Why Should You Attend:
The consequences of an immune response to biological drugs, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. To develop efficacious and therapeutic biologicals, one need to investigate the immunogenicity of these drugs, i.e. their ability to induce the generation of anti-drug antibodies, that might abrogate the efficacy of these drugs and, in a worst case situation, might be very harmful to the patients. For this reason, Regulatory Agencies all over the world requires drug developers to have immunogenicity plan that include mitigation steps in the event of the development of anti-drug antibodies.
Scientists involved in developing such drugs, need to be cognizant of the biochemical characteristics of their drugs and their immunogenicity potential. Moreover, they need to know how to test for the generation of an immune response and plan mitigation steps if need be.
In this webinar, we will discuss the ability of a biologicals to induce the generation of an immune response against the drug itself (immunogenicity potential) and the consequences of such response. To be able to detect the immunogenicity potential of a drug, we will discuss the need to develop assays that can specifically and reliably measure the immune response. Additionally, we will discuss the different methods used_and their caveats_to predict, a priori, the immunogenicity potential of biologicals.
Areas Covered in the Webinar:
In this webinar, we will discuss:
Who Will Benefit:
Scientist with more than 20 years of experience in small biotechnology and large pharmaceutical companies. Developed protein-based (peptides, mAb, ADC, bispecific antibodies), small molecules and liposomal products. Carried these products from inception through preclinical development into early clinical development. Developed products for the treatment and diagnosis of cancer, for the treatment of immunological diseases, including those that can facilitate transplantation of solid organs, and for neurological dieses (Alzheimer’s). Directed the safety as well as bioanalytical studies (PK and Immunogenicity) of many of the products in the preclinical setting. wrote Preclinical sections of regulatory submissions.
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