21 September 2018

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and a major public health concern, particularly for the very young and very old. Around the world, sepsis kills more people than AIDS, breast cancer and prostate cancer combined. The mortality rate can be as high as 50%, and those who survive are often left with long-term consequences that may include physical and psychological disabilities.

Sepsis becomes fatal as a consequence of multiple organ failure caused by an overwhelming cascade of inflammatory mediators released into the bloodstream. But exactly how this response to infection is regulated, and whether it is in fact a regulated response, remains uncertain. Some authors have suggested that the body goes through different immune states while fighting sepsis, starting by activation of immunity and then reaching immune paralysis or exhaustion. Current treatments have shown limited efficacy and patient outcome is in most cases unpredictable.  [Read more…]

9 August 2018

A new study by scientists from the Vrije Universiteit Brussel calls for a new gold standard in research to treat non-alcoholic steatohepatitis (NASH), an obesity-linked chronic liver disease impacting millions of people of all ages worldwide. The disease can progress to liver cancer if untreated, creating a massive strain on an already overburdened healthcare system. The study, published in Pharmacological Research, proposes a human-specific roadmap to better understand the biological mechanisms behind NASH, a crucial missing link in the effort to develop effective, and urgently-needed, treatments for the disease.

Dr Robim Rodrigues and Prof Tamara Vanhaecke of the Vrije Universiteit Brussel, lead authors on the study, commented that “In vitro models that reflect population diversity and specific mechanisms of the disease are already valuable tools today.” Modern techniques, including transcriptomics, proteomics, and metabolomics, are rapidly becoming more reliable and may therefore provide insights into the mechanistic background of NASH.” Dr Rodrigues explains that several drugs in development for NASH have been tested using in vitro models, clearly indicating the value of these systems in NASH R&D. He is optimistic that further development of predictive, human-based tools will provide a more cost-effective and reliable methodology for much-needed drug development for NASH liver disease.  [Read more…]

31 July 2018

Recommendations to come out of a workshop attended by representatives of the U.S. National Institutes of Health, the Federal Drug Administration, big pharma, and academia hold a dire warning: unless we invest more funding in human- rather than animal-based medical research to better predict which new drugs will treat human disease, the development of new drugs could dry up completely in the next 50 years. The paper, Recommendations toward a human pathway-based approach to disease research, published in the journal Drug Discovery Today summarizes the results of a two-day workshop that took place at the National Institutes of Health in June 2017.

The BioMed21 workshop, co-organized by the National Institutes of Health, The Humane Society of the United States, and Humane Society International, presented a comprehensive overview of existing efforts to prioritize human-based biology for health research and proposed key recommendations to revitalize the drug discovery process.  [Read more…]

10 July 2018

The world’s most industrialized economies have been increasingly investing in technologies and opportunities that will eventually replace animal-models used in toxicology and biomedical research. In South America, too, a number of scientists have already recognized this trend and are interested in doing research that do not rely on animal models. Now, the BioMed21 Collaboration, a group of scientists and other stakeholders who together work towards replacing the use of animals in research, has published a paper in the journal Drug Discovery Today entitled Human-specific approaches to brain research for the 21st century: A South American perspective. The paper reports on a two-day workshop that took place in Rio de Janeiro, in May 2017, organized by Humane Society International in collaboration with D’Or Institute for Research and Education (IDOR).

The meeting brought together leading scientists, representing scientific institutions in Brazil and in Argentina, Brazil’s National Council for Scientific and Technological Development (CNPq), and other stakeholders to leverage existing national and international projects to improve health research and to engage scientists to shape a new human-specific paradigm for biomedical research in the region. [Read more…]

3 July 2018

Humane Society International, co-founder of the BioMed21 Collaboration, teamed up with global fashion brand H&M and together they financially supported China’s 8th Workshop on Alternative Methods, held June 11-13 in Shanghai. The event provided more than 200 scientists from industry, government bodies and academia with in-depth theoretical and hands-on experience in contemporary “new approach methods” (NAM) applicable to regulatory and research environments.

A keynote lecture by The Humane Society of the United State’s Chief Scientific Officer, Dr Andrew Rowan, kicked off the meeting on the theme of ‘Move to a new research paradigm.’ Dr Rowan was later interviewed for shangzhibo tv, where he expressed optimism regarding China’s potential role in further developing and promoting new approach methods, concluding that China’s proven ability to embrace new technologies could allow them to become a ‘world beater’ in alternative methods. [Read more…]

19 June 2018

Earlier this year, the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) published its new Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products. This seminal document offers a consensus perspective, incorporating the views of 16 federal regulatory and research agencies, several interagency workgroups and public opinion.

The Roadmap provides a conceptual framework supporting the development, evaluation and use of the “new approach methodologies” (NAM), expediting the use of human relevant methods and reducing reliance on existing animal-based approaches to risk assessment. Its overall aim is: “To expedite the use of 21st-century science to protect and improve public health, federal agencies and stakeholders will work together to build a new framework to enable development, establish confidence in, and ensure use of new approaches to toxicity testing that improve human health relevance and reduce or eliminate the need for testing in animals.” [Read more…]