Toxicology Pharmacology Expert Witness

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Expert Witness No.1114

Texas

Education

1975-1976, Molecular Pharmacology Fellow - Department of Cell Biophysics, Baylor College of Medicine.

Cardiovascular pharmacology research in isolated organs subs cellular preparations, and conscious chronically instrumented animals. The leading edge in pharmaceutical methods was mastered in this specialty. This training unified the diversified educational background from graduate and undergraduate universities.

1973-1975, Post-doctoral Fellow - Department of Pharmacology, Baylor College of Medicine.

An advanced apprenticeship in protein - nucleic acid interactions as they related to the development and maintenance of carcinogenic processes. Two-dimensional electrophoresis - analysis of nuclear proteins in collaboration with P. O'Farrell. In vivo phosphorylation control mechanisms for protein function

1969-1973, Doctor of Philosophy, Department of Biochemistry and Nutrition University of North Carolina at Chapel Hill. Dissertation:

The Isolation and Characterization of Protamines from Bovine Spermatozoa. Advanced techniques in protein isolation, analysis and primary amino acid sequencing. Viral genetics, enzymology, chromatographic methods and electrophoresis techniques were mastered. Electron micrographic methods using biochemical procedures, gamete nuclear proteins were discovered. National Science Foundation Fellow and NIH training grant recipient.

1968-1969, Pharmacology Department, Jefferson Medical College Graduate Program.

First year medical school curriculum was completed. Courses: Molecular Pharmacology, Medical Biochemistry, Human Physiology, Neuro-Anatomy, Histology and Teratology. The basis for my diversity in biomedical sciences was forged during this year. Additional work in molecular pharmacology was initiated.

1964-1968, Bachelor of Science, Chemistry and Biochemistry, University of Delaware, Newark, Delaware

Modern concepts in molecular, elemental analysis, quantum mechanics, molecular orbital theory, and statistical thermodynamics. Cancer therapeutic agent - l-asparaginase research. Organic synthesis of metal catalysts for nylon precursor production. Advanced calculus and organic chemistry part of the degree requirements. Minor in English Literature. Columnist on the "Blue Hen Messenger". President of Young Democrats. Kudos: Foreign Language Scholarship Competition Award (German). Organic Chemistry Graduate Record Examination top 10% nationwide.

Memberships & Nominations (Past and Present)

Biophysical Society
American Association of Clinical Chemists
American Society of Biological Chemists
American Association For The Advancement of Science

Employment

1996-Present, Science Consultant:

Manufacturers of Diagnostic Assay Kits: diagnostic and therapeutic device developers and manufacturers; clinical laboratories in the development of "in house" assays Current Interests: Receptor mediated assays; ultrasound and microwave radiation in the control of biochemical reactions; utilization of Buckmeisterfullerenes in clinical assays and DNA of sperm.

1991-1996, Chief Executive Officer, Emerald Biomedical Sciences, Inc. The Woodlands, TX.

Established a CLIA '88 approved clinical laboratory for limited analysis of blood specimens using specialized assays. Developed and implemented assays for the determination of Silicone Antibody levels (SARA™ System), myelin basic protein, and collagen I antibodies at EBSI. Advanced quality assurance protocols were established and adhered to exceeding government requirements. Received two (2) patents (US 5,385,825 - an invention that preserves protein hormone analytes in blood specimens without freezing. Two publications is world renowned peer-reviewed journals.

1989-1991 , Litigation - Science Consultant and Consultant to Biotechnology Firms

1986-1989 , Vice -President of Research and Development, AMTEC Diagnostics International, Conroe, TX

Conducted high complexity laboratory tests in conjunction with development of diagnostic test kits and other devices. Presented R & D goals in lay terms in revised Business Plan. Developed eighteen (18) new products for marketing and sale. Introduced modern biochemical methods to the manufacturing process for serological and diagnostic reagents. Seven (7) successful FDA product submissions.

1983-1986, Director of Research and Development, Biotecx &Isotex Diagnostics, Friendswood, TX.

Developed and manufactured radioimmunoassay kits for reference and clinical laboratories. Instrumental in the manufacture of several radio- pharmaceuticals. Introduced research on one agent useful in assessing cardiac damage after infarction. Extensive interaction with the FDA in device approval process. Company technical representative to laboratory technicians, nephrologists and cardiologists.

1976-1983, Assistant Professor, Principal Investigator, Department of Experimental Medicine, Pharmacology and Cell Biophysics, Baylor College of Medicine, Houston, TX.

Leader of an independent research laboratory supported by major Federal (NIH and
EPA) grants. Published thirteen (13) in major peer-reviewed journals and presented numerous oral presentations at scientific meetings. Lectured at the International Union of Pharmacology, Paris, 1978. Conducted original research in molecular toxicology - the impact of organophosphates on skeletal muscle protein metabolism.

Research Expertise

Biochemistry

Protein chemistry, enzymology, and nucleic acid techniques.

Physiology and Biophysics

Neurological and cardiovascular system dynamics on a cellular basis.

Pharmacology and Toxicology

Structure activity relationship models, ionophore research, cardiac ionotropy research

Scientific Publications

Available upon request

FDA Submissions

Radioimmunoassay of Apoliporotein A1 in Human Plasma or Serum (Isotex Diagnotics). 

Approved Radioimmunoassay of Apolipoprotein B in Human Plasma or Serum (Isotex Diagnostics). 

Approved Ficin Stablized Enzyme Kit for the treatment of red cell antigens (Amtec Diagnostic International). 

Approved Antibody Elution System for the Elution of Human Immunoglobulins from red cells (Amtec Diagnostics International). 

Approved Latex Agglutination Assay for Rheumatoid Factor in Human Serum (Amtec Diagnostics International). 

Approved Latex Agglutination Assay for C - Reactive Protein in Human Serum (Amtec Diagnostics International).

Approved Latex Agglutination Assay for Heterophile Antibodies in Infectious Mononucleosis (Amtec Diagnostics International)

Patents

Available upon request

Educational Basis For Opinions

Analytical Chemistry Physical Chemistry Organic Chemistry

Minor in English Literature

Bachelor of Science in Chemistry
Evaluation of reports containing results of gas chromatography, mass spectral analysis, e.g. EPA priority pollutants. Analysis of chemical manufacturing protocols and methods to determine by-products. Statistical methods in physical chemistry extend to other disciplines. Communication skills refined by minor in English literature.

Biochemistry

Advanced Topics in Pharmacology and Toxicology

Medical Physiology

Histology

Embryology

Neuro-anatomy

Teratology

Jefferson Medical College
These medical science courses allow the development of opinions that comprise the scientific basis for medical opinions and differential diagnosis. The pharmacology and toxicology expertise is supported by mastering the knowledge of physiological homeostasis. Opinions in the disciplines of neurotoxicology, carcinogenesis, and birth defects are developed from the curriculum of the first year of medical school.

Tissue culture, University of North Carolina
Sterile techniques, normal and malignant cell culture methods with emphasis on cell cycle events. Conducted collagen production and amino acid modification research - thalidomide.

Autoradiography of brain sex hormone receptors
Nuclear protein isolation
Amino acid analysis
Electrophoresis
Chromatography

The specific effects of testosterone and estrogen and their synthetic derivatives in various organ systems were learned. Opinions on the impact of over-dose of these hormones rely upon this knowledge. Knowledge of the biochemistry of mitosis, its control and the loss of control permits development of structure activity relationship models of carcinogens and onco gene theory. Analytical methods learned in the graduate curriculum and in actual laboratory work extends my expertise to laboratory testing and clinical assay utilization.
Baylor College of Medicine Department of Pharmacology - Post Doctoral I
Research relating to the biochemical control mechanisms allows the development of concepts relating to DNA - protein alterations. The discovery of covalent bonding of chemicals to DNA and its relationship to carcinogenic properties by departmental researchers permitted the development of expertise in the chemical basis for carcinogenicity.

Baylor College of Medicine Post Cell Biophysics Department - Post Doctoral II
Faculty and fellows participated in the NIH Super Center Grant for Cardiovascular Research and Demonstration - Michael E. De Bakey, MD, Principal Investigator. From this association, experience in basic research in the biochemistry and physiology of vascular smooth muscle, heart failure, papillary muscle preparations, cholesterol apolipoproteins, calcium release, and dietary effects was obtained.

Case Experiences: 1987-Present – Plaintiff & Defense Issues

Toxicology

Available upon request.

Pharmacology

Available upon request

Clinical Laboratory Practices - Drug and Alcohol Testing

Available upon request