What happens when a pregnant woman takes prescription drugs that can cause birth defects?
It's a question that is important enough to women's health, the drug manufacturer and the Federal Drug Administration that a company in Wilmington has been following the problem - for 18 years.
That company, Kendle International Inc., is one of at least seven such firms - clinical research organizations, or CROs - that have clustered in
Wilmington as their industry has shot up in size and revenues.
The women are monitored in what is called a pregnancy registry, said Pat Steigerwald, Kendle's vice president global late phase. "The registry involves 12,000 patients from 50 countries at more than 1,700 sites worldwide," she said.
Though Kendle is headquartered in Cincinnati, Wilmington is the headquarters for its global late clinical research phase, registry and epidemiology activities, headed up by Steigerwald.
Following drug and patient results beyond the drug approval process, such as Kendle's pregnancy, disease and other registry programs, comprises but one service that Kendle and other CROs provide their clients.
To understand the breadth of what CROs do is to answer the question: How do you know that a drug is effective and safe?
A drug from a manufacturer such as Eli Lilly or Johnson & Johnson must be tested through four clinical trials that involve anywhere from a handful of people to thousands. And, it can take up to two decades and cost $1 billion, according to the Association of Clinical Research Organizations, a trade group.
The cost and time are two of the reasons that drug firms outsource the process to CROs. And the outsourcing trend is increasing, according to industry analysts.
The total value of the CRO market is predicted this year to be $22.54 billion, according to Jefferies and Co., while Goldman Sachs estimates $21 billion.
That may help to account for the cluster of CROs that are doing business in Wilmington. The most prominent is PPD Inc., which has its headquarters in a new high-rise on the Cape Fear River in downtown
Wilmington where it employs more than 1,000 of its approximately 10,000 employees worldwide.
Companies such as PPD find the researchers to test the drug, help find the patients who will be part of the clinical trials, conduct the trials, manage the data collected, take care of the regulatory work, and then continue tests on the drug or its effects even after it is approved by the FDA.
Kendle will follow the women in its pregnancy registry for a year before a new group takes their place for subsequent study, Steigerwald said.
"These are drugs that cause birth defects," Steigerwald said. "The purpose is to keep women from becoming pregnant if they are taking them. If they do become pregnant, we need to follow them to see what happens.
"We'll be conducting more of these registries," Steigerwald said, "because we don't want to get to the point where agencies don't approve a drug because it might cause problems for pregnancy."
How drugs get to the clinical testing phases involves more than a pharmaceutical firm taking an idea and making it into a capsule, inhaler or hypodermic form.
The product development and testing requirements have become so complex, that the work often is farmed out to CROs. That trend is increasing.
A sector's strengthPPD's headquarters and the industry's strength - health care-related businesses are seen as good investments even in a weakening economy - are behind the CRO cluster here, company executives say. But other factors include a growing pool of highly skilled clinical professionals here, the University of North Carolina Wilmington and Cape Fear Community College, and the area's desirability and its effect on recruiting, Wilmington CROs say.
"CROs have really emerged in Wilmington organically," said Scott Satterfield, head of Wilmington Industrial Development. "Such firms as PPD were not lured here. That is the nature of biotech companies. They direct their own movement based on a highly unique, specialized set of business criteria.
"Supporting the cluster is more indirect," Satterfield continued. "By improving Wilmington's overall appeal, we boost our appeal to CROs.
"Without a doubt the most effective promotion comes from CRO executives who are here," he said. PPD CEO "Fred Eshelman is a tireless advocate of our region."
Satterfield pointed out - and so did local CRO executives - that the lion's share of the jobs at CROs here are highly skilled and relatively highly paid.
The average Wilmington salary in clinical research runs from $44,000 for a clinical program coordinator to $64,000 for a clinical trial associate to $94,000 for a senior clinical research associate, according to indeed.com, a job search site.
Satterfield also sees most CRO-related job growth in Wilmington coming by expansions of firms that are already here.
"I would not be surprised to see significant growth in Wilmington, North Carolina and the whole of the U.S. for Chiltern," said James D. Esinhart, executive vice president, biometrics and late phase, for Chiltern International, a United Kingdom-based company with an office in Wilmington that is expanding.
"The CRO industry is growing every year. Outsourcing is going to continue to grow," said an
AAIPharma official.
Industry biggie Quintiles Transnational Inc., with about 19,000 employees worldwide, recently said it is opening an office in Wilmington, but it would not reveal how many people it expects to employ here.
Not all CROs, however are one-stop shops with hundreds of employees. Rather, they concentrate on one or more pieces of the clinical research pie.
Inclinix Inc. is specifically what it calls an enrollment CRO, meaning that it finds researchers who want to work on a drug trial, helps the researchers better manage their databases of trial candidates and also finds additional people to participate in trials, according to J. Tobin Geatz, president and CEO.
The company, which employs about 65 full-time and 50 part-time, wants to expand its facilities here.
Industry trendsCROs are not without controversy.
A great deal of the industry's growth - including PPD's and others with offices here - is overseas as the companies seek new candidates for clinical trials.
One reason is to cut costs, the companies agree. But there are other reasons.
"If you're trying to do big trials on ovarian cancer, which is a rare disease ... you might want to look outside the U.S., to Latin America, Mexico, globally" to find enough candidates for clinical trials, said AAIPharma's Smith.
One criticism of trials abroad is whether participants are being fully informed about the process to give informed consent.
In the U.S., the FDA has stringent rules for consent. The law says that in most cases, "no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject."
Such protections didn't always exist in the U.S., Smith said.
"That's true globally," he added. "Today (the regulations) are pretty much the same."
The drug discovery process is also undergoing change, Smith said. "We've seen that there has been a shift in the kind of companies doing drug development. Big pharmaceutical companies ... don't do as much drug discovery. They look toward academia and startup companies," he said.
Though pharmaceutical and medical-device makers are spending more on research and development, their efforts are focused on core research, keeping new products in the pipeline, product management and marketing, according to the Association of Clinical Research Organizations (ACRO)
CROs themselves, are participating more in early drug safety trials as product safety becomes a bigger public issue. They also are managing more research efforts that take place after a product's regulatory approval, the trade organization said.
Additionally, smaller, niche CROs are transforming or merging into companies offering a complete range of services.
Wayne Faulkner: 343-2329
wayne.faulkner@starnewsonline.com
