Voting Member Institutional Review Board, Baylor Health Care System, Dallas, TX
Consulting Toxicologist, Expert Witness in Federal and State Court (Civil and Criminal)
Clinical Consultant, Plaza Reference Laboratory, Baylor Enterprises Group, Dallas, TX
Vice President, ESN Research Inc., Dallas, TX
Consulting Scientist, Life Sciences Division, NASA, Houston, TX
Teaching Assistant, Lamar University and University of Texas at Dallas, TX
Key words and phrases related to this expert's capabilities include:
Insulin-like Growth Factors IGF - research publications, consulting support for clinical trials with pharmaceutical companies, laboratory support and testing
Growth Hormone therapy - research publications, consulting support for clinical trials with pharmaceutical companies, laboratory support and testing
Growth Hormone cancer risk - research publications, study design and laboratory support for academia and National Cancer Institute
Kidney stones urolithiasis - research publications, diagnostic reference laboratory, therapeutic drug development
Oral sodium phosphate - renal side effects, research publications
Gastroenterology GI laboratory testing - diagnostic reference laboratory, research publications
Nephrotoxicity renal failure - research publications, diagnostic clinical testing
Nephrotoxicity kidney side effects - research publications, diagnostic clinical testing, including in vivo testing (GFR)
Calcium supplements - research publications, FDA approval studies (Phoslo), this consultant discovered calcium citrate and performed early studies to get it on the market as Citracal
Clinical laboratory - 25 years experience, testing, safety, administration, regulatory affairs, laboratory director (CLIA, CAP, COLA)
Toxicology laboratory - Forensic Urine Drug Testing Certified Director (2 years), Technical Director of large urban hospital toxicology laboratory (7 years)
Drugs of abuse testing - assay selection of screening immunoassays, GCMS confirmations, interpretation for litigation and patient care
Human toxicology - side effects of drugs and chemicals for litigation and patient care, laboratory support
Clinical toxicology - laboratory support for research and patient care for hospital and emergency department, interpretation of symptoms and laboratory results, laboratory methods
Forensic toxicology - consultant with County Medical Examiner, this consultant performs testing for suspected cases of insulin overdose (one of the few laboratories in the USA doing post-mortem insulin), Certified Director of Forensic Urine Drug Testing reference laboratory
Regulatory affairs ISO - While working with in vitro diagnostic manufacturer, DSL, this consultant was Director of Regulatory Affairs for 5 years, taking the company through its initial ISO certification and recertification renewals
Stevens Johnson Syndrome litigation - expert witness in litigation for plaintiffs with this skin disorder caused by ibuprofen
Toxic epidermal necrolysis litigation - expert witness in litigation for plaintiffs with this skin disorder caused by ibuprofen
Regulatory affairs biomedical - over 30 years experience working under regulations, administrative responsibilities (writing policies and procedures, quality control and assurance QC/QA, hosting inspections) : JCAHO (hospitals), College American Pathologists CAP (clinical laboratories), CLIA (Federal certification of clinical laboratory), FDA, OSHA, EPA
FDA in vitro diagnostics - as technical director at DSL, this consultant oversaw studies and submissions for FDA approval of our in vitro diagnostics products, during my 9 years we received approval of about 75 products, this consultant had involvement in clinical trials, technical details, package insert, manufacturing processing, labeling
FDA pharmaceuticals - consultant and research that was used as part of the information submitted to FDA for drug approval, consulted with major pharmaceutical and small biotech companies, Phase 1-4, this consultant is familiar with record keeping and negotiations with FDA staff, laboratory support
Clinical trials FDA - this consultant had a small laboratory at DSL to do testing for clinical trials with major pharmaceutical and small biotech companies, helping clients design testing protocols and reporting formats
Institutional Review Board IRB - this consultant is a voting member of the Institutional Review Board for Baylor Health Care System, reviewing study protocols and confidential industry sponsor materials for purpose of protecting safety and rights of patients at Baylor participation in research
Chlorine toxicity exposure - this consultant was expert witness for plaintiffs in Texas and Montana in litigation over injuries sustained after exposure to chlorine gas, reviewing and offering opinion in over 100 cases from a train wreck releasing chlorine gas.
Has also worked on some cases in litigation of truck spills that exposed dozen of people. These cases have provided opportunity to get experience relevant to terrorist acts with chemical weapons of mass destruction. Some publications have used similar accidents to study for purpose of preparedness and training first responders. Interested and able to help with projects related to chemical terrorism.
Extensive experience as expert witness and in support of litigation. Also able to contribute to industry projects supporting drug and device studies. Has experience with patent applications and infringement while working at DSL.
