CROs 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 secret and hidden even from the researchers. Veerman and his colleagues have since undertaken several similarly secretive projects.
That’s both the frustration and the beauty of working for contract research organizations (CROs), says Veerman, an organic chemist who works for Mercachem, a Dutch CRO that employs about 100 people.
Working In CROs
https://youtu.be/sVB0lv3tSkY
Aside from the secrecy, one downside to working as a CRO—or it could be the other way around, depending on your inclination—is that scientists typically jump from one project to another, spending anywhere from 2 weeks to 2 years on each. Another advantage: CRO scientists are comfortable with their service orientation and pride themselves on their considerable skill and flexibility. “The reward is that you can solve [the client’s] problems,” says Veerman. “They can’t make [a molecule] and we can.”
CROs sell services that help pharmaceutical and biotech companies make products, says John Hubbard, senior vice president and global head of development operations at Pfizer. CRO 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 has increased along with the number of jobs. “In the 1980s, CROs were very small [and] doing something no one else wanted to do,” says Hubbard. At the time, CROs typically took on “projects that didn’t move forward,” boring and repetitive lab work, and low-priority light-hearted projects, he says. Today, CRO scientists are involved in all phases of the R&D process, from drug discovery to clinical trials and beyond.
Industry growth in a declining industry
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 research and development positions in CROs worldwide between 2000 and 2010.
This means that 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. Another report from GBI Research states that the global R&D outsourcing market accounted for about a quarter of total pharmaceutical R&D spending in 2010 and is expected to reach 37.1% by 2018.
In 2010, the largest CRO in the world was Durham, North Carolina-based Quintiles, with more than 20,000 employees worldwide. Close behind were Princeton, New Jersey-based Covance; 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.
Blurring the boundaries
Broadly speaking, the role of CROs is to fill the ever-widening gaps in the internal capacity of pharmaceutical 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 studies. Some CROs also help companies take products through the regulatory process and handle advertising and patents. A pharmaceutical or biotech company “can pretty much work with a CRO,” says Hubbard.
Also read:- What Do Gastroenterology Clinical Trials Do?
Individual CROs can be found across the spectrum. Some CROs, such as PPD and Covance, do everything from drug discovery to post-approval services, including commercialization and pharmacovigilance. Others work in specialized areas, with companies like Parexel focusing largely on clinical trials, for example.
CROs are sometimes differentiated by whether and what they specialize in (see box for ambiguity). CROs that focus primarily on clinical trials – process management and data crunching — are sometimes called clinical research organizations. Clinical research organizations don’t do as much “hands-on science” as bench-oriented CROs, but they still do “problem solving for the customer,” says Richard Mark, senior vice president of global human resources at INC Research, a clinical research firm. research organization based in Raleigh, North Carolina. Mark is looking to hire up to 1,000 people this year, including entry-level data managers and scientists in biology, chemistry, biochemistry, statistics and public health.
Position of CROs in the Current Market
CROs have reached a point where they have as much in-house expertise as some of the larger pharmaceutical companies, Hubbard says. Their importance in research and development has also increased. Getz says, “Over the past 5 years, the ways in which companies use CRO has changed dramatically.”
Pharmaceutical companies are moving from “transactional outsourcing” – in Getz’s words – where a company hires a CRO to supplement its workforce when its workload peaks, to “functional outsourcing” where the CRO takes over an entire function and serves as a corporate e.g. statistical analysis. Pfizer has decided to outsource almost everything but early discovery to two leading CROs — Icon (Hubbard’s former employer) and Parexel, Hubbard says.
Also read:- 8 Steps To Start A Contract Research Organization
Another way CROs are integrating into the traditional drug R&D environment is through greater workforce integration: It’s more common to jump from traditional companies to CROs and back again. As traditional pharmaceutical companies close facilities and restructure, “working at a company like Bayer no longer means you stay there for the rest of your life,” says Gerhard Müller, senior vice president for medicinal chemistry at Mercachem. Müller predicts that you will “change [employers] three or more times” over the course of your career. These companies can be traditional pharmaceutical companies or CROs. “Boundaries are blurring,” he says.
The Unchanged
Similarities aside, important differences remain. Big pharma often keeps the more creative (and riskier) drug discovery in-house-allowing them to retain more control over their own ideas—so CRO work tends to be a little more routine than in-house work. But that doesn’t mean it’s boring, says David Swinney, who after losing his position at Roche started a two-person CRO, the Belmont, Calif.-based Institute for Rare and Opposed Diseases Drug Discovery.
“Creativity can come in many flavors,” he says. CRO scientists may be challenged to find a way to set up a cheaper test for a target chemical or new targets for a drug molecule, for example. CROs typically offer employees diverse tasks and “a fluctuating, vibrant project base with teams of varying sizes,” says Mercachem’s Müller.
Even more than a traditional pharmaceutical company, the ability to work in teams, including teams with frequent schedule changes, is essential for a CRO. At Mercachem, three or four employees may work together on a project for a few months before being reassigned to different teams. “We have to have people who can adapt,” says Müller. CROs even need to adapt to new corporate cultures as client companies change, Hubbard says.
Benefit of CROs
Yet there can also be a sense of permanence in the work of a CRO. Most CROs try to maintain a long-term, full-time relationship with most of their employees. For some companies, the compound may look very similar to that of a traditional pharmaceutical company. But this is hardly universal; some companies are “virtual” and rely on a small core team that is largely responsible for outsourcing each step of the process to other companies or individual suppliers.
A good way to start in a CRO is to do a master’s project there. Internships are offered, for example, by Mercachem. Internship experience can also help you determine if CRO is the job for you, Veerman says. Another way to connect with CROs is to approach CRO scientists at pharmaceutical and biochemistry conferences, where they sometimes sponsor poster sessions.
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But don’t expect to present your work at these conferences or publish it in peer-reviewed journals after you land a CRO job. 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 achieve something and then see the credit for another scientist. But overall, he doesn’t miss the academy.
CRO: One acronym, two meanings?
Contract research organizations and clinical research organizations share an acronym; sometimes the names are even use interchangeably. Whether it’s one or two kinds of company depends on who you talk to.
While contract research organizations can cover the entire pharmaceutical pipeline from drug discovery to clinical trials and beyond, clinical trials are usually manage by the clinical research company. R&D people often think of clinical research management companies as a subset of the broader CRO category. But those in medicine and public health tend to think of clinical research as its own kind, unrelated to CROs, which focus on bench work. This is something to keep in mind when applying for a CRO job: Make sure you research potential companies well so you know what kind of company you’re talking about.
Contact Vial a USA based Contract Research Organization for more information.
