Bernadette Dunham

Bernadette Dunham

Bernadette Dunham

Ph.D.

Professorial Lecturer

Part-time Faculty


School: Milken Institute School of Public Health

Department: Environmental and Occupational Health

Contact:

Office Phone: 202-288-9833
Milken Institute School of Public Health 950 New Hampshire Avenue, NW Washington DC 20052

Bernadette Dunham, D.V.M., Ph.D.

Professorial Lecturer, Milken Institute School of Public Health at the George Washington University. Former Director, Center for Veterinary Medicine, U.S. Food and Drug Administration.

Dr. Bernadette Dunham is a Professorial Lecturer at the Milken Institute School of Public Health at the George Washington University, where her focus is on One Health issues (One Health is a collaborative, multisectoral, and trans-disciplinary approach - working at the local, regional, national, and global levels - with the goal of achieving optimal health outcomes for people, animals, plants, and their shared environment).  In October 2019, Dr. Dunham was appointed as a member of the National Academies of Sciences, Engineering and Medicine's Board on Agriculture and Natural Resources for a three year term thru December 2022.  On a part-time basis, Dr. Dunham returned to the U.S. Food and Drug Administration (FDA) in August 2019, where she is currently serving as an Advisor for the new FDA One Health Initiative.  From April 2016 - December 2017, Dr. Dunham was a Visiting Professor at the Milken Institute School of Public Health and the Senior Science Advisor to the Deputy Commissioner, OFVM, U.S. Food and Drug Administration. 

Dr. Dunham served as the Director of the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) from 2008 -2016.  As Center Director, she oversaw the regulation of the manufacture and distribution of drugs, medical devices and food additives that are given to animals. These include animals from which human foods are derived, as well as pet (or companion) animals and minor species which include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. Dr. Dunham was responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. Dr. Dunham coordinated the outreach to educate consumers as well as the regulated industry; the careful evaluation of data on proposed veterinary products before permitting them to be marketed; the discovery of violative marketed products through surveillance programs; the initiation of legal action, if necessary, to bring violators into compliance with the law; and the research to support Center activities.

Prior to becoming CVM’s Director in 2008, Dr. Dunham had been CVM’s Deputy Director. Dr. Dunham also served as the Director of CVM’s Office of Minor Use and Minor Species from August 2006 to January 2008. She came to CVM in December 2002 as the Deputy Director of CVM’s Office of New Animal Drug Evaluation. Dr. Dunham has served as an Adjunct Professor in the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine from 1996 to 2012. She lectured on a variety of topics from emerging issues and opportunities in veterinary medicine to the role of consensus building in policy development.

Prior to joining FDA, Dr. Dunham was Assistant Director for the American Veterinary Medical Association’s Governmental Relations Division in Washington, D.C. from 1995-2001. In that position, she participated in the formation and execution of AVMA policies, objectives and programs, with emphasis on Federal legislation and regulatory issues. Dr. Dunham’s work also involved identifying Congressional and regulatory issues that might impact the veterinary medical profession, as well as developing strategies for response to these issues. From 1989 to 1995, Dr. Dunham was the Director of Laboratory Animal Medicine and Adjunct Professor of Pharmacology at the State University of New York Health Science Center in Syracuse, N.Y. Dr. Dunham’s research focused on the molecular regulation of cardiac gap junction proteins. She participated in a post-doctoral residency program in the Department of Pathology at the New York State College of Veterinary Medicine, Cornell University, Ithaca, N.Y., from 1987 to 1988. Dr. Dunham was a Research Assistant Professor at Boston University from 1984 to 1987. Prior to returning to academia to pursue her Ph.D., Dr. Dunham was in private clinical practice in Ontario, Canada from 1975 to 1979.

Dr. Dunham received the degree of Doctor of Veterinary Medicine in 1975 from the Ontario Veterinary College at the University of Guelph in Ontario, Canada and her Ph.D. in cardiovascular physiology in 1984 from Boston University in Boston, Massachusetts.

Dr. Dunham is a member of the American Veterinary Medical Association, the American Academy of Veterinary Pharmacology and Therapeutics, the National Academies of Practice, and the American Public Health Association.  She is an Honorary Diplomate and an awardee of the K.F. Meyer - James H. Steele Gold-Headed Cane Award from the American Veterinary Epidemiology Society. She has served on peer review panels for the National Academies of Science, the American Heart Association - New York State Affiliate, United States Department of Agriculture-Cooperative State Research, Education and Extension Service, Competitive Programs, and the National Institutes of Health. Dr. Dunham also served as the Chairperson for the 18th Session of the Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods.


EXPERTISE: 

Global Environmental Health

Global Health

Environmental and Occupational Health

Infectious Disease

 

EDUCATION: 

1975 - Doctor of Veterinary Medicine (D.V.M.)  Ontario Veterinary College, University of Guelph, Ontario, Canada

1984 - Doctor of Philosophy (Ph.D.)  Boston University

 

PROFESSIONAL EXPERIENCE

1975 – 1978  Private Practice, Oshawa, Ontario, Canada

1979 – 1984  Research Associate, Boston University, Boston, MA

1980 – 1986  Research Associate, Harvard University Medical Center, Boston, MA

1984 – 1986  Research Assistant Professor, Boston University, Boston, MA

1987 – 1988  Resident, Department of Pathology, New York State College of Veterinary Medicine, Cornell University, Ithaca, NY

1988 – 1989  Assistant Professor, Department of Pharmacology, State University of New York (SUNY) Health Science Center, Syracuse, NY.

1989 – 1995  Adjunct Professor, Department of Pharmacology, State University of New York (SUNY) Health Science Center, Syracuse, NY

1989 – 1995  Director of Laboratory Animal Medicine, Department of Laboratory Animal Resources, State University of New York (SUNY) Health Science Center, Syracuse, NY

1995 – 1996  Policy Specialist, Governmental Relations Division of the American Veterinary Medical Association, Washington D.C. Office, Washington, D.C.

1995 – 1996  Policy Specialist, Governmental Relations Division of the American Veterinary Medical Association, Washington D.C. Office, Washington, D.C.

1996 – 2002  Assistant Director, Governmental Relations Division of the American Veterinary Medical Association, Washington D.C. Office, Washington, D.C.

1996 – 2012  Adjunct Professor, Virginia-Maryland Regional College of Veterinary Medicine, Blacksburg, VA

2002 – 2002  Acting Director, Governmental relations Division of the American Veterinary Medical Association, Washington, D.C. Office, Washington, D.C.

2002 – 2006  Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration, Department of Health and Human Services, Rockville, MD

2006 – 2008  Deputy Center Director, Center for Veterinary Medicine Director, and Director, Office of Minor Use and Minor Species Animal Drug Development, U.S. Food and Drug Administration, Department of Health and Human Services, Rockville, MD.

2008 – 2016  Director, Center for Veterinary Medicine, U.S. Food and Drug Administration, Department of Health and Human Services, Rockville, MD

2016 – 2018  Visiting Professor, Milken Institute School of Public Health, the George Washington University, Washington, D.C. and Senior Science Advisor to the Deputy Commissioner, OFVM, U.S. Food and Drug Administration, Silver Spring, MD.

2018 – Present  Professorial Lecturer, Milken Institute School of Public Health, the George Washington University, Washington, D.C

 

TEACHING: 

l980 - l982  Laboratory Instructor for M-MEDIC Human Physiology BI-528, (Spring semester) 12 periods  (3 hr each). Boston University.

l981 - l986  Teaching Assistant and Lecturer for Vascular Physiology BI-547, (Fall semester) 4 lectures(1 hr each).  Boston University.

1988 - 1992  Conference Leader for MSI - Cell and Molecular Biology Conferences,  First Year Medical Students (Fall semester). Topics include: Sickle Cell Disease, Muscular Dystrophy and Familial Hypercholesterolemia.  8 periods (3 hr each). SUNY Health Science Center at Syracuse.

1990 – 1995  Pharmacology Lecturer,  Second Year Medical Students. (Spring semester). Topics include Inflammation, Analgesics, Arthritis and Gout. Special lecture: Care and Treatment of Animals in Biomedical Research 4 lectures (1 hr each). SUNY Health Science Center at Syracuse.

1991 – 1995  Course Coordinator and Lecturer for the American Association for Laboratory Animal Science Training Program for Certification of Laboratory Animal Health Technicians and Laboratory Animal Health Technologists. 34 lectures (1 hr. lecture plus 6 wet labs at 2-3 hr). SUNY Health Science Center at Syracuse.

1993 – 1995  Instructor and Lecturer for Medicine and Society Course MMHU 100 in the Program in Medical Humanities, First Year Medical Students (Fall and Spring semester).  Topics include: Becoming a Physician; The Dissection Experience; Advocacy for Handicapped Persons; Life Styles, Life Chances and the Treatment of Diabetes; The Tuskegee Episode; Caring for Patients with Coma; Ethical Issues in the Treatment of Parkinsonism; Gender, Race and Access to Health Care; The Use of Animals in Research and Teaching.  1 hr. lecture per topic and 9 discussion periods at 2 hr each. SUNY Health Science Center at Syracuse.

1994 – 1995  Instructor and Lecturer for Medicine and Society Course MMHU 200 in the Program in Medical Humanities, Second Year Medical Students (Fall and Spring semester).  Topics include:  The Autopsy Experience;  Physician Mistakes:  Case of Barb;  HIV Infection:  Confidentiality;  Can I Catch It:  Case of William;  Organ Donation and Transplantation;  Drugs in OUR Culture;  Helping Those Who Resist Help:  Schizophrenia;  Health Care Costs/M.D. Decision Making.  1 hr. lecture per topic and 8 discussion periods at 2 hr each. SUNY Health Science Center at Syracuse.

1996 – 2002  Emerging Issues in Veterinary Medicine.  1 lecture @1 hr. The Profession of Veterinary Medicine. VM 8004, VA-MD Regional College of Veterinary Medicine.

2016 – Present 

· PUBH-2110 Public Health Biology - Undergraduate Program in Public Health Spring and Fall Semester (2019 - P) Milken Institute SPH, George Washington University.

“One Health” lecture series to the MPH students: Department of Health Policy - PH 6015.16 (2 hr. lectures). Milken Institute SPH, George Washington University.

· “One Health a Reality - Crossing Bureaucratic Boundaries" lecture to the Summer Institute "Issues & Trends in Regulatory Science" School of Medicine and Health Sciences - George Washington University.

· Introduction to One Health for the Dr.PH. class (2 hr lectures) at Milken Institute School of Public Health, George Washington University.

· One Health lecture series- Undergraduate class (2 hr lectures) in Global Health and Development, Milken Institute School of Public Health, George Washington University.

· One Health Engaging in a Multidisciplinary Approach – Session 8 in Population and Community Health; On-line Module for the Masters of Science in Management of Health Informatics and Analytics (MS-MHIA).

 

COMMUNITY SERVICE: 

Member of the Design and Planning Committee for the Charles River Campus Laboratory Animal Care Facility [A.A.A.L.A.C. Standards]. Boston University, Boston, MA (1981 - 1983)

Member of the Institutional Animal Care and Use Committee. Boston University, Boston, MA (1983 - 1987)

Member of the Institutional Biosafety Committee. SUNY Health Science Center, Syracuse, NY (1989 - 1995)

Executive Secretary for the Institutional Animal Care and Use Committee. SUNY Health Science Center, Syracuse, NY (1989 - 1995)

Medical Student Applicant Interview Committee for the College of Medicine. SUNY Health Science Center, Syracuse, NY (1989 - 1995)

Member of the Personal Safety Committee. SUNY Health Science Center, Syracuse, NY (1990 - 1995)

Member of the Design Committee - Satellite Laboratory Animal Facility in the “Institute for Human Performance and Multidisciplinary Research” building. SUNY Health Science Center, Syracuse, NY (1990 - 1995)

Member of the Strategic Planning Committee: Task Group 2A SUNY Health Science Center, Syracuse, NY (1992)

Member of the Teaching and Research Program Planning Committee. SUNY Health Science Center, Syracuse, NY (1992 - 1995).

Member of the Council for Oversight of Campus Regulatory Committees. SUNY Health Science Center, Syracuse, NY (1993 -1995).

Member of the Chancellor’s Advisory Committee on The Care and Use of Laboratory Animals SUNY Central, Albany, NY (1992 - 1995).

Member of the Working Group for the USDA Classification Scheme for Reporting Pain and Distress in Animal Research. AVMA, Washington, D.C. (1995 to 1999).

Member of the Veterinary Steering Committee for the National Museum and Medicine. AVMA, Washington, D.C (1995 to 1997).

Member of the Working Group on Research and Diagnostics Needs for Animal Health Emergency Preparedness and Response. Animal Agriculture Coalition, Washington, D.C. (1997-1999).

Member of the Task Force on Communication. AVMA, Schaumburg, IL (1998-2002).

Member of the Long Range Planning Committee. AVMA, Schaumburg, IL (2000-2002).

Member of the AVMA-AAVMC Task Force on Research. AVMA, Washington, D.C. (2001-2002).

Staff consultant for the AVMA Legislative Advisory Committee. AVMA-GRD, Washington, D.C. (1999-2002).

Board Member of the Conservation Research Center Foundation, Smithsonian Conservation Research Center, Front Royal, VA (2001-2006).

Board Member, National Coalition for Food and Agricultural Research (NC-FAR), Savoy, IL (2002 – 2002).

Board Member, Center for Government and Corporate Veterinary Medicine Advisory Board, VA-MD Regional College of Veterinary Medicine, College Park, MD (2002 – present).

Board Member, Staff College Governing Board, FDA-Center for Veterinary Medicine, Rockville, MD (2003 – 2008).

Executive Secretary to the U.S. Delegate on the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF),  15th Session of the CCRVDF, Washington, D.C. October 26-29, 2004.

Committee Planning Co-Chair and Co-Organizer, 14th Biennial Symposium of the American Academy of Veterinary Pharmacology and Therapeutics “Veterinary Pharmacology 2005 – Advances, Challenges and Insights” Rockville, MD May 16-18, 2005.

Executive Secretary to the U.S. Delegate on the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF),  16th Session of the CCRVDF, Cancun, Mexico.  May 6-12, 2006.

Member of the American Veterinary Medical Association’s House Advisory Panel. Schaumburg, IL.  2008 – 2016.

Chairperson, Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), 18th Session of the CCRVDF, Natal, Brazil.  May 9-16, 2009.

Chairperson, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), 25th VICH Steering Committee meeting, Washington, D.C.,  February    23-24, 2011.

Member, North American Veterinary Medical Education Consortium. Roadmap for Veterinary Medical Education in the 21st Century: Responsive, Collaborative, Flexible.  Washington, D.C.  July 17, 2011.

Chairperson, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), 28th VICH Steering Committee meeting, Washington, D.C., February     19-21, 2013.

Chairperson, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), 31st VICH Steering Committee meeting, Washington, D.C., February      24-26, 2015.

Member, Joint Association Public Land-grant Universities and the Association of American Veterinary Medical Colleges Task Force on Antibiotic Resistance in Production Agriculture. Washington, D.C., January - October 2015.

Member, National Institute of Food and Agriculture (NIFA) “Call to Conversation - US Agricultural Enterprise”, Univ. of Maryland, College Park, MD. February 15, 2017.

Member, Executive Committee of the Association of Public and Land-grant Universities (APLU) and the Association of American Veterinary Medical Colleges (AAVMC) Antimicrobial Resistance Initiative, Washington, D.C. January 2017 – Present.

Member, Center for Animal and Human Health in Appalachia (CAHA) Executive Advisory Board, Lincoln Memorial University, College of Veterinary Medicine, Harrogate, TN. March 2016 - Present.

Member, Bat Rabies Education Team (BRET) – One Health Commission. https://www.onehealthcommission.org/en/one_health_resources/bat_rabies_education/#batrabiesteammembers  November 12, 2017 – Present.

 

INSTITUTES AND CENTERS: 

RESPONSIBILITIES AND ACCOMPLISHMENTS AS DIRECTOR OF LABORATORY ANIMAL MEDICINE and ADJUNCT ASSISTANT PROFESSOR OF PHARMACOLOGY

Job Title: Director, Laboratory Animal Medicine and Adjunct Assistant Professor of Pharmacology

Dates of Employment: 07/1989 to 01/1995

Employer’s Name and Address:  State University of New York Health Science Center at Syracuse

750 East Adams Street, Syracuse, N.Y. 13210

The position of Director of Laboratory Animal Medicine at the SUNY Health Science Center at Syracuse included the following responsibilities:

Provide veterinary medical services for the laboratory animals housed in the Department of Laboratory Animal Resources (DLAR); manage animal health programs; develop and implement standard operating procedures for DLAR; play a key role as a consultant to faculty researchers; evaluate animal care and use research protocols; serve on the Institutional Animal Care and Use Committee; plan for future needs for the facility; supervise and conduct training programs in laboratory animal medicine for animal care personnel, technical staff and faculty; conduct the American Association for Laboratory Animal Science (AALAS) laboratory animal technician and laboratory animal technologist training courses; develop budgets; attract extramural support for improvement of the laboratory animal resources program; interact with administration and the public; supervise acquisition of laboratory animals and maintenance of accurate inventories of all laboratory animals [species handled by DLAR include: non-human primates (New World: Cebus apellaSaimiri sciureus.  Old World: Macaca fasicularisMacaca mulattaMacaca nemistrina), cats, dogs, sheep, swine, rabbits, ferrets, guinea pigs, hamsters, gerbils, mice, rats, chickens, quail, amphibians (Xenopus laevisRana pipiensRana catesbeiana); prepare and submit all necessary reports required by the state and federal agencies, OPRR, USDA, etc.; ensure compliance with federal and state agencies regarding laws and regulations appertaining to the care and use of laboratory animals in biomedical research; work closely with deans and directors to implement and promote all animal use policies and procedures; major responsibility is directing the Health Science Center’s Department of Laboratory Animal Resources which is comprised of approximately 27,000 square feet and 17 employees.

My major accomplishments as Director of Laboratory Animal Medicine and Adjunct Assistant Professor at the SUNY Health Center at Syracuse included the following:

My tenure as Director of Laboratory Animal Medicine in the Department of Laboratory Animal Resources (DLAR) with the SUNY-HSC at Syracuse (1989-1995) provided me with the greatest experience in planning and managing major animal oriented research programs because I was responsible for the entire university.  I supervised a staff of 17 laboratory technicians and one part-time consulting veterinarian.  I handled complex administrative and management issues and I was successful in bringing about change through my positive attitude, my support of people, my problem solving approaches and my team building skills.  I had an open door policy that extended outside of the University to the public at large.  I reached out to the University community and the Public community to help raise awareness and education regarding the use of animals in biomedical research.  I had direct interaction with every Principal Investigator, student and technician that utilized animals in their research projects.  I provided veterinary medical services for the laboratory animals; managed the animal health programs; developed and implemented standard operating procedures; played a key role as a consultant to faculty researchers in helping them understand the principles, theories and practices of health related research that involved animals; evaluated animal care and use research protocols; served on the IACUC as Executive Secretary; and I assisted the Principal Investigators with their laboratory animal care budgets for grant submissions.  I prepared and submitted all necessary reports required by the state and federal agencies and I ensured compliance with federal and state laws and regulations appertaining to the care and use of laboratory animals in biomedical research.  I addressed the budgetary needs of DLAR with the university budget accountants; provided full documentation and justification for required resources to the Dean of the Medical School; and I successfully obtained several upgrades in the DLAR infrastructure [for example: new caging units; automatic watering; key card and security camera installation; improvements to the HUVAC systems; laminar flow hoods; new cage and rack washer; isoflurane inhalation anesthetic units; and a new autoclave].  In 1990 I received a grant from the National Center for Research Resources, NIH, which required matching funds from the SUNY-HSC to upgrade the HUVAC system for the DLAR.  I taught the American Association for Laboratory Animal Science laboratory animal technician and laboratory animal technologist training courses and I had every member of my staff receive certification, including 10 at the highest level of Laboratory Animal Technologist.  I brought the DLAR into full compliance with all federal and state regulations and developed a complete animal care and use program to meet requirements for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

As Adjunct Assistant Professor in Pharmacology I was recognized for my scientific research skills by serving as a Scientific Reviewer for the American Heart Association (3 year appointment).  I was appointed to nine University Committees.  I taught Pharmacology courses to the second year medical students and I helped develop and teach an ethics course entitled Medicine and Society.  I served on M.Sc. and Ph.D. dissertation examination committees.  The National Heart, Lung and Blood Institute awarded a Program Project Grant entitled "Intercellular Communication and Impulse Propagation" to Jose Jalife, Grant Number IPOIHL39707-OlAl for a total project period from 05-01-90 through 04-30-95.  I was co-investigator on Project V, entitled "Structure, Function and Regulation of Gap Junction Proteins" which received $3,924,768 in funding.  I attended and gave poster presentations of my research accomplishments at the ‘Molecular Biology of the Gap Junction’ meeting in Irsee, Germany (1989) and at the ‘International Meeting on Gap Junctions’ in Asilomar, CA (1991).

 

SUMMARY OF RESEARCH ACCOMPLISHED AT THE SUNY HEALTH SCIENCE CENTER AS ADJUNCT ASSISTANT PROFESSOR OF PHARMACOLOGY

Molecular Regulation of Cardiac Gap Junction Proteins

In myocardium, electrical coupling through gap junctions (collections of oligomeric integral membrane proteins referred to as connexins) permits propagation of the action potential and the synchronized contraction of myocytes.  During tissue injury, such as that observed in ischemia, an increase in the resistance across junctions may serve to localize damage to the affected site.  Thus gap junctions play a central role in transcellular signal transduction and elucidation of their regulation is of crucial importance to understanding cardiac intercellular communication in both normal and pathophysiologic states.  A cDNA encoding the major myocardial gap junction protein, connexin43 (Cx43), has been identified and there is considerable homology between the extracellular and transmembrane domains of connexins from different tissues.  However, the cytoplasmic domains of connexins from different sources are not homologous and may represent unique regulatory sites.  The overall objective of the research was to elucidate, in part, the molecular basis for Cx43 activity and regulation. Toward this end we studied two aspects of Cx43 function.

1.  The role of the cytoplasmic domain of Cx43 in channel function.  Using oligonucleotide-directed site specific mutagenesis, a series of mutant cDNAs encoding Cx43 were generated.  mRNAs encoding wild-type and mutant Cx43 proteins were microinjected into a paired Xenopus laevis oocyte expression system and the junctional conductances determined.  Membrane localization of the translation product of these mRNAs was documented by [35S]-methionine labeling, Western blot analysis and immunocytochemistry using specific anti-Cx43 peptide antibodies.

2.  The role of second messengers and their respective protein kinases in the regulation of Cx43.  Various physiologic and pharmacologic stimuli may be mediated by intracellular second messengers acting through their respective kinases.  Modulation of other types of ion channels by protein kinases is well established and several potential phosphorylation sites have been identified in the cytoplasmic domains of the connexins.  Using an in vitro re-constitution system containing Cx43 and one of 3 purified kinases (cAMP-dependent protein kinase, protein kinase C or Ca++/calmodulin-dependent protein kinase) the specific peptides that are phosphorylated and the specific phosphoamino acids were determined.  In situ phosphorylation of wild-type and mutant Cx43 was examined using the Xenopus laevis oocyte expression system.

A manuscript detailing these findings has been published [Dunham, B., S. Liu, S. Taffet, E. Trabka-Janik, M. Delmar, R. Petryshyn, S. Zheng, R. Perzova and M. Vallano. Immuno-localization and expression of functional and non-functional cell-to-cell channels from wild-type and mutant rat connexin43 cDNA. Circulation Research. 70 (6):1233-1243 (1992)] and a summary is provided below.

The carboxyl terminal cytoplasmic domain of distinct gap junction proteins may play an important role in assembly of functional channels as well as differential responsiveness to pH, voltage and intracellular second messengers.  Oligonucleotide-directed site specific mutagenesis in a paired Xenopus laevis oocyte expression system was used to examine the expression of mRNAs encoding wild-type and carboxyl terminal mutant connexin 43 (Cx43) proteins.  Oocytes were stripped, injected with mRNA or distilled water (dH20), preincubated for 16-20 hours and then paired for 5-10 hours followed by electrophysiological recording using the dual voltage clamp technique.  Initial experiments compared the relative junctional conductances in oocyte pairs expressing Cx43 (382 amino acid residues) and two truncated mutants lacking most or a portion of the cytoplasmic carboxyl terminal.  The shortest mutant (M241) contained 240 amino acid residues, was devoid of all phosphorylatable serine residues in the cytoplasmic tail, and its length approximated the length of liver Cx26.  The longest mutant (M257) tested contained 256 amino acid residues, including two serine residues. Oocyte pairs expressing M241 yielded a junctional conductance (Gj) similar to that of oocytes injected with dH20, whereas M257 yielded a Gj similar to that of oocytes injected with Cx43. Immunoprecipitation studies showed that Cx43, M257 and M241 proteins were readily detectable in oocytes injected with their respective mRNAs indicating that the lack of Gj observed with the M241 mRNA was not due to reduced translation.  Immuno-cytochemical studies revealed that wild-type and both truncated mutants were localized to the area of cell-cell contact between the paired oocytes indicating that protein targeting to the membrane was not inhibited in oocytes injected with M241 mRNA.  Oocyte pairs expressing mutants in which serine residues were replaced with non-phosphorylatable amino acids [serine codon #255 AGC was converted to GGC, glycine, designated as M255S÷G and serine codon #244 AGC was converted to GCC, alanine, designated as M244S÷A] showed Gj’s similar to M257 indicating that these serine residues, and by inference, their phosphorylation state, are not critical for expression of functional channels.  The importance of carboxyl terminus length was assessed by comparing the Gj’s in a series of mutants that were intermediate in length between M257 and M241.  Gradual shortening of the carboxyl terminus produced a gradual reduction of junctional conductance relative to M257.  However, simple deletion of amino acid residues 241 through 257 from the wild-type Cx43 did not affect Gj  relative to M257.  These data suggest that a critical length, and not phosphorylation, of carboxyl terminus is required for detectable expression of Cx43 channels in the Xenopus oocyte system.

 

RESPONSIBILITIES AND ACCOMPLISHMENTS WITH THE GOVERNMENTAL RELATIONS DIVISION OF THE AMERICAN VETERINARY MEDICAL ASSSOCIATION (AVMA)

Job Title:  Assistant Director/Acting Director

Dates of Employment:  01/1995 to 12/2002 (served as Acting Director from April-December 2002)

Employer’s Name and Address:  American Veterinary Medical Association, 1101 Vermont Ave., N.W., Washington, D.C. 20005-3521

The responsibilities of the Acting Director and Assistant Director positions of the American Veterinary Medical Association’s Governmental Relations Division included the following:

The Acting Director is responsible for directing and supervising the activities of the staff of the AVMA Governmental Relations Division (GRD) to ensure that all GRD operations comply with the objectives and mission of the AVMA as set by the AVMA Executive Board.  The Acting Director participates in the formation and execution of association policies, objectives, and programs as they relate to the association’s strategic plan; with particular emphasis on federal legislative and regulatory issues.  The Acting Director is responsible for the overall management of a staff of six (two Assistant Directors, Program Assistant/Office Manager, Policy and Program Specialist, PAC Coordinator, and a Secretary/Receptionist).  The Acting Director provides staff support to the Legislative Advisory Committee; attends all meetings of the Political Action Committee Policy Board;, the Executive Board and, as requested, the House Advisory Committee to provide these bodies with updated information of division activities.  The Acting Director ensures that lobbying reports and other reports of congressional contacts are prepared and submitted as required.  Other responsibilities include preparation of the GRD budget and overall accountability for the GRD office site, which includes collection of rents, approval of payments, and computation of local taxes.

The Assistant Director is responsible for identifying Congressional and regulatory issues that may impact on the profession as well as develop strategies for response to these issues.  Develop and foster relations with Members of Congress, their staff, key federal regulators, and commodity, producer, humane, and allied health organizations.  Communication with AVMA members on both an individual and group basis with respect to conveying an understanding of the legislative process and the impact made by political decisions.  Directly involved in developing and recommending policy positions and statements; designing budgets; and Congressional hearing preparation including witness selection and testimony writing.  Attend and participate in meetings, symposiums and forums related to the various issues being addressed by the GRD office.  Direct lobbying of Congress and development of coalitions to support the AVMA positions or initiatives.  Organize the annual Congressional Science Fellowship Orientation Programs and participate in the mentoring of the students participating in the AVMF-GRD Externship Program.  Supervise support staff; serve as support staff to the Legislative Advisory Committee; serve as liaison staff consultant for the Council on Research and the Animal Welfare Committee.  Attend political fund-raisers and events of the AVMA as needed.  Prepare and present slide/power point presentations for meetings, seminars, and conferences.  Travel as necessary to provide information through presentations, to AVMA members, universities and other interested groups on AVMA policies, positions, and issues.

My major accomplishments at the American Veterinary Medical Association’s Governmental Relations Division (AVMA-GRD) included the following:

The objective of the AVMA is to advance the science and art of veterinary medicine, including its relationship to public health, biological science and agriculture.  The AVMA provides a forum for the discussion of issues of importance to the veterinary professions and for development of official positions.  In this regard, I presented a testimony on behalf of the AVMA regarding the “National Senior Citizen Pet Ownership Protection Act” (H.R. 1619 - 105th Congress) at a Congressional Briefing and Press Conference held at the Rayburn House Office Building (March 21, 1996).  Its provisions allowed senior citizens in federally assisted rental properties to keep their pets, even if the property had rules against pet ownership.  The language from that bill was added to the 1998 Veterans Affairs and Housing and Urban Development Appropriations bill, which was enacted into law. I led the successful pursuit for legislative recognition and appropriations of the Food Animal Residue Avoidance Databank (FARAD) both in developing S.1153 and in having the this language inserted into S.1150, the Agriculture Research, Extension and Education Reauthorization Act of 1998 which was signed into law by President Clinton on June 23, 1998 (105th Congress).  I continued to take the lead in obtaining additional support for FARAD through the Animal Agriculture Coalition.  We successfully lobbied for the much needed appropriations for FARAD and by 2002 the appropriations for FARAD reached $1 million. 

In 1999 I spearheaded the development of the “Coalition for USDA-Animal and Plant Health Inspection Services (APHIS)-Animal Care Appropriations” because APHIS Animal Care had been level funded for the previous nine years at $9 million and it no longer had sufficient resources to conduct the necessary inspections and enforcement of the Animal Welfare Act.  The Coalition successfully obtained a $2 million increase in FY2000, another $3 million increase in FY2001; and finally an additional increase of $2 million for FY2002 bringing the total appropriations for APHIS –Animal Care to $16 million.  The success of this Coalition was based upon the fact that I had brought a very diverse group of associations together on a single issue.  In 1999 another very important Coalition was formed: the Minor Use and Minor Species (MUMS) Coalition.  The MUMS Coalition worked closely with FDA-CVM and members of Congress to develop the legislative language that would help make more medications legally available to veterinarians and animal owners to treat minor animal species and uncommon diseases in the major animal species.  The legislation was first introduced during the 106th Congress in 2000 but it was not until the 108th Congress that the MUMS Act of 2004 was officially passed and signed into law.  This piece of legislation was very unique in that I worked the issue with the AVMA from 1999-2002, establishing a wonderful rapport with key sponsors Senator Jeff Sessions and Representative Charles “Chip” Pickering and then I stepped into a government position with the FDA-CVM in 2002 and was able to join FDA Commissioner Dr. Mark McLellan and CVM Director, Dr. Stephen Sundlof in the final public outreach to help educate and confirm the authority FDA had over the MUMS legislation.  It was fabulous to see the bill reach final consensus in Congress in 2004 and be officially signed into law. 

I also had the honor of participating in the Animal Agriculture Coalition Task Force on Biocontainment that enabled me to visit in 1997, the Federal Laboratories for Health Canada and Canadian Food Inspection Agency in Winnipeg, Manitoba prior to their official opening of their new Biohazard Level 3 and 4 containment facilities; and also to visit in 1998, the USDA National Animal Disease Center at Plum Island, N.Y.  The purpose was to gather first hand information needed to heighten awareness of the need to either upgrade the facilities at Plum Island/or build new facilities on the mainland, for animal disease research and diagnostics.  On behalf of the AVMA I was a key player in the major push to alert Congress to the impact of agroterrorism and the critical need for improvements to the infrastructure of the facilities at the National Veterinary Services Laboratory in Ames, IA.  In 1999 I helped organize the GenCon Symposium on Food Security (Bioterrorism) and then in 2000 I participated in the National Symposium on Medical and Public Health Response to Bioterrorism.  I was involved in all of the meetings with Secretary Tom Ridge of the Department of Homeland Security when the discussions fell to animal agriculture and bioterrorism threats.  The accomplishment of all of these meetings was to raise the awareness to the need have veterinary medicine at the table and an awareness of just how severe the impact to the U.S. economy would be following a deliberate agroterrorism attack to animal agriculture.  Case in point: the devastation that would follow if there was intentional release of the Foot and Mouth Disease Virus in the U.S. Veterinarians are the first responders if and when a new emerging animal disease or biological threat to the animal agriculture industries should occur.

Another very special accomplishment that I attained during my eight years with AVMA was the opportunity to reach out and touch the lives of so many students through the mentoring programs of the AVMA-GRD Externship Program, as well as the AVMA Congressional Fellowship for graduate veterinarians.  I helped to broaden the perspective of the diversity of the veterinary profession in the eyes of the veterinary students that participated in the externship.  Many thought the veterinarian medical profession was a career in private practice and never realized the vast opportunities and need for veterinarians in non-private practice positions.  The Pew Health Professions Commission in Health America: Practitioners for 2005 stated: “There also is evidence that there is a potentially significant market for veterinarians and veterinary services, particularly in non-traditional and non-private practice arenas.”  By introducing the students to many veterinarians in positions within government I was able to have them return back to their universities with new outlook on the role of veterinary medicine in public health.

 

RESPONSIBILITIES WITH THE U.S.FOOD AND DRUG ADMINISTRATION’S CENTER FOR VETERINARY MEDICINE – OFFICE OF NEW ANIMAL DRUG EVALUATION (ONADE)

Job Title:  Senior Advisor for New Drugs/Veterinary Medical Officer [Deputy Director, ONADE]

Dates of Employment:  12/2002 to 08/2006

Address:  Department of Health and Human Services - Food and Drug Administration- Center for Veterinary Medicine, 7500 Standish Place, MPN-II, HFV-100, Rockville, MD 20855.

The responsibilities of the Deputy Director for the Office of New Animal Drug Evaluation included the following:

The Deputy Director position shares full responsibility with the Director in planning, managing, and directing all the regulatory review operations, program segment(s), functions, and activities of the Office of New Animal Drug Evaluation (ONADE).  Applies a knowledge of administrative and program management principles and skills to carrying out the mission of the office in association with the Office Director, as well as to addressing and solving unusual and often precedent setting problems associated with the Office regulatory review program segment(s). Seeks and develops the most cost effective and fiscally responsible methods to conduct this program segment(s) and to solve problems.  In consultation with the Office Director, the Deputy Director initiates decision-making processes and documents, and participates fully in discussions and decisions concerning Office plans, programs, and activities, both in strategic planning and in the actual determination, allocation, and administration of Office program segment(s), functions, and activities of the Office.  Participating fully with the Office Director, the Deputy Director develops and implements Office policies and plans, ands makes critical decisions and provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to Office goals and objectives and Federal budgetary and economic realities.  Continually evaluates budget, fiscal, and administrative controls to manage Office program segment(s) and services.  Develops and makes recommendations for the enhancement and improvement of the mission and functions of the Office.

The Deputy Director represents the Office in dealing and negotiating with individuals representing organizations such as the Congress and other Federal agencies, State, local and foreign governments, the regulated industry, professional and industry organizations and public interest groups.  Directs the preparation, clearance, and finalization of Office responses to inquiries covering all aspects of the program segments, functions, and activities of the Office.

The Deputy Director, sharing fully with the Office Director, directs the preparation of analyses of the impact of proposed changes to Agency laws and regulations which affect the functions, program segment(s), and activities of the Office.  Decides on changes and additions to the functions, program segment(s), and activities of the Office necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of Office functions, program segment(s), and activities.

The Deputy Director, participating fully with the Office Director, directs the implementation of new laws and regulations which impact on the mission of the Office.  This includes responsibility for the initiation and implementation of new policies, systems, procedures, and organizational structures.  The Deputy Director routinely meets with AVMA Congressional Fellows, AVMA Student Externs, and veterinary medical students from various Veterinary Medical Colleges to provide overviews of the FDA-Center for Veterinary Medicine, discuss career options, serve as a mentor, and help expand their network of contacts.

My major accomplishments as Deputy Director for the Office of New Animal Drug Evaluation (ONADE) at the Center for Veterinary Medicine-FDA included the following:

The Office of New Animal Drug Evaluation (ONADE) evaluates the safety and effectiveness of new animal drugs in pharmaceutical dosage forms or for use in animal feed, and the safety aspects of drug and food additive residues remaining in food produced for human consumption from animals, intentionally or otherwise, administered drugs or food additives.  My executive leadership efforts were focused on assisting and supporting the Director of ONADE in planning, managing, organizing and directing all of the regulatory review operations, program segments, function, and activities of the Office.  I have worked to assure that ONADE maintains full support of the President’s Management Agenda, the Agency’s and the Center’s Strategic Plan and the Center’s mission and goals through open communication and a two-way dialogue.  I have utilized my strengths in leadership and bringing people together to help the members of ONADE handle the many exciting changes that have taken place in ONADE.

The Animal Drug User Fee Act (ADUFA) was passed in 2003 as an amendment to the Federal Food, Drug and Cosmetic Act; authorizing FDA to collect fees for certain applications and establishments, products and sponsors of those applications in support of the review of animal drugs. These additional resources will support FDA's responsibilities under the Act to ensure that new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption.  ADUFA also contained key performance goals that ONADE must achieve by 2008.  Many dealt with a reduction in the new animal drug submission review times.  In order to help the reviewers meet these performance goals the increased resources provided by the ADUFA were used to hire many new reviewers which meant an increased need for orientation and training programs.  There were 120 people on staff in ONADE when I joined the team in 2002 and there were 184 people when I left ONADE in 2006.  I worked closely with the CVM Staff College to develop a number of seminar series that address cross cutting scientific issues of immediate relevance to the approval of safe and effective new animal drugs (CVM Emerging Technologies Series included, for example, Pharmacogenomics, Current Issues in Antimicrobial Use, and Process Analytical Technology).  From the many personal contacts I had developed during the years I had worked with the AVMA I was able to invite many outside speakers from universities, associations, and pharmaceutical companies to participate in the seminars.  I also encouraged many of the scientists within ONADE to give presentations thereby raising the visibility of their expertise amongst everyone at CVM.  I spearheaded the creation and development of a New Reviewer Orientation Training Program to help new employees gain an understanding of the review process and to achieve productivity in a relatively short period of time.  Further, I worked with a fabulous group of creative individuals from each of the Divisions within ONADE to develop an electronic ONADE Reviewer Reference Page (ORRP) on the FDA Intranet.  The ORRP enables reviewers to access pertinent pieces of information easily and rapidly from one site, similar to a one-stop shopping approach.  It has been most rewarding to provide the tools/resources necessary to enable them to develop subsets specific to their reviews that enhance the productivity simply by reducing the time it takes to search for a guidance or regulation.  The feedback from the reviewers at ONADE has been excellent and in fact the ORRP has served as a model for the FDA’s proposed centralized reviewer page.  CVM recognition awards were given for the development of the New Reviewer Orientation Training Program and for development of the ORRP.  ONADE surpassed our productivity measurements by exceeding all ADUFA goals for 2004 and 2005 which primarily required ONADE to conduct complete reviews of all sponsor submissions within ever shortening time frames.

I had the tremendous opportunity of participating in the Federal Executive Institutes’ Leadership for a Democratic Society program from July 25th to August 20th, 2004 in Charlottesville, VA.  This experience further broadened my perspective on the meaning of leadership.  Upon returning to the office I encouraged the development of monthly Leadership Forums to enhance our Team Leaders.  I shared a number of experiences and many of the educational materials received during the program with the members of ONADE.  I provided each Division with a copy of Dr. Warren Blank’s 108 Skills of Natural Born Leaders because it used day-to-day work experiences to correlate one’s development as a leaders and it provided tools for overcoming barriers to change in an organization.  It was an excellent stimulus for discussion within the Divisions and it encouraged people to share their ideas.

To help minimize any anxiety that may have confronted some of our employees I worked to establish Town-Hall meetings as a means to provide a conduit for people to ask questions, provide constructive criticisms and recommendations and to be reassured that we were behind them 100%.  Assessing customer satisfaction be it our employees or our stakeholders was critical.  The 360 Feedback Assessment was instituted within ONADE down to the Team Leader level, as one tool to measure employee satisfaction.  I was humbled by the incredibly high accolades that I received following my 360 Feedback Assessment.  In 2004 I worked with the Animal Health Institute (AHI) an organization which represents sponsors from approximately 80% of the approved animal drugs, as they developed a survey to assess their level of satisfaction with ONADE.  We received their customer satisfaction report and once again we were recognized with good to high scores.  All of these approaches are formulated in the High Performance Organization (HPO) learning model which is employed throughout the CVM.  Moreover I was instrumental in gaining buy-in by the reviewers to utilize a project management system for all of the non Submission Tracking And Reporting System (non-STARS) work.  This included goals, milestones, human resources and capital cost estimates.  CVM utilized “Back to Basics” strategic goals and one tool that was implemented at ONADE was activity Based Costing (ABC) practices that directly support these goals and performance plans.  In addition we implemented the Activity Time Reporting (ATR) which enabled us to better manage and assign the true costs of business processes, activities, services and products.  The open communication approach that I fostered helped all of our employees adopt these tools, become comfortable and skilled at using these tools to fine tune their work and the business of ONADE.

I participated with numerous interagency projects to help build relationships while ensuring that CVM’s interests were protected.  One very rewarding project was working with the Office of Personnel Management (OPM) Veterinary Medical Officer (VMO) Expert Panel when OMB was revising the VMO Classification Standards (701 Series) in 2004.  Each agency had a representative VMO and together we edited the various documents on file, provided examples of specific Knowledge, Skills and Aptitudes needed for various Position Descriptions for the diverse job opportunities that veterinarians hold within FDA, as well as examples of the requirements to be met for GS-12 through GS-15 ratings.  This project was successfully completed and approved in the spring of 2006.

As a member of the CVM Staff College Governing Board we strived to provide high quality training and career development opportunities to enable our employees to not only meet our organization’s mission but to advance their careers within FDA.  We engaged the University of Maryland to bring to our CVM Staff College a Masters Degree program such as a Masters of Public Health.  I worked closely with the faculty and the Dean Dr. Glenn Morris, to develop a course curriculum that was taught using both didactic classroom lectures and distance learning technologies.  This program, modeled after the highly successful Clinical Research Training Program established between NIH and Duke University, went live in the fall of 2006.

On the international level, I served as Executive Secretary to the Codex Alimentarius Committee on Residues of Veterinary Drugs in Food Animal (CCRVDF) organizing all meetings and position responses of the U.S. Delegation, and then participating in the 15th and 16th Sessions of the CCRVDF.  At that time, Dr. Steven Vaughn was the U.S. Delegate and Dr. Stephen Sundlof was the Chair of the CCRVDF.

All of the leadership strategies that I helped institute within ONADE embraced the HPO model and by developing the strategy, structure and systems to succeed, ONADE will continue to be a learning/self evaluating organization that sustains its reputation as a world class pre-market review organization that ensures safe and effective new animal drugs will meet the therapeutic and production needs of today as well as the future.

The crowning recognition that I received for my time spent with the dedicated members of ONADE was a plaque on which was inscribed: “In deep appreciation for your superior service through unrivaled kindness, compassion, and personal friendship for each member of ONADE.”

 

RESPONSIBILITIES AS DIRECTOR OF THE OFFICE OF MINOR USE AND MINOR SPECIES ANIMAL DRUG DEVELOPMENT and as DEPUTY DIRECTOR FOR THE CENTER FOR VETERINARY MEDICINE

Job Title:  Deputy Director for the Center for Veterinary Medicine and Director, Office of Minor Use and Minor Species Animal Drug Development

Dates of Employment:  08/2006 to 01/2008

Address:  Department of Health and Human Services - Food and Drug Administration- Center for Veterinary Medicine, 7519 Standish Place, MPN-IV, HFV-1, Rockville, MD 20855.

The Center for Veterinary Medicine (CVM) is responsible for regulating the manufacture and distribution of food additives and drugs that will be given to animals.  These include animals, from which human foods are derived, as well as food additives and drugs for pet (or companion) animals.  The position of Deputy Center Director is located in the office of the Center Director for CVM, and it provides scientific and regulatory expertise for regulatory surveillance and compliance activities and for approving and disapproving of animal drugs, feed additives and devices proposed for testing or marketing.  Additionally, the Deputy Director for CVM assists and supports the Director as an active partner in leading and managing the organization, particularly operational functions and staff performance.  The Deputy Director provides vision and creative leadership for CVM supervisors and employees to assure the smooth internal operation of the Center and all of its functions.

On the international level, I served as the Chair the Codex Alimentarius Committee on Residues of Veterinary Drugs in Food Animal (CCRVDF) for the 18th Session of the CCRVDF.

The Office of Minor Use and Minor Species (OMUMS) Animal Drug Development was established in November of 2004.  The MUMS Animal Health Act (MUMSAHA) became law in August 2004 and several elements became immediately effective on that date including the provisions for designation of MUMS drugs and for conditional approval of MUMS animal drugs. The Office makes “minor use” determinations for intended uses in major species (horses, cattle, pigs, dogs, cats, chickens, and turkeys). Minor use status makes a new animal drug intended for such use eligible for designation, for conditional approval, and for waivers from user fees.

The Office “designates” qualified new animal drugs for specific minor uses or for specific intended uses in minor species (all species that are not major species). The incentives for designated new animal drugs include grants to support MUMS drug approval or conditional approval and seven years of exclusive marketing rights after approval or conditional approval.

OMUMS is responsible for establishing and maintaining the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). Indexing is an alternative process to the FDA approval process to allow legal marketing of drugs for certain non-food minor species and non-food early life stages of food producing minor species.​

 

RESPONSIBILITIES AS DIRECTOR OF THE CENTER FOR VETERINARY MEDICINE, U.S. FOOD AND DRUG ADMINISTRATION

Job Title:  Director of the Center for Veterinary Medicine

Dates of Employment:  01//07/2008 to 03/31/2016

Employer’s Name and Address:  Department of Health and Human Services - Food and Drug Administration- Center for Veterinary Medicine, 7519 Standish Place, MPN-IV, HFV-1, Rockville, MD 20855.

The mission statement for FDA’s Center for Veterinary Medicine (CVM) reads: “Protecting Human and Animal Health.” To achieve this broad mission, CVM:

  • Makes sure an animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, and chickens. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals—meat, milk, and eggs—are safe for people to eat;
  • Monitors the safety and effectiveness of animal drugs on the market;
  • Makes sure food for animals—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled;
  • Makes sure a food additive for use in food for animals is safe and effective before approving it;
  • Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and
  • Helps make more animal drugs legally available for minor species, such as fish, hamsters, and parrots; and for minor (infrequent and limited) uses in a major species, such as cattle, turkeys, and dogs.

To that end, the functions of the Director of the Center for Veterinary Medicine are as follows:

  • Directs overall Center activities and coordinates and establishes Center policy in the areas of research, management, scientific evaluation, compliance, and surveillance.
  • Directs systems for planning, programming, and budgeting and provides administrative and information support for the Center.
  • Plans and coordinates the Center's Equal Employment Opportunity Program.
  • Approves New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs), and issues notices of withdrawal of new animal drug approvals when opportunities for hearings have been waived.
  • Authorizes, for use as edible products, animals treated with investigational drugs and terminates exemptions for investigational trials.
  • Approves the use of animal food additives.
  • Ensures that industry submitted NADAs for food-producing animals are reviewed and evaluated with respect to possible effects on human health. The Director also serves as the Center's representative and spokesperson concerning CVM activities. The Director's contacts include the general public, industry, other government agencies, and national and international organizations.
  • Through the CVM Ombudsman, investigates and seeks to resolve issues related to science and science-based policy decisions for products under the jurisdiction of CVM.                                                                                                                                                                                                

A few of the highlights accomplished during my position as Center Director of CVM are provided below: 

    It has been both an honor and a privilege to have served as the Director of the Center for Veterinary Medicine (CVM) for the past eight years.  I have had the opportunity to work with incredibly talented and dedicated colleagues that continue to bring their passion, their creativity, and their innovative thought processes to the many challenges that cross our desks every day.   They advance the science that is needed to achieve our mission, they pursue the scientific solutions to advance both human and animal health, and they nurture a culture of respect and caring that helps CVM continue to attract and retain the best of the best.   The entire life cycle of an animal drug is at the heart of CVM, as we conduct the preapproval review of a pharmaceutical sponsor’s animal drug application (both pioneer and generic) followed by the post approval monitoring once the drug is on the market and being utilized in clinical practice.   The successful attainment of three animal drug user fee authorizations (ADUFA: 2003-2008; 2008-2013; 2013-2018) and two generic animal drug use fee authorizations (AGDUFA: 2008-2013; 2013-2018) is a huge accomplishment for CVM.   We moved from paper applications to electronic submissions (e-Submitter) thereby streamlining the review process and reducing the overall review times.  On the post-approval side we saw the Adverse Event Reporting (ADEs) move from paper to an electronic format in 2014, thereby enhancing the review times and enabling regulatory action to be taken quicker. Under the regulatory enforcement arm a series of actions are available that can lead to frontline corrective actions via warning letters, inspections, recalls, injunctions, and seizures, as needed. 

    CVM developed the IVET (InnoVation Exploration Team) to address new ways of facilitating the review of innovative new animal drug products that draws on expertise across the Center, FDA, other federal agencies, the academic community, and the animal health industry.  Moreover we enhanced the integration of genomic and proteomic research tools to define new biological indicators “biomarkers” of disease in animals and for measuring responses to drug treatment.  The breakthrough accomplishments utilizing stem cell technologies in dogs, cats, and horses led to the publication of a Guidance for Industry #218 Cell-Based Products for Animal Use in 2015, where animal stem cell based products (ASCPs) means articles containing, consisting of, or derived from stem cells for use in animals.

    Starting in 2009 CVM took the lead for establishing the One Health Initiative for FDA and it was most rewarding to see then, FDA Commissioner Dr. M. Hamburg, attend and give a key note address at the One Health Colloquium held in London England (Dec. 2014). The one health concept is based on the recognition that human health, animal health and ecosystem health are inextricably linked.  One of the biggest steps forward CVM took under my leadership was to address antimicrobial drug resistance using a One Health approach.  Working with pharmaceutical companies, veterinarians and food animal producers we brought everyone to the table to embrace judicious use of medically important antibiotics in food producing animals and to agree that these products should be used for therapeutic purposes and not used for growth promotion or feed efficiency. Guidance for Industry #209, published in 2010, provided the framework for policy regarding the appropriate use of medically important antibiotics and the need to have these products issued under oversight by a veterinarian. The details of accomplishing the label changes and working with the pharmaceutical companies, was outlined in Guidance for Industry #213 which published in 2014.  The label changes and requirement for the medically important antibiotics to have oversight by a veterinarian, through a Veterinary Feed Directive (VFD), are scheduled to be completed by Dec. 2016.  Moreover, President Obama embraced the One Health initiative when he released his Executive Order 13676 (2014) and National Action Plan for Combating Antibiotic Resistant Bacteria (2015).  This is a tremendous step forward in having everyone execute stewardship of antimicrobials, be if for human health or animal health (food producing animals and companion animals). 

    The National Antimicrobial Resistance Monitoring System (NARMS) continues to expand and enhance its capabilities. Most recently the adoption of whole genome sequencing (WGS) has opened the door to vastly improve the microbiology and epidemiology of infectious diseases.   WGS will enhance outbreak investigations, attribution of resistant infections, and research on the evolution and spread of resistant bacteria in the food supply, among other things.  The NARMS partners at FDA, CDC and USDA are working together to incorporate WGS technology into NARMS.  NARMS played pivotal role in the 2011 multistate Salmonella Heidelberg outbreak investigation. Ground turkey was identified as the source of the outbreak as a result of routine testing via NARMS – the retail meats were collected and cultured for enteric bacteria; the genetic fingerprints of the Salmonella were uploaded into the CDC PulseNet database and they were found to match the outbreak strain causing the illnesses seen in patients.

    The safety of animal feeds and pet foods is monitored by CVM. The economically adulterated pet food incident with melamine, led to adoption of the Food Protection Plan in November 2007. This was followed by the FDA Amendments Act of 2007 that led to an early warning surveillance system to identify adulteration of the pet food supply and outbreaks of pet illnesses associated with consumption of adulterated pet food products.  A Reportable Pet Food Registry was developed along with an electronic Safety Reporting Portal that enables rapid and easy reporting of incidents. In 2011 the passage of the Food Safety Modernization Act took place which led to a shift from having regulators respond to contamination of the food (for humans and animals) supply to preventing it.  The four pillars are: (1) prevention; (2) responsibility and accountability through inspections; (3) compliance and quick response to outbreaks; and (4) import safety and enhanced partnerships.  A Risk-based decision-making inspection process in animal food facilities has been developed.  In 2010, a joint MOU was established between State veterinary diagnostic laboratories and FDA via the Veterinary Laboratory Investigation and Resource Network (Vet-LIRN) to help document, investigate and diagnose animal feed, pet food and animal-drug-related illnesses.

    The advancement of genomics and genetically engineered processes led CVM to create the Animal Biotechnology Interdisciplinary Group (ABIG) for the review of applications involving animals.  The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because an rDNA construct introduced into an animal to change its structure or function meets the definition of a drug.  In 2009, CVM working jointly with the Center for Biologics Evaluation and Research (CBER) approved first biological product produced by genetically engineered (GE) animals. The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency. ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries. GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.  Subsequently, in 2015 CVM and the Center for Food Safety and Applied Nutrition (CFSAN) approved the first GE food producing animal. FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely, safety and effectiveness. The data demonstrated that the inserted genes remained stable over several generations of fish; that food from the GE salmon is safe to eat by humans and animals; that the genetic engineering is safe for the fish; and the salmon meets the sponsor’s claim about faster growth.  Also in 2015, CVM approved an application for a recombinant DNA (rDNA) construct in chickens that are genetically engineered (GE) to produce a recombinant form of human lysosomal acid lipase (rhLAL) protein in their egg whites. The Center for Drug Evaluation and Research (CDER) approved the human therapeutic biologic (Kanuma), which is purified from those egg whites, based on its safety and efficacy in humans with LAL deficiency.  Kanuma (sebelipase alfa) is the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.

    The research arm of CVM plays a key role in addressing current and evolving regulatory issues related to the safety of animal-derives food and animal health products. Two examples are: To assist reviewers in their evaluation of stem cell products, a ground breaking study on defining markers of stemness in canine mesenchymal stem cell products from various tissue sources was conducted. The identification of five cell surface markers and twelve mRNA markers that describe canine adipose and bone marrow-derived mesenchymal stem cells was completed. CVM has developed molecular identification methods (DNA barcoding) for targeted species and to validate and transfer methods to FDA field laboratories thereby enhancing the detection of mislabeled products (e.g. labeling a product as containing material from one species when material from another species has been substituted).  

    Personalized medicine also exists for animals. By way of example, the MDR-1 gene encodes for P-glycoprotein (P-gp), a transmembrane efflux protein that affects the absorption, distribution and elimination of certain drugs.  A mutation in the MDR-1 gene is known to occur in several dog breeds (Collies and Collie-X breeds). Since P-gp is an important efflux transporter for a wide range of compounds, dogs homozygous recessive for the MDR-1 mutation may have altered pharmacokinetic and toxicity profiles for P-gp substrates including avermectins (heart worm preventive drugs). Most importantly, life threatening toxicity has been reported when certain P-gp substrates are administered to dogs that are known to be homozygous for the MDR-1 mutation. Initially only Collie were used to determine drug safety/toxicities of new avermectins.  Research conducted at CVM led to in vivo (knock-out mouse line) and in vitro systems to identify P-gp substrates. Now dogs can be screened for the MRD-1 P-gp mutation and if they test positive then an alternate heart worm medication can be given, thereby avoiding any possible life-threatening outcomes from administering an avermectin drug.

    The Minor Species and Minor Uses Animal Health Act of 2004 has provided innovative ways to bring products to market for these small populations of animals and has helped pharmaceutical companies overcome the financial roadblocks to bringing to market the limited-demand or more commonly referred to as  “orphan” animal drugs.  There are now 134 designated drugs (these drugs qualify for grants to support safety and effectiveness testing); 18 drugs on the index (drugs intended for use in species too rare or varied, e.g. zoo animals and wildlife, to be used in traditional safety and effectiveness studies); and two drugs that have gone from conditional approval (sponsor has completed safety data and then is allowed five years to collect effectiveness data) to full approval. We even approve drugs for honeybees!

    On the international front, in 2009 CVM was approved by the World Animal Health Organization (OIE) General Assembly to become one of its official Collaborating Centers.  This designation facilitates CVM’s ability to enhance animal drug and food safety around the world.  Focal Points lectures on strengthening veterinary regulatory infrastructures have been given in Botswana, Morocco, and Kenya.  Numerous workshops and seminars have been given in China, Thailand, Japan, Europe, Central and South America. CVM remains active with the Codex Alimentarius Committees, specifically the Codex Committee on Residues of Veterinary Drugs in Human Food (CCRVDF).  CVM is also involved with the International Cooperation on the Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) covering the standards and protocols for the studies that should be undertaken to demonstrate safety, efficacy and quality of veterinary medicinal products that are licensed or approved in the VICH regions (USA, Europe and Japan).  CVM participates in quarterly bilateral meetings with the European Medicines Agency and Canada’s Veterinary Drug Directorate to exchange information of regulatory and scientific issues of mutual concern to further collaboration and harmonization.

    The final area I want to highlight is related to the tremendous culture that has been nurtured over the years and embraced by all at CVM.  The culture we have developed is the “wind beneath our wings”!  The 2015 Federal Employee Viewpoint Survey once again showed that, overall, CVM scored higher than the Food and Drug Administration and Department of Health and Human Services, as well as Government-wide on all evaluation measures.  In general, The Center–wide results show that employees are willing to go above and beyond the call of duty to ensure that the mission, priorities, and goals of CVM are achieved.  I have nurtured a work culture, where employees' input is solicited by managers during decision-making processes that will impact work performed by those employees. Employees are viewed as an active and responsible member of the decision-making process within the Center.  To further illustrate this we developed the following leadership philosophy at CVM: We are dedicated, creative, trustworthy, competent individuals who want to do a good job.  We are motivated by a sense of duty to our mission and co-workers, and a desire for continual improvement in our organization’s performance.  Each of us assumes technical, management, and leadership responsibilities for our work.  We are committed to increasing the quality of our lives and believe that the performance of the organization is enhanced by investing in the growth and development of the individual.  We feel responsible for and dedicated to each other’s and CVM’s success.  We are committed to serving each other, our customers, and our stakeholders with fairness and respect.

    As the Chinese proverb says, "Every great journey begins with but a single step." The Center has embarked upon its journey to continual higher performance within the context of a positive, supportive, and caring work environment. As challenges and change mounts, we continue to exert our positive influence on the shared destiny of animals, humans and our environment.

RESEARCH: 
PRESENTATIONS

“Modification of the Inflammatory Response to Aspiration with Ibuprofen.”  Federation of American Society for Experimental Biology, New Orleans, LO.  April 20, 1982.

“Inhibition of Vascular Permeability Induced by A23187 Stimulated Polymorphonuclear Leukocytes (PMN).”  Federation of American Society for Experimental Biology.  Chicago, IL.  April 12, 1983.

“Stimulation of Endothelial Cell Thromboxane Production by Vasoactive Agents.”  Third International Symposium on the Biology of the Vascular Endothelial Cell.  Cambridge, MA.  June 26, 1984.

“Arachidonic Acid Metabolism and the Endothelial Cell.”  Department of Pathology, Cornell University, New York State College of Veterinary Medicine, Ithaca, N.Y.  June 20, 1989.

"Cardiopulmonary Microcirculation and Vascular Homeostasis.”  Department of Surgery, SUNY Health Science Center, Syracuse, NY.  May 31, 1989

“Eicosanoids: Physiological Actions and Regulations.” Department of Pharmacology, SUNY Health Science Center, Syracuse, NY.  April 6, 1989.

“Expression of Functional Cell-to-Cell Channels from Cloned Rat Heart Gap Junction cDNA.”  Department of Pharmacology, SUNY Health Science Center, Syracuse, NY.  April 12, 1990.

“Care and Treatment of Laboratory Animals in Research.”  College of Health Related Professions, Respiratory Care Program, SUNY Health Science Center, Syracuse, NY. October 10, 1990.

“Expression and Function of Cx43 Mutants.”  Department of Pharmacology, SUNY Health Science Center, Syracuse, NY May 23, 1991.

“Immunolocalization and Expression of Wild-type and Mutant Connexin43 cDNA.”  Department of Pharmacology, SUNY Health Science Center, Syracuse, NY.  November 14, 1991.

“Regulations, Care and Use of Laboratory Animals in Biomedical Research.”  American Heart Association (AHA), New York State Affiliate, Inc. Headquarters, Syracuse, NY (AHA Management Team for New York State followed by the AHA Board of Directors for New York State), April 13 and 29 (respectively), 1993.

“Care and Treatment of Laboratory Animals in Research.”  College of Health Related Professions, Respiratory Care Program, SUNY Health Science Center, Syracuse, NY. September 15, 1993.

Ethical Issues Concerning the Use of Animals in Biomedical Research.”  New York State College of Veterinary Medicine, Cornell University, Ithaca, NY. October 20, 1993.

Testimony on behalf of the AVMA: “National Senior Citizen Pet Ownership Protection Act - H.R.1619”  Congressional Briefing and Press Conference, Rayburn House Office Building, (105th Congress) Washington, D.C., March 21, 1996.

“The Impact of a Dynamic (Changing) Environment on Animal and Human Health. Hazards and Ecosystem Health.”  Public Health Medicine.  AVMA Annual Meeting, Louisville, KY., July 22, 1996.

“The Research Viewpoint.”  USDA/APHIS/Regulatory Animal Care (REAC) 30th Anniversary of the Animal Welfare Act (AWA) and 10th Anniversary of the Animal Welfare Information Center (AWIC). Sept. 12, 1996.

“Legislative Action on Behalf of the Food Animal Residue Avoidance Databank (FARAD).”  Livestock Conservation Institute’s Leadership Summit 1997. Washington, D.C. September 8, 1997.

“Discussion of Emergency Funding Options for the Food Animal Residue Avoidance Databank (FARAD).”  FARAD Workshop, USDA, Washington, D.C. September 11, 1997.

“Issues on the Hill.” United States Animal Health Association, Washington, D,C. February 23, 1998.

“Acclimation Certificates,” Transportation Breakout Session, Animal Care Public Meeting, USDA-APHIS-AC, Riverdale, MD.  May 12, 1998

“Coalition Building in Washington.” Fellowship in Science, Politics and Animal Health Policy, University of Maryland, Washington, D.C. May 15, 1998.

“Perspectives on Ensuring Safety of the National Food Supply”  Combined Conference on Food and Agriculture Security, Guarding Against Natural Threats and Terrorist Attacks Affecting Health, National Food Supplies, and Agricultural Economies. National Consortium for Genomic Resources Management and Services (GenCon), Washington, D.C. September 28-30, 1998.

“Legislative Action on Behalf of the Food Animal Residue Avoidance Databank (FARAD)”  Livestock Conservation Institute’s Leadership Summit 1998.  Washington, D.C. October 14-15, 1998.

“Veterinary Medicine: An Umbrella of Opportunities” College of Veterinary Medicine, University of Georgia. Athens, GA February 18, 1999.

“Veterinary Medicine: Career Perspective from Government/Corporate Opportunities” Pre-veterinary students at the University of Maryland, Dr. W. Hueston’s Advisory Class, College Park, MD April 7, 1999.

“Bioterrorism and Food Safety” National Food Safety and Toxicology Center, Michigan State University, Lansing, MI April 30, 1999.

“Animal Health Research Program” USDA-Agricultural Research Service, National Program Planning Workshop, College Park, MD September 28-29, 1999.

 “Research Priorities” USDA-National Research Initiative/Cooperative State Research, Education and Extension, Washington, D.C. December 7-8, 1999.

“Players, Process, Politics and Possibilities” A legislative seminar for the AVMA Executive Board, Washington, D.C. April 9-11, 2000

“Consensus Building in Policy Making: What’s the Role of Science?”  VA-MD Regional College of Veterinary Medicine, Student Summer Externship Program, Washington, D.C. July 7-8, 2000.

Presentation to the Science, Politics and Animal Health Policy Fellowship participants-VA-MD Regional College of Veterinary Medicine, on Capitol Hill, Washington, D.C. October 5, 2000.

Representative for the AVMA at the Award Ceremonies commemorating Dr. John Richardson and his work during his tenure with the Centers for Disease Control, Washington, D.C., October 23, 2000.

Invited Lecture: National Policy Issues Related to Veterinary Medicine to the 2nd year students at VA-MD Regional College of Veterinary Medicine, Ballston, VA, November 13, 2000

Presentation to the Food and Agriculture Crises and Enhancing Cooperative Readiness Conference, USDA-National Animal Health Emergency Management Systems (NAHEMS), Washington, D.C., December 01, 2000.

Invited Lecture: Veterinary Medicine - An Umbrella of Opportunities to the 2nd year students at College of Veterinary Medicine, University of Georgia, Athens, GA, January 17-18, 2001

Presentation to the USDA-APHIS-Animal Care Basic Training Program participants – AVMA-GRD and the Power of Coalitions, Riverdale, MD, January 15, 2001.

Presentation to the United States Animal Health Association - Governmental Relations Committee Meeting, Washington, D.C., February 12-13, 2001.

Invited Lecture to the Public Veterinary Practice Club, “Government-Corporate Opportunities in Veterinary Medicine”, VA-MD Regional College of Veterinary Medicine, Blacksburg, VA, April 9-10, 2001

Invited Chair at the Preparing the Veterinary Profession for Corporate and Trade Issues in the Americas symposium, Santiago, Chile, May 5-10, 2001

Invited Speaker at the Foot and Mouth Disease Conference hosted by the American Meat Institute, Washington, D.C., June 14, 2001

Invited Lecture:  The Political Side of Veterinary Medicine Inside the Beltway to the 3rd year students VA-MD Regional College of Veterinary Medicine, Ballston, VA, September 14, 2001.

Invited Lecture: Veterinary Medicine – An Umbrella of Opportunities to the Undergraduates at Notre Dame College, Baltimore, MD October 11, 2001

Invited Speaker: Overview of the Minor Use and Minor Species (MUMS) Animal Health Act of 2003.  American Academy of Veterinary Pharmacology and Therapeutics, Charlotte, NC  June 3, 2003.

Invited Speaker: Veterinary Medicine: An Umbrella of Opportunities, D.C. Academy, Arlington, VA June 5, 2003.

Invited Speaker: U.S. Food and Drug Administration’s Center for Veterinary Medicine Update, American Zoo and Aquarium Association Legislative Conference, Washington, D.C. May 10, 2004.

Invited Speaker:  An Introduction to the Center for Veterinary Medicine. Maryland Veterinary Medical Association.  Timonium, MD November 10, 2004.

Invited Lecture:  Veterinary Medicine: An Umbrella of Opportunities in the Public Health Arena, 2005 SCAVMA Symposium, Texas A&M University, College Station, TX  March 11-12, 2005.

Invited Lecture: Veterinary Public Policy, VMRCVM, Blacksburg, VA November 7, 2005.

Invited Speaker: Veterinary Medicine: An Umbrella of Opportunities in the Public Health Arena​ SCAVMA (Dwayne Blackeney), VMRCVM, Blacksburg, VA November 7, 2005.

Invited Lecture: Veterinary Medicine: An Umbrella of Opportunities in the Public Health Arena, The College of Veterinary Medicine, Washington, State University, Pullman, WA  February 7, 2006.

Invited Lecture: Opportunities for Veterinarians with the FDA-CVM, Public Practice Career Symposium 2006 SAVMA Convention, Minneapolis, MN March 10, 2006.

Invited Lecture: A Career in Public Practice: The Doors it Can Open - Opportunities for Veterinarians within the U.S. Food and Drug Administration, 2007 SAVMA Convention, Raleigh, NC, March 17, 2007.

Invited Speaker: CVM Update, FDA-AAFCO Annual Briefing and Planning Conference, Rockville, MD, October 22, 2007

Invited Speaker:  CVM Update, FDA Field Committee Meeting, Rockville, Maryland, February 5, 2008.

Invited Speaker: Key Issues at CVM, National Association of State Departments of Agriculture Midwinter Meeting, February 9, 2008, Washington, DC

Invited lecture: CVM’s Food Protection and Import Safety Role, Embassy Briefing, Washington, D.C., February 28, 2008.

Invited Speaker: CVM Update, Food and Drug Law Institute, 51st Annual Conference, Washington, D.C., March 27, 2008.

Invited Speaker: CVM Update, National Cattleman’s Beef Association Spring Meeting, Washington, D.C., April 2, 2008.

Invited Speaker: CVM Update, AFIA Board of Directors Meeting, May 20th, 2008, Washington, D.C.

Invited Speaker: Partnerships Contribute to Food and Feed Safety, National Renderers Association 75th Annual Convention, Laguna Niguel, California, October 23rd, 2008

Invited Speaker:  AAFCO and CVM A Partnership for Feed and Food Safety. AAFCO, FDA Planning Meeting, Rockville, Maryland, October 27, 2008

Invited Speaker: Overview of Current CVM Issues, Animal Health Institute’s Regulator Day, Arlington, Virginia November 12, 2008

Invited Speaker: Sustaining the Momentum of Change, Animal Health Corridor Advisory Board, Kansas City, Missouri, March 19, 2009.

Invited Speaker: CVM Highlights, Priorities, CVM Field Committee, Gaithersburg, Maryland, April 7, 2009

Invited Speaker:  2009 CVM Update, Federation of Animal Science Societies, Washington, D.C., May 4, 2009.

Invited Speaker: CVM 2009 Update, National Cattlemen’s Beef Association. Washington, D.C. September 15, 2009.

Invited Speaker: CVM Update, National Cattlemen’s Beef Association/Cattle Health and Well Being Committee, San Antonio, Texas, January 29, 2010.

Invited Speaker: CVM Update, 2010 Legislative Conference, National Cattlemen’s Beef Association, Washington, D.C., September 15, 2010.

Invited Speaker: Updates on FDA Antibiotics Policy. Animal Health and Food Security Policy Committee Meeting, National Pork Producers Council. Washington D.C., January 10, 2011.

Invited Speaker: Updates from the Center for Veterinary Medicine, 2011 PDA/FDA Joint Regulatory Conference, Washington, D.C., September 21, 2011.

Invited Speaker: Updates from the Center for Veterinary Medicine, Food, Drug and Law Institute’s Annual Conference, Washington, D.C., April 5, 2011.

Invited Speaker:  2012 Updates from CVM ORA Joint CVM Field and Field Food Committee’s Annual Conference Wiley Auditorium, CFSAN, College, Park, MD, March 13, 2012

Invited Speaker: Updates from the Center for Veterinary Medicine, Food, Drug and Law Institute’s 55th Annual Conference, Washington, D.C., April 24, 2012.

Invited Speaker: Updates from the Center for Veterinary Medicine, American Association of Feed Control Officials, Rockville, MD, October 16, 2012.

Invited Speaker: Updates from the Center for Veterinary Medicine, Animal Health Institute’s Regulator Day, Alexandria, VA, October 23, 2012.

Invited Speaker: Updates from the Center for Veterinary Medicine, American Society of Animal Science, Rockville, MD, November 16, 2012.

Invited Speaker: FDA Antibiotic Update, National Turkey Federation’s Annual Convention. San Diego, CA  February 14, 2013.

Invited Speaker:  FDA Antibiotic Update, American Farm Bureau Federation’s Commodity Advisory Committee, Washington, D.C., February 22, 2013.

Invited Speaker: Updates from the Center for Veterinary Medicine, 2013 PDA/FDA Joint Regulatory Conference, Washington, D.C.  September 18, 2013.

Invited Speaker: The Food Safety Modernization Act, Highlights Related to Animal Production, National Institute for Animal Agriculture, Annual Conference, Louisville, KY, April 16, 2013.

Invited Speaker: CVM Updates, Animal Health Institute Regulator Day, Washington, D.C., February 4, 2014.

Invited Speaker: One Health in Veterinary Medical Education, Highlights from FDA’s Center for Veterinary Medicine, Association of American Veterinary Medical Colleges, Alexandria, VA,  March 14, 2014.

Invited Speaker: Status of New FDA Guidelines Affecting Antibiotic Use in Food-Producing Animals, Midwest Poultry Federation Convention, St. Paul, Minnesota, March 20, 2014.

Invited Speaker: Center for Veterinary Medicine Updates, Food, Drug and Law Institute Annual Conference, Washington, D.C.,  April 23, 2014.

Invited Speaker: Updates from the Center for Veterinary Medicine, 2011 PDA/FDA Joint Regulatory Conference, Washington, D.C.,  September 10, 2014.

Invited Speaker: Center for Veterinary Medicine Updates, Food, Drug and Law Institute Annual Conference, Washington, D.C.,  April 20, 2015.

Invited Speaker:  President’s National Action Plan for Combating Antibiotic-Resistant Bacteria, Science Board to the FDA, Silver Spring, MD. July 29, 2015.

Invited Participant: President’s National Action Plan for Combating Antibiotic-Resistant Bacteria - White House Forum on Antibiotic Stewardship. White House, Washington, D.C.  June 2, 2015.

Invited Speaker:  Cancer in Pets, Sirrius XM Radio “Doctor Radio” Show with Dr. Frank Adams, November 3, 2015.

Invited Speaker: Center for Veterinary Medicine Updates, Animal Health Regulator Day, Rockville, MD November 18, 2015.

Invited Speaker: Key note Address- Farm Foundation’s National Summit Antimicrobial Stewardship: Policy, Education and Economics. Washington, D.C.  January 20, 2016. 

Invited Speaker: One Health and Antibiotic Resistance, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Hubert H. Humphrey Bldg, Washington, D.C. March 31, 2016.

Invited Speaker: Library of Congress – One Health presentation – webcast, Washington, D.C. May 18, 2016. https://blogs.loc.gov/inside_adams/2016/05/one-health-lecture-may-18-dr-bernadette-dunham/

Invited Speaker: “One Health a Reality - Crossing Bureaucratic Boundaries" Summer Institute "Issues & Trends in Regulatory Science" School of Medicine and Health Sciences - The George Washington University, July 14, 2016.

Invited Speaker:  One Health – In Silico Modeling webinar for One Health Day event, Controlled Release Society, Webinar, July 15, 2016.

Invited Speaker:  One Health lecture at Department of Microbiology and Immunology, Georgetown School of Medicine, 301 Med-Den building, 3900 Reservoir Rd, NW, Washington, D.C.  Nov. 2, 2016

Invited Speaker:  National Institute for Animal Agriculture (NIAA) 2016 Antibiotic Symposium – Working Together for Better Solutions. Herndon, VA Nov. 3, 2016. http://www.swinecast.com/dr-bernadette-dunham-building-a-coalition-one-health-approach-preserving-antibiotic-effectiveness

Invited Speaker:  One Health event “Antimicrobial Resistance”, Milken Institute School of Health, George Washington University, Nov. 3, 2016.

Invited Speaker: Craniomaxillofacial Disorders and Solutions in Man and Animals, UCLA Luskin Conf. Center, Los Angeles, CA.  Nov. 12-13, 2016.

Invited Speaker: One Health-Engaging in a Multidisciplinary Approach.  One Health Academy, Washington, D.C. Dec. 8, 2016.

Invited Speaker:  Prep Lecture for the American College of Preventive Medicine (ACVPM) exam – Overview of FDA - webinar. Feb. 24, 2017.

Invited Speaker: One Health – Linking Human, Animal and Ecosystem Health. Ravenwood Media. March 7, 2017. https://www.youtube.com/watch?v=2pyLm2j3jxI&feature=youtu.be

Invited Speaker:  The Missouri Valley Parenteral Drug Association (PDA) – One Health. Kansas City, MO April 17, 2017.

Invited Speaker: “An Overview of One Health Activities” 20th Biennial of the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT), Potomac, MD., May 22, 2017.

Invited Speaker: “Making One Health a Reality - Crossing Bureaucratic Boundaries" Regulatory Science Summer Institute, Issues & Trends in Regulatory Science, School of Medicine and Health Sciences - The George Washington University, Washington, D.C., May 24, 2017.

Invited Speaker: One Health-Engaging in a Multidisciplinary Approach.  Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, D.C. September 22, 2017.

Invited Speaker:  One Health and Antimicrobial Resistance. Annual Center for Animal and Human Health Meeting, Lincoln Memorial University, Lexington, KY. October 4-5, 2017.

Invited Speaker:  One Health-Engaging in a Multidisciplinary Approach.  Environmental Health Policy, Georgetown University, Washington, D.C., October 18, 2017.

Invited Chair: Operationalizing One Health:  Observe, Analyse, Communicate,  Group on  Earth Observations (GEO) IV Plenary, Washington, D.C., October 23, 2017.

Invited Speaker: One Health-Engaging in a Multidisciplinary Approach. Department of Microbiology, Georgetown University, Washington, D.C., November 14, 2017.

Invited Speaker:  One Health-Engaging in a Multidisciplinary Approach, The Franklin-Littleton-York Distinguished Lecture, Auburn University, February 6, 2018.

Invited Speaker:  One Health, Biostatistics Center, George Washington University, Rockville, MD April 5, 2018.

Invited Speaker:  Keynote address on One Health, Biotechnology Innovation Organization (BIO) International,  Boston, MA, June 4, 2018.

Invited Speaker: One Health, NASA-Global Precipitation Measurement Workshop on Vector and Water Borne Disease, Wilson Center, Washington, D.C. May 17, 2018.

Invited Participant: Antimicrobial Resistance, National Institute of Food and Agriculture, Waterfront Center, Washington, D.C. August 15, 2018.

Invited Speaker: “Making One Health a Reality - Crossing Bureaucratic Boundaries" Regulatory Science Summer Institute, Issues & Trends in Regulatory Science, School of Medicine and Health Sciences - The George Washington University, Washington, D.C., August 23, 2018.

Invited Chair:  One Health in the Appalachia Region:  Multiple Domains oh Health, 2018 Appalachia One Health Leadership Experience, Lincoln Memorial University, Harrogate, TN, September 14-15, 2018.

Invited Speaker:  One Health-Engaging in a Multidisciplinary Approach.  Environmental Health Policy, MICB 589 Course, Georgetown University, Washington, D.C., September 20, 2018.

Invited Participant: Workshop on Global Health Security, Rand Corporation, Crystal City, VA, October 17, 2018.

Invited Speaker:  One Health Day – Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, MD, November 2, 2018.

 
PUBLICATIONS: 

Chapman, H. and Dunham, B. Engaging with One Health Audiences. The Clinical Teacher. (Manuscript ID: TCT-2019-0201.R1  Accepted for publication July 2019).

Dunham, B. and Kaplan, B.  Advancing Legislation on ‘One Health’ in the United States of America. One Health Newsletter, Volume 11, Issue 1, January 2019,  (http://www.vet.k-state.edu/OneHealth/Vol11-Iss1/advancing_legislation.html

Martinez M, Antonovic L., Dunham B, Fahmy R, Gilbert J, Hungerford L., Modric, S., Papich M., Smith M., Yan S.S. Veterinary Pharmaceuticals: Factors Influencing their Development and Use.  In: Encyclopedia of Pharmaceutical Technology, 1 (1).  Taylor and Francis Group, Boca Raton, FLA. (2011).

Martinez M., Berson, M., Dunham, B., Gotthardt, J., and Hungerford, L.  Regulatory Chapter for Veterinary Pharmacology and Therapeutics, In Veterinary Pharmacology and Therapeutics, 9th Edition, J. Riviere and M. Papich, Editors, Blackwell Publishing. (2009).

Martinez MN, Berson M., Dunham B, Gotthardt J, and Hungerford L. The Drug Approval Process.  In: Veterinary Pharmacology and Therapeutics, MPapich and JERiviere (eds), Wiley- Blackwell, Ames IA. pp. 1365-1406 (2007).

Martinez M, Clark J, Dunham B, Hunter RP, Langston C, Lucas A, Jordan D.   American academy of veterinary pharmacology and therapeutics 14th biennial symposium. J Vet Pharmacol Ther., 28:495-498. (2005).

Dunham, B.  Food/Agricultural Biosecurity: The Need to Protect One of Our Critical Infrastructures.  Agro Washington, Vol. 2, No. 4: 33-35 (2002).

Patil, V.U., C.R. Fairbrother, and B.M. Dunham. Use of the Laryngeal Mask Airway for Emergency or Elective Airway Management Situations in Pigs.  Contemporary Topics. Vol. 36, No.6: 47-49 (1997).

Dunham, B.  AVMA roundtable elicits discussion on variety of issues. Journal of the American Veterinary Medical Association.  Vol. 209 (3): 524 (1966).

Dunham, B.  TSE Control Approaches Scrutinized at Symposium. Journal of the American Veterinary Medical Association  Vol. 209 (1): 21-25 (1996).

Dunham, B. “BSE: Does the U.S. Need to be Concerned?”  In:  DQA Quest, Vol. 3, No. 1, pg. 8 (1996).

Raef, T.A., and B. Dunham.  Flexible labeling, streamlined drug approval advocated at workshop.  From the April 17-18, 1995 Professional Flexible Labeling Interactive Workshop on 1st Principles.  Journal of the American Veterinary Medical Association Vol. 207 (1): 7-9 (1995).

Hile-Fallico, D., C. Fairbrother, V.U. Patil, A.S. Tute and B.M. Dunham. Use of the Esophageal-Tracheal Combitube for Emergency Airway Management in Pigs.  Lab Animal. 24 (10): 23-34 (1995).

Fairbrother, C.R., D. Hile-Fallico, V.U.Patil and B. Dunham.  Two-Part Intubation Catheter: A Guide to Endotracheal Intubation in Pigs.  Contemporary Topics in Laboratory Animal Science.  31(3): 91-93 (1995).

Anumonwo, J., H.-Z. Wang, E. Trabka-Janik, B. Dunham, R. Veenstra, M. Delmar and J. Jalife. Gap Junctional Channels in Adult Mammalian Sinus Nodal Cells: Immunolocalization and Electrophysiology. Circulation Research 1 (2): 229-239 (1992).

Dunham, B., S. Liu, S. Taffet, E. Trabka-Janik, M. Delmar, R. Petryshyn, S. Zheng, R. Perzova and M. Vallano. Immunolocalization and expression of functional and non-functional cell-to-cell channels from wild-type and mutant rat connexin43 cDNA. Circulation Research. 70 (6): 1233-1243 (1992).

Dunham, B.M., W.I. Anderson, H. Steinberg and J.M. King.  Renal dysplasia with multiple concurrent urogenital and large intestinal anomalies in a Holstein-Friesian calf.  Veterinary Pathology. 26: 94-96 (l989).

Anderson, W., B.M. Dunham, J.M. King and D.W. Scott. Presumptive Subcutaneous Surgical Transplantation of a Urinary Bladder Transitional Cell Carcinoma in a Dog.  Cornell Vet. 79: 263-266 (1989).

Chung-Welch, N., Shepro, D., Dunham, B. and Hechtman, H.B.  Prostacyclin and prostaglandin E2 secretions by bovine pulmonary microvessel endothelial cells are altered by changes in culture conditions.  Journal of Cellular Physiology 135:  224-234 (1988).

Shepro, D. and B.M. Dunham.  Physiology of the vessel wall.  In:  Hemostasis and Thrombosis: Basic Principles and Clinical Practice.  Eds.:  Colman, R.W., J. Hirsh, V.J. Marder and E.W.  Salzman.  J.P. Lippincott Co., Philadelphia, PA, 2nd edition, pp. 781-792 (1987).

Shepro, D. and B. Dunham.  Endothelial cell metabolism of biogenic amines.  Annual Review of Physiology  48:335-345 (1986).

Garay, R., P. Hannaert, F. Rodrigue, M.O. Longchamps, J.C. Feray, C. Rosati, B. Dunham, C. Nazaret, M. Cantin, J. Genest, P. Meyer and P. Braquet.  Involvement of cytosolic free calcium in the action mechanism of atrial natriuretic factor (ANF).  Regulatory Peptides (11) Suppl. 4:  97-101 (1985).

Dunham, B.M., H.B. Hechtman, C.R. Valeri and D. Shepro.  Antiinflammatory agents inhibit microvascular permeability induced by leukotrienes and by stimulated human neutrophils. Microcirculation, Endothelium and Lymphatics 1:  465-489 (1984).

Dunham, B.M., D. Shepro and H.B. Hechtman.  Leukotriene induction of TXB2 by cultured bovine aortic endothelial cells.  Inflammation 8 (3):  313-321 (1984).

Mathieson, M.A., B.M. Dunham, W.V. Huval, S. Lelcuk, L.I. Stemp, C.R. Valeri, D. Shepro and H.B.Hechtman. Limb ischemia stimulated thromboxane production and myocardial depression.  Surgery, Gynecology and Obstetrics 157:  500-504 (1983).

Huval, W.V., B.M. Dunham, S. Lelcuk, C.R. Valeri, L.I. Stemp and H.B. Hechtman.  Thromboxane mediation of cardiovascular dysfunction following aspiration.  Surgery 94 (2): 259-266 (1983).

Huval, W.V., M.A. Mathieson, L.I. Stemp, B.M. Dunham, A.G. Jones, D. Shepro and H.B. Hechtman. Therapeutic benefits of 5-hydroxytryptamine inhibition following pulmonary embolism.  Annals of Surgery 197 (2):  220-225 (1983).

Utsunomiya, T., M.M. Krausz, B. Dunham, C.R. Valeri, L. Levine, D. Shepro and H.B. Hechtman.  Modification of inflammatory response to aspiration with ibuprofen.  Journal of Physiology (Heart and Circulatory Physiology) 12: H903-H910 (1982).

Krausz, M.M., T. Utsunomiya, B. Dunham, C.R. Valeri, D. Shepro and H.B. Hechtman.  Inhibition of permeability edema with imidazole.  Surgery 92 (2):  299-308 (1982).

Utsunomiya, T., M.M. Krausz, B. Dunham, D. Shepro and H.B. Hechtman.  Depression of myocardial ATPase activity by plasma obtained during positive end-expiratory pressure.  Surgery 91:  (3):  322-328 (1982).

Utsunomiya, T., M.M. Krausz, B. Dunham, L. Levine, D. Shepro and H.B. Hechtman.  Circulating negative inotropic agent(s) following pulmonary embolism.  Surgery 91 (4):  402-408 (1982).

Krausz, M.M., T. Utsunomiya, L.L. Levine, B. Dunham, D. Shepro and H.B. Hechtman.  Adverse effects of prostacyclin used to perfuse isolated lung lobes.  American Journal of Physiology (Heart and Circulatory Physiology) 11:  H745-H750 (1982).

Utsunomiya, T., M.M. Krausz, B. Dunham, J.A. Mannick, P.D. Allen, D. Shepro and H.B. Hechtman.  Maintenance of cardiodynamics with aspirin during abdominal aortic aneurysmectomy (AAA).  Annals of Surgery l94 (5):  602-608 (1981).

Valli, V.E., B.J. McSherry, B.M. Dunham, R.M. Jacobs and J.H. Lumsden.  Histocytology of lymphoid tumors in the dog, cat and cow.  Veterinary Pathology 18:  494-512 (1981).

Dunham, B.M., G.A. Grindlinger, T. Utsunomiya, M.M, Krausz, H.B. Hechtman and D. Shepro.  Role of prostaglandins in positive end-expiratory pressure induced negative inotropism.  American Journal Physiology 241 (Heart and Circulatory Physiology) 10:  H783-H788 (1981).

Grindlinger, G.A., J. Manny, R.E. Justice, B. Dunham, D. Shepro and H.B. Hechtman.  Presence of negative inotropic agents in canine plasma during PEEP.  Circulation Research 45:  460-467 (1979).