1. JULIE SKARE
8674 Hampton Bay Place Home 513-229-0172
Mason, Ohio 45040 Cell 513-543-4959
julie.skare@gmail.com
Senior Toxicologist
Ensured product safety and ability to market consumer products globally through skills in ingredient and product
risk assessment. Skilled in leading cross-industry toxicology issues management and problem solving via trade
associations/industry consortia and global corporate project teams. Experienced in preparing regulatory toxicology
submissions and in presenting before regulatory agency expert panels. Excellent communicator and collaborator
with experience in coaching, mentoring and training toxicology staff.
• Risk Assessment
• Toxicology Data Analysis
• Project Management
• Multi-disciplinary Approaches to Complex
Problem Solving
• Post-marketing Adverse Event Analysis
• Use of Animal Testing Alternatives
• Clinical Safety Study Design and
Interpretation
Education
Ph.D., Biochemistry - University of Wisconsin, Madison 1980
Thesis Title: Estrogen-Induced Pituitary Growth and DNA Synthesis: Genetic Differences in Response to Chronic
Treatment in the Rat
B.A., Chemistry and Biology - Concordia College, Moorhead, MN 1976
Technical Skills
• Broad knowledge in the development of safety programs appropriate to support consumer products
spanning several business sectors
• Risk assessment expertise, with particular emphasis on carcinogenicity risk assessment
• Skilled at the application of multidisciplinary approaches, e.g., involving toxicology, clinical safety studies,
post-marketing adverse event analysis, and epidemiology to address safety issues
• Application of alternatives to animal testing in safety assessments, including in vitro methods, in silico tools,
structure-activity relationship and read-across approaches, and use of the threshold of toxicological
concern approach
• Experienced in preparing for and presenting at advisory committee/expert panel meetings and regulatory
agencies, including the EU Scientific Committee on Consumer Safety, the US Cosmetic Ingredient Review
Expert Panel, and US FDA
• Excellent technical writing skills
• Experience as a corporate fact witness and company representative in product liability litigation
Professional Experience
INDEPENDENT CONSULTANT 2012-present
• Prepared safety dossiers on cosmetic ingredients for submission to the European Union Scientific
Committee on Consumer Safety
• Prepared manuscripts for publication in peer reviewed toxicology journals

2. THE PROCTER & GAMBLE COMPANY
Research Fellow, Central Product Safety - Beauty Care Research and Development - 2003 – 2012
• Led P&G's global hair dyes toxicology team, including toxicology safety programs for proprietary new dye
development and managing safety issues for marketed hair dye products
• Key toxicology leader for the hair dye industry-wide global consortium (Hair Colorants Technical
Secretariat) in the preparation of toxicology dossiers on hair dye ingredients and reaction products
submitted in the European Union (EU)
• Review and critique of epidemiology studies on the association of hair dyes with various types of cancer;
wrote evaluations of the epidemiology literature for industry consortium regulatory submissions in the EU
• Leader for the US industry efforts on hair dye safety as chair of the Personal Care Products Council Hair
Coloring Technical Committee
• Provided strategic direction for the US cosmetics trade association committee responsible for interfacing
with the Cosmetic Ingredient Expert Panel on review of cosmetic ingredient safety and acceptance of
alternatives to animal testing
Key Accomplishments:
• Conducted metabolism research on hair dye aromatic amines in response to an epidemiology study
suggesting that hair dye use was associated with an increased risk of bladder cancer. Results refuted the
hypothesized mode of action of hair dye ingredients as bladder carcinogens. The putative hair dye/bladder
cancer association was not reproducible in subsequent epidemiology studies, confirming the conclusions of
the metabolism research.
• Conducted a cancer risk assessment for 4-aminobiphenyl (4-ABP) as a potential trace level contaminant of
hair dyes that was shared with the US FDA and the EU Scientific Committee on Consumer Products
(SCCP), both of which agreed that any risk related to trace levels of 4-ABP was insignificant. Shared this
risk assessment with the supplier of a key hair dye raw material and convinced them that trace 4-ABP in
their raw material did not present a risk and that good product stewardship practices were maintained.
• Reviewed toxicology and metabolism protocols and study reports for over 40 hair dye ingredients.
Reviewed or wrote toxicology dossiers for submission in the EU. Favorable reviews by the Scientific
Committee on Consumer Safety (SCCS, formerly SCCP) have led to continued ability to formulate products
containing these ingredients. For two critical ingredients with potentially unfavorable SCCS conclusions due
to insufficient margins of exposure, played a key role in developing a toxicokinetic-based approach to
establishing an acceptable margin of exposure.
• Served as a credible industry expert for the Cosmetic Ingredient Review (CIR) Expert Panel, giving
presentations to update the Expert Panel on hair dye cancer epidemiology studies and to provide relevant
safety data for their hair dye ingredient safety reviews. Wrote evaluations of the epidemiology literature for
EU SCCS dossiers. As a result, the hair dye/cancer issue has been effectively managed in both the US and
the EU, and consistency between EU and US ingredient safety reviews has been enhanced.
• Represented the global hair dye industry at a 2008 IARC Working Group meeting to re-evaluate hair dyes
and cancer. Despite strict IARC rules to avoid undue industry influence on IARC deliberations, gained
credibility with the Working Group due to knowledge of the epidemiologic literature and ensured that hair
dyes received a balanced evaluation.
• Provided industry leadership on the scientific content of a dossier addressing potential
genotoxicity/carcinogenicity concerns related to the final colored reaction products of oxidative hair dye
ingredients. A favorable 2010 SCCS opinion opened the door for the EU Commission to close out the open
question on this topic and to proceed with development of an approved dye list.
• Played a key leadership role in guiding P&G’s toxicology testing programs supporting new dye
development and in preparing dossiers for submission in the EU. One new ingredient has received a
favorable SCCS review, and review of submissions on other new dyes is pending.
Research Fellow, Central Product Safety - Oral Care Research and Development - 1999 – 2002
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3. Developed and executed safety testing programs for upstream development projects in P&G's Oral Care R&D
organization.
Key Accomplishments:
• Designed and monitored a dose-response clinical safety study to evaluate a potential safety issue for
glucose-6-phosphate dehydrogenase deficient subjects as a sensitive subpopulation for an oral care active
ingredient under upstream development. Based on results, provided the project team with
recommendations for ensuring product safety. Project was subsequently dropped for lack of efficacy.
• Provided safety leadership on upstream licensing and acquisition technologies for antibacterials. Identified
that genotoxicity potential was a critical question and collaborated with the partner company to screen initial
candidates selected by structure-activity relationship considerations.
• Designed a key study to address potential bone safety issues with a potential new anticaries active.
Conclusive results raising safety concerns led to timely termination of the project, saving company
resources.
• Identified the safety testing program needed to support safe use of novel peroxide delivering polymers for
cleaning/whitening benefits that were under development via a global joint venture.
Research Fellow, Toxicology - Regulatory and Clinical Development - OTC Health Care - 1994 – 1999
• Safety issues management for products in the respiratory care, analgesics, gastrointestinal and oral care
categories including serving as safety expert on product liability litigation.
• Provided safety input on potential Rx to OTC switches
• Safety program development and execution in the women's health category.
• Job scope required a multidisciplinary approach utilizing pre-clinical and clinical safety and pharmacokinetic
data, analysis of post-marketing adverse event reports, and critical review of epidemiologic studies.
Key Accomplishments:
• Led trade association technical strategy development for data analysis and presentation to FDA Advisory
Committee on epidemiology studies related to ethanol-containing mouth rinses and oral cancer. FDA's
concerns on mouth rinses and oral cancer were alleviated.
• Led the trade association technical strategy to use poison control center data to defend antihistamine
safety in OTC cold medications and to address pediatric dosing schedules for cold medications. Data on
antihistamine-containing cold medications showed no increased likelihood for adverse outcomes vs. cold
medications not containing an antihistamine, supporting continued safe marketing in children and adults.
• Completed an analysis of poison control center data on acetaminophen-associated hepatotoxicity which
showed that acetaminophen-containing cold/flu products are not an important contributor to the overall
number of cases of acetaminophen-associated hepatoxicity. As a result, the safety of these products was
not questioned at an FDA Advisory Committee meeting subsequently held in 2002.
• Summarized decades of research on bismuth subsalicylate safety, including reports of bismuth-related
encephalopathy and salicylate toxicity. This review and assessment was a valuable source document for
regulatory submissions needed for global expansion of Pepto Bismol.
• Assisted Legal department in several product liability suits involving respiratory care and analgesic
products, including development of responses to interrogatories and participating in depositions. Efforts led
to successful resolution of suits.
• Analyzed safety considerations related to potential Rx to OTC switches of antibiotics for urinary tract
infection. This work led to the redirection of resources to more promising R&D projects.
• Led the development of internal corporate guidelines for safety evaluation of dietary supplements and
employed these in the evaluation of women's health supplements developed for test market.
Section Head, Toxicology and Environmental Safety, Regulatory and Clinical Development, Respiratory
Care and Analgesics Categories - 1988 – 1993
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4. • Managed toxicologists involved in the design and execution of safety testing programs to support
development of OTC respiratory care and analgesic products.
• Managed the preparation of safety assessments for both internal corporate use and for submission to the
FDA.
• Addressed safety issues on currently marketed products/ingredients in these categories.
Key Accomplishments:
• Doxylamine Succinate: Developed the technical strategy, prepared the dossier for FDA submission,
managed several consultants, and took leadership in the execution of follow-up studies to address positive
rodent carcinogenicity study results for this OTC antihistamine used in NyQuil. Following three FDA
advisory committee meetings, the OTC Drugs Advisory Committee ultimately voted unanimously that a
warning label regarding potential carcinogenicity was not warranted.
• Ethanol Content of OTC Medicines: Took leadership at the Nonprescription Drug Manufacturers'
Association for analysis of poison control center data to defend the safe use of ethanol as a vehicle in OTC
cough/cold medicines. The FDA's Nonprescription Drugs Advisory Committee concurred with the industry
proposal, minimizing impact on currently marketed products without compromising safety.
• Ibuprofen + Caffeine (I+C) Renal Toxicity: Managed the presentation of I+C preclinical and clinical safety
data to the FDA's Arthritis Advisory Committee and developed a preclinical research program to study the
mode of action of renal toxicity in rodents and relevance to humans. Results were instrumental to the
successful licensing of this technology.
• Acute Epiglotittis: Evaluated post-marketing surveillance reports of acute epiglottitis alleged to be
associated with use of a sore throat spray product and prepared a risk assessment that served as the basis
for discussions with the UK Board of Health and US FDA and led to a pragmatic approach for labeling
changes.
Section Head, Human Safety - Professional and Regulatory Services - Paper Products Division - 1987 – 1988
• External issues management for currently marketed Paper Division products
• Managed toxicologists to provide safety support for development of new products in the disposable diaper,
catamenial, facial tissue, and paper towel categories.
Key Accomplishments:
• Led the development of a cancer risk assessment for exposure to trace levels of dioxin in bleached pulp
used in paper products which provided the foundation for discussions with key external scientific experts
and for successfully addressing technical external relations issues.
• Led the preparation of risk assessments to ensure compliance of Paper Division products with the newly
enacted California Proposition 65 legislation.
• Managed the safety testing program for proprietary materials for use in catamenials and diapers, including
addressing toxicology questions related to monomers and low molecular weight impurities.
Group Leader, Human Safety - Professional and Regulatory Services - Packaged Soap and Detergent Division
- 1985 – 1987
Planned and executed safety programs to support research and development of new products in the laundry
detergent and automatic dishwashing detergent categories. Served as the first level manager for new toxicologists
supporting this business.
Key Accomplishments:
• Developed and executed safety testing programs for two novel laundry detergent product forms in record
time from project inception to test market.
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5. • Problem-solved genotoxicity testing issues with a new proprietary soil release polymer, resulting in
successful EPA review of a pre-manufacturing notification.
• Supervised efforts to design and execute a toxicology testing program for pre-manufacturing notification
filing for a new proprietary detergent builder. The filing received a favorable review by the EPA.
Staff Scientist, Genetic Toxicology, Human & Environmental Safety Division - 1981 – 1985
Development and validation of new genotoxicity assay methods and completion of genotoxicity assays on potential
new ingredients across all of P&G's research and development divisions.
Key Accomplishments:
• Developed a Tier II in vivo alkaline elution assay for measuring DNA damage in germ cells. The assay was
successfully used at P&G to address issues with key ingredients (sodium fluoride and a formaldehyde
releasing preservative) and was recommended by the EPA as a Tier II test to resolve in vitro test results for
specific chemicals.
• Successfully employed in vitro methods to address genotoxicity issues/testing needs for materials of key
importance to P&G (sodium saccharin, sodium fluoride, a formaldehyde releasing preservative, Olestra,
zinc pyrithione, and proprietary detergent ingredients).
Affiliations / Associations / Memberships
Society of Toxicology - 1987 to Present
Hair Coloring Technical Committee, Personal Care Products Council - Chair 2007 to 2012, Vice Chair 2006,
Member 2003-2005
Cosmetic Ingredient Review Science and Support Committee, Personal Care Products Council - 2009 to 2012
Global Hair Colorants Technical Secretariat Toxicologists Team, 2003-2012
Toxicology Forum Board of Directors, 2009-2012
Toxicology Forum US Program Planning Committee, 1997-2012
ILSI Health and Environmental Sciences Committee on Biological Significance of DNA Adducts, 2004-2012
Publications / Patents
Preston RJ, Skare JA, and Aardema MJ. A review of biomonitoring studies measuring genotoxicity in humans
exposed to hair dyes. Mutagenesis, 25:17-23 (2010)
Jarabek AM, Pottenger LH, Andrews LS, Casciano D, Embry MR, Kim JH, Preston RJ, Reddy MV, Schoeny R,
Shuker D, Skare J, Swenberg J, Williams GM, and Zeiger E. Creating context for the use of DNA adduct data in
cancer risk assessment: I. Data organization. Critical Reviews in Toxicology 39:659-678 (2009)
Skare JA, Hewitt NJ, Doyle E, Powrie R, and Elcombe C. Metabolite screening of aromatic amine hair dyes using in
vitro hepatic models. Xenobiotica 39:811-825 (2009)
Strife RJ, Mangels ML, and Skare JA. Separation and analysis of dimethylaniline isomers by supercritical fluid
chromatography - Electrospray ionization tandem mass spectrometry. Journal of Chromatography A, 1216:6970-
6973 (2009)
Hu T, Bailey RE, Morrall SW, Aardema MJ, Stanley LA, and Skare JA. Dermal penetration and metabolism of p-
aminophenol and p-phenylaminediamine: Application of the EpiDermTM
human reconstructed epidermis model.
Toxicology Letters 188:119-129 (2009)
Goebel C, Hewitt NJ, Kunze G, Wenker M, Hein DW, Beck H, and Skare J. Skin metabolism of aminophenols:
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6. Human keratinocytes as a suitable in vitro model to qualitatively predict the dermal transformation of 4-amino-2-
hydroxytoluene in vivo. Toxicology and Applied Pharmacology 235:114-123 (2009)
Bailey JE and Skare JA. Letter to the editor in response to Morton et al. (2007) Carcinogenesis 28, 1759-1764.
Carcinogenesis 29:1851 (2008)
Sander M, Cadet J, Casciano DA, Galloway SM, Marnett LJ, Novak RF, Pettit SD, Preston RJ, Skare JA, Williams
GM, Van Houten B, and Gollapudi BB. Proceedings of a workshop on DNA adducts: Biological significance and
applications to risk assessment (Washington, DC, April 13-14, 2004). Toxicology and Applied Pharmacology
208:1-20 (2005)
Stanley LA, Skare JA, Doyle E, Powrie R, D'Angelo D, and Elcombe CR. Lack of evidence for metabolism of p-
phenylenediamine by human hepatic cytochrome P450 enzymes. Toxicology 210:147-157 (2005)
Nohynek GJ, Skare JA, Meuling WJA, Hein DW, De Bie AThHJ, and Toutain H. Urinary acetylated metabolites and
N-acetyltransferase-2 genotype in human subjects treated with a para-phenylenediamine-containing oxidative hair
dye. Food and Chemical Toxicology 42:1885-1891 (2004)
Skare JA and Abeln SB. Antihistamine-containing cough/cold medications present a low hazard in pediatric
accidental exposure incidents: Analysis of poison control center data. Veterinary and Human Toxicology 39:367-
371 (1997)
Bookstaff RC, Murphy VA, Skare JA, Minnema D, Sanzgiri U, and Parkinson A. Effects of doxylamine succinate on
thyroid hormone balance and enzyme induction in mice. Toxicology and Applied Pharmacology 141:584-594 (1996)
Thompson GA, St. Peter JV, Heise MA, Horowitz ZD, Salyers GC, Charles TT, Brezovic C, Russell DA, Skare JA,
and Powell JH. Assessment of doxylamine influence on mixed function oxidase activity upon multiple dose oral
administration to normal volunteers. Journal of Pharmaceutical Sciences 85:1242-1247 (1996)
Skare JA, Murphy VA, Bookstaff, RC, Thompson GA, Heise MA, Horowitz ZD, Powell JH, Parkinson A, and St.
Peter JV. Safety assessment of OTC drugs: Doxylamine succinate. Archives of Toxicology, Supplement 17:326-
240 (1995)
Skare KL, Skare JA, and Thompson ED. Evaluation of olestra in short-term genotoxicity assays. Food and
Chemical Toxicology 28:69-73 (1990)
Thompson ED, McDermott JA, Zerkle TB, Skare JA, Evans LBL, and Cody DB. Genotoxicity of zinc in 4 short-term
mutagenicity assays. Mutation Research 223:267-272 (1989)
Skare JA, Wong TK, Evans BLB, and Cody DB. DNA-repair studies with sodium fluoride: Comparative evaluation
using density gradient ultracentrifugation and autoradiography. Mutation Research 172:77-87 (1986)
Skare JA, Schrotel KR, and Nixon GA. Lack of DNA-strand breaks in rat testicular cells after in vivo treatment with
sodium fluoride. Mutation Research 170:85-92 (1986)
Skare JA and Schrotel KR. Validation of an in vivo alkaline elution assay to detect DNA damage in rat testicular
cells. Environmental Mutagenesis 7:563-576 (1985)
Skare JA and Wong TK. Lack of specific inhibition of DNA repair in WI-38 human diploid fibroblasts by sodium
saccharin. Cancer Letters 26:191-200 (1985)
Skare JA and Schrotel KR. Alkaline elution of rat testicular DNA: Detection of DNA cross-links after in vivo
treatment with chemical mutagens. Mutation Research 130:295-303 (1984)
Skare JA and Schrotel KR. Alkaline elution of rat testicular DNA: Detection of DNA strand breaks after in vivo
treatment with chemical mutagens. Mutation Research 130:283-294 (1984)
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7. Wiklund JA and Gorski J. Genetic differences in estrogen-induced deoxyribonucleic acid synthesis in the rat
pituitary: Correlations with pituitary tumor susceptibility. Endocrinology 111:1149-1149 (1982)
Lieberman ME, Maurer RA, Claude JP, Wiklund J, Wertz N, and Gorski J. Regulation of pituitary growth and
prolactin gene expression by estrogen. Advances in Experimental Medicine and Biology 128:151-163 (1981)
Wiklund J, Rutledge J, and Gorski J. A genetic model for the inheritance of pituitary tumor susceptibility in F344
rats. Endocrinology 109:1708-1714 (1981)
Wiklund J, Wertz N, and Gorski J. A comparison of estrogen effects on uterine and pituitary growth and prolactin
synthesis in F344 and Holtzman rats. Endocrinology 109:1700-1707 (1981)
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