Kelly MS Hugunin

Division Special Assistant for Signal Detection and Management with 10 years of experience in pharmacovigilance at FDA-CVM. As subject matter expert on disproportionality analysis, integrated data mining into FDA-CVM's adverse drug event review processes, enabling improved safety review for all regulated veterinary products without increased resources. Consistently demonstrate expertise in identifying, investigating, and communicating emerging safety issues to internal colleagues and external stakeholders, including industry and other regulatory agencies, both foreign and domestic. Provide valuable guidance and coaching to safety reviewers on signal detection and risk communication. Nine years serving as the agency expert on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) Subcommittee focusing on enhancements which improve signal detection. Previous experience in generic animal drug approvals at the FDA, comparative animal medicine at the NIH and academia, epidemiology, and biostatistics.

American College of Laboratory Animal Medicine 2010 – retired 2017

North Carolina Veterinary Medical Board

2005

FDA Group Recognition Award (Non-agency Crosscutting)    2023

OSC’s Office Quality Committee

CVM Excellence in Veterinary Public Health Award     2021

Novel Animal Biotech Product Approval Team

CVM Team Excellence Award        2021

Isoxazoline Review Team

FDA Group Recognition Award (Non-agency Crosscutting)    2016

Generics Question Based Review (QbR) Working Group

FDA Outstanding Service Award        2015

Electronic Document Submission and Review Group

Association of Primate Veterinarians       2007

Student Travel Award

NCSU, College of Veterinary Medicine       2005

Excellence in Wildlife Medicine

Society of Phi Zeta          2004

Member Induction

Delta Omega Honor Society in Public Health      1999

Honorary Membership

Cotroneo T, Hugunin K, Shuster K, Hwang H, Kakaraparthi B, Nemzek J.  2012.  Effects of buprenorphine on cecal ligation and puncture models in C57BL/6 mice.  J Am Assoc Lab Anim Sc 51(3): 357-65.

Nowland MH, Hugunin KMS, Rogers KL.  2011.  Effects of short term fasting in male Sprague Dawley rats.  Comp Med 61(2): 138-44.

Hugunin KMS, Fry C, Shuster K, Nemzek JA.  2010.  Effects of tramadol and buprenorphine on select immunologic factors in a cecal ligation and puncture model.  Shock 34(3): 250-60.

Lee J, Lee CS, Hugunin KM, Maute CJ, Dysko RC.  2010.  Bacteria from drinking water supply and their fate in gastrointestinal tracts of germ-free mice: a phylogenetic comparison study.  Water Res 44(17): 5050-8.

Nemzek JA, Hugunin KM, Opp MR.  2008.  Modeling sepsis in the laboratory: merging sound science with animal well-being.  Comp Med 58(2): 120-8.

Meier TR, Maute CJ, Cadillac JM, Lee JM, Righter DJ, Hugunin KM, Deininger RA, Dysko RC.  2008.  Quantification, distribution, and possible source of bacterial biofilm in mouse automated watering systems.  J Am Assoc Lab Anim Sci 47(2): 63-70.

Duran-Struuck, Hartigan A, Clouthier SG, Dyson MC, Lowler K, Gatza E, Tawara I, Toubai T, Weisiger E, Hugunin K, Reddy P, Wilkinson JE.  2008.  Differential susceptibility of C57BL/6NCr and B6.Cg-Ptprca mice to commensal bacteria after whole body irradiation in translational bone marrow transplant studies.  J Transl Med 6: 10-22.

Hall AJ, Hugunin K, Deaville R, Law RJ, Allchin CR, Jepson PD.  2006.  The risk of infection from polychlorinated biphenyl exposure in the harbor porpoise (Phocoena phocoena): a case-control approach.  Environ Health Perspect 114(5): 704-11.

Hugunin K, Duggirala H. FDA-CVM Talent Development and Learning Center. Rockville, MD. September 24, 2019. “Epidemiological Applications to the Post-Approval Setting: Principles of epidemiology and its applications at FDA-CVM.”

Walter-Grimm L, Hugunin K, Palmer LA.  Animal Health Institute, Pharmacovigilance Workshop. Rockville, MD, October 25, 2016. “Early experience with adverse drug event signal detection and management at CVM.”

Case report presentation at the 62nd annual meeting of the American Association of Laboratory Animal Science.  San Diego, CA, October 4, 2011.  “Periocular abnormalities in an SIV-infected rhesus macaque.”

Poster at the American College of Laboratory Animal Medicine Forum (Invited).  Newport, RI, May 2-5, 2010.  “Effects of buprenorphine and tramadol on select immunologic parameters in a cecal ligation and puncture model.”

Poster at the 60th annual meeting of the American Association of Laboratory Animal Science.  Denver, CO, November 11, 2009.  “Colonization of abiotic mice by biofilm bacteria.”

Poster at the 32nd annual Conference on Shock hosted by the Shock Society.  San Antonio, TX, June 7, 2009.  “Immunologic effects of opioid analgesia in a cecal ligation and puncture model of sepsis.”

Poster at the 59th annual meeting of the American Association of Laboratory Animal Science.  Indianapolis, IN, November 11, 2008.  “The effect of reverse osmosis, deionization, and ultraviolet filtration on biofilm development in automated watering manifolds.”

Case report presentation at the 2007 Annual Workshop of the Association of Primate Veterinarians.  Charlotte, NC, October 11, 2007.  “Acute anorexia and lethargy associated with pyrexia in an adult rhesus macaque”.

“What’s your diagnosis” presentation at the 58th annual meeting of the American Association of Laboratory Animal Science.  Charlotte, NC, October 16, 2007.  “Weight loss and anorexia in a guinea pig.”

“What’s your diagnosis” presentation at the 58th annual meeting of the American Association of Laboratory Animal Science.  Charlotte, NC, October 16, 2007.  “Acute anorexia and lethargy associated with pyrexia in an adult rhesus macaque”.

American Association for Laboratory Animal Science

• Editorial Review Board 2014 -2017
• Ad hoc reviewer 2010 – 2014

DC Academy of Veterinary Medicine      2012-Present

Veterinary Seminar Series

Fairfax, VA

CL Davis DVM Foundation         2010

Workshop and Symposium on Laboratory Animal Diseases

Chicago, IL

CL Davis DVM Foundation & NC Association of Laboratory Animal Medicine  2010

Workshop in Laboratory Animal Medicine

Raleigh, NC

Air Force Institute of Pathology        2009

Pathology of Laboratory Animals

Bethesda, MD

Charles River Laboratories         2008

Short Course (in Laboratory Animal Topics)

Newton, MA

Johns Hopkins University, Bloomberg School of Public Health      2005-2006

Doctor of Philosophy courses (degree not conferred, left in excellent academic standing after one year to pursue post-doctoral fellowship)

Baltimore, MD

Centers for Disease Control and Prevention      2004

Epidemic Intelligence Service Elective for Senior Veterinary and Medical Students

Atlanta, GA and Taft, CA

Sea Mammal Research Unit        2003, 2004

One month externships performing laboratory, statistical, and field investigations involving immunologic aspects of marine mammals

St. Andrews, Scotland