March 17, 2006
CTI importing business from overseas biotech companies
Firms seek consulting service as products developed for U.S.
CINCINNATI BUSINESS COURIER - MARCH 17, 2006
BY James Ritchie
CTI Clinical Trial & Consulting Services has been developing a market niche without trying.
The seven-year-old contract research and consulting firm in Blue Ash has had a traditional client base of small and large firms, including six of the world's 10 biggest pharmaceutical companies. But in the last 18 months it has had an influx of eight or nine small foreign biotech companies seeking consulting services as they develop product candidates for the U.S. market.
They've come from Japan, Canada, Germany, Israel, France and the United Kingdom and have mostly had early-stage candidates, two-to-six years from U.S. Food and Drug Administration approval.
"The regulatory structure in the U.S. still is pretty much the gold standard," CEO Tim Schroeder said, "so if you do studies that get you approved in the U.S., likely those studies would get you approved in other places."
He said the companies have come to his privately held firm, with 65 full-time employees, largely through word of mouth. CTI typically works with up to three dozen companies at any given time and focuses on areas related to the critically ill, such as organ transplants. The firm has worked with four U.S.-based biotech firms.
Schroeder said an improved world economy and a growing awareness of the opportunities in biotech seem to be creating more venture capital availability outside the United States.
"We review the technology, review any data they've gathered and put forward a plan on how to expedite it and clear all of the hurdles" to get FDA approval, he said.
When companies need to conduct studies, he hopes they will use CTI's contract research arm to design and carry them out.
The former University of Cincinnati professor would not release revenues for CTI, which he started with money from exercised stock options after leaving SangStat Medical Corp. in California. He anticipates 40 percent growth in 2006, continuing several years of double-digit increases. He said CTI has seen profit since its first year.
Ritchie covers health care for the Courier. To reach him, call (513) 337-9442 or e-mail email@example.com.