This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.
Why Should You Attend:
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.
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 last 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:
Ana T. Menendez, Ph.D. is Senior Director of Biotechnology at Catalent, a full-service solution provider to the biopharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Potency bioassays, PK/PD, immunogenicity and viral clearance. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.
Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez identified and/or optimized several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.
Dr. Menendez obtained her Ph.D. in Microbiology/Immunology from NY Medical College. She is an international speaker and course instructor on Immunogenicity and Bioassay Method Development and Validation..
