Monrovia, California (PressExposure) October 17, 2012 -- Jacques Descotes Professor and Head at the Poison Center and Pharmacovigilance Department at Lyon University General Hospitals, Lyon, France will give a feature presentation "Immunotoxicity evaluation: from standard toxicity studies to first-in-man clinical trials" at the Inaugural Immunogenicity and Immunotoxicity conference (Jan 31 - Feb 1, 2013 in San Diego, CA).
As recommended by the ICH S8 guideline, nonclinical Immunotoxicity evaluation should be incorporated into standard drug development to allow for a weight-of-evidence decision making approach prior to phase III clinical trials at the latest. Clinical signs, changes in standard hematology and clinical chemistry, and histology of lymphoid organs in repeat-dose toxicity studies are critical findings to be considered. Of concern is the finding that some drug candidates without an identified cause for concern significantly impaired immune function. Selected relevant immune function assays depend on whether the drug candidate is intended to modulate, or unexpectedly found to alter immune responses. The collected data should serve the purpose of risk assessment. Currently, a major gap is the lack of relevant translational findings to extrapolate animal data to first-in-man clinical trials and beyond. Dr. Descotes' presentation will focus on those immune function measurements beyond TDAR assays, which could be incorporated into long-term repeat-dose toxicity studies to serve as a rationale for immunological monitoring during clinical trials of drug candidates.
Dr. Descotes has been active in clinical and nonclinical research on Immunotoxicology and regulatory safety evaluation for the past 30 years. He is the author of 13 books, 75 chapters from multi-authored books, 234 original scientific papers, 73 review papers, 434 oral presentations and posters. Dr Descotes has been a fellow of the US Academy of Toxicological Sciences since 2001. He was the recipient of the 2002 Eurotox Gerhard Zbinden Memorial Annual Award and 2010 (US) Society of Toxicology's Jeff Vos Career Achievement Award in Immunotoxicology.
In addition to Dr. Descotes featured presentation, Steve Swanson from Amgen will also present and the keynote address will be given by Anne De Groot from EpiVax.
The Inaugural Immunogenicity and Immunotoxicity conference will bring together a mix of academic and industry experts from leading affiliations (such as MedImmune, Roche, Ambryx, Aegis Therapeutics, Antitope, Epiontis, Amgen, EpiVax, Ablynx, Eleven Biotherapeutics, Bayer HealthCare and more) to cover many current and relevant aspects of Immunogenicity and Immunotoxicity.
This conference is also part of the 2nd Novel Cancer Therapeutic Summit, which consists of this track and three other tracks:
1) 5th Immunotherapeutics and Immunomonitoring
2) 11th Cytokines and Inflammation
3) 2nd Allergy Drug Discovery
For more information, please visit http://www.gtcbio.com