I think the fundamental principle for all regulated industry whether it be biopharmaceuticals, medical devices, is that scientific concepts do not result in products for patients at the end of the day. And that journey, the journey is as important as the concept.
So, when scientists and brilliant minds out there who are developing these new therapies are really doing the heavy lift on the research behind how our disease states… How do they occur? How do we prevent? Them? It’s important that they understand and their teams that they pull together their investors understand that that past that point of concept it is critically important that you understand the regulated commercialization process. Because your stakeholders are not just the scientists who are trying to get a concept, they are the regulated community, the in the United States the FDA, and the Health Authorities around the world, that are that are responsible for ensuring efficacy of products, spend for our government, which is a big payer, and safety for the American public. So, that is one of the stakeholders, and that part of the kind of the structured commercialization process is critically important. And it’s often given kind of a…it’s almost an annoyance or it seems to be almost an annoyance to some companies that are early stages. They’re so focused on the technology, they’re so focused on the science, and think that that will kind of give them a pass, and it won’t because there’s been a lot of great concepts that have never made it to market for a variety of reasons especially in this the regulated space.
There was a gentleman named Bill George who was CEO of Medtronic and I don’t know how many years ago, but I’ll never forget a statement he made in one of the articles that talked about the fact that in a in the regulated sector that that that success is only about 10% research, development, and concept… and it’s about 90% of process and getting the product to market.
So, one of the things we do is we help companies understand that process. What is important? What are the what is the data and the information they need to generate to support the regulatory scrutiny and to meet the regulators’ objectives and their criteria for protecting public health and for ensuring public health these products? So that sort and it’s a complex framework of requirements and expectations and it’s often tied to the regulated product class, the therapeutic profile, or the targeted therapy. And so that structure, even though it may seem kind of slow and daunting, is critically important for the patients and for the companies because once they do that successfully their commercial results will be much improved because they’ve got full characterization, they understand control, they understand how to make it, patients will be happy, regulators will be happy, and most importantly their shareholders and their internal stakeholders will be happy.
