This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development, which enables a lower cost, lower risk, and faster path to regulatory approval and market. When properly executed, a Pre-IND meeting sets a 505(b)(2) development program up for success.
Focusing on high-level strategies, this webinar will clarify common misconceptions associated with 505(b)(2) Pre-IND meetings and emphasize how to achieve success, including:
- What studies are needed –the endpoints, measurements, and information sufficient for a protocol design (not: a pharmacokinetics study, but what pharmacokinetics study)
- What the studies should cost, how long they should take, what the order should be, what the risks are
- How to gain a solid plan
- What defines a successful Pre-IND meeting