CURRICULUM VITAE
Robert J. Mitkus, PhD, DABT
USFDA/CBER
1401 Rockville Pike
Rockville, MD 20852
Email: robert.mitkus@fda.hhs.gov
Tel: 301-827-6083
Professional Experience in Toxicology
2010-Present
Computational Toxicologist
Office of Biostatistics and Epidemiology, Center for Biologics
Evaluation and Research, USFDA, Rockville, MD
 Conduct cutting-edge quantitative risk assessments for individual
vaccine components
 Perform pharmacokinetic modeling of vaccine adjuvant disposition
using published human and animal parameters
 Provide project-specific toxicological expertise in a team
environment
 Represent the office in computational toxicology meetings with
other government regulatory agencies
2004-2010
Mammalian Toxicologist
Health Effects Division, Office of Pesticides Programs
US Environmental Protection Agency, Arlington, VA
 Served as Lead Branch Toxicologist and point of contact for
branch chief on toxicological issues, problem solving, and
resolution
 Led branch peer review (scientific quality control function) of
toxicological safety studies and serve as branch senior scientist in
toxicology
 Mentored two PhD-level pharmacologists and provide direction to
other staff in branch on toxicological and risk assessment issues
 Provided peer review of all branch risk assessments
 Independently reviewed over 100 short-term and long-term in vivo
and in vitro animal toxicology and ADME (absorption,
distribution, metabolism, and excretion) studies
 Independently synthesized toxicological data into hazard
characterizations and/or provided peer review of hazard
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1999-2004
assessments for over 50 pesticide active ingredients
Represented the branch/division as a senior toxicologist in
meetings with industry stakeholders and other government
regulatory agencies
Served as member of divisional Technical Evaluation Panel that
reviewed and evaluated candidate contract organization applicants
for divisional toxicology contracts
Collaboratively served on Cancer Assessment Review Committee
that ensures consistent divisional interpretation of rodent
carcinogenicity studies and cancer mode of action data
Served on divisional Developmental Neurotoxicity (DNT)
Workgroup that collaboratively reviews and evaluates DNT study
data, protocol reviews, and responses to industry stakeholders
Maintained state-of-the-art knowledge of toxicology and review
applicable literature as part of my job
Collaborated with other staff to present original research data at
scientific meetings, as necessary
Graduate Research Assistant
Program in Toxicology
University of Maryland, Baltimore, MD
 Dissertation explored the relationship between metal and endotoxin
content in mixtures of airborne particulate matter (microparticles)
and the release of inflammatory mediators from human alveolar type
II and murine monocytic cells in vitro
 Laboratory experience in cell-based cytotoxicity assays, fluorescent
enzyme-linked immunosorbent assays (ELISA),
immunocytochemistry, cellular transepithelial electrical resistance
measurements, and test sample preparation
 Extensive experience in human and rodent cell culture
 Mentored younger graduate lab members and visiting undergraduate
students
1996-1999
Research Technician in Drug Discovery
Charles River Laboratories, Baltimore, MD
 Independently administered (via intraperitoneal, or tail vein
injection) cocaine, experimental cocaine agonists and antagonists, or
their combination to mice
 Assessed neurotoxicological endpoints (clinical signs of
neurotoxicity, locomotor activity) in dosed animals
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 Assisted with drug administration and other experimental procedures
(e.g., retro-orbital bleed) in animals, including rats, rabbits, and nonhuman primates
 Mentored and assisted graduate, professional, and undergraduate
students
 Responsible for SOP writing and protocol development
 Responsible for preparation of experimental drugs as solutions or
suspensions
 Collected, analyzed, organized, and recorded data appropriate for
publication and future reference by other laboratory members
 Maintained complete and detailed records of all laboratory
experiments
 Used a variety of statistical methods for analysis of data
 Interpreted findings, summarized conclusions and prepared data in
final form for publication in scientific journals and reports
 Collaborated with staff to submit manuscripts to scientific journals
and other related professional publications
 Co-authored one manuscript in a peer-reviewed journal
Education
1999-2004
UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE
Baltimore, MD
Ph.D., Toxicology
1990-1991
OXFORD UNIVERSITY
England
Rotary Foundation Ambassadorial Scholar
1987-1991
LOYOLA UNIVERSITY
Baltimore, MD
B.S. Summa Cum Laude, Biology
Honors and Awards
2009
2009
2008
2008
Diplomate, American Board of Toxicology
Awarded USEPA Bronze Medal for Commendable Service (For
coordination of the risk assessment of three global review pesticides)
Awarded USEPA Bronze Medal for Commendable Service (For
completion of the first trilateral review of a new chemical with
multiple international partners)
Received Office of Pesticides Programs Science Award for
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2007
2006
2003-2004
2002-2004
2001-Present
2000-2002
Excellence (For scientific leadership advancing the spirit of global
harmonization)
Accepted as Full Member, Society of Toxicology
Awarded USEPA Bronze Medal for Commendable Service (Organic
arsenicals herbicides team)
Student Representative, National Capital Area Chapter of the
Society of Toxicology
Student Member, Society of Toxicology
Member, National Capital Area Chapter of the Society of Toxicology
NIH Pre-doctoral Training Fellow in Toxicology
Professional Publications and Presentations
Publications:
1. Shoenfelt J, Mitkus RJ, Zeisler R, Spatz RO, Powell J, Fenton MJ, Squibb KA,
Medvedev AE. Involvement of TLR2 and TLR4 in inflammatory immune
responses induced by fine and coarse ambient air particulate matter. J Leukoc Biol
86(2):303-12, 2009.
2. Mitkus RJ. 2004. Analysis of the Role of Zinc, a Major Component of Ambient
Baltimore Fine Particulate Matter, in Eliciting Cytokine and Chemokine Release
and Disrupting Cellular Tight Junctions In Vitro [PhD Dissertation]. Baltimore,
MD:University of Maryland.
3. Katz JL, Kopajtic TA, Myers KA, Mitkus RJ, Chider M. Behavioral effects of
cocaine: interactions with D1 dopaminergic antagonists and agonists in mice and
squirrel monkeys. J Pharmacol Exp Ther 291(1):265-79, 1999.
Poster presentations:
1. Mitkus RJ, Walderhaug MO, Hess M, Updated aluminum pharmacokinetics in
infants following exposures through diet and vaccination, Abstract submitted for
2011 Society of Toxicology Meeting.
2. Manibusan M, Mitkus R, Shah PV, Rowland J, May B, Akerman G, Baetke K,
Dellarco V, Assessment of the rodent carcinogenicity testing requirements for
pesticides. Abstract 1495, Presented at Society of Toxicology Meeting (March
2009), Baltimore, MD.
3. Potnis PA, Mitkus RJ, Powell JL, Squibb KS, Strauss K, In vitro effects of metal
mixtures on RAW 264.7 monocytes. Toxicological Sciences 90 (S1): Abstract
2082, 2006.
4. Powell JL, Spiegl NM, Pancras JP, Mitkus RJ, Ling H, Squibb KS, Ondov JM,
Measurement of endotoxin in ambient particulate matter, Health Effects Institute
Annual Conference, Boston, MA, May 2-4, 2004.
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5. Mitkus RJ, Powell JL, Pancras JP, Ondov JP, Squibb KS, Seasonal metal content
measured in Baltimore PM2.5 SEAS samples correlates with cytokine and
chemokine release in an in vitro assay system, Toxicological Sciences 78 (1-S),
Abstract 1392, 2004.
6. Mitkus R, Powell J, Akkerman M, Ondov J, Squibb K, Cytokine responses
elicited by PM2.5 SEAS samples collected at the Baltimore Supersite during a
2002 intensive study, American Association for Aerosol Research, Particulate
Matter: Atmospheric Sciences, Exposure, and the Fourth Colloquium on PM and
Human Health, Pittsburgh, PA, March 31-April 4, 2003, Abstract P08-25.
7. Mitkus R, Powell J, Zeisler R, Akkerman M, Squibb K, Comparison of the
biological activity of NIST Interim Reference Material for PM2.5 with NIST
Standard Reference Material 1648 for urban particulate matter, American
Association for Aerosol Research, Particulate Matter: Atmospheric Sciences,
Exposure, and the Fourth Colloquium on PM and Human Health, Pittsburgh, PA,
March 31-April 4, 2003, Abstract P08-26.
8. Mitkus R, Powell J, Akkerman M, K Squibb, Differential in vitro immunological
responses to zinc (Zn), an active component of urban particulate matter (PM),
Toxicological Sciences 72 (S-1), Abstract 1454, 2003.
9. Mitkus RJ, Falconer MO, Powell JL, Ondov JM, and Squibb KS, In vitro assay of
the biological activity of ambient PM2.5 collected by a high frequency aerosol
sampler, Toxicological Sciences 66 (1-S), Abstract 1758, 2002.
10. Mitkus R, Powell J, Ondov J, Squibb K, In vitro assay of the biological activity of
PM2.5 and two of its component collected by a high frequency aerosol sampler at
an urban supersite, American Association for Aerosol Research, 21st Annual
Conference, Charlotte, NC, October 7-11, 2002, Abstract PA3-09.
11. Mitkus RJ, Mwebi N, Guo Y, Desai T, Amstad P, Blough N, Gutierrez PL,
Detection of hydroxyl radicals and Cr(V) at toxicologically relevant
concentrations of Cr(VI), Toxicological Sciences 60 (1), Abstract 1504, 2001.
12. Izenwasser S, Kunko PM, French D, Mitkus RJ, Katz JL, Newman AH, Acute
and Chronic Administration of JHW 007, a Novel Dopamine Uptake Inhibitor
with Behavioral Effects Unlike Cocaine. Soc Neurosci Abstr 23, Part 2, Abstract
432.15, 1997.
Leadership Roles
1. Councilor, National Capital Area Chapter of the Society of Toxicology (NCACSOT) (2009-12)
2. Faculty, Pharmacology and Toxicology, FAES Graduate School at NIH (2009Present)
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3. USEPA Delegate for OECD Workshop on Lessons Learned with the Planning and
Implementation of Joint Reviews of Pesticide Dossiers, Bonn, Germany (2008)
4. USEPA Delegate for OECD Integrated Approaches to Testing and Assessment
Exercise, Arlington, VA (2007)
5. Represented US as the lead toxicologist for multi-country (“global”) risk
assessments for the herbicide pyrasulfatole and the insecticide spirotetramat
Teaching and Mentoring Experience
2010, Fall
2010, Spring
2009, Fall
2008-10
2008
2004
2003
2001
1997-99
Course master and lecturer, TOXI 303 Introductory Toxicology,
Foundation for Advanced Education in the Sciences (FAES) Graduate
School at the National Institutes of Health (NIH)
Invited lecturer, MIEH 720, Principles of Toxicology, University of
Maryland College Park School of Public Health
Course master and lecturer, TOXI 303 Introductory Toxicology,
FAES Graduate School at the NIH
Mentored two professional toxicologists in regulatory toxicology and
safety assessment within EPA work unit
Lecturer, BIOL 319, Insights into stem cells and their niches, FAES
Graduate School at NIH
Mentored high school teachers in 2-hour risk assessment exercise,
“Paracelsus Goes to School” Teacher Workshop, 43rd Annual Meeting
of the Society of Toxicology
Mentored undergraduate student in summer research project,
University of Maryland Baltimore, Baltimore, MD
Lectured to the faculty of Baltimore County Community College,
Essex Campus, on the detection of hydroxyl radicals in mammary
gland epithelial cells after exposure to chromium (VI)
Mentored professional, graduate, and undergraduate students in
summer research projects at the National Institute on Drug Abuse,
Baltimore, MD
Continuing Education & Special Training
 Toxi 609, Methods in Toxicology, University of Maryland School of Medicine
(Spring 2010)
 Study Director Training, 29th Annual American College of Toxicology Meeting
(2008)
 Study Monitor Training, 29th Annual American College of Toxicology Meeting
(2008)
 Practical Methods in In Vitro Toxicology, Institute for In Vitro Sciences,
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Gaithersburg, MD (2008)
 Humane Handling and Use of Rodents and Rabbits Training, Department of
Veterinary Resources, University of Maryland Baltimore (2003)
 NIH Course in Research Ethics (CIPP 907), University of Maryland Baltimore
(2001)
References: Available upon request
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