop and validate isoelectric focusing (IEF) method for testing charge heterogeneity of proteins produced for customers of Percivia through the use of Per.C6 cell line; develop and validate ELISA assays.
• Design and write development and validation plans and technical reports for ELISA assays, IEF and Western blotting methods.
• Perform SE-HPLC to analyze samples for the presence of aggregates.

Paris, France, FR

• Perform cross-over studies to validate new critical reagents (such as: standards, controls, and conjugates) used in assays for clinical trial testing.
• Develop and test serum panels used for lot comparability studies of commercial ELISA kits.

Cambridge, Massachusetts, US

• Receive, log in, store and track samples generated from human clinical trials.
• Perform BCA assays, electrophoresis, and chemiluminescent Western blotting.
• Mammalian cell culture and maintenance of cancer cell lines.
• Cell proliferation assays using CyQuant Assay kit.
• Write, review, and revise SOPs and laboratory documents as necessary.
• Generate queries for clinical trial sites regarding sampling.

• Self-owned English proofreading and editing business working with individuals and businesses, located in Tokyo, Japan.

US

• Receive, log in, store and track samples generated from human clinical trials.
• Assay development (ELISA and Westerns) for the Clinical Assays and Quality Control laboratories.
• Perform ELISA testing on human clinical trial samples (BSL2) to determine sample components including antibodies, drug level (PK), and complement activity levels (specifically C3a~desArg and sC5b-9).
• Perform electrophoresis and chromogenic Western blot testing and assay development.
• Write, revise, and review SOPs and laboratory documents as necessary.
• Data preparation, analysis, and review for internal audits.

Arlington, Virginia, US

• Honorable Discharge, March 1999.

Certificate, Clinical Research

B.A., Biology