A psychiatrist by training, Dr. Bill Carson has a wealth of knowledge around regulatory compliance and working through FDA approvals having successfully brought a number of mainstream drugs to market, including Abilify, which returned multiple billions of dollars for the six months gained at the end of the Abilify patent for obtaining pediatric exclusivity. Also under his leadership Otsuka was able to launch the Abilify follow-on, Rexulti, Jynarque for polycystic kidney disease, and ultimately the first FDA-approved digital medicine, Abilify MyCite.
Here he shares what he’s learned along the way about the complexities of regulatory testing and approvals, and what every healthcare startup executive should plan for.
Every month we’ll share Pioneer Spotlights where we sit down with our network of accomplished industry veterans on what they’ve learned and advice for startup founders. We look forward to showcasing more of our ecosystem with you.
A big challenge for companies looking to combine pharma with digital health is that the cadences of development for the two are vastly different. Pharma is long and we’ve all gotten comfortable with the fact that it can take 5-10 years, but on the digital side the thinking is new, new, new! The problem is you can’t tell regulatory authorities that the newer version is better because they will of course want to wait for that, and then you keep moving the goal post.
Think of your product as frozen in time at ONE place. Answer all questions on the product to that one moment in time, and keep your focus there. You must strike a balance speeding up the pharma side while asking the digital side to slow down to achieve an aligned development cadence.
Spend a lot of time on your target product profile. Everyone plays a role in figuring out the market viability of your product — not just commercial teams — but also scientists, regulatory, etc. all have to do their part. As you collect data on who can or can’t use your product, you start to either verify that the idea is attainable, or see there are things you have to explain, that you didn’t or couldn’t predict, or that just happened. The challenge is how do you develop an ideal target profile that is still a product with market value. Always ask “can we commercialize this product and is there a market for it?”
It’s easy to think you are working on something novel, but the issue with novel things is there is nothing to compare it to. In most cases you will have to attach what you do to something already established. Regulations are built on tradition, and for new areas they will say, “we don’t have anything in this area so we are going to use this standard.” You may have to establish why that standard shouldn’t apply to what you are working on, so be prepared with ways around it.
Figure out who the best person is to champion your product with decision makers, and realize it may NOT be a scientific person. Business development, or even a consultant that really knows your area can be invaluable because in today’s digital age we have to do things by design, not by default. Having these conversations early and anticipating what could go wrong, and what you need to to stop from happening is crucial because if you do it wrong, you will pay for it at a different point in time.
The most important, and difficult, thing to understand is the power of regulatory authority. It’s easy to underestimate how complicated development is when you must separate every detail of a trial (granular details that are often separate from the science), but they all come to play at the end of the day.
Clinical trials are long to start, difficult to do, and may have unforeseen problems, so a clear understanding of why you have to go through the process, who is in the various bodies, and how best to work with them is critical. Understand the rules from the beginning to facilitate success because the last thing you want to do is repeat something because it wasn’t done to the standards.