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.

Who Will Benefit:

This webinar will provide valuable assistance to all companies that are developing biopharmaceuticals that are NOT being used as vaccines. The employees who will benefit include:

• Pharmacologists
• Toxicologists
• Clinicians
• Project Managers
• Regulatory personnel
• Consultants

Instructor Profile:

Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular molecular and immunological procedures. Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.

Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.

Topic Background:

Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. All biopharmaceutical development programs need to quickly identify and characterize antibodies that can affect the potency and safety of the drug. Intrinsic drug specific attributes plus several external and internal factors can have a tremendous impact on the immunogenic response of a biopharmaceutical. In addition, lack of understanding of industry expectations and regulatory documents regarding immunogenicity can needlessly jeopardize a development program. A clear strategic path to evaluate risk and manage immunogenicity issues is essential to not only be successful in the clinic but also throughout the entire life cycle of a drug.