Expert Details

Expert in Bioanalytics, Chemistry

Expert ID: 736002 Texas, USA

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As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic method development as well as pharmaceutical discovery/ development.

At the Navy Drug Screening laboratory in 1998, his research on a more sensitive method for detection resulted in discovery of 2-Oxo-3-HydroxyLSD as the prevalent metabolite in human urine. This resulted in a more sensitive method of detecting LSD use with a window of detection involving weeks versus the current method of LSD with a detection window of hours. Over his 6+ years at Array in the role of the DMPK point person, for several projects in discovery and development, Expert's efforts resulted in five compounds in various phase clinical trials. Actively interested in research, he continued in his role discovering new compound primarily focused on the treatment of cancer and inflammatory disease and developing this compound for IND filing and updates.

At Worldwide Clinical Trials, Expert was developing methods for bio-analytical analysis of human clinical and animal development studies in various matrices. He was also responsible for the conduct of mass balance studies using radio labeled compounds in human feces, urine, plasma and whole blood. Furthermore, he was responsible for metabolite identification and profiling in urine and plasma.

Education

Year Degree Subject Institution
Year: 1991 Degree: Ph.D. Subject: Organic/Analytical Chemistry Institution: University of Iowa
Year: 1991 Degree: Ph.D. Subject: Chemistry Institution: Ripon College
Year: 1984 Degree: B.A. Subject: Chemistry Institution:

Work History

Years Employer Title Department Responsibilities
Years: 2017 to 2019 Employer: Sonic reference Laboratory Title: Technical Director Department: Analytical Responsibilities:  As an Analytical Technical Director, responsibilities involve method development, improvement and implementation of bio-analytical assays for therapeutic, toxicological, pain management and comprehensive targets.
 Development of a 130+ analytes of a drug monitoring LC/MS/MS method in 8 months
 Other responsibilities include overseeing the analytical division in all aspects that insured the analytical division is in CLIA and CAP compliance.
 Supervision of managerial staff and research and development.


Years: 2014 to 2017 Employer: Pain Specialists of Austin Title: Laboratory Director Department: Clinical Laboratory Responsibilities:  As a Laboratory Director for Pain Specialists of Austin, duties involved development, improvement and implementation of bio-analytical assays for pain management including illicit drugs of abuse. This includes methods development and validation and analysis of biological fluids for drugs and their metabolites. That employs HPLC and mass spectrometry for these analyses.
 Other duties include reviewing clinical data for linearity, accuracy, precision, chromatography and consistency.
 I am responsible for investigating any inconsistencies in patient results. Providing irrefutable conformation to the provider.
Years: 2008 to 2014 Employer: Worldwide Clinical Trials Title: Senor Research Scientist Department: Analytical Research and Development Responsibilities:  As a Research Fellow for Worldwide Clinical Trials, duties involved development and implementation of bioanalytical assays. This includes methods development and validation and analysis of biological fluids for drugs and their metabolites. That employs HPLC with UV, fluorescence and electrochemical detection systems, along with mass spectrometry for these analyses. The duties also involved in chiral separations.
 Other duties include Mass Balance studies in determination of the disposition and metabolism of drugs in humans, incorporating radio labeled (14C) compounds in plasma, whole blood, feces and urine matrices. Analysis included liquid scintillation counting (LSC) and combustion oxidation (Perkin Elmer Model 307 oxidizer) of feces and whole blood samples.
 Furthermore, I am responsible for metabolite identification and profiling of cold and radio labeled (14C) compounds in plasma and urine.
Years: 2001 to 2008 Employer: Array Biopharma Title: Research Scientist Department: Analytical research and Development Responsibilities: • Determination of disposition and metabolism of drugs incorporating radio labeled (14C) compounds in “Mass Balance” studies in plasma, feces and urine matrices. These studies used LSC and on line HPLC radioactivity detection (β-RAM).
• Development of an ADME analytical division working with ARRAY biologists, incorporating the use of in vitro (liver microsomes\hepatocytes, and CACO2\PAMPA) and in vivo pharmacokinetic models to ensure the success of a drug from discovery into clinical development
• At all phases of discovery, metabolite identification using an LC/MS/MS (API Sciex 4000) and Ion trap (Finnigan DECA) were used, to assist medicinal chemists in improving compound hepatic stability and establish interspecies correlations for future PK studies
• CACO2/PAMPA and PK data was used to establish good oral bio-availability and the disposition of compounds in rodent PK studies is established as metabolic or renal/ biliary clearance
• ADME coordinator and analyst developing methods on LC/MS/MS (API Sciex 4000) and Ion trap (Finnigan DECA) for all in vitro and in vivo studies primarily focused on the treatment of cancer and inflammatory disease, correlations were made for all assays resulting in three projects that have been successfully taken from discovery to preclinical development in less than one-year
• Acted as a liaison with biology, pharmacology, and API synthesis colleagues in order to ensure business established milestone dates were met
• Along with continuing discovery and improvement of potential drug candidates, current work includes preclinical development via higher species PK studies
• Supported prioritized programs for IND submissions in a team based- dynamic environment
• Progression of three compounds (oncological and inflammation indications) and two collaboration compounds into various phase clinical trials
• Development, conduct and method validation of GLP analysis of human plasma
• Mentored junior colleagues in growing their skills in new areas of company interest

Years: 1996 to 2001 Employer: Navy Drug Screening Laboratory Title: Chemistry Supervisor Department: Analytical researchand Development Responsibilities: • Development of extraction and GC/MS, LC/MS and LC/MS/MS analysis methods for the identification of drugs and their respective metabolites at pico- to nanogram concentrations in bio-matrices
• Development of methodologies in extraction including liq-liq and automated Solid Phase Extraction
• Identification of new drugs and interfering compounds in drug analysis, synthesis of commercially unavailable metabolites and literature searches following new trends in drug abuse
• Maintenance, trouble-shooting and operation of HPLC, GC/MS, LC/MS and LC/MS/MS
• Supervisory responsibilities (3 reports), as well as technical writing in the form of SOP's, monthly reports and manuscripts for technical journals
• Development of a practical method for the detection of LSD at < 100 pg/mL in urine by LC/MS via discovery and method development of analysis of 2-Oxo-3-Hydroxy LSD, a major (16X more prevalent) LSD metabolite

Fields of Expertise

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