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Toxicology Pharmaceutical Chemical Exposure Expert Witness

Provides Opinion & Testimony In:

Toxicology, Toxicology, Pharmaceutical, Chemical Exposure Causation, Solvents, Butadiene, Phenylpropanolamine, Metabolism, Biotransformation, MSDS, Cancer, Drugs, Malpractice, Overdose, Prescriptions, Poison, Poisoning, Toxicologist, Dust Exposure, Stem cell, Industrial Hygiene, Air sampling, Occupational exposure pharmaceuticals, Occupational exposure chemicals, Occupational exposure solvents, Occupational exposure limits OELs, Drug related malpractice, Industrial hygiene, Environmental compliance, Hazard communication, Toxicological causation, Chemical exposure, cancer, Potent pharmaceutical compounds, Pharmaceutical impurities, toxicity, Pharmaceutical product exposure, Dust explosion risks, Air purification system, Design implementation of an effective potent compound program, Lithium drug interaction resulting in toxicology, Potency categorization, Industrial hygiene monitoring, Reproductive toxins in the workplace, Residual solvent level justification, Excipient levels above the FDA inactive ingredient guideline justifications, Environmental reporting for SARA, Biennial hazardous waste reporting,

Expert Witness No. 3119

Colorado

 

EMPLOYMENT/EXPERIENCE

Toxicology, Research and Consulting Experience:
April 2004 – present:  Senior Toxicologist, Superior Toxicology & Wellness
Main mission:  Maintain excellent relationships with multiple clients through superior work products combined with outstanding project progress and genuine customer service.
•    Legal Expert Responsibilities:
o    Case review, literature review for chemical/drug related litigation and malpractice
o    opinion report on causation or relationship between effect and agent,
o    deposition analysis for opposing opinions
o    depositions and testimony
•    Cases to date:  Available Upon Request
•    Toxicology Responsibilities:
o    OEL development for products, solvents, raw materials and intermediates, preliminary potency categorization of product candidates,
o    industrial hygiene-monitoring, analysis of data, interpretation of results,
o    reproductive toxins in the workplace and issues for family planning of all employees,
o    hazard communication
    training programs: annual requirements, chemical specific training
o    MSDS writing, reviewing, approving,
o    impurity justification for presence in final product, raw material, intermediates, residual solvent level justification, excipient levels above the FDA inactive ingredient guideline justifications,
o    environmental reporting for SARA, biennial hazardous waste reporting, monthly air emissions of volatiles, pharmaceutical solids,
o    safety training on many topics,
o    review of any procedures necessary for HS&E regulations or any toxicological processes,
o    emergency response plan development and review,
o    toxicology training and coordination of spill response teams,
o    product exposure investigation and possible dose reconstruction,
o    chemical hazard testing data interpretation for dust explosion potential
•    Wellness Responsibilities:
o    dramatically changing lifestyle wellness through analysis and recommendations
o    multiple drug analysis for overdose/toxicity, interactions of drugs
o    air purification applications using compact state-of-the-art technology to remove dust, smoke, odors, chemicals, pet dander, allergens, mold and mildew.

October 2005 – present:  Senior Toxicologist, Affygility Solutions, contracted by Dean M. Calhoun, CIH.
Responsibilities:  Prepare potent compound assessments, set occupational exposure limits and devise safe handling guidelines for drug discovery projects for Affygility Solutions clients.  Design and participate in world-class webinar internet-based training on multiple topics.

Green Energy Research Management:
January 2008 – December 2015:  C.E.O., Colorado Energy Research Technologies
Main mission:  We create abundant solutions by developing advanced innovative technology that responds to global needs through more profound understandings of resonance.
•    Customer interactions
•    Investor interactions
•    Daily operations management
•    Oversee 6-30 employees dependent upon projects
•    Develop and maintain appropriate budgets
•    Contract negotiations

August 2007 – present:  Marketing Consultant and Member of Scientific Advisory Board, Vitro Biopharma, contracted by Jim Musick, Ph.D.
Responsibilities:  Bring new stem-cell related products for diabetes research to scientific, pharmaceutical, and ultimately medical markets.

March 2011 – present:  Editorial Board, Toxicology Mechanisms and Methods, published by Informa Healthcare.

February 2007 – March 2013:  Aquatics Instructor, Power Wellness Management.  Lakeshore Athletic Club, Broomfield, CO.
Main mission:  Maintain excellent relationships with multiple clients through superior work products combined with genuine customer service.

October 2007 – 2011:  Guest Editor & Ad Hoc Reviewer, Toxicology Mechanisms and Methods, published by Informa Healthcare.

May 98 – April 2004:  Industrial Toxicologist, Sandoz, formerly Geneva Pharmaceuticals.
Responsibilities:  Toxicological evaluation of new and existing products to establish safe occupational exposure levels.  Justify safe levels of pharmaceutical contaminants, excipients and solvents for ANDA submissions.  Review and revise handling procedures for all chemical hazards on site and maintain employee right-to-know label system.  Administer the hazard communication and reproductive hazard review programs.  Conduct extensive training of all employees on multiple topics and the HS&E department on all required SOP training.  Provide toxicology support to Geneva Pharmaceuticals Technology Corporation in NJ, oversee contract toxicology studies and interact with Novartis toxicologists to avoid redundant work practices.  Project manager for improvement of dust control engineering in production.  Containment manufacturing suite – team member.  Manage Industrial Hygiene program including contracting for analytical method development, air sampling, data analysis, implementing recommended changes based on data and supervising IH staff.  Regulatory compliance, filing of environmental reports SARA title III and form R, biennial hazardous waste report, Novartis docount report, and monthly air emissions report.  Represent Sandoz in various external committees, maintain adherence to GMP and back up safety specialists and environmental staff.

May 2001 – April 2004: Editorial Board Toxicologist, Micromedex, Inc.
Responsibilities:  Toxicological evaluation of potential new products and databases as needed.

July 2002 – August 2002:  Senior Toxicologist, Affygility Solutions, contracted by Dean M. Calhoun, CIH.
Responsibilities:  Prepare potent compound assessments, set occupational exposure limits and devise safe handling guidelines for drug discovery projects for Affygility Solutions clients.

February 2001 – August 2001: Human Health Risk Assessment Toxicologist
Responsibilities:  Toxicological evaluation of over 100 chemicals in support of a Human Health Risk Assessment of a US Naval incinerator in Osaka, Japan.

Nov. 97 – July 98:  Toxicology Consultant, Clinical Consultants
Responsibilities:  Litigation support including evaluation of plaintiff, defendant, witness and expert witness materials and depositions for toxic exposure litigation.  Evaluate opinions of experts, critically evaluate scientific and case literature.

June 93 – May 98:  Doctoral Toxicology Researcher, School of Pharmacy, University of Colorado, Molecular Toxicology and Environmental Health Sciences Program
Responsibilities:  Critical analysis of literature in order to develop analytical methodology for the detection and quantitation of benzene and butadiene metabolites and conjugates, involving high pressure liquid chromatography (HPLC), gas chromatography (GC), GC-mass spectroscopy (MS), extraction, tissue culture, enzyme kinetics and toxicity testing.  These methods were then used to produce metabolic profiles investigating effects of stereochemistry on toxicity and metabolism of butadiene in a freshly isolated hepatocyte cellular system.  Results were critically evaluated and documented for publication.  Directed laboratory technician in support of the butadiene research grant.
Dissertation committee chairman and advisor:  Dr. David Ross

Feb. 96 – Dec. 97:  Analytical Toxicology Consultant, Department of Ophthamology, University of Colorado Health Sciences Center, Denver, CO.  Analytical and Technical Consultant for “Delivery of Viroptic® across the cornea by use of a collagen shield” and for “Delivery of Tobradex® across the cornea by use of a collagen shield.”
Responsibilities:  Revise and implement an HPLC method to detect and quantitate Viroptic® following extraction from biological matrices.  Formulate the data in a clear and concise report in a timely manner following receipt of samples.  Develop a method to detect both substituents of Tobradex® (tobramycin and dexamethasone) following extraction of these compounds from corneal tissue and from aqueous humor.  Advise on long term storage of samples until necessary equipment for analysis of tobramycin is located, borrowed or acquired.

July 96 – Nov. 97:  Computer Network Consultant, FirstLinkTM Consulting, Boulder, CO.  Network Technician
Responsibilities:  Set up local area networks and assure proper function.

Aug. 91 – June 93:  Biochemistry Researcher, School of Pharmacy, University of Colorado, Molecular Toxicology and Environmental Health Sciences Program
Responsibilities:  Conduct biochemical studies to determine the inhibitory effects of acrolein and iodoacetamide on DNA polymerase alpha.  Techniques included cell culture methods, nuclear isolations, DNA synthesis assays, use of p-32 labeled nucleotides, scintillation counter functions and calculations using Igor software.

Jan. 91 – July 91:  Molecular Toxicology and Biotransformation Intern, Dow Chemical Company, Midland, MI.
Responsibilities:  Designed, set up and completed an inhalation study involving rats and mice exposed to 14C-labeled ethyl chloride in order to determine the disposition and biotransformation of ethyl chloride.  Daily tasks included monitoring and care of study animals, handling and tracking for radiolabeled gaseous compounds, inhalation chamber equilibration and exposure monitoring to achieve desired dose range, tissue collection and analysis for radioactivity, generation of a data set via GLP and presentation of scientific data.

Sept. 89 – Dec. 90:  Molecular Toxicology Technologist and Project Monitor, Dow Chemical Company, Midland, MI.
Responsibilities:  All duties necessary to maintain the day to day operations of a biotransformation toxicology testing laboratory from washing dishes, to preparing for studies, to packaging and tracking radioactive and hazardous laboratory wastes.  As a study monitor, duties included daily care of the animals post dosing with the radiolabeled compound of the study, taking daily samples (urine, feces, CO2, and tissues at termination), analyzing those samples and generating the data set via GLP.

Sept. 88 – May 89:  Undergraduate Student Researcher, Central Michigan University, Department of Biology, Mt. Pleasant, MI. Undergraduate Research Project
Responsibilities:  Design and conduct the experiments necessary to complete the project entitled “Effects of storage on ion transport in corneas from Rana catsbiana (bullfrog).”  Techniques include corneal dissection, use of electrophysiological ion monitoring equipment, glass electrode assembly, ion fluctuation detection in single corneal cells, designing procedures for storage of the corneas, daily care of frogs and making all necessary solutions including pond water, storage buffer and perfusion buffer.  The proposal won competitive approval for funding by the Department of Biology at Central Michigan University.

EDUCATION

Doctor of Philosophy, Pharmaceutical Sciences.  Molecular Toxicology and Environmental Health Sciences Program, School of Pharmacy, University of Colorado.
Dissertation:  JL Nieusma.  Stereochemical aspects of 1,3-butadiene metabolism and toxicity.  University of Colorado, School of Pharmacy, Molecular Toxicology and Environmental Health Sciences Program.

Bachelor of Science, Biology and Chemistry.  Department of Biology, Central Michigan University.

    Communication Training:

Team Communication Training, Mike Bensley, Instructor, Geneva Pharmaceuticals, July, 2003.
Leadership Concepts and Practices, Sue Strong, Instructor, Geneva Pharmaceuticals April to August 2003.
Media Training for Toxicologists Workshop, March 1999
Geneva Pharmaceuticals Media Communications Training, September, 1998
Media Workshop: Breaking News, Breaking Barriers, March 1998
Risk Communication Workshop at the Occupational Toxicology Roundtable, October 2007, Indianapolis, IN

Continuing Education:

  • Cutaneous Toxicity-Current Methods and Concepts in Safety Evaluation and Relevance to Human Exposure, Society of Toxicology Annual Meeting,
  • Salt Lake City, UT, March 2003.
  • Industrial Hygiene Course, Traveler’s Insurance, Hartford, CT, April 2002.
  • Toxicology of Naturally Occurring Toxins—Don’t Mess with Mother Nature, Society of Toxicology Annual Meeting, Nashville, TN, March 2002
  • Complete Environmental Regulations Course on the applicability and impact of the regulations of the United States Environmental Protection
  • Agency on industrial and commercial operations.  Lion Technology, Inc.  Denver, CO, January 2002
  • Project Management II, Best Practices of Project Management.  Franklin Covey, Denver, CO, September 2001.
  • Containment of Potent Compounds.  Advanced Containment Technologies and Regulatory Guidelines.  Barnett International, Philadelphia, PA, June 2000.
  • Tetra Tech EM Inc. Environmental Compliance Series, Denver, CO
  • Pollution Prevention Programs and Projects in Colorado.  Parry Burnap CDPHE, Kendra Morrison EPA, Michael Keefe Tetra Tech, January 2001
  • Groundwater Models-Can They Provide a Cost-Effective Solution?  Jim Wulff, June 2000
  • Surviving Maximum Achievable Control Technology, William Cote, April 2000
  • Using Risk Assessment to Facilitate Contaminated Site Closure, Paul Damian, Ph.D., MPH, DABT, March 2000
  • Environmental Risk Assessment and Applied Toxicology, University of Colorado Health Sciences Center, Dr. David Pyatt, instructor, 1999
  • In Vitro Methods for Evaluating Biokinetic Parameters for Risk Assessment,  Society of Toxicology Annual Meeting, New Orleans, LA, March, 1999
  • Target Organ Toxicology:  Respiratory Tract Dosimetry and Response to Inhaled Toxicants, Society of Toxicology Annual Meeting, New Orleans, LA, March, 1999
  • International Harmonization of Non-Clinical Toxicology:  Regulation vs. Practice, Society of Toxicology Annual Meeting, Seattle, WA, March, 1998
  • Effective Risk Communication:  Avoiding the Pitfalls, Society of Toxicology Annual Meeting, Seattle, WA, March, 1998
  • Toxicology of Agents:  Metals,  Society of Toxicology Annual Meeting, Cincinnati, OH, March, 1997
  • Use of the Benchmark Dose in Risk Assessment,  Society of Toxicology Annual Meeting, Cincinnati, OH, March, 1997
  • Basic Applications in Risk Assessment,  Society of Toxicology Annual Meeting, Baltimore, MD, March, 1995
  • Basic Molecular Methods for the Analysis of Gene Regulation and Expression, Society of Toxicology Annual Meeting, Baltimore, MD, March, 1995
  • Occupational Toxicology Roundtable, Risk Communication Workshop, Boston, MA Sept. 2006

ACTIVITIES/AWARDS

  • Toxicology Mechanisms and Methods, Guest Editor Occupational Toxicology Special Edition, March 2011.
  • Society of Toxicology; associate member
  • Occupational Toxicology Roundtable
  • Rho Chi Honor Society inducted 1992
  • Outstanding Research Award at the 3rd annual UCHSC Graduate Student Research Forum, January, 1995.
  • Society of Toxicology, Mountain West Chapter, Award for research presentation 1995.
  • Society of Toxicology, Mountain West Chapter, Award for research presentation 1996.
  • Cedar Cove Condominium Owners Association, Aurora, CO; president 1997 – 2004, VP 96-97.
  • Denver Men’s Adult Baseball League; president Jan. 97 – Jan. 99; VP Jan 95-Jan. 97.
  • Sunwest Homeowner’s Association, president July 2001 – October 2002, secretary Nov. 2000 – July 2001.
  • Inline Hockey Team Captain, January 2000 – June 2002, January 2003-March 2003.
  • 1st Annual Labor Day Heroes Ice Hockey Tournament–Patriot’s Division Champions ‘02
  • Ice Hockey Summer Season 2002 Champions.
  • Ice Hockey Summer Season 2002 Championship Game Most Valuable Player.
  • Adult Ice Hockey Team Captain, February 2003-present.
    Fall/Winter 2004-2005 league champions
    Spring 2008 league champions
    Winter 2008-2009 league champions
    Summer 2010 league champions
    Fall/Winter 2010-2011 league champions
  • Occupational Toxicology Roundtable – annual meeting co-organizer, October 2003, South Seas Resort, Captiva Island, FL.
  • Broomfield Local Emergency Planning Committee, co-chair January 2004-January 2005.
  • YMCA Volunteer Coach Little Sluggers tee ball program 2005, 2006.
  • Monarch Little League Volunteer Coach baseball 2007, 2009, 2012.
  • Rock Creek Flyers Swim Club Stroke Judge, 2006.
  • Rock Creek Flyers Swim Team Parent Board 2007- present.  Secretary & Volunteer Job Coordinator, 2011 Vice-president & Volunteer Job
  • Coordinator, 2012-present Vice President.
  • Boulder Valley Youth Ice Hockey Association volunteer coach Mites level 2006-2010.
  • Superior Mustangs Youth Football Coach 2008 to 2012.
  • Bonfils Blood Center, Over 10 gallons donated.

BIBLIOGRAPHY

  • Manuscripts:  Available Upon Request

Presentations/Seminars/Abstracts:

Available Upon Request

REFERENCES:

Available Upon Request

Groups