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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM’s New Deputy Director Brings Diverse, Far-Reaching Experience to Job

by Vashti Klein, Management Analyst, Communications Staff
FDA Veterinarian Newsletter 2007 Volume XXII, No IV

Dr. Bernadette Dunham, appointed as Deputy Director of the Food and Drug Administration’s Center for Veterinary Medicine earlier this year, brings to the post a perspective gained from wide experience in veterinary and human medicine.

Dr. Dunham received her Doctor of Veterinary Medicine degree from the Ontario Veterinary College, University of Guelph, Ontario, Canada. Her career began in Ontario, where she was in private practice, treating primarily companion animals, including some equine.

She later acquired a Ph.D. in cardiovascular physiology from Boston University and worked as a biomedical researcher at both Boston University and Harvard Medical School studying the microvascular vasoactivity and vasotoxicity of arachidonic acid products that underlie inflammation as well as intervention by various non-steroidal anti-inflammatory drugs.

Later, at the State University of New York Health Science Center at Syracuse, NY, she served as an Adjunct Professor in the Department of Pharmacology, concurrent with being Director of Laboratory Animal Medicine. There the research focus was on the molecular regulation of cardiac gap junction proteins and intercellular communication.

In 1995, she joined the American Veterinary Medical Association’s (AVMA’s) Governmental Relations Division in Washington, DC, where she had the opportunity to work with members of Congress and their staff regarding legislation impacting human and animal health.

She came to CVM in 2002 as Deputy Director of CVM’s Office of New Animal Drug Evaluation (ONADE). In 2006, Dr. Dunham was appointed Director of CVM’s Office of Minor Use and Minor Species (OMUMS) Animal Drug Development. In February 2007, she was appointed CVM Deputy Director.

Based on her years of experience inside and outside of government, Dr. Dunham is able to say that CVM is a great place for veterinarians and other scientists to work. “It is like being in a mini-university, because of the extensive diversity that we have in scientific expertise, i.e., veterinary medicine, microbiology, toxicology, animal science, pharmacology, pathology, law, chemistry, molecular biology, physiology, aquaculture, mathematical statistics, policy and regulation, public health, business, and education—all within CVM,” she said.

Tying into CVM’s mission

At each step of her career, Dr. Dunham’s goal has been to improve and enhance animal and human health. Her vast experience in veterinary and human medicine serves as the foundation for her work as Deputy Director of CVM.

“My background in human and animal medicine ties into CVM’s mission, which is to protect public and animal health,” Dr. Dunham said in a recent interview. She pointed out the link between human and animal research that she found was evident when she was involved in human biomedical research. “The information gleaned from laboratory animal studies leads to advances not only in human medicine, but it is frequently added to the body of medical knowledge about animal health. Many times the medicines are the same for both animals and humans,” she added.

Because of the combined human and animal benefit she saw in the research she was doing, Dr. Dunham strongly endorses the concept behind the “One Health” initiative. Under that initiative, the American Medical Association (AMA) and AVMA are forging a partnership between the worlds of human and animal medicine. “I deeply subscribe to the sentiments of the One Health initiative,” Dr. Dunham said. (See the following article, “Dr. Dunham Supports AVMA/AMA ‘One Health’ Initiative.”)

What you know, who you know

Her varied background has helped her in other ways, Dr. Dunham said. “The vast network and friendships that I have built up over the years have helped me at CVM. My contacts with people from various associations, members of Congress and their staff, and my university colleagues have assisted with a number of issues being addressed at CVM.”

Knowing more than just the scientific issues has helped Dr. Dunham in other ways, too. “Even though CVM is a science-based and science-led organization that has a tremendous caliber of scientific expertise,” she said, “other issues come into play. Science alone does not always decide the regulatory policy under which we operate, because there is always a degree of inherent uncertainty that can be challenged.”

“My experiences with the AVMA’s Governmental Relations Division, where I was involved with numerous coalition groups that helped develop and influence various pieces of legislation that Congress addressed, helped me appreciate the importance of society’s role in developing policy,” she said.

Key skills beyond those of a scientific nature for Dr. Dunham are people skills, and she acquired many of them as a practicing veterinarian. “In veterinary medicine, you learn the science of medicine, but you cannot treat a single pet in your hospital without the owner’s consent. Developing good people skills helps in the communication outreach. Clients will better understand the need for a specific medical treatment or procedure for their pets and will make an informed decision. I have always been a strong advocate of encouraging clients to ask questions to ensure they understand the specific disease their pet may be afflicted with or side effects of a medication to watch for, and the need to stay in touch with their veterinarian,” Dr. Dunham said.

Mentoring

Though Dr. Dunham’s efforts in ONADE were focused on assisting and supporting ONADE Director Dr. Steven Vaughn in planning, managing, organizing, and directing all of the regulatory review operations, program segments, functions, and activities of the Office, she also served as a mentor to the staff in the organization.

Mentoring is an important aspect of CVM’s management philosophy—“High Performance Organization,” or HPO. An organization such as CVM uses HPO as a lens through which to see what is happening within it and what needs to happen to improve its performance.

Dr. Dunham describes a good mentor as someone who has the ability to listen to people and understand them. “Mentors must be interested in learning about their employees, understanding their skills and interests, and then must take the time to help the employees identify gaps. A mentor also includes their mentee in networking opportunities, which is very important,” she added.

“Some mentors use individual development plans (IDPs), which they create alongside their employees. There are different models of IDPs from which to choose, and they can be structured according to an individual’s or organization’s needs. For example, it can be something as simple as taking the time to look at someone’s educational background and their career goals and making recommendations for further study to improve their skills. A mentor can also help the mentee become more visible in an organization,” she said.

In ONADE, Dr. Dunham was known for devoting the time it takes to recognize people’s skills and talents, and she took time to provide the staff with opportunities to grow. She is known for having provided the ONADE staff with encouragement, support, and appreciation for the work done. She also has the ability to listen to opposing points of view and to incorporate the best ideas into a solution.

Dr. Dunham attributes her mentoring and many of her people skills to the fact that during her career she was able to work with individuals that she considered to be remarkable mentors and role models. She was able to take the skills and lessons learned from those experiences and share them with others at CVM, she said.

“My parents were fabulous mentors, and I had wonderful mentors in my high school teachers and my university professors. It is through my mentors’ encouragement that doors have opened for me. The mentors were also role models, as I learned how their careers evolved and what they did to achieve their career goals.” Dr. Dunham said.

When she left ONADE to become Director of the OMUMS, the ONADE staff recognized Dr. Dunham for her mentoring skills. They provided her with a special award that reads, “In deep appreciation for your superior service through unrivaled kindness, compassion, and personal friendship for each member of ONADE.”

OMUMS

While taking on the duties as Deputy Director of the Center, Dr. Dunham continues as Director of OMUMS, a job she willingly kept because of the importance she sees in increasing the supply of safe and approved drugs for minor uses and minor species. (Minor species are all animal species other than cattle, swine, chickens, turkeys, horses, cats, and dogs, which are considered the major species. Minor use is the use of a drug in a major species to treat a rare disease.)

“There will never be enough FDA approved drugs for all of the animal species and their specific diseases or ailments, due to the economics of drug development. This situation is especially true for minor species, where the numbers of animals are often small and the return on investment is low. We are hopeful that some of the incentives afforded through the MUMS Animal Health Act (passed in 2004) will encourage pharmaceutical companies to develop some of the needed medications for minor species or for minor uses in major species.” Dr. Dunham said.

OMUMS was established in November of 2004. “Its development involved a lot of hard work by a coalition of stakeholders, CVM, and Congress,” she said.

Under the careful direction of Dr. Andrew Beaulieu, the former OMUMS Director, and Dr. Margaret Oeller, a Veterinary Medical Officer who conducts most of the OMUMS day-to-day activities, many provisions of the MUMS Act have been implemented. “Dr. Beaulieu and Dr. Oeller have been the backbone of the OMUMS and now we are all looking forward to building the office up over the next few years,” Dr. Dunham said.

Dr. Dunham said there was a need for the MUMS Act to change the Federal Food, Drug, and Cosmetic Act (FFDCA), thus creating a pathway that would help make drugs for either a minor use or minor species economically viable.

“It is very frustrating for you as a veterinarian not to have a safe and effective product in your armamentarium of therapies to reach for to treat the vast array of minor species that come to your clinic, or that you travel to treat on farms. And there are exotic species of animals that are in zoos and aquariums that require treatment. Even though the Animal Medicinal Drug Use Clarification Act of 1994 enables legal extralabel drug use by veterinarians, it is preferable to have an approved drug for a specific species, for a specific indication, and with a known dosage range that is safe and effective. MUMS makes that possible,” Dr. Dunham said.

As Director of OMUMS, Dr. Dunham is responsible for developing regulations to implement the MUMS Act, according to the schedule described in the law, and publishing MUMS drug designations on the MUMS Web page.

The MUMS Act modifies provisions of the FFDCA in three ways: designation, indexing, and conditional approval. The implementing regulation for drug designation was the first to be developed by the new Office, with a proposed regulation issued on September 27, 2005, and a final regulation issued on July 26, 2007. The proposed regulation for the indexing provisions of the law was issued on August 22, 2006, and will become effective upon publication of final implementing regulation. The proposed regulation for conditional approval is under development.

Dr. Dunham is a strong advocate of MUMS. She was involved at the beginning and now is involved during implementation. She was working for AVMA’s Governmental Relations Division when the Minor Use and Minor Species (MUMS) Coalition was formed in 1999. The MUMS Coalition worked closely with CVM and members of Congress to develop the MUMS Act. When Dr. Dunham joined CVM in 2002, she was involved in the final public outreach to help educate stakeholders about the MUMS legislation.

Goals at CVM

When asked during the interview what she would like to accomplish during her tenure at CVM, Dr. Dunham replied, succinctly:

  • “Successful implementation of all of the regulations developed under the MUMS Act; completion of the guidances for each of the regulations; a fully funded and staffed OMUMS, complete with an operational grants program; and many new approved products on the market for minor uses and minor species.”
  • “Heightened awareness of CVM as a terrific place to pursue a career, as evidenced by our ability to attract and keep highly talented individuals.”
  • “Enhanced communication and collaboration among the CVM offices.”
  • “A communication and outreach program with our stakeholders and the general public; and improved awareness, understanding and support of CVM by the general public.” (See next page: “Dr. Dunham Stresses Importance of Communications for CVM”)
  • “Expanded involvement for CVM in new technologies, for example, cloning; genetically engineered animals; pharmacogenomics, microarrays, nanotechnology.”
  • “Finally, to know that, as Deputy Director, I am able to assist Dr. Sundlof with his vision for CVM and to make his job easier wherever possible.”

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Dr. Bernadette Dunham, who earlier this year was appointed Deputy Director, CVM, brings to that post a background in veterinary and human medicine.