Regulatory agencies all over the world today put significant emphasis on the importance of preclinical safety evaluations. This is an important consideration for small biotechs as they may not always have toxicology experts on board.

What should small biotechs keep in mind for toxicology studies as their compounds progress through the discovery stages of hit and lead optimization ?

Syngene, a global CRO with over 25 years of experience of working with some of the leading pharma and biotech companies will address this question in the symposium on ‘developing a road map for preclinical development to IND’ being organized at COBIS on September 24, 2019. The event will address aspects such as a) selection of compounds through tox screening prior to development; b) what is the desired purity of the compounds;  c) what are regulatory standards for studies; d) special considerations for peptide, biologics and vaccines; e) factors that determine species selection especially selection of non-rodents for both small and large molecules; f) challenges in bioanalysis for small and large molecules; and g) adverse findings in animals studies and its relevance, translation to human and prediction of toxicity during clinical trials.

Agenda

1:30

Registration and coffee

2:00 

Welcome and introduction

2:05

Role of Toxicology in supporting initiation of clinical trials and risk assessment for humans

Srinivasa Prahalada, Ph.D, Consultant, Syngene

Speakers

Srinivasa Prahalada, Ph.D.