Shaping the Future of Drug Development: Organ-on-a-Chip Technology

Saransh Chaudhary is the President of Global Critical Care at Venus Remedies Ltd. and CEO of Venus Medicine Research Centre. With a strong background in finance from Cass Business School and Harvard University, Saransh joined Venus Remedies in 2016. He excels in drug discovery and development, driving key initiatives and augmenting the company’s intellectual property. He has previously led significant projects, including Phase 3 clinical trials of Elores and establishing India's first organ-on-a-chip lab.

In the era of biomedical engineering, the development of new drugs has long been marked by ever-extending timelines and staggering failure rates. Conventional methods, often taking an average of 12 years from inception to market, face an uphill battle, with an estimated 86% of drug candidates failing in clinical trials. An innovative research approach that models human organs-on-a-chip (OOAC) is rewriting the rules of drug development, promising shorter research cycles and higher success rates.

Traditionally, the initial stages of drug testing have relied on experiments conducted with cells cultured in laboratory dishes—a method that inadequately replicates the complexity of human organ systems followed by animal trials. Cells grown in two-dimensional monolayers on plastic surfaces lack the three-dimensional structure and dynamic environment present within the human body, leading to inaccuracies in predicting drug responses. Recognizing these inherent limitations, organ-on-a-chip technologies have risen as a superior alternative, providing a more accurate representation of how new drugs interact with the human body.

The FDA Modernization Act 2.0 by the US back in 2022 marked a pivotal moment in drug development history. This legislation revised the Federal Food, Drug, and Cosmetics Act of 1938, signifying a departure from the mandate of mandatory animal testing for new drug development protocols. While the previous century saw animal testing as essential for ensuring quality and safety standards, recent scientific advancements have presented compelling alternative preclinical models. OOAC, organoids, and sophisticated in-silico approaches are now leading the charge in accelerating drug discovery and development globally.

At the heart of OOAC technology lies miniature biological testing systems that emulate human organs on small chips, integrating diverse cell types in three-dimensional configurations. These devices boast hollow microfluidic channels that facilitate fluid flow, mirroring the physiological conditions of real organs. By closely mimicking the intricate interplay of cells and fluids within the body, OOAC models offer a more precise depiction of organ function and drug responses, catalyzing a paradigm shift in preclinical testing methodologies.

The research potential in OOAC technology is vast, offering the capability to amalgamate multiple mini-organs on a single chip, each housing different cell types. This versatility enables the creation of comprehensive models that mirror the interconnectedness of organs within the human body, unlocking new frontiers in biomedical research. OOAC technology and its application can thus extend beyond drug development to also include personalized medicine. Unlike traditional models, which struggle to accommodate genetic variations among patients, OOAC models provide a platform for studying individualized drug responses. By incorporating patient-specific cells, researchers can tailor treatments to specific populations, augmenting therapeutic efficacy while mitigating the risk of adverse reactions.

Recent breakthroughs in OOAC research underscore its transformative potential. A collaborative endeavor spearheaded by the Wyss Institute for Biologically Inspired Engineering has yielded a microfluidic human in vitro model of complex cervix tissue—a breakthrough with profound implications for women's health research. By surmounting the limitations of existing models, such as animal testing and static in vitrocultures, this innovation opens new vistas for studying conditions like Bacterial Vaginosis (BV) and developing urgently needed treatments.

As we harness the power of this transformative technology, we stand at the precipice of a new era in research and drug development—one characterized by precision, efficiency, and patient-centric care, shaping the future landscape of healthcare research.