Oncology? Limiting? Not in the least. That’s what Tom Ludlam says. He’s CEO of the Columbus, Ohio-based contract research organization (CRO) Prologue, which only conducts cancer trials. The company has more work than it can shake a stick at. 

“There is certainly plenty of opportunity,” Ludlam says.

That’s putting it mildly. According to the publication R&D Directions, more than one-third (561) of the 1,443 drugs in development in 2006 were for oncology. And the consulting firm IMS Health recently put out a report indicating that the global drug development market is slated to grow 5 to 6 percent to $745 billion in 2008, when the oncology class is expected to grow by 21 percent.

Prologue, though small, has been getting its share of that. The company has done 108 trials during the company’s 10-year existence, and is currently working on 43. Revenues, which are undisclosed, have grown by an average of 35 percent annually over the past three years. By 2010, Ludlams says he expects those revenues to double, and the number of employees—now 80—to spike.

Ludlam of Prologue

Lots of Players

There are plenty of CROs chasing the cancer contracts. Many of the big ones have of late established oncology divisions, and lots of small oncology-oriented CROs are popping up. To name a few, there’s Medelis of Phoenix, Arizona; Nexus Oncology of Edinburgh, Scotland; Beardsworth of Flemington, New Jersey; and Onyx Oncology of Minneapolis, Minnesota.

What sets Prologue apart? “Expertise,” asserts Ludlam. In contrast to many of the company’s competitors, he says, everyone at Prologue, from biostatisticians to data managers, has a background in oncology. The company was spun off from the Ohio State University’s James Cancer Center/Solove Research Center, with an initial line of credit from the University. Several of the center’s employees left to join Prologue when it was launched.

Brain Trust

Right after that, Adria Laboratories, a then-local oncology-focused drug maker, was purchased by Pharmacia & Upjohn and moved to Kalamazoo, Michigan. Many of Adria’s employees were snapped up by Prologue.

From there, no more lines of credit were needed. The work started flowing and never stopped; all operations since have been funded from income. And all the while, Prologue has kept its very strict hiring procedures: personnel have to have several years of experience in oncology. No entry-level newbies allowed.

Complicated, Delicate

Why? Because, says Ludlam, oncology is a particularly delicate and complicated area.

“Most CROs build an infrastructure to handle clinical research and the theory is that the underlying mechanisms [of different therapeutic areas] are similar—that a clinical trial is a clinical trial is a clinical trial,” says Ludlam. “Prologue was founded with a view that oncology is a very different therapeutic category. We view oncology as being much more intensively dependent on clinical expertise.”

Ill Populations

Typically, he explained, oncology researchers deal with ill patients from Phase I forward, as opposed to healthy volunteers. This puts a lot more demand on clinical knowledge and experience than other areas, he says.

Additionally, drug regimens in oncology trials are often very complicated. Not atypical is a breast cancer trial with four different types of treatments, some chemotherapy-based and others biologically based, Ludlam said. And then there are often substantial adverse events in cancer trials.

All of this adds up to make oncology trials intricate undertakings.

Ohio Only

Though Prologue has employees in 16 states, it only has one office: its Columbus headquarters. And nothing overseas. That will change soon, though, says Ludlam. He expects Prologue to establish a presence abroad within six to 12 months, probably in Europe. At the same time, the company will look for collaborative relationships with companies that have a presence in places like India and South America. 

When a sponsor requests a specific electronic data capture (EDC) vendor, Prologue will collaborate with it. That happens about half the time. For the other trials, the company sticks to paper for data management. Prior to last year, it used a home-grown, fax-based clinical trial management system. Some sponsors didn’t like the lack of standardization, so two years ago, Prologue purchased Oracle Clinical software for data management of paper. The company has no in-house EDC option.

Room for Everyone

Prologue’s clients for 2007 lined up like this: 25 percent large pharma; 45 percent mid-sized biotech and pharma; and 30 percent small biotech and small pharma.

Even though more oncology-centric CROs seem to be entering the market all the time, and large CROs continue to develop their cancer programs, Ludlam isn’t nervous. That’s because the amount of work to be done still far exceeds the amount of players jockeying for it. 

“Oncology doesn’t just refer to one disease—it’s hundreds of diseases with thousands of different options for potential treatment,” Ludlam says.  “The competition has heated up in the last couple of years, and will continue to, but the market is big enough to accommodate a lot of people.”

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