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Amendment of FDA Act, organ chip leading drug R&D reform
2022-09-08 2456

FDA bill amendment,<a href=“ http://www.daxiangbio.com/ "Target=" _blank "title=" FDA bill amendment, organ chip leads drug R&D reform ">organ chipleads drug R&D reform

Introduction: Recently, the U.S. House of Representatives passed the H.R.7667 - Food and Drug Amendments of 2022, which officially included organ chips in the non-clinical trials of drugs.

Amendment to the bill:organ chipleads drug R&D reform

On June 8, 2022, the United States House of Representatives passed a bill, the Food and Drug Amendments of 2022 (H.R.7667 - Food and Drug Amendments of 2022), to amend the Federal Food, Drug and Cosmetic Act (FFDCA).

FFDCA is the general name of a series of bills passed by the United States Congress in 1938, giving the United States Food and Drug Administration (FDA) the power to supervise and regulate food safety, drugs, and cosmetics, which has been the core basis of FDA's regulatory authority since its promulgation.

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This revised bill readjusts the cost input of FDA for specific drugs and medical devices, improves the requirements for the diversity of clinical trials, and expands and improves the various process links of drug research and development.

Two important adjustments have been made to the relevant provisions of FFDCA (21 U.S.C. 355) drug development:

(1) The" animal experiment "in the original bill is uniformly revised to" non-clinical experiment ", which reduces the strong correlation between" animal experiment "and" preclinical experiment "in traditional cognition, and clearly defines" non-clinical experiment ": in vitro experiment or non-human in vivo experiment conducted before or during the drug clinical trial stage.

(2) TheThe organ chipand the microphysiological systems (Organ chips and microphysiological systems) are included in the bill as independent non-clinical experimental evaluation systems of drugs. Organ chips and cell models, computer modeling and animal models are regarded as equally important research tools.

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The concept of organ chip has a long history, and was listed as one of the" top ten emerging technologies "in Davos Forum in 2016. Organ chip refers to a kind of organ physiological microsystem built on the chip, with microfluidic and tissue engineering as the core, which can simulate and build a tissue and organ microenvironment containing a variety of complex factors such as living cells, functional tissue interface, biological fluid and mechanical stimulation in vitro, reflecting the main structure and functional signs of human tissues and organs.

In 2010,The organ chiptechnology began to really embark on the fast track of development. From the early organ chip prototype, lung, intestine, liver and other single organ chips to the multiple organ chips connected with multiple organs, scientific researchers gradually developed models with more complete and complex functions and higher simulation degree.

In 2011, the United States government took the lead in launching the national strategy of human micro-physiological system (organ chip), and formulated a support plan for organ chips from a strategic level; then European countries have also increased their investment in organ chips. In the industry, many European and American head pharmaceutical companies have established the non-profit organization IQ Alliance (Innovation and Quality Consortium) to promote the standardized application of organ chips in drug research and development.

In 2020, the Chinese Academy of Engineering selected the organ chip as the cutting-edge technology of global engineering.

In 2021, China issued guidelines for cell therapy and gene therapy, which is a milestone in legislation.

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At the same time, based on the 3R principle, many institutions in Europe and the United States have issued policies to promote animal substitution experiments. The United States Environmental Protection Agency plans to cancel all mammalian tests in 2035 and use organ chips as drug evaluation standards.

For a long time, the effectiveness and safety of drugs need to be verified on animal models before they enter clinical research. However, animal models can not accurately simulate the real human pathophysiological system. According to data, about 92% of drugs proved safe and effective in animal experiments, but failed in clinical trials.

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The launch of this revised bill shows the FDA's positive attitude towards the application of emerging technologies in the research and development of new drugs, and also confirms the important position of organ chip/microphysiological system as a non-clinical experimental research model, hoping to bring revolutionary breakthroughs to the early research and development and clinical transformation of drugs with the help of this human-origin system, high-bionics, and high-throughput innovation model.

Organ-like chip:" upgraded "organ chip

Organoids-on-chips is a high-throughput, high-bionic in vitro model construction platform created by combining Organoids and Organ chips technology.

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Organ-like organisms tend to be biological, and use cytokines to induce adult stem cells to self-assemble to form human micro-organs. Its advantages lie in its high fidelity, which has highly similar histological characteristics and functions to human organs, but has limitations in controllability and repeatability.

Organ chip is biased towards biomedical engineering. It is based on microfluidic chip to build human organ physiological microsystem. It has advantages in the controllability and standardization of modeling, and can realize the construction of more complex models through co-culture technology. However, the organ chip model built from a single kind of cells is far from enough in the biological bionic degree.

Organ-like chips integrate the advantages of the two technical routes, which is the practice of the intersection and integration of the most advanced technologies, and break through the limitations of single organ and organ chips to a greater extent, bringing new ideas to the rapid development of the pharmaceutical industry. In 2019, the concept of organo-like chips was first put forward in a review published by Science magazine, and organo-like chips are also considered as one of the most cutting-edge directions in the development of organ chips.

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Beijing Daxiang Technology Co., Ltd. is a leading high-tech company in China that develops and produces human organ chips, and is committed to promoting and leading the wide application of organ chips in the fields of new drug research and development, disease modeling and personalized precision medicine. At present, the company has successfully constructed more than 10 kinds of highly bionic organ chips including normal human physiological organ models and tumor disease models.

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These models will help the precise screening and research and development of new drugs, improve the prediction rate of in vitro efficacy test data to clinical trials; as a cost-reducing and efficiency-enhancing method, assist the pharmaceutical company IND safety evaluation experiment not limited to the current expensive animal experiments; provide richer and more valuable experimental scenarios for new therapeutic products such as cell therapy and gene therapy.

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At present, Big Oak Technology has completed the signing of cooperation with Wuhan National Human Genetic Resources Database