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.• Final approval for all data in assigned studies; accountable for quality & integrity of data, methods, and reports.• Function independently as Principal Scientist and technical expert in the direction and execution of bioanalytical validations and biostudies.• Provide oversight of the laboratory and mentor research staff in areas such as protocol interpretation, method development, validation, and troubleshooting, and study related problem resolution.• Provide scientific expertise and oversight for study design, conduct, and interpretation.• Independently review, interpret, analyze, evaluate, and discuss study results with research staff and Sponsors. • Review protocols, reports, and scientific documents of direct reports.• Provide scientific and technical leadership to resolve analytical challenges in a timely fashion, and to evaluate new technologies for potential integration into existing portfolio of services.• Provide direct daily supervision and review the work of assigned departmental employees to ensure scientific accuracy and adherence to departmental policies, practices, and procedures.• Monitor and increase the technical performance of direct reports through coaching and mentoring; prepare and deliver salary and performance reviews.• Schedule and prioritize workload of direct reports.

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.• Ensure all study personnel are trained on applicable SOPs, protocols and amendments.• Maintain metrics to track workflow. Assist in the development and maintenance of review schedules and functional area metrics as applicable.• Preparation and review of SOP, BP, or protocol deviation documentation, associated corrective actions and prompt notification of the Study Director and/or Sponsor.• In coordination with Lab Management, Method Development/Validation, QC, QA and Reagent Groups to ensure that resources are available for proper execution of the assay schedule.• Scheduling and coordination with QC of study review, addressing finding promptly, with corrective actions.• Coordination with QA of audit events, including in-process audits; address and correct issues arising from QA audits promptly, with corrective actions.• Coordinate with Management, method development and validation staff to troubleshoot methods as needed including conduct and reporting of laboratory investigations.• Sponsor interactions including maintenance of meeting minutes, critical Sponsor communication documentation and timely transfer of data and records.• Responsible for updating report and project tracking to ensure timelines are being met.

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.• Primary point-of-contact for Sponsor visits and study audits (on-site and remote).

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)• Perform SE-HPLC/UPLC to confirm conjugation success and purity of Streptavidin-BSA, Anthrax PA-Streptavidin/HRP and other conjugation complexes.• Developed freezer tracking/mapping system.• Coordinate work with other team members.• Perform immunological methods and protein purification and conjugation techniques, microtiter plate immunoassays, serology and infectious disease pathogens.• Working in an R&D team environment under GLP compliance• Document procedures and results according to GLP regulations• Communicate and work closely with Quality Assurance and regulatory personnel to ensure laboratory compliance.• Work on transitioning manual ELISA procedures to automated system (Tecan Evo, Dynex DSX and Stratec Gemini).

• 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.• Train lab personnel in laboratory and safety procedures.• Responsible for maintaining calibration of department equipment (including: micro-pipettes, plate readers, freezers, incubators, platform/incubator shakers, and other scientific equipment) through use of outside vendors.• Safety committee member; point-of-contact for QA safety inspections for Quality Testing/Clinical department.

Arlington, Virginia, Us

• Honorable Discharge, March 1999.

Certificate, Clinical Research

B.A., Biology