New Management Roles at IIVS
IIVS is pleased to announce a new management structure in 2015. Rodger Curren has assumed the role of Chief Executive Officer and will remain Chairman of the Board of Directors. As the senior corporate officer, Rodger will concentrate on key programs and strategies for the organization's growth. Erin Hill has been promoted to President and will be responsible for planning, directing and supervising IIVS activities and programs. Hans Raabe will continue in his capacity as Vice President and will also assume the responsibilities of Chief Operating Officer where he will implement strategies and policies to maximize efficiencies across all IIVS programs. Through these new positions, all three officers will continue to ensure that IIVS maintains a leadership role in the promotion of
in vitro test methods.
|
SCIENCE
|
Replacing Animals for Skin Sensitization Testing Gains Momentum as OECD Publishes Test Guidelines for Non-Animal Based Methods
| Ninety-six well plates used for luciferase induction in the KeratinoSens assay for skin sensitization. |
Determination of skin sensitization potential is a critical toxicological endpoint in the safety assessment of novel chemicals. Although the Guinea Pig Maximization Test (GPMT) and in vivo Local Lymph Node Assay (LLNA) have traditionally been used to assess skin sensitization, recent activity has focused on the development of novel alternative assays for the endpoint. As a culmination of these efforts, the Organization for Economic Cooperation and Development (OECD) published the following test guidelines for non-animal skin sensitization testing on 5 February 2015: ARE-Nrf2 Luciferase Test Method (also referred to as the KeratinoSens™ Assay) (OECD TG 442D) and Direct Peptide Reactivity Assay (DPRA) (OECD TG 442C). IIVS is pleased to offer both of these non-animal assays for detecting skin sensitizers.
The KeratinoSens™ assay is a cell-based reporter gene assay which identifies skin sensitizers by measuring the induction of luciferase under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene. The method addresses the second key event, gene expression in keratinocytes, associated with the antioxidant/electrophile response element (ARE)-dependent pathways, in the Adverse Outcome Pathway (AOP) leading to skin sensitization. IIVS was pleased to have participated in the inter-laboratory study lead by Givaudan to assess the KeratinoSens™ assay which demonstrated that the assay was transferable, reproducible, and accurate as compared to the historical animal data. Following an extensive review of these data by EURL ECVAM , the assay was recommended for use in determining skin sensitization and the OECD guideline was drafted for the assay. We have used our experience with the assay to deliver a GLP compliant method for broader use, and since 2011 have offered the assay as a commercial service.
The DPRA is an in chemico assay that identifies dermal sensitizers based on their reactivity with synthetic peptides containing either lysine or cysteine. The assay models the first key event in the skin sensitization AOP, protein reactivity. Through collaboration with the method developers at Procter & Gamble, IIVS scientists received training and successfully transferred the technology in-house. IIVS currently offers the assay as a commercial service. IIVS is exploring the use of the DPRA method in combination with the KeratinoSens™ assay to improve predictions.
Given the complex cascade of events leading to skin sensitization, it is generally thought that an integrated testing approach combining multiple assays and in silico predictive tools will be needed to fully replace the animal based methods. There is a significant effort underway to ascertain how the recommended non-animal assays may be combined to both qualitatively and quantitatively assess skin sensitization. IIVS toxicologist Dr. Kimberly Norman served as a member of the OECD Expert Group on Skin Sensitization Alternative Methods and works with sponsors to determine how results from both OECD approved methods for non-animal skin sensitization testing, the KeratinoSens™ and DPRA assays, can be used effectively as part of our GLP-compliant laboratory testing services. Please contact us for information on these skin sensitization assays and how they may be used as part of an integrated testing strategy within your existing testing program.
|
EDUCATION |
IIVS's Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA): Training at NIFDC Beijing, China
| IIVS Biologists and Study Directors with participants in the October training course. |
Through the support of the member companies of its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICAARA), IIVS presented training at the National Institute for Food and Drug Control (NIFDC) in Beijing over the course of four and a half days in October. The training focused on practical, hands-on laboratory techniques for in vitro toxicology assays such as the Bovine Corneal Opacity and Permeability (BCOP) assay, chorioallantoic membrane assay (CAMVA) and Skin Irritation Test (SIT). Three dimensional skin constructs were obtained from the Chinese company TecSkin for use in the training. Twenty eight scientists representing several institutions including Food and Drug, Medical Device Control, and General Logistics Institute for Drug Control (among others) attended the training.
Wang You-chun, Deputy Director at NIFDC, attended the post-training graduation ceremony and stressed the need to accelerate the further development of in vitro methods for use in cosmetic, food, and drug safety evaluation. He hopes that the participants of the course can easily apply the methods to their day-to-day work. IIVS presenters praised the course participants for their thoughtful questions and high level of interaction, specifically concerning the application of the methods to satisfy regulatory requirements. IIVS staff and scientists will continue to share their expertise with the participants of this program to answer any questions they may have about further implementation of the methods.
2015 Practical Methods for In Vitro Toxicology Training Course
The Practical Methods training is one of the key educational programs at the Institute. For over 18 years IIVS has instructed scientists from industry, government, and academic institutions on laboratory techniques for conducting in vitro assays through the hands-on laboratory activities practiced in this course. IIVS Study Directors assist participants in learning how to interpret the resulting data from these assays through case study presentations and round-table discussions. During the multi-day program, participants are exposed to a variety of in vitro methods through lectures and hands-on activities with our highly trained biologists and Study Directors.
This year's course, held January 12-16 at our Gaithersburg, MD facility, featured hands-on instruction on the Bovine Corneal Opacity and Permeability Assay (BCOP), 3T3 Phototoxicity assay, and use of 3D tissue constructs for Skin Irritation Testing (SIT). Participants observed demonstrations of a number of other assays during the 3 and a half day course including the Cytosensor Microphysiometer assay for eye irritation testing, and the Corrositex assay for determining DOT packing groups and hazard classification. Presentations on the NociOcular (to determine eye sting), percutaneous penetration, global acceptance of in vitro methods, the use of Good Laboratory Practices, the US Tox 21 program, and new technologies for cell cultures rounded out the program. The number of participants in this year's program was at a record high. We would like to thank our invited speakers, Dr. Martin Stephens of the Johns Hopkins' Center for the Alternatives to Animal Testing (CAAT) and Dr. Terry Riss of Promega for their valuable contributions to the course.
| Participants in the 2015 Practical Methods Course and IIVS staff. |
|
OUTREACH
|
IIVS Hosted Workshop - Assessment of In Vitro COPD Models for Tobacco Regulatory Science
The Food and Drug Administration Center for Tobacco Products (CTP), has articulated research priorities that include the identification of in vitro models and assays for assessing tobacco constituent or compound hazards, and for comparing the respiratory toxicity of different tobacco products. With its experience in working collaboratively to optimize and validate in vitro methods, IIVS designed a workshop to bring together a consortium of experts and participants to specifically address the CTP's relevant research goals. Speakers from the CTP, TCOR centers, animal welfare groups, academia, and tobacco companies joined IIVS scientists to discuss the need for non-animal models to explore potential inhalation toxicology and determine the current state of the science. Chronic Obstructive Pulmonary Disease (COPD) can be a very complex disorder with many pathways leading toward disease expression. The areas of inflammation and oxidative stress, ciliary dysfunction and ion transport, goblet cell hyperplasia and mucus production, and parenchymal/bronchial tissue destruction and remodeling were the focus of this three day workshop. A poster session and breakout groups were held to engage all participants in determining a path forward on these topics.
The momentum gained during the December meeting continues through discussions among participants. A full manuscript on the conference proceedings is currently being drafted. IIVS will present a summary workshop report at the annual SOT meeting in San Diego, March 23, from 5-7 in Torrey Pines rooms 1-3 at the Marriott. IIVS scientists will also be available in the exhibit hall at booth 1026 to answer questions about the workshop or future plans for our inhalation toxicology program. Please plan to visit or contact Dr. Holger Behrsing at [email protected] Funding for this conference was made possible, in part, by the Food and Drug Administration through grant 1 R13 FD 005299 - 01. Views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Humans Services; nor does any mention of the trade names, commercial practices or organization imply endorsement by the United States Government."
|
Upcoming Events
|
GlobalChem 2015March 2-4 Baltimore, MD, US March 4-5 London, UK March 5 Webinar Workshop on Systematic Review: What is Systematic Review? An Introductory CourseMarch 9 College Park, MD, US March 11-12 Beltsville, MD, US March 17-18 Berlin, Germany
March 22-26 San Diego, CA, US Workshop Report: In Vitro COPD Models for Tobacco Regulatory Science - Highlights and Paths ForwardMarch 23 San Diego, CA, US "AOPs 201": A Seminar on Development, Recording, and Use of Adverse Outcome PathwaysMarch 23 San Diego, CA, US Updates on Activities Related to 21st Century Toxicology and Evidence-based Toxicology: Invited Presentation and Open MicrophoneMarch 26 San Diego, CA, US March 22-26 Denver, CO, US
March 25 Breda, the Netherlands BioTQ MeetingMarch 27 Queretaro, Mexico FRAME Training SchoolMarch 30 Coimbra, Portugal International Conference on the Science of BotanicalsApril 13-16 Oxford, MS, US Cosmetic Compliance Summit 2015April 27-29 New Jersey, US Meeting the Information Requirements of the Animal Welfare Act: A Workshop May 6-7 Beltsville, MD, US
International Conference Of Alternatives to Animal Experimentation May 8-9 Lisbon, Portugal
|
News
|
Slides Available from the PISC/Chemical Watch Webinar Series on the Use of Alternative Methods for REACH
Chemical Watch and the PETA International Science Consortium, Ltd. (PISC) co-sponsored a series of REACH focused webinars. The webinars presented alternative methods and testing strategies that can be used to meet REACH requirements. IIVS Study Directors Dr. Emilia Costin and Dr. Kimberly Norman served as presenters for two of the topics in the series. Slides and recordings of these complimentary webinars have been made available on the PISC website.
Toxicology Community Saddened at the Passing of Dr. Edward Carney
IIVS staff is deeply saddened by the news that long-time friend and colleague Edward Carney, Founding Director of the Dow Predictive Safety Assessment Center, has died at 55. An employee of The Dow Chemical Co. for over 22 years, Dr. Carney held a deep commitment to ensuring that scientific advances and technologies are safe and sustainable for people and the environment. He was a Research Fellow within Toxicology and Environmental Research and Consulting (TERC) at The Dow Chemical Co., and was an active member of many scientific societies, including the American Society for Cellular and Computation Toxicology (ASCCT). Ed will be missed by his friends and colleagues around the world.
|
|
|
|
2015 Society of Toxicology Meeting
March 22-26
San Diego, CA
Visit booth #1026 to speak with our Study Directors about our in vitro testing services including ocular, dermal, sensitization, eye sting, and inhalation toxicology during the 2015 SOT meeting. We will present several posters throughout the conference and will host a special workshop report session Monday evening to present learnings from our meeting Assessment of In Vitro COPD Models for Tobacco Regulatory Science (March 23, 5-7 Torrey Pines I-III, Marriott Hotel). Stop by our booth or contact us now to reserve some time to speak one-on-one with our Study Directors about your testing programs.
| |
BioTQ
March 27 Queretaro, Mexico
IIVS Study Director Dr. Kimberly Norman will present information on the NociOcular assay for determining the potential of a material to cause eye sting during the 3rd BioQT meeting in Mexico. Representatives from industry, government, and academia will be attending to listen to lectures and network. Please visit the BioTQ website for more information.
| |
International Conference on the Science of Botanicals
April 13-16 Oxford, Mississippi
Join IIVS Study Director Dr. Kimberly Norman at the International Conference on the Science of Botanicals to discuss approaches for post market surveillance, risk and safety assessment, quality control and adverse event reporting (AER) for botanical dietary supplements (BDS) and natural products. Current regulatory perspectives from government, manufacturers and trade associations will also be explored. Members of CFSAN/FDA, trade associations, and industry will discuss pressing topics that affect BDSs and their impact on consumers. Dr. Norman will present on the use of in vitro assays to assess the sensitization potential of botanicals.
| |
Show Your Support Support IIVS in its mission to develop new in vitro technologies.
Make a Donation to IIVS Today!
IIVS Contributors
|
|
IVTIP Launches New Website
The In Vitro Testing Industrial Platform (IVTIP) has launched a newly revised website. The new site contains news items, agendas of upcoming events, information on IVTIP member companies and publications. There is also a restricted area for members of IVTIP. If you would like to learn more about IVTIP, its membership and how to become involved, please visit www.ivtip.org. Check back often in the coming weeks as new features continue to go live.
|
Apply Now for a 2015 ARDF Alternative Research Grant
The Alternatives Research & Development Foundation, a U.S. leader in the funding and promotion of alternatives to the use of laboratory animals in research, testing, and education, is currently soliciting research proposals for its 2015 Alternatives Research Grant Program. For over 20 years, this program has created opportunities for scientists who have interest and expertise in alternatives research. Visit the ARDF website for more information on applying for a grant.
|
The International Foundation for Ethical Research supports the development, validation, and implementation of innovative scientific methodologies that advance science and replace the use of animals in research, testing, and education. To that end, the foundation is accepting applications for the IFER Graduate Fellowship Program from graduate students whose program of study shows the greatest potential to replace the use of animals in science.
|
Korea MAFRA Plan to Phase Out Animal Testing Still Needs Formal Approval
Korea's Ministry of Agriculture, Food, and Rural Affairs (MAFRA) plan to phase out the use of animal testing on finished cosmetic products and ingredients needs final approval prior to implementation. The draft ban will be reviewed by the MFDA, the Ministry of Education and the Ministry of Science, ICT & Future Planning prior to finalization. Impact of the ban is uncertain since, among other things, no implementation timeline has been proposed. For more information, please visit the full article on the Cosmetics Design website.
|
EURL-ECVAM Hosts Carcinogenicity and Genotoxicity Database
The Carcinogenicity Genotoxicity experience (CGX) dataset, previously hosted on the Lhasa Limited Site, is now available from the JRC/ EURL ECVAM website. The CGX dataset is a collection of publicly available data that can be used for a variety of scientific purposes, including structural-based evaluation of chemical genotoxicity and the development of alternative approaches to animal testing. Visit the EURL ECVAM website directly for access to this database.
|
QSAR Application Toolbox Training Workshops Announced
The QSAR Application Toolbox was developed to facilitate the use of the OECD category approach and QSAR methods to fill data gaps in classification and labeling of chemicals. Use of the Toolbox is intended to save resources, reduce the need for animal testing, and greatly accelerate the hazard assessment process. Both basic and advanced training is being offered by REACH Monitor. Visit the REACH Monitor website for additional details on the content of the training and registration.
|
|
|