Risk is still an important issue, and the fundamental premise is that there is so much to do.
The science is so complex. The regulatory environment is so complex. The business operating environment is so complex that companies can’t do everything, so they have to have an understanding of prioritization and really risk is where that flows from.
Risk of product, risk of success in the marketplace, risk of commercialization likelihood or not, and risk of enforcement from the Regulators. So, that understanding is something that really takes years and years to really understand how interconnected all these pieces are. Also, how to create the characterization of risks such that you can create a prioritization of the types of things that are most important.
An example of that is on quality systems for early-stage companies. We get asked a lot and work with early-stage companies on what “Well, we want we want quality systems and operating environments that that are appropriate for where we are in our life cycle.” And that’s really critical, right? You cannot overlay a complete set of commercial requirements to a company that is in a commercialization model, because there’s just there’s too much there for them to do, and it really isn’t necessary at that stage of the lifecycle. And those early life cycles you need to be focused on characterization of your entity, your critical quality attributes, your target product, profiles, making sure you understand that, focusing on clinical outcomes you’re trying to achieve, what is suitable for that product both from a safety and efficacy perspective, and those are the processes and activities that you have to nail. And some of the other things, I mean if you don’t do training as well, or you know you don’t do some of these other things, that is a risk-based approach and model, and it’s OK to do that.
This understanding this really deep understanding of risk and prioritization, particularly for these companies that are creating the innovation is critical, frankly I think now more than today than it was back then in 2016.