Biotechnology, Medical Device and Pharmaceutical Occupational and Toxicology Expert

Expertise

• Occupational and industrial toxicology, development programs (both preclinical and clinical) and study design.
• Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.
• Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.
• Identifying, developing and implementing new technology in writing reports, position papers, Material Safety Data Sheets, MAA/PLA/IND/NDA/PNA toxicology and pharmacokinetic summaries and package inserts.
• Preparing and maintaining INDs, MMFs, NADAs , DMFs, IDEs and 510(k)s; preparing labels and package inserts for drugs, devices, combination products and consumer products.
• Providing presentations to FDA and in designing experiments, designing and executing surveys; pharmacokinetic and statistical analysis of both experimental and clinical data; risk assessment; Proposition 65 assessments and labeling; registration of OTC, dietary supplement, nutraceutical, and sterilant products; and the development and production of biologic products.

Expert Witness Experience

• Pharmaceuticals, medical devices, poisoning, occupational toxicology and for workman's compensation cases.

Experience

Undisclosed Company, Principal, 1994 - Present

• Provide regulatory, statistical, preclinical and clinical study support services to over 350 clients in the pharmaceutical, biotechnology, dietary supplement, medical device and animal health industries.
• Core business support for the pharmaceutical development in the U.S. and internationally with successfully opening 96 IND's in the areas of antiviral, hematologic agents, anti-infective products, CNS, oncology, cardiovascular, vaccines, neurology, analgesia and others.
• This support has succeeded under a range of funding situations, including private investor, public company, NIH and SBRI grants models.
• Provide technical consulting, occupational toxicology, neurotoxicology training and evaluation, statistical analysis and report writing for contract research organizations (both preclinical and clinical).
• Due diligence of potential products and companies for investors and companies.
• Occupational exposure classification systems development for pharmaceutical manufacturing.

Synergen, Director of Toxicology, 1993 - 1994

• Responsible for all aspects of safety assessment of potential drugs being developed by Synergen.
• Supervised a staff of 4. Wrote safety and pharmacology sections of MAA filing for Antril.
• Developed compound retention and departmental SOP systems.
• Oversaw safety assessment and pharmacology for the development of a protein therapeutic for Parkinson's.

Becton Dickinson, Director, Medical Affairs Product Support Services, 1991 - 1993

• Responsible for all aspects of biological safety for Becton Dickinson products.
• Supervised a staff of 19 with an operating budget of $2.4 million.
• Laboratory performed some 9200 biological and analytical chemistry assays annually.
• Frequent direct interaction with regulatory, quality assurance, product development, division medical directors and marketing.

G. D. Searle & Company, Senior Director of Product Safety and Metabolism, 1989 - 1991

• Responsible for all aspects of safety testing for Searle compounds and intermediates.
• Supervised staff of 49 (11 PhD/DVMs, 10 direct reports), including pathology, histology, hematology and the below detailed toxicology operation, including a $3.44 million operating budget.
• Member of Portfolio Management Committee for prioritization of research and development compounds.
• Frequent direct interaction with foreign firms for licensing, and with both domestic and international regulatory agencies and plants.
• Developed and put in place worldwide occupational airborne control objectives and Material Safety Data Sheets (MSDS) available on electronic mail system.
• Responsible for coordination and integration of efforts with Belgian laboratory.
• Reviewed, approved and released all safety study protocols, reports and IND/NDA summaries.
• Integrated in vitro lab into support of Discovery operations with validated hepatocyte, myocyte, and fibroblast target organ toxicity screens.

Director of Toxicology, 1989 - 1989

• Responsible for all product safety/toxicity and health effects testing including; internal (chronic, subchronic, subacute, reproductive, developmental and genetic toxicity, including primate and canine studies) and external testing programs for development of new and defense of existing products.
• Headed MSDS and worker safety support data development.
• Supervised staff of 34 and directed testing program in support of potential new drugs and existing products, including insuring smooth interface and coordination with pathology, metabolism, analytical, discovery, pharmaceutical and chemical development, regulatory, project management and clinical functions.
• Developed system for integrated (pharmacology/ toxicology/pathology/clinical) planning, interpretation and problem solving down to study basis.
• Overall project team leader for development of biotechnology derived pharmaceutical products.
• Initiated and staffed in vitro lab to develop library of specific target organ screening tests.
• Responsible for an operating budget of $1.94 million plus contract budget.
• Toxicology summaries preparation and IND/NDA preparation and submission.
• Direct interactions with FDA and foreign regulatory agencies on pre IND, IND, NDA and post marketing matters.

Allied Corporation, Manager, Mammalian Toxicology, 1980 - 1986

• Responsible for all mammalian toxicity testing for Allied Corporation, including the operation of the entire Department of Toxicology laboratory (a 17,000 square foot building with a staff of 26) and all external contract testing (including placing and monitoring studies at domestic and foreign laboratories).
• Recruited and trained staff, equipped and put into operation AALAC certified laboratory.
• In house testing included acute, subacute, and subchronic oral, dermal and inhalation studies and specialty reproductive, behavioral, hematological and renal function toxicity studies.
• Preparation of risk assessments, submissions and presentations to regulatory agencies and trade associations.

Shell Development Lab, Supervisor of Inhalation and Neurotoxicology, 1979 - 1980

• Responsible for bringing on line new inhalation toxicology research facility, (design of air handling control and data acquisition systems, selection and purchasing of equipment, development of techniques and SOPs, and hiring and training of technicians) and for designing and conducting studies at that facility.

Union Carbide Toxicology Laboratory, Research Center, Chemical Hygiene Fellowship, 1977 - 1979

• Developed system for assessment of toxicity of polymer thermal decomposition products (developed equipment, protocols and personnel).
• System certified to test by City of New York for combustion toxicity testing and as such evaluated 50 materials.
• Member of NBS ad hoc committee for development of standardized combustion toxicology test protocol.
• Conceived, developed and implemented initial program (personnel and procedures) for GLP quality assurance at the CHF. Provided statistical consulting expertise to corporation.
• Group Leader for Inhalation and Neurotoxicology.
• Responsible for performance of all inhalation studies at CHF, including 2 year multiple species studies.
• Supervised one Ph.D. and nine technicians. Included among these studies were specialized inhalation and neurotoxicology studies, (inhalation, behavioral teratology, reproduction and dominant lethal studies for gases, vapors, aerosols and powders). Also brought on line new testing procedures for guinea pig sensitization.

Military Service, 1968 - 2009

• Enlisted Reserve with periods of active duty - Navy OCS
• Active duty Naval Officer
• Drilling reserves with annual periods of active duty.

Key Accomplishments

• Directed the design, conduct, writing and successful filing of 96 complete INDs plus 3 PLA, 2 MAA, 4 NDA and 10 NDA safety packages on anti-infective, antivirals, vaccines, cardiovascular, gastrointestinal, imaging agents, anti-inflammatory, oncology, excipients, central nervous system, and immune modulatory products derived from both biotechnology and traditional synthetic organic processes for U.S. and foreign filings, (36-510(k)s, 8 IDEs, and 5 PMAs plus OTC petitions and sterilant approvals for medical devices).
• Successfully completed 8 CDB (Clinical Database) projects for clients.
• Developed and implemented programs to clarify and solve problems-issues around the preclinical, clinical, and manufacturing safety of pharmaceutical products and medical devices, keeping development, production and marketing of drugs on or near plan.
• Oversaw completion, identified and solved quality problems, and completed reports on clinical trials.
• Designed minority subject recruitment plans for NIH intramural studies.
• Product project team member for nine potential drug products through the course of preclinical and clinical development. Provided safety oversight and counsel for clinical development of drugs and devices.
• Directed positive regulatory interactions with domestic and foreign regulatory agencies, allowing product approval/registration, and initiation and continuation of clinical trials.
• Performed risk assessments and prepared reports on them for pharmaceutical, industrial, agricultural and environmental agents.
• Created and directed programs to provide highly interactive safety assessment support to drug discovery groups, allowing more rapid, efficient and effective identifications of lead compounds and product candidates.
• Reviewed and provided recommendations on 112 potential in license packages. Key member of small negotiating team for five foreign and domestic compounds.
• As Study Director, responsible for the design, conduct and reporting of over 900 studies of all types: primate, canine, acute, subchronic, chronic, carcinogenicity, reproductive and developmental toxicity, inhalation, neurotoxicity, immunotoxicity, in vitro toxicity, and environmental toxicity.
• Directed the conduct of over 9000 device safety assessment studies a year, upgraded all laboratory operations and changed the focus group of 20 from a contract testing lab to a full range, product support organization.
• Prepared group to successfully complete their first FDA GLP inspection in 10 years (Becton Dickinson).
• Initiated and managed occupational toxicology program at Searle, identifying needs, developing data and generating material safety data sheets for all compounds and process intermediates, making them available worldwide by an electronic system.
• Generated airborne control objectives for all production materials, allowing cost effective engineering of safe facilities, compliance with domestic and international regulations, and flexible management of synthesis and manufacturing operations.
• Initiated and directed the development of a computerized indexing and retrieval system of thirty years of data on biocompatibility and safety of medical devices and their components and constituent materials.
• Developed, validated, put into use and got acceptance of new test methods and techniques (functional observational battery [FOB]; mouse ear swelling test [MEST]; in vitro screens for hepatotoxicity and cardiotoxicity; reduced animal use designs) which are faster, more effective, and use fewer animals and less test compound. The FOB is the starting point for EPA's and FDA's neurotoxicity evaluations. The MEST is now accepted by international regulatory agencies.

Honors & Publications

Credentials

• Diplomat of the American Board of Toxicology - D.A.B.T.

Academic and Professional Affiliations

• Fellow, Academy of Toxicological Sciences
• Society of Toxicologic Pathologists
• Wiki Working group
• Society of Toxicology - SOT
• American College of Toxicology
• Roundtable Toxicology Consultant
• Midwest SOT
• Teratology Society
• Biometrics Society
• American Statistical Society
• Safety Pharmacology Society- Program Committee
• Society for Toxicologic Pathology - Education Committee
• Toxicology Methods - Editor-in-Chief and Founder
• Journal of Applied Toxicology - Editorial Board
• Inhalation Toxicology - Editorial Board
• International Journal of Toxicology - Editorial Board
• Toxicology and Industrial Health - Editorial Board
• Acute Toxicology - Associate Editor
• Toxicology and Applied Pharmacology, Fundamental & Applied Toxicology, Toxicological Sciences, In Vitro Toxicology, Journal of Alzheimer's Disease and Toxicology Letters - Reviewer
• American Council on Science and Health - Board of Scientific and Policy Advisors
• NTP Interagency Center for the Evaluation of Alternative Toxicological Methods: Chair of the HET-CAM
• Human Toxicology - Editorial Board

Awards

• Ford Foundation Native American Graduate Fellow

Publications

Author and Co-Author

• 44 books
• 56 independent chapters
• 104 papers
• 212 presentation and abstracts

Education

• Ph.D. Pharmacology/Toxicology, University of Texas at Austin, Austin, TX
• B.S. Chemistry and Biology, Whittier College, Whittier, CA