The Future of Clinical Trials
By Adam Farley, Deputy Editor
August / September 2014
ICON plc. is pushing the boundaries of what clinical researchers thought was practical. Adam Farley speaks with Dr. Brendan Buckley, ICON’s Chief Medical Officer, about how it came to be and where it plans to go.
The view from Brendan Buckley’s office at the ICON headquarters is east by northeast over the Leopardstown Racecourse. If the building were taller, you could see the Dun Laoghaire piers and Dublin Bay. But if the building were taller, the office wouldn’t be in the South County Business Park, rubbing shoulders with Microsoft, Fónua, and VeriFone. It doesn’t get much more Irish office-park tech than this.
The only thing is, ICON, founded in 1990 by Dublin pharmacologists Dr. Ronan Lambe and Dr. John Climax, isn’t your standard Dublin tech company. It is one of the world leaders in clinical research, with 83 offices in 38 countries that employs approximately 11,000 people worldwide – with a mid-year guidance of $1.5 billion – that is driving innovation in the clinical development process. Brendan Buckley is ICON’s Chief Medical Officer.
Buckley was born in Cork in the 1950s. His mother was a scientist and his father worked for the civil service, but they were fairly non-interventional parents, he says. “They figured I’d find out what I wanted to do in due course. But I suppose I was good at science at school and the biology was more interesting than the raw molecules to me. I had good teachers who steered me and they gave me the insight that gave them their enthusiasm. If that hits you, that’s it.”
“It,” for Buckley, now ranges from advising the CEO to risk assessment, and acting as an academic liaison because, he jokes, “I’ve got grey enough hair that on those occasions I can call myself ‘Professor.’” Buckley, of course, is also a professor and teaches 12-15 classes per year at University College Cork and other places, “to air my personal prejudices to the impressionable,” he says, discernibly less than half jokingly.
He is a measured and deliberate speaker with a bass voice more suitable perhaps to a meditation seminar than a Ted Talk, and our near two-hour conversation this past June ranged from jet lag to Kodachrome, soccer to Switzerland, and opticians to the mental health of GAA players. Somewhere in between such “shooting the breeze,” as he will call it, we managed to discuss the future of clinical trials, ICON’s role in medical research, and its devotion to maintaining what Buckley calls its “Irish ethos.”
You joined ICON relatively recently in 2012. How did you come to be here?
I set up a business called Firecrest with a few guys from Limerick about ten years ago, which ICON bought three years ago. Essentially what it does is what nobody else did up until then. It was the first company to focus on an online solution for training and supporting the staff who actually perform clinical trials at their hospitals and doctors offices. If you wanted to go to a place with a real buzz – it’s a kind of Silicon Valley/Google-type buzz in the office there – that’s where you go.
So Firecrest has a very young workforce, much like ICON.
It does. Really, it’s mostly young people trying to change the way medical information is spread throughout the industry. ICON recognized that the quality of work performed at sites could be substantially improved by providing on-demand, monitored, and certified training.
The conventional way was to fly people off to two days of death by PowerPoint somewhere, and it could be six months before you ever saw a patient for the trial. The Firecrest system basically allows the staff conducting the research at their own study sites to have any support they require, for example visit-by-visit guides for each time they see a patient on a trial, at their fingertips. There is probably nothing like it still in the industry.
Is that the first company you were involved in founding?
No, over the years I’ve been involved in other stuff. There were lots of failures. But you forget the failures and remember the successes, and Firecrest is probably the most disruptive success.
My background is essentially what you would call a “simple country doctor.” I’m a physician by training – an endocrinologist – and taught, and still do a little bit of teaching, endocrinology in UCC. I came into medicine indirectly. I did biochemistry first as an undergraduate and then did my doctorate in Oxford with a man I was very lucky to work with – Hanz Krebs, notorious for the Krebs Cycle, which has bothered students for decades.
What were some of your previous ventures?
Largely the stuff I wanted to set up were itches I had to scratch. They were things that seemed so obviously required. We have to do clinical trials all the time because we need new drugs. And sometimes you have to ask questions which can only be answered in a clinical trial.
My first company was established to train and employ nurses to be sent to rural areas of Cork for a clinical trial I was conducting on the effects of statins in the elderly. That was in 1997.
So the companies arise out of medicinal, rather than business, needs.
Every day, every practitioner, every good practitioner, should be asking themselves questions. And sometimes you can go to the literature to get the answer, and sometimes the answer ain’t in the literature. And when the answer is not in the literature, it is to a degree incumbent then to ask, “Is that a question that I have any possibility of answering myself?” Mostly the answer is no, for many reasons. But sometimes the answer is yes, and if the window opens you have to go look through it.
And where do you see the future of clinical trials going?
I think in general patient autonomy is going to increase through the use of mobile devices. For example, I can do my cardiograph on my cell phone case now, diabetics can measure their blood glucose, and blood pressure is easily measurable. Why do you need to be seen in the clinic if you’re doing fine? The ability to hand over some degree of autonomy and self-management to patients will change the way patients are seen by doctors. And that will change how we can access whether and how drugs are working.
How do you think that will impact the way that clinical trials are conducted?
Well, let’s take diabetes for example. There are more diabetics than doctors can look after at the moment. The reality is that with present models your doctor will ask to see you twice a year or whatever is deemed necessary whether you are in trouble or doing fantastically well. Yet, the patient has infinite access to information on the internet, so in the near future, most diabetics are going to manage themselves at home and their cell phones are going to transmit their clinical measurements into a central server in the clinic. That means the ones who do actually need to be seen frequently will be and those who don’t can continue to manage themselves.
That also means that if you want to trial a drug in diabetes, most of the participants won’t be coming in to see their doctor, and you get to hitchhike onto the informatics platform for that. So instead of the couple of measurements that are taken twice a year at clinic visits, you’re receiving four or five measurements per day direct from the patient.
How many years away from that do you think we are?
That’s imminent. Those are things that are capable of being done soon. If you look out through social media, there is such a drive now to autonomy and choice. And the challenge we have is to make that choice as informed as possible, and to help people find useful information in the morass of noise that is out there on the internet. One of the greatest challenges for patients is actually finding information that is useful as opposed to misleading.
What is your greatest challenge as a medical professional?
Well, the kind of fun thing that provides the challenge, and the opportunity, is the conservative nature of the industry. Pharma companies are operating on relatively low probabilities of a drug getting to the market, so they are risk averse. Change and innovation inevitably carry an element of the unknown and is therefore perceived as being somewhat risky, even though it is recognized that the present way of doing things is probably less successful than it could be. This can make it quite difficult for innovation to get a grip. A drug starting out in clinical development has about the same chance of success as picking a number at roulette.
Would you say trying to beat that wheel is the most exciting part of your job at ICON?
The best part is the varied nature of what I do. Any single week is very different from any other week. For example, to take the next ten days: in two days I go to Basel in Switzerland with an Irish trade mission with the aim of demonstrating the attractiveness of Ireland as a place for investment. I’ll spend the next day meeting various pharmacology people in town and maintaining the relationship. Two days after that I’m off to San Diego for the Drug Information Association annual meeting to speak about Big Data and give a seminar. Part of it is business development, and part of it is company networking. In between times, I will work on strategy and on ensuring ICON’s focus on patient safety and benefit.
Tell me more about the Irish ethos of the company.
In addition to our headquarters being in Dublin, there are qualities of Irishness that I think are helpful to the business. We are naturally very competitive as a nation. The reason that Ireland is so visible internationally in spite of being very small is because we shout very loudly and we’re intensely competitive, particularly when we go into any kind of international arena. That competitiveness is based on a strong sense that we succeed based on excellence. There is nothing in the Irish character that allows for complacency when it comes to a competitive arena; there’s no sense of entitlement.
In ICON, we translate traditional Irish esteem for education by bringing everybody who is at the level of manager or above to UCD to do an executive management course at the Smurfit Business School. We centralize this here in Dublin rather than devolve it because it’s part of our team process. Every business has to have a soul that resides in a place, and Ireland is the place where our soul resides.