Panel Discussion: How Can We Improve Clinical Translation by Bridging the Gap Between Preclinical & Human Studies
11:00 am - Thursday 21st January 2027
- Discuss common causes of translational disconnect in efficacy, durability, safety, and immunogenicity from preclnical studies to humans
- Compare the strengths and limitations of rodent, rabbit, minipig, and nonhuman primate models for disease modeling, PK/PD characterization, biodistribution, and safety assessment.
- Discuss the potential of organoids, microphysiological systems, ex vivo human ocular tissues, and computational modeling to complement or replace traditional animal studies.
- Discuss common deficiencies, evidence gaps, or study design limitations that lead to regulatory questions, delays, or clinical holds for preclinical IND packages
