Tacey E.K. White has over 25 years of experience in pharmaceutical safety assessment and drug development. She currently works as a senior consultant, advising on nonclinical safety strategies throughout drug development. Previously, she held roles at Exponent, Covance, and GlaxoSmithKline, where she designed and directed developmental and reproductive toxicity and juvenile toxicity studies to support regulatory submissions. She has deep expertise in areas like developmental toxicity, juvenile toxicity, and pregnancy and lactation labeling.

1. ACLAIRO
Pharmaceutical Development Group, Inc.
1950OldGallowsRoad,Suite300,Vienna,VA22182
TACEY E.K. WHITE, Ph.D.
1950 Old Gallows Road, Suite 300 Mobile Tel: 215-290-8051*
Vienna, VA 22182 Vienna Tel: 703-506-6760 x403
twhite@aclairo.com
EXPERIENCE
2015 - Present Aclairo Pharmaceutical Development Group, Inc.
Senior Consultant
Consultant advising pharmaceutical and biotech companies on nonclinical safety assessment strategies
throughout the entire drug development process, including creating customized nonclinical strategies,
placing and monitoring studies, developing human risk assessments for toxicology issues, addressing
regulatory questions, and contributing to regulatory documents (IBs, INDs, CTAs, Briefing Books,
PIPs/PSPs, NDAs, MAAs).
Deep regulatory and investigative expertise in developmental and reproductive toxicity (DART), and
juvenile toxicity. Strong background in conducting/monitoring DART and juvenile studies,
interpreting complex data, evaluating human risk, addressing regulatory questions, writing position
papers and regulatory communications. Experienced safety assessment representative on global drug
development teams, responsible for the conduct of nonclinical toxicology packages and written
contributions to global regulatory submissions for small molecules and gene therapy products in
diverse therapeutic areas including endocrine, cardiovascular, metabolic, oncology, and ocular.
Applies 14 years of pharmaceutical drug development and CRO experience, consulting experience
(3+ years), and deep knowledge of ICH, FDA, and EMA guidelines to help clients with:
• Comprehensive nonclinical strategies for safety assessment of small molecules and biologics
• Interpretation of DART / juvenile and general toxicity data, and human risk assessment based
on mode of action, relevance to target pharmacology, and patient population
• Written communication of toxicity findings and human risk in regulatory documents - IBs,
INDs, CTAs, Briefing Books, PIPs/PSPs, NDAs, MAAs
• Evaluation of clinical pediatric plan and recommendations for juvenile toxicity assessments
• Pregnancy and Lactation labelling recommendations for US and EU
• Study support services including protocol creation and review, study monitoring, study report
review, scientific interpretation and peer review for general, juvenile, and genetic toxicity,
DART, safety pharmacology, toxicokinetic, analytical, and bioanalytical studies
• Due diligence evaluation of nonclinical study packages for in-licensing and out-licensing
• Toxicity issue resolution and regulatory communications
• Impurity and metabolite safety assessment; use of toxicokinetics to interpret safety information
• Medical device and veterinary drug safety assessments, using working knowledge of FDA
(drugs, devices, veterinary), ICH, VICH, OECD and EPA guidelines

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2012 – 2015 Exponent, Inc.
Managing Scientist (Consultant)
Consultant advising pharmaceutical and biotech companies on nonclinical safety assessment
strategies, including the design and conduct of general and juvenile toxicity, DART, genetic toxicity,
and safety pharmacology studies. Placed and monitored the full range of safety assessment,
toxicokinetic, analytical and bioanalytical studies. Created written summaries, overviews, and CTD
tables for IBs, INDs, CTAs, Briefing Books, PIPs/PSPs, NDAs, MAAs. Provided safety assessments
for manufacturing impurities and metabolites.
Reviewed and interpreted DART data for a diverse range of pharmaceuticals and chemicals. Provided
expert assessment of human risk; wrote regulatory responses (FDA, EPA) and worked with agencies
on study protocols; recommended content for Pregnancy and Lactation Labelling for US and EU. Co-
organized ILSI-HESI DART and FDA workshop on FDA Pregnancy and Lactation Labeling Rule.
Evaluated clinical pediatric plans and recommended juvenile toxicity study strategies. Contributed
significantly to PIPs (EMA) and PSPs (FDA), and provided written responses to regulatory
comments; designed and monitored juvenile toxicity studies.
Created safety risk assessment documents for medical devices using biocompatibility studies and
literature reviews according to ISO 10993 biocompatibility standards. Evaluated safety of veterinary
drugs based on VICH and CVM guidelines. Evaluated toxicity information, and recommended and
monitored studies for pesticides using EPA and OECD guidelines, including an extended one-
generation reproduction toxicity (EOGRT) study.
2010 – 2012 Covance Laboratories, Inc.
Global Director of Small Animal Developmental and Reproductive Toxicology
(DART)
Responsible for developing and maintaining state of the art DART and juvenile toxicity capabilities,
and ensuring delivery of quality scientific strategy at all small animal DART sites, worldwide. (1)
Scientific leader for the design, conduct, interpretation and reporting of DART and juvenile toxicity
studies, including management review of all study reports. (2) Consultant for pharmaceutical/biotech
clients to develop fit-for-purpose DART and juvenile toxicity study packages to streamline drug
development efforts. (3) Scientific lead for relocation of the US DART services (development of
organizational structure, compiling and training staff, and revising standard operating procedures),
including implementing a new DART data collection system (Pristima), (gap analysis, customization,
harmonization across sites, validation).
2002 – 2010 GlaxoSmithKline, King of Prussia, PA
Safety Assessment Project Team Representative, DART Study Director, and
Manager of Investigative Teratology Laboratory
Safety Assessment representative on drug development project teams. (1) Planned safety assessment
strategies and implemented toxicology studies to support clinical trials and regulatory submissions;
(2) wrote toxicology portions of CIBs, INDs, briefing booklets, etc.; (3) collaborated with discovery
teams to select and transition drug candidates into development. Projects included NCEs and gene
therapy products for cardiovascular, metabolic, oncology, endocrine, and ocular indications.

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Primary world-wide DART internal consultant for biological products (e.g., monoclonal antibodies,
DNA vaccines, peptide molecules): Collaborated with SA project representatives to plan and execute
DART testing strategies for all large molecule therapeutics, including customized designs and special
research projects. Participated in monthly meetings for biologics project team representatives.
Study Director for the full range of DART and juvenile toxicity studies for all therapeutic areas world-
wide. (1) Worked with project team representatives to design fit for purpose DART packages based on
regulatory expectations and clinical plans; (2) responded to regulatory agency questions and resolved
DART issues through lab experimentation and literature-based review; (3) managed DART study
directors. (4) User representative for validation of DART data collection systems and automated
statistical analysis; (6) Co-authored a world-wide SOP on inclusion of women of child bearing
potential into clinical trials.
Manager of the GSK Investigative Teratology laboratory: (1) Oversaw investigations into
mechanisms underlying teratogenic effects identified in regulatory studies, in support of human risk
assessment; (2) authored in-depth literature reviews on the DART potential of therapeutic target
modulation; (3) oversaw the use and development of in vitro models (pre- and postimplantation whole
embryo culture, ovary culture) to generate mechanistic information; (4) managed technical staff,
provided scientific direction over PhD investigators for laboratory activities, and was the thesis
advisor for several Masters of Science thesis projects.
1998 – 2002 Sanofi-Synthelabo Research, Malvern, PA
Research Investigator / Senior Research Investigator
Study Director for full range of DART studies to support U.S and international regulatory
submissions. (1) Organized and ran bi-weekly DART technical staff meetings; (2) participated in
international harmonization of DART procedures after company merger; (3) contributed to regulatory
agency responses concerning DART issues; (4) world-wide department lead for evaluation of human
risk assessment of DART effects using the FDA Integrative Assessment Tool Guidance. (5) Lead user
for in-house document management system and DART data collection system (TFR/Tox).
Member of the Sanofi-Synthelabo Molecular Toxicity Working Group to devise genomic research
strategies world-wide. Set up the site Molecular Toxicology laboratory and participated in regular lab
meetings. Committee member for Masters of Science Thesis Candidate.
Member of the site Institutional Animal Care and Use Committee. Reviewed and approved all studies
involving animals at the site; participated in semi-annual vivarium inspections and annual reviews of
the Animal Care and Use Program.
1996 - 1998 Fox Chase Cancer Center, Philadelphia, PA
Postdoctoral Associate, Department of Medical Oncology
Studied the function of a new lab-identified putative tumor suppressor gene on chromosome 17p13.3,
and its role in breast and ovarian cancer, using a variety of cloning and expression techniques.
1992 – 1995 University of Rochester, Rochester, NY
Postdoctoral Fellow, Department of Environmental Medicine

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Received an NIH NRSA grant to investigate the molecular mechanisms involved in the observed
antiestrogenic effects of TCDD, with emphasis on the downregulation of the estrogen receptor (ER).
1992 – 1995 University of Rochester, Rochester, NY
Predoctoral Candidate, Toxicology Training Program
Developed novel, 3-D culture systems for the human trophoblast and the normal human endometrium,
as a model system for testing the effect of xenobiotics on embryonic implantation.
EDUCATION
1991 Ph.D., Toxicology, Toxicology Training Program, School of Medicine and
Dentistry, University of Rochester, Rochester, NY
1988 M.S., Toxicology, University of Rochester, Rochester, NY
1984 B.S., Chemistry; second major, Biology, Southampton College of Long Island
University, Southampton, NY, graduated Magna cum Laude
PROFESSIONAL ORGANIZATIONS and ACTIVITIES
Teratology Society: Current President (2015-2016)
• Vice President elect (2013-2014), Vice President (2014-2015)
• Council Member (2010-present); Education Cmte (2006-2010, Chair 2008-2009); Public
Affairs Cmte (2006-2009); Publications Cmte (2009 to 2012); TS Member (1987-present)
ILSI-HESI DART Subcommittee, Scientific Advisor (2012 – present)
• FDA Pregnancy Labeling Revision – Co-organizer of “Labels Without Categories: A
Workshop on FDA’s Pregnancy and Lactation Labeling Rule”, 20-21 May 2015,
Arlington, VA
• FcRn Cross-Species Expression Project
• Neonatal Drug Development Project
Editorial Board for Reproductive Toxicology
Editorial Board for Journal of Applied Toxicology
Reviewer for Birth Defects Research, Part B
BioSafe, member (2008–2012); member of Expert WG on CBER products (2007–2012)
Oligonucleotide Safety Working Group: Reproductive Toxicology approaches for
Oligonucleotides (2011-2014)
Mid-Atlantic Reproduction and Teratology Association (MARTA), member (1994-present),
council member (2001-2004)
SELECTED PUBLICATIONS, ABSTRACTS, PRESENTATIONS
Invited Speaker Presentations
White, TEW. Using Animal Data to Communicate Human Risk. Labels Without Categories: A
Workshop on FDA’s Pregnancy and Lactation Labeling Rule, 20-21 May 2015, Arlington, VA
White, TEK. Oligonucleotide Safety Working Group (OSWG) Subcommittee Report on
Reproductive and Developmental Toxicity Testing of Oligonucleotide Therapeutics.

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DIA/FDA Oligonucleotide-based Therapeutics Conference, Washington, DC, 25–27 September
2013.
White, TEK. The Effects of Glucose Lowering Drugs and Hypoglycemia on Embryo-Fetal
Development. American College of Toxicology, 33rd
Annual Meeting, Champions Gate, FL,
November 4-7, 2012.
White TEK, Posobiec L. In vitro tests and their use in the assessment of risks to reproduction. UK
Industrial Reproductive Toxicology Discussion Group (IRDG) Meeting, November 19, 2009.
White TEK. HESI Developmental Toxicology – New Directions Workshop, Overview of
afternoon session: refinement of traditional dart study designs (45 min talk with examples).
Washington, DC, April 29–30, 2009.
White TEK. Species selection for reproductive toxicity testing of biopharmaceuticals. Annual
MARTA Meeting, Philadelphia, PA, October 17, 2008.
White TEK. Debate on the use of non-human primates for reproductive and developmental
toxicity studies for monoclonal antibody biopharmaceuticals. Annual BioSafe Meeting, San
Diego, California, October 2–3, 2007.
White TEK, Clark RL. Mechanisms of artesunate-induced developmental toxicity in the rat and
primate and ramifications for human exposures. World Health Organization, Geneva, Switzerland,
January 2006.
White TEK. Production of α2-PEG by endometrial cells in ECM culture. International
Conference on Endocrinology and Metabolism in Human Reproduction, Guy’s Hospital, London,
United Kingdom, September 1989.
White TEK. The human trophoblast in spheroid culture. American Gynecology Club Meeting
Rochester, NY, May 18–20, 1988.
White TE. Direct fetal injection: A method and its application to the study of Cd-induced
hydrocephalus in the Wistar rat fetus. Annual MARTA Meeting, Groton, CT, October, 1986.
Original Research Articles
Cavagnaro J, Berman C, Kornbrust D, White T, Campion S, Henry S. Considerations for
assessment of reproductive and developmental toxicity of oligonucleotide-based therapeutics.
Nucleic Acid Therapeutics 2014; 24(5): 313-325.
DeSesso, JM, Scialli AR, White TEK, Breckenridge CB. Atrazine multigeneration reproductive
toxicity and male developmental reproduction studies in rats. Birth Def Res Part B: 2014;
101:237–253 [Epub ahead of print, 2 May].
Posobiec LM, Bushdid PB, Laffan SB, Clark RL, White TEK. Dihydroartemisinin (DHA)
treatment causes decreased proliferation and apoptosis in rat embryonic erythroblasts in whole
embryo culture. Birth Defects Research, Part B 2013; 98: 445–458. [Recipient of the 2014
Teratology Society Wilson Award for best paper.]

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Ziejewski, MK, Solomon HM, Stanislaus D, Clark RL, White TEK, Apostoli AR. The potential
role for corticosterone in the induction of cleft palate in mice after treatment with a selective NK-1
receptor antagonist, Casopitant (GW679769B). Birth Defects Research, Part B 2011; 95:54–62.
Clark RL, Lerman SA, Cox EM, Gristwood WE, White TEK. Developmental toxicity of
artesunate in the rat: Comparison to other artemisinins, comparison of embryotoxicity and
kinetics by oral and intravenous routes, and relationship to maternal reticulocyte count. Birth
Defects Research, Part B 2008; 83:397–406.
White TEK, Clark RL. Sensitive periods for developmental toxicity of orally administered
artesunate in the rat. Birth Defects Research, Part B 2008; 83:407–417.
Clark RL, Arima A, Makori N, Nakata Y, Bernard F, Gristwood W, Harrell A, White TEK, Wier
PJ. Artesunate: Developmental toxicity and toxicokinetics in Monkeys. Birth Defects Research,
Part B 2008; 83:418–434.
Rehm S, White TEK, Zahalka EA, Stanislaus DJ, Boyce RW, Wier PJ. Effects of food restriction
on testis and accessory sex glands in maturing rats. Toxicologic Pathology 2008; 36:687–694.
White TEK, Bushdid PB, Ritter S, Laffan SB, Clark RL. Artesunate-induced depletion of
embryonic erythroblasts precedes embryolethality and teratogenicity in vivo. Birth Defects
Research, Part B 2006; 77:413–429.
Clark RL, White TEK, Clode SA, Gaunt I, Winstanley P, Ward SA. Developmental toxicity of
artesunate and an artesunate combination in the rat and rabbit. Birth Defects Research, Part B
2004; 71:380–394.
White TEK, Rucci G, Liu Z, Gasiewicz TA. Weanling female Sprague-Dawley rats are not
sensitive to the antiestrogenic effects of 2,3,7,8-tetrachlorodibbenzo-p-dioxin (TCDD).
Toxicology and Applied Pharmacology 1995; 133:313–320.
White TEK, Gasiewicz TA. The human estrogen receptor structural gene contains a DNA
sequence that binds activated mouse and human Ah receptors: A possible mechanism of estrogen
receptor regulation by 2,3,7,8-tetrachlorodibenzo-p-dioxin. Biochemical and Biophysical
Research Communications 1993; 193(3):956–962.
White TEK, Di Sant’Agnese PA, Miller RK. Human endometrial cells grown on an extracellular
matrix form simple columnar epithelia and glands. In Vitro Cellular & Developmental Biology
1990; 26(6):636–642.
White TEK, Baggs RB, Miller RK. CNS lesions in the Wistar rat fetus following direct fetal
injections of cadmium. Teratology 1990; 42:7–13.
White TE, Saltzman RA, Di Sant’Agnese PA, Keng PC, Sutherland RM, Miller RK. Human
choriocarcinoma (Jar) cells grown as multicellular spheroids. Placenta 1988; 9:583–598.

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Woodhead AD, Grist E, Carlson C, White TE, Waldstein E, Cao E-H. Presence of O6-
methylguanine acceptor protein in the tissues of different classes of vertebrates and invertebrates.
Comparative Biochemistry and Physiology 1986; 85(B):125.
Conference Presentations
White TEK, Simmons SJ, Noteboom SA, Qualls CD, Chmielewski G, Harris SB, Ivett JL. Cardiovascular defects
induced by 6-aminonicotinamide in a validation study with NZW rabbits. Platform Presentation, Teratology Society
Meeting, Baltimore, MD, 2012.
Carruthers, CM, Thakur A, Chen H, Stitcher B, White TEK (presenter), Ivett J. Rat fetal pathology concordance
study. Poster Presentation, Teratology Society Meeting, San Diego, CA, 2010.
White TEK, James A, Roberts K, Laffan S, Thomas R, Bushdid P, Gibbard A, Steplewski K, Wier P, Clark R.
Disruption of visceral yolk sac proteolysis underpins developmental toxicity of a multiple Cathepsin inhibitor (SB-
462795) in rodents. Poster Presentation, Teratology Society Meeting, Puerto Rico, 2009.
White TEK, Lordi AW, Bushdid PB, Cox EM, Floyd LE, Fishman CE, Solon EG, Clark RL. Autoradiography
reveals specific labeling of embryonic and fetal red blood cells by the anti-malarial, Artesunate. Birth Defects
Research, Part A 2007; 79:362. Platform Presentation, Teratology Society Meeting, Pittsburgh, PA, 2007.
White TEK, Ritter S, Chadderton AR, Bushdid PB, Laffan SB, Clark RL. Early artesunate-induced changes in the
rat embryo preceding embryolethality and teratogenicity. Platform Presentation, Teratology Society Meeting, St.
Petersburg, FL, 2005.
White T, Clode S, Gaunt I, Ward S, Powell C, Clark R. Developmental toxicity of the antimalarial artesunate in rats
and rabbits. Platform Presentation, Teratology Society Meeting, Vancouver, Canada, 2004.
White TEK, Prowse AH, Horak S, Vanderveer L, Godwin AK. OVCA2, a RBAb461/VBP1 interacting protein that
is abnormally expressed in multiple tumor types. Poster Presentation, American Association for Cancer Research
Meeting, New Orleans, LA, 1998.
White TEK, Rucci G, Lui Z, Gasiewicz TA. TCDD is not antiestrogenic in weanling Sprague-Dawley rats. Poster
Discussion Presentation: Society of Toxicology Meeting, Baltimore, MD, 1995.
White TEK, Gasiewicz TA. The TCDD-activated Ah receptor binds a DRE sequence in the human estrogen receptor
(hER) gene. Poster Discussion Presentation: Society of Toxicology Meeting, New Orleans, LA, 1993.
White TEK, Scott KJ, Miller RK. Peri-implantation toxicity of cadminum: Effects on three-dimensional cultures of
human endometrium and trophoblast. Poster Presentation, 12th Annual Rochester Trophoblast Conference,
Rochester, NY, 1992.
White TEK, Teisner B, Grudzinskas JG, Miller RK. PP-14 production by human endometrial cells in extracellular
matrix (ECM) culture varies with the phase of the menstrual cycle. Biology of Reproduction 1990; 42 (suppl. 1):163.
Poster Presentation, 23rd Annual Society for the Study of Reproduction Meeting, Knoxville, TN, 1990.
White TEK, Miller RK, Grudzinskas JG, Lower A, Fay T, Teisner B. Human endometrial cells grown on
extracellular matrix (ECM) form an in vivo-type morphology and produce the endometrial protein PP-14, (a2-PEG).
Placenta 1989; 10:520. Poster Presentation, European Placental Group Meeting, Dourdon, France, 1989.
White TEK, Miller RK. Coculture of three-dimensional trophoblast cultures with human endometrial cells. Platform
Presentation, 11th Annual Rochester Trophoblast Conference, Rochester, NY, 1988.
White TEK, Miller RK. Human endommetrial cells grown on extracellular matrix (ECM): Formation of a simple
cuboidal epithelium and primitive glands. Biology of Reproduction 1988; 38 (Suppl. 1):132. Poster Presentation,
21st Annual Society for the Study of Reproduction Meeting, Seattle, WA, 1988.

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White TE, Baggs RB, Miller RK. Cadmium-induced hydrocephalus in the Wistar rat fetus following direct fetal
injections. Teratology 1986; 33:65C. Poster Presentation, Annual Teratology Meeting, Boston, MA, 1986.
Abstracts
Laffan, S, James A, Mirabella R, Zimmerman D, Yeager J, Wier P, Clark R, White TEK. Visceral yolk sac
alterations associated with the developmental toxicity of the Cathepsin inhibitor SB-462795. Poster Presentation,
Teratology Society Meeting, Puerto Rico, 2009.
Posobiec LM, Bushdid PB, Laffan SB, Clark RC, White TEK. Dihydroartemisinin (DHA) treatment causes
decreased proliferation and apoptosis in rate embryonic erythroblasts in whole embryo culture. Birth Defects
Research, Part A 2007; 79:361. Platform Presentation, Teratology Society Meeting, Pittsburgh, PA, 2007.
Laffan S, James A, Maleeff B, Pagana J, Bushdid P, Clark R, White TEK. Mitochondrial involvement of artesunate
toxicity in rat embryonic erythroblasts. Platform Presentation, Teratology Society Meeting, Tucson, AZ, 2006.
Bushdid PB, Gibbard A, Pagana J, White TEK. Calvarium organ culture. Poster Presentation, Teratology Society
Meeting, Tucson, AZ, 2006.
Clark RL, Kumemura M, Makori N, Nakata Y, Bernard FA, Harrell AW, White TEK, Arima A. Artesunate embryo-
fetal development study in cynomolgous monkeys. Platform Presentation, Teratology Society Meeting, Tucson, AZ,
2006.
Laffan, SB, Chadderton AR, White TEK, Solomon HM, Clark RL. In-vitro sensitivity of rat embyronic blood cells
to the anti-malarial drug artesunate. Platform Presentation, Teratology Society Meeting, St. Petersburg, FL, 2005.
Chadderton AR, Kartikeyan R, Zhang C, Bushdid P, Schiccitano M, Clark RL, White TEK. Development of colony
forming assays to evaluate haematopoiesis and erythropoiesis in the rat embryo and visceral yolk sac. Platform
Presentation, Teratology Society Meeting, Vancouver, Canada, 2004.
Chadderton, A, McFarland D, Floyd L, Zimmerman D, White TEK, Clark R, Wier P, Augustine K. Development
and Validation of a 5-color, 7 parameter flow cytometry assay to quantify vascular endothelial cells (VECS) in rat
embryo and yolk sac. Platform Presentation, Teratology Society Meeting, Philadelphia, PA, 2003.
Roadcap, LT, Shultz VD, White TEK, Roberts AE. Investigation of gene expression profiles of hepatotoxic and non-
hepatotoxic thioxanthone anti-tumor agents using cDNA microarrays. Poster Discussion Presentation: Society of
Toxicology Meeting, Nashville, TN, 2002.
Roadcap, LT, Shultz VD, White TEK, Roberts AE. Utilizing gene array technology to investigate toxicity
mechanisms of cisplatin and its analog, DACH-Pt(II). Poster Presentation, Functional Genomics Satellite Meeting to
the 8th International Conference on Environmental Mutagens (ICEM), Seattle, WA, October, 2001.
Yermakoff, JK, White TEK, RT Drew. Increases in lung lysyl oxidase and cells recovered in rats following short
term ozone exposure. The Toxicologist. Proceedings from the 1983 Society of Toxicology Meeting.