Current and Novel Immuno-Oncology Drug Evaluation Methods via Humanized Mouse Models

In this webinar, Dr. Xu will summarize recent data on inherited risk for prostate cancer, including germline mutations in high-penetrance genes (HPGs), risk-associated SNPs, and SNP-based genetic risk score (GRS). He will present detailed data supporting the broad-sense validity of GRS in risk assessment as well as the need for assessing the narrow-sense validity of GRS values. Finally, he will review the data supporting the importance of GRS when estimating the penetrance of HPGs.

Incorporation of patient-focused drug design principles is increasingly becoming essential to ensure that a new drug is commercially successful and delivers the best patient outcomes. Often, patient factors and insights are not considered or discovered until the later phases of drug development when dose form, dose strength, and route of administration are already decided. There is tremendous potential benefit of equipping formulators and other scientists with patient insights earlier in the development process so that the drug product can be designed to address the specific needs of target patient populations.

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars.

Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications. They are made of a highly toxic payload, a linker, and an antibody.