I think the fundamental principle for all regulated industry. Whether it be the biopharmaceutical industry or medical devices, 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. The article below will elaborate on the journey companies can take to achieve success within the biopharmaceutical industry.
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The Imperative of Regulated Commercialization in Therapeutic Innovation
So, when scientists and brilliant minds out there who are developing these new therapies in the biopharmaceutical industry 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 very important that they understand and their teams that they pull together their investors understand that that past that point of concept. It is also critically important that you fully understand the regulated commercialization process. Because your stakeholders are not just the scientists who are trying to get a concept. These stakeholders are the regulated community, the United States, the FDA, and the Health Authorities around the world, that are that are responsible for ensuring efficacy of products. They are also responsible for 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 of this process. 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. The quote explained that success is only about 10% research, development, and concept… and it’s about 90% of process and getting the product to market. This quote emphasizes the vitality of ensuring a thorough process to properly execute your concept.
Enhancing Biopharmaceutical Success Through Comprehensive Understanding
So, one of the things we do is we help biopharmaceutical industry 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. This is important because once they do that successfully their commercial results will be much improved. These improved results derive from having 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.
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