An Introduction to Tissue Print Technologies with Dr. Sandra Gaston

Question and Answer with Dr. Sandra Gaston of Tufts Medical Center

As a featured speaker for the Biorepositories and Sample Management Summit on October 12-14th, 2015, in Boston, Massachusetts, Dr. Sandra Gaston has presented on “Tissue Print Technologies: An Innovative and Practice Approach to Obtaining High Quality Research Samples from Biopsies and Other Challenging Biospecimens.”

As an attendee and sponsor of the event, I was deeply honored to have the chance to interview Dr. Gaston about about her research techniques, novel approaches to specimen management, and the use of these techniques in precision medicine. Her answers to our interview questions are below.

Question and Answers about Tissue Print Technology

Question 1: What are you speaking about at the “Biorepositories and Sample Management Summit” in Boston?

Dr. Gaston: I'm focusing my talk on the use of innovative tissue print technologies that my laboratory has developed in order to obtain high quality samples from biospecimens like tissue biopsies that are too small to be sampled by conventional methods.

Question 2: What are tissue prints and how would you define them?

Dr. Gaston: Tissue prints are in some ways similar to touch preps, but we use nitrocellulose instead of glass slides to blot the fresh tissue surface and obtain a thin layer of cells and extracellular matrix for molecular biomarker analysis. The tissue print collection technique results in a nitrocellulose blot that can be immediately snap frozen to preserve RNA and DNA quality, and we have used this approach to study gene expression and mutation patterns in needle biopsies without compromising these critical specimens for diagnosis.

Question 3: What is the value of using tissue print technologies?

Dr. Gaston: Tissue print technologies can be readily adapted for collecting high-value samples from biospecimens that can’t be readily sampled by conventional slice or shave methods. Key advantages of tissue print technologies include:
• The collection technique is easily learned by support staff
• The nitrocellulose is inexpensive and widely available
• Tissue prints can be collected quickly both in outpatient and surgical pathology settings
• Tissue prints take up very little space in the freezer
• The “imprint” can be directly aligned with the tissue histology to facilitate biomarker-pathology correlations.

Question 4: What impact is tissue print technology having on the biobanking community?

Dr. Gaston: The major scientific impact of the tissue print technology approach is that it expands the range and representation of biospecimens that are available for analysis.

Question 5: What is your current role at Tufts Medical Center Biorepository?

Dr. Gaston: The Tufts Medical Center Biorepository is a service of the Department of Pathology and Laboratory Medicine. We are accredited by the College of American Pathology (CAP) and affiliated with the NCI Cooperative Human Tissue Network (CHTN). We are a core research resource for Tufts affiliated investigators and for investigators from the larger research community, including scientists from pharma and biotech companies.

Author: This post was written by Cade Hildreth, President/CEO of BioInformant Worldwide, LLC, a market research firm specializing in the stem cell industry. For more conference updates, follow Cade on Twitter (@StemCellMarket) or LinkedIn.

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Day 2 Summary for the "Biorepositories and Sample Management Summit"

Biobanks are diverse processing and storage facilities that maintain biospecimens. These stored biological materials can be used for drug development and discovery efforts, precision medicine studies, biomarker-based preclinical research, and more. Increasingly, biobanks are also storing stem cell lines, such as induced pluripotent stem cell lines that are being derived from both healthy and diseased donors. Biobanks can also contain cord blood units collected from newborns, as well as associated tissues that may contain stem cell and progenitor cells, such as umbilical cord blood tissue or placental tissue.

The goal of biobanking is to preserve biological samples for potential use at a future point in time. As the range of tissues being stored for future use has increased, the potential research and therapeutic applications have also expanded, driving growth of the global biobanking market. While this growth is generally positive for the industry, there have also been “growing pains” associated with this industry expansion. To explore these issues and opportunities, the “Biorepositories and Sample Management Summit” was held over the past few days at the Hilton Hotel in Boston, Massachusetts.

Recap of Day 2 of the “Biorepositories and Sample Management Summit” 

Delivering a jam-packed day of content, Day 2 of the “Biorepositories and Sample Management Summit” kicked off bright and early today with the morning sessions that emphasized information management strategies to support biobanking for drug development. The afternoon sessions centered on strategies for sample quality assurance and control. Finally, the conference concluded by highlighting the importance of sustainable biobanking business practices and techniques for establishing predictable cash flow through biospecimen provision to commercial partners.

The opening talk of the day was presented by Dr. Ty Hoover from the MD Anderson Cancer Center, who spoke about American College of Medical Genetics and Genomics (ACMG) informed consent guidelines for biobanking of patient samples. As he emphasized, “these are guidelines, not laws backed by government or a regulatory body.” While the ACMG guidelines can inform policy decisions, Dr. Hoover stated, “ACMG policy guidelines are just that, guidelines; they are not the Standard of Care (SoC).” Nonetheless, he recommended a thorough understanding of these guidelines and brought attention to the key points they contain. He also re-introduced the faand controversial topic of whether primary data should be returned to patients. This was also a hot-topic for discussion on Day 1 of the event, as the concept was previously introduced for discussion by Dr. Stephen Abel of Abbive who suggested that Ethics Committees (EC) are more and more often asking after this topic. 

The next talk was given by Drs. Lesch and Nepochatov of OHSU, who shared their internal strategies for migrating specimen inventory within the OHSU Biobank. Importantly, Dr. Nepochatov highlighted the four aspects of data migration, which are the:
1) Data Environment;
2) Data Cleaning;
3) Staging Database;
4) Migration Scripts.

This talk was followed by Dr. Eric Hall of Duke University, who presented a case study of “Duke’s Implementation of an In-House Informatics Overhaul.” In this presentation, he honestly and humorously revealed the difficulty of implementing an enterprise-wide system for biobanking specimen management. He shared that his group’s cost for the effort has been $3M, allocated over a five-year period. As other conference participants shared their costs for similar enterprise-wide efforts, the results ranged from figures as low as $1M and to as high as $20M.

Next, Dr. Lokesh Agrawal of the of the NIH/National Cancer Institute presented on techniques for assessing biomarkers to determine biospecimen quality. Specifically, he highlighted the importance of creating highly-specific quality assessment resources, tools, and guidelines for human blood-derived biospecimens. He also presented methods to assess the quality of DNA and RNA isolation protocols, and introduced the concept of an RNA Integrity Number (“RIN”).

Dr. Karen Pitt, also from the NIH/National Cancer Institute, then spoke on strategies for cost reduction, using her organization’s biobank as a model system. She spoke about the “Lean Six Sigma” (LSS) approach to biobanking, which is a principle-based management philosophy focused on high consumer value, planned elimination, and waste reduction.

In the final talk before lunch, Dr. Nicole Perfito of Science Exchange addressed the importance of increasing accuracy and reproducibility of preclinical research results. She opened with the shocking statistic that only about 50% of cancer biology studies are reproducibly by outside groups, usually for reasons such as insufficient method reporting, pressure to withhold negative findings, vendor reagent variability, and more. Using her group’s experience in managing a “Reproducibility Project” focused on cancer biology studies, she shared lessons that included the importance of building tools to help capture research workflow and data, the value of uniquely identifying commercial reagents, and the benefits of establishing an open-line of communication with the original study authors. 

After lunch, Dr. Cicek of the Mayo clinic addressed how to optimize procedures to deliver high quality specimens, noting that “everything at the Mayo Clinic from physician care to biobanking is focused on the patient experience.” She highlighted that in biobanking, “Optimization and Standardization” goes hand-in-hand throughout the life cycle process. One enhances the other, and vice versa.

Finally, in my favorite presentation of the day, Dr. George Wilson of the Biobank at William Beaumont Hospital concluded by highlighting methods for creating a sustainable biobanking business model. In particular, he emphasized that biobanks need to create predictable cash flow streams to be sustainable. Interestingly, Dr. Wilson’s Beaumont Biobank was formed in 2007 due to a $2M gift, but subsequently went $6M in debt due to operational costs that were incurred from 2007 to present. Now in 2015, the biobank finally has revenue streams that will make it sustainable into the future. Specifically, he advised that biobanks establish links with commercial partners to provide biospecimens, thereby establishing a “value chain.” He also emphasized the importance of creating a two-pronged cash flow strategy that involves:
1) “Financial Revenue” (money derived from the sale of biospecimens and services);
2) “Academic Revenue” (money derived from academic grants and scientific output).

Sustainability of biobanks was arguably the most discussed topic at this year’s event, which made Dr. Wilson’s talk an exceptional platform with which to conclude the event.

Summary of the “Biorepositories and Sample Management Summit” 

In summary, the “Biorepositories and Sample Management Summit” has been the ultimate biobanking experience of 2015, because it highlighted the most important topics of interest to industry participants. This year, these topics included the:
•    Science and technology of biobanking
•    Business strategies
•    Information management systems and software
•    Regulatory requirements and recently updated policy guidelines
•    Ethics conversations
•    Emerging market segments

Did you enjoy this recap of Day 2 of the “Biorepositories and Sample Management Summit”? View the Day 1 recap here or search the hashtag #biorep2015 to view the live updates that were posted during the event.  

Author: This post was written by Cade Hildreth, President/CEO of BioInformant Worldwide, LLC, a market research firm specializing in the stem cell industry. For more conference updates, follow Cade on Twitter (@StemCellMarket) or LinkedIn.

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Day 1: Biorepositories and Sample Management Summit | Summary

Biobanks are biomedical research facilities that process and stores a wide variety of biospecimens, to include whole tissue, blood, DNA, plasma, purified saliva, cell lines, stem cell populations, and more. The goal of biobanking is to preserve biological samples for storage, and importantly, potential use at a later point in time. Biobanks are now playing a major role in assisting pharmaceutical companies with drug discovery and development efforts. They are also driving forward precision medicine efforts, as they have the capacity to allow physicians to select the best treatment option for specific patients. However, effectively preserving tens of thousands, or even hundreds of thousands, of biological samples can be a daunting task.

To honor this growing industry, speakers at the “Biorepositories and Sample Management Summit” held today at the Hilton Hotel in Boston, Massachusetts delivered a jam-packed day of content.

We heard presenters discuss biobanking topics that included:

• A trend toward broader consent procedures
• Approaches to sample sourcing
• Price negotiation techniques for sample acquisition
• Traditional and non-traditional methods of acquiring patient consent
• How to determine patient identify when using online consent methods
• Financial planning models and web-based applications to assist business planning
• The importance of monitoring sample quality over time
• And much more

Clearly, the biobanking industry is moving rapidly in new directions.

Drs. Miranda and Yanak discussed the growing importance of the industry by stating, “Biobanking is no longer just storage; it incorporates the entire product lifecycle.” They spoke about biobanks moving from “giant freezer farms” to now function as “facilities that provide much needed services to drug development companies, from the start to the finish of the process.” They also highlighted the importance of evaluating specimen value and quality over time, including the effect of long-term storage and the impact of freeze-thaw cycles.

Dr. Beth Karlson of Brigham and Women’s Hospital and Harvard Medical School wins my award for "Best Talk of the Day" for her presentation on the important and controversial topic of implementing “Electronic Informed Consent (eIC)." This novel approach to consent has the potential to transform the biobanking industry, a community that has traditionally relied on paper-based methods and in-person consent procedures. At Partners Healthcare, Dr. Karlson’s team is achieving electronic consent rates as high as 3.5%, by emailing individuals through their Patient Portal System.

Dr. Sandra Gaston also gave a fascinating talk on tissue print technologies and how the approach can expand the range and representation of biospecimens that are available for analysis. She used prostate cancer as her example case, but the technique can can be applied to biospecimens for breast cancer, ovarian cancer, and more. Importantly, she highlighted that tissue print technologies can be used obtain high quality samples from biospecimens, like tissue biopsies, that would usually be too small to be sampled by traditional methods.

Dr. Brian Hart of Ventana Medical Systems-Roche spoke on the topic of “Moving Toward Strategic Partnerships with Biospecimen Providers,” in which he introduced the novel concept of using an online auction to collect bids from multiple vendors when large sample quantities are required. Through his case study, he demonstrated that pricing stability can be introduced into an otherwise volatile marketplace and that vendor bids can be driven down by as much at 50%. He also wins my award for the best quote of the day by stating, “Nothing gets done without the biospecimen.” With this pity statement, he highlighted that the biospecimen is the beginning of all research and development activities that are designed to create safer and more effective treatment options for patients.

In summary, major trends that were explored during the conference today included:

1. Could biobanks potentially have the ethical responsibility to “return” clinical findings to patients in the future? Will ethics committees (EC) gradually move in this direction in the future?
2. How can the biobanking community best broaden consent language to incorporate all potential future uses for biospecimens, including future technologies that may not yet exist?
3. How can the biobanking industry standardize pricing of biospecimens? Is it possible to introduce pricing stability into the industry at large? Is it the obligation of the biospecimen vendor or the buyer to establish reasonable cost parameters?
4. Can equal (or potentially even higher) rates of patient consent for biobanking be achieved through electronic communication, such as sending emails through a healthcare provider’s Patient Portal System (PPS)? Will electronic informed consent (eIC) gradually replace traditional in-person methods? Will these electronic methods be legally robust approaches that will stand the test of future litigation?
5. Can cost modeling and web-based applications be used to improve cost recovery at biobanks? Will biobanks be willing to integrate this technology to assist with business planning? 

Did you enjoy this recap of Day 1 of the “Biorepositories and Sample Management Summit”? Follow hashtag #biorep2015 to get tomorrow's updates! 

Author: This post was written by Cade Hildreth, President/CEO of BioInformant Worldwide, LLC, a market research firm specializing in the stem cell industry. For more conference updates, follow Cade on Twitter (@StemCellMarket) or LinkedIn. 

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Could Cord Blood Banking be the Next Big Trend in the BioBanking Market?

What is a Diversified Biobank versus a Stem Cell Biobank? 

A biobank is a type of biological repository that stores biological samples (usually human) for use in research and medicine. The registration of each sample entering and exiting the system is centrally stored on a computer system that is frequently backed up, and the physical location of each sample is noted to allow efficient location of specimens. Storage of the specimens may range from controlled ambient (room temperature), to +4°C, -20°C, -80°C, and -196°C (liquid or vapor nitrogen, LN2).

Currently, there are three purposes for which stem cells would be stored:

•   Biobanking (both public and private)
•   The storage of stem cells for use in medical applications, including cellular therapy, regenerative    medicine, tissue engineering, and personalized therapeutics
•   The storage of stem cells for use in scientific research.

A stem cell biobank is a dedicated stem cell storage company or organization. What distinguishes it from the rest of the cryogenic storage marketplace is that it is focused exclusively on the storage of stem cell samples. In contrast, diversified biobanks or biorepositories may collect a wide range of biological samples, including blood components, whole blood, buccal swabs, DNA, RNA, protein, cell lines, marrow, plasma, serum, RBC, white cells, fluid, urine, solid tissues, tumor and biopsy materials, and more.

Therefore, the stem cell storage market is a sub-segment of the broader cryogenic storage market that is composed of diversified biobanks and biorepositories.

Could Cord Blood Banking be the Next Big Trend in the BioBanking Market?

While there are many different market segments within the stem cell biobanking market, cord blood banking has recently been on the rise. Over a trailing three year-period, this area of the stem cell biobanking market has been growing faster than other key marking segments, including the storage of bone marrow stem cells, peripheral blood stem cells, adipose-derived stem cells, dental pulp stem cells, and more.

A cord blood bank is a facility which stores umbilical cord blood for potential future medical use. Stem cell samples stored in private (“family”) banks are available only to the individual or family who has chosen to collect the stem cells. The companies that offer this service are for-profit companies, and the fees for the collection, processing, and ongoing storage of the stem cells are paid by the individual or family for whom the unit is stored.

Public storage of umbilical cord blood involves donation of the cord blood unit to a public bank at the time of birth and subsequent storage of it for use by any member of the public who has medical need and is a genetic match.

The field of cord blood banking is a relatively recent field, as it was not until 1988 that the first successful cord blood transplant occurred and not until 1995 that the first private cord blood bank, the Cord Blood Registry, began operations. There are now nearly 500 cord blood banks worldwide across most countries worldwide. In addition, there has been rapid progress made with the success of cord blood transplantation. Since the first transplant was performed in 1988, the number of transplants performed worldwide has since risen to 35,000.  

Another interesting trend in the cord blood banking industry has been the recent introduction of the option for expectant parents to store cord tissue. The reason to store both umbilical cord blood and umbilical cord tissue is that they contain different types of stem cells (hematopoietic versus mesenchymal stem cells) and each type has the potential to treat different types of injury and disease.

When a cord blood unit is collected, the blood contained within the umbilical cord of a newborn baby is extracted from the cord, collected in a cord blood kit, transported to a cord blood bank, and cryogenically stored. Similarly, in cord tissue banking, 4-8cm of the umbilical cord is collected, placed in the tissue collection kit, and transported to a cord blood bank (or laboratory) for storage. While the collection process and reasons for storage are very similar, cord tissue banking only emerged as a commercial option in the U.S. beginning in July 2010, while cord blood banking has been commercially available in the U.S. since 1995.

When cord blood banking first emerged as a service in the early 1990’s, cord blood storage was the only service that was offered by companies operating within the industry. However, by 2008 a Taiwanese company (HealthBanks Biotech Company Ltd.) had expanded it stem cell storage services to also include cord tissue storage, because cord tissue contains stem cells that differ from cord blood. By 2010, the Cord Blood Registry made the same decision in the United States and offered it as a complement service for their cord blood banking service. Since then, cord tissue storage has had a significant impact on the U.S. cord blood banking industry, as nearly half of private U.S. cord blood banks now offer the service.

The key differences between umbilical cord blood and umbilical cord tissue are described below.

COMPARISON OF UMBILICAL CORD BLOOD VS. UMBILICAL CORD TISSUE

Since cord tissue banking was introduced, the market for biobanking of various stem cell samples has continued to expand, with placental banking being offered by LifeBank USA and Americord. Recently thereafter, Cryo-Cell International began offering storage of stem cells from menstrual blood.

Cade Hildreth, CEO, BioInformant

To learn more about trends within the biobanking market and opportunities for optimizing your sample management practices, view program details for the “Biorepositories and Sample Management Summit” in Boston, MA, on October 12-14, 2015.  Use the code "XP2098BioInform" to get 15% off your Event Pass.

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Are You passionate about the Future of Biobanking? Join our event as a Guest Blogger!

Earn a complimentary all-access pass to the 8th Annual Biorepositories and Sample Management Summit by serving as a Guest Blogger at the event.

IIR's 8th Annual Biorepositories and Sample Management Summit
October 12- 14, 2015
Hilton Back Bay
Boston, MA

We are looking for an industry expert with interest in the following topics:

• New technology and innovative sample management;
• Sample Quality Assurance/Control Methods;
• Sustainable business models for Sample management
• Biospecimens;
• Biobanking to Support Drug Development;
• Bioprocessing and Biopreservation Techniques;
• Precision medicine;

...and who would like to learn about the future trends in biobanking!

The premise is to provide Biorepositories and Sample Management - related articles, whitepapers, and overall original content.

What You get is:
• FREE pass to the conference (valued up to $2,195);
• Access to extensive social learning activities;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our five health related-blogs with over 2000 unique visitors monthly each and more than 20 healthcare LinkedIn groups. 

Learn more about the IIR's 8th Annual Biorepositories and Sample Management Summit by visiting the website.

Interested & want to learn more about this opportunity? Please contact Alexandra Pump at apump@iirusa.com

We hope to have you join us in Boston!

Stay tuned for our weekly news round up! 

Subscribe to our blog or follow us on Twitter: @futurebiopharma

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Conscious Commercialization and Agile Biobanking. Part III

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

Start with Part I and Part II.

Q: What success factor in addition to recovering costs is fundamental to ensuring sustainable development?

A: Agile Biobanking.

Agile biobanking is the idea of creating operations that can respond to what the customer and market needs in real time. And when project requirements shift making the necessary refinements reasonably quickly.

So, let’s return to the biobanks who are thriving. What do they do exactly?

They proactively plan and prioritize their collections and let the end user requirements drive collections (in line with their mission of course) - before they bank.

1. Utilization specific strategic planning: Before these biobanks commit to any collections, products and/or services, they dedicate a portion of their strategic planning to substantiate the market need for the types of samples and services they can offer.

2. Voice of customer driven collections: They meet with potential customers early on to determine sample requirements (e.g. type, format, processing needs, amount, etc.) and downstream targets- so they can be sure the sample is “fit-for-purpose”.

3. Secured customers with funded contracts: They take a project based costing approach. They create a transparent yet relatively expeditious process to confirm the contract is finalized and the funding is secure - before they begin any dedicated collection.

4. Real time evidence based refinements to projects: Working closely with their customers, they typically pilot a percentage of the samples upfront - making sure that the samples pass proficiency measures and are of sufficient quality. Then as appropriate refine their sample methodologies.

5. Timely capture and reporting of outcome and utilization data: They collect data on the project outcomes to demonstrate impact of the bioresource. They debrief on lessons learned and tweak their approach if needed.

How does this approach help ensure sustainability?

Agile biobanking ensures that all specimens collected have a respective end user and are utilized in a reasonable timeframe - so impact can be measured. This fulfills a biobank’s utilization mission. It makes certain that every project has a business case to support it: a committed budget, a guaranteed funding source and a mechanism for bringing in revenue. This assured return on investment increases the likelihood of obtaining additional stakeholder funding later on.

The approach allows the biobank to preserve and maximize its resources and better understand its needs going forward. Understanding what end users (e.g. academic, pharmaceuticals, and diagnostic and biotech companies) need to fulfill their R&D requirements makes any collection more valuable and more likely to be utilized in a relevant, meaningful way.

The agile biobanking approach is consistent with an insight I shared in an expert column in Biopreservation and Biobanking in 2010 (regarding challenges/opportunities for biobanks in the next 3-5 years?): “The ability for Biobanks to embrace the changing perspective of viewing the biospecimen as a potential work product and provide focus on the life cycle and related process chain and related pipeline planning will be hugely beneficial.”

How can you help apply these lessons?

This October, I’ll be giving a workshop in Boston on biobank business planning - focused on strategic and sustainable development.

In the morning workshop we’ll dig deeper into other success factors, lessons learned and peer case studies - which serves as a primer for the afternoon session. The afternoon biobank business planning boot camp is designed to be interactive to allow participants to work through a problem they are dealing with in real time. The approach will be similar to one I used for a biobank business plan boot camp in Switzerland, where a group of Core Directors worked together as a sounding board. They left with peer based experiential knowledge that they could put to work for their organization. This approach proved extremely fruitful. If this opportunity interests you, I encourage you to register for the upcoming workshop.

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. She is 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 roles 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 at lisabmiranda@biobusinessconsulting.com Download her 2014 podcast on the future of biobanking.

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Conscious Commercialization and Agile Biobanking: Part II

Conscious Commercialization and Agile Biobanking

A Three Part Series in Biobank Business Planning: Part II
By Lisa B Miranda, President and Chief Executive Officer, Biobusiness Consulting Incorporated
6/30/2015

PART II

Start with Part I.

One of my key recommendations around strategic business planning for biobanks is to take time to develop tools for success. This includes a putting together a financial roadmap, plan, process and mechanism for recovering costs. Though many biobanks were created with monies from publicly available grants and internal stakeholder funding, the days of “wine and honey” are long gone. With grant applications converting to contract mechanisms, funding in limited supply and requirements for return on stakeholder investment increasing, monetization of existing bioresources through cost recovery is now essential. Willing acceptance of this reality in tandem with timely cultural change about ways to garner revenue makes all the difference in the outcome.

So, let’s return to the topic of conscious commercialization and how this fits in: What do you mean by the term “conscious commercialization”?

Conscious commercialization begins with thinking about how business rules can meet the needs of the entire stakeholder community and still fulfill one’s bottom line. It incorporates a well-defined and thoughtful process about how to monetize an entity - i.e. biospecimen core facility. Groups that focus on finding creative, mixed and/or alternative mechanisms to generate revenue are essentially commercializing a percentage of their operations.

The term, “conscious commercialization” emanated from an idea in the business world disseminated by Whole Foods Market co-founder John Mackey and Raj Sisoda, PhD. The strategy centers on the belief that both business and capitalism are inherently good and that one can build on the foundations of capitalism, (e.g. voluntary exchange, entrepreneurship, competition, freedom to trade and the rule of law.) According to the theory, for a company to really be healthy it must incorporate elements of relationship building i.e. trust, compassion, collaboration and value creation.

Mackey and Sisoda’s philosophy is built on four pillars: higher purpose, stakeholder orientation, conscious leadership and conscious culture. These pillars (seen below in Figures 1 & 2) also intuitively apply to business considerations in the biobanking world, what we refer to as “biobusiness”:


The four pillars adapted for biobank business planning (“biobusiness”):

Higher Purpose (a.k.a. Mission): Recognizing that every biobank has some mission that defines its creation and higher purpose. While its purpose may not necessarily be to generate profit, it does bring in dependable sources of funds and/or revenue. This revenue can drive the mission forward. By sustainability focusing on its mission, the biobank can inspire, engage and energize its stakeholders.

Stakeholder Orientation: Recognizing that the capability to achieve innovation in medicine, life science, and biobanking is interdependent and reliant on the human foundations of business. A biobank needs to create tangible value with and for its various stakeholders (e.g. funders, customers, employees, vendors, investors, scientific and medical communities, etc.). Real time recognition of this fact leads to a healthy business system.

Conscious Leadership: Biobanks are created and guided by leaders – people who see a path and inspire others to travel along the path. Conscious Leaders understand and embrace the Higher Purpose (mission) of business and focus on creating value for and harmonizing the interests of the business stakeholders. They recognize the integral role of culture and purposefully cultivate Conscious Culture.

Conscious Culture: The core values, principles and practices – underlying the social fabric of the biobank’s business infrastructure and key activities, which connects the stakeholders to each other integrating the purpose, people and processes that comprise the value of the organization.

Figures and text adapted from the book “Conscious Capitalism: Liberating the Heroic Spirit of Business” by John Mackey and Raj Sisoda, PhD and website reference: www.consciouscapitalism.org

The take home for me, at least from reading about their idea, is that commercialization to some degree while not for everyone can be a positive activity. It can be leveraged successfully to meet your business goals while still serving your biobank’s organizational mission. One can inherently create more value by applying validated business strategies that clearly define the goals of your organization (e.g. biobank) while working cooperatively with your stakeholders to help drive economic viability. We can utilize the free market economy as an opportunity to drive progress forward. Biobanks and their stakeholders (including industry) play synergistic roles in innovation. We all need each other to thrive.

Tune in on July 7th for part three of the series when I present observations from peer case studies demonstrating how conscious commercialization and agile biobanking strategies can drive success in biobank utilization.

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 (UPENN). She began her career in clinical care and community based research in local hospitals and then moved to clinical and epidemiology research. She spent over 14 years in research at UPENN 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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Show me the (“Fit-for-purpose”) Biospecimen Evidence Based Practices (BEBP’s) Data

By Lisa B Miranda

The term Biospecimen Evidence Based Practices or BEBP’s appears to have been recently coined by colleagues from the United States National Institutes of Health National Cancer Institute Biorepositories and Biospecimen Research Branch.  Last month, Engel et al published an article in Biopreservation and Biobanking titled “National Cancer Institute Evidence Based Practices: A Novel Approach to Pre-Analytical Variability Standardization”. As many in the biobanking field are aware variance in sample management practices can affect biospecimen integrity and often alters quality.   Biobanks typically aim to address this issue via adherence to standard operating procedures and protocols, documentation of any inter-specimen variability for reference during analysis downstream, as well as implementation of automated sample processing technologies, which some believe may reduce technical inconsistencies often found in manual practice.  In Kelly et al’s article the cogent point is made that while internal standardization of biobanking sample management practices aides in optimizing pre-analytical variability of specimens at one’s own site, this does not address the equally important issue of managing variability across biobank sites.   Optimizing and understanding pre-analytical variability across sites is a common issue for an abounding number of biospecimen research collaborations (i.e. multi-center clinical trials) and network based biobanking activities (i.e. aggregation of and analysis samples across sites), etc.  

Looking back in retrospect from last year’s conference while looking prospectively to the 2014 conference, it is clear that quality-driven-collaboration is an ongoing theme echoed again this year by the theme of optimizing quality control and sample integrity.  In my opinion the one thing that ties these two themes together and addresses the issue of cross-site inter-variability is “fit for purpose” evidence based biobanking.   This approach advocates prospective development of BEBP’s, which regardless of site of origin should provide reproducible validated results.  Navigating “fit for purpose” evidence based protocol requirements requires a certain level of precision. Planning of which should be driven by the specimen, molecule and analyte of interest otherwise referred to as an SMA-approach. To increase the likelihood that a biospecimen collection is managed in a fit-for-purpose fashion, it is essential that biobanks and biospecimen resources prospectively define their procedures using an evidence based focus.  What isn’t so apparent is how to get there so that this idea can become a common reality. 

In 2012 I developed a fit-for-purpose evidence based protocol framework which was distributed in its early stages at when IIR’s conference was its 5^th year.  In September I’ll be giving a talk with a colleague at IIR’s 7^th Biorepositories and Sample Management Conference.  The talk will offer insight from a recent collaboration amongst pharmaceutical, academic and biotech colleagues with whom the fit- for- purpose evidence based protocol development framework has been vetted.  In this talk we plan to present a brief overview along with relevant lessons learned, feedback and take homes from presentation and peer based discussion amongst the broader biobanking community.  The technical and scientific framework is meant to function as a quality control instrument, consists of nine sections and is designed to offer utility in a two ways.  Firstly, it can be used as a guidance document (checklist and worksheet) and fit-for-purpose (FFP) planning exercise (to assist biobanks in understanding evidence based biobanking requirements) so that BEBP’s can be established in real time. Secondly, it can be utilized retrospectively as an internal audit tool (to ensure your biobank protocols, operations and equipment can support FFP sample management.)  The comprehensive document factors in best practices as well as relevant reporting guidelines (e.g. BRISQ).  With the advent of biospecimen science leading the way for evidence based biobanking practices, Biobankers have an amazing opportunity to impact both the biomedical research and clinical realms in a significant capacity.  This instrument if implemented across biobank sites could accelerate real time practice of evidence based biobanking and remedy the issue Engel et al raise regarding variability between multiple sites.  If all sites in an organization or collaboration incorporate this framework, they’d be more apt to increase proficiency of biospecimen collection quality and be more adept at ruling out variability between collections across sites.  If this topic and information interests you, we hope to see you at the conference September 8-10, 2014 in Boston.  Check out what we’ve got lined up.

Save your seat now and you could SAVE 15%. Use discount code XP1998BLOG. Register here.

About the Author:  Lisa Miranda is President and Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory based in the Greater Boston Area.  She is known worldwide as a biobanking and clinical research subject matter expert.  Much of her work focuses on biobank strategic planning and/or development of biospecimen research applications and biotechnology commercialization.  She may be reached at: lisabmiranda@biobusinessconsulting.com

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Save the Date for the 4th Annual Biorepositories Event!

Save the date for the 4th Annual Biorepositories conference, taking place September 19-21 in Boston at the Sheraton Hotel and World Trade Center. Learn advanced strategies to take your biorepository from operational to profitable.

You will gain crucial insights into how to:

• -Guarantee full life-cycle specimen quality control
• -Uncover the balance between on-site and outsourced operations ideal for your business model
• -Master state-of-the-art techniques in specimen storage, management, and transportation
• -Implement surefire added value strategies for your collection
• -Maximize biospecimen renewability and stability
• -Develop and comprehensively track the most useful informed consent
• -Harmonize biospecimen research techniques with input from the physician and patient communities to improve treatment outcomes
• -Target opportunities and avoid obstacles in domestic and international partnerships and expansions

Find out more about the 2011 Biorepositories Event.

Are you interested in speaking? We currently have a limited number of speaking spots available. To learn more, please contact Matthew Greenbaum at MGreenbaum@iirusa.com.

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