Scientific advancements and evolving regulatory requirements are continually reshaping the drug development process. Navigating the intricacies and financial challenges of bringing new therapies to market in this dynamic landscape, demands innovative approaches and strategic decision-making. In this context, in vitro pre-clinical models have emerged as indispensable tools for accelerating the translation of promising discoveries into life-saving treatments.
As in vitro technologies advance, pre-clinical models, particularly those utilising human cells and tissues, offer a powerful platform for evaluating drug efficacy, safety and mechanisms of action early in the development pipeline. They provide a controlled environment where researchers can study complex biological processes and interactions, gaining valuable insights into drug behaviour and potential therapeutic benefits. By strategically leveraging in vitro models, biopharmaceutical companies can make more informed decisions, streamline development timelines and reduce reliance on animal testing, a critical consideration in modern drug development.
In this article, Dr Agapitos Patakas, RoukenBio’s Chief Scientific Officer (CSO), explores the multifaceted role of in vitro models in advancing therapeutic innovation. He examines the key drivers behind their increasing adoption, delves into the diverse types and applications of cell-based models and discusses strategies for ensuring their robustness and reliability. He also addresses the challenges and future directions in the field, highlighting how ongoing advancements and innovative approaches will shape the future of drug development.
The Evolving Landscape of in vitro Models
Technological advances are enhancing the predictive power of in vitro models in assessing eventual drug success in a clinical setting. Drug developers are increasingly relying on in vitro models in pre-clinical drug development as they offer the potential to streamline the process and improve efficiency. This growing reliance is further fuelled by a number of factors:
• Regulatory Evolution
The introduction of the FDA Modernisation Act 2.0 has allowed developers to utilise diverse testing methods – including human-relevant in vitro models – for evaluating the safety and efficacy of new drugs and biosimilars before they progress to human trials. This change in legislation reflects a growing recognition of the limitations of traditional animal testing and the need for more predictive and human-relevant pre-clinical models.
• Increasing Availability of Advanced In Vitro Technologies
The development of sophisticated three-dimensional (3D) cell culture systems, organ-on-a-chip platforms and microphysiological systems has enabled researchers to create more complex and physiologically relevant models that better mimic human biology. Advancements in materials science have also been instrumental in replicating the extracellular matrix (ECM) of tissue microenvironment to facilitate the application of these technologies. Such advancements allow intricate drug interactions, cellular responses and disease mechanisms to be studied in a more controlled and human-focused environment.
• The Rising Costs and Complexities of Drug Development
Drug development is becoming increasingly expensive, placing a greater emphasis on efficiency and informed decision-making. In vitro models offer a cost-effective and time-saving approach to pre-clinical research, allowing developers to rapidly screen drug candidates and identify potential safety or efficacy issues early in the development process. As a result, researchers can prioritise promising candidates and allocate resources more effectively, ultimately accelerating the translation of discoveries into therapies.
• A Growing Emphasis on Ethical and Sustainable Practices in Research By providing human-relevant data earlier in the drug development process, in vitro models can potentially limit the need for animal studies. Adopting effective in vitro modelling contributes to a more humane and responsible approach to drug development, aligning with the ethical concerns of researchers and the public. This is particularly important in areas such as immunology and immunooncology, where the intricacies of the human immune system can be challenging to replicate in animal models.
