A Day in the Life
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Office: Office of New Animal Drug Evaluation
Division: Division of Therapeutic Drugs for Food Animals
In my current position, I review therapeutic drugs for food animals for safety and effectiveness prior to their approval and release on the market. More specifically I work with dewormers and physiologic drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and reproductive drugs. I look at studies that drug companies have conducted in order to prove their products are safe and effective. I review blood work, necropsies, and study procedures. I work with drug companies to develop study protocols and to help them understand our regulatory framework. Although entirely different from my position as a veterinarian within a practice, I love this job.
This position allows me to combine the veterinary knowledge I gained in school with the practical experience I gained in the field and collaborate with not only my federal colleagues, but also scientific experts in various fields. Scientific discussions revolving around the methodology of a new diagnostic test or the most recent paper on an infectious livestock disease are frequent occurrences within my office that have challenged me to apply my knowledge and experience to the task at hand.
Outside of my regulatory review duties, I have been fortunate in this position to take part in spearheading a new initiative focused on educating the public about antiparasitic resistance in grazing livestock. This opportunity has truly been my pride and joy on which to work, granting me leadership and public speaking skills that I would not have been able to accomplish otherwise.
The thought of contributing to something as part of a far bigger whole is exciting to me and one major reason I was originally drawn to CVM. The longer I am here, the more opportunities to professionally excel reveal themselves, which I believe is a great strength of the Center’s. The perception of a public servant in the face of today’s growing agricultural challenges is humbling and inspirational to me and ultimately why my tenure here at CVM has been so enriching and continues to grow.
Office: Office of Research
Division: Applied Veterinary Research (DAVR)
Education: M.S., Bioinformatics
Born and raised in Baltimore, I’ve known since kindergarten that I wanted to be a researcher. I learned of a fellowship position available at CVM’s Office of Research (OR) at a time when I desired more opportunities for growth and training than were available to me. It sounded like an opportunity to expand my skill set and learn about non-academic research environments, so I felt that it would be a great move. A former classmate had gone through a fellowship at OR and spoke highly of the experience, noting the research, environment, and the staff as high points. I initially joined OR as an ORISE fellow in 2010 and was converted to Staff Fellow in 2013.
My duties include performing basic research as a member of the Molecular Biology Team, with my current research projects focusing on veterinary stem cell characterization and related questions; service on various Office and Center-wide committees relating to training and education of staff, and occasionally hosting student interns from around the country.
My favorite project so far has been the effort to find characterization criteria for canine mesenchymal stem cells. Veterinary stem cells are a growing area of interest that is unfortunately lagging far behind developments on the human side. Working in this novel area allowed me to interact more with personnel at other parts of CVM, other FDA Centers, and outside of FDA. I got to be a part of laying the foundational understanding of a new research program area and expand the techniques our office is able to use. This project further highlighted some of the strengths of our Team/Office in that we were able to adapt and grow to meet the needs of the questions being asked, as well as learn from and communicate with a host of collaborators concurrently.
One of the benefits that I think many CVMers enjoy is the opportunity to use skills in areas outside of regular duties. The opportunity to go on details and learn within a different structure, gain training and attend meetings, and have support in career development from managers are a few of the benefits of working here.
Office: Office of New Animal Drug Evaluation
Division: Division of Scientific Support
Education: Ph.D., Statistics
About 10 years ago, I joined CVM as a statistical reviewer in the Division of Scientific Support. I collaborated with veterinary reviewers and other scientists to evaluate animal drug approval applications. I worked with veterinary reviewers to evaluate whether the design, observations, and statistical analysis of a study proposed by a drug sponsor will likely generate quality data appropriate to the drug claim being tested. Additionally, when a sponsor submits the report from a study conducted to support effectiveness or safety, I provide the statistical expertise to evaluate the quality of the data generated from the study, and whether the data supports the approval. Today, using the knowledge and experience I gained, I mentor new reviewers and help develop a working environment that fosters collaboration among scientists from different disciplines in order to develop drug review processes that are efficient, adhere to scientific principles, and are responsive to the needs of the American public.
CVM is a great place to work for me for several reasons.
First, I like applying statistics to real world problems. A CVM statistician works daily on issues that directly impact the safety and effectiveness of drugs on the animals that need them and the safety of humans that may consume dairy, meat, and other animal products.
Second, the diversity, dedication, and creativity of the professionals working for animal drug regulation make CVM a challenging and fulfilling place to practice my profession. On any given day, I can be in discussions with veterinary medical officers, management specialists, policy advisors, molecular biologists, or even fellow statisticians.
Third, CVM is an organization that nurtures creativity and innovation. Each person has the opportunity to participate in improving review science, the center’s business processes, and office policy; and contributions are recognized and rewarded. Management creates and maintains a work environment that fosters work-life balance through flexible working hours, teleworking, and other office policies that allow employees flexibility to schedule work and personal commitments around each other.
Office: Office of New Animal Drug Evaluation
Division: Division of Human Food Safety
Team: Residue Chemistry Team
Education: Ph.D., Endocrinology and Animal Biosciences
I began at CVM immediately after obtaining my doctorate degree in Endocrinology and Animal Biosciences. I knew that I did not want a position in academia. However, a government position had never crossed my mind until I received an email from a member of my graduate committee passing along a job posting at CVM. Although I was not offered that initial position, my CV was passed along and here I am – a biologist on the Residue Chemistry Team in the Division of Human Food Safety. As a member of the Residue Chemistry Team, I:
- evaluate drug residues in the edible products of treated food animals and recommend tolerances and withdrawal periods and/or milk discard times;
- discuss residue chemistry data requirements with a diverse customer base;
- facilitate U.S.A. approval of safe and effective new animal drug products for use in food-producing animals; and
- interface with scientific regulatory counterparts to ensure continuous improvement in worldwide human food safety practices.
Although review work is the main part of my job, I have been involved in various projects updating federal regulations and exploring the feasibility of pursuing other statutory revisions, consistent with the Agency’s mission to protect and promote the public health. Such projects have helped me to expand my statutory writing skills and provide me with a broader network of colleagues within CVM. In addition, I am an invited speaker at the Office of Regulatory Affairs (ORA) tissue residue and nonclinical Good Laboratory Practices (GLP) training courses for FDA inspectors, where I am responsible for presenting an overview of human food safety information. These courses allow me to get back to my roots of teaching and interact with the inspectors in the field who have a different perspective of the drug approval process than those of us working at the Center level.
CVM has many attractive qualities and strengths that have made it easy for me to stay. One of the main attractants was the work-life balance. Having just finished a PhD program, spending 16+ hours in the lab a day, being able to have a flexible schedule and work from home was a definite plus. As an added bonus, the ability to interact with other scientists, veterinarians, policymakers, members of industry, etc., on a daily basis has helped to keep me abreast of the new science and policy. I am using my graduate training in a way that I never thought possible; combining my joy of science and critical thinking with my passion for writing. One would think that, as a reviewer, the job would become monotonous; however, that is not the case. No two submissions are alike and each presents their own challenges; not to mention the additional side projects with which we are tasked.
Office: Office of the Center Director
Team: International Affairs Team
The best career advice I have ever heard is, “Find out what you want to do in your life and then find a way for someone to pay you to do it.” I would amend that slightly by adding, “And, make sure that what you choose to do is of benefit to others.”
My position with CVM has allowed me to live this advice. I have a position that is personally rewarding and fulfilling and it makes a difference in people's lives. The work we do as part of CVM’s International Affairs Team, allows us to advance a “One Health” approach that promotes the health of humans, animals, and the environment that we all share. It makes no difference if you live in a highly developed country like the US or in a developing country, we all need access to safe and nutritious food and can benefit from the positive effects of the human-animal bond that we enjoy with companion animals.
As a young girl growing up in Mississippi, I initially wanted to follow in my mother's footsteps and become a teacher. As I became older, and likely because I grew up on a working cattle farm, my interest pivoted to veterinary medicine. However, even as a veterinary student, I knew that the traditional route of clinical practice was not for me. I wanted to have a more broad impact. I was introduced to the concept of public practice by an energetic and passionate visiting USDA veterinarian during a Public Health class. When he spoke of a “herd”, he was often speaking of all the animals in an entire country or region; and he spoke of how the decisions that he and his staff made frequently impacted not just one animal or farm, but potentially thousands of farms, or even millions of animals, and improved the socio-economic status of populations of people. I was fascinated – and hooked!
My current position with CVM has allowed me to combine my initial desire to teach with my degree in veterinary medicine. I have had the enormous privilege and awesome responsibility to travel the world on behalf of the FDA on numerous capacity building assignments. I help to develop and I participate in seminars, workshops, and conferences that provide the most current information on key issues such as antimicrobial resistance, quality and good governance of veterinary medicines, and international harmonization of standards for product registration. Providing this information is important because safe and effective veterinary medicinal products improve the health and welfare of animals which, in turn, helps to ensure food safety and food security for humans. And the effects are felt worldwide.
Finally, through CVM’s visiting veterinary student program, I have had the opportunity to mentor and give career advice to dozens of veterinary students who also want to pursue non-traditional careers in public practice. I assure them that they too will be “real vets” who will find a place where they can grow and be impactful. Quite recently, a colleague of mine referred to one of these students as my “protégé”. I couldn’t help but smile as I sensed a true “full circle” moment from my youth when I was looking into the future for a fulfilling career - that would make a real difference in people’s lives.