8th Annual Immunogenicity and Bioassay Summit
In-Person Event
Oct 26 - 28, 2016
Baltimore, Maryland, USASpeakers
OVERVIEW
8th Annual Immunogenicity and Bioassay Summit is organized by Cambridge Healthtech Institute and would be held during Oct 26 - 28, 2016 at Hyatt Regency Baltimore on The Inner Harbor, Baltimore, Maryland, United States of America.
Immunogenicity Prediction and Control is designed to help investigators design and select non-immunogenic products for early-stage decision making, while Immunogenicity Assessment & Clinical Relevance and Optimizing Bioassays for Biologics will enable investigators to overcome the complexities of immunogenicity assessment and bioassays, and develop programs that ensure their products are safe and efficacious, and satisfy regulatory requirements.
What's New for 2016 :
• FDA on meeting regulatory expectations, documentation, and aggregates
• Immunogenicity case studies for TNF inhibitors, endogenous products, ADCs, enzymes, Factor VIIa, gene therapy products, etc.
• Focus on drug tolerance and target interference
• Significance of neutralizing antibodies and pre-existing antibodies
• Immunogenicity assessment of biosimilars
• Factors that contribute to immunogenicity
• Relationship between predictive immunogenicity and clinical outcome
• Overcoming immunogenicity, deimmunization and tolerance
Immunogenicity Prediction and Control is designed to help investigators design and select non-immunogenic products for early-stage decision making, while Immunogenicity Assessment & Clinical Relevance and Optimizing Bioassays for Biologics will enable investigators to overcome the complexities of immunogenicity assessment and bioassays, and develop programs that ensure their products are safe and efficacious, and satisfy regulatory requirements.
What's New for 2016 :
• FDA on meeting regulatory expectations, documentation, and aggregates
• Immunogenicity case studies for TNF inhibitors, endogenous products, ADCs, enzymes, Factor VIIa, gene therapy products, etc.
• Focus on drug tolerance and target interference
• Significance of neutralizing antibodies and pre-existing antibodies
• Immunogenicity assessment of biosimilars
• Factors that contribute to immunogenicity
• Relationship between predictive immunogenicity and clinical outcome
• Overcoming immunogenicity, deimmunization and tolerance
KEY DATES
26 Oct, 2016
Event Start Date
28 Oct, 2016
Event End Date
SPECIALITIES
Biochemistry and Molecular GeneticsImmunology and MicrobiologySUGGESTED HOTELS
CONFERENCE VENUE
Hyatt Regency Baltimore Inner HarborRELATED CONFERENCES & LIVE WEBINARS
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