More than 60 percent of investigational drugs fail in human clinical trials due to a lack of effectiveness, despite promising pre-clinical studies using cell and animal research models. To help combat this translational science problem, the National Institutes of Health announced 13 two-year awards totaling about $15 million per year, with FY18 funds subject to availability, to develop 3-D microphysiological system platforms that model human disease. The funding is for the first phase of a five-year program. These platforms, called “tissue chips,” support living cells and human tissues to mimic the complex biological functions of human organs and systems and provide a new way to test potential drug efficacy.
“The goal is for these tissue chips to provide more accurate platforms to understand diseases, and to be more predictive of the human response to drugs than current research models, thereby improving the success rate of candidate drugs in human clinical trials,” said NCATS Director Christopher P. Austin, M.D.
The new Tissue Chip awardees will study a wide range of common and rare diseases, from rheumatoid arthritis, kidney disease and human influenza A viral infection to amyotrophic lateral sclerosis (ALS), hereditary hemorrhagic telangiectasia and arrhythmogenic cardiomyopathy.
New booklets to help people replace, reduce and refine the use of animals in research have been developed by the New Zealand arm of ANZCCART, the Australian and New Zealand Council for the Care of Animals in Research and Teaching. The principles of replace, reduce and refine are known as the 3Rs: Replacement: Where possible, replacing animal use with alternative techniques
The booklets, which have been produced in collaboration with the Ministry of Primary Industries, will be provided to animal ethics committees, the research community, and to schools around New Zealand.
“We hope the booklets will enable researchers to think creatively about how they can follow the principles of replace, reduce and refine in research they are involved with,” says Dr Wiles. “We also hope that the booklets will show school children and the wider public the techniques being used to reduce, refine and replace the use of animals in research, teaching and testing.”
Genoskin provides a unique alternative to animal testing using excess human skin that is kept alive in testing wells. The skin is donated by patients after common plastic surgery procedures, such as tummy tucks. At the end of these procedures, any excess skin is generally disposed of by the hospital. The Genoskin team now recycles this skin into a patented testing model for cosmetic, pharmaceutical and chemical companies as well as research institutions. The retrieved skin is placed in a testing well that contains a special biological matrix to keep the skin alive for several days.
Unlike animal skin, bioprinted skin or skin that is grown in laboratories, Genoskin’s skin tissue model contains real, live human skin to study drug and compound toxicity and efficacy on a model that is as close as possible to in vivo human skin.
“Animal testing is inefficient, time-consuming, expensive and increasingly perceived as unethical. We believe our technology marks a turning point. Not only do our human skin models address all these issues, they also help eliminate the major problem of efficacy and toxicity issues that arise due to differences between animal and human tissue,” said Pascal Descargues, founder and CEO of Genoskin. “Our skin models help academic institutions, pharma, cosmetic and chemical companies obtain more predictive results in order to lower R&D costs.”
Organs on chips are no longer at their simplest stage of production. Technological advancements have allowed for researchers to create organs on chips for a wide range of organs and systems modelling the functions of human systems and the responses to various chemicals and drugs. The latest research is focused on creating a “body on a chip” where 10 chips, functioning as different systems, are connected together to observe the interactions between the different organs in the human body.
American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs.
Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for sale and distribution. Key among these requirements is the need for hemocompatibility testing, governed by the international standard ISO-10993-4 – recently updated to reflect some of the most recent advances in the science of blood compatibility.
the In-vitro Blood Loop Assay – utilizes blood from donor sheep pumped through a closed tubing loop, which simulates the circulation in the animal. The test and comparator devices (up to nine of each, allowing statistical assessment of endpoints) are deployed in the flowing blood for a similar duration of about four hours, after which the devices are removed and quantitatively evaluated for the presence of blood clots in a manner similar to that used in the NAVI model.
American Preclinical Services (APS) has been awarded AAALAC’s 2017 Global 3Rs Award for North America – a significant acknowledgement from a well-respected external organization that APS’s ongoing efforts to redesign thrombogenicity testing can have a global impact. The end-goal is to significantly enhance the accuracy and performance of thrombogenicity testing and substantially reduce the number of research animals used to accomplish these goals.
At the very least, the approval of this test method by the FDA will provide medical device manufacturers and other contract research organizations a superior alternative method for testing that is acceptable for use in manufacturers’ submissions to regulatory bodies for approval.
Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices.
The work of the lubricant industry, the Institute for In Vitro Sciences (IIVS), the PETA International Science Consortium Ltd., and the Consumer Healthcare Products Association (CHPA) follows efforts to show that animal testing for lubricants can and should be replaced by non-animal methods, in part because rabbits and humans have very different physiologies.
Human in vitro tissue models are now available that may replace RVI. The project will collect existing data and conduct targeted in vitro testing as necessary to determine if these animal-free methods can be used in place of RVI for personal lubricant products. The results of the study will be submitted to FDA and, following successful evaluation, the in vitro tissue model methods will be usable for personal lubricants.