The relevance of immunogenicity in preclinical development

2^nd International Conference and Exhibition on Biowaivers & Biosimilars

September 23-25, 2013 Hilton Raleigh-Durham Airport at RTP, NC, USA

Ciriaco Maraschiello

Scientific Tracks Abstracts: J Bioanal Biomed

Abstract :

The relevance of immunogenicity in preclinical trials will be discussed as a hot topic in the development of biopharmaceuticals and biosimilars. The preclinical and non clinical development of biopharmaceuticals and related regulatory issues will be reviewed and discussed. Two preclinical cases involving parenteral administration will be presented and discussed in terms of immunogenicity and relevant species for the preclinical safety assessment. Study designs and results will be presented. The prediction of immunogenicity and the cytokine release syndrome as part of anaphylactoid reactions will be also discussed.

Biography :

Ciriaco Maraschiello works with Harlan Laboratories Inc. since 1998. Harlan Laboratories CRS offers preclinical and non clinical services including drug discovery and translational medicines to the Pharmaceutical, Chemical and Agrochemical Business segment. He held various positions in Harlan Laboratories CRS from Study Director to manage larger teams over the years and acquired a solid background especially in the preclinical pharmaceutical arena. He managed the whole Harlan Toxicology platform in the CRS (Contract Research Services) branch and is currently in charge of the Drug Discovery & Translational Medicines operational platform, manage the strategic portfolio of CRS and responsible to open new business streams for the company.