Ed Tourtellotte's Why I am Doing This
When the news first got out that I was going back into the clinical technology space, one of my old friends and colleagues wrote asking, “How many times can you build the same system?”
Hah, hah! Yes, very excellent question and I told him so, and I think my answer was something like, “Three.”
That is all in jest of course, but because people might have this exact question (or similar) I want to take a moment to say that the “system” that we are building “this time around” is radically different from anything I have ever seen in this or any other industry.
Why? Well, the “core” innovation (which we think is so cool that we’ve filed for patent protection on it!) is the notion of writing a carefully drawn up RTSM specification with a smart editor and then using natural language processing on the specification to directly program the system, instantly and automatically. A specification by definition must hold all of the logic and information required to build an RTSM system… so, why not use it?
We’re doing a variety of new things with forecasting, too - starting with the notion that the forecaster should be central to the RTSM itself - why not? Why forecast something in a tool that doesn’t share the exact same algorithm and control parameters as the target RTSM or IRT system? And once you have a forecaster in the heart of your system, well… you always have forecasting available. And if you always have forecasting available then when not use the forecaster to figure out things like safety stock or floor-ceiling parameters, and use it to help optimize choices such as lookahead window? We’re going to replace all current site and depot resupply control paradigms with simple dials - what risk will you tolerate in supporting your projected patient arrival rate? 95% confidence? Let’s peak over at 99% confidence and see what it would cost us. Now let’s look at 85% and see what it would save us. OK, run it that way.
There’s the business side too, of course, and that’s something that I have a special hankering to see done differently. Third and Fourth generation systems are fundamentally different from all that came before, and the business and support model around them should be fundamentally different as well. The traditional “Project Manager” role - the interface between customer and programmer - no longer exists. There is a new role, called “Expert,” which directly interacts with customers *and* writes the specification - which in our case is all we’ll need to automatically build the system.
So, why do this?
I’m competitive, sure, and I love inventing and building things. I love working with great teams, and having worked in a number of other industries, I actually really like the pharmaceutical clinical trials space. Say what you will about regulation and bureaucracy, but everyone in this industry is doing something good, bringing new medicines into the world.
This brings me to the real reason why I’m doing this:
It’s funny, I’ve been building RTSM and related systems for over a decade, systems that dispensed real drugs to many thousands of real patients in the real world. And yet I had never, up until the time that I “retired” from Bioclinica, ever seen the “business end” of a clinical trial. (Perhaps many of us haven’t.)
Then, a few months into my retirement, my wonderful wife and soul mate Heather, my partner in every possible way, was diagnosed with triple-negative breast cancer. At the time of diagnosis, it was already in her lymph nodes.
The prognosis was still reasonable if we did every possible thing we could to defeat it. Twelve weeks of chemo, double mastectomy, more chemo, lots of radiation. And it all started with a clinical trial. The first time I ever saw an actual clinical trial dispensing was when they gave my wife RAD001 (or placebo) in combination with her first twelve weeks of chemo.
Unfortunately, I think it was a placebo.
For the better part of two years of our lives, we rode this roller coaster, Heather taking on devastating amounts of drugs and sometimes being overcome with them, and bravely soldiering on. We would do anything to cure her, anything at all, and we did. Finally, late in 2013, we had a clean scan, and another one, and the doctors declared “No Evidence of Disease.”
Not exactly in the clear, but after five years or so of no recurrence, the stats start working in your favor. Five years is all we had to wait, to start feeling safe and sane again. Just five years.
Two weeks later Heather started having trouble with her words and having some balance issues. A few weeks after that they found a 3x5cm tumor in her brain, with the suspicion that cancer had metastasized into the dura (brain lining.) (It had.) When that happens it isn’t years or months you have left, it’s weeks.
Whole-brain radiation, fifteen treatments. She nearly died from swelling after the first one.
Chemo injected directly into the brain fluid.
Nothing would cure it, of course, but we just wanted time. Time for Heather to take one special trip with each of our four kids, for them to remember her by. One trip for me in there, too.
The time went really, really fast. In April we were walking the streets of Paris with one daughter, but by June we had to combine two kids' trips together just to get them done. Heather spent most of her time in bed. She passed away in July.
Once I knew there would be no cure, once I knew how soon the end would come, all I wanted to do was trade places with her. “You have the hard part,” she’d tell me. So I tried to face it.
She told me once, in the thick of all that, that she’d be watching over me after she was gone. And she’d be proud of me when I did good, and she’d forgive me when I did bad.
I’m trying to do good. I’m trying to make a difference.
Ed Tourtellotte, 4G Clinical CTO was the founder of Tourtellotte Solutions, a clinical trials consulting and technology company (acquired by Bioclinica). Ed designed and built the world’s first configurable IRT in 2000, and also designed the clinical trial supply simulator tcVisualize as well as Trident IWR.