505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success

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)?

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