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A New Era of Non-Rodent Models, Alternative Approaches, and Ethical Advancements
Nonclinical safety assessment is continually evolving, driven by the adoption of alternative animal species and changes in regulatory frameworks. For decades, animal models have played a crucial role in nonclinical research. However, there is a growing push to reduce the reliance on animal models, in particular specific large animal species, in favor of a different choice of species, or the potential of leveraging non-animal alternatives.
New Alternative Methods
Nonclinical drug development often relies on prior programs and precedent as a guide to the future. However, the future cannot be constrained by the past. The latest trends and developments in nonclinical drug programs are identifying new approaches to bring safer and more effective drugs to market.
Recent Regulatory Updates
The FDA Modernization Act (FDAMA) 2.0 is a new law that emphasizes the importance of non-animal testing methods. FDAMA 2.0 introduces the term ‘nonclinical test’ to drug development, which is defined, in part, as a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test. The act encourages the development and use of alternative testing methods to reduce or replace animal testing. These alternatives include organoids (such as organ-on-chip technology, which mimics human organ conditions for more accurate research) and New Alternative Methodologies (NAMs). NAMs encompass a variety of techniques, tools, applications, and systems that are designed to minimize the use of animals in research.
In essence, FDAMA 2.0 promotes alternative means to collect relevant data/information for nonclinical safety and efficacy, with an aim to create a more level playing field among in vivo, in vitro, in silico, and other approaches. Traditionally, animal tests were seen as a gold standard for drug development, but now, with FDAMA 2.0, things have changed. What has not changed is the requirement for all research and development efforts to include the best methods and approaches to meet the program's goals. It is important to be flexible and open to all options, and ultimately to choose the approach that can be scientifically justified.
Advancing Responsible Science
Ethical considerations will continue to play a pivotal role in safety assessment's evolution. We are committed to the principles of the 3Rs (Replacement, Reduction, and Refinement) and are actively working on innovative methods, such as virtual control groups, to reduce and refine the need and numbers of live animals in studies. Efforts to investigate and develop in vitro, in silico, organoids, and other nonanimal testing methods will provide direct opportunities for replacement. At Charles River our extensive history of investing in and embracing the components of the 3Rs has sharpened our aim to advance science guided and driven by a foundationally important fourth R –Responsibly. This fourth R, which was developed specifically for Charles River ensures that we are placing a lens of responsibility on everything we do.
Replacement
Partnering and investing in technology alternatives to animal models, like Endosafe® Trillium® recombinant technology, in vitro oncology models, in silico approaches
Reduction
Collaborating with clients on study design and planning to minimize the use of animal models, like reduction in the use of spare animals, JET studies, and validating Virtual Control Groups
Refinement
Developing procedures that significantly reduce impacts on animals such as less invasive identification methods, harmonized blood collection guidelines, species appropriate social housing, and species-specific habituation trainings.
Responsibility
Leading progressive change within the industry regarding animal use through cooperative efforts internally, clients and with regulatory agencies.
A Brave New World: Challenging Precedents
The experts from our Scientific Advisory Services team of scientists present alternative approaches in animal testing using case studies of different drug modalities.
Watch the Video
Preclinical safety assessment is poised for a transformation, becoming more precise, predictive, and patient-centered. According to industry experts, this transformation will be driven by the convergence of biology, technology, and ethics. It has the potential to usher in a new era of drug development, with safer and more effective medications reaching patients faster.
Contact us to learn more about how we can help you develop and implement a non-rodent safety assessment strategy for your drug development program.