Experts share tips for developing drugs using a virtual model
ORLANDO - These days, the whole notion of lean and mean in biotechnology has been getting a thorough review. With drug development costs running at a premium, building a drug development company on a parsimonious budget has become a high priority among investors backing start-ups. And I got a chance to hear about some of the best strategies to do just that at the Partnerships in Clinical Trials conference in Orlando last week, where I moderated a panel discussion on the virtual biotech model.
Virtual biotechs operated by small staffs have to outsource important tasks. One of the main focuses of the discussion centered on the company's relationship with the CRO in charge of early and mid-stage trials.
"Get the team right," said Solomon Babani, the senior director of outsourcing and vendor management at Celtic Pharma Development Services. When you pick a CRO, he added, it's more than just a financial arrangement. The success of the trial will depend heavily on the team that the CRO selects to manage the work.
Stephen Porter, chairman and CEO of VDDI Pharmaceuticals, which specializes in virtual drug development, agreed, adding that the project leader is the most important player in the bunch. "Those are the guys that make a successful team," he told the audience.
CROs, meanwhile, need to understand that when they're working with a small developer, they need to be particularly thrifty. It doesn't make any sense to get entire teams on a single conference call that can run up a $10,000 bill. "The CRO has to offer virtual drug developers plenty of transparency on how they make a decision," said Kevin Pojasek, executive director, development projects leader at Satori Pharmaceuticals.
If you're working with a niche CRO, added Porter, you need to be acutely aware of just how well respected they are "up the food chain" of drug development, among the big pharma companies that are most likely to be interested in a licensing pact.
There was considerable agreement on the panel on the balancing act that is required in managing the CRO relationship. The days of command and control are over. You need to trust the CRO well enough to let them do the day-to-day work that's necessary to advance a program, and expect them to perform without a lot of micromanagement.
"You want someone who can anticipate every need," insisted Porter, who compared the job of the CRO to "Radar" O'Reilly on the old TV show M*A*S*H, who often responded to a command before it was given.
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