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European Organ-on-Chip Society open for active membership

2019-07-10

The founding phase is complete: the European Organ-on-Chip Society (EUROoCS) is now welcoming members to join. The annual conference, held this year in Graz (Austria), saw the launch of the community website and the start of its availability as an information resource. “We invite scientists, engineers, as well as regulators and patient representatives interested in these new laboratory models to become active members of the society and contribute to efforts of the Organ-on-Chip community in promoting recognition and implementation of  this exciting research field,” says Christine Mummery, chair of EUROoCS and professor of Developmental Biology at Leiden University Medical Center, the Netherlands 

Organ-on-Chip (OoC) systems are among the latest emerging technologies for healthcare research. It is believed they will accelerate drug discovery, advance drug efficacy and toxicology testing and open new opportunities for personalized medicine. “Organ-on-Chip systems can reduce and perhaps eventually replace animal experiments and provide predictive human data before expensive and lengthy clinical trials actually start,” vice-chair Peter Loskill says. The biophysicist heads the Organ-on-Chip research group at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Germany.  

OECD issues new and updated in vitro and in chemico Test Guidelines

2019-07-10

The Organisation for Economic Co-operation and Development (OECD) issued three new and six updated Test Guidelines on June 18. Included among the new documents are tests relevant to replacing or reducing animal use for common acute toxicity endpoints. Links to the new Test Guidelines are available at  http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm

  • Test Guideline 494 (new) describes the in vitro Vitrigel-Eye Irritancy Test (EIT) to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage.
  • Test Guideline 442C (updated) describes in chemico assays that measure covalent binding of a test chemical to skin proteins, a key event in the adverse outcome pathway for skin sensitization. The previous TG 442C described the direct peptide reactivity assay. The updated Test Guideline also describes a similar method, the amino acid derivative reactivity assay (ADRA), and discusses how in chemico protein binding assays could be used within integrated approaches to testing and assessment for skin sensitization.
  • Test Guideline 492 (updated) describes in vitro reconstructed human corneal epithelium test methods to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage. The Test Guideline is based on four commercial methods of this type. It includes descriptions of essential test method components and a list of chemicals to be used to demonstrate proficiency with the assays.
  • Test Guidelines 431 and 439 (updated) describe in vitro reconstructed human epidermis test methods to identify chemicals that may cause skin corrosion (TG 431) or irritation (TG 439). The test guidelines were revised to include a greater number of commercial methods of this type. Both Test Guidelines include lists of chemicals to be used to demonstrate proficiency with the assays.

ECHA to scrutinise all REACH registrations by 2027

2019-06-27

The European Chemicals Agency ECHA has announced that the European Commission will propose an amendment to REACH, requiring that compliance checks of registration dossiers are performed on 20% of dossiers in each tonnage band instead of currently 5%. This means that around 30% of all dossiers of registered substances will be checked. This amendment is a result of a joint action plan of ECHA and the Commission to improve compliance of registration dossiers and thus ensure that safety data on chemicals is complete.

ECHA further states that it aims to screen all registration dossiers that were submitted by the 2018 deadline - for substances in the > 100 tonnage band by 2023; for substances in lower tonnage bands by 2027. Similar substances will be assessed in groups and substances will be categorized by the end of 2020 as a priority for risk management, data generation or of low priority for further action.

ECHA Press release: ECHA/NR/19/09

Use of cell-based assay for botulinum toxin products approved

2019-06-18

Ipsen Pharma has received approvals from U.S. and Canadian regulatory authorities for use of their in vitro Cell-Based Assay to establish stability and potency of its botulinum toxin products. This follows prior approval received in the European Union and Switzerland for this application of the Cell-Based Assay.

The basis of the Cell-Based Assay is the BoCell® technology platform, developed by BioSentinel Inc., a Madison, Wisconsin-based company that specializes in developing platforms for the detection and measurement of botulinum toxins. BioSentinel and Ipsen collaborated closely in development of the Cell-Based Assay, which achieves a level of precision comparable to the mouse-based LD50 assay.

The announcement of the approval is available at https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/2019/02/01155324/00-IAW-POSITION-STATEMENT-US-and-CN-approvals-01-02-2019.pdf.

ICE version 2.0 now available

2019-06-04

On May 20, NICEATM released a major update of the Integrated Chemical Environment (ICE), available at https://ice.ntp.niehs.nih.gov/. ICE provides data and tools to help develop, assess, and interpret chemical safety tests. The ICE update introduces a new user interface to simplify searches and new tools that will let users explore chemical properties and toxicity in more detail.

The new ICE home page delivers users easy access to all the tools within ICE, as well as user guides and related information. The updated ICE search tool includes a new module that simplifies assay selection. Another new feature allows users to add chemicals with the same core structure, such as different salt forms and stereochemistry, to their search, which expands the relevant toxicity data returned from the search.

In addition to the search tool, ICE includes in vitro to in vivo extrapolation (IVIVE), machine learning, and chemical characterization tools. The updated IVIVE tool provides more complex models, including those from the U.S. Environmental Protection Agency’s httk package, to improve prediction accuracy.

Slides and video available from ICCVAM Public Forum

2019-06-04

Slides and a video recording from the May 23 ICCVAM Public Forum are available on the NICEATM website at https://ntp.niehs.nih.gov/go/iccvamforum-2019. ICCVAM holds annual public forums to share information and facilitate direct communication of ideas and suggestions from stakeholders. The May 23 meeting was held at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland.

Over 40 attendees and more than 200 webcast viewers heard presentations by ICCVAM members representing eight U.S. agencies on current activities related to the development and validation of alternative test methods and approaches. Presenters described member agency activities to implement the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. A key focus was progress made towards reduction and replacement of animal use for acute toxicity tests required by regulatory agencies: acute systemic toxicity, skin and eye irritation, and skin sensitization testing. Public comments submitted to the meeting praised specific actions agencies have taken in the past year to advance the strategic roadmap goals, and suggested additional activities that could support further progress.

ICCVAM activities will also be discussed at the September 19-20 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods, to be held at the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition in College Park, Maryland. Information about that and other upcoming NICEATM events is available on the NICEATM 3Rs Meetings and Workshops page at https://ntp.niehs.nih.gov/go/3Rs-wksps.

Animal Free Research UK calls for grant proposals for pilot studies

2019-06-03

Animal Free Research UK has started a call for grant proposals. Grants will be awarded to research with a focus on the development of non-animal technologies and human relevant methods to advance human health.

PhD studentships or postdoctoral research associates: up to three years of funding.

One-year pilot studies: funding up to £5,000.

Apply now: http://bit.ly/2Wp7odJ

Application deadline: 2 August 2019

Jan van der Valk receives Björn Ekwall Award

2019-05-17

Dr. Jan van der Valk, director of the 3Rs-Centre ULS, has been selected as the recipient of the Björn Ekwall Memorial Award for the year 2019. The annual award recognizes scientists who have substantially contributed to the field of cell toxicology, e.g. by developing new in vitro tests, or via mechanistic or validation studies.
Dr van der Valk was recognized for his work to make scientists aware of the issues regarding the use of fetal calf serum (FCS), which is harvested from bovine foetuses taken from pregnant cows during slaughter. In the past 20 years, Dr van der Valk has organized workshops, given lectures and published several papers on this topic, including recently in ALTEX (doi:10.14573/altex.1705101). The 3Rs-Centre Utrecht Life Sciences and Animal Free Research UK launched the FCS-free Database in 2017, where researchers can find FCS-free media for specific cell-types.

EPAA Refinement Prize 2019: Call for submissions

2019-04-28

The European Partnership for Alternative Approaches to Animal Testing (EPAA) is proud to announce its 2019 refinement prize. This prize of €6000 will be granted to a laboratory technician, animal care- taker or technologist who has demonstrated outstanding achievements in new, novel approaches to advance implementation and/or awareness raising of Refinement of animal testing.

Laboratory technicians, technologists and animal caretakers carry out much of the work using animals for regulatory safety and efficacy testing purposes and are thus closely involved in efforts to apply refinement strategies in such studies. Refinement is one of the 3Rs (replacement, reduction and refinement of testing on animals). Refinement refers to the modification of any procedure, husbandry and care practices with laboratory animals along their entire lifetime, to minimise pain and distress and enhance their well-being.

The purpose of this prize is to target those implementing alternative approaches to animal testing and/or raising awareness of their role for the day to day application and innovation of the refinement principles in particular.

The EPAA partners will sponsor a €6000 prize to be awarded in 2019. The prize can be applied for by an individual or a team. The money awarded is a prize, not a grant, therefore it does not require any prior justification of how it will be used. Nevertheless, the EPAA recommends linking its use to (further) promotion of alternatives, e.g. for travel and accommodation fees for a conference, publication costs, etc. The winner (or the winning team) will be invited to the EPAA annual conference in October 2019 to receive the prize and briefly describe his/her/their contribution to the 3Rs.

Submission deadline: September 2, 2019
More Information

China accepts nine non-animal testing methods for the regulation of cosmetics

2019-04-08

China’s National Medical Products Administration (NMPA) has accepted certain non-animal test methods for the regulation of cosmetics as reported by the Institute for In Vitro Sciences. In a March 22 notice, NMPA announced acceptance of nine test methods, including the direct peptide reactivity assay for skin sensitization and the short time exposure test assay for eye irritation. These new regulations will go into effect January 1, 2020 and will be the preferred toxicological tests for the registration and pre-market approval of cosmetic ingredients. 

New book available: Animal Experimentation: Working Towards a Paradigm Change

2019-04-01

There is growing recognition that a focus on human-relevant data is needed for the understanding and possible treatment of chronic, complex diseases, many of which are not well understood and, thus, cannot be readily modeled in non-human animals. The technology revolution has greatly changed the field of life sciences and now provides us with tools enabling a shift away from animal experimentation. The 51 experts who have contributed to Animal Experimentation: Working Towards a Paradigm Change (Brill open access) review current animal use in science, and they discuss innovative, human-relevant approaches to advance the life sciences and to accelerate the shift towards the replacement of animals in research, testing and education.
 
Background: The book was initiated by Kathrin Herrmann, Director of CAAT’s Evidence-based Refinement Program. Besides co-editing the book with Kimberley Jayne, Kathrin wrote the introductory chapter.

You can read the open access book online or purchase a physical copy here.

Read CAAT Director Thomas Hartung's article, Research and Testing Without Animals: Where are We Now and Where Are We Heading? and Refinement on the Way Towards Replacement: Are We Doing What We Can? by CAAT's Director of Evidence-based Refinement program, Kathrin Herrmann. 

Felix Wankel Animal-Welfare-Research-Award for Dorothea Döring

2019-03-29

On March 14, 2019 the Felix Wankel Animal-Welfare-Research-Award 2019 was bestowed at the Ludwig Maximilians University in Munich on Dr Dorothea Döring for her work on the behaviour of laboratory dogs and aspects of animal protection in dog husbandry. Prof. Dr Christian Klimmt gave a keynote lecture on public acceptance of animal experiments from the perspective of a communications scientist.

Dr Döring has published an article in ALTEX on the behaviour of dogs before and after rehoming to private homes: https://doi.org/10.14573/altex.1608171

The prize of €30.000 is awarded every two years.

 

NICEATM SOT presentations available

2019-03-27

A webpage summarizing NICEATM and ICCVAM activities at the March 10-14 Society of Toxicology (SOT) annual meeting is available at https://ntp.niehs.nih.gov/go/niceatm-sot19. The page includes links to presentations from the ICCVAM exhibitor-hosted session, “ICCVAM Update on Implementing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.” Six NICEATM poster presentations are also available on the webpage.

Australian cosmetic animal test ban bill passes Senate

2019-03-04

The Industrial Chemicals Bill passed by the Australian Senate on February 14, 2019 includes measures to prohibit reliance on new animal test data for chemicals introduced into Australia for use as ingredients in cosmetics. The Government reached an agreement with the Humane Society International to commit to reinforcing measures that ensure that all cosmetic ingredients are included in the ban and to fund and support the development and uptake of non-animal test methods.
To date there are nearly 40 national bans and further national bans are under discussion in numerous states. The Humane Society International with its global campaign #BeCrueltyFree and its partners have played a leading role in raising awareness in the countries and negotiating with the governments on the issue of banning animal testing for cosmetics ingredients.

SOT honors scientists working on alternative methods

2019-02-21

The recipients of the 2019 SOT Awards have been announced, among them the following scientists working in the field of alternatives to animal experiments:

Nicole Kleinstreuer, NIEHS/NICEATM will receive the SOT Achievement Award to recognize her leadership and distinction in contributing to the field of toxicology, particularly in the areas of alternative toxicological methods and computational toxicology.
Suzie Fitzpatric, US FDA, wins the SOT Enhancement of Animal Welfare Award for her expertise in alternative toxicological methods and work to improve animal welfare within the field of toxicology.
Yvonne Chang, Oregon State University, will receive the Colgate-Palmolive Award for Student Resaerch Training in Alternative Methods.
Helena Hogberg, Johns Hopkins University, and Hao Zhu, Rutgers, both win the Colgate-Palmolive Grant for Alternative Research.

EURL ECVAM issues status report on alternatives

2019-02-13

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has issued its 2018 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” The status report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Key findings include:

  • Significant progress has been made in combining in vitro and computational methods to 'read-across' toxicological properties between similar chemicals to avoid unnecessary animal testing.
  • There is increased use of alternatives to identify endocrine disruptors and assess chemical mixtures.
  • Challenges still prevent the use of alternatives alone to fully characterize complex toxicological properties of chemicals that cause chronic systemic health effects.

EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.

A link to the report and an interview with two of its authors are available at https://ec.europa.eu/jrc/en/news/finding-alternatives-animal-testing-going-win-win-win. More information about EURL ECVAM is available at https://ec.europa.eu/jrc/en/eurl/ecvam.

ICCVAM members recognized by SOT

2019-01-17

The Society of Toxicology will present awards to two ICCVAM members at its annual meeting in March.

Suzanne Fitzpatrick of the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) will receive the 2019 SOT Enhancement of Animal Welfare Award. This award recognizes contributions that advance toxicological science through development and application of methods that replace, refine, or reduce the need for experimental animals. This marks the fourth consecutive year that an ICCVAM or NICEATM affiliated scientist has been honored with this award. Fitzpatrick, who is principal FDA representative on ICCVAM, is a Senior Science Advisor for Toxicology at CFSAN. She is the FDA lead for Tox21 and chair of the FDA Predictive Toxicology Roadmap Committee. She also plays a leading role in FDA evaluations of organs-on-chips technology.

NICEATM Deputy Director Nicole Kleinstreuer will receive the 2019 SOT Achievement Award. This award is presented to an SOT member who, within 15 years since obtaining their highest degree, has made significant contributions to toxicology. Kleinstreuer’s research focuses on mathematical and computational modeling of biological systems and perturbations that result in adverse health outcomes. She has made key contributions to strategies that combine in vitro high throughput assay data with computational models to predict the likelihood of toxicity. She also represents the National Institute of Environmental Health Sciences on ICCVAM.

Collaborative Acute Toxicity Modeling Suite (CATMoS) now available

2018-12-20

NICEATM has released the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity. CATMoS is implemented in v2.0 of the Open Structure-Activity/Property Relationship App (OPERA), a free and open-source quantitative structure-activity relationship (QSAR) tool. OPERA v2.0 can be downloaded from the NIEHS Github repository at https://github.com/NIEHS/OPERA/releases.
CATMoS is the result of a global collaboration to develop in silico models to predict acute oral toxicity. It is a suite of consensus models developed by combining the results of individual models contributed by participants in the April 2018 Workshop on Predictive Models for Acute Oral Systemic Toxicity (see https://ntp.niehs.nih.gov/go/atwksp-2018 and https://doi.org/10.1016/j.comtox.2018.08.002). The individual models were built using information on chemical structures and rat oral acute toxicity data for nearly 9000 chemicals, and tested using approximately 3000 chemicals.
CATMoS includes models for predicting five acute oral toxicity endpoints: very toxic, non-toxic, U.S. Environmental Protection Agency hazard classification, United Nations Globally Harmonized System of Classification and Labelling of Chemical (GHS) hazard classification, and LD50. Predictions generated by CATMoS may be useful to those developing or triaging new chemicals or for prioritizing existing chemicals for more detailed and rigorous toxicity assessments.

NICEATM Integrated Chemical Environment updated

2018-12-13

Updates to the NICEATM Integrated Chemical Environment (ICE) resource were launched in September and November. ICE is available at https://ice.ntp.niehs.nih.gov/.

Successful computational toxicology projects depend on freely available, high-quality data that are formatted for use in computational workflows. ICE provides data from NICEATM and its partners, as well as other resources and tools, in an environment designed to support chemical safety assessment and new method development.

Recent ICE updates have:

  • Expanded physicochemical property predictions to include over 720,000 chemicals using an updated set of predictive models (described in Mansouri et al. 2018, https://jcheminf.biomedcentral.com/articles/10.1186/s13321-018-0263-1)
  • Updated the curated high-throughput screening data from the Tox21 initiative to include increased curation and the most up-to-date data release
  • Added new workflows to enable:
    • In vitro to in vivo extrapolation (method described in Casey et al. 2018, https://ehp.niehs.nih.gov/doi/10.1289/ehp1655)
    • Construction of machine-learning models to predict chemical hazard
    • Characterization of chemical lists using physicochemical properties to relate chemicals

Future updates will allow users to get physicochemical property predictions on their own data sets, add chemical use descriptions to chemical characterizations, and provide a three-compartment generalized physiologically based pharmacokinetic model for in vitro to in vivo extrapolation.

The History of Alternative Test Methods in Toxicology published

2018-12-01

The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique.

The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity.

OECD releases revised GD 150 on evaluating chemicals for endocrine disruption

2018-11-23

The revised edition of Guidance Document (GD) 150 includes new and updated test guidelines that have been validated, or are currently in the validation process. Updates to the test guidelines concern all levels in the OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupting Chemicals, and the Conceptual Framework itself has been updated. The revised GD includes various cross-cutting issues and a summary of some experiences gained from using the guidance in the first edition.

Of the five levels of the Conceptual Framework, Level 1 considers existing data and existing or new non-test information and Level 2 considers in vitro assays providing data about selected endocrine mechanism(s)/pathway(s). Levels 3-5 consider in vivo assays on endocrine mechanism(s)/pathway(s), on adverse effects on endocrine-relevant endpoints, and more comprehensive data on adverse effects on endocrine-relevant endpoints over move extensive parts of the life cycle or the organism.

The tests included in Level 2 are:
– Estrogen (OECD TG 493) or androgen receptor binding affinity (US EPA TG OPPTS 890.1150)
– Estrogen receptor transactivation (OECD TG 455, ISO 19040-3), yeast estrogen screen (ISO 19040-1 & 2)
– Androgen receptor transactivation (OECD TG 458)
– Steroidogenesis in vitro (OECD TG 456)
– Aromatase assay (US EPA TG OPPTS 890.1200)
– Thyroid disruption assays (e.g. thyroperoxidase inhibition, transthyretin binding)
– Retinoid receptor transactivation assays
– Other hormone receptors assays as appropriate
– High throughput screens

Use of NAMs in risk assessment webinar series started

2018-11-19

A new webinar series on the use of new approach methodologies (NAMs) in risk assessment is being organized by the Physicians Committee for Responsible Medicine, the U.S. Environmental Protection Agency (EPA), and the PETA International Science Consortium Ltd. The first webinar in this series was presented on November 7 and can be viewed at https://www.piscltd.org.uk/nam-webinars/. The next webinar in the series is planned for January 2019, and details of the webinar will be posted on the PISC webpage.

The November 7 webinar focused on the two testing strategies included in EPA’s “Policy on the Use of Alternative Approaches for Skin Sensitization Testing” (available at https://www.epa.gov/pesticides/epa-releases-draft-policy-reduce-animal-testing-skin-sensitization). Susanne Kolle described BASF’s “2 out of 3 approach” and Taku Nishijou discussed Kao Corporation’s sequential testing strategy for in vitro skin sensitization testing.

LUSH Prize 2018 awarded

2018-11-17

The winners of the LUSH Prize in the categories science, public awareness, training, lobbying and young researchers were announced at a gala dinner in Berlin on November 16. The Andrew Tyler Award was presented to Prof. Dr Horst Spielmann for his lifetime achievements. The dinner followed a conference titled: Is there an end in sight for animal testing? Can Organ-on-a-Chip replace animal use in safety testing with advanced human focused approaches?

NC3Rs launches Tech3Rs newsletter

2018-11-14

The NC3Rs has launched a new newsletter aimed at animal technicians, focusing on refinements and animal welfare. Tech3Rs will feature updates on the most relevant resources, research and events, supporting technicians to identify opportunities to embed the 3Rs in practice.

Issues will be published quarterly on the NC3Rs website in a downloadable PDF format. Facilities in the UK can also order hard copies for display.

NICEATM, PISC workshop explores alternatives to animal use for pyrogen testing

2018-10-23

A workshop on September 18-19 at NIH explored challenges to acceptance of a human cell-based assay for pyrogen testing of medical devices. The workshop was organized by NICEATM and the PETA International Science Consortium.
Pyrogens are substances that can produce fever when present as contaminants in a drug or medical device. Most pyrogens are biological substances derived from bacteria, fungi, and viruses; material-mediated pyrogens (MMPs), while less common, may also be present. Drugs for injection and medical device products for implantation or other systemic exposure should meet pyrogen limit specifications before they are marketed. Animal-based pyrogen tests are often conducted to investigate the presence of pyrogens. Non-animal monocyte activation tests (MAT) are widely available but infrequently used for pyrogen testing.
At the September workshop, regulators, test developers, medical device manufacturers, and other experts explored how the U.S. Food and Drug Administration Medical Device Development Tools Program could be used to qualify the use of MAT as a standalone pyrogen test for specific medical device contexts-of-use. There was general agreement that the MAT could be qualified as acceptable for batch-release testing for microbial-based pyrogens. However, additional studies were recommended to demonstrate its ability to detect known MMPs. This testing would determine whether the assay can be used for both biocompatibility and sterility or if other information on MMPs would be needed to address biocompatibility.
More information about NICEATM and ICCVAM evaluation of pyrogen test methods is available at https://ntp.niehs.nih.gov/go/iccvam-pyrogen. An agenda, presentations, and other materials from the meeting are available at https://www.piscltd.org.uk/medical-device-pyrogen/.

NICEATM and IABS hold rabies vaccine workshop

2018-10-23

NICEATM and the International Alliance for Biological Standardization co-organized an October 16-17 workshop “Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond” at the National Institutes of Health (NIH) in Bethesda, Maryland. Over 60 scientists from government, academia and industry gathered to develop recommendations to advance alternative methods for human and veterinary rabies vaccine testing.
Presentations on the first day of the workshop detailed the current state of the science of non-animal alternatives to traditional rabies vaccine potency and safety tests. On day two, separate breakout group discussions focused on the steps necessary for implementing alternatives for veterinary and human rabies vaccine potency testing. Participants identified actions and data still needed to achieve this, and laid the foundation for a roadmap towards successful implementation. Meeting outcomes and associated recommendations will be summarized in a report in the journal Biologicals.

Postdoctoral opportunities available at NTP

2018-10-23

The U.S. Food and Drug Administration is accepting applications for postdoctoral fellows to develop human cell- and protein-based assays for assessing cardiotoxicity of new drugs. These projects are part of an initiative to design, build, and test new non-animal approaches to assess cardiotoxicity hazard. The initiative is supported jointly by the National Toxicology Program (NTP; Biomolecular Screening Branch and NICEATM), the U.S. Food and Drug Administration Center for Drug Evaluation and Research, and the Health and Environment Sciences Institute.
Candidates for these two postdoctoral positions should have received Ph.D. or equivalent degrees in computer sciences or life/health/medical sciences within the last five years. Work will be done at National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC. More information about the projects and instructions for applying are available at https://ntp.niehs.nih.gov/go/cardio.

SACATM meeting focuses on key issues in replacing animal testing

2018-10-23

At its September 5-6 meeting, members of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) and other experts advised U.S. government scientists on issues to be addressed to replace animal use for safety testing. About 60 participants met at NIEHS for the annual advisory committee meeting. Participants discussed actions needed to advance goals outlined in a strategic roadmap for new approaches to evaluating the safety of chemicals and medical products.
At the meeting, industry representatives indicated a need for regulators to clearly communicate both their information requirements and willingness to accept data from new approach methodologies to fulfill those requirements. Participants also discussed the need for high-quality reference data from past animal tests to evaluate the performance of new methods, and considered issues involved in sharing and using those data.
SACATM, the advisory committee for ICCVAM, is a panel of experts drawn from industry, academia, and animal welfare organizations. SACATM meets annually to advise ICCVAM, NICEATM, and the NIEHS director on activities related to ICCVAM’s mission.
Materials from the SACATM meeting are available at https://ntp.niehs.nih.gov/events/past/index.html?type=SACATM, and a longer summary is available in an article in the October issue of the NIEHS Environmental Factor newsletter at https://factor.niehs.nih.gov/2018/10/science-highlights/toxicity_testing/index.htm.

UK Home Office publishes 2017 statistics on animal experiments

2018-10-14

The ‘Annual Statistics of Scientific Procedures on Living Animals, Great Britain’ was published by the UK Home Office on the 19th of July 2018.
The figures show that 3.79 million animal experiments took place in Great Britain in 2017, a slight decrease of 4% compared to the previous year. Of these, 1.90 million (50%) related to the creation or breeding of genetically altered animals who were not used in further procedures, while the remaining 1.89 million experiments (50%) were experiments on animals for various purposes. These purposes were basic research (55%); translational/applied research (17%), regulatory tests (27%), and others (1%).
In 2017, there were increases in the number of experiments conducted on horses (up 18% to 10,600) and cats (up 4% to 198 experiments) in Great Britain. However, there were decreases in the use of other species, including mice (down 10% to 1.1 million), rats (down 2% to 234,000), non-human primates (down 17% to 2,960) and dogs (down 22% to 3,847).
Almost 700,000 experiments (32%) carried out in Great Britain in 2017 were deemed to have caused moderate or severe suffering to the animals involved; moderate or severe suffering was alse experienced by 5% of the genetically altered animals not used for further procedures. Moderate suffering is described by Directive 2010/63/EU as causing short term moderate pain or distress or long-lasting mild pain or distress to animals while severe suffering is described as causing severe pain or distress or long-lasting moderate pain or distress to animals.

German Federal Animal Protection Research Prize awarded for secondary nanobodies

2018-10-11

Dirk Görlich and Tino Pleiner of the Max-Planck-Institute for Biophysical Chemistry in Göttingen today receive the Animal Protection Research Prize of the German Federal Ministry of Nutrition and Agriculture (Bundesministerium für Ernährung und Landwirtschaft). The scientists have developed secondary nanobodies as a new form of secondary antibody for use in medicine and research. Secondary nanobodies are based on very small antibodies of Alpakas and are multiplied in bacteria. This approach can reduce the number of animals used for secondary antibody production.

Biomed21 launches newsletter

2018-10-04

The Biomedical Research for the 21st Century (BioMed21) Collaboration brings together scientists and institutions from across Europe, Asia and the Americas who share a vision of a human-focused paradigm in health research. This unique mix of biomedical stakeholders provides both a broad, global outlook as well as deep ties at regional and national levels. BioMed21 welcomes new collaboration opportunities with like-minded organizations and individuals.
The Biomed21 website is designed to be a hub for information related to innovative, human-specific approaches in health research, including relevant publications, funding opportunities, workshops, training opportunities, and other events.
The newsletter delivers top highlights to your inbox every quarter.

NIH to build cell map of human body

2018-10-02

The National Institutes of Health has issued its first set of research funding awards for the Human BioMolecular Atlas Program (HuBMAP). HuBMAP is an open, global framework that will support research community efforts to map the adult human body at the level of individual cells. The project is planning to award $54 million over the next four years to support:

  • Generating, standardizing, and validating data sets on cell organization and variability
  • Development of new tools and techniques to construct high-resolution tissue maps
  • Coordinating program activities, managing HuBMAP data, and building an atlas of tissue maps

An announcement of the grant awards is available at https://www.nih.gov/news-events/news-releases/nih-build-detailed-map-cells-within-human-body. The project website is located at https://commonfund.nih.gov/hubmap

ALTEX Prize 2018 awarded to Martin Paparella

2018-09-28

The ALTEX Prize 2018 for the best paper published in ALTEX in the previous year was awarded to Dr Martin Paparella, Medical University Innsbruck, as first author of "Uncertainties of testing methods: What do we (want to) know about carcinogenicity" at the social evening of the EUSAAT Congress in Linz on September 25 by Dr Sonja von Aulock. Martin Paparella is a regulatory toxicologist; he is coordinator of the Austrian OECD WNT (Working Group of National Coordinators of the Testing Guidelines programme) and of the PARERE (Preliminary Analysis of Regulatory Relevance) network.
The ALTEX Prize is awarded annually and was again kindly sponsored by the Doerenkamp-Zbinden Foundation.

Input Requested on Scientific Program for 11th World Congress

2018-09-11

The 11th World Congress on Alternatives and Animal Use in the Life Sciences (WC11) will be held in Maastricht, the Netherlands, on 23-27 August 2020. Visit the congress website http://wc11maastricht.org/ for the latest updates.

The general theme of the congress, “3Rs in Transition: From Development to Application”, emphasizes the increasing focus on the use of better, more human-relevant models for personalized and preventive health care, safer products and innovative research. A scientific committee is currently being established and the first meeting will take place before the end of this year. The scientific committee will set up the scientific program of the congress around four main themes: safety, disease, innovative technologies, and ethics and welfare. Input on topics for the scientific program is welcomed; please visit the congress website for details.

Guidance Document on Good In Vitro Method Practices (GIVIMP) now online

2018-09-11

The Guidance Document on Good In Vitro Methods Practices (GIVIMP) is a project led by the European Commission’s Joint Research Centre. The aim of this document is to provide guidance in order to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by applying all necessary good scientific, technical and quality practices from method development to implementation for regulatory use. The document is targeted towards test method developers and test guideline users and provides best practices for designing guideline in vitro methods, carrying out safety tests and assuring quality and scientific integrity of the resulting data. The GIVIMP is intended to be an important resource that can help to avoid a scientific reproducibility crisis in in vitro toxicological sciences.

ICCVAM publishes 2016-2017 Biennial Report

2018-08-09

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has published a report summarizing activities of member agencies during 2016 and 2017.
The 2016-2017 ICCVAM Biennial Report is available at https://ntp.niehs.nih.gov/go/2017iccvamreport

The report highlights member agency activities supporting toxicology innovation, as well as regulatory agency initiatives to promote the 3Rs (replace, reduce, or refine animal use) and to provide information about the use of in vitro methods.
Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

- Publication of A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.

- Guidance documents published by the U.S. Environmental Protection Agency describing approaches to reduce animal use in testing required for pesticide registration.

- Notices published by the U.S. Department of Agriculture describing approaches to reduce animal use for vaccine testing.

- A Predictive Toxicology Roadmap published by the U.S. Food and Drug Administration.

- A non-animal defined approach developed by NICEATM and EPA that identifies substances that may interact with the androgen receptor.

- A non-animal defined approach developed by NICEATM and ICCVAM to predict skin sensitization risk.

- A proposed method developed in collaboration with international partners to evaluate non-animal approaches to identify skin sensitizers.

- Launch of the NICEATM Integrated Chemical Environment (ICE), an online resource that provides high-quality curated data and computational workflows for chemical safety assessment.

Ellen Fritsche and Hamid Reza Noori to receive Ursula M. Händel Animal Protection Prize 2018

2018-07-26

The Ursula M. Händel Animal Protection Prize 2018 of the German Research Council (DFG) will be shared between the toxicologist Prof. Dr Ellen Fritsche of the Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University in Düsseldorf and the mathematician, physicist and physician Dr Dr Hamid Reza Noori of the Max-Planck-Institute for Biological Cybernetics in Tübingen. This is the seventh time the prize will be awarded to scientists who improve animal protection in science in accordance with the 3R principle (Reduce, Replace and Refine).

2018 CRACK IT Challenges announced

2018-07-24

This year’s CRACK IT Challenges competition consists of three Challenges identified jointly by the NC3Rs and sponsors:
Challenge 29: ImmuLiver – An immunologically-competent liver model to assess attenuation of yellow fever vaccines.
Challenge 30: RaTSRaman Transmission Spectroscopy for objective monitoring of rheumatoid arthritis progression in rodent models.
Challenge 31: MoshersMouse Smart Hoppers.

This year the competition is funded by the NC3Rs, with co‑funding provided by EPSRC (RaTS) and in-kind contributions from the sponsors.

Improving peer review of in vivo research proposals - videos online

2018-07-24

The NC3Rs recently hosted a workshop on experimental design for funding panel members of the NC3Rs, BBSRC, CRUK, MRC and Wellcome Trust. Videos of the workshop presentations are now available to watch online. As well as supporting funding panel members to assess in vivo research proposals, the videos can help applicants to ensure their proposals provide quality information on experimental design.

NC3Rs announce 2019 highlight notice

2018-07-24

To encourage funding applications relating to areas of strategic importance to the NC3Rs, regular highlight notices are issued that apply across all funding schemes. The 2019 highlight notice will support the development or transfer of innovative applications of non-mammalian organisms by facilitating new partnerships between rodent and non‑mammalian model organism users. A highlight notice launch event will take place on September 4, 2018 in Central London; attendance is free but registration by August 21, 2018 is essential.

 

3Rs-Centre ULS launches e-learning on humane endpoints in animal research and veterinary practice

2018-07-05

The 3Rs-Centre Utrecht Life Sciences has developed an E-learning module on humane endpoints in animal research and veterinary practice. This module is available free of charge, for everyone who works with animals, on www.humane-endpoints.info. It provides both a solid basic training on humane endpoints, and practice opportunities with case studies. This E-learning will contribute to refinement by preparing the users to make well-balanced decisions regarding animal welfare and science.

3Rs-Centre ULS Newsletter July 2018

Experiments on primates to be reduced by 40% in The Netherlands

2018-06-29

Ingrid van Engelshoven, Minister for Education, Culture and Science has called on the Second Chamber to phase out experiments on primates in the Netherlands. The first step will be a 40% reduction of experiments on primates in the Biomedical Primate Research Centre (BPRC) in Rijswijk and a reduction of the colony size by introducing birth control. The letter to the Chamber is a response to the commissioned report "Van Aap na Beter" (from ape to better) of the Rathenau Institute.

With around 1500 primates, the BPRC is Europe's largest primate center.

HESI workgroup surveying use of thyroid assays

2018-06-29

The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee Thyroid Hormone Workgroup and the European Teratology Society Thyroid Hormone Task Force have initiated a survey to collect historical data for thyroid hormone measurements from nonclinical studies. This effort aims to provide clarification and guidance regarding the collection, assessment, and interpretation of thyroid hormone data for regulatory toxicology and risk assessment. The data collected will be anonymously archived in a database that will ultimately be available for public use and incorporated into a workshop planned for spring 2019. The ultimate goals of this effort are to improve data interpretation, establish biologically relevant ranges for each assessment, and develop recommendations for best practices for thyroid assessment.

If your organization conducts or has conducted these assays and you are interested in participating in the survey and contributing to the data collection effort, please contact Connie Chen at cchen@hesiglobal.org for more information.

 

3R relevant OECD Test Guidelines and updates released

2018-06-29

On June 25, OECD adopted a set of new and updated Test Guidelines for chemicals safety testing.

Those include two new Test Guidelines on in vitro methods for fish hepatic clearance, TG 319A and TG 319B that can be used to improve in silico predictions of the test chemical bioaccumulation in fish.

Important updates to existing Test Guidelines encompass the inclusion of endocrine-related endpoints in TG 408 (90-d repeated dose toxicity study) and TG 414 (Developmental toxicity study); also Test Guidelines in the area of eye irritation and skin sensitisation have been revised to either improve predictivity of the existing method (TG 438, isolated chicken eye method) or include similar methods to those already existing (me-too methods in TG 442B, TG 442D, TG 492) ensuring more readily usable practical matter by members and Mutual Acceptance of Data (MAD) adhering countries.

A few other Test Guidelines have been slightly amended as well and can be accessed from the sections mentioned below:

A set of supporting documents and Guidance Documents associated to these Test Guidelines will soon be published.

http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm

US EPA releases strategic plan to reduce animal testing for TSCA

2018-06-27

The U.S. Environmental Protection Agency (EPA) has published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. The document describes how EPA will promote development and implementation of methods and strategies that reduce, refine, or replace vertebrate animal testing to provide chemical safety information required under the Toxic Substances Control Act (TSCA).
The core components of the plan are (1) identifying, developing, and integrating new approach methodologies (NAMs) for TSCA decisions; (2) building confidence that the NAMs are scientific reliable and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions.
The strategic plan and related documents are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/strategic-plan-reduce-use-vertebrate-animals-chemical

NICEATM News June 27, 2018

NC3Rs publish strategy to update ARRIVE guidelines

2018-06-22

In 2010 the NC3Rs developed the ARRIVE guidelines, a 20-item checklist covering the key information that should be included in scientific publications describing animal studies to ensure transparency and reproducibility. Despite widespread endorsement of the guidelines, there is mixed evidence of their impact on the quality of reporting. The NC3Rs have published a strategy for the revision of the ARRIVE guidelines, developed with an international working group of experts, in BMJ Open Science.

Report Available from BioMed21 Workshop

2018-06-22

The June 2017 BioMed21 workshop, co-organized by NICEATM and the Human Toxicology Project Consortium, examined actions needed to implement a human systems-biology approach to understanding disease and improving interventions. The report from the workshop has been published in the journal Drug Discovery Today and is available at https://www.ncbi.nlm.nih.gov/pubmed/29870792.

Catherine Sprankle (NIH/NIEHS)

US Government Accountability Office assesses animal use in federal research

2018-06-14

The U.S. Government Accountability Office (GAO) has published a report on the submission of data from agencies to the ANimal and Plant Health Inspection Service (APHIS) and the National Institutes of Health. The report finds that agencies publicly report some data on animal use but do not report other data unless asked. Some data may not be reported accurately because of inadequate instructions, i.e. research with birds, activities outside the United States, and field studies outside a typical laboratory. The GAO recommends that APHIS improve its instructions.
USDA stated that APHIS will take steps to implement GAO's recommendations, with the exception of clarifying reporting instructions for activities outside the United States.

HighlightsFull report

India approves non-animal alternatives to the pyrogen and the abnormal toxicity test

2018-06-05

The Indian Pharmacopoeia Commission has replaced the rabbit pyrogen test and the guinea pig abnormal toxicity test with non-animal alternative methods for drugs manufactured and marketed in India according to The Hindu. The new guidelines will come into effect on July 1, 2018.
The pyrogen test, which is used to test drug batches for fever-inducing contaminations, will be replaced by the bacterial endotoxin test or a monocyte activation test. The abnormal toxicity test, a batch test done for vaccines, which has already been stricken from the U.S. and European pharmacopoeia, can be waived if a compliance certificate is obtained from the National Control Laboratory.

California to ban cosmetics and cosmetic ingredients tested on animals

2018-06-05

Californian senators have voted for a piece of legislation to ban the sale of cosmetic products tested on animals or cosmetic products containing ingredients tested on animals from January 1, 2020. The bill, authored by Senator Cathleen Galgiani, was supported by the Physicians Committee for Responsible Medicine (PCRM) and Social Compassion in Legislation (SCIL). The state's assembly will make a final decision on the bill by the end of September.

Utrecht Advanced In Vitro Models (U-AIM) HUB inaugurated

2018-05-25

The Utrecht Advanced In Vitro Models (U-AIM) was officially launched on May 16, 2018. The goal of U-AIM is to become a “one-stop shop” where high potential in vitro models are being developed, validated and transitioned to stakeholders. Through a strong cooperation between scientists, students, regulators and industry, U-AIM aims to strongly reduce animal experimentation and increase market potential of innovative models. The 3Rs-Centre ULS is directly involved in the U-AIM activities.

FDA final guidance on toxicokinetics studies reduces numbers of animals needed

2018-05-24

In a May 10 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies.

The Federal Register notice is available at https://www.gpo.gov/fdsys/pkg/FR-2018-05-10/pdf/2018-09930.pdf. All FDA guidance documents are available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

BfR awards fellowship to Malcolm Macleod

2018-04-17

The German Federal Institute for Risk Assessment (BfR) has awarded the first Maria Sibylla Merian Fellowship to Malcolm Macleod for his contribution to improving animal welfare.

EPA requests comments on draft policy on skin sensitization testing

2018-04-13

The U.S. Environmental Protection Agency has released a draft science policy to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation or sensitization of the skin. The draft policy is open for public comment until June 9, 2018.

NC3Rs awards 2017 International 3Rs Prize

2018-03-27

The prize was awarded to Dr Elisa Passini and colleagues from the University of Oxford and Janssen Pharmaceutica for developing an in silico model to predict the potential of drugs to cause heart arrhythmia.

OECD launches QSAR Toolbox version 4.2.

2018-02-07

The Toolbox is a software application intended to the use of governments, chemical industry and other stakeholders in filling gaps in (eco)toxicity data needed for assessing the hazards of chemicals. 

SOT announces award winners

2018-01-31

Among the prizes to be awarded at the SOT this March, numerous prizes will be awarded for 3Rs related activities.

CERST to become state institute

2018-01-22

The parliament of North Rhine Westphalia in Germany has increased the budget of the Centrum für Ersatzmethoden zum Tierversuch (CERST) and will make it a state institute.

Norecopa turns 10

2018-01-08

Norway's 3R center and National Consensus Platform for the Replacement, Reduction and Refinement of animal experiments celebrates its anniversary.