Trial by Fire: Designing and Executing Ophthalmic Studies That Deliver

So, one of my several hats, we were just laughing at the number of hats each one of us wears.

One of my hats is an adjunct at Stanford, and there, for a number of years, every summer, we teach innovation course, and the... lectures that seems to be the most popular ones that I usually give, is questions as the answers to successful innovation.

And essentially, the key to successful innovation is to stop and think from the moment that light bulb goes off in your head for a medical product, to start thinking about all of the questions that you need to answer before you take each one of the baby steps.

The other things that, I'm trying to summarize a course in a couple of bullets.

What I think the most important lesson, if there's one thing that the young entrepreneurs, the really early startups can take away from this panel is the concept of instead of forecasting, backcasting.

And most people say, huh? So what I like to teach those who are first starting their first medical product development is before you jump in, head first and spend millions of dollars, lots and lots of time and lots of commitment, stop and think and envision what would you like ultimately your medical product be for which population, on which medical markets, what is its utility, and then do what I call back castings.

What do I need to do at this point in time in order to delineate a number of parallel pathways to get there most expeditiously.

And my first degree in engineering, so I always talk about block diagrams.

Yes, parallel pathways, not serious parallel, because you want to make sure you maximize the opportunity, minimize the time and the investment that you need to get to your ultimate endpoint.

And the only way to do that is to draw a number of parallel lines that minimizes the risk to the endpoint.

That's a great point.

And the other thing, too, I always think about is we think about the here and now.

Like, for instance, developing a topical IOP lowering agent.

Well, if it was four years ago or five years ago and you didn't have a generic, you were going to have a very different price point, right? But if you're launching...

three years from now, your comparator is now a generic, and it's a very different landscape.

So you really do need to think in the future.

You may not have a crystal ball.

And I know, Rick, you've been passionate about sort of the living document, or how TPP can change.

Yeah, thanks.

I think that when I first looked at putting together a target product profile, I did what most of us probably do, and I went in to look at the guidance.

And the guidance document on a target product profile is this huge piece of work.

And then when I was at Alcon doing glaucoma there, they had a very shortened version of a target product profile.

And so the concept is, is a target product profile is something that you're going to change multiple times, but you need to start on it, as Malvina said, very, very early on.

And you want to know based on what the unmet need is.

And I haven't heard anybody say that, but basically what we're doing in innovation is we're identifying an unmet need.