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THOMAS J. MOSKAL Curriculum vitae CONTACT Email: [email protected] CAREER OBJECTIVE Provide professional service in science-based consumer protective programs. Work to promote public and animal health. Engage in collaborative research. Participate in professional organizations devoted to promoting and enhancing public and animal health through practice and regulation of science and medicine. Pursue association with research programs focusing on novel applications in medicine and pharmacology. EDUCATION Doctor of Veterinary Medicine, Virginia-Maryland Regional College of Veterinary Medicine, June 1987. Bachelor of Science, General Biological Sciences, University of Maryland, May 1981. Spanish language conversant. BOARD CERTIFICATION American College of Laboratory Animal Medicine, 1996 WORK EXPERIENCE Veterinary Medical Officer, U.S. Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance, Rockville, MD. RESPONSIBILITIES Serve as Veterinary Medical Officer in the Office of Surveillance and Compliance, Division of Surveillance. Perform pharmacovigilance of marketed veterinary drugs including analysis of Oracle database of adverse drug experiences reported by product sponsors. Obtain and evaluate reports of adverse drug experience and review consumer and veterinary practitioner complaints and reports. Conduct product surveillance including evaluation of clinical experience and promotional material. Responsible for analysis and interpretation of data, and other scientific and regulatory activities intended to ensure the safety and efficacy of marketed animal drugs, feeds, devices, and other articles. Provide scientific support and technical leadership in assuring safety and efficacy of marketed animal drugs, feeds, devices, and other articles. Make full and comprehensive reviews of periodic drug experience reports submitted by the sponsors of approved new animal drug applications under the provisions of 21 CFR 510.300. Recommend actions to correct significant hazards or potential dangers from inadequate directions for use and/or inadequate warnings and cautionary information. Request and review regulatory supplements to new animal drug applications and make appropriate recommendations. Advise the Team Leader in connection with the formulation of policy regarding marketed veterinary products that should be investigated to determine the accuracy of therapeutic representations, margin of safety of dosing, and course of treatment relative to all requirements of the Act. Evaluate labeling and other materials submitted for marketed unapproved drugs for determination of regulatory status and conformity with the Act, and FDA and CVM regulations and policies. Provide scientific reviews to support recalls and medically necessary veterinary product determinations. DUTIES – Attain and utilize a working knowledge of the Federal Food, Drug, and Cosmetic Act and its implementing regulations as they pertain to approval and marketing of approved and unapproved animal drugs, devices, and medicated feeds. Develop working knowledge of the components of Center for Veterinary Medicine, and scientific and administrative processing of New Animal Drug Applications. Meet and deal effectively with Scientists, Veterinarians, Administrators, and members of the public to accomplish the Center’s mission. Maintain current scientific knowledge of veterinary medicine in general, and develop knowledge in specific areas including biotechnology, antimicrobial pharmacology, food animal medicine, and medicated feeds. Review and tabulate pharmacovigilance data using various CVM databases. Serve on various Working Groups as assigned. Currently working with The Animal Biotechnology Working Group (ABWG) to measure risk and develop CVM policy associated with cloned and genetically engineered organisms. Represent the CVM at national meetings of veterinary practitioners (AVMA, AAHA, AABP, ASV, APV), and various allied trade organizations (FDLI, AHI, AFIA). ACCOMPLISHMENTS – Appointed to serve as CVM’s Promotion and Advertising Liaison from 2001 – 2003 and 2011 present. This assignment carries the responsibility to interact with liaisons from all FDA Centers in developing policy and interpreting regulations concerning the promotion and advertising of pharmaceutical products and medical devices to the public, and communicate with trade organizations and the public through public speaking and journal articles. Completed Basic Food and Drug Law Training course. Have composed over 100 documents for signature by the Director of the Office of Surveillance and Compliance, Director of the Division of Surveillance, and other CVM officials representing a variety of official correspondence to public and industry. Spearheaded the application of a boxed environmental warning to pentobarbital euthanasia products, and initiated a communications campaign to inform stakeholders, including large animal veterinarians, and humane and environmental organizations, of this change. Served as Co-Chair of the Animal Biotechnology Working Group in FY-04. Developed an Access Database cataloging research and commercial activities in animal transgenesis. Prepared and delivered a presentation, on behalf of CVM, entitled “Regulation of Genetic Engineering in Animals – An FDA Perspective” to attendees of the 7th National Symposium on Biosafety, an international symposium sponsored by the American Biological Safety Association and the U.S. Centers for Disease Control and Prevention. Prepared and presented a clinical case concerning Delayed-Type Hypersensitivity in a Cynomolgus Macaque at Association of Primate Veterinarians National Meeting in San Diego, CA, and National Capitol Area Branch of the American Association of Laboratory Animal Science in Hagerstown, MD. Enrolled in Drexel University program to earn Master of Library and Information Science. Completed >50% of required coursework. GPA = 4.0. SKILLS – Refined ability to meet and deal with scientific and administrative professionals at all levels. Advanced skills in researching and composing technical analytical and legal documents. Working knowledge of the Federal Food, Drug, and Cosmetic Act and implementing regulations. Experience with formal presentation in scientific, professional, and trade meetings using PowerPoint. Computer literate and keyboard proficient. Working knowledge of computer applications including Microsoft Office (Outlook, Word, Excel, PowerPoint, Access), Word Perfect, Adobe products, HTML editing software (Dreamweaver), Graphics editing software (PhotoShop). Experienced in web site design and implementation. Refined experience with Internet, WWW, and online data searching. Fifteen years experience composing technical and scientific documents. Specialized biological and medical knowledge with a variety of mammalian species including rodents, rabbits, dogs, cattle, swine, and non-human primates. Consumer Safety Officer, U.S. Food and Drug Administration, Center for Veterinary Medicine, Division of Compliance, Rockville, MD. RESPONSIBILITIES Serve as Consumer Safety Officer in the Office of Surveillance and Compliance, Division of Compliance. Responsible for applying surveillance tools in investigations of fraudulent commerce of unapproved animal drugs and devices that occurs on the Internet. Mine Internet data and other open source intelligence sources to discover in depth information concerning organizations and individuals responsible for conducting fraudulent online commerce involving animal drugs and devices. Aquaculture responsibilities - responsible for maintaining ongoing aquaculture regulatory activities formerly carried out by GS-14 Aquaculture Expert. Responsible for administration of Import Tolerance inquiries and formally submitted requests. This responsibility includes correspondence with international representatives of a range of countries and their aquaculture industry. The majority of inquiries come from aquaculture industry representatives in countries other than the U.S. Administer contract to develop a drug residue database (AQRIS) established to document drugs and chemicals used in aquaculture in countries that import seafood into the U.S. This project also includes management and operation of a risk ranking tool (AQRRT) that uses data stored in the AQRIS database to determine priorities for development of residue test methods. DUTIES – Work together with and support the missions of FDA’s Office of Criminal Investigations, FDA’s Office of Enforcement, and Office of Regulatory Affairs. Implement investigations of fraudulent animal drug marketing and other violations of the Food, Drug, and Cosmetic Act to support the mission of CVM’s Division of Compliance. ACCOMPLISHMENTS Served for four years on working group tasked with drafting Import Tolerance regulation to fulfill Import Tolerance obligation imposed by the Animal Drug Availability Act (ADAA) of 1996. Participate in working group tasked with establishing policy for regulating unapproved drugs currently marketed for use in aquarium and ornamental fish species. Have initiated actions and participated in inter-Center actions that have resulted in issue of five (5) Warning Letters in two year period. SKILLS Refined ability to mine data from the Internet, and to use a variety of Library search tools such as Dun & Bradstreet, Lexis and Nexis, WorldCat, Web of Knowledge, etc. Highly refined ability to meet and deal with scientific and administrative professionals at all levels. Advanced skills in researching and composing technical analytical and legal documents. Experience with formal presentation in scientific, professional, and trade meetings using PowerPoint. Fifteen years experience composing technical and scientific documents. Specialized biological and medical knowledge with range of mammalian species. Private Contractor/Consulting Veterinarian for NIH Animal Center, Primate Services Program, Poolesville, MD. RESPONSIBILITIES – Provide service as a Clinical Veterinarian for the National Institutes of Health Animal Center Primate Services Program located in Poolesville, MD, under a contract with R.O.W. Sciences. Endeavor to provide outstanding service to all scientific investigators utilizing the Primate Services Program while remaining focused on excellent animal care that is at all times ethical and humane. Provide daily clinical care and disease surveillance for a colony of over 900 non-human primates. Provide clinical care and disease surveillance on a rotational basis for research colonies of beagle dogs, exotic felids, swine, sheep, and rodents. Respond to clinical problems using clinical diagnostic methods including physical examination, clinical pathology, radiology, and ultrasound. Prescribe treatments as indicated for clinical problems and preventive health. Prescribe and administer anesthetic, analgesic, antimicrobial, and surgical treatments. Provide surveillance of animal colony disease status. DUTIES – Assess and diagnose medical problems of research animals. Manage primates in the quarantine facility. Perform surgical procedures and treatments as needed. Maintain detailed medical records on daily basis using the Problem Oriented Veterinary Medical Records format. ACCOMPLISHMENTS – Received award of special recognition and appreciation for service to the program. Worked-up a remarkable and unique presentation of delayed-type hypersensitivity in a Cynomolgus Macaque resulting from “ballistic” or “shotgun transfection” with a DNA vaccine and presented findings as a case presentation at two professional meetings. SKILLS – Board Certified by the American College of Laboratory Animal Medicine (ACLAM). Licensed Veterinary Practitioner in the State of Maryland. Over 10 years experience in providing clinical veterinary care and oversight for rodents, rabbits, dogs, cats, goats, sheep, swine, and non-human primates. Nine years experience in administering a facility IACUC program. Knowledge and familiarity with the National Institutes of Health (NIH) administrative structures, communications, and support facilities. Specialized biological and medical knowledge with a variety of mammalian species including rodents, dogs, sheep, swine, and non-human primates. Interested in surgery and qualified as a general veterinary surgeon. Broad knowledge and aptitude in pharmacology, particularly in the areas of analgesia, anesthesia, and antimicrobial therapy. Computer literate and keyboard proficient. Have five semesters of computer science course work in Fortran, Pascal, and Assembly Language programming. Experienced with DOS and Windows XP operating systems. Experience with software includes MS Office applications including Word, Access, Excel, Photoshop and Outlook. Experienced with Internet, WWW, and online data searching. Work experience as a reference librarian so have exceptional skill in literature searching and acquisition. Assistant Director and Attending Veterinarian, BIOQUAL, Inc., Rockville, MD. RESPONSIBILITIES – Provide service to all scientific investigators contracting the services of BIOQUAL while remaining focused on excellent animal care that is at all times ethical and humane. Assist the facility director in administration of the 30,000-sq. ft. non-human primate research facility and staff of 50 employees. Provide veterinary clinical care for over 500 monkeys and apes of 10 different species. Support experimental carcinogenesis work by National Cancer Institute investigators. Respond to clinical problems using clinical diagnostic methods including physical examination, clinical pathology, radiology, and ophthalmoscopy. Prescribe and perform treatments as indicated for clinical problems and preventive health. Prescribe and administer anesthetic, analgesic, and antimicrobial treatments. Serve as attending veterinarian for research projects including Hepatitis, Retrovirus, and respiratory virus research, behavioral studies, parasitology studies, and chronic cancer studies. Many of these studies were performed under Good Laboratory Practices (GLP). Serve as attending veterinarian on the facility Animal Care and Use Committee. Correspond with regulatory agencies including USDA-APHIS and DEA. Participate with the Diagnon, Corp. Department of Primate Ecology in developing environmental enrichment strategies for our animals. DUTIES – Review all scientific protocols for completeness and compliance with standards established under the Animal Welfare act, Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals. Communicate directly with all investigators as needed to compile information required for IACUC approval of scientific protocols. Constantly maintain over 150 current protocol files for inspection by regulatory agencies. Consult with investigators in the development and refinement of animal use protocols. Developed specific methodology for medical and surgical treatment of non-human primates, rabbits, and rodents in the performance of scientific investigations. Supervise and support animal technician staff through coaching and mentoring on a constant basis. Review technical and husbandry practices on a constant basis to apply quality management standards to the work performed. Often pitch-in manually to facilitate handling of large equipment, improve sanitation methods, and to improve efficiency in completing the work. Provide clinical veterinary care as needed, and research clinical literature to resolve challenging cases. Perform gross necropsy as needed for scientific protocol completion or for diagnostic purposes. Periodically present specific training programs including Biosafety, Animal Husbandry, and specific technical topics. Attend and support the corporate Health and Safety Committee. Author and review Standard Operating Procedures on an ongoing basis. ACCOMPLISHMENTS – In 1989 received a $5000 salary increase and recognition, including a letter from the President of BIOQUAL for successfully filling the position as Acting Director during the search period for a new Facility Director. Received outstanding performance evaluations and 5% or greater pay increases every year of my employment with BIOQUAL. Contributed to dramatic facility development and improvement including the construction of state-orthe-art chimpanzee biocontainment chambers. This project required cooperative effort between behavioral staff and animal care staff in defining specific strategy for housing needs based upon the 1990 revisions in the Animal Welfare Act, creating designs for housing and caging, and implementing those designs. Modernized the Animal Care and Use documentation to more adequately comply with the 1990 revised standards to 9 CFR Chapter 1, Subpart C. Developed surgical services to include orthopedic applications and intravascular catheterization. Developed a clinical program to implement “jacket and tether” applications for constant infusion of experimental drugs to immunodeficient macaques. Acquired budget and purchased equipment for anesthesia delivery and surgical patient monitoring. Designed necropsy facility, acquired budget, purchased equipment, and implemented the project to improve necropsy facilities. This effort resulted in greatly improved safety to personnel handling macaque tissues. Designed the radiology facility, developed plans, selected equipment, acquired budget, and implemented the radiology service. Developed plans for photographic services, selected appropriate photographic equipment, and developed a gross necropsy photographic service. Cost for the entire project, completed in May 1997, was well under budget at $1950.00. Identified the need for ultrasound technology, convinced investigators of the ethical need to refine inoculation procedures through the use of ultrasound imaging, worked to define specific ultrasound equipment for consideration for purchase. This effort led to a project to investigate the potential for ultrasound irradiation to damage viral nucleic acids and detrimentally impact scientific investigations. Participated for four years with the U.S. Army Laboratory Animal Medicine Seminar Program, and for three years with study groups in preparation for the qualifying examination for the American College of Laboratory Animal Medicine (ACLAM). Passed the practical portion of the ACLAM Examination in 1994, and the written portion in 1996. Presented case reports at the national meeting of the Association of Primate Veterinarians. Successfully established a consultation business relationship with MedImmune, Inc. providing animal care, management, and Animal Care and Use oversight to comply with federal standards. Developed a project and co-authored a publication to report the pharmacokinetics of a novel antimicrobial drug. The drug is currently approved for use in cattle, and we seek to define its usefulness in primate medicine. SKILLS – Board Certified by the American College of Laboratory Animal Medicine (ACLAM). Licensed Veterinary Practitioner in the State of Maryland. Over 10 years experience in providing clinical veterinary care and oversight for rodents, rabbits, dogs, cats, sheep, swine, and non-human primates. Nine years experience in administering a facility IACUC program. Knowledge and familiarity with the National Institutes of Health (NIH) and National Cancer Institute (NCI) administrative structure, communications, and support facilities. Specialized biological and medical knowledge of laboratory animal species including rodents, rabbits, and non-human primates. Interested in surgery and qualified as a general veterinary surgeon. Broad knowledge and aptitude in pharmacology, particularly in the areas of analgesia, anesthesia, and antimicrobial therapy. PROFESSIONAL EXPERIENCE Veterinary Medical Officer, Division of Surveillance, CVM Promotion and Advertising Liaison, FDA/CVM, 2001 to 2003, 2011 to present. Consumer Safety Officer, Division of Compliance, CVM Product Manager for Veterinary NSAIDs Animal Biotechnology Working Group, Co-chairman, 2003-2004. Animal Biotechnology Working Group, FDA/CVM, 2000 to 2006. Reviewer of articles submitted for publication in Contemporary Topics in Laboratory Animal Science, 1996 to present. Committee Chairman, Boy Scout Troop 944, Ellicott City, MD, 2004 to 2007. Representative, PTA Council of Howard County, MD, 2002 to 2005. IACUC Protocol Reviewer for Veterans Administration, 1998 to 2000. Adjunct Member, ACLAM Examination Committee, 1997 to 1999. Chairman of Program Committee for the 24th Annual NCAB/AALAS Seminar, 1997. Private Ownership of Primates Task Force of the American Society of Primatology - Member; Co-author of Private Ownership of Primates - A White Paper Report, October 1995. Clinical veterinarian at Shady Grove Animal Hospital, Rockville, MD, 19891992. AWARDS FDA Honor Award – Group Recognition, Agency Cross-Cutting, 2009 H1N1 Consumer Protection Team – for extraordinary efforts in implementing an aggressive strategy to identify and take action against fraudulent H1N1 products and preventing them from proliferating throughout the marketplace. September, 2010 FDA/CVM Team Excellence Award - NSAID Education Outreach Team, for outstanding and creative teamwork in identifying a critical information need and designing a highly successful outreach strategy to address that need: the NSAID Education Outreach Program. April 2007 FDA/CVM Team Excellence Award, for outstanding performance in the pharmacovigilance of marketed veterinary drugs and implementing labeling revisions to further insure their safety and effectiveness under actual use conditions. April 2006 FDA Group Recognition Award, for producing CVM’s sector-specific portion of the National Infrastructure Protection Plan (NIPP) for the Department of Homeland Security. April 2005 FDA Group Recognition Award, Animal Cloning Risk Assessment Group, for outstanding achievement in developing the Animal Cloning Risk Assessment and presenting the Risk Assessment document to the VMAC members at the November, 2003, public meeting. Time Off Award - for editing a draft animal care guide entitled Health Assessment and Care for Animals Involved in the Cloning Process on behalf of the International Embryo Transfer Society (IETS). Time Off Award – for outstanding customer service and quality performance, and in recognition of participation as panel member at the 2004 FDLI Meeting in Washington, DC. Time Off Award – for outstanding service as editor of the Health Assessment and Care for Animals Involved in the Cloning Process guide document produced by and for the International Embryo Transfer Society (IETS), 2006. PUBLICATIONS Moskal, T.J. Minimizing the risk factors associated with veterinary NSAIDs. News article in Journal of the American Veterinary Medical Association, Vol. 224, No. 8, April 15, 2004. Moskal, T.J. Regulation of Genetic Engineering in Animals- An FDA Perspective - 7th National Symposium on Biosafety, Managing Risk in Animal Care and Use, ABSA/CDC 7th National Symposium Proceedings: Prudent Practices for the New Millennium, Atlanta, GA, October, 2002. Olivero, O.A., Anderson, L.M., Diwan, B.A., Haines, D.C., Harbaugh, S.W., Moskal, T.J., Jones, A.B., Rice, J.M., Riggs, C.W., Logsdon, D., Yuspa, S.H. and Poirier, M.C. Transplacental Effects of 3' Azido-2', 3'-Dideoxythymidine (AZT): Tumorigenicity in Mice and Genotoxicity in Mice and Monkeys. Journal of the National Cancer Institute, November, 1997. Giurgiovich, Alejandra J., Anderson, L.M., Jones, A.B., Dove, L.F., Moskal, T.J., Rice, J.M., Olivero, O.A., and Poirier, M.C. Transplacental Cisplatin Exposure Induces Persistent Fetal Mitochondrial and Genomic DNA Damage in Patas Monkeys. Reproductive Toxicology 1997; V. 11, No. 1: 95-100. Shamkhani, Hamadi, Anderson, L.M., Henderson, C.E, Moskal, T.J., et.al. DNA Adducts in Human and Patas Monkey Maternal and Fetal Tissues Induced by Platinum Drug Chemotherapy. Reproductive Toxicology 1994; V.8, No. 3: 207-216. Tsarev, Sergei A., Tsareva, T.S., Emerson, S.U., Yarbough, P.O., Legters, L.J., Moskal, T.J., and Purcell, R.H. Infectivity Titration of a Prototype Strain of Hepatitis E Virus in Cynomolgus Monkeys. Journal of Medical Virology 1994; 43:135-142. Lu, Lee-Jane W., Anderson, L.M., Jones, A.B., Moskal, T.J., et.al. Persistence, gestation stage-dependent formation and interrelationship of benzo[a]pyreneinduced DNA adducts in mothers, placentas and fetuses of Erythrocebus patas monkeys. Carcinogenesis 1993; V. 14, No. 9: 1805-1813. Anderson, Lucy M., Koseniauskas, R, Burak, ES, Moskal, TJ, et.al. Reduced Blood Clearance and Increased Urinary Excretion of N-Nitrosodimethylamine in Patas Monkeys Exposed to Ethanol or Isopropyl Alcohol. Cancer Research 1992; 52:1463-1468. Jones, Ann B., Jones, C.R., Anderson, L.M., Moskal, T.J., et. al. Cytochrome P450 3A Isoforms in Tissues of Pregnant and Fetal Patas Monkeys. Proceedings of the American Association of Cancer Research 1992; 33:152, 1992. Keith, Jr. James C, Moskal, TJ, Eggleston, MK, Konczal, C, Howerton, TL. Thromboxane Synthetase Inhibition Produces Maternal and Fetal Vasodilation During Ovine Pregnancy-Induced Hypertension: A Doppler Flow Velocimetric Study. Journal of Perinatology 1992; V. XII, No. 3: 210-214. Bacher, John, Kassianides, C, Moskal, TJ, Matthews, DM, Hoofnagle, JH. A Technique for Liver Biopsy in Pekin Ducks. Laboratory Animal Science 1989; 39:67-68. Keith, Jr, J.C., Moskal, T.J., Howerton, T.L. Characterization of a Sheep Model of Pregnancy-Induced Hypertension: Effects of Thromboxane Synthetase Inhibition on Maternal-Fetal Homeostasis. Abstract: Presented at National Perinatal Association. Annual Clinical Conference, Washington, DC November 10-14, 1989. Eggleston, Jr, M.K., Keith, Jr, J.C., Moskal, T.J. Treatment of Ovine PregnancyInduced Hypertension with Thromboxane Synthetase Inhibitors Normalizes Arterial Systolic-Diastolic Flow Ratios and Correlates with Improved Fetal Condition. Abstract, presented at: 20th International Meeting of Organization Gestosis, Cork, Ireland, July 27-29, 1988. Young, John K., Moskal, T.J. Effects of Insulin Infusions and Underfeeding of LH in the Rat. Abstract in Federation Proceedings 1984; 43: 526. PROFESSIONAL MEMBERSHIPS American College of Laboratory Animal Medicine American Association of Laboratory Animal Science American Society of Laboratory Animal Practitioners American Veterinary Medical Association VETERINARY LICENSURE State of Maryland, 1988 to present PRESENTATIONS T.J. Moskal, Internet Enforcement of Unapproved New Animal Drugs. eBay and PayPal, Salt Lake City, UT and Omaha, NE, September 23 and 25, 2009. T.J. Moskal, CVM Policy and Enforcement Update. Drug Information Association, Boston, MA, June 23, 2008. T.J. Moskal, OS&C Roundtable – Risks Associated with Veterinary NSAIDs, CVM, Rockville, MD, February 22, 2005. T.J. Moskal, CVM Policy and Enforcement Update. Animal Health Institute, Alexandria, VA, November 14, 2002. T.J. Moskal, CVM Policy and Enforcement Update. Food and Drug Law Institute, Washington, DC, October 16-17, 2001 and September 11, 2002. T.J. Moskal, CVM Policy and Enforcement Update. Drug Information Association, New York, NY, February 21, 2002. T.J. Moskal, Regulation of Genetic Engineering in Animals- An FDA Perspective - 7th CDC Symposium on Biosafety Managing Risk in Animal Care and Use, Atlanta, GA, January 28, 2002. T.J. Moskal, Review of Promotion and Advertising Materials, Instructional presentation for CVM Staff College, July 11, 2002. T.J. Moskal, Polka-dot dermatitis in a Cynomolgus Macaque. Assoc. of Primate Veterinarians Annual Meeting, 2000. T.J. Moskal, What's Your Diagnosis? Zinc Deficiency in a Captive Chimpanzee. Assoc. of Primate Veterinarians Annual Meeting, 1994. T.J. Moskal, What's Your Diagnosis? Meningitis Secondary to Simian Immunodeficiency Virus in a Rhesus Macaque. Association of Primate Veterinarians Annual Meeting, 1994. TEACHING Review of Promotion and Advertising Materials. FDA/CVM Reviewer Training, CVM Staff College, Rockville, MD July 11, 2002. Bacterial Diseases of Non-Human Primates. U.S. Army Laboratory Animal Seminar Program, Uniformed Services University of the Health Sciences, Bethesda, MD, December 1993, December 1995, and September 1997. Rats: Biology, Care, Nomenclature, Genetics, and Breeding. U.S. Army Laboratory Animal Seminar Program, Uniformed Services University of the Health Sciences, Bethesda, MD, January, 1993. Biological Safety Training, presented to BIOQUAL Maintenance and Security Staff, February, 1992. Laboratory Animal Medicine, presented at Career Day, Montgomery County Community College, Germantown, MD, January, 1991. CONTINUING EDUCATION FDA Supervisory Potential Course, Eastern Management Development Center, Shepherdstown, WV, 2005 FDA Regulatory Policy Program, Maryland School of Public Affairs, Office of Executive Programs, 2005 The North American Veterinary Medical Conference, 2005 PhRMA/FDA Genomics (Microarray) Biostatistics Workshop, 2004 Functional Genomics Training Workshop, PhRMA/FDA, 2003 UC Davis Transgenic Animal Research Conference IV, 2003 Technical Writing, Daniel O. Graham, 2003 FDA Science Forum, 2001-2005 Foundation for Advanced Education in the Sciences (FAES) / BioTrac course Recombinant DNA Methodology, 2002. DC Academy of Veterinary Medicine, 2002, 2001, 2000, 1999 ACVIM Forum, 2002, 2003, 2004 ACLAM Forum, 2002, 1999, 1997 AALAS National Meetings, 2001, 2000, 1996, 1995, 1989, 1988 NCAB-AALAS Annual Symposium, 2000, 1996-1988 Association of Primate Veterinarians, 2001, 2000, 1995, 1990, 1988 American Society of Primatology, 1991, 1990 Cancer: A Multidisciplinary Approach, VRA, September 1999 Vivarium Facilities Design, Construction and Management, San Diego Branch AALAS, 1998 Alternatives in Monoclonal Antibody Production, JHU-CAAT and OPRR, 1997 OPRR Seminar - Surgery and Post Surgical Care, April, 1991 Basic Microvascular Surgery Workshop, USUHS, November, 1988 C.L. Davis Laboratory Animal Diseases Symposium, 1990 C.L. Davis Pathology of Laboratory Animals, 1993 References available on request.