505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success
Date: May 9th, 2018
Presented by: Ken Phelps, president and co-founder, Camargo
The 505(b)(2) regulatory pathway enables a lower cost, lower risk, and faster path to regulatory approval and market. With early strategy, it is possible to set up a program from the beginning to improve the chance of success. A strategic assessment helps to prevent common industry missteps by determining the target market, cost for development, medical need, and regulatory strategy.
Focusing on high-level strategies, this webinar will discuss ways to maximize 505(b)(2) benefits through case studies and the four pillars of drug development:
- How do I utilize a target product profile to position my product for the optimal market?
- What current prescribing habits and medical standard-of-care should be considered?
- How can I enhance existing science to achieve product differentiation?
- What are the regulatory opportunities? Which clinical studies are / are not necessary for 505(b)(2)?