Registration is open for the fourth ICCVAM Communities of Practice webinar scheduled for January 23. The webinar topic is “Machine Learning in Toxicology: Fundamentals of Application and Interpretation.” NICEATM is organizing this webinar on behalf of ICCVAM.
This webinar will explore the fundamentals of machine learning approaches, including how they work, how they are interpreted, and precautions that should be taken when evaluating their output. Sean Ekins, Chief Executive Officer of Collaborations Pharmaceuticals, Inc., and NICEATM Deputy Director Nicole Kleinstreuer will address issues specific to machine learning approaches used in a regulatory context. Case studies will highlight where such techniques have been successfully applied both nationally and internationally.
The January 23 webinar will be held from 1:00-2:30 p.m. Eastern Time. It is free and open to the public, although registration is required to attend.
A report of the February 2016 workshop, In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making, and the preceding webinar series was published online December 5 by the journal Toxicology In Vitro. Toxicology In Vitro is making the workshop report publicly available to all readers, regardless of subscription status, through February 23. To read the article, go to https://authors.elsevier.com/a/1WKoG39kyQjVLj.
The workshop report discusses activities and resources that promote inclusion of in vitro to in vivo extrapolation (IVIVE) in regulatory decision-making. It considers properties of models that successfully generate predictions of in vivo doses from effective in vitro concentration, areas of success, and areas for improvement to reduce model uncertainty. Finally, the report provides case studies on the uses of IVIVE in safety assessments.
Materials from the workshop, which was co-organized by NICEATM and the U.S. Environmental Protection Agency (EPA) Office of Research and Development, are available at https://ntp.niehs.nih.gov/go/ivive-wksp-2016.
The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics recently added Veterinary Services (VS) Memorandum 800.116 Target Animal Safety Testing Exemption to its website. All VS Memoranda are available at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologics-regulations-and-guidance/ct_vb_vs_memos.
VS Memorandum No. 800.116, signed in August 2017, replaces an earlier version issued in July 2013. The memorandum provides guidance to licensed firms on requesting an exemption under title 9, Code of Federal Regulations (9 CFR), part 113.4, to target animal safety testing as required for testing of live and inactivated vaccines and antibody products. Such exemptions can reduce animal use in facilities that have documented consistency in manufacturing processes and product safety.
USDA Animal Care seeks your input on whether we should recognize inspections (and similar reviews) by third-party programs when determining the frequency of federal inspections for facilities regulated under the Animal Welfare Act.
We would like your feedback. Beginning on January 18, 2018, we will host four in-person listening sessions and one virtual session. Any interested person may speak. A list of locations and dates for these sessions, along with instructions for registering, are located here. You will also find instructions for submitting written comments.
Our inspectors conduct routine, unannounced inspections of all Animal Welfare Act licensees and registrants. Various factors determine the inspection frequency for each entity – including a facility’s history of adhering to the federal regulations and standards. Some licensees and registrants already use a third-party program to support animal welfare at their facilities. We are interested in learning more about these programs, and hearing our regulated community’s and stakeholders’ views on how we might consider the use of these programs in our administration of the Animal Welfare Act.
“We are always looking for ways to serve our regulated community and direct our resources more effectively,” said Animal Care Deputy Administrator Bernadette Juarez. “Recognizing third-party inspections may be a good way to support compliance at facilities, while allowing us to devote more of our time to helping those licensees and registrants who need it most.”
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is establishing a new research consortium "Microphysiological Systems for Modeling Diabetes." This consortium will support the development and validation of human tissue chips that closely mimic the normal physiology of key metabolic tissues, including the pancreatic islet, liver, skeletal muscle, and white adipose tissue. An essential feature of this consortium will be a
multidisciplinary approach that brings together basic science experts and physician scientists in stem cell biology, bioengineering, computational
biology, pharmacology, liver biology, islet biology, adipose biology, metabolism and diabetes.
To establish the consortium, NIDDK intends to commit up to $3 million per year for Fiscal Years 2018 through 2019, and up to $6 million per year for Fiscal Years 2020 through 2022 to fund 2-3 awards. Eligible institutions include U.S.-based higher education institutions, nonprofits, for-profit organizations, and government entities.
Letters of intent are due February 20, 2018; applications are due March 20, 2018. Complete funding information is available on the NIH Grants website at https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-17-035.html. Helpful information about applying for NIH grants is available on the NICEATM
website at https://ntp.niehs.nih.gov/pubhealth/evalatm/resources-for-test-method-developers/funding-opportunities/index.html.
The National Institute of Environmental Health Sciences (NIEHS) is offering Small Business Innovation Research (SBIR) grants to develop novel in vitro systems using cells from experimental animal models typically used for toxicology testing. The intent is that these systems will replicate biological responses within the corresponding animal tissues or organs. When developed and validated, these systems will (1) provide information needed to predict toxicity of chemical and drug candidates, (2) enable comparisons with existing in vivo animal toxicity data, (3) serve as newer assays for toxicology testing, and (4) have the potential for reducing the numbers of animals used in toxicology testing.
These grants of up to $150,000 for Phase I awards and up to $1 million for Phase II awards are only available to U.S. small businesses. Letters of intent to apply for these grants are due December 12, with an application due date of January 12, 2018. The funding announcement for this opportunity is available at https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-18-001.html; more information about NIEHS SBIR grants is available at https://www.niehs.nih.gov/funding/grants/mechanisms/sbir/index.cfm.