Cambridge Healthtech Institute’s 15th Annual

Immunogenicity Assessment and Management   

Evaluating Clinical Relevance and Mitigating Toxicity

May 16-17, 2023

 

As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerating the adoption of new biologic therapies. In addition, understanding and controlling immunogenicity-related risks are critical in the development of biotherapeutics to ensure they meet regulatory requirements. This conference brings together leading industry, regulatory and academic experts to share best practices in immunogenicity assessment and management of both novel and traditional biologics.

 

Coverage will include, but is not limited to:

 

  • Clinical Relevance of ADA: Cost of developing assays and new techniques, collecting good data, and detecting ADA
  • Assay Development and Validation: Selecting the optimal format for your assay, overcoming technical challenges, data reporting, and cut point calculations
  • Managing Assay/Drug/Target Interference and Drug Tolerance: Strategies to improve drug tolerance and manage interference
  • Recent Advances with Novel Modalities: Including but not limited to cell therapy, gene therapy, peptides, bispecifics, trispecifics, biosimilars, immunotherapies, ADCs, and oligonucleotides
  • Regulatory Perspectives: Critical insight on new/updated guidance and recent submissions
  • Translation into the Clinic: How can the data generated be used in the clinic?  What is the true value of the preclinical assays and how can this be proved?
  • Risk Assessment: Overcoming issues with impurities and aggregation, what does the FDA want to see?
  • Predictive Assays, Studies, and Tools: How can these be improved? Examples include but not limited to T cells, MAPPS, and Abirisk
  • Immune Tolerance: Immunosuppression, tolerance induction, check point inhibitors, and cytokine therapies
  • Informatics and Statistics: Successful implementation of algorithms and mathematical models

 

The deadline for priority consideration is October 21, 2022.

 

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

Opportunities for Participation:

 

 

For more details on the conference, please contact:

Gemma Smith

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+44) 7754-518-131

Email: gsmith@cambridgeinnovationinstitute.com

 

For sponsorship information, please contact:

Companies A-K

Jason Gerardi

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-5452

Email: jgerardi@healthtech.com

 

Companies L-Z

Ashley Parsons

Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-1340

Email: ashleyparsons@healthtech.com