Pharmaceutical companies live or die on their ability to introduce new drugs. Yet the industry is notorious for long cycle times and delays. How do you change the game?
Drug development sounds like it’s all about chemistry and biology, scientists and physicians. It’s really about information. The key to developing drugs fast is developing information fast. That’s the core idea behind this company.
People at Quintiles come from an incredible range of disciplines: toxicologists, pharmacologists, physicians, statisticians, health economists, computer experts. But they’re all working to create the same thing — high-quality information on the benefits and risks of particular drugs. And all that information converges in two places: the New Drug Application (NDA) we submit to the Food and Drug Administration (FDA), and the package insert that tells doctors what they need to know to prescribe the drug. These aren’t just documents. They represent all the knowledge that exists about a new drug. That’s our job: doing the best we can, as fast as we can, to capture that knowledge and communicate it effectively.
Why can’t other companies do what you do?
The first reason is our strategic focus. The big, integrated pharmaceutical companies are really in four different businesses. I call them the four Ds: dollars, discovery, development, distribution. The skills you need to be excellent in any one of these businesses are different from — sometimes at odds with — the skills you need in another. Scientists working to discover a new drug do great research based on their university training. But I wouldn’t expect them to work more quickly in order to add $50 million to the value of their discovery.
The second reason is that what we do is hugely complex, and making it work takes real discipline. At any one time we might have 20 trials going on around the world. Each one involves thousands of patients, hundreds of specialists, millions of pages of clinical data. Last spring, we submitted two NDAs on the same day. Some companies submit only one NDA in an entire year! Our people called it “March Madness.” On that day, we shipped 1.4 million pages of documentation to the government and our clients. People worked late into the night for months. Toward the end, people slept here so they could keep working. You’d walk in and find sleeping bags, stale pizza crusts. It was an incredible achievement.
Obviously it takes more than all-nighters to stick to your timetables. What techniques do you use to move quickly?
Much of our success or failure is determined before we ever start the trials. You have to be able to envision, up front, what the FDA will want to know about this drug three to five years from now. What kind of protocol do you write, what is the breadth and depth of your studies? That’s where focus and experience come in. Over the last five years, we’ve run virtually every program for new Alzheimer’s drugs. Any company working on Alzheimer’s is going to want to talk to us.
Of course, we can’t guarantee how long a clinical trial will take. We can’t predict if a drug will encounter adverse events, which can mean more testing, or if it’s not as effective as we expected. But we’re very fast on what we can control. One big reason companies come to us is the speed with which we can start projects. Early on, we really kick into gear. We may put 200 people on a project team. Their job is to sign up doctors and enroll patients. It’s very much a crash exercise.
Our global presence is important, too. We conduct trials in multiple countries, sometimes as many as 10 or 15. We’ve expanded into places like Eastern Europe and South Africa. They aren’t big markets for pharmaceuticals, but their patient base is very good, and the doctors there are keen to participate in clinical studies. It helps us start faster.
What else helps you go faster?
Technology. It affects every part of our business. We’re leaders in using touch-tone phones for entering patient data. In many other trials, patients keep their own records and a doctor might visit once a month to check on things. Most of those diaries are paper-based. How often do you think patients forget to enter data? And what percentage of that data is scribbled on a patient’s hand?
With our technology, patients enter daily information over the phone. It’s so much faster and more reliable. If the patient misses a day, the system automatically generates a fax to an investigator who follows up: “Are you OK? You didn’t do your diary today.”
So much of what happens at Quintiles is organized around project teams. What have you learned about making projects work?
Project managers have to do four things at once: keep the client happy, keep their colleagues happy, stay on time, and stick to budgets. It’s a rare person who can do all those things. We are very serious about training our people. We are very serious about mentoring; it’s not unusual for experienced project managers to spend 20% of their time advising younger project managers.
Projects also create a short-term rhythm that you have to work by. You have to keep appraising and adjusting. Every week, we have a worldwide videoconference for all our project managers. So much can happen so quickly: a client wants to accelerate a timetable by two months, a trial is generating adverse events, the FDA has questions. When issues get raised we resolve them within 48 hours. We use the weekly videoconference as a kind of sunset law. We don’t change everything every week, but we do reevaluate every week.