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Will xenotransplantation address the human organs shortage?

24 May 2022

by Bianca Marigliani

Current patients’ need for organ transplantation far exceeds the availability of donors [1]. This is a pressing issue with a distressing human cost: all over the world people die while still on the waiting list for donated organs. To address this issue and save lives, some scientists have proposed xenotransplantation as a solution for the worldwide organ shortage crisis and recent press reports have discussed breakthroughs with this technique.

The first successful heart transplant from a genetically modified pig to a human being hit the headlines in January [2]. The 57-year-old patient, who had advanced heart failure, received a pig’s heart with ten genetic modifications. These included knock out of certain pig genes and the addition of human genes to reduce the risks of rejection, as well as removal of a growth hormone receptor gene to reduce the growth of pig heart tissue after transplantation. Sadly, the patient died in March 2022. [Read more…]

Regulators and public funding bodies plan the future of health research sector in India

9 December 2021

The September 2021 BioMed21 regulatory roundtable discussion in India focused on the way forward for the development of human biology-based technologies through sustained funding, training and education, and the in-country development of such technologies. The Centre for Predictive Human Model Systems, a collaboration between Humane Society International/India and the Atal Incubation Centre-Centre for Cellular and Molecular Biology, organized the event as a follow-up to the first scientist roundtable that was held by them in December 2020.

The roundtable brought together key regulators from the Central Drugs Standard Control Organization and the Indian Pharmacopoeia Commission, government bodies like the Indian Council of Medical Research-National Animal Resource Facility and the Committee for the Purpose of Control and Supervision on the Experiments of Animals, and public funding bodies like the Department of Biotechnology, and industry stakeholders to strategize the development and uptake of human biology-based methodologies.

In his remarks, Dr Vinay Nandicoori, Director, CSIR-CCMB, laid emphasis on the importance of stakeholder dialogue involving governments, regulatory bodies, and technology developers to promulgate development of these methodologies in India. The CEO of AIC-CCMB, Dr Madhusudhana Rao affirmed the impetus provided by such meetings to streamline the process of adoption of new model systems in regulatory mandates and drug development. [Read more…]

Proof in Animals: Has journal editorial policy fallen behind advances in human-based approaches?

2 November 2021

by Marcia Triunfol

On August 31st, 2021, a group of five panelists at the 11th edition of the World Congress on Alternatives and Animal Use in the Life Sciences responded to the question: “Proof in animals: Has journal editorial policy fallen behind advances in human-based approaches?”

One of the panelists, Pep Pàmies, chief editor at Nature Biomedical Engineering, recalled Betteridge’s law of headlines, “any headline that ends in a question mark can be answered by the word no.” But as it turns out, the question raised here does not have a clear, one word answer, even though recent evidence from 90 scientists responding to our survey points towards a practice of ‘publication bias’ in which specialized journals request that animal data be provided to validate studies produced using human biology-based approaches, such as organoids and organ on a chip. According to many scientists, such requests cannot be justified and illustrate widespread resistance to full acceptance of non-animal methods. The fact that some editors and/or peer-reviewers continue to regard animal model data as the gold standard and in many cases make acceptance for publication conditional on providing “proof in animals” (which may involve performing new animal experiments), can become a barrier to scientific progress. [Read more…]

Here’s what we were busy with in WC11!

15 October 2021

The BioMed21 Collaboration recently contributed to several sessions within WC11—the 11th World Congress on Alternatives and Animal Use in the Life Sciences. This triennial event was postponed in summer 2020 and took place virtually between August 23 – September 2 this year. With more than 100 sessions, 30 exhibitors and sponsors, and 500 e-posters, it was as vibrant and busy as a real-life event!

Click on the links below to access our presentations associated with our ongoing projects and efforts around the globe: [Read more…]

European Parliament votes in favour of EU plan to replace animal experiments with cutting-edge science

16 September 2021

The European Parliament has adopted a resolution vote calling on the European Commission to establish an EU-wide Action Plan for the active phase out of the use of animals in experiments by defining milestones and targets to incentivise progress in the replacement of animals with non-animal human-relevant methods. Nearly 10 million animals are used in invasive experiments in EU laboratories every year, including monkeys, dogs, cats, rabbits, rats and mice, a huge number of animals that has remained relatively unchanged in the last decade. The vote has been welcomed by animal welfare groups; Humane Society International called the vote “an historic opportunity to take animal suffering out of EU the equation and shift the focus to modern, cutting-edge, human relevant research.”

Whilst acknowledging European-level initiatives to reduce and refine the use of animals, the Parliament recognised that an active, coordinated approach for the full replacement of animals has not been achieved. By requiring an EU-wide action plan with an ambitious timeline and list of milestones, the European Parliament is aiming to drive the active phase-out of animals used for all scientific purposes. [Read more…]