Close

Have A Question?


Connect with Camargo today.

Contact Us
Blog & Resources Webinars 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success

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

Date: May 9th, 2018

Download

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)?

Get Our Diverse Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our Solutions or Contact Us.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
2505 Meridian Parkway
Suite 150
Durham NC, 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights