• Dr. Scialli

    is a leading expert in the areas of Developmental and Reproductive Toxicology (DART), study design and interpretation, reproductive epidemiology, pregnancy labeling, and more.

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  • Services

    Scialli Consulting offers a wide array of expert review and consulting services.



Dr. Scialli's consulting services include, but are not limited to, the following.

Expert Review

Dr. Scialli brings his expertise in the interpretation of experimental animal and epidemiology literature to your regulatory and litigation problems. He has provided consultation on the meaning and significance of data packages in developmental and reproductive toxicology (DART) particularly with respect to regulatory implications. He has functioned with teams preparing for regulatory submissions and hearings.

  • Review of nonclinical DART package in preparation for submission
  • Evaluation of nonclinical package with respect to
    • Contraception recommendations for clinical trials
    • Go/no-go decisions in product development
    • Product labeling negotiations
  • Medical record and literature review for litigation
  • Presentations to regulatory agencies and advisory bodies
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Research and Writing

Dr. Scialli has provided extensive literature reviews for internal use or for publication. His experience as a journal editor, reviewer, and contributor enable him to compile, format, and place papers for publication where they will reach your intended audience. Dr. Scialli has contacts in contract and university laboratories and has placed and monitored studies in these research organizations.

  • Literature review on the childhood effects of pregnancy exposures to a common pharmaceutical product
  • Review of implications of REACH legislation and revised classification and labeling scheme
  • Participation in workshop on the impact of maternal toxicity in experimental studies
  • Novel evaluation method of methotrexate embryopathy
  • Comprehensive reviews on aspects of reproductive physiology to assist in development of consumer products
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Educational Programs

As an experienced medical educator, Dr. Scialli continues to participate in the teaching programs of two academic medical centers. He remains active in lecturing and in the conduct of seminars in the health care arena.

  • Partipates in a national course in teratology
  • Serves on Teratology Society committees that assist in the development and design of Society meetings
  • Designs and presents programs for other national professional societies
  • Invited faculty at national and international educational programs
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Other Services

Developmental and Reproductive Toxicology (DART)

Design and Interpretation of DART Studies (including alternative test systems)

Reproductive Epidemiology

Obstetrics, Gynecology, and Reproductive Medicine

Pharmaceutical Products and Devices in Reproductive Medicine

Regulatory Aspects of Reproductive and Developmental Toxicology

Pregnancy Labeling of Pharmaceutical Products

Medical Education


Dr. Scialli's biography, curriculum vitae, and recent projects.
  • About Dr. Scialli

    Tony Scialli is a specialist in reproductive and developmental toxicology and in obstetrics and gynecology. In addition to his consulting services, he is Clinical Professor of Obstetrics and Gynecology at George Washington University School of Medicine and Adjunct Professor of Obstetrics and Gynecology and of Pharmacology and Physiology at Georgetown University Medical Center.

    Dr. Scialli directs the Reproductive Toxicology Center, a non-profit foundation in Washington, D.C., which maintains Reprotox®, an online data base on the effects on reproduction of drugs, chemicals, biologicals, and physical agents.

    A Little History

    Dr. Scialli received his Doctor of Medicine degree from Albany Medical College and completed a residency in obstetrics and gynecology at George Washington University Hospital. He took a fellowship in Reproductive Toxicology with Sergio Fabro, one of the original thalidomide researchers. Dr. Scialli was Professor of Obstetrics and Gynecology and Residency Program Director at Georgetown University Medical Center for many years.

    Dr. Scialli continues to be actively involved in medical education and teaches on a regular basis at academic medical centers in Washington, D.C. He founded and was editor-in-chief of the journal Reproductive Toxicology for 17 years and is a past president of the Teratology Society.

    Curriculum Vitae

    A current version of Dr. Scialli's Curriculum Vitae is provided below:

    Curriculum Vitae - Tony Scialli.pdf

    Recent Projects

    • Reviewed nonclinical DART package in preparation for meetings with FDA
    • Presented at FDA Advisory Committee meetings
    • Reviewed material for presentation to the European Chemicals Agency
    • Evaluated nonclinical package with respect to contraception recommendations for clinical trials
    • Reported on aspects of reproductive physiology to assist in development of consumer products
    • Reviewed medical records and scientific literature for litigation
    • Provided expert testimony
    • Prepared and participated in educational programs and grand rounds
    • Researched and prepared scientific articles and reviews with oversight through the submission, revision, acceptance, and publication process


    • Project completed on time and within budget.
    • We received a through and comprehensive report, well written, and before the deadline.
    • Dr. Scialli has an excellent understanding of the field and the regulatory environment.
    • Excellent presentation; we learned a lot.

Recent Publications

Dr. Scialli has worked on numerous publications, some of which are listed below.
  • Recent Publications

    Beyer BK, Chernoff N, Danielsson B, Davis-Bruno K, Harrouk W, Hood RD, Janer G, Liminga UW, Kim J, Rocca M, Rogers J, Scialli AR. ILSI/HESI Maternal Toxicity Workshop Summary: Maternal toxicity and its impact on study design and data interpretation. Birth Defects Res (Part B) 2011;92:36-51.


    Boffetta P, Scialli AR. TCDD and birth weight of Vietnamese infants. Environ Sci Pollution Res 2016;23:17857–17858.


    Bridges J, Dekant W, Klaunig JE, Scialli AR. Comments on the safety assessment of decamethylcyclopentasiloxane (D5). Regul Toxicol Pharmacol 2017;89:305–306.


    Carney EW, Ellis AL, Tyl RW, Foster PMD, Scialli AR, Thompson K, Kim J. Critical evaluation of current developmental toxicity testing strategies: A case of babies and their bathwater. Birth Defects Res (Part B) 2011; 92(5):395-403.


    Damkier P, Scialli AR, Lusskin SI. Acetaminophen in prgnancy and adverse childhood neurodevelopment. JAMA Pediatrics 2017; doi:10.1001/jamapediatrics.2016.5049


    Chambers C, Scialli AR. Teratogenesis and environmental exposure. In Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moore TR, Greene MF. Creasy & Resnik’s Maternal-Fetal Medicine 7th ed. Philadelphia: Elsevier Saunders; 2014: 465–472.


    Daston GP, Beyer BK, Carney EW, Chapin RE, Friedman JM, Piersma AH, Rogers JM, Scialli AR. Exposure-based validation list for developmental toxicity screening assays. Birth Defects Res (Part B) 2014;101:423–428.


    Daston GP, Chapin RE, Scialli AR, Piersma AH, Carney EW, Rogers JM, Friedman JM. A different approach to validating screening assays for developmental toxicity. Birth Defects Res (Part B) 2010;89:526–530.


    Dekant W, Bridges J, Scialli AR. A quantitative weight of evidence assessment of confidence in modes-of-action and their human relevance. Regul Toxicol Pharmacol 2017;90:51–71.


    Dekant W, Scialli AR, Plotzke K, Klaunig JE. Biological relevance of effects following chronic administration of octamethylcyclotetrasiloxane (D4) in Fischer 344 rats, Toxicol Lett 2017;279S:42–53.


    DeSesso JM, Scialli AR, White TEK, Breckenridge CB. Multigeneration reproduction and male developmental toxicity studies on atrazine in rats. Birth Defects Res (Part B) 2014; DOI: 10.1002/bdrb.21106


    Fugh-Berman AJ, Scialli AR, Bell AM. Why lunch matters: Assessing physicians’ perceptions about industry relationships. J Cont Ed Health Prof 2010;30(3):197–204.


    Goodman M, Mandel JS, DeSesso JM, Scialli AR. Atrazine and pregnancy outcomes: A systematic review of epidemiologic evidence. Birth Defects Res (Part B) 2014; DOI: 10.1002/bdrb.21101


    Huo S, Scialli AR, McGarvey S, Hill E, Tügertimur B, Hogenmiller A, Hirsch AI, Fugh-Berman A. Treatment of men for “low testosterone”: A systematic review. PLOS ONE 2016; DOI:10.1371/journal.pone.0162480.


    Hyoun SC, Običan SG, Scialli AR. Teratogen update: Methotrexate. Birth Defects Res (Part A) 2012; 94(4):187-207.


    Jean PA, Plotzke KP, Scialli AR. Chronic toxicity and oncogenicity of decamethylcyclopentasiloxane in the Fischer 344 rat. Regul Toxicol Pharmacol 2016; 74:S57–S56.


    Kim J, Scialli AR. Thalidomide: The tragedy of birth defects and the effective treatment of disease Toxicological Sciences 2011; 122(1):1–6. doi: 10.1093/toxsci/kfr088


    Klaunig JE, Dekant W, Plotzke K, Scialli AR. Biological relevance of decamethylcyclopentasiloxane (D5) induced rat uterine endometrial adenocarcinoma tumorigenesis: Mode of action and relevance to humans. Regul Toxicol Pharmacol 2016;74:S44–S56.


    Laufersweiler MC, Gadagbui B, Baskerville-Abraham IM, Maier A, Willis A, Scialli AR, Carr GJ, Felter SP, Blackburn K, Daston G. Correlation of chemical structure with reproductive and developmental toxicity as it relates to the use of the threshold of toxicological concern. Regul Toxicol Pharmacol; 2012; 62:160–182.


    Običan SG, Finnell RH, Mills JL, Shaw GM, Scialli AR. Folic acid in early pregnancy. A public health success story. FASEB J 2010; 24:4167–4174.


    Običan SG, Jahnke GD, Soldin OP, Scialli AR. Teratology Society Public Affairs Committee position paper: Iodine deficiency in pregnancy. Birth Defects Res (Part A) 2012; 94(9):677–682.


    Običan SG, Scialli AR. Teratogenic exposures. Am J Med Genet (Part C) 2011;157(3):150–169.


    Scialli AR. Serotonin reuptake inhibitors and heart defects. Reprod Toxicol 2016;63:140–141.


    Scialli AR. The National Birth Defects Prevention Study: How to communicate data. Semin Fetal Neonat Med 2014;19:170–176.


    Scialli AR, Clark RV, Chapin R. The predictivity of non-clinical male reproductive findings for human effects. Birth Defects Res 2017; doi: 10.1002/bdr2.1102


    Scialli AR, Bailey G, Beyer BK, Bøgh IB, Breslin WJ, Chen CL, DeLise AM, Hui JY, Moffat GJ, Stewart J, Thompson KE. Potential seminal transport of pharmaceuticals to the conceptus. Reprod Toxicol 2015;58:213–221.


    Scialli AR, Daston G, Chen C, Coder PS, Euling SY, Foreman J, Hoberman AM, Hui J, Knudsen T, Makris SL, Morford L, Piersma AH, Stanislaus D, Thompson KE. Rethinking developmental toxicity testing: Evolution or revolution. Birth Defects Res 2018; DOI: 10.1002/bdr2.1212.


    Scialli AR, DeSesso JM, Breckenridge CB. Developmental toxicity studies with atrazine and its major metabolites in rats and rabbits. Birth Defects Res (Part B) 2014; DOI: 10.1002/bdrb.21099


    Scialli AR, Watkins DK, Ginevan ME. Agent Orange exposure and 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in human milk. Birth Defects Res (Part B). 2015; 104:129–139.


    Scialli AR, Guikema AJ. REACH and reproductive and developmental toxicology: Still questions. Syst Biol Reprod Med 2012;58(1):63–69.


    Scialli AR. Developmental and reproductive toxicity evaluation under the European Union REACH regulations. In Hood RD, ed., Developmental and Reproductive Toxicology, Third Ed. New York: Informa Healthcare; 2012:730–735.


    Scialli AR, Ang R, Breitmeyer J, Royal MA. A review of the literature on the effects of acetaminophen on pregnancy outcome. Reprod Toxicol 2010; 495–507.


    Scialli AR, Ang R, Breitmeyer J, Royal MA. Childhood asthma and use during pregnancy of acetaminophen. A critical review. Reprod Toxicol 2010; 508–519.


    Scialli AR, Bonde JP, Brüske-Hohlfeld I, Culver D, Li Y, Sullivan FM. An overview of male reproductive studies of boron with an emphasis on studies of highly exposed Chinese workers. Reprod Toxicol 2010;29:10–24.


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Scialli Consulting is conveniently located in Georgetown, a short walk from the Foggy Bottom metro station in Washington, D.C.

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1050 30th St NW
Washington, D.C. 20007-3822

Phone: (703) 647 - 4178
Fax: (202) 249 - 0111

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