Report for OBBR Hosted Workshop on Biospecimen Reference Sets and Drug-Diagnostic Codevelopment Now Available

The development of FDA-approved assays, drugs, and devices for the diagnosis and treatment of cancer is frequently hindered by the lack of access to standardized sets of high-quality well-annotated biospecimens. The codevelopment of drugs and their companion diagnostics faces additional scientific and regulatory hurdles. On January 21, 2011, OBBR convened a small group of experts from the biospecimen research and biobanking communities, the FDA and NCI, and the diagnostics and pharmaceutical industries to address unmet needs related to the acquisition and use of high- quality biospecimens. Questions focused on technical, business, and regulatory bottlenecks resulting from insufficient biospecimen-based reference sets, and were addressed in moderated discussions guided a series of key questions along with several short presentations from some of the participants. Information learned from this workshop will allow caHUB to understand the role that biobanks play in the field of drug- diagnostic codevelopment, and will prepare caHUB to provide high-quality biospecimens to aid navigation through the codevelopment pipeline.

A summary report from the workshop is available here.

Furthermore, the following presentations were given during the workshop:

1. The Cancer HUman Biobank (caHUB) - Carolyn C. Compton M.D., Ph.D. - Office of Biorepositories and Biospecimen Research
2. Perspectives From An Industry Pathologist - Myla Lai-Goldman M.D. - Personalized Science, LLC
3. Roche Sample Needs in Oncology Research - Diane Leong Ph.D. - Genentech
4. The Importance of High Quality, Appropriately-annotated Specimens in the Development, Registration and Commercialization of Candidate Drugs and Diagnostics: Observations from the Perspective of a Pharmaceutical Sponsor and Government Consultant - John C Bloom, VMD, PhD - Bloom Consulting Services, LLC
5. Biospecimens & Companion Diagnostics: FDA Perspective - Reena Philip, PhD - OIVD/CDRH, Food and Drug Administration
6. Tissue Collection Challenges in Co-Development Clinical Trials - Eric Walk, MD PCAP - Ventana Medical Systems/Roche Tissue Diagnostics
7. Real-World Rx-CDx Learnings - David M Jackson PhD - QIAGEN Manchester

If you have further questions, please contact Dr. David Litwack (david.litwack@nih.gov)