We are pleased to present the second episode in a new format and series we’re adding to our 505(b)(2) Blog: a video blog / podcast called What Went Wrong?
For our second episode, Ken Phelps, CEO, and Dr. Ruth Stevens, CSO, Camargo Pharmaceutical Services, discuss important outcomes for a successful Pre-IND meeting, which is essential for 505(b)(2) drug development.
To watch the 2-minute dialogue, press play below.
Ken: Welcome to the next installment of our series on What Went Wrong? This series is on what we can do to correct these types of situations.
Ruth, last week, I received a call from a company that thought they had a pretty successful Pre-IND meeting. The reason for the call was they wanted to know what the study would be for the opening IND. I don’t think that’s our definition of a successful Pre-IND meeting. So would you give us an idea of what a client would expect from us when we do a Pre-IND meeting?
Ruth: Our clients should leave a Pre-IND meeting knowing the study design elements of each of their studies as they progress through their drug development program. For example, they should know that their opening protocol would be a pharmacokinetics study, but beyond that, they would know that it’s a 3-way crossover study design that would be under fed conditions, which is high-fat and high-calorie, versus fasted conditions, versus a listed drug, if that was a part of a bridging study where they needed a listed drug.
Ken: Why do we provide that level of detail in a Pre-IND meeting?
Ruth: The level of detail is for when the client is leaving the Pre-IND meeting so they know what the cost of the studies are, their duration, and to reduce the overall risk of the program.
Ken: I know one of the things Camargo tries to do is to reduce the regulatory risk. When you talk about the risk of the program after the Pre-IND meeting, what do we know from the FDA about that study?
Ruth: That we have reduced the execution risk. That we know that they’re looking for bioavailability, or is it bioequivalence? Do they need a single dose, or is it a multiple dose study? Do we need a dose-ranging study? Do we need a pivotal Phase 3 trial or is it two Phase 3 trials?
Ken: In summary, at Camargo, we believe a successful Pre-IND meeting needs to have detailed study designs for each of the studies expected through NDA approval so that we’ve reduced the regulatory risk.
Are you interested in learning more about how Camargo will be able to help align your program from success from the start with a Pre-IND meeting that reduces your regulatory risk? We would love to talk with you. Contact us to learn more.