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  1. Science & Research

How Our Research Gets Done

It takes a team with diverse expertise to meet our mission.

A boy feeds a cat by hand
A table placed outside with a pitcher and glass on it, both full of milk. In the distance are rolling hills with cows.
A woman wearing veterinary scrubs petting a horse.

Our research focuses on things that directly impact your life and the animals in your life.

  • We work to assure that the food your pets eat is safe.
  • We work to assure that food from animals is safe to eat.
  • We work to assure that the medicines given to animals are safe and effective.

Curious to know how we do that?

Important Questions Motivate our Work

Every day, we are asked questions that support important regulatory decisions about animal food and drugs.

This graphic shows five cartoon dialogue boxes, each containing one question. The five questions are: Can we trust that any lab in our national network will deliver accurate results? Is there a rapid, reliable, and portable way to test for bacteria in food? Can we trust the result of a new method for testing milk quality? Is there a way to satisfy regulatory standards without testing in animals? Can we trust this new method for measuring a new drug in an animal?

Answering these questions requires quality data.

It’s our job to collect the data needed to answer important questions like these.

It takes a diverse team with different strengths to get answers to these questions.

  • Our scientists develop tests to detect contaminants in milk and other animal products.
    They write study protocols and conduct experiments to gather and analyze data.
  • Our administrative support team makes sure needed resources are available to conduct experiments and coordinate testing.
  • Our facilities management staff make sure that laboratories are safely equipped for research.
  • Our quality assurance specialists make sure experiments are conducted in accordance with all regulations.
  • Our project managers keep folks on track, meeting their goals.    
  • Our veterinarians and animal caretakers take excellent care of all our animals.
  • Our leadership makes sure we are focusing on what matters to the health of people and animals across the United States.

Meet Our Staff

Here’s a snapshot of staff members describing their roles and responsibilities in the Office of Applied Science. This small subset of our entire team of scientists, administrators, and leadership is intended to provide a glimpse of the multidisciplinary teamwork responsible for our success.

Regina Tan, Director of the Office of Research

Regina, Director of the Office of Applied Science

We have very important work at the Office of Applied Science (OAS), supporting FDA’s mission to protect the nation’s public health. Because we are in the Center for Veterinary Medicine, it’s our privilege to work keeping the nation’s animals safe. When you go to the veterinarian, the medicine that veterinarian gives to dogs, cats, horses, fish, cows, etc. needs to be safe. We also run monitoring and investigation programs like Vet-LIRN and NARMS. Unsafe pet foods can make animals sick, and their people too. Veterinary drugs given to large animals can end up in grocery stores for people to eat.

At the Office of Applied Science, we have a community of people who all work together for the same goal: keeping American people and pets safe. 

Nicole Lopez

Nicole, Project Manager

My work supports research at the Office of Applied Science by assisting each Principal Investigator (“PI”) with planning their studies. The PI and I have different responsibilities for the study but work in tandem to make sure the study goals and objectives are met. I create and manage the schedule, manage risk and issues, and report status to upper management via an executive report. I also develop tools or revise existing tools to support research during the study. And ensure the administrative aspects of the study are managed.

Cong Li, Microbiologist

Cong, Microbiologist

Over the course of my career, I have used instruments from each generation of DNA sequencing technology. I have witnessed the revolutionary change of how we use whole genome sequencing data in public health. I am extremely proud of having been an active member in this field and provide my technical skills on both the laboratory and bioinformatics fronts. I am also grateful for being offered the front-line opportunity. I look forward to continuing to contribute to the Office of Applied Science with my knowledge in the future.

Sarah Nemser, Consumer Safety Officer

Sarah, Consumer Safety Officer

Vet-LIRN Program Office works with network laboratories to develop methods that support our case investigations. To find any toxicant or contaminant we must have a method in place that works with the specific matrix and a lot of times veterinary diagnostic matrices are difficult to work with. In those cases, we do end up in the laboratory at the Office of Applied Science to prepare samples for method evaluation for the laboratories. The laboratories receive blinded samples to evaluate, and we review the results together to make sure methods are working and can even improve detection of the toxicant. This work also supports collaboration amongst the network laboratories because methods may be evaluated at multiple laboratories to support capacity building for emergency response. Once a method is established it can be rolled out to the entire network as part our of Proficiency Exercise Program.

Cynthia Smith, Quality Assurance Specialist

Cynthia, Quality Assurance Specialist

As a Quality Assurance Professional, what comes to mind is our Mission – Protect Human and Animal Health. Data generated from research projects needs to have accuracy and integrity. If data are compromised, the regulatory agency is unable to make sound reliable regulatory decisions, subsequently compromising the Agency’s ability to protect Human and Animal Health.

The Quality Assurance Specialists support research by monitoring facilities, equipment records, personnel, procedures, and research projects and reviewing protocols, study forms, study data, study procedures and study final reports for conformance with applicable regulations, standards, and other quality guidelines. All this is made possible by providing on-going guidance, data sharing, communication, and collaboration across the Agency.

Eric Evans, Facility Manager

Eric, Facility Manager

As Facility Manager, I am the principal liaison between Office of Applied Science (OAS) management, scientific, and administrative staff, and the various contract entities that enable OAS to function day-to-day; these include Operations & Maintenance, Custodial, Landscaping, Waste Removal, and Security. I routinely communicate with contract personnel to plan and coordinate services, prepare for outages or interruptions, and address any deficiencies in service. These vital services allow the office to carry out its mission by providing the infrastructure and utilities, as well as the associated support services, needed for a large research facility to operate.

Angela Shade, Program Support Specialist

Angela, Program Analyst

My job is similar to the stage crew for a live production. While public focus may be on the researcher and the outcomes of that research, administrative staff ensure that staff have what they need to get the work done and provide guidance on rules and regulations that do not directly affect research. 

One of the most important things that the Business Management and Operations Branch is responsible for is budget forecasting and execution. On a small scale, it involves processing supply requests and timekeeping. On a larger scale it involves anticipating retirements, onboarding, overtime and awards. Coming in under budget can allow for funding of capital purchases that advance research. Exceeding the budget can result cutbacks or halting research. 

Another aspect of my job is being the softer side of human resources. Starting a new job is stressful. Onboarding during a global pandemic adds a whole new dimension. Programs such as Paid Parental Leave are awesome benefits but come with lots of forms and regulations. How can I not mention all the acronyms like LES, SCD, and WFH/WAH? I am the voice that says, “Yes, it seems as clear as mud, but I can help you figure it out.”

Robin Wilson, Management Officer

Robin, Management Officer

As the Management Officer for the Office of Applied Science, I work with senior management in development and implantation of programs, policies, standards, procedures, and guidelines. These are necessary to keep the high standards of excellence we have for our research and our researchers.

As the Management Officer for the Office of Applied Science, I work with Office of Management staff to ensure funds are planned and executed for the upcoming years.  I also work with them to plan ahead for increases in the number of staff.  I directly support our public health staff with procurement for their research studies.

Kithsiri Herath

Kithsiri, Research Chemist

I am Principal Investigator, research chemist in the Division of Residue Chemistry (DRC) in Office of Applied Science. 

Recently, I have developed and validated a high-resolution mass spectrometric method for the quantitation and confirmation of 30-veterinary drug residues in raw milk. FDA needs to determine their residue concentrations in raw milk to see whether their concentration exceeds the established tolerances. This will enable regulatory decision-making on veterinary drug residues in raw milk to help keep the nation’s milk supply safe for human consumption. 

I also have conducted method validations as part of the New Animal Drug Application (NADA) packages. Our laboratory is the only government participant in these method validation trials. We conduct method trials to determine whether the drug sponsor’s analytical method meets the performance criteria. Successful validation will allow the agency to monitor potentially harmful residues in cattle tissues and thereby ensure human food safety of cattle products.
 

 
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