Thursday, July 7, 2011

How should your biorepository function to enable better drug development?

The design of your sample acquisition and research protocols, and their approval by the IRBs overseeing your access to patients and specimens, must be a focal point of your attention if your biorepository is to function smoothly and enable new drug development.

Ideally your protocols would give you the greatest possible latitude in sample storage and research methods, but in practice some IRB stipulations may get in the way of your normal operational procedures: they may insist that, upon a patient withdrawing their informed consent, you locate and destroy all samples from that patient within 7 days, which could prove to be operationally impossible without extensive and costly outsourcing. Sometimes IRBs may even overrule the wishes of the patients themselves, by placing firm boundaries on the research applications allowed on specimen types. Further complicating the issue is that no two IRBs have exactly the same criteria—and these differences grow even more pronounced when you are attempting to acquire and work on samples from international sources.

If, despite your best efforts at setting up protocols that are as research-friendly as possible, your IRB still insists on a more strict interpretation, you may have to resort to calling in outside experts to appear before the IRB or write letters to it on your behalf in order to explain the validity and urgency of your work.

At Biorepositories 2011, you can learn the best methods for managing and tracking the informed consent status of your samples. There will also be an opportunity learn to plan for the strategic use of outside experts to argue on behalf of your research protocols before the IRB. For more information on the event, which will be taking place as a part of the Clinical Business Expo, download the brochure here.

Exclusive Savings! Our Future BioPharma readers can receive an additional 10% off the current early bird pricing expiring tomorrow, July 8. That’s a savings of up to $600 off the standard registration rate. To redeem, register here. Be sure to include Priority Code XP1698BLDI to receive the discount. This offer expires tomorrow so register early. If you have any questions about the agenda or event, please contact Jennifer Pereira at

Are you writing your research protocols and interacting with your Institutional Review Boards correctly in order to secure the greatest possible amount of exploratory freedom in your research?

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