News And Notes From The Leaders In Biobanking Congress 2017

By Bio-IT World Staff

November 1, 2017 | “I feel this is such a great group of people from both academic and private practice settings, as well as pharma and diagnostics companies, and everyone in between,” Michael Roehrl, Director of the Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center and speaker at the 9^th annual Leaders in Biobanking Congress, told the assembly in Nashville, Tennessee last week. “It’s rare to have these kinds of meetings. Usually you have institutional meetings or industry meetings, but not much else.”

The conference featured lectures from prominent experts in the field of diagnostics and biobanking, and included discussions on topics of clinical research and precision medicine, which often go hand in hand. Here are just a few highlights from the program:

The bench-to-bedside view of medicine is flipping, said Michael Tanen, Director of Clinical Biomarker Specimen Management at Merck, in a bedside-to-bench direction. The patient’s data reveals what works in drug discovery, and what doesn’t work. It’s essential. In fact, Tanen argued, patient biospecimens may be the most important part of drug discovery. I don’t want to take away from the patients, Tanen said, they are almost as important as their samples! But the samples are valuable, varied, and—in some cases—very limited. Tanen argued that in focusing on only patient and data safety, risk-based monitoring is neglecting the crucial safety and management of biospecimens. Of the 141 Key Risk Indicators in TransCelerate’s Risk Indicator Library (opens XLS file), none are connected to biospecimens. On the group’s Risk Assessment and Categorization Tool (RACT, opens XLS file), only 5 of 65 questions is devoted to samples. Tanan issued a challenge to the clinical trial community: take specimen safety and management much more seriously.

Sarah Gray joined the Leaders in Biobanking Congress with an emotional plea to better connect biobank donors with the research they enable. Gray’s twin pregnancy took an unexpected turn when one of her identical twin boys was born with anencephaly. Although little Thomas was too small to serve as an organ donor, the Grays discovered that after his death, his tissues could be donated for research. But while organ donors often learn what happened to their loved ones’ donated organs, the same doesn’t happen for research donations. Gray set out to track her son’s donations, and was encouraged by the medical research his donation was enabling at the University of Pennsylvania, Duke University, and Harvard. His retinas, for instance, were donated to the University of Pennsylvania’s Genetics Diagnostics lab where Arupa Ganguly told Gray she had waited six years for such a specimen in her retinoblastoma research. Gray’s book, A Life Everlasting: The Extraordinary Story of One Boy’s Gift to Medical Science, recounts her family’s experiences.

At the Kaiser Permanente Research Bank, Executive Director Nazneen Aziz is working to build a cohort of 500,000 individuals in the Research Bank. Of those 500,000—half of the initial national goal as part of the All Of Us program—25,000 will be pregnant donors and 30,000 should be newly diagnosed with cancer. Another emphasis, Aziz said, is to build a biobank the reflects the diversity of the Kaiser Permanente family. At least 22% of samples should be from minority populations, she said. Already the pool is 21% minority, and Aziz doesn’t plan on stopping. Enrollment for the project is slated to be over in March 2018. But along with sample collection, Aziz is planning an ambitious survey of Kaiser Permanente members and healthcare providers. We want to understand the barriers and facilitators of precision medicine, she said. How ready are KP physicians to handle genomics and precision medicine? What are the expectations around returning results? What infrastructure is needed to do so? Aziz already sees some of the challenges. Just getting permissions and approvals to conduct the survey proved challenging, she said.

Biobanking is only one of the pillars enabling pathologists to do what we want to do, Michael Roehrl, Director of the Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center, told those in attendance. “A lot of the things we’re doing [at this conference] in terms of biobanking and the science that goes around using human specimens is very intimately related to understanding human disease better, and ultimately trying to find better drugs.” Roehrl discussed the new and existing technologies within Memorial Sloan Kettering’s Precision Pathology Center. The Center collects samples from over 8,000 patients from surgeries and clinical trials, and Roehrl was quick to mention that one area where they can be much stronger is in data handling. “In current state of the art 2017 clinical trials you wouldn’t believe how few trials there are that actually get samples on-treatment,” he said. The Memorial Sloan Kettering Cancer Center is trying to change that. We want the Center to be our hub for specimen-centered precision clinical trials, Roehrl said.

When is clinical research a clinical application of a biospecimen? This was a question posed by Mary Edgerton, Associate Professor in the Department of Pathology at the University of Texas MD Anderson Cancer Center. Mislabeled samples from a biobank are bad enough, but when those samples are used for treatment it can be catastrophic for the patient. This is where Clinical Laboratory Improvements Amendment (CLIA) compliance is key, Edgerton said. CLIA compliance is required for tissue samples that may impact patient therapy, making it mandatory for every pathology lab. Using recent events with the MD Anderson Institutional Tissue Bank, as well as 23andMe’s approval by the FDA earlier this year, Edgerton laid out the scenarios where CLIA compliance is necessary. Are these results that will be returned to a patient that might affect their choice of a therapy now or in the future? is the question pathologists should be asking themselves, she said.

James Cerhan, Professor of Epidemiology at the Mayo Clinic College of Medicine and Science, Health Sciences Research, Mayo Clinic, discussed the building and facilitation of the Mayo Clinic Biobank, a collection of samples, including blood and blood derivatives, and health information donated by Mayo Clinic patients. Launched in 2009 the biobank is a resource for ongoing health research in general, and is not a disease biobank. As of now, the Mayo Clinic has enrolled over 57,000 patients for the biobank with banked DNA, serum/plasma, questionnaire data, and prospective access to the electronic health record. About 40% of those samples coming from local patients who get treatment at the Mayo Clinic in Rochester, Minnesota, Cerhan said. “It’s not a population-based sample,” he said. “It is a biobank. And it’s full of people who want to participate.” Suzette Bielinski, also a Professor of Epidemiology at the Mayo Clinic College of Medicine and Science, Health Sciences Research, Mayo Clinic, then discussed the biobank from the perspective of a user. Focusing on pharmacogenomics, Bielinski was able to recruit over 11,000 patients from the biobank in order to conduct a study that prospectively assessed the effect of pharmacogenetic data in the electronic health records. She also showed results from clinical survey and patient focus groups that show a high level of enthusiasm among patients for pharmacogenomics. In fact, 91% of those surveyed agreed that they would be more likely to be adherent to their medication if pharmacogenomics was used to select them.