Recently our co-founders, Diana Caldwell and Gretchen Bowker were interviewed by Heidi Muller for the fall Lilly alum network newsletter which was published and distributed in early December 2010. To read full article, click here and be sure to go to page 4 for the feature article. And all you Lilly alum out there following us, update your profile and sign up at www.lillyalumni.com . Some of our most valued clients, employees, partners, and contacts are from the Lilly network.
Key excerpts:
“As the gatekeepers of all clinical trials in the United States, institutional review boards (IRBs) make critical decisions that affect hundreds of potential medicines every year. IRBs traditionally have been the purview of hospitals and universities, where boards are staffed by volunteers who meet monthly to review submitted protocols. But as backlogs build, and as sponsor firms and the contract research organizations who serve them are looking for ways to minimize delays, commercial IRBs are receiving increased attention as an option for clinical protocol review……..
A key component of Pearl’s strategy is to provide clients with a reliable timetable for reviews. The board meets every Thursday and issues a decision the week after the protocol is submitted. “And if we don’t approve an application, we make sure our clients know the reasons, so they can address the issues. Good communication and transparency are critical,” Bowker says, “because our ultimate goal is to help companies make progress for the benefit of patients.”
Another advantage Caldwell sees to an independent IRB is the ability to centralize protocol review. “You may have 400 sites in and outside the U.S., which can be a nightmare to manage,” Caldwell says. “With us, you can get it all done at one time, and if anything needs to be changed, it’s easier to fix it from one central location.”
Bowker adds that this view recently received support from Dr. Jerry Menikoff, director of OHRP, in the October 21, 2010 issue of the New England Journal of Medicine. In his article, “The Paradoxical Problem with Multiple-IRB Review,” Menikoff says, “In terms of protocol review, the current system whereby multiple IRBs review a multi-site study leads to a diffusion of responsibility and reduces the likelihood that appropriate changes will be made to protocols.”……
Reflecting on the activity and accomplishments of the past 18 months, Caldwell says, “Running a company is difficult but extremely rewarding. And I think often about how much the mentors, the training, and the experiences I had at Lilly contributed to my ability and desire to start this company with Gretchen.”
Bowker agrees that being an entrepreneur is demanding. “It’s been a lot more work than I envisioned, but it’s nice to control your own vision and where you’re going. I have really been impressed with the support we’ve received in establishing Pearl IRB—and a lot of that support has come from other Lilly alumni.”