12.09.21 -- Immunosafety, IND Submissions, Complex Biotherapeutics, & Bispecific Antibodies

In addition to threatening the safety of patients, drug candidates that fail because of immunosafety issues also cost drug developers significant losses in time and money. Assessing immunogenicity and immunotoxicity potential at the earliest possible stage is critical.

This is a new era for many companies, as the number of regulatory submissions to China is increasing. This webinar provides an overview of the China regulations with a specific focus on data and regional requirements for clinical trial applications.

In recent years, the number of biotherapeutic molecules requiring more complex assemblies has greatly increased. These multichain molecules typically require a more agile approach to early developability and method development.

Assessing your drug candidate’s immunogenicity potential is essential in preclinical development. To support your regulatory filing, you need to generate reliable, high quality data. Watch our presentation where we share our experience in assessing immunogenicity for regulatory submission.

Explore the trends in new molecular formats, one of the current drivers of renewed interest in fermentation technologies, and some of their challenges, along with considerations for an early process development strategy to plan a program with the end goal in mind.

Hear about trends in bispecific research and development, the hurdles and opportunities they present, and how young companies can optimize their development approach.