FDA recommendations on immunogenicity risk assessment for synthetic peptide drugs

Narasimha Rao is a Senior Scientist, Global Clinical Management function of Dr. Reddy’s laboratories limited. He obtained Master’s degree in Biotechnology in year 2006 from University of Madras, India and started his career as a research officer in Virology R&D in Vaccine Manufacturing , and currently works at Dr. Reddy’s, a leading multinational pharmaceutical company based in India. Since 2010 he has worked on pre-clinical assessment of high value therapeutic products/small molecules, drug repositioning and drug discovery programs and is currently investigating the immunogenicity of complex therapeutic generic peptides.

In this talk he presents the current FDA recommendations on immunogenicity risk assessment for synthetic peptide drugs in the context of both both innate and adaptive studies.