Bridging the gap between preclinical and clinical research remains one of the most pressing challenges in drug development. While early-stage studies often produce promising results, many therapies ultimately fail to demonstrate efficacy in the clinic. One major factor contributing to this gap is the design of preclinical studies that fail to reflect real-world clinical scenarios. At MD Biosciences, our translational approach is built around improving the relevance of preclinical models to better inform clinical outcomes.
1. Designing for Clinical Relevance
The relevance of a preclinical study lies in how well it models human disease physiologically, behaviorally, and procedurally. Standard models may successfully demonstrate proof-of-concept, but they often exclude key variables such as comorbidities and variability in patient populations, including age and sex. These limitations can reduce a therapy’s predictive value in human populations. To address this, we integrate comorbidities into preclinical models, including age, sex, and conditions such as diabetes. Accounting for these factors early in the research process helps deliver data that more accurately reflects therapeutic potential across diverse patient populations.
2. The Role of Back-Translation
Back-translation is crucial in drug discovery, helping bridge the gap between preclinical and clinical research. Clinical experience, particularly from surgeries and procedures, plays a key role in validating preclinical experiments and aligning them with real-world scenarios. Techniques like electrophysiology benefit from this approach, as clinical methods improve the validity and reliability of preclinical models. Our scientists participate in surgical procedures involving intraoperative electrophysiological monitoring and apply these same methods in preclinical studies using rodent and large animal models to assess neural function, pathway integrity, and treatment response.
3. Beyond Rodents: The Value of Large Animal Models
While rodent models remain foundational in early-stage research, they can fall short in simulating the full complexity of human physiology, particularly in conditions involving surgical interventions, nerve repair, or spinal cord injury. Large animal models, including pigs, play a critical role in bridging this gap. Pig models offer several important advantages. heir size and anatomical structure allow for procedures and device interactions that more closely resemble those in human patients, and they provide the scale necessary for certain pharmacokinetic and safety evaluations. These models are especially well suited for neurology and pain research, where functional outcomes depend on precise anatomical and behavioral assessments.
View this webinar to learn more about our methods for enhancing clinical relevance in preclinical studies, or contact us today to speak to a scientist.