Johan Veerman spent part of last year leading seven other scientists in an effort to synthesize molecules for a large pharmaceutical company. The team knew all the attributes the new molecules should have, but the application was a secret, concealed even from the researchers. Veerman and his colleagues have since taken on several similarly secretive projects.
“In the last 5 years, the ways that companies are using CROs changed dramatically.” —Kenneth Getz
Therein lie both the frustration and the beauty of working for contract research organizations (CROs), says Veerman, an organic chemist who works for Mercachem, a Netherlands-based CRO that employs about 100 people.
Apart from the secrecy, one downside of CRO work—or it may be an upside, depending on your inclination—is that scientists usually hop from one project to another, spending anywhere from 2 weeks to 2 years on each one. Another upside: CRO scientists take satisfaction in their service orientation and pride themselves on their considerable skill and flexibility. The “rewarding part is that you can solve [a client’s] problems,” Veerman says. “They cannot make [a molecule], and we can.”
CROs sell services that help pharmaceutical and biotech companies make products, says John Hubbard, a senior vice president and worldwide head of development operations for Pfizer. CROs’ research capabilities have expanded as the pharmaceutical industry has undergone profound changes, including outsourcing tasks and jobs. As a result, the quality and complexity of CRO work have increased along with the number of jobs. “In the 1980s, CROs were very small [and] they did something nobody else wanted to do,” Hubbard says. In those days, CROs typically took on “projects that wouldn’t advance,” boring and repetitive lab work, and low-priority, back-burner projects, he says. Today, CRO scientists are engaged at every stage of the R&D process, from drug discovery through clinical trials and beyond.
A growth sector in a diminishing industry
It’s not a bed of roses, but overall, the CRO sector is experiencing healthy growth. The Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine in Boston recently reported a 7% average annual growth rate in the number of R&D positions at CROs worldwide between 2000 and 2010. That means the number of such positions doubled in a decade, says Kenneth Getz, an assistant professor at CSDD who specializes in pharmaceutical R&D management and contributed to the study. A different report from GBI Research says that the global R&D outsourcing market accounted for approximately a quarter of total pharmaceutical R&D expenditures in 2010 and is expected to reach 37.1% by 2018.
As of 2010, the world's biggest CRO was Quintiles, headquartered in Durham, North Carolina, with more than 20,000 employees worldwide. Close behind were Covance, based in Princeton, New Jersey; Pharmaceutical Product Development Inc. (PPD) in Wilmington, North Carolina; Parexel in Waltham, Massachusetts; and Icon in Dublin. But many CROs are small, with fewer than 50 employees.
Broadly speaking, the job of a CRO is to fill the ever-expanding gaps in the in-house capacity of pharma and biotech companies. The services they provide range from drug discovery tasks—including organic synthesis, analytical chemistry, biochemistry, molecular modeling, and medicinal chemistry—to clinical research trials. Some CROs also help companies guide products through the regulatory process and handle advertising and patents. A pharma or biotech company “can pretty much go end to end working with CROs,” Hubbard says.
Individual CROs can be found along the entire spectrum. Some CROs, such as PPD and Covance, do everything from drug discovery to post-approval services, including commercialization and pharmacovigilance. Others work in niche areas, with companies such as Parexel largely focusing on clinical trials, for example.
Sometimes a distinction is made among CROs depending on whether, and on what, they specialize (see box for disambiguation). CROs that focus mostly on clinical trials—managing the process and crunching the data—are sometimes called clinical research organizations. Clinical research organizations do not do as much “hands-on science” as bench-oriented CROs, but they still do “problem-solving for a customer,” insists Richard Mark, senior vice president of global human resources at INC Research, a clinical research organization based in Raleigh, North Carolina. Mark is looking to hire as many as 1000 people this year, including entry-level data managers and research scientists in biology, chemistry, biochemistry, statistics, and public health.
CROs have reached the point where they have as much in-house expertise as some of the larger pharmaceutical companies, Hubbard says. Their importance in R&D has also increased. Getz says, “In the last 5 years, the ways that companies are using CROs changed dramatically.” Pharma companies have been transitioning away from "transactional outsourcing"—Getz's words—where a company hires a CRO to supplement its workforce when its workload peaks, and toward “functional outsourcing,” where a CRO takes over a whole function, serving as a company’s statistical analysis department, for example. Pfizer has decided to outsource pretty much everything except early discovery to two leading CROs—Icon (Hubbard’s former employer) and Parexel, Hubbard says.
Another way that CROs are becoming integrated into the traditional drug R&D landscape is that the workforces are more integrated: It has become more common to hop from traditional companies to CROs and back again. With traditional pharma companies closing facilities and restructuring, “a job with a company like Bayer no longer means you will stay there the rest of your life,” says Gerhard Müller, senior vice president for medicinal chemistry for Mercachem. Müller predicts that over the span of your career “you will change [employers] three or more times." Those companies may be traditional pharma companies or CROs. “The boundaries are blurring,” he says.
A lively project base
Beyond the similarities, important differences remain. Large pharma companies often keep the more creative (and risky) drug discovery in-house—allowing them to keep more control over proprietary ideas—so CRO work tends to be a bit more routine than in-house work. But that doesn’t mean it is dull, says David Swinney, who launched a two-person CRO, the Institute for Rare and Neglected Diseases Drug Discovery, based in Belmont, California, after losing a position at Roche. “Creativity can come in different flavors,” he says. Scientists at a CRO may be called on to find a way to set up a cheaper assay for a target chemical or new targets for a drug molecule, for example. CROs usually offer employees a diversity of assignments and “a fluctuating, lively project base with various different-sized teams,” Mercachem’s Müller says.
Even more than at a traditional pharmaceutical company, at a CRO, the ability to work in teams, including teams with frequent roster changes, is essential. At Mercachem, three or four employees may work together on a project for a few months and then get reshuffled onto different teams. “We have to have people who can adapt,” Müller says. CRO scientists even need to adapt to new corporate cultures as client companies change, Hubbard says.
Yet, there can also be a sense of permanence in CRO work. Most CROs try to maintain a long-term, full-time relationship with the majority of their employees. At some companies, the mix can look a lot like the mix in a traditional pharmaceutical company. But that's hardly universal; some companies are “virtual,” relying on a small, core team that is largely responsible for hiring out every step of the process to other companies or to individual contractors.
Where to start
A good way to get started at a CRO is to do your master’s degree project there. Mercachem, for example, offers internships. An internship experience can also help you determine whether CRO work is for you, Veerman says. Another way to connect with a CRO is to approach CRO scientists at pharmaceutical and biochemical conferences, where they sometimes sponsor poster sessions.
But don't expect to present your work at those conferences after you get a CRO job or to publish it in peer-reviewed journals. As in other private-sector companies, CRO scientists cannot always publish freely. That's definitely a downside: It can be hard, Veerman says, to know you're the first to accomplish something and then see credit go to another scientist. But on the whole, he says, he does not miss academia.
Contract research organizations and clinical research organizations share an acronym; sometimes the names are even used interchangeably. Whether this is one kind of company or two depends on whom you talk to.
While contract research organizations can span the entire pharma pipeline from drug discovery to clinical trials and beyond, a clinical research company mostly manages clinical trials. People in the R&D business often consider clinical research management companies a subset of the broader CRO category. But those in the medical and public health sector tend to consider clinical research organizations their own species, unrelated to CROs that focus on bench work. That’s something to bear in mind when applying for a CRO job: Make sure you research prospective companies well so you know what kind of company you're talking to.