After starting out at Wyeth and Hoffmann-La Roche, Kevin Keim has spent 30 years in the industry. He’s assisted or run 400 trials. Most recently, Keim joined INC Research, a mid-sized contract research organization (CRO). He’s a pharmacologist who previously served (among other things) as the CEO of Vela Pharmaceuticals and as an executive at Quintiles. At INC, Keim is chief development officer, overseeing global business development, pediatrics, marketing and communications, regulatory services (including safety and pharmacovigilance), early clinical-phase product development services—and a new effort in Japan.

So … what is a chief development officer?
Keim: My responsibility is in the nonlinear stuff. When it becomes nonlinear and you need people to point the way or avoid the pitfalls, that’s where I’ll find myself being busy.

How are you finding INC Research?
Keim: It’s a company that I’ve really enjoyed. I really felt this was the place I wanted to add my experience to. There is a culture here—it is a can-do culture. There is the attitude that there is nothing we can’t do.

Are your customers considering Asia as a location for more trials?
Keim: We’re seeing a very strong interest in India. Maybe not first in man [studies]. But we’re seeing biotechs go over there and need a proof of concept trial. The competition in Korea and China is increasing as well. The frontier in China is going to be extremely exciting, for the entire industry as well as our firm.

INC recently hired a new executive to help in Japan.
Keim: We brought on Dr. [Tetsushi] Inada. The Japanese pharmaceutical industry is a very interesting one. In the past, the founders of the major companies would swear they would never merge. Now we see all this consolidation that is going on. It is very, very difficult to do large clinical trials for registration purposes in Japan. There is a lot of out-sourcing there.

Kevin Keim

Are there any new twists to the advice INC can offer?
Keim: One of the venues for work may be an appeal to venture capital groups that have a portfolio of life science companies to which we could bring proven expertise. There are so many of these biotech or venture-backed companies that make so many of the same mistakes.

What sort of mistakes?
Keim: It’s the typical error that goes around what a company thinks a drug might do versus the better odds of what the drug will do. It goes to wrong dosage, wrong therapeutic area, wrong outcome measurement, a clinical trial that is not controlled. It comes to a series of small leaks. Many, many clinical trials are pushed by pharmaceutical management or marketing to enroll too quickly. Once you start enrolling too quickly, you don’t get the group of patients who are well defined for registration.

Why is pushing enrollment a problem? Isn’t it often necessary?
Keim: I have seen many, many times where trials fail because the enrollment’s been pushed. [In one failed trial that Keim analyzed retrospectively, he found that] as soon as they doubled the enrollment rate, they doubled the placebo response. You see things like that that are just silly. It’s the [statistical] variance that I always harp on. What you want to do is keep your variance tight. We try to find historical references for what the variance should be, and based on that, we choose our population size.

How does INC differentiate itself?
Keim: We have an extraordinary process here. We’ve labeled it “the trusted process.” The whole issue of patient selection, patient recruitment, protocol design—it all works into how tightly can you keep your hand on all the variables that lead to an unsuccessful trial? These pieces, when you string them together, when you overlap them, are where you find your efficiencies.

Are you hiring? Is the INC headcount growing?
Keim: It is strategic and metered. We are driven by opportunity. We have done a fair amount of work attempting to bring new clinical research associates (CRAs) into this business. It’s a tremendous career path. As we say in our company, we have no noncombatants. They are all involved in clinical trials. After our training program, these CRAs, after 9-12 months, are better than CRAs that we can attract with years and years of experience.

In the new year, what will you be emphasizing?
Keim: One of our major objectives for the next year is training. We’ve engaged people to do role playing—to be the nasty physician or the uncooperative coordinator. How do you train people to do this? It’s one thing to do a fire drill. It’s another thing to get out of the building when you see flames. One of our goals is to make this real and make these people sharp.

Technology firms say that CROs generally don’t invest enough in technology. Your response?
Keim: We think we are a technology company. We use and need to use technology to keep our own costs down. We’ve basically committed to partner or use off-the-shelf technology and not build our own technology. Instead of bringing data to the customer, we’re bringing the solution. We know which technology is going to fit best with the trial they are going to do.

So you’re not feeling any pressure from technology-centric firms?
Keim: The way you measure a company like this is the ability to recover from a problem. One of our hallmarks is that in clinical trials, with people all over the world, something is going to happen. How fast can you recover? People with experience will recover.

Thank you, Dr. Keim.