Before a drug candidate can transition from the lab into clinical testing, robust non-clinical data must demonstrate an acceptable risk profile for human studies. Translating evidence from in vitro and in vivo models to first-in-human (FIH) trials is a critical step that requires careful evaluation of pharmacodynamics, pharmacokinetics, and toxicology data to ensure patient safety.

Key takeaways

  • Non-clinical studies evaluate pharmacodynamics, pharmacokinetics, safety, and potential risks, providing essential insights to plan and mitigate uncertainties in early clinical development.
  • For advanced therapies like CAR-T cells, pharmacokinetics pose unique challenges as these "living drugs" can persist and replicate in the body.
  • Immunogenicity, the immune response to biotherapeutics, must be evaluated for potential safety issues like hypersensitivity reactions and efficacy concerns like neutralizing antibodies.
  • Selecting the appropriate animal models that accurately represent human disease mechanisms and biology is crucial for translational research.

To learn more about overcoming translational challenges in moving drug candidates from preclinical to clinical stages, read the full article.


You don't have to go it alone!

Our experienced team has been there before, and we're ready to guide you through the unknown. Share your challenges with us, and together, we'll create a plan to efficiently reach your milestones and turn your vision into reality.

Building Better Biotechs

This field is for validation purposes and should be left unchanged.