Alicia Sable-Hunt, MBA, RN

Program Manager
Multiple Myeloma Research Consortium

The following is a case study on tissue banking by the Multiple Myeloma Research Consortium (MMRC), a cutting-edge research model that brings together leading academic institutions to accelerate drug development in myeloma. At the heart of this novel research model is the MMRC Tissue Bank, a state of the art biorepository that serves as the underpinning for all MMRC research and drug development efforts.

This case study follows the progress and results of the MMRC’s Tissue Bank through an interview with Alicia Sable-Hunt, MBA, RN, the MMRC’s Program Manager who oversees the Tissue Bank. FasterCures caught up with Alicia during the summer of 2006 to share some of the Tissue Bank’s successes and to offer advice to other organizations pursuing biobanking.

Why did the MMRC go into tissue banking?

Although progress has been made in recent years against multiple myeloma, an incurable cancer of the plasma cell, the disease remains uniformly fatal with few effective treatments options. The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient and Founder and CEO of the Multiple Myeloma Research Foundation (MMRF), as a new model for myeloma research and drug development that would rapidly and systematically address critical challenges slowing drug development in myeloma.

One such challenge cited by both industry and academia alike was the scarcity of high-quality tissue needed to advance research efforts. Because myeloma is an uncommon cancer, quality tissue samples were both limited in number and scattered throughout the country. Without the critical mass of tissue necessary to identify optimal genetic targets for myeloma and drugs active against these targets, new drug discoveries that offer the only hope of long-term survival for many myeloma patients remained elusive.

In response to this challenge, the MMRC developed the MMRC Tissue Bank, an advanced biorepository that integrates pre-clinical and clinical research and discovery efforts across the MMRC’s 11 Member Institutions. Located at the Mayo Clinic in Scottsdale, Ariz., and overseen by Rafael Fonseca, MD, the MMRC Tissue Bank is the only biobank of its kind that integrates myeloma tissue samples with corresponding genomic and clinical data. Now, for the first time, researchers have access to the critical mass of highly annotated tissue needed to identify druggable targets for the disease, validate novel and combination therapies for myeloma, and conduct critical correlative analyses to determine patients' responses to current and emerging therapies.

How long did it take to go from concept to an up-and-running tissue bank?

Believe it or not, it only took us seven months from concept to our first tissue transfer. We started the Consortium with four academic Member Institutions, with each institution helping to accrue patient tissue samples into the MMRF Tissue Bank. Today, the MMRC includes 11 Member Institutions in the U.S. and Canada, an expansion that has enabled the more rapid accrual of samples into the Tissue Bank.

To date, we have accrued more than 700 bone marrow aspirates and matched peripheral blood samples, with ongoing collection of tissue samples at our Member Institutions nationwide. To further accelerate accrual, we have also launched a direct-to-patient program to enable myeloma patients to donate their tissue to the MMRC Tissue Bank.

So, how does the Tissue Bank work?

Anytime a myeloma patient treated at an MMRC Member Institution has a bone marrow draw as part of his or her routine care, he or she is asked to donate an extra sample for the Tissue Bank. Every week, the MMRC sends out a kind of "report card" to each Member Institution, which tells them how many samples each site has shipped. A system was set up to allow each center to track the specimens and enter patient data in a standard fashion.

The MMRC Tissue Bank operates under very stringent standards called Good Laboratory Practices, or GLPs, and following more than 60 SOPs. Every step in the process of accruing a sample is uniform across our 11 Institutions, from how the samples are collected, to how they are shipped, to how they are stored, to how they are processed. These practices not only ensure tissue and accompanying data are of the very highest quality, but guarantee that we are always in compliance with HIPAA and other regulatory requirements.

MMRC researchers can then request tissue samples needed for research efforts.

What kind of research is the Tissue Bank supporting?

The MMRC Tissue Bank plays a pivotal role in research efforts conducted across the MMRC’s three Research Cores: Genomics, Validation, and Clinical Trials. For instance, the MMRC Tissue Bank offers researchers a way to test new drugs and to study and better understand the biology of a disease. The MMRC Tissue Bank also offers the best way of finding new targets for novel and combination drugs.

Currently underway are several pre-clinical drug screening projects and two correlative science projects that rely exclusively on the Tissue Bank. The MMRC Tissue Bank also plays a critical role in advancing the Multiple Myeloma Genomics Initiative—a three-year, multi-million dollar genome mapping program. The Initiative’s research and discovery programs hinge on the ability to study, analyze, and characterize a large number of untreated myeloma patient tissue samples in great detail and until the development of the MMRC Tissue Bank, this important research was not possible.

What were some of the biggest hurdles in starting the tissue bank?

There were a lot of hurdles in starting the MMRC Tissue Bank—defining the standards to operate, identifying the infrastructure needs, the staff, the service providers, and, of course, the budget. But like other challenges we have faced, we took an all fronts approach to each and systemically removed each barrier.

But some key hurdles that remain today are policy and regulatory-based: Research Ethics Boards and their understanding of biotissue banking; the whole issue of patient privacy and how do you ensure you comply; the decision to use the samples for which studies by which researchers.

What will be the big hurdles for biotissue banks in the next 10 years?

As tissue banking takes on a larger role in medical research, several issues will likely come to the fore. We are already facing challenges surrounding issues of patient privacy, tissue ownership, and IP protection that will likely continue to exist in the future. We have tried to anticipate any challenges relating to these issues by staying one step ahead—for instance, we de-identify samples to ensure patient privacy and address ownership issues with our Member Institutions through our contracts and Member Agreements.

How does MMRC’s experience translate into other groups?

Any disease group can do this and, as tissue banking continues to take on a more critical role in medical research, starting a bank is truly an obligate strategy for disease groups who really want to make rapid progress. This is particularly true for rare diseases where individual centers may not see enough patients to collect a critical mass of samples, and smaller drug companies often don't have the resources to find patients.

While our practices have been specific to the needs of the myeloma research community, the concept can be tailored to meet the needs of any disease group. And we truly believe that any disease group needing high-quality, highly characterized patient tissue samples can use this model.

What is your advice to other groups who want to start up a tissue bank?

Successful tissue banking is highly dependent on both a strong scientific plan and strong business plan and patient advocacy groups that can help with the accrual are essential. It must be collaborative to truly succeed; there are many different groups and institutions trying to launch their own individual tissue banks, but partnering to create the critical mass is essential. You have to be committed; this cannot be done part-time. You must have the financial and human resources, and the full support of the business and academic community.