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Follow on Google News |  Call for Speakers: CHI’s Immunogenicity and Bioassay Summit 2015CHI, organizer of the 7th Annual Immunogenicity and Bioasssay Summit 2015, has issued a call for papers for those who would like to present at its event on Nov. 17-19, 2015 in Baltimore, MD. Submission deadline is May 7, 2015.
CHI seeks high-quality papers related to the following topics: • Regulatory expectations regarding immunogenicity assessment • Case studies on meeting regulatory expectations with immunogenicity assessment • Practical application of immunogenicity preclinical risk assessment • Strategy for non-clinical ADA testing: How you interpret the results and understand the clinical relevance • Different assay formats and technologies for immunogenicity assessment • Experiences with neutralizing antibody (Nab) assays • Interpretation and handling of drug interference • Overcoming target interference in non-clinical studies • Dealing with pre-existing positive ADA activity in study patients • Critical issues in cut point determination and ADA assay validation • Immunogenicity experiences with different products: MAbs, bispecifics, ADCs, peptides, etc. • Clinical case studies on specific biotherapeutics • Relationship between immunogenicity assay results and PK • Immunogenicity assessment of biosimilars and non-innovator biologicals • Risk factors that contribute to immunogenicity • Tools and approaches for immunogenicity risk prediction • Development of mouse models for predictive studies • Impact of different routes of administration on immunogenicity • Roles of sub-visible particles and aggregates in immunogenicity • Impact of impurities on the immune response • Deimmunization approaches • Progress towards inducing immunological tolerance to biotherapeutics • Focus on challenging therapeutic areas such as enzyme replacement therapy, anti-TNF and Factors VII and VIII • Working with different assay types (Potency assays, Alpha screen assays, Fluorescence- • Bioassays for cell and gene therapies • Statistical design for assay development and validation • Assay comparability case studies • Characterization assays in support of characterization of antibody therapeutics • Characterization and methods for ADCs and bispecifics • Selecting the relevant method of action • Method transfers to other groups or CROs • Monitoring change and variability • New technologies or formats for bioassays • Expectations of health authorities Follow this link to submit a speaker proposal: http://www.immunogenicitysummit.com/ Submission Deadline is May 5, 2015. To inquire about sponsorship and exhibit opportunities, contact: Carolyn Benton, Tel: 781-972-5412, cbenton@healthtech.com. About Cambridge Healthtech Institute (CHI) Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Cambridge Healthtech Media Group, The Knowledge Foundation, and OpenHelix. http://www.chicorporate.com End
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