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

Physician Executive, Jan-Feb, 2005 by Ross Tonkens

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.