Clinical Research organizations offer wide range of management opportunities for physician executives.

Have you always secretly dreamed of being a venture capitalist, funding startups and helping take them public?

Maybe you harbor a secret desire to teach.

Perhaps you love computers, have developed computer science skills and wish you could find some application for those skills that uses your medical training, as well.

Maybe even deep within you is a salesman yearning for an opportunity to close that multi-million-dollar deal.

Within the traditional pathways of most physician executives, those dreams would simply remain "Walter Mitty" fantasies. But what if there was a career option that combined aspects of traditional career paths with opportunities to develop exciting new interests?

Well, it does exist. It's called working in a clinical research organization (CRO). What's a CRO? A brief review of the drug development process helps define it.

It now costs about $1 billion dollars and takes eight to 12 years to take a drug from molecule to market. Historically, only about 1 in 800 compounds synthesized even makes it into human trials for evaluation. Of those that do make it into human clinical trials, only one out of five drugs actually reaches the market, and of those, generally only about 30 percent ever recoup their development costs.

As the cost of drug development skyrocketed and regulatory complexities increased, pharmaceutical, biotechnology and medical device companies found it economical and prudent to outsource many aspects of their development work.

In steps the CRO.

While some large pharmaceutical companies still do much of their own development work in house, the pharmaceutical industry as a whole is beginning to resemble the movie industry with pharmaceutical and device companies (the studios) outsourcing much of the production work to production companies (CROs).

Smaller firms may even outsource marketing and distribution. Indeed, taken to the extreme, this trend has resulted in what are now known as "virtual" pharmaceutical companies. These small companies, run by a few people, usually possess patent rights to a compound and outsource everything from pre-clinical and clinical trials to regulatory support for submission of appropriate documents for approval and even marketing of their products to physicians and the public.

So how does a CRO differ from a pharmaceutical, biotechnology or medical device company?

Originally, pharmaceutical and medical device companies contracted with CROs to perform some or all of the clinical trials necessary to obtain regulatory approval to bring a product to market rather than always maintaining the large staff necessary for these operations on their own payrolls.

The CROs functioned as independent entities, performing clinical trials for their pharma clients and vouching for the quality of the data submitted to regulatory agencies for marketing approval (and sometimes, rejection). The CROs would "farm out" the actual work of recruiting patients and conducting clinical trials to principal investigators (PIs) both in the United States, and, in large global trials. PIs may be full time academics, but most are in private practice, both group and solo.

Over time, some CROs began offering additional services, such as data management, statistical analysis, consulting, protocol and final report writing, preparation and even defense of results before the Food and Drug Administration (FDA) in the U.S., the European Medicines Evaluations Agency (EMEA) and Ministry of Health and Welfare (MHW) in the recently expanded European Union and Japan.

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The largest CROs branched out even further into related areas, well beyond product development. Quintiles, based in the Research Triangle in North Carolina, for example, maintains its own global contract detail force and its own internal venture capital-like strategic investment group.

Quintiles even runs its own manufacturing and packaging facilities in Kansas City, its own central clinical laboratories in Atlanta, Scotland, South Africa, Singapore, and Argentina, and its own centralized electrocardiographic (ECG) collection/interpretation facility (called a "core laboratory") in India, manned 24/7 by board-certified cardiologists. All of these resources are devoted solely to conducting clinical trials.

Every day is different

Often a physician working for pharma will be assigned to a single product line. He or she may be involved in the initial development and approval processes for a drug or device and follow it all the way through post-marketing clinical trials even out to patent expiration.

A physician could spend an entire career on one or two compounds and their metabolites. While low, the risk does exist in traditional pharma that if a medical advisor's company merges or is acquired, or a product line is discontinued or sold to another company, the physician could be out of a job.

At a CRO, by contrast, every day is different. Over the span of his career, a CRO physician will likely be involved with the successful (and unsuccessful) evaluation and approval processes of scores of products at different stages of clinical development, for dozens of sponsors.

The largest CROs employ physicians representing a broad range of specialties, offering their clients depth of expertise in the specific disease entities their products are intended to treat. Because CROs bid against one another for business, CRO physicians are called upon to assist with bid development and to participate in the actual sales presentation (called a "bid defense") to the potential client (called a "sponsor").

Generally, at any one time the CRO physician juggles half a dozen or more compounds or devices for different companies through various stages of development, serving as an advisor to the PIs conducting the clinical trials, to the CRO staff managing the trials and to the sponsors themselves, all the while carefully monitoring the safety of volunteers receiving the experimental agents.

For every clinical development program in which he participates, the CRO physician will usually attend one or more investigator meetings where he will recap what is already known about a new compound or device, explain the research protocol in detail and field questions from the PIs who have been flown in to learn in detail about the trial they will be conducting.

As one clinical trial reaches its conclusion, new bids are being developed and defended, and new clinical trials are continually commencing. This environment provides the CRO physician with a broad range of experience in the problems unique to developing drugs and devices for his particular specialty.

Through these varied experiences, the CRO physician is generally exposed to many more opportunities to gain a comprehensive understanding of the economics of the pharmaceutical, biotechnology and medical device industries. The CRO physician may co-author a peer-reviewed journal article after overseeing a particularly significant clinical trial or provide comment on behalf of the CRO to a government agency on a proposed regulation or policy affecting the drug development and approval process.

Broad expertise

Developing such varied expertise can be tremendously satisfying for the CRO physician while making him all the more valuable to his employer. Sponsors often request advice on how best to proceed with a multi-million dollar drug or device development program in order to maximize the likelihood of approval.

CRO physicians perform these consultations routinely, researching the market, the competition, and the historical regulatory requirements for approval of similar products, consulting opinion leaders, and writing reports with recommendations on how best to develop the sponsor's product.

Sometimes this leads to the CRO physician writing a research protocol for the sponsor as well. Since a variety of new projects constantly replace completed ones and the CRO physician, like an attorney, generates income (billable hours) for his employer, job security is high for the CRO physician.

Physicians working at Quintiles share their knowledge by creating and teaching courses in their respective fields of expertise for an internal university. Quintiles physicians are enlisted, as well, to assist with curriculum development for the company's education division that offers continuing medical education to practicing physicians.

Medical officers frequently serve as advisers on due diligence teams along with business, finance, manufacturing, statistical and regulatory experts. In this role, they may spend several days on site with their team members at a biotech, drug or device company, poring through thousands of pages of its scientific, regulatory and financial records in order to determine whether the company should provide financial assistance to, invest in, or partner with the company to aid in developing or commercializing its product.

After these trips, the physicians help compile a report and present their findings to the committee that makes the final decision. Getting to see new technologies up to 10 years before they are available to the public and watching how scientific input is used in making multi-million dollar financial decisions can be heady stuff.

By Ross Tonkens, MD

Ross M. Tonkens, MD, FACP is director of medical and scientific services and global scientific head of cardiovascular therapeutics at Quintiles, Inc. in Research Triangle Park, N.C. He can be reached 919-998-2396 or [e-mail]. Tonkens thanks his colleagues, Dr. Raymond Huml, and Dr. David Frakes, for their help with this article.