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)?

Featured Speaker

Kenneth V. Phelps 

President and CEO
Camargo Pharmaceutical Services

Ken Phelps is co-founder and Chief Executive Officer of Camargo. He has over 40 years of industry experience, including a number of executive-level positions in areas such as quality control, project management and regulatory, clinical and medical affairs. 


Register now for this webinar