Select Publications and Posters - PETA Science Consortium International e.V.

The following are select scientific publications and posters co-authored by PETA Science Consortium International and its members. Additional publications related to reducing animal use can be found here.

Acute Systemic Toxicity (General)

Sullivan K, Allen DG, Clippinger AJ, Wilson DM, Edwards SW, Glover K, Mansouri K, Settivari R, Wijeyesakere S, Casey W. Mind the gaps: prioritizing activities to meet regulatory needs for acute systemic lethality. ALTEX. 2021;38(2):327-335.
Strickland J, Clippinger AJ, Brown J, Allen D, Jacobs A, Matheson J, Lowit A, Reinke EN, Johnson MS, Quinn MJ Jr., Mattie D , Fitzpatrick SC, Ahir S, Kleinstreuer N, Casey W. Status of acute systemic toxicity testing requirements and data uses by US regulatory agencies. Regul Toxicol Pharmacol. 2018;94:183-196.
Hamm J, Sullivan K, Clippinger AJ, Strickland J, Bell S, Bhhatarai B, Blaauboer B, Casey W, Dorman D, Forsby A, Garcia-Reyero N, Gehen S, Graepel R, Hotchkiss J, Lowit A, Matheson J, Reaves E, Scarano L, Tunkel J, Wilson D, Xia M, Zhu H, Allen D. Alternative approaches for identifying acute systemic toxicity: moving from research to regulatory testing. Toxicol In Vitro. 2017;41:245-259.
Manuppello JR, Charles-Horvath P, Sandler J. Avoiding dermal systemic toxicity testing. Appl In Vitro Toxicol. 2015;1(3):173-174.

Antibodies

Groff K, Weber T, Clippinger AJ. Practical pathways to address reagent source as a variable in study reproducibility. Poster presented at: American Society for Cellular and Computational Toxicology 11^thAnnual Meeting; 2022; Chapel Hill, NC.
Groff K, Allen D, Fiebig M, Cosson P, Casey W, Clippinger AJ. An approach to identifying quality research antibodies. BioTechniques. 2022;73(4):167-170.
Naab A, Brown J, Wenzel E, Dübel S, Stickings P, Hust M. Novel human-relevant preclinical safety testing strategy for recombinant human monoclonal antibodies directed against foreign targets. Poster presented at: Summer School on Innovative Approaches in Science; 2022; Research Triangle Park, NC.
Brown J, Wenzel E, Coombs L, Dübel S, Stickings P, Sesardic T, Hust M. Successful development of recombinant human diphtheria antitoxin: a project update. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.
Wenzel EV, Bosnak M, Tierney R, Schubert M, Brown J, Dübel S, Efstratiou A, Sesardic D, Stickings P, Hust M. Human antibodies neutralizing diphtheria toxin in vitro and in vivo. Sci Rep. 2020;10(1):571.
Groff K, Allen D, Casey W, Clippinger AJ. Increasing the use of animal-free recombinant antibodies. ALTEX. 2020;37(2):309-311.
Wenzel E, Coombs L, Brown J, Dübel S, Stickings P, Sesardic T, Hust M. Development of recombinant human anti-diphtheria toxin neturalizing antibody for diphtheria therapy. Poster presented at: 2^nd German Pharm-Tox Summit; 2017; Heidelberg, Germany.
Groff K, Brown J, Clippinger AJ. Affinity reagents to replace animal-derived antibodies. Poster presented at Pan-American Conference for Alternative Methods; 2016; Baltimore, MD.
Groff K, Brown J, Clippinger AJ. Modern affinity reagents: recombinant antibodies and aptamers. Biotechnol Adv. 2015;33(8):1787-1798.
Echko MM, Dozier SK. Recombinant antibody technology for the production of antibodies without the use of animals. AltTox.org. 2010.

Carcinogenicity and Genotoxicity

Freeman E, Wilson K, Hilton G, Wolf DC, Goetz AK. Key learnings from OECD IATA case studies on carcinogenicity assessment of agrochemicals. Poster presented at: Society of Toxicology 63^rdAnnual Meeting; 2024; Salt Lake City, UT.
Braun P, Fowler P, Hendriks G, Stoddart G. A framework for interpreting in vitro genotoxicity data: Using mechanistic data to interpret positive results. Poster presented at: 51^stCongress of the European Environmental Mutagenesis and Genomics Society; 2023; Malaga, Spain.
Hilton GM, Corvi R, Luijten M, Mehta J, Wolfe DC. Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment. Regul Toxicol Pharmacol. 2023;137:105301.
Hilton GM, Adcock C, Akerman G, Baldassari J, Battalora M, Casey W, Clippinger AJ, Cope R, Goetz A, Hayes AW, Papineni S, Peffer RC, Ramsingh D, Riffle BW, Sanches da Rocha M, Ryan N, Scollon E, Visconti N, Wolf DC, Yan Z, Lowit A. Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): a reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays. Regul Toxicol Pharmacol. 2022;131:105160.
Felter SP, Bhat VS, Botham PA, Bussard DA, Casey W, Hayes AW, Hilton GM, Magurany KA, Sauer UG, Ohanian EV. Assessing chemical carcinogenicity: hazard identification, classification, and risk assessment. Insight from a Toxicology Forum state-of-the-science workshop. Crit Rev Toxicol. 2022;51(8):653-694.
Groff K, Evans SJ, Doak SH, Pfuhler S, Corvi R, Saunders S, Stoddart G. In vitro and integrated in vivo strategies to reduce animal use in genotoxicity testing. Mutagenesis. 2021;36(6):389-400.
Hilton GM, Akerman G, Baldassari J, Battalora M, Buesen R, Clippinger AJ, Cope R, Goetz A, Hayes AW, Kormos T, Lowit A, Melching-Kollmuss S, Papineni S, Peffer RC, Williamson Riffle B, Sanches da Rocha M, Ryan N, Scollon E, Visconti N, Wolf DC, Yan Z. Rethinking carcinogenicity assessment for agrochemicals. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.
Goetz A, Ryan N, Sauve-Ciencewicki A, Lord C, Hilton GM, Wolf DC. Assessing human carcinogenicity risk without the rodent cancer bioassay. Poster presented at: Society of Toxicology 60^th Annual Meeting; 2021; Virtual.
Luijten M, Corvi R, Mehta J, Corvaro M, Delrue N, Felter S, Haas B, Hewitt NJ, Hilton G, Holmes T, Jacobs MN, Jacobs A, Lamplmair F, Lewis D, Madia F, Manou I, Melching-Kollmuss S, Schorsch F, Schutte K, Sewell F, Strupp C, Willem van der Laan J, Wolf DC, Wolterink G, Woutersen R, Zvonar Z, Heusinkveld H, Braakhuis H. A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals. Regul Toxicol Pharmacol. 2020;118:104789.

Computer Modelling

PETA Science Consortium International. QSARs, grouping and read-across. A guide to sources of information and advice.
Aladjov H, Clippinger AJ, Sullivan K, Veith G. Effectopedia – an open collaborative platform for AOP development and application. Poster presented at: Society of Toxicology 54^th Annual Meeting; 2015; San Diego, CA.
Sullivan KM, Manuppello JR, Willett CE. Building on a solid foundation: SAR and QSAR as a fundamental strategy to reduce animal testing. SAR QSAR Environ Res. 2014;25(5):357-365.

Developmental Neurotoxicity

Culbreth M, Byrd G, Harris F, Willis C, Carstens K, Harrill JA. High-throughput phenotypic profiling approach for the screening and prioritization of potential developmental neurotoxicity hazard. Poster presented at: Society of Toxicology 62^nd Annual Meeting; 2023; Nashville, TN.

Dissection

PETA International Science Consortium Ltd. Humane alternatives to animal dissection: a practical guide to cutting out dissection.

Ectoparasiticides

Groff K. Non-animal efficacy testing approaches for ectoparasiticides. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.
Groff K, Bishop P. Itching for change: embracing modern flea and tick product development. Regul Toxicol Pharmacol. 2017;88:349-355.

Endocrine Disruption

Bishop P, Willett C. The use and acceptance of other scientifically relevant information (OSRI) in the US Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program. Birth Defects Res B Dev Reprod Toxicol. 2014;101(1):3-22.
Willett CE, Bishop PL, Sullivan KM. Application of an integrated testing strategy to the US EPA Endocrine Disruptor Screening Program. Toxicol Sci. 2011;123(1):15-25.

Ecotoxicity

Faßbender C, Green JW, Handley J, Hutchinson TH, Weltje L, Faber D, Stoddart G. Reducing the number of controls in fish early life stage toxicity tests when solvents are used. Poster presented at: European Society of Alternatives to Testing on Animals (EUSAAT) congress; 2022; Linz, Austria.
Paparella M, Scholz S, Belanger S, Braunbeck T, Bicherel P, Connors K, Faßbender C, Halder M, Lillicrap A, Liska R, Schirmer K, Stoddart G, Thomas P, Walter-Rohde S. Limitations and uncertainties of acute fish toxicity assessments can be reduced using alternative methods. ALTEX. 2020;38(1):20-32.
Faßbender C, Paparella M, Belanger S, Bicherel P, Bopp S, Braunbeck T, Connors K, Halder M, Kienzler A, Langan L, Laue L, Lillicrap A, Schirmer K, Scholz S, Walter-Rohde S, Stoddart G. Developing an integrated approach to testing and assessment for acute fish toxicity. Poster presented at: SETAC Europe 29^th Annual Meeting; 2019; Helsinki, Finland.
Faßbender C, Stoddart G, Halder M, Salinas E, Wigh A, Hunter W. Testing poorly water-soluble test chemicals according to the updated OECD Guidance Document 23 on aqueous-phase aquatic toxicity testing of difficult test chemicals. Poster presented at SETAC Europe 29^th Annual Meeting; 2019; Helsinki, Finland.
Hilton G, Odenkirchen E, Panger M, Waleko G, Lowit A, Clippinger AJ. Evaluation of the avian acute oral and sub-acute dietary toxicity test for pesticide registration. Regul Toxicol Pharmacol. 2019;105:30-35.
Hilton G, Panger M, Odenkirchen E, Lowit A, Clippinger A. Examination of the acute oral versus sub-acute dietary testing in avian risk assessment conclusions. Poster presented at: Society of Toxicology 58^th Annual Meeting; 2019; Baltimore, MD.
Stoddart G, Faßbender C, Halder M, Salinas E, Hunter W. Updates to OECD Guidance Document 23: aqueous-phase aquatic toxicity testing of difficult test chemicals. Poster presented at: 54^th Congress of the European Societies of Toxicology; 2018; Brussels, Belgium.
Faßbender C, Altmann D, Paparella M, Walter-Rohde S, Rawlings J, Belanger S, Braunbeck T, Scholz S, Stoddart G. Reducing the number of fish used in acute toxicity testing: incorporation of the fish embryo acute toxicity test into the threshold approach. Poster presented at: Fish and Amphibian Embryos as Alternative Models in Toxicology and Teratology symposium; 2016; Paris, France.
Bishop P, Faßbender C, Altmann D, Paparella M, Walter-Rohde S, Rawlings J, Belanger S, Braunbeck T, Scholz S, Stoddart G. Reducing the number of fish used in acute toxicity testing: incorporation of the fish embryo acute toxicity test into the threshold approach. Poster presented at: 7^th SETAC World Congress/SETAC North America 37^th Annual Meeting; 2016; Orlando, FL.
Stoddart G, Faßbender C, Bishop P, Halder M, Sullivan K. Strategies for reducing the number of fish used in aquatic toxicity tests. Poster presented at: SETAC Europe 26^th Annual Meeting; 2016; Nantes, France.
Stoddart G, Sullivan K. Strategies to reduce the number of fish used in ecotoxicity tests. Poster presented at: 9^th World Congress on Alternatives and Animal Use in the Life Sciences; 2014; Prague, Czech Republic.

Eye Irritation/Corrosion

Daniel A, van der Zalm AJ, Raabe H, Clippinger AJ, Kleinstreuer N, Allen DG. Predicting GHS hazard classification for eye irritation/corrosion potential of agrochemical formulations using defined approaches. Poster presented at: Society of Toxicology 63^rdAnnual Meeting; 2024; Salt Lake City, UT.
van der Zalm AJ, Daniel AB, Raabe HA, Choksi N, Silva TJ, Breeden-Alemi J, O’Dell L, Kleinstreuer NC, Lowit AB, Allen DG, Clippinger AJ. Defined approaches to classify agrochemical formulations into EPA hazard categories developed using EpiOcular^TM reconstructed human corneal epithelium and bovine corneal opacity and permeability assays. Cutan Ocul Toxicol. 2024;43(1):58-58.
Beardslee RA, Salazar K, van der Zalm AJ, Camacho IA, Brunner R, Raabe H, Allen D, Daniel A, Kleinstreuer N, O’Dell L, Clippinger AJ, Scarano L, Lowit A. Evaluating new chemicals in the US under the Toxic Substances Control Act: application of new approach methods to evaluate eye irritation. Poster presented at: Society of Toxicology 62^nd Annual Meeting; 2023; Nashville, TN.
Daniel AB, van der Zalm AJ, Clippinger AJ, Kleinstreuer NC, Allen DG. Three-phase testing of agrochemical formulations: developing a defined approach for eye irritation potential. Poster presented at: Society of Toxicology 62^nd Annual Meeting; 2023; Nashville, TN.
Clippinger AJ, Raabe HA, Allen DG, Choksi N, van der Zalm A, Kleinstreuer N, Barroso J. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.
Clippinger AJ, Raabe HA, Allen DG, Choksi N, van der Zalm A, Kleinstreuer N, Barroso J, Lowit AB. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxicol. 2021;40(2):145-167.
Allen D, Choksi N, Gehen S, Casey W, Clippinger AJ. Public-private partnerships to advance in vitro eye irritation testing methods and approaches. Poster presented at: American Society for Cellular and Computational Toxicology 7^th Annual Meeting; 2018; Bethesda, MD.
Clippinger AJ, Hill E, Curren R, Bishop P. Bridging the gap between regulatory acceptance and industry use of non-animal methods. ALTEX. 2016;33(4):453-458.

Foetal Bovine Serum

Chary A, Groff K, Stucki AO, Contal S, Stoffels C, Cambier S, Sharma M, Gutleb AC, Clippinger AJ. Maximizing the relevance and reproducibility of A549 cell culture using FBS-free media. Toxicol In Vitro. 2022;83:105423.
Chary A, Stucki AO, Groff K, Contal S, Stoffels C, Cambier S, Sharma M, Gutleb AC, Clippinger AJ. Using FBS-free media in in vitro cell cultures: a case study in transitioning and characterizing A549 cells. Poster presented at: Society of Toxicology 61^st Annual Meeting; 2022; San Diego, CA.
PETA Science Consortium International e.V. Alternatives to the use of foetal bovine serum in cell culture applications.
Stoddart G, Faßbender C. Towards the replacement of foetal bovine serum in cell culture applications. Poster presented at: 10^th World Congress on Alternatives and Animal Use in the Life Sciences; 2017; Seattle, WA.

Food Safety

Groff K, Pandey A. International approaches to implementing alternative test methods for marine biotoxins in shellfish. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.

High Production Volume Chemical Testing Program

Bishop PL, Manuppello J, Willett CE, Sandler JT. Animal use and lessons learned in the US High Production Volume Chemicals Challenge Program. Environ Health Persp. 2012;120(12):1631-1639.
Manuppello J, Willett C, Sandler J. US Environmental Protection Agency High Production Volume Chemicals Challenge Program: accounting for the animals. Poster presented at: 7^th World Congress on Alternatives and Animal Use in the Life Sciences; 2009; Rome, Italy.
Sandusky CB, Even M, Stoick K, Sandler J. Strategies to reduce animal testing in US EPA’s HPV Programme. ALTEX. 2006;23:117-119.

Inhalation Toxicity

Sharma M, Stucki AO, Verstraelen S, Jacobs A, Roldan N, Hollanders K, Van Laer J, Remy S, Frijns E, Clippinger AJ. The INSPIRE initiative: using human cell-based in vitro systems to assess respiratory toxicity of surfactants delivered as liquid or aerosols. Poster presented at: Society of Toxicology 63^rdAnnual Meeting; 2024; Salt Lake City, UT.
Sharma M, Stucki AO, Verstraelen S, Stedeford TJ, Jacobs A, Maes F, Poelmans D, Van Laer J, Remy S, Frijns E, Allen DG, Clippinger AJ. Human cell-based in vitro systems to assess respiratory toxicity: a case study using silanes. Toxicol Sci. 2023;195(2):213-230.
Marimoutou M, Patel VS, Amin K, Ukishima L, Wahab AF, Alvarez J, Battle K, Hughes J, Stucki AO, Clippinger AJ, Behrsing HP. Application of a performance characterization protocol for the assessment of normal and diseased cryopreserved human precision-cut lung slices. Poster presented at: Society of Toxicology 62^nd Annual Meeting; 2023; Nashville, TN.
Patel VS, Amin K, Wahab A, Marimoutou M, Ukishima L, Alvarez J, Battle K, Stucki AO, Clippinger AJ, Behrsing HP. Cryopreserved human precision-cut lung slices provide an immune competent pulmonary test system for “on-demand” use and long-term cultures. Toxicol Sci. 2023;191(2):253-265.
Luettich K, Sharma M, Yepiskoposyan H, Breheny D, Lowe FJ. An adverse outcome pathway for decreased lung function focusing on mechanisms of impaired mucociliary clearance following inhalation exposure. Front Toxicol. 2021;3:750254.
Petersen EJ, Sharma M, Clippinger AJ, Gordon J, Katz A, Laux P, Leibrock LB, Luch A, Matheson J, Stucki AO, Tentschert J, Bierkandt FS. Use of cause-and-effect analysis to optimize the reliability of in vitro inhalation toxicity measurements using an air-liquid interface. Chem Res Toxicol. 2021;34(6):1370-1385.
Jarabek AM, Stedeford T, Ladics GS, Price OT, Tveit A, Hayes MP, Tremblay RT, Snyder SA, Salazar KD, Osman-Sypher S, Irwin W, Odin M, Melia J, Carlson-Lynch H, Sharma M, Clippinger AJ, Stucki AO, Henry TR. Poorly soluble, low toxicity (PSLT) polymer category: an integrated approach to testing and assessment (IATA) including new approach methods (NAMs) under the Toxic Substances Control Act (TSCA). Poster presented at: Society of Toxicology 60^th Annual Meeting; 2021; Virtual.
Henry TR, Salazar KD, Hayes MP, Kennedy W, Keene AM, Jarabek AM, Price OT, Moors S, Jovanovich L, Rose JL, Tveit A, Tremblay RT, Becker RA, Osman-Sypher S, McMullen PD, Slattery SD, Irwin W, Odin M, Melia J, Sharma M, Clippinger AJ, Stucki AO, Stedeford T. Surfactants category: an integrated approach to testing and assessment (IATA) including new approach methods (NAMs) for assessing inhalation risks under the Toxic Substances Control Act (TSCA). Poster presented at: Society of Toxicology 60^th Annual Meeting; 2021; Virtual.
Sharma M, Rothen-Rutishauser B, Barosova H, Stone V, Hayden P, Maione A, Jackson GR, Clippinger AJ. Characterization and use of organotypic lung model to assess the pulmonary fibrosis of nanomaterials. Poster presented at: Society of Toxicology 59^th Annual Meeting; 2020; Virtual.
Barosova H, Maione AG, Septiadi D, Sharma M, Haeni L, Balog S, O’Connell O, Jackson GR, Brown D, Clippinger AJ, Hayden P, Petri-Fink A, Stone V, Rothen-Rutishauser B. Use of EpiAlveolar lung model to predict fibrotic potential of multi-walled carbon nanotubes. ACS Nano. 2020;14(4):3941-3956.
Clippinger AJ, Allen D, Hotchkiss JA, Wilson D, Jarabek AM, Rothen-Rutishauser B, Barosova H, Maione A, Sharma M, Chortarea S, Zerimariam F, Clift MJD, Hayden P, Stone V. Alternative approaches to inhalation toxicity testing. Poster presented at: 20^th International Congress on In Vitro Toxicology (ESTIV2018); 2018; Berlin, Germany.
Clippinger AJ, Allen D, Behrsing H, BéruBé KA, Bolger MB, Casey W, DeLorme M, Gaça M, Gehen SC, Glover K, Hayden P, Hinderliter P, Hotchkiss JA, Iskandar A, Keyser B, Luettich K, Ma-Hock L, Maione A, Makena P, Melbourne J, Milchak L, Ng S, Paini A, Page K, Patlewicz G, Prieto P, Raabe H, Reinke E, Roper C, Rose J, Sharma M, Spoo W, Thorne PA, Wilson DM, Jarabek AM. Pathway-based predictive approaches for non-animal assessment of acute inhalation toxicity. Toxicol In Vitro. 2018;52:131-145.
Clippinger AJ, Allen D, Behrsing H, Hinderliter PM, Landsiedel R, Reinke EN, Stone V. Nonanimal approaches to assessing the toxicity of inhaled substances: current progress and future promise. Appl In Vitro Toxicol. 2018;4(2):82-88.
Clippinger AJ. Application of in silico and in vitro approaches to assess the toxicity of inhaled substances. Appl In Vitro Toxicol. 2018;4(2):81.
Clippinger AJ, Allen D, Jarabek AM, Corvaro M, Gaça M, Gehen S, Hotchkiss JA, Patlewicz G, Melbourne J, Hinderliter P, Yoon M, Huh D, Lowit A, Buckley B, Bartels M, BéruBé K, Wilson DM, Indans I, Vinken M. Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: an international workshop report. Toxicol In Vitro. 2018;48:53-70.
Allen D, Wilson D, Hotchkiss J, Morefield S, Casey W, Clippinger AJ. Integrating alternative approaches to replace animals in inhalation toxicity testing. Poster presented at: 10^th World Congress on Alternatives and Animal Use in the Life Sciences; 2017; Seattle, WA.
Hilton G, Barosova H, Rothen-Rutishauser B, Bereman M. Development of a targeted mass spectrometry protein assay to identify early stages of pulmonary response to carbon nanotube exposure in a 3D lung model. Poster presented at: 10^th World Congress on Alternatives and Animal Use in the Life Sciences; 2017; Seattle, WA.
Sharma M, Nikota J, Halappanavar S, Castranova V, Rothen-Rutishauser B, Clippinger AJ. Predicting pulmonary fibrosis in humans after exposure to multi-walled carbon nanotubes (MWCNTs). Arch Toxicol. 2016;90(7):1605-1622.
Clippinger AJ, Ahluwalia A, Allen D, Bonner JC, Casey W, Castranova V, David RM, Halappanavar S, Hotchkiss JA, Jarabek AM, Maier M, Polk W, Rothen-Rutishauser B, Sayes CM, Sayre P, Sharma M, Stone V. Expert consensus on an in vitro approach to assess pulmonary fibrogenic potential of aerosolized nanomaterials. Arch Toxicol. 2016;90(7):1769-1783.
Polk WW, Sharma M, Sayes CM, Hotchkiss JA, Clippinger AJ. Aerosol generation and characterization of multi-walled carbon nanotubes exposed to cells cultured at the air-liquid interface. Part Fibre Toxicol. 2016;13:20.

Medical Devices

Nguyen A, Brown J, Costin G-E. Bringing NAMs into regulatory decision-making: Replacing the use of animals in personal lubricant biocompatibility testing via FDA’s MDDT Program. Poster presented at: American Society for Cellular and Computational Toxicology 11^th Annual Meeting; 2022; Chapel Hill, NC.
Costin G-E, Hill E, Brown J, Clippinger AJ. Qualification of a non-animal vaginal irritation method admitted as nonclinical assessment model (NAM) in the incubator phase of the United States Food and Drug Administration (US FDA) Medical Devices Development Tool (MDDT). Toxicol In Vitro. 2019;62:104680.
Brown J, Costin G-E, Hill E. Modernizing biocompatibility testing: replacing animal tests through the FDA CDRH Medical Device Development Tools (MDDT) Program. Poster presented at: International Union of Toxicology 15^th International Congress of Toxicology; 2019; Honolulu, HI.

Method Development, Validation, and Implementation

Lee KM, Corley R, Jarabek AM, Kleinstreuer N, Paini A, Stucki AO, Bell S. Advancing new approach methodologies (NAMs) for tobacco harm reduction: synopsis from the 2021 CORESTA SSPT—NAMs Symposium. Toxics. 2022;10(12):760.
Stucki AO, Clippinger AJ, Henry TR, Hirn C, Stedeford TJ, Terry C. Editorial: Chemical testing using new approach methodologies (NAMs). Front Toxciol. Published online 10 November 2022. doi.org/10.3389/ftox.2022.1048900.
Marty S, Andrus A, Groff K. Developing metrics to track animal use and the impact of NAMs. Poster presented at: American Society for Cellular and Computational Toxicology 11^thAnnual Meeting; 2022; Chapel Hill, NC.
Van der Zalm A, Barroso J, Browne P, Casey W, Henry TR, Kleinstreuer NC, Lowit AB, Perron M, Clippinger AJ. A modern framework to establish scientific confidence in New Approach Methodologies (NAMs). Poster presented at: American Society for Cellular and Computational Toxicology 11^th Annual Meeting; 2022; Chapel Hill, NC.
Miller-Holt J, Behrsing HP, Clippinger AJ, Hirn C, Stedeford TJ, Stucki AO. Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products. Front Toxciol. Published online 9 September 2022. doi.org/10.3389/ftox.2022.943358.
Stucki AO, Barton-Maclaren TS, Bhuller Y, Henriquez JE, Henry TR, Hirn C, Miller-Holt J, Nagy EG, Perron MM, Ratzlaff DE, Stedeford TJ, Clippinger AJ. Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health. Front Toxciol. Published online 1 September 2022. doi.org/10.3389/ftox.2022.964553.
Van der Zalm A, Barroso J, Browne P, Casey W, Gordon J, Henry TR, Kleinstreuer NC, Lowit AB, Perron M, Clippinger AJ. A framework for establishing scientific confidence in new approach methodologies. Arch Toxicol. 2022;96(11):2865–2879.
Marty MS, Andrus AK, Groff K. Animal metrics: tracking contributions of new approach methods to reduced animal use. ALTEX. 2022;39(1):95-112.
Pandey A. The changing face of chemicals legislation in India: opportunities to minimise testing on animals. Poster presented at: 11^th World Congress on Alternatives and Animal Use in the Life Sciences; 2021; Virtual.
Harrill JA, Viant MR, Yauk CL, Sachana M, Gant TW, Auerbach SS, Beger RD, Bouhifd M, O’Brien J, Burgoon L, Caiment F, Carpi D, Chen T, Chorley BN, Colbourne J, Corvi R, Debrauwer L, O’Donovan C, Ebbels TMD, Ekman DR, Faulhammer F, Gribaldo L, Hilton GM, Jones SP, Kende A, Lawson TN, Leite SB, Leonards PEG, Luijten M, Martin A, Moussa L, Rudaz S, Schmitz O, Sobanski T, Strauss V, Vaccari M, Vijay V, Weber RJM, Williams AJ, Williams A, Thomas RS, Whelan M. Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology. Regul Toxicol Pharmacol. 2021;125:105020.
Petersen EJ, Reipa V, Xia M, Sharma M. Resources for developing reliable and reproducible in vitro toxicological test methods. Chem Res Toxicol. 2021;34(6):1367-1369.
Petersen EJ, Nguyen A, Brown J, Elliott JT, Clippinger AJ, Gordon J, Kleinstreuer N, Roesslein M. Characteristics to consider when selecting a positive control material for an in vitro assay. ALTEX. 2021;38(2):365-376.
Bishop P, Faßbender C, Stoddart G. The dollars and sense of animal-free testing. IJEBL. 2017;6(4):118-130. PDF of article available on request.

Nanotechnology

Sharma M, Stucki A. Using non-animal approaches for the assessment of nanomaterials. European Union Observatory for Nanomaterials. 2020.
Septiadi D, Rodriguez-Lorenzo L, Balog S, Spuch-Calvar M, Spiaggia G, Taladriz-Blanco P, Barosova H, Chortarea S, Clift M, Teeguarden J, Sharma M, Petri-Fink A, Rothen-Rutishauser B. Quantification of carbon nanotube doses in adherent cell culture assays using UV‐VIS‐NIR spectroscopy. Nanomaterials. 2019;9(12):1765.
Sharma M. Analytical techniques to characterize nanomaterials in pristine form and as used in food contact materials. In: Veraart R, ed. The Use of Nanomaterials in Food Contact Materials – Design, Application, Safety. DEStech Publications Inc; 2017:271-306.
Sharma M, Shatkin J, Cairns C, Canady R, Clippinger AJ. Framework to evaluate exposure relevance and data needs for risk assessment of nanomaterials using in vitro testing strategies. Risk Anal. 2016;36(8):1551-1563.
Godwin H, Nameth C, Avery D, Bergeson L, Bernard D, Beryt E, Boyes W, Brown S, Clippinger AJ, Cohen Y, Doa M, Olgilvie Hendren C, Holden P, Houck K, Kane A, Klaessig F, Kodas T, Landsiedel R, Lynch I, Malloy T, Miller M, Muller J, Oberdorster G, Pleus R, Sayre P, Stone V, Sullivan K, Tentschert J, Wallis P, and Nel AE. Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making. ACS Nano. 2015;9(4):3409-3417.
Sharma M, Shatkin JA, Cairns C, Canady R, Clippinger AJ. Framework to evaluate exposure relevance and data needs for risk assessment of nanomaterials using in vitro testing strategies. Poster presented at: Society of Toxicology 54^th Annual Meeting; 2015; San Diego, CA.
Sharma M, Stoddart G, Clippinger AJ. A tiered-testing strategy for nanomaterial hazard assessment. Poster presented at: 18^th International Congress on In Vitro Toxicology (ESTIV2014); 2014; Egmond aan Zee, the Netherlands.

PETA Science Consortium International Information

PETA Science Consortium International e.V. brochure
Stoddart G. 2015 Lush Training Prize winner: PETA International Science Consortium Ltd, UK. Altern Lab Anim. 2016;44:493-494.
Melbourne J, Bishop P, Brown J, Stoddart G. A multi-faceted approach to achieving the global acceptance of animal-free research methods. Altern Lab Anim. 2016;44:495-498.
Stoddart G, Brown J. A campaign to end animal testing: introducing the PETA International Science Consortium Ltd. Altern Lab Anim. 2014;42(6):387-393.

Pyrogenicity

Brown J, Clippinger AJ, Briglia CF, Casey W, Coleman K, Fritsch A, Hartung T, Maouyo D, Muller T, Reich J, Robert L, Roeder R, Sanchez G, Sawyer AY, Solati S, Tirumalai R, Zwisler W, Allen D. Using the monocyte activation test as a stand-alone release test for medical devices. ALTEX. 2021;38(1):151-156.
Allen D, Clippinger AJ, Morefield S, Casey W, Ghosh C, Goode J, Brown J. Using the monocyte activation test for medical devices. Poster presented at: Society of Toxicology 58^th Annual Meeting; 2019; Baltimore, MD.

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Faßbender C, Stoddart G, Baines J, Clippinger A. Non-animal testing: it’s within REACH (References). Poster presented at: SETAC Europe 26^th Annual Meeting; 2016; Nantes, France.
Brown J, Barroso J, Patlewicz G, Butterworth R, Clippinger A, Stoddart G. Effectiveness of toxicology-based webinars to promote nonstandard methods for REACH. Poster presented at: Society of Toxicology 54^th Annual Meeting; 2015; San Diego, CA.
Patlewicz G, Cronin M, Baines J. How QSARs and read-across can help address REACH 2018. Chemical Watch. 2015.
Baines J, Stoddart G. Avoidable animal tests continue under REACH. Chemical Watch. 2014.

Regulatory Assessment

Hilton GM, Bhuller Y, Doe JE, Wolf DC, Currie RA. A new paradigm for regulatory sciences. Regul Toxicol Pharmacol. Published online 2 November 2023. doi.org/10.1016/j.yrtph.2023.105524.
Wolf DC, Bhuller Y, Cope R, Corvaro M, Currie R, Doe J, Doi A, Hilton G, Mehta J, Saltmiras D, Sewell F, Trainer M, Déglin SE. Transforming the evaluation of agrochemicals. Pest Manag Sci. Published online 30 August 2022. doi.org/10.1002/ps.7148.

Skin Sensitisation and Irritation/Corrosion

Clippinger AJ, Keller D, McKim JM Jr, Witters H, Van Rompay AR. Inter-laboratory validation of an in vitro method to classify skin sensitizers. Poster presented at: Society of Toxicology 53^rd Annual Meeting; 2014; Phoenix, AZ.
Brown J. Problems and progress with replacing the use of animals for skin corrosion testing. AltTox.org. 2013.

Tobacco

Lee KM, Corley R, Jarabek AM, Kleinstreuer N, Paini A, Stucki AO, Bell S. Advancing new approach methodologies (NAMs) for tobacco harm reduction: synopsis from the 2021 CORESTA SSPT—NAMs Symposium. Toxics. 2022;10(12):760.
Miller-Holt J, Behrsing HP, Clippinger AJ, Hirn C, Stedeford TJ, Stucki AO. Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products. Front Toxciol. Published online 9 September 2022. doi.org/10.3389/ftox.2022.943358.
Manuppello JR. Avoiding animal testing under the US Family Smoking Prevention and Tobacco Control Act. Appl In Vitro Toxicol. 2017;3(1):10-11.
Behrsing H, Raabe H, Manuppello J, Bombick B, Curren R, Sullivan K, Sethi S, Phipps R, Tesfaigzi Y, Yan S, D’Ruiz C, Tarran R, Constant S, Phillips G, Gaça M, Hayden P, Cao X, Mathis C, Hoeng J, Braun A, Hill E. Assessment of in vitro COPD models for tobacco regulatory science: workshop proceedings, conclusions and paths forward for in vitro model use. Altern Lab Anim. 2016;44(2):129-166.
Manuppello JR, Sullivan KM. Toxicity assessment of tobacco products in vitro. Altern Lab Anim. 2015;43(1):39-67.

Vaccine

Rogers B, Brown J, Allen DG, Casey W, Clippinger AJ. Progress towards the replacement of in vivo leptospirosis vaccine potency testing in the United States. Poster presented at: American Society for Cellular and Computational Toxicology 11^th Annual Meeting; 2022; Chapel Hill, NC.
Rogers B, Brown J, Allen DG, Casey W, Clippinger AJ. Replacement of in vivo leptospirosis vaccine potency testing in the United States. Biologicals. 2022;78:36-44.
Dozier S, Brown J, Currie A. Bridging the gap between validation and implementation of non-animal veterinary vaccine potency testing methods. Animals (Basel). 2011;1:414-432.
Dozier S, Brown J, Currie A. Bridging the gap between validation and implementation of non-animal potency testing methods. Poster presented at: Interagency Coordinating Committee on the Validation of Alternative Methods Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions; 2010; Bethesda, MD.

*****

To request hard copies of the above documents, please e-mail [email protected].