AMS Spring 2023

To End Animal Testing, BICO & CCS Push FDA Modernization Act

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As the world continues developing alternatives to animal testing like bioprinting, in vitro models of human tissues, and predictive computer models, the demand for live animal testing has become outdated and unreliable. As the process of phasing out animal testing takes shape, more than 41 countries have already passed laws to limit or ban the practice, and now the United States is following suit. In 2021, there has been major progress for millions of animals in laboratories after US Senators Cory Booker and Rand Paul introduced the FDA Modernization Act to end animal testing mandates that demand experimental drugs must be pushed on animals before they are used on humans in clinical trials.

One of the major public endorsers of the legislation has been bioconvergence giant BICO. Last year, the Sweden-Boston-based company highlighted the importance of having a law that gives researchers a choice to test drugs or cosmetics on human models. BICO co-founder and CEO Erik Gatenholm also pointed out that the decision will help advance “Health 4.0” (adapted from the Industry 4.0 principles) and put to rest a bigger ethical issue that has plagued the life sciences industry for decades.

However, it seems endorsing the law was not enough for the leading bioprinter manufacturer. Determined to reduce animal testing in life sciences, BICO just announced a new partnership with the Center for Contemporary Sciences (CCS), a leading advocacy organization behind the bill founded by former FDA officials and life science executives. Moving forward, the two organizations will work closely to build support for the bipartisan FDA Modernization Act and reduce animal testing by promoting human-specific medical research technologies that include advanced in vitro tissue models and bioprinting.

BICO considers this initiative of great importance due to the potential to significantly accelerate the adoption of bioprinting in the drug development process while also reducing animal testing. As part of the company’s objective to improve patient health, the focus is on developing tissue engineering, diagnostics, multiomics, and cell line development technologies. To that end, BICO’s product line enables 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.

BICO partnered with the Center for Contemporary Sciences to support FDA Modernization Act of 2021.

BICO partnered with the Center for Contemporary Sciences to support the FDA Modernization Act of 2021. Image courtesy of Center for Contemporary Sciences.

Since its inception in 2016, BICO (formerly known as Cellink) has centered its product development on non-animal models, certain that the elimination of unnecessary animal testing was needed to advance the life science field. Today, its wide range of products originating from 11 subsidiaries are in high demand by some of the most renowned medical corporations, labs, and universities worldwide. Researchers are leveraging cell-based assays, bioprinting platforms, organ chips, and micro physiological systems that the company has developed while collaborating in innovative case studies that could change the paradigm of biomedicine and biomedical engineering.

Through the new collaboration, the partners will work to promote bioprinting to industry and regulators, educate them on its benefits, and hold educational meetings with key congressional offices responsible for the passage of the bill.

Commenting on the move, CCS Chief Science Officer, Zaher Nahle said, “The partnership with BICO, one of the most exciting and credible bioconvergence forces in the industry today, reflects our commitment to work alongside like-minded organizations to modernize the drug development process through dedicated advocacy efforts and discerning policies rooted in evidence-based science. It is also a realization of the vision of CCS co-founder and CEO, Aysha Akhtar, MD, MPH [former Deputy Director of the Army’s Traumatic Brain Injury Program and FDA medical adviser] and the Board, to bring real change to a process that has been woefully neglected for far too long, and that would save both human and animal lives.”

Neglected indeed! In the US alone, more than 100 million animals are experimented on and euthanized for use in biomedical research each year. Aside from the ethical considerations of using animals in the lab, 95% of all drugs shown to be safe and effective in animal tests fail in human trials, and over $12 billion in taxpayer money are spent on this type of research every year. Instead, the FDA Modernization Act would amend the 1938 Federal Food, Drug, and Cosmetic Act legislation that requires all new pharmaceuticals be tested on animals for safety and efficacy, regardless of whether such tests are predictive or relevant to outcomes in humans.

“Over the years, research has demonstrated that animal testing can often be inefficient in predicting drug effects and efficacy in humans. I’m proud to join Sen. Paul in introducing legislation that will cut FDA red tape, allowing drug manufacturers and sponsors to innovate clinical trial designs and utilize modern alternatives to demonstrate safety and efficacy,” pointed out Senator Mike Braun, who co-sponsored the legislation in 2021.

Researcher injects novel medicine into laboratory rabbit by intravenous injection for testing toxicity and safety.

Researcher injects novel medicine into laboratory rabbit by intravenous injection for testing toxicity and safety. Image courtesy of Humane Society.

Even though the bill would not ban animal testing outright, it would allow drug sponsors to use alternative methods where they are suitable. Today, BICO and CCS plan to closely align their strategy and outreach efforts to support the passage of the bipartisan FDA Modernization Act of 2021, along with other initiatives to reduce animal testing in the life sciences industry. One of the main goals of the partnership is to promote bioconvergence technologies to accelerate human-relevant drug development and other applications without experimentation on animals. The partnership also comes a month after CCS partnered with BICO subsidiary MatTek, a leading developer of in vitro human tissue models widely used in the drug, cosmetic, and chemical industries to replace animal testing.

Although change will probably come slowly, creating, investing, and promoting non-animal alternative technologies that are more reliable and do not cause animal suffering are the best bet if animal testing is slated to end by 2035 in the US, as per the US Environmental Protection Agency (EPS) announcement from 2019. After centuries of animal testing, it might be time to replace it with more human-relevant methods and aim for modernized drug development initiatives to improve human health and advance personalized medicine altogether.

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