Speakers: Laura Salazar-Fontana, PhD (Sanofi), Boris Gorovits, PhD (Pfizer), Kei Kishimoto, PhD (Selecta Biosciences), Jim McNally, PhD (EMD Serono), Yongchang Qiu, PhD (Shire), Bonnie Rup, PhD (Bonnie Rup Consulting LL)
Organizers: Valerie Theobald, Shire Chandra Prakash (Agios), Jing-Tao Wu (Takeda)
Date: 12/5/2016
Time: 8:30-16:30
Registration fee (USD): For Academic / Unemployed: $125; Regular: $175;
Location: Courtyard by Marriott Boston Cambridge, 777 Memorial Dr, Cambridge, MA 02139
Major Sponsor:
Vendor show vendors registered to date: (5)Absorption Systems; AIT Bioscience; ICON plc; MicroConstants; Science Exchange
Registration: https://www.PBSS.org
Registration deadline:11/30/2016  (it will close sooner if the seating cap is reached)

About the Topic

Biotherapeutic products are the fastest growing medicines in the pharmaceutical market. Despite their clinical success, the immunogenicity of biotherapeutics continues to be a major concern. Assessment of immunogenicity as well as appropriate interpretation of immunogenicity data is therefore, of critical importance for defining safety profile and it is one of the regulatory requirements for the approval of these products. In the past decade, much progress has been made towards how immunogenicity should be studied. At this workshop, experts from industry, academia and former FDA will provide an overview of the methods used for assessing immunogenicity of biotherapeutics, case studies as well as current challenges and the most important considerations in interpreting results in the context of regulatory review of these products.