Conscious Commercialization and Agile Biobanking

A Three Part Series in Biobank Business Planning
By Lisa B Miranda, President and Chief Executive Officer, Biobusiness Consulting Incorporated
 
Part I:

Forward-looking market statements tout biobanking as a burgeoning and bountiful global market. For example, the company Vision Gain published in September 2014 that “the biobank world market will reach $22.7 billion in 2018.  In particular, rising demand for biobanked samples for use by pharmaceutical companies in preclinical research stimulates that market.” Despite the potential business opportunity for biobank growth and market expansion, economic viability remains a prevalent pressing issue for biobanks globally.  

So, why aren’t all biobanks thriving if the market earning potential is there? Well, that is a longer conversation. However, the short answer, based on my expertise, is that the biobanks who are thriving are doing so because they are readily implementing key business success factors into daily practice.   

Based on a review of sustainability case studies I conducted last fall, the first of these critical success factors is the recognition that sustainability is a legitimate imminent financial concern. No one is immune. Longevity is not necessarily an indicator of sustainability. It’s not unreasonable to say this because in today’s economic climate, we observe both notable well established as well as new biobanks dealing with sustainability issues. As John F. Kennedy said, “Change is the law of life and those who look only to the past or present are certain to miss the future."  

Once you recognize that sustainability is crucial, time is off the essence. Proactive strategic planning is imperative and should follow the same logic as beginning your retirement planning: it’s never too early. The sooner you make a financial roadmap, the better. 

In fact, in some cases new biobanks may be able to be more agile and adaptive in this regard, since their business model and infrastructure may not be predetermined and thereby malleable. This is particularly true for implementation of a cost recovery model.  As many Biobank Directors will convey it can be problematic to successfully recover costs for a sample, product and/or service if it was historically provided free of charge. It also can be more difficult to identify and understand cost components later. In an economic survey of over 100 biobanks last year conducted for a client we found this to be true. Web based applications (e.g. US NIH/NCI BBRB biobank economic modeling tool (the BEMT) and CTRNET user fee calculator) can be useful tools for positive steps towards developing an informed model for cost recovery. 

Driving culture change around financial planning can be crucially expedited by securing organizational support and commitment to devote resources towards evaluating the need to do things more sustainably. This can often be a catch-22 situation however as one often needs to show a reasonable business plan, market value and/or a path to impact to garner unwavering support. The work is worth it though as biobanks with organizations that support a culture of change towards cost recovery and sustainable development typically experience compounded success in this area. 

I can relay happily that this is a valid observation from my past life as a Core Facility Director.  I also see this frequently firsthand with the organizations I work with, both public and private.  These issues are not necessarily sector-specific - they merely present differently. My first attempt at a business plan in Academia for my bioresource required a second revision, but it was well worth the time. And looking back dozens of business plans later, I try to use those lessons learned with clients in real time. And as Mark Sanborn so wisely said, "Your success in life isn't based on your ability to simply change. It is based on your ability to change faster than your competition, customers and business."  

Tune in June 30th for part two of the series when we discuss how  “conscious commercialization” is another critical factor for success in business planning.

About the Author:
Lisa Miranda is President & Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory with global reach based in the Greater Boston Area. She has 25 years of experience, complimented with 14 years of higher education including nine years of graduate study at the University of Pennsylvania. She began her career in clinical care and community based research and then moved to clinical and epidemiology research. She spent over 14 years in research at the University of Pennsylvania conducting clinical and investigator initiated trials to bring new drugs and clinical therapies to market, testing and helping develop emerging medical/surgical technologies, diagnostic devices and evaluating novel biotechniques. In 2005 she launched and directed her first core facility a biospecimen resource for UPENN called TTAB. Recruited for her first consulting job in 2007 as a contractor for the United States National Institutes of Health, National Cancer Institute’s Biorepositories and Biospecimens Research Branch (BBRB), she expanded her consulting practice full time in 2008. Known worldwide as a biobanking and clinical research subject matter expert, much of her work focuses on biobank business planning, strategic development of biospecimen research applications and biotechnology commercialization. Prior biobanking and biotechnology commercialization. Executive positions have included Vice President, Strategy and Business Development for MEMS based Biotechnology Company Bluechiip, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers, and Technical Director, Tumor Tissue and Biospecimen Bank Core Facility, UPENN). For more information email Lisa: lisabmiranda@biobusinessconsulting.com or download her 2014 podcast on the future of biobanking.

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Top Three Biobanking Challenges Today

The Memorial Sloan Kettering Center is known as the premier cancer research institute in the world.  Needless to say, their research team is well acquainted with some of the challenges the biobanking industry currently faces today.  Who better to provide the latest on the challenges in the field than Vinagolu Rajasekhar, a Senior Research Scientist working on live tissue banking with the Memorial Sloan Kettering Cancer Center and a speaker at this year’s Biorepositories and Sample Management Conference.  He filled us in on what he sees as the three biggest hurdles in the industry today as well as a couple of other minor obstacles. 

What are some of the challenges that you’re experiencing in your industry today?

Raj: I am glad that you brought up this very important point of the present context regarding functional biospecimens and biorepositories. In fact, this is not only the challenge that we face but it is also a challenge for all those striving to succeed in clinical translation studies all over the world.  Particularly as a team member of the Memorial Sloan-Kettering Cancer Center, which you all know as the world premier cancer research institute and also the cancer clinic, my perspective to this query is different from what one may normally expect from industries.

Developing durable and functional therapies against human cancers is the prime challenge for all of us. This is very difficult task to accomplish unless we have set up faithful pre-clinical experimental models that closely mimic that of real time patients’ situations.

Human tumors are generally composed of heterogeneous tissues, I mean multiple cell types within a single tumor mass.  So, it becomes important to comprehend well with the science behind the biospecimens we obtain. Present cancer cell line models and also genetically engineered mouse tumor models would never recapitulate the original patient tumor heterogeneity that we all have to deal with during the real time treatment situations. Particularly, as a Working Group Member of Biospecimen Science in the International Society for Biological and Environmental Repositories (ISBER), and also collaborating with Dr. Fay Betsou at the Integrated Biobank of Luxembourg (IBBL), I must also bring to the light that the most cancer therapeutics developed to date all over the world have also relied on the data obtained from conventional bio-repositories of flash frozen bulk tumor specimens, which might not represent the real time clinical situations.

First, human tumors are also dynamic organs.  Thus, they manifest variability in their tissue heterogeneity during cancer development within an organ. These also add up to inter- and intra- tumor heterogeneities among different foci of the same cancer within the same organ and within the same tumor lesion across the radius or from the center to the margins of the tumor. Therefore, flash frozen tissues are not harmonized specimens.  Studies based on these biospecimens would not reflect the real time patient situation. We are increasingly convinced of the significance of patient specific treatments for cancers from our personal experience with the laboratory bench and at the patient bedside.

Second, the conventional biorepositories are exhaustible and cannot be replenished. So now the prime challenge is to aim at developing live tumor banks that are continuously available, which is a sort of renewable or replenishable as harmonized biospecimens.

Towards this goal, I and Dr. John Healey, the Chief of Orthopedic Surgical Oncology are together developing various live banks of human tumors as viable biorepositories. These live bio-repositories are nothing but patient derived xenograft (PDX) models of human cancers. Here upon our internal review board approved consenting of the cancer patients, we utilize their surgically resected tumor specimens. We transplant the fresh tumor specimens into immunocompromised rodents (mice for example) and follow the development of tumor growth.

Essentially, here patient tumor tissues are transplanted into the mice whose immune system is genetically shut down to facilitate the tumor take-in, and the growth of PDX as clinically relevant experimental models. This approach will facilitate us conveniently harvest sufficient tumor volumes and functionally characterize these tumors at different developmental stages in vivo and in the laboratories. These PDX models would, on the other hand, generate the original patient tumor-specific heterogeneity in real time comparable to that of patient situation. Thus, these models form clinically relevant experimental models for carrying out functional pre-clinical studies. For example, any drugs we identify by screening for the sensitive compounds that affect the growth of the at least early PDX models are expected to be functional in the real patient tumor microenvironment.

Finally, this live biobanking approach can be also utilized in co-clinical trials in terminally ill patients as well as for sharing among different clinical research groups worldwide for facilitating simultaneous global collaborations with relevant tumor types.

In this process, we also encounter some minor technical challenges as well.

For example:  

1. Isolating cells from human tumors present more complex hurdles than that of from the so far relied mouse tumors.  

2. Each organ human tumor type is different from the other organ tumors within the same patient. For instance, the tissue of human brain tumor cannot be the same as another human breast tumor or a liver tumor. So, even to disassociate and extract these cells in functional from, we need to have sound experimental skills and intellectual expertise and a few others of minor importance that we can deal another time.

You can download the full interview with Vinagolu here.

You can hear more from Vinagolu as well as other leaders in the biobanking at the Biorepositories and Sample Management Conference.  Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1998BLOG.

SEE ALSO: FREE WEBINAR- Optimizing Samples for Future Use: Innovative technology to improve the functional quality control of DNA samples

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Four Reasons "Smart Outsourcing" Biorepositories Can Work for You

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

We are at point where researchers from nearly every medical discipline have come to appreciate the importance of having a centralized biorepository and the technological framework to house the data associated with these samples.  Transitioning from a decentralized model of storing these samples to a more centralized method has proved to be difficult and has led many institutions to begin outsourcing this task.  Kristina Robson of BioStorage Technologies says outsourcing is a smart option for companies that don’t have the internal bandwidth or expertise to manage these assets.   “Outsourcing sample management with an experienced service-provider has both financial and operational benefits” explains Robson.    

The operational benefits of some of the sophisticated sample management systems are fairly obvious as these providers offer a high quality, consistent solution for handling samples.  On the financial side, Robson cited a number of drivers that make “smart outsourcing” approaches an attractive option:

Speed — It could take as long as a year to establish a biorepository that can adequately store physical specimens needed to maximize today’s clinical endeavors. Insourcing alleviates this difficulty, as appropriate infrastructure for data management and storage can be developed in a matter of months. 

Decreased Cost — Sample management “smart outsourcing” models reduce infrastructure cost, thereby decreasing the need for large operations teams to manage/map data, provide governance and build custom query application.

Scalability — Because large quantities of biological materials are generated during drug R&D, thousands of samples need to be properly stored and tracked throughout clinical trials and beyond. Through innovative outsourcing partnership models, companies gain the ability to move samples offsite seamlessly to add capacity.

Quality Assurance — By leveraging SOPs already developed and validated by an outsourced partner, risk of specimen degradation through handling and storage techniques can be mitigated. 

You can check out Kristina Robson’s article in its entirety here.

What can these data-rich biorepositories do for your research?  We have the answer.  Join our free webinar- 4/30, 2:00-3:00PM EST.

Register here. DISCOUNT CODE: XP1998BLOG

Need the latest biorepository research? Check out Biorepositories and Sample Management Conference.

September 8-10 | Boston, MA

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