Cambridge Healthtech Institute’s Eight Annual
Immunogenicity Assessment & Clinical Relevance
Technologies and Strategies for Safe and Efficacious Products in the Clinic
Part of the 11th Annual PEGS: the essential protein engineering summit
May 6-7, 2015 | World Trade Center | Boston, Massachusetts


Assessment of immunogenicity is a real challenge for the biotherapeutics industry. Every year at Immunogenicity at PEGS we present NEW findings and NEW case studies. Furthermore, we encourage NEW speakers to participate; from industry, from academia and from the regulatory authorities. In this track on Immunogenicity Assessment and Clinical Relevance we are looking for risk assessment strategies, for real examples of immunogenicity assessment in preclinical studies and the clinic, and data showing the relationship between immunogenicity assay results and PKPD.

I am looking for NEW case studies and practical experience of the following: 

  • Immunogenicity strategy and assay methodology for various products such as novel biotherapeutics, enzyme replacement therapies, interferon beta, and PEGylated products
  • Experiences with immunogenicity assessment challenges in the clinic such as statistical approaches, assay validation, and the impact of pre-existing reactivity on cut point determination
  • Challenges in developing neutralizing antibody (Nab) assays and approaches for overcoming drug and matrix interference in the assay
  • Strategies for overcoming drug and target interference
  • New and interesting studies such as the significance of anti-drug IgG4 in the clinic
  • Immunogenicity preclinical risk assessment: factors to take into consideration when putting together a risk analysis and risk mitigation plan
  • Immunogenicity risk management in the clinic for high and low risk products and for different conditions: acute, chronic, malignant, autoimmune etc.
  • Meeting regulatory expectations regarding immunogenicity assessment: what is the essential strategy and how much is enough and how much is too much?

Scientists who wish to present their knowledge and expertise to their colleagues are asked to click here to submit an abstract. Remember to specify the conference that you are interested in and please provide your full contact information.

The deadline for submission is October 3, 2014. 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, 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. 

For more details on the conference, please contact:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
T: +44 7791 866489
E: nlyscom@healthtech.com 

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452
E: jgerardi@healthtech.com 

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com