Despite technology advances that have improved the ability of bench scientists to rapidly identify new drug targets, translating laboratory discoveries into marketable products remains a frustratingly slow process that often leads to dead ends. But by establishing an early dialogue with the FDA—when potential products are still in preclinical testing—companies can gain valuable insights that could boost their chances of success.
In 2019, the FDA announced a new effort to modernize drug development, which included helping companies to streamline the preclinical phase of the process. The agency expressed an interest in working with companies to identify technology tools that can be used instead of animal trials to test toxicity, for example, and to improve the detection of biomarkers that might enhance patient selection for clinical trials.
This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process.
- Strategies for determining the best timeline for approaching the FDA with a new drug candidate
- A review of new technologies designed to speed up preclinical testing
- How fast is too fast? Ensuring the proper balance between streamlining preclinical research and gathering enough data to satisfy regulators