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 apella, Saimiri sciureus.  Old World: Macaca fasicularis; Macaca mulatta; Macaca nemistrina), cats, dogs, sheep, swine, rabbits, ferrets, guinea pigs, hamsters, gerbils, mice, rats, chickens, quail, amphibians (Xenopus laevis, Rana pipiens, Rana 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 M255^S÷G and serine codon #244 AGC was converted to GCC, alanine, designated as M244^S÷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 106^th Congress in 2000 but it was not until the 108^th 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 25^th to August 20^th, 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 15^th and 16^th 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 18^th 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.