SWITZERLAND — Swiss drugmaker Roche is leading the charge in preclinical drug development with the launch of its Institute of Human Biology (IHB), an initiative that aims to create better models for predicting how patients will respond to drug candidates.
The IHB was rebranded from Roche’s Institute for Translational Bioengineering, which was established in 2021 to advance the use of human model systems in drug discovery and development.
The company plans to expand the IHB to around 250 scientists and bioengineers over the next four years, with staff from Roche working alongside academics from the Swiss Federal Institutes of Technology, ETH Zurich, and EPFL.
Roche is betting that human model systems, such as organoids, will provide a more accurate way to gather data for predicting patient responses to drug candidates.
Currently, animal models are the go-to method used by drug developers to assess how a drug is likely to perform in clinical trials.
However, the company acknowledges that the results from animal models may not translate well to humans.
Roche believes that human model systems, such as organoids, are the key to collecting data that more accurately predict patient response to a molecule.
The IHB is designed to change this paradigm by focusing on biology, bioengineering, and data science around human model systems, and applying them to real-world challenges in drug discovery and research.
Matthias Lutolf, head of the IHB at Roche, has expressed his confidence that the institute’s work has the potential to redefine how the company discovers and develops medicines in the next decade.
He also stated that the IHB is in a unique position to bring together biology, bioengineering, and data science, and to apply these disciplines to real-world challenges in drug discovery and research.
Hans Clevers, M.D., Ph.D., a pioneer in organoids research, was hired by Roche last year as the head of pharma research and early development.
Clevers believes that human organoids can be implemented at every stage of drug development, from target identification and validation through preclinical safety and efficacy, to stratification in clinical trials, and even as a tool to predict individual patient response in personalized medicine.
As Roche forges ahead with its investment in organoid technology, experts predict that 3D organoids will soon become a vital tool in biological research, drug discovery, and drug screening.
According to Agnieszka Zuchowska, Chair of Medical Biotechnology at the Warsaw University of Technology Faculty of Chemistry in Poland, these models have the potential to revolutionize the drug development process, which is traditionally lengthy and costly, with each new drug costing over US$1 billion to bring to market.
With Roche at the forefront of this technology, the pharmaceutical giant is poised to reap the benefits of this rapidly growing market while also making strides in transforming drug development.
By leveraging the power of organoids, Roche is not only working to create more accurate and predictive models but also seeking to streamline the drug discovery process and ultimately bring more effective treatments to patients faster.
Meanwhile, the U.S. Food and Drug Administration (FDA) has recently made an announcement that is set to transform the world of drug discovery using advanced cell models called organoids.
This is a groundbreaking development that could herald a new era in drug discovery. The FDA will allow an existing drug to be repurposed based on efficacy data generated using these microphysiological systems.
This is a major breakthrough in validating the utility of these models, which have the potential to revolutionize treatments for rare diseases.
Hesperos Inc., one of the pioneers in this field, has demonstrated the efficacy of organoids in finding treatments for rare autoimmune diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP).
The company used its model of peripheral motor neuron conduction velocity to test serum from CIDP patients, which led to increased antibody binding and activation of the complement cascade.
Based on this data, Sanofi’s sutimlimab was tested and received FDA approval in February 2022 for the treatment of cold agglutinin disease, another rare condition in which the immune system destroys healthy red blood cells.
Hesperos is now looking to replicate this success in other rare diseases where there are no animal models available.
James Hickman, the CEO of Hesperos, pointed out that there are 7,000 rare diseases but only 400 research programs looking at them due to the unavailability of animal models.
Organoids could fill this void, and their potential in discovering new treatments for rare diseases is enormous.
This breakthrough represents a turning point in the search for new therapies, and organoids are likely to become an indispensable tool for biological research, drug discovery, and drug screening within a few years.
The market for organoids is projected to reach US$3.43 billion globally by 2027, growing at a CAGR of 22.1% over the next five years, according to US-based Insight Partners.
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