Pavitra Ramachandran
Seminars
Thursday 21st January 2027
Panel Discussion: How Can We Improve Clinical Translation by Bridging the Gap Between Preclinical & Human Studies
11:00 am
- 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
Thursday 21st January 2027
Selecting & Validating Animal Models for Ophthalmic Drug Delivery
12:45 pm
- Discuss how to select the most predictive animal models for your delivery route, formulation, and indication by understanding the strengths and limitations of rabbit, non-human primate, and minipig studies
- Determine when disease models provide meaningful pharmacodynamic insights
- Reduce development timelines, costs, and regulatory risk through strategic non-GLP and GLP study planning that supports stronger IND submissions
