New York, New York, United States – 12-10-2022 (PR Distribution™) –
An attempt to look into the future and learn how fast we can develop new drugs.
The crisis of models
Drug development remains a lengthy and costly activity, with a low probability of success. Scientists estimate that average investments in this field of research comprise 1.3 billion dollars per drug, while approximate development time varies from 5.9-7.2 and 13.1 years for non-oncology and oncology medications, respectively.
Out of 5,000 compounds that reach preclinical studies, only five make it to Phase I of clinical trials. The overall approval rate of trialed drugs does not exceed 13.8%. Toxicity and low efficiency are considered the main reasons for clinical trial failures.
Those failures often occur due to poor choice of models: compounds that showed great potential during animal tests turn out to be ineffective when administered to people. That is why one of the main tendencies of the present-day drug design is to thoroughly analyze how adequate a model used for preclinical research (be it a rat or a macaque) is, compared to the human body.
3D models and organs-on-a-chip
One of the ways to bridge the gap between humans and animals is to apply three-dimensional models of human organs that effectively recreate the conditions of a human body thanks to the environment of neighboring cells and the extracellular matrix.
For instance, 3D models help to estimate a more precise dosage during cancer drug trials. External cells get a higher dose than those within the culture, just like cells in a living body (especially in the case of solid tumors).
Still, 3D models are expensive and difficult to design and use. That is why, despite their functional advantages, they are less popular among researchers than two-dimensional versions. But perhaps they will become commonplace three decades from now.
Organs-on-a-chip (OOCs) is a more sophisticated model. Those devices cultivate cell cultures, simulating mechanical and physiological responses of organs and even organ systems, and combine a 3D organ model with a microfluidic platform. Scientists have already developed the OOC models of microvessels, lungs, kidney, intestine, liver, and their combinations.
Omics data in drug design
Some issues associated with preclinical trials can be resolved by omics data — vast pools of molecules (collected on various levels of biological processes) that demonstrate the state of a body or a body part. Omics data are analyzed by bioinformatics, an interdisciplinary field that combines biology, statistics, and computer science.
Omics data are mainly used at the earliest stages of preclinical trials to assess the properties of candidate molecules via the information collected from cells and to get a “mold” of a sick organism to test the impact of various substances.
A classic case of the same-level omics data application involves comparing tissue transcriptomes of healthy and diseased people. Scientists study the gene expressions to detect damaged molecular pathways; after that, they select candidate molecules that can impact the target molecules.
The recent tendency involves analyzing multi-omics data, i.e., the information on peptides, proteins, metabolites, and DNA and RNA sequences. This helps to see the complete picture of a disease, as pathological processes affect multiple cell levels.
In an ideal case, it will become a standard practice 30 years from now to collect various data arrays at the beginning of preclinical studies to identify disease progression patterns, detect and test potential targets, select and verify candidates, and leave out toxic molecules. All this will make drug design much faster and more personalized.
Held back by the law
Legislation remains a critical factor that influences the speed and implementation of technologies. Present-day approaches to clinical trials must follow detailed protocols to ensure compliance with scientific procedures and prevent potentially dangerous drugs from being released.
However, it seems obvious the legislation will change in the near future, as more success stories of AI-centered trials appear. By the mid-21st century, more than a few drugs will appear on the market that had in silico tests playing a crucial role in their development. Even now, the latest technologies make the development process faster and cost-saving. Soon, they will make it more effective as well.
Summing up, scientists keep coming up with new ways to solve current challenges and confirm the safety and efficiency of new medications. They include both in silico (computer models) and in vitro (3D cell cultures and OOCs) methods. Maybe we will witness the times when the development of a new drug does not make any living creature suffer, and its introduction to the market takes months instead of years.
Rustam Gilfanov – a business angel and Venture Partner of LongeVC.
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