If it “takes a village” to raise a child, it takes a network of pharmaceutical firms to bring a drug to market, and clinical research organizations (CROs) — which shepherd a drug through the testing process — perform some of the most crucial tasks. Princeton’s two dozen CROs, with 800-person Covance being the largest, provide more than 2,000 jobs.
Not as large as Covance, but growing, is Theradex. This week Theradex makes a significant expansion, moving to larger quarters. Until now Theradex had been located next to the Princeton Junction train station at 14 Washington Road, where it had 85 employees in just over 21,000 square feet. With that office complex’s future shadowed by possible redevelopment of the train station area, Theradex has made a move to 4365 Route 1 South, just south of the Doubletree hotel. The new offices are 30 percent larger, and, according to Theradex executives, have a configuration and technology arrangements that will be a major improvement.
Theradex distinguishes itself by an unusual contract, to monitor all of the Phase I clinical trials for all the oncology drugs presented to the National Cancer Institute. This puts Theradex on the front line of the quest for cancer drugs that work. Yet the company does not have the labs often associated with scientific research. It is a paperwork company that does not do clinical tasks. Founded in 1982, Theradex monitors the work of clinical researchers, and it has seen dramatic changes in both the quantity of this work and the way it is performed.
Robert Royds, the chairman, estimates that over the past 25 years he has sent 300 to 400 drugs through the trials of NCI, an arm of the National Institutes of Health that administers government sponsored research. Currently his firm is supervising the trials of several dozen drugs at NCI.
This arduous process starts with identifying a compound, which is then tested in a preclinical trial, maybe in a petri dish or perhaps on laboratory mice. Using it for the first time on humans is called the Phase I clinical trial. The purpose: to be sure the drug carries no harmful side effects. If the drug were not a cancer drug, the Phase I trial would be performed on healthy individuals, and the Phase II trial — on patients with the disease — would determine whether the drug is effective.
But a Phase I oncology drug is, by definition, potentially harmful. Its purpose is to kill cancer cells and it will likely kill healthy cells as well. So it must be tried out on those who already have some form of cancer.
Phase I researchers not only check the drugs for side effects, but they also look for clues that the drugs actually work. That’s where the collective experience of Theradex’s staff can help. Royds, the chairman, and Meg Valnoski, the president and CEO, note that the staff has put hundreds of drugs through the clinical trial process. “We can’t discuss confidential information,” says Valnoski, “but if we have just had an experience with a compound, and we know the FDA’s views, we can save steps for the next client in the development of its compound.”
The clinical trial process has changed since Theradex began. For instance, the E-patient movement — patients educating themselves by using the Internet — affects the administration of trials. Typically just a small percentage of patients eligible to participate in a trial, from three to five percent, agree to participate. Valnoski says that posting clinical trials on the Internet can help to attract trial participants. “If patients go online to understand the clinical trial process, and to find clinical trials, that’s positive,” she says.
Nevertheless, E-patients sometimes generate unwanted pressure, such as when they use the Internet to find out about drugs not yet on the market, says Royds. Phase I drugs are not available to the general public, only to those who qualify for the trial. Those who don’t qualify sometimes get frantic and try to finagle a way to get the new drug. Sometimes Theradex has received pressure from a celebrity or a politician to supply a particular drug for a friend or family member. That’s counterproductive, says Royds. If the pharma company must spend a lot of time fending off these requests, he thinks that can actually delay the process of getting the drug to market.
“We get these calls, but we try not to get in the middle of it,” says Royds, who notes that it is important to realize that no cancer patient in a clinical trial is getting a placebo. All patients get some therapy, whether it is a previously approved therapy or a new one. Likewise, those who have been shut out of the clinical trial are also getting good care. Royds assures anxious patients and families: “If you are not in a clinical trial, the treatment you are likely to receive is state of the art.”
Another fast-changing part of the clinical trial business is the transition from paper records to electronic records. The transition is 20 percent complete and in 10 years, some predict, electronic data capture (EDC) will replace paper and pen. You would think that EDC would help the clinical trial administrators, but no, at least not for now.
“It is a widespread misconception that remote data capture saves you time and money,” says Royds. Think back to the 1980s when office workers struggled to learn the computer programs that are standard today. Into that confusing picture, imagine trying to standardize electronic record procedures for healthcare workers at far-flung locations. Unless Theradex has an ongoing relationship with the staff at a particular hospital, paper records are still the easiest.
This is so because someone trained on one software program might object to learning another. “But put a piece of paper in front of them, and it is hard to argue with that,” says Valnoski. Using electronic records actually slows down the auditors of oncology trials, she says, because they must go through each page of each record to look for errors. That’s because cancer patients accumulate more pages of records than do most other patients, for instance those with cardiac disease or hypertension.
“You are not just looking for data that’s recorded,” Royds says, “but you are also looking through medical progress notes and nursing notes to make sure nothing is there that might indicate toxicity.” And even though the electronic files are searchable, auditors find that it’s faster to flip through and compare pages from paper files than to work within the confines of a computer screen.
Another potential glitch with electronic data is a temporary one: As oncology clinics move from paper to computer records, they might cut corners to meet a deadline. “Typically the institution will decide on a date by which everything should be electronic. The only way that the medical records department can cope with that is to scan the records in batches,” says Royds. “Recent records will have been scanned in individually, but there will be batches of 300 records that can contain anything. We have no way of knowing what is contained in that batch of pages.”
Royds grew up in Yorkshire, England, where his father was a physician. He went to public school (a “private” high school) in Edinburgh, graduated from St. Bartholomew’s Medical College of the University of London, then taught and practiced internal medicine for eight years. Merck recruited him to come to the United States, and he later worked for Hoffman-LaRoche. He and his wife have two 20-something daughters, one a patent examiner and the other a federal government worker.
He set up Theradex in 1982 to compete with Besselaar, the predecessor to Covance. He bid and won the contract to monitor Phase I oncology trials for the National Cancer Institute, and he has kept that contract ever since. According to a spokesperson for NCI, the current seven-year contract has two more years to go and is worth $2.6 million annually. Theradex is supervising about 60 Phase I protocols, assigned based on first time use of an agent in humans, safety of an agent, and the toxicity of the new agent.
Valnoski grew up in North Jersey, where her father was a machinist supervisor. She graduated from Delaware Valley College in 1978 and began working at Schering Plough, doing veterinary research. She has always loved animals, and she is an accomplished equestrian. But she saw more career opportunities in the ethical pharmaceutical market, so she decided to change careers and do health research for humans while nurturing her love for animals in her private life. Valnoski is an avid foxhunter and serves as master of the Monmouth County Hunt. On her horse farm in Allentown, New Jersey, she has both field hunters and young show horses, which have accumulated a satisfying number of trophies. “I bred these babies, and I am enjoying watching them grow up,” says Valnoski.
After working in health research at Pittman Moore, Valnoski was hired by Royds as a medical writer at Theradex in 1988. The firm had just 19 people at that time, and as her job grew she developed the regulatory side of the business. In 1994 Royds made her president and CEO, in charge of operations, while he remains the chairman.
Theradex has private clients in addition to its NCI contract. For foreign clients and smaller U.S.-based biotechs, it shepherds new drugs through the Food & Drug Administration, and it has six to eight investigational new drug applications (INDs) wending their way through the approval process. It offers clinical trial auditing services to well-known academic institutions, and it has a contract with the National Aeronautic and Space Administration to oversee biomedical projects, such as how the effects of drugs are altered in space, or how kinetics change in weightlessness situations.
Theradex leaves behind the challenges of an older building, with offices strung out along a hall, spread over two floors, and technology — wires everywhere — that could not be hidden. “We are really looking forward to getting a fresh start in our new space,” says Royds. But he has had a good quarter-century run at Washington Park, where a trip to Washington, D.C., begins with just a walk across the parking lot to the train station.
Tom Romano of Newmark Knight Frank helped find the new space, 27,260 square feet. “Theradex’s new landlord is very fortunate to have landed such a tenant,” says David Newton, Royds’ former landlord at Washington Park. “Bob Royd signed a new 10-year leaseand unlike many others he didn’t try to hold me hostage to outrageous concessions.”
The environment for cancer research is indeed changing, so that “personalized medicine,” the practice of concocting therapies for your particular DNA, is becoming more important. But the search for cancer cures is still “not a race, but a process,” Valnoski says. “People will look back in 20 years and see the progress, but such minor progress is made. Yet we are not doing the same things we did 20 years ago. Everyone has to keep up — that is what makes it exciting.”
Theradex Systems Inc., 4365 Route 1 South, CN 5257, Princeton 08543-5257; 609-799-7580; fax, 609-799-4148. Meg Valnoski, president. Home page: www.theradex.com.