Partnering with Industry: Best Practices Module (Page 20)
Transcript of interview with Jennifer Kerr, President of Cook Research
So, of course, when interacting with universities or academic centers, and actually quite with any hospital, there are questions about overhead and there are questions about indirect payments, and where the funding is going to go. What we have found is that everybody has a slightly unique structure based upon what their business model is, from a university to a private hospital or to a physician group, and really what we’re trying to do is be in a situation where it’s a win-win for both groups, making sure that the funding that’s necessary to support the infrastructure for clinical research, that that money is going there to take care of that infrastructure, to make sure that it’s hiring research staff or personnel that can handle that clinical study. And we, as with anybody, would want to negotiate those indirects or overhead down so that means that more money, instead of it going into that particular bucket, it’s actually going in and being used towards the infrastructure of that particular department or perhaps that particular group of physicians.
So development work, taking an idea from perhaps a sketch or a drawing, or maybe even a crude prototype, is a significant financial commitment to a company. It could even be a very significant commitment to a university or an academic center if they would choose to pursue the appropriate pathways to bring it to commercialization. And as a company, we have to begin thinking about those things very early on when we’re presented with an idea because we’re not only looking at the United States and looking at FDA and understanding what that regulatory pathway would be, but we’re also looking at the other regulatory environments, looking at the other 135 countries that you could distribute products in, and understanding what that regulatory pathway is because that will determine the viability of that particular idea or that particular design, and so you do have to think about from the very beginning.
This interview is from the UIDP module, Partnering with Industry: Best Practices. Download the complete module here:
Download the first module in this series, Compliance, here: