Managing Immunogenicity Risk in Biopharmaceuticals

Why Should You Attend:

This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy.

The second-half of the presentation demonstrates how to use pre-clinical results to further characterize (but not predict) the immunogenicity response and utilize this information to be ready for adverse effects during clinical trials. The presentation finishes with recommendations on a sampling strategy and a representative clinical case study describing the importance of immunogenicity testing not only during clinical trials but also after the drug is commercialized.

Areas Covered in the seminar:

This presentation reviews the following important topics to understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals:

• Self versus non-self.
• Risk factors associated with immunogenicity.
• Regulatory expectations on immunogenicity testing .
• How to use immunogenicity results from pre-clinical studies.
• Minimizing immunogenicity risk.
• Phase specific sampling plan.
• Case study and commercialization strategy.

For Registration:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701493?channel=worldconf