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

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