Before any pharmaceutical therapy, device or product is tested in or used by patients and consumers, it is evaluated, modified and refined in the laboratory. During this important product development stage, preclinical toxicologists and safety scientists evaluate product safety in a scientific and data-driven manner. They highlight potential risks that should be evaluated prior to and during use in people. Simply put, preclinical science is an essential component of Johnson & Johnson’s ability to deliver safe and innovative healthcare solutions.
Johnson & Johnson’s Gary Eichenbaum, Ph.D., Vice President, Translational Science and Safety, Office of the Chief Medical Officer, explains the role of preclinical science in product development and how preclinical leadership, expertise and capabilities are working in close partnership with medical safety. Together, they are driving excellence in safety science and innovative solutions for patients and consumers.
What does the term “preclinical science and safety” mean to Johnson & Johnson?
Preclinical science and safety is an integral part of the safety assessments for our products. Preclinical may draw on many scientific disciplines including toxicology, drug metabolism, pharmacokinetics, computational and systems modeling, bioengineering and veterinary sciences. We have preclinical science and safety teams in each sector of J&J that work in close partnership with Medical Safety to determine whether there is sufficient safety evidence to enable the safe testing and use of the product in people.
Preclinical science and safety within the OCMO works closely with colleagues in the preclinical science and safety teams across all of Johnson & Johnson’s sectors. The preclinical groups in each of the Johnson & Johnson sectors are unique in the industry because collectively the expertise and capabilities that they have span pharmaceuticals, medical devices and consumer products, providing us with a unique perspective on preclinical safety and risk assessment.
What is the role of preclinical science in the development of safe products for consumers and patients?
It is critical…I like to think about the job of Medical and Preclinical Safety as being similar to how air traffic control functions in aviation. Like air traffic controllers, we bring a unique and different perspective from the planes – the R&D project teams – that are taking off or landing and work closely with them to ensure that they can reach their destination safely and efficiently. Building on this analogy, preclinical serves to develop and use radar systems – the preclinical models – that provide scientific evidence on things that could cause harm and determine what may need to be tested further in humans, or should not be tested in humans. Preclinical aims to characterize potential risks that enable Medical Safety to make judgements about how to safely study and use our products. Preclinical colleagues in the sectors, working with OCMO, are on the front lines of safety risk management for products at all stages of development.
Our scientists often develop and use benchtop, cell-based, tissue-based or computer models to test a product’s safety. We then make improvements to the product using the insights we gained from the studies.
How does preclinical science and safety help drive innovation?
Innovation can take many shapes and forms. We drive innovation by coming up with better ways – techniques and methods – to assess safety. Identifying and creating better, more predictive forecasting tools is true innovation. That’s one of the exciting areas where we add value.
The preclinical groups in each sector are unique in that they interface with all Johnson & Johnson’s R&D platforms and products at all stages of development. As a result, they are in a position to bring together expertise from different platforms to drive innovation. I have the privilege in my role, with visibility to the talent, expertise and capabilities in the preclinical R&D groups across sectors to help catalyze innovation initiatives across the sectors.
Many people don’t realize the critical importance of the role that preclinical safety plays. There’s a high degree of skill and innovation required to do it effectively. As we advance our models, expertise and capabilities, we have the potential to enhance the safety and accelerate and enhance the efficiency of our R&D engine.