CHI to Host Roundtable Breakout Discussions at its Immunogenicity and Bioassay Summit 2014

NEEDHAM, Mass. - Sept. 22, 2014 - PRLog -- The following roundtable breakout discussions will be held at Cambridge Healthtech Institute’s (CHI’s) Sixth Annual Immunogenicity and Bioassay Summit 2014 scheduled for November 17-19, 2014 at the Hyatt Regency Bethesda in Bethesda, MD. Each roundtable breakout discussions provides conference delegates and speakers an opportunity to choose a specific roundtable discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to network, meet potential collaborators share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor.

Regulatory Expectations Regarding Immunogenicity Assessment
Moderators: Laurie Graham, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies FDA/CDER
Steven J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical Immunology, Amgen, Inc.

Challenges in Developing Neutralizing Antibody (Nab) Assays
Moderator: Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

Dealing with Pre-Existing Positive ADA Activity in Study Patients
Moderator: Jim McNally, Ph.D., Senior Principal Scientist, Biotherapeutics Research, Pfizer, Inc.

Critical Issues in ADA Assay Validation
Moderator: Harry Yang, Ph.D., Senior Director, Translational Sciences, MedImmune, LLC

Concerns Regarding Immunogenicity of Multi-Domain Proteins
Moderator: Laura Salazar-Fontana, Ph.D., Senior Staff Fellow and Immunogenicity Program Coordinator, Therapeutic Proteins, CDER/FDA

Focus on Immunogenicity of Biosimilars and Non-Innovator Biologicals
Moderator: Bridget Heelan, MB, Ph.D., Vice President, Consulting, Parexel, (ex-MHRA)

Strategies for Bioassays with Multiple Mechanisms
Moderator: Gillian Payne, Senior Director, Bioanalytical Science, ImmunoGen, Inc.

Selecting the Right Bioassay
Moderator: Natko Nuber, Ph.D., Biologics R&D, Novartis

Maintaining Assay Consistency
Moderator: Janet Lathey, Ph.D., Consultant, Product and Assay Development and Evaluation

Risk Factors that Contribute to Immunogenicity
Moderator: Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

Sub-Visible Particles, Aggregates and Immunogenicity
Moderator: Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, FDA/CDER

Methods for Examining Impurities that May Impact the Immune Response
Moderators: Daniela Verthelyi, Ph.D., Chief, Laboratory of Immunology, Therapeutic Proteins, FDA/CDER
Lydia Haile, Ph.D., Postdoctoral Fellow, Laboratory of Immunology, Therapeutic Proteins, FDA/CDER

Current Tools and Approaches for Immunogenicity Risk Prediction
Moderator: Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.

Progress towards Inducing Immunological Tolerance to Factor VIII and Other Biotherapeutics
Moderator: David C. Wraith, Ph.D., Professor, Experimental Pathology, University of Bristol, & CSO, Apitope International NV

Writers and editors are invited to attend. To request a press pass, contact Lisa Scimemi, lscimemi@healthtech.com

For more information and to register, visit http://www.immunogenicitysummit.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, and The Knowledge Foundation. www.chicorporate.com