The research of PrecisionTox Working Group 6 (Regulatory Analysis & Application) explored the barriers to the uptake of NAMs, as perceived by stakeholders. Following this, PrecisionTox now presents the results of the follow-up study that determined solutions to overcome these barriers and that can foster the take-up of NAMs.
The researchers determined the level of consensus for particular policy options among key stakeholders in the EU, since fostering broad consensus among stakeholders is vital to a successful policy transition. : Regulatory use of data ; Education and training strategies ; Routes towards validation.
Read the policy brief summarizing the main findings
As part of its Science & Dialogue discussion series, supported by PARC and the FC3R, Pro Anima Scientific Committee organized last October its 3rd panel in partnership with the Fondation pour la Recherche Médicale (FRM). The panel focused on the essential question of public awareness on the new animal-free methods that are transforming chemical safety assessment and biomedical research.
In light of the challenges of our century, towards global health and more reliable science, the roundtable highlighted the need for collaborative and proactive approaches, from researchers, institutions and the media, to restoring trust in science and encouraging a better understanding of scientific and technological advances, notably through a more transparent communication and effective dissemination.
Despite several legislative strides towards the acceptance of non-animal technologies in countries such as India, US, Canada, Brazil, South Korea, and Japan, the uptake of non-animal new approach methods (NAMs), including microphysi-ological systems (MPS), has been slow in academia and industry. Standardization can be an enabler of innovation. However, addressing standardization needs and advancing the development of these systems requires prioritized funding.
To initiate a dialogue with relevant stakeholders towards developing recommendations, HSI India organized an international webinar in collaboration with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India ; StemPeers ; and CPHMS. Attracting 133 participants from 13 countries, this forum brought together key global stakeholders from the area of standardization, technology developers and policy makers, public and private funding bodies, philanthropic organizations, and venture capitalists, enabling participants to develop several key recommendations from the meeting.
Are you a young data scientist with a compelling story to tell about your achievements ? Can you demonstrate impact and innovation ? If you can answer yes to these questions then you could win the2025 Young Data Scientist of the Year Award which seeks to recognise, reward and nurture this vital talent in the life sciences industry.
This award is free to enter and is open to all young data scientists working in life sciences, anywhere in the world. The submission deadline is 31 January 2025 at 23.59 GMT. Three finalists will be selected to present to a judging panel on 26 March 2025 where the winner will be announced and will receive a cash prize of USD $1,500 as well as mentoring from the panel of judges.
Featuring real-world case studies to walk scientists through animal-free testing step by step, the curriculum launched by the Animal-Free Safety Assessment Collaboration (AFSA) has attracted over 1,200 participants from nearly 70 countries since its debut in 2023, highlighting a global interest in innovative, ethical testing methods. Its final module is now open for registration, completing the ten-module course.
Dr. Catherine Willett, senior director of science and regulatory affairs at HSI and principal coordinator of the AFSA Master Class, said, “Learning more about the cutting – edge tools available in the animal-free toolbox, and how to use them to make safety decisions, can be challenging. The AFSA Master Class demystifies animal – free safety assessment, making it easier for companies to replace rats, rabbits and guinea pigs with advanced non-animal models and computer simulations.”
The AFSA Master Class is freely available online.
Targeting of drugs to the brain presents one of the greatest challenges in medicine. We know more than ever about brain diseases, yet drugs developed often fail in the clinic. One major reason is that drugs cannot cross the blood-brain barrier (BBB). For Alzheimer’s disease alone, almost 300 experimental drugs have been tested in more than 1,000 clinical trials over the past 10 years. More than 99% of these trials have failed, in part because the drugs could not reach their optimal concentration in the brain.
To solve this problem, the Wyss Institute is creating a premier center for brain-targeted therapeutic innovation, which promotes unique pre-competitive collaborations among competing pharma, biotech and academic labs, granting agencies, and philanthropies. This initiative arises from the Brain Targeting Program established in 2019.
Learn more about the Wyss Brain Program and nascent center
The U.S. National Science Foundation (NSF) has invested $14 million in seven interdisciplinary research projects through the Emerging Frontiers in Research and Innovation (EFRI): Biocomputing through EnGINeering Organoid Intelligence program. This investment fosters fundamental and ethically responsible research and development of organoid intelligence systems while also broadening participation in biocomputing research.
“NSF’s investment will lead to biological computing with superior power and efficiency by harnessing the mechanisms behind complex biological behavior for smart systems,” said Susan Margulies, NSF assistant director for Engineering. “Advances in biocomputing will open new opportunities for artificial intelligence, biotechnology and more sustainable computing.”
In vitro toxicology studies are increasingly being included as evidence in systematic reviews and chemical risk assessments. INVITES-IN, a tool for assessing the internal validity of in vitro studies, is currently under development. The first step in developing INVITES-IN involves the creation of an “item bank,” an overview of study assessment concepts that may be relevant to evaluating the internal validity of in vitro toxicology studies.
The item bank contains 405 items of potential relevance to evaluating the internal validity of in vitro toxicology studies. Developed to be a useful resource for supporting the development of appraisal tools, this is the second item bank of any kind to have been created for toxicology studies, and the first to use focus groups as a data source alongside literature analysis. Due to the broad applicability of many items in the item bank, it may also be informative for study designs beyond the in vitro domain.
Read the article in Evidence-Based Toxicology
Parkinson’s disease, an aging-associated neurodegenerative disorder, is characterised by nigrostriatal pathway dysfunction caused by the gradual loss of dopaminergic neurons in the substantia nigra of the midbrain. Current human in vitro models do not incorporate aging characteristics which potentially contribute to the development of Parkinson’s disease.
A new article presents a nigrostriatal pathway model based on midbrain-striatum assembloids with inducible aging. Prof Schwamborn, former EthicScience prize laureate, and his team demonstrated thatthese assembloids can develop characteristics of the nigrostriatal connectivity, with catecholamine release from the midbrain to the striatum and synapse formation between midbrain and striatal neurons. Moreover, Progerin-overexpressing assembloids acquire aging traits that lead to early neurodegenerative phenotypes. This model shall thus help to reveal the contribution of aging as well as nigrostriatal connectivity to the onset and progression of Parkinson’s disease.
Read the publication in Communications Biology
Glioblastoma (GBM) is an aggressive form of cancer, comprising about 80% of malignant brain tumors. There are no effective treatments for GBM due to its heterogeneity and the presence of the blood-brain barrier (BBB), which restricts the delivery of therapeutics to the brain. Despite in vitro models contributing to the understanding of GBM, conventional 2D models oversimplify the complex tumor microenvironment.
There is a sudden increase in GBM-on-a-chip models that can significantly advance the knowledge of GBM etiology and revolutionize drug development by reducing animal testing and enhancing translation to the clinic. In this review, an overview of GBM-on-a-chip models and their applications is reported for drug screening ; the researchers also discuss current challenges and potential future directions for GBM-on-a-chip models.
Read the review in Nano Micro Small
Microphysiological system (MPS) is a powerful tool for the in vitro disease validation platform. It aims to assist or replace preclinical studies for validating the efficacy of anti-cancer drugs, precision medicine, and investigating metastatic mechanisms. However, it still faces formidable challenges due to poor and complex usability, low yield, and limited applications for heterogeneous biological samples.
In a new article, Kim & al. present a newly developed MPS consisting of a binary tumor-microenvironment-on-a-chip. These individually formed compartments for the tumor and microenvironment via concurrent processing can be interconnected whenever needed through simple mechanical compression, resulting in a fully integrated tumor-microenvironment-on-a-chip system. This interconnected system enables precise validation of drug efficacy. In this study, the researchers also propose anisotropic tumor remission by forced convection phenomenon.
Read more in Biosensors & Bioelectronics