Lab Assistant

When Shawn Blackburn started writing computer code as an eighth grader in Minnesota, his goal was to create a hockey game, which he never finished.

"I was easily distracted," the 45-year-old Downingtown resident said.

He has not changed much, which makes him the perfect start-up partner, said Jaime Cook, cofounder with Blackburn of Y-Prime Inc., a Malvern company formed in 2006 to provide clinical-trial-management products and services for the pharmaceutical and biotech industries.

Chief executive officer Blackburn no sooner helps launch a new product or land a new client and he's looking for the next "something shiny," said Cook, 42, of Phoenixville. As Y-Prime's executive vice president, Cook said, he is "the detail guy."

The result is a cutting-edge contract research organization (CRO) with nearly $10 million in revenue, 65 employees, and 56 clients that no longer thinks in terms of if it survives.

"We can see the light at the end of the tunnel," said Blackburn, whose company is a sponsor of the Pennsylvania pavilion at the 2015 Bio International conference, which will end Thursday at the Convention Center.

"They definitely have a leg up on their competition because they were in the game much earlier," said Christopher Molineaux, president and CEO of Pennsylvania BIO, a trade association for the life-sciences industry.

Y-Prime - a name chosen because "it's a derivative of normal," Blackburn said - started as a leap of faith that clinical-trial-management outsourcing would become the industry standard it has as companies look to reduce costly overhead and risks associated with research and development.

Blackburn and Cook had been working in the clinical-research department at Cephalon, the Fraser-based drugmaker bought by Teva Pharmaceuticals in 2011, when a former employer, a software firm, asked Cook to help with a large systems upgrade for Merck & Co.

Blackburn and Cook left Cephalon to update Merck's clinical-trial-management system. The seed for Y-Prime was sown.

"We were going out on a limb," Cook said. "But we were young. Probably cocky, too."

Soon after, Cephalon was asking Blackburn and Cook to do similar work. For that, Y-Prime made its first hire: Cook's wife, Lillian. By its third year, Y-Prime had 20 employees.

Initially, customers were seeking consulting services, such as supplemental database programming and building performance and metric reports. By 2010, Y-Prime's advisory board was pressing the company to pivot to product creation for better profit margins.

Y-Prime has four products on the market, including an interactive-voice or interactive-Web response system that enables doctors to determine which drugs to give patients and track drug supply, and a system that allows patients to enter by phone or tablet their experiences with the drugs they take.

A vast overseas migration of such work was originally feared. Instead, many U.S.-based R&D companies like Y-Prime have emerged, Molineaux said. More than 700 were created in Pennsylvania alone from 2008 to 2013, he said.

Should outsourcing of such sensitive work raise concerns about its integrity? No, said Molineaux and other industry experts.

"These companies pride themselves, and build their reputations and their businesses, on being objective while providing this critical service," he said. "As important, the sponsor companies have an incentive to use objective CROs because it allows them to fully understand the potential, or lack of potential, of their product. The companies want to succeed fast or fail fast and minimize their spending."

Because of quality-control measures typically in place, data integrity does not differ significantly between in-house clinical trials and outsourced work, said J. Kevin Buchi, president and CEO of TetraLogic Pharmaceuticals Corp. in Malvern. The 11-year-old start-up with 30 employees has three clinical trials underway, one - a lymphoma study - handled by Y-Prime.

"The bigger issue with using CROs generally tends to be timeliness and responsiveness," said Buchi, former chief executive of Cephalon. "A CRO will have many clients, and there is always a risk that you don't get the best team within the CRO or that another company project is given a higher priority."

It's a chance that small biopharma companies, in particular, have to take, he said.

"Smaller pharma can't justify the costs to handle these kinds of tests," Buchi said. "The logistics associated with it can be quite daunting. If you've got a good vendor, you're often better off."

215-854-2466 @dmastrull