BICO Endorses FDA Modernization Act of 2021
The legislation would end the mandate on animal testing for drug and cosmetic development in the United States and has the potential save the lives of hundreds of millions of animals each year
BICO, a leading bio convergence company, announced today it is endorsing the bipartisan FDA Modernization Act of 2021. The bill, H.R. 2565 / S.2952, would allow drug and cosmetic makers to develop new products using non-animal models including cell-based assays, organ chips and micro physiological systems, sophisticated computer modelling, and other human biology-based test methods. Since its founding, BICO has been a leader in the effort to end animal testing in the life sciences community, and plan to actively build support for the legislation.
Each year more than 100 million animals are estimated to be experimented on and euthanized for use in biomedical research in the United States alone, according to the Humane Society. This is in large part due to the 1938 Federal Food, Drug, and Cosmetic Act which requires that all new products be tested on animals to ensure safety and efficacy, regardless of if it provides scientific value. More than 80 years later, technological breakthroughs including tissue engineering, single cell isolation, live cell imaging and others can be converged to accelerate drug development without the use of animal experimentation.
There is an ongoing global debate concerning the relevance of animal testing. In September 2021, the European Parliament adopted a resolution calling on the European Commission to establish an action plan to actively phaseout animal experiments. This year, Mexico also banned the use of animal testing for cosmetic development while also banning imports of products tested on animals worldwide meaning U.S. developed products forced to test on animals will lose market access.
“There is no bigger ethical issue plaguing the life sciences industry in the United States today than this mandate on animal experimentation,” says Erik Gatenholm, CEO and co-founder of BICO. “Passing this law is not only the right thing to do, but also will advance Health 4.0 and ensure the U.S. continues to be a global life science leader in the coming decades.”
Nearly all BICO’s 13 group companies contribute to advancing drug development including several that provide direct alternatives to animal testing, including:
- CELLINK – 3D bioprinting to fabricate human tissue samples that provide much more physiologically relevant drug testing than animals.
- MatTek – In vitro human tissue models including skin, ocular, oral, respiratory, and intestinal tissue models to replicate toxicity and efficacy of human cells.
- Visikol – In Vitro assays for drug screening and toxicity assessment using high content screening, confocal microscopy, ELISA, and other assays.
- SCIENION - automated precision dispensing that can be used to accurately and reproducible distribute physiologically relevant biological material.
- Cellenion - single large-particle sorting and dispensing technology that enables the handling of complex 3D cellular models such as spheroids and organoids, and that can replace animal testing in pre-clinical research.
“Human tissue replacement models are undoubtably a better indicator of toxicity and efficacy than dogs or mice, which share very little physiology to humans,” says Alex Armento, President of MatTek, a BICO group company. “By giving researchers the choice of testing on animals or human-models, we’ll ultimately enable them to make the best decision based on the science.”
To learn more about BICO’s efforts to reduce animal testing, please visit: www.bico.com/reduce-animal-testing
United States House Bill, H.R 2565 - FDA Modernization Act of 2021
United States Senate Bill, S.2952 - FDA Modernization Act of 2021
BICO Press office US
Riley Munks, PR Manager: + 1 (650) 863-6699
Alyssa D’Orazio, PR Manager: + 1 (617) 634-9601
Email: press@bico.com
This information was submitted for publication, through the agency of the contact persons set out above, on December 14, 2021, at 3pm (CET).
About BICO
Founded in 2016, BICO (formerly CELLINK) is the leading bio convergence company in the world. By combining different technologies, such as robotics, artificial intelligence, computer science, and 3D bioprinting with biology, we enable our customers to improve people's health and lives for the better.
The company has a focus on developing technologies that will advance Health 4.0 Next Generation Core Industry Ecosystems that enable tissue engineering, diagnostics, multiomics, and cell line development. BICO’s technologies enable researchers in the life sciences to culture cells in 3D, perform high-throughput drug screening and print human tissues and organs for the medical, pharmaceutical, and cosmetic industries. We create the future of health.
The Group’s instruments in the field amounts to 25,000, including all the top 20 pharmaceutical companies, are being used in more than 65 countries, and have been cited in more than 9,500 publications. BICO is listed on Nasdaq Stockholm under BICO. www.bico.com