Tuesday, September 10, 2013

Biorepositories 2013 Conference Preview: An Interview with Philip Branton, M.D., FCAP

About the author: My name is Alex Gelman and I’m deeply interested in the biorepository industry. I’m the Managing Partner of Poplar Partners, an investment firm looking to acquire a company in the biorepository space. Before founding Poplar Partners, I worked at KKR Capstone and before that at McKinsey &Co. I have an MBA from the Stanford Graduate School of Business and a BA from Dartmouth College.

6th Annual BioRepository and Sample Management Conference Preview:
An Interview with Philip Branton, M.D., FCAP

By: Alex Gelman
September 10, 2013

Ahead of the 6th Annual Biorepository and Sample Management Conference in Boston in two weeks, I sat down with some of the leading minds in the industry to get their take on this fast-moving field. Below are edited excerpts from our interview with Dr. Philip Branton, a consulting pathologist at the National Cancer Institute’s Office of Biorepositories and Biospecimen Research and Fellow of the College of American Pathologist (CAP). Dr. Branton is currently Vice Chair of the CAP Biorepository Accreditation Committee and Chair of its Surgical Pathology Committee. Dr. Branton told us his views on the changing industry, gave us a preview of his talk on CAP’s accreditation program for biorepositories, and walked us through the challenges that all biorepositories will face in the coming years.

Us: Dr. Branton, the College for American Pathologists has recently launched its biorepository accreditation program. However, not all biorepositories are created equally. What counts as a biorepository for the CAP’s accreditation program?

Dr. Branton: A biorepository is defined as an entity that receives, stores, processes, and/or disseminates biospecimens, their derivatives, and relevant data, as needed. For purposes of CAP accreditation, a biorepository encompasses the physical location as well as the full range of activities associated with its operation. Biospecimens are tissue, blood, or serum samples that are taken from a living creature. In isolation, it is simply a specimen bank - it can be genetic material or breast cancer tissues. There are different types of biorepositories. Some are simply repositories – they check a sample in, hold it, and check it out. There are some that are much more complex that may collect and preserve specimens fresh from the operating room. There are lots of combinations and permutations in between. There is no “one size fits all” definition for biorepository.

Us: Does CAP’s accreditation program focus on a certain type of biorepository?
Dr. Branton: The program is applicable to those facilities that store biospecimens for research. The program is not applicable to tissues being stored for transplant purposes; however, the CAP Laboratory Accreditation Program does inspect the storage of transplant tissues when they are under the purview of the laboratory director. Before the CAP accredits any biorepository, they need to fill out questionnaire that has questions like, “what kind of specimens they receive”, “how they process them”, “do they do histology on site”, and “do they have a pathologist on site”. These are all things we need to know before we send an inspection team.

Us: So how would you compare a for profit cord blood bank to a university affiliated cancer cell bank?
Dr. Branton: We don’t compare or rank them. The CAP, in conjunction with other entities, has drawn up lists of standards. We evaluate biobanks against what they represent themselves as doing. We operate on a checklist model. We’ve been accrediting hospital medical laboratories for more than 50 years. For the biorepository accreditation program, we are utilizing a similar model. There are agreed upon standards of care for a given service and we test to see if they meet those standards. Depending on the level of services the biorepository provides, the check list can be very long or it can be relatively short.

Us: So you’ve seen dozens if not hundreds of biorepositories. What are the biggest challenges facing the biorepository industry today?
Dr. Branton: That is a complex question with a somewhat complex answer. Not all biospecimens are the same. Learning how to collect biospecimens under the right conditions at the right time is the biggest problem. The rise of molecular testing and personalized medicine has changed the rules of game. Bioscientists need to figure out the optimal times when a specific biospecimen needs to be collected. This is biggest challenge facing biospecimen collection, and by extension biorepositories. Even though biorepositories may not remove a specimen, they need to annotate it and they need to know when the specimen was removed from the patient and did the specimen sit out on counter for 30 minutes.

Us: Conversely, what is the biggest opportunity for the biorepository industry?
Dr. Branton: Thousands of biorepositories exist, varying in size, nature of collections, specimen types, purpose, quality, and age.

We can develop easy-to-use information technology (IT) interfaces that can reliably provide annotated specimens to the research community. One thing that’s become evident to me is that robust IT is critical.

Further, recently there has been a realization that some biorepositories do not fulfill research requirements (most importantly personalized medicine); a high degree of heterogeneity exists in the methods used to collect, process, and store biospecimens. Excellence and quality measures in biorepositories are interrelated concerns that have a direct bearing on research that can help advance health care.

Us: There will be a lot of folks at the conference that are debating whether they should outsource or build a biorepository. How should a biorepository make the buy/build decision?
Dr. Branton: They need to figure out where they need to be in 5-10 years. The decision is so incredibly complex. There are very few institutions that can do it all on their own. Public/private partnerships can often be very helpful. One model going forward can be large hospitals partnering with large laboratory organizations. The industry can provide the infrastructure and IT support and the universities can supply professional expertise.

Us: Thank you so much for your time, Doctor!
Dr. Branton: Thank you and see you in Boston.

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