CVM Organizational Structure • Office of the Center Director

– Director: Steven Solomon, DVM, MPH – Deputy Director: Tracey Forfa, JD – Deputy Director, Science Policy: William Flynn, DVM, MS

• Office of Management – Director: Roxanne Schweitzer – Deputy Director: Lynnette Riggio

• Office of New Animal Drug Evaluation – Director: Matt Lucia, DVM – Deputy Director: Elizabeth A. Luddy, DVM

• Office of Surveillance and Compliance – Director: Tim Schell, PhD – Deputy Director: Martine Hartogensis, DVM

• Office of Research – Director: Vacant – Deputy Director: Mary E. Allen, PhD

• Office of Minor Use Minor Species Animal Drug Development – Director: Margaret Oeller, DVM

Mission “Protecting Human and Animal Health”

Center for Veterinary Medicine Office of Research

[Vacant] Director

Mary E. Allen, MS, PhD Deputy Director

CVM’s Office of Research (OR) • >165 acres

• 8401 Muirkirk Road

• About 85 staff

• Large-animal housing and surgery suites

• Specialized laboratories

• Aquaculture

• Pastures

• Feed mixing facility

• Quarantine facility

OR’s Mission Protecting human and animal health byproviding meaningful research to support regulatory decision making about food, feed,and drugs.

OR’s Vision We are the leader among internationallyrecognized research programs ensuring the safety of feed, animal derived food, and animal health products.

Part 1What Makes CVM/OR Unique?

• OR scientists provide critical research to support regulatory actions that are protective of human and animal health.

• Capability to study large animals: – cattle, swine and aquaculture food fish

• Understand animal drug and feed industries • Leverage partnerships:

– federal agencies – regulated industry – universities

• Investigate questions that may: – lack grant funding – may not be particularly publishable

Part 2What Makes CVM/OR Unique?

• Work closely with review scientists to – conduct timely studies – answer critical questions to facilitate reviews

• Investigate antimicrobial resistance • Detect contaminants (drugs, chemicals and microbiological) in

– animal feeds – tissues from food producing animals

• Wide breadth of research genome > cell > organ systems > whole animal

• Fully AAALAC accredited • Conduct GLP studies

OR Subject Expertise

• Animal/Dairy/Food Science • Biology/Microbiology/Molecular Biology • Chemistry/ Biochemistry • Epidemiology • Immunology • Pathology • Pharmacology • Stem Cell Biology • Toxicology • Veterinary Medicine

Office of Research • Division of Residue Chemistry

• Dr. Phil Kijak, Director

• Division of Applied Veterinary Research• Dr. Raoul Gonzales, Director

• Division of Animal and Food Microbiology• Dr. Maureen Davidson, Director

• NARMS • Dr. Patrick McDermott, Director • Dr. Heather Green Tate,

Coordinator

• Vet-LIRN • Dr. Renate Reimschuessel,

Director

NARMS Objectives

1. Monitor trends in antimicrobial resistance among foodbornebacteria from humans, retail meats, and animals

2. Disseminate timely information on antimicrobial resistance to promote interventions that reduce resistance amongfoodborne bacteria

3. Conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance

4. Assist the FDA in making decisions related to the approval of safe and effective antimicrobial drugs for animals

Structure of NARMS-2017 • Campylobacter and Salmonella isolates obtained from the

human population by physicians are submitted to local and state labs, and then to the CDC.

• Campylobacter, Salmonella, Enterococcus, and E. coli isolates obtained in 14 states through random stratified sampling and ORA imported foods of retail meats including beef, pork,chicken, and turkey are sent by state labs to the FDA.

• Campylobacter, Salmonella, Enterococcus, and E. coli isolates obtained from HACCP and from random cecal sampling ofslaughtered chickens, turkeys, pigs, and cattle are sent to theUSDA’s Eastern FSIS Laboratory.

• NARMS integrates all of the data into an annual report.

Division of Animal and Food Microbiology

• AMR mechanisms and • evolution • Microbiology • NARMS routine testing • AMR, feed, veterinary pathogens

• Plasmid sequencing • Contamination and AMR in Feeds • Whole genome sequencing • Metagenomics • Bioinformatics

Division of Residue Chemistry

• NADA method trials • Milk projects • Detection of mycotoxins in animal feed • Antibiotics in distiller’s grains • Hormones in animal muscle

Division of Applied Veterinary Research

Stem cell research Milk and meat safety Biomarker research

Aquaculture research GE animals Antimicrobial resistance

Aquaculture Research

Our Fish • Hybrid tilapia • Rainbow trout • Atlantic salmon • Channel catfish • Goldfish • Yellow perch

Research areas • Develop Methods – Antimicrobial

Susceptibility Testing (AST) • Develop and validate methods to

detect fish drugs and chemicals • Develop fish disease models • Phish Pharm database

Veterinary Laboratory Investigation and Response Network (Vet-LIRN)

To promote human and animal health by collaborating with veterinary diagnostic laboratories to provide scientific information, to build laboratory capacity for routine and emergency response and to train scientists to investigate issues with CVM regulated products.

• 2010 – Concept 2017 – Network of 40 laboratories

• Confidentiality agreements Grants/Contracts

• Collaborate with other networks

• Activities: Proficiency Testing Method Development Grants Emergency Response Exercises AMR surveillance Investigate Consumer Complaint Cases

Developed mechanisms for conducting investigations

Including Jerky Pet Treat Cases and Raw Foods Product testing Fanconi testing Necropsy examinations

VET-LIRN CASE INVESTIGATIONS • Report received and reviewed by CVM • Forward to Vet-LIRN for further action • Vet-LIRN – contacts owner/vet for in-depth feeding history and

medical records • Vet-LIRN – requests additional tests (blood, urine, necropsy) • Vet-LIRN – arranges shipping of samples to network lab(s) • Lab(s) – test diagnostic samples – report to Vet-LIRN • Vet-LIRN – reports diagnostic results to vet – to share with

owner • Food testing – decision often based on diagnostic test

outcomes – Always hold product