The impact of immunogenicity in biopharmaceuticals on efficacy is costing the industry vast amounts every year and denying patients much needed treatment. Moreover the danger of adverse reactions is ever present. Investigators are improving assay performance and finding means of overcoming complications such as pre-existing antibody and interfering drug, and for interpreting the data. This conference will enable investigators to work out non-clinical and clinical immunogenicity testing strategies for their particular product that satisfies themselves and the regulatory authorities that their product is safe and efficacious for taking through to the next stage. 

I am looking for new and exciting case studies on the following topics:

• Improvements in development and validation of assays including neutralizing antibody assays
• Assessment of cross reacting antibodies
• New platform technologies
• Assessment and impact of immune complexes
• Clinical immunogenicity testing strategies
• Managing interfering drug in clinical and pre-clinical serum samples
• Experiences with pre-existing antibodies
• Regulatory experiences regarding immunogenicity
• Updates on regulatory guidance
• Evaluation of immunogenicity in complex and novel therapeutics such as gene therapy vectors, conjugates, multi-specifics, scaffolds, etc.
• Focus on anti-TNF monoclonal antibodies
• Immunogenicity considerations for biosimilars

If you are interested in presenting, please click here to submit a speaking proposal for review. Please note that due to limited speaking slots, preference is given to abstracts from those within pharmaceutical and biotech companies, regulators and those from academic centers.  Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.

Deadline for submission is May 3, 2013.

We truly welcome your comments, suggestions and speaker referrals as we shape the 2013 program.

For questions or suggestions about the meeting, please contact:
Nicole Lyscom B.Sc. M.Sc. Ph.D.
Conference Director
Cambridge Healthtech Institute
Phone: +44 7791 866489
Email: nlyscom@healthtech.com      

For exhibit and sponsorship opportunities, contact:
Tim McLucas
Business Development Manager
Cambridge Healthtech Institute
Phone:  781-972-1342
Email: tmclucas@healthtech.com 

For marketing and media partnerships, please contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute
Phone:  781-972-5486
Email: jprudhomme@healthtech.com