Testing the Waters in Pharmaceutical Research

Clinical drug evaluation is one of the many important jobs in industry. Those interested in a career in pharmaceutical clinical testing should have a strong science background and the ability to work within a team. These scientists often have research experience in academia and government but choose to use their skills to ensure that consumer medicines adhere to strict safety standards.

One such scientist is Michael King, associate director of experimental medicine at Johnson & Johnson in Raritan, New Jersey. Specializing in phase 1 and phase 2A clinical drug-testing trials, King's research group helps new drugs gain U.S. Food and Drug Administration (FDA) approval.

King, who started his research career in academia, says his move to clinical industrial research was a natural progression because he always wanted to do what he calls "science with a twist." "I knew I wanted to do something different when I was in academia, not just straight bench research," he says.

A native of Cleveland, Ohio, King plays an important role in helping bring new products to market. Science's Next Wave profiles King's career and finds out what happens before prescription drugs reach the pharmacy.

Interested in Science

King's fascination with science began in the third grade when he wrote a book report on split-brain surgery. King was intrigued when he read how people who underwent this surgery behaved differently than other people. "Researchers covered the left eye of these patients and asked them to describe what they saw with their right eye," King explains. "They then covered the right eye and asked them to remember what they just saw. Many patients could not recall because the corpus callosum--a thick bundle of nerves in the center of the brain which connects the two hemispheres--had been cut. Their brains were operating separately. I've been interested [in neuroscience] ever since."

As an undergraduate at Ohio Wesleyan University in Delaware, Ohio, King changed his major several times, but his focus was always on science. "I wound up getting a bachelor's in psychology, but the emphasis was on physiological psychology," he says. "It was the closest thing to neuropsychology and neuropharmacology I could find."

King went on to grad school at Kent State University in Kent, Ohio, intending to study fetal exposure to crack cocaine, but the death of his grandmother from cancer pushed him in a new direction. King remembered the pain his grandmother had suffered and decided to do pain research, the control of cancer-related pain in particular. He completed his Ph.D. in neuropharmacology and went on to do a postdoc at one of the most prestigious cancer centers in the country, Memorial Sloan-Kettering in New York City.

Making the Transition From Academia to Industry

As a postdoc working with Gavril Pasternak at Sloan-Kettering, King had a chance to do different kinds of biomedical research, but he soon was attracted to clinical research.

Under Pasternak's tutelage, King learned how to run a clinical research lab, but the most important benefit of his time at Sloan-Kettering, he says, was the improvement in his analytical skills: "He really taught me how to become a better thinker."

After completing his postdoc, King headed to Johnson & Johnson. "It was easy for me to take that step from academia into industry, where I was doing 100% clinical research and [using] my preclinical background to help me understand compounds from the beginning to end."

Johnson & Johnson

King's research group is responsible for clinical drug evaluation for Johnson & Johnson. As a compound is characterized preclinically, King's team designs a series of trials to determine whether the compound is safe and effective for humans (see text box).

The Phases of FDA Approval Prescription pharmaceutical drugs produced in the United States must undergo four periods of testing or "phases." Phase 1 examines the safety of the drug. Scientists determine the pharmacokinetics of the drug and test whether it is easily tolerated by the human body. Phase 2A and 2B determine preliminary efficacy. Phase 2A usually occurs in a healthy population, whereas phase 2B tends to be in a patient population that is relatively healthy such as diabetic outpatients. Both phase 1 and 2 use small numbers of test subjects, between 50 and 250 people. Phase 3 is large-scale testing of the drug using 1000 to 2000 patients from the target population who are not healthy. After successful phase 3 testing, the company that produced the compound may apply to FDA for approval to launch the drug. Phase 4 occurs after the drug launch and can have several objectives. The main purpose is to further define the compound's mechanism of action, but sometimes the goal can be to differentiate the compound from a competitor's.

When asked to describe a typical day at work, King says it's usually long, 11 or 12 hours, but that depends on which compound is being tested in the clinic and whether there are major issues to deal with. "Half of my clinical team is in Europe, so I get in the office at 6:30 a.m. so I can interact with them," King says. "I leave about 5:30 p.m. but sometimes handle cases later on using my Blackberry. It's like anything else. It goes in peaks and valleys."

With such long workdays, balancing work and personal life is a struggle, but he makes a serious effort. It's important, he says, to make time for oneself. "Everyone is so quick to make time for work and other people, but they forget about themselves," he says. "It's something I try not to do. I regularly go to the gym and have other extracurricular activities."

Aspiring scientists can have rewarding careers in pharmaceutical research, says King, but it takes years of hard work and sacrifice. "No one gets to where they want to be without help and mentoring," he says. "I've been very fortunate, but I've also been very smart to take advantage of the opportunities that were given."