The discovery of new therapeutic agents is met with significant challenges in preclinical discovery and development. Both efficacy and safety endpoints must be adequately assessed prior to testing a new investigational agent in humans. Perhaps the most challenging part of drug discovery is the mitigation of safety risks that arise during most drug discovery optimization efforts. Successful drug discovery teams will properly design and execute experiments that adequately assess and discharge risks prior to first human dose (FHD).
This course begins with a thorough assessment of the finish line for preclinical drug hunters鈥搕he successful filing of an Investigational New Drug (IND) application to regulatory agencies, such as the FDA or EMA. The course content will include detailed descriptions of the preclinical data that must be included in the IND to support the design and safety of the FHD dosing protocol. With this background, the course will then cover many of the most common risks and modern mitigation strategies to help scientists navigate an optimization effort that will deliver safe and well tolerated potential new therapies in the shortest time possible.
This course begins with a thorough assessment of the finish line for preclinical drug hunters鈥搕he successful filing of an Investigational New Drug (IND) application to regulatory agencies, such as the FDA or EMA. The course content will include detailed descriptions of the preclinical data that must be included in the IND to support the design and safety of the FHD dosing protocol. With this background, the course will then cover many of the most common risks and modern mitigation strategies to help scientists navigate an optimization effort that will deliver safe and well tolerated potential new therapies in the shortest time possible.
