Press Contact:
Michael Clark
Miller Brooks, Inc.
317-873-8100
michael@millerbrooks.com

INDIANAPOLIS (Dec. 15, 2011) – BioStorage Technologies, a global provider of comprehensive scientific management solutions, biomaterial storage and cold chain logistics for the bioscience industry, is pleased to announce the company has donated proceeds raised from its inaugural fundraising campaign to the Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center. The $1,000 donation was presented to the Komen Tissue Bank on Monday, December 12th, 2011.

As part of the yearlong campaign, BioStorage Technologies donated one dollar or euro for anyone who left a business card, participated in booth activities or completed a contact form during industry tradeshows and conferences. Funds to the Susan G. Komen for the Cure® Tissue Bank at IU Simon Cancer Center will be used to support research and new technologies in the areas of breast cancer awareness, education and advocacy.

“We’re honored and flattered that BioStorage’s first fundraising campaign was set up to benefit the Komen Tissue Bank,” said Anna Maria Storniolo, M.D., co-director of the tissue bank and professor of clinical medicine at Indiana University School of Medicine. “The funds will help us to continue our important breast cancer research.”

There are a number of biobanks globally that store tissue from women with breast cancer, but Komen Tissue Bank is the only known repository in the world for normal breast tissue and matched serum, plasma and DNA. These materials give researchers the resources needed to determine the differences between diseased and normal populations, which could lead to a better understanding of the disease.

Since becoming partners in 2009, BioStorage Technologies has stored a third of the tissue bank’s breast tissue and blood samples at its Indianapolis-based biorepository.

“The Komen Tissue Bank is truly transforming breast cancer research by offering normal, high-quality, richly annotated tissue samples to scientists worldwide,” said Greg Swanberg, Chief Executive Officer, BioStorage Technologies. “We’re pleased that BioStorage Technologies is able to help successfully raise both awareness and funds to help support the tissue bank, as it will ultimately give researchers valuable and unprecedented research data. We look forward to continuing the partnership in 2012.”

About BioStorage Technologies, Inc.:
BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering onsite or outsourced management of sample assets, BioStorage Technologies manages the complete life cycle of samples. With a team of global sample experts, state-of-the-art temperature-controlled storage facilities, and a real-time, web-based sample intelligence and tracking system, the company supports customers in maximizing opportunities, minimizing risk and reducing the cost of sample management. BioStorage Technologies, Inc. is privately held and headquartered in Indianapolis with an additional full-service site near Frankfurt, Germany. For more information, visit www.biostorage.com or call +1 (866) 697-2675 or +49-6155-898-1011.

About the Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center
Susan G. Komen for the Cure Tissue Bank at IU Simon Cancer Center is the only normal breast tissue bio-repository of its kind in the world. As such, it is uniquely positioned to characterize the molecular and genetic basis of normal breast development and compare it to the different types of breast cancer. The bank was established expressly for the acquisition of normal tissues — breast tissue, serum, and DNA — from volunteer donors with no clinical evidence of breast disease and/or malignancy. The Komen Tissue Bank represents a unique resource available to –and used by — an international group of investigators

By: Greg Swanberg, CEO, BioStorage Technologies

Properly managing biospecimens and their associated data has become an increasingly important component of today’s drug development and discovery process. Today, biomaterials such as whole blood, human tissue, DNA and RNA serve as the foundation for translational research that holds the promise of bringing personalized therapeutics from bench to bedside. These materials are being leveraged by organizations around the world as the basis for biomarker programs, which can give researchers insight into predicting future patterns of disease.

By incorporating biospecimen and biomarker components into discovery initiatives, researchers can incorporate information about cell biology and its impact on treatment options and patient prognosis. Through this new understanding, novel treatment options may be developed to target specific pathways for all manners of diseases such as cancer and Alzheimer’s. Biomarker assays may also help identify patients with specific mutations or abnormal protein expression in certain cell pathways, allowing for individualization of therapies addressing specific abnormalities.

Given the intrinsic value of these materials, preserving specimens to the highest of standards is critical, not only from an operational and scientific perspective, but also from a regulatory and financial standpoint. As a result, it has become critical for biotechnology and pharmaceutical companies of all sizes to have a profound understanding of sample management strategies, and biorepository operations that help ensure the long-term preservation of biospecimen samples. Here, we outline preparation techniques, best practices for sample storage and transportation, and explain how information systems can enhance global biorepository operations and help optimize biospecimen integrity.

Techniques for preparation of biological samples

Pre-analytical variables introduced during clinical sample collection and processing significantly impact the molecular integrity of specimens and bias the results of assays and/or biomarker studies. Therefore, an essential component of any sample management strategy is a set of standardized protocols for sample preparation techniques.

Inexact sample preparation can lead to sample loss, reprocessing or complicated data interpretation. For example, to prevent degradation of RNA and DNA, stabilize the matrix (e.g., with alcohol) immediately upon collection. After the matrix has been stabilized, store it at the proper temperature without temperature excursions.

Compartmentalized storage equipment, continuous temperature monitoring and redundant power sources are essential. Furthermore, because modern assay technology requires very small volumes for most tests, it could be useful to divide biospecimen samples into multiple controlled-volume vessels.

Good storage practices for long-term specimen management

To ensure biospecimens are properly handled, transported and stored, many drug developers and research organizations are aware of and adhere to Good Storage Practices (GSP) guidelines. While GSP is not a regulatory mandated requirement, the International Society of Biological and Environmental Repositories (ISBER) as well as governmental organizations like the U.S. National Cancer Institute (NCI) have established specific good storage practices guidelines.

In 2008, ISBER drafted guidance of best practices for the collection, storage, retrieval and distribution of biological materials for research. Even more recently, the College of American Pathologists has launched its accreditation for biorepositories program, which will begin in 2012. The program aims to help biorepositories identify stages in the biospecimen management sequence, from patient to analysis, where documentation variances can render specimen quality unknown and introduce variables that may alter specimens’ molecular structure. Industry experts expect these guidelines to evolve into regulations such as those that exist in other GXP environments (for example, GTP, GCP, GLP and GMP). The guiding principles of GSP mandates standardization of sample handling and management processes to ensure materials are prepared and stored in consistent conditions.

Factors that should be considered in defining sound storage practices include:

• Secure, modern and scalable facilities strategically located to reduce environmental risks and other external threats
• Advanced and scalable storage and inventory management technologies and systems
• A wide range of storage temperature capabilities, from controlled-room temperature to vapor phase liquid nitrogen (-190°C)
• Reliable, state-of-the-art storage and temperature-monitoring equipment
• A robust scalable operational infrastructure
• Expert, highly trained staff
• Thorough, consistently applied standard operating procedures (SOPs)
• Regulatory compliant processes, systems and technologies

Cold chain logistics and management

Cold chain management defines how temperature-sensitive materials such as biospecimens, study drugs and active pharmaceutical ingredients are packaged, transported and stored throughout the research and development process. Weakness or failure at any point in the chain can compromise product integrity, breach security, delay shipments and ultimately result in financial loss or liability.

As such, the importance of training site personnel in correct shipping and receiving processes for temperature-sensitive materials cannot be overstated. Set-up and handling are common causes of temperature deviations; it is crucial that all cold chain partners are properly qualified and have been adequately instructed in handling these materials. In fact, the International Air Transport Association (IATA) requires organizations and individuals that ship or receive biological materials to be trained properly in packaging, labeling, documentation, declaration, hazard assessment and emergency response. This is of the utmost importance, as lack of compliance can delay shipments at inspection points. This bottleneck can delay studies, thereby reducing a potential drug candidate’s time on the market.

To ensure compliance and optimize the biomaterial cold chain, organizations should take a holistic approach to cold chain management in which processes are an integrated component of the organization’s overall best practices.

Information and data management for global sample inventories

While proper storage and transportation are critical, samples are useless unless they can be located with their associated data, in a timely fashion. In the past, researchers applied ad-hoc tracking systems such as spreadsheets to track and plot information associated with biospecimens. Today, the complexity of clinical trial research has rendered these outdated and archaic systems inefficient to handle expanding biospecimen inventories. The ideal system should offer tracking and reporting processes through all stages of a sample’s shipping, handling and storage lifecycle.

Because pharmaceutical and biotech labs typically implement a wide range of information systems, sample management systems should seamlessly interface with other systems, provide global data integration and access, and be highly configurable to easily integrate with a variety of laboratory workflow models. The integration of sample storage, consent authorization and clinical result data is another area of expansion occurring due to the advent of new technology systems. Connecting information on sample storage location, temperature and pre-testing evaluation with the resulting data from a clinical study can enable researchers to improve their selection of samples for biomarker testing while shortening development timelines.

The growing role of outsourcing in global sample management

Organizations initiating a sample management strategy have a number of options when deciding where and how to store their specimen inventories, including storing on-site, off-site or both. However, due to the exponential amount of biospecimen samples generated during clinical research and the complexity of handling and transporting these temperature-sensitive materials across international borders, it has become commonplace for organizations to outsource their biorepository operations to specialized providers.

These services are well-suited for outsourcing due to their required capital investments in equipment, facilities, trained personnel, technology, security and transportation infrastructure. Additionally, organizations are outsourcing their storage operations with increased frequency as a result of escalating and costly industry regulations regarding audit trails, reporting requirements and chain-of-custody procedures.

Central laboratories that test blood and tissue samples sometimes offer storage as an ancillary service. However, given the increased value gained over many years of storage, it is essential that biorepository facilities be optimized for reliable, long-term storage and information management. Specialized biorepository vendors may provide services such as automated sample tracking and reporting, fully verifiable audit trails; extraction of nucleic acid; verification of DNA purity, yield and concentration; and volumetric and normalized aliquoting. These services allow researchers to customize various quantities of samples from a given subset of subjects into the sample size and tubes required for testing.

As cost concerns and risk management continue to be critical factors, companies are increasingly establishing hybrid approaches to on-site sample management where inventories are stored on-site, but are dictated by standard operating procedures and technology provided by an outsourced provider. This allows for the appropriate tracking, assigning and processing of individual samples across multiple studies on a routine basis. Additionally, it leads to more efficient lab processes, given that most services that require automation are assigned to specimens across studies.

Like many aspects of drug development, selecting a biorepository partner is a complex, strategic proposition. Only by carefully screening and evaluating all available options can an organization identify a biorepository service provider that is truly a partner.

The industry recognizes the one-size-fits-all approach to drug development is no longer the pathway to success. Today, the industry is focused on a more targeted approach to drug development, where the right treatment is prescribed to the right person, at the right time. As personalized medicine and genomic-based therapies become the gold standard in drug discovery, specimens such as blood, serum and tissue may hold the key to better understanding some of the world’s most devastating diseases. With this in mind, now is the time for pharmaceutical and biotech companies, both large and small, to assess their current sample management strategies to ensure current and future drug discovery is not jeopardized by sub-optimal management processes or samples or lack of sample data.

Gregory Swanberg is CEO of BioStorage Technologies in Indianapolis. He has provided management and consulting support, both domestically and globally, to companies including Pfizer Inc., Merck & Co. Inc., Genentech Inc., Novartis AG, Eli Lilly & Co. Inc., Morgan Stanley, AT&T, Whirlpool and Lexmark. Swanberg holds a bachelor’s degree from the University of Kentucky, a master’s degree in public administration from Georgia Southern University and a master’s degree in business administration from Northwestern’s Kellogg Graduate School of Management.

Press Contact:
Michael Clark
Miller Brooks, Inc.
317-873-8100
michael@millerbrooks.com

INDIANAPOLIS (Dec. 16, 2011) – BioStorage Technologies, a global provider of comprehensive sample management solutions, including storage, cold chain logistics and virtual sample intelligence and tracking for the bioscience industry, is pleased to announce that Mike Reffeitt has been named “CFO of the Year” by the Indianapolis Business Journal (IBJ). Reffeitt was recognized as the top honoree in the private companies category with $100 million or less in annual revenue.

“I am very honored to be selected for this prestigious award. With so many deserving applicants, it is truly a privilege to be recognized throughout the state,” said Reffeitt.

Now in its fourth year, the IBJ’s “CFO of the Year” awards program recognizes top financial leaders. With a panel of judges comprised of local business experts, winners were chosen based on their dedication to their organizations’ obligations, high ethical standards, contributions to their organizations’ overall growth and their involvement in the company.

“This award showcases Mike’s financial leadership and community stewardship and gives him the recognition he has earned. As a key member of our executive team, Mike has set the financial direction from the inception of BioStorage Technologies, which has positioned the company for long-term growth and financial success,” said Gregory Swanberg, Chief Executive Officer, BioStorage Technologies.

A member of BioStorage Technologies since its founding in 2003, Reffeitt is an active member in the financial and investor community and regularly attends the Indianapolis CFO roundtable. With a strategic role in the overall management of BioStorage Technologies, he spearheads development of all long- and short-term business plans, and is the main conduit between the company and its investors and global stakeholders. Through his due diligence and financial expertise, Reffeitt has led the company to significant growth for nearly a decade.

About BioStorage Technologies, Inc.:
BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering onsite or outsourced management of sample assets, BioStorage Technologies manages the complete life cycle of samples. With a team of global sample experts, state-of-the-art temperature-controlled storage facilities, and a real-time, web-based sample intelligence and tracking system, the company supports customers in maximizing opportunities, minimizing risk and reducing the cost of sample management. BioStorage Technologies, Inc. is privately held and headquartered in Indianapolis with an additional full-service site near Frankfurt, Germany. For more information, visit www.biostorage.com or call +1 (866) 697-2675 or +49-6155-898-1011.

By: Tawn Parent

Top Honoree, Private Companies (revenue $100 million or less)

The seeds of Mike Reffeitt’s success were sown in his modest childhood.

“I was always exceedingly financially conscious and responsible,” he said. “I saved my pennies, hated waste and was an extreme planner. That allowed me as a CFO to be financially responsible and look down the road and be a strategic thinker and an effective leader.”

Those traits have paid off in his work as CFO of Indianapolis-based BioStorage Technologies Inc., which provides tissue and blood sample management, biomaterial storage and cold-chain logistics for the bioscience industry worldwide.

Reffeitt has helped drive BioStorage’s annual growth of 60 percent to 70 percent in recent years by spearheading both short-and long-term growth plans and serving as the main conduit between the company and its investors and other global stakeholders.

He played a central role in the opening of the company’s 60,000-square-foot headquarters near Indianapolis International Airport in May. He secured financing and worked with city and state officials to secure millions of dollars in tax incentives and abatements. The expansion will result in 125 new jobs.

Reffeitt also has been involved in the company’s move from being purely an off-site storage provider to one that brings its services directly to clients. Those customers include pharmaceutical firms, donor banks and academic organizations. On-site services will be a prime avenue for growth in the coming years, he said. The company also plans to make a big push into Asia and the Pacific region within the next year.

In 2009, Reffeitt was instrumental in nearly doubling the size of BioStorage’s German operations. He also oversaw all strategic development and financing for the launch of BioStorage’s ReloFleet, the first-ever mobile biorepository.

“Mike Reffeitt has set the financial direction from the company’s inception that has positioned Bio-Storage for sustainable fiscal success and long-term economic vitality,” wrote CEO Gregory Swanberg in a letter nominating Reffeitt for CFO of the Year.

The company in 2008 received Techpoint’s Mira Award for Innovations in Health and Life Sciences.

BioStorage, which has historically been backed by venture capital, remains almost debt-free, which enables it to continually reinvest its profits into new markets and services. BioStorage also consistently receives 100-percent clean external finance audits.

Reffeitt’s responsibilities extend to overseeing strategic development, IT, human resources, facilities and shareholder relations.

Being a top-notch CFO requires both paying attention to detail and looking at the big picture, Reffeitt said.

“It’s making sure that your processes and procedures are airtight, but not getting too caught up in the day-to-day details that you lose sight of the future,” he said.

Successful CFOs also must keep on top of the latest advancements in the field and monitor market conditions, Reffeitt said, citing the saying that “Not all readers are leaders, but all leaders are readers.”

Reffeitt said it has been particularly rewarding to help build 9-year-old BioStorage from the ground up. He started at the company when it was just him and the two co-founders in a cramped office in 2003. Those were the “blood, sweat and tears” days, he said. He played a major role in gathering early-stage funding and developed the company’s financial controls and reporting processes. He also was involved in expanding services and moving into new markets. Over the years the company has regularly posted double-digit revenue increases and its staff has grown by 50 percent or more annually.

“I’ve enjoyed the satisfaction of creating high-paying jobs for people, developing a strategic road map for the company, securing financing, raising capital to grow … and expanding our service providers and markets,” Reffeitt said.

He believes everyone at some point in their career should help launch an entrepreneurial company. It makes all the textbook knowledge come alive in an exciting way, he said.

Reffeitt previously spent almost 10 years as director of finance at Covance, which then was based in Indianapolis. He helped that company grow from 200 employees to more than 1,000.

Reffeitt puts a priority on balancing his life in a triangle: family, faith and career.

“The way I look at it, I’ve had a successful career because I’ve had that balance,” he said.

Press Contact:
Michael Clark
Miller Brooks, Inc.
317-873-8100
michael@millerbrooks.com

INDIANAPOLIS (Dec. 8, 2011) – BioStorage Technologies, a global provider of comprehensive sample management solutions including consulting, storage, cold chain logistics and virtual sample intelligence and tracking for the bioscience industry, announced today that Thomas J. Newman, M.D., has been appointed to the company’s board of directors. Dr. Newman joins BioStorage Technologies with more than 30 years of executive and leadership experience in the contract services and pharmaceutical industries.

“We are pleased to have an industry expert of Dr. Newman’s caliber as a member of our board and are certain that he will provide significant contributions to the shared vision for BioStorage Technologies’ growth and market expansion next year and beyond,” said Gregory Swanberg, Chief Executive Officer, BioStorage Technologies. “His vast amount of experience in contract services will only add to our boards’ already extensive knowledge of the pharmaceutical industry.”

Most recently, Dr. Newman served as President of PharmaNet Development Group, a global drug development services company, where he was responsible for worldwide operations. He also served in various capacities of executive leadership at Covance (NYSE: CVD) and Bristol-Myers Squibb (NYSE: BMY). Prior to joining industry he was on the faculty of the Department of Pediatrics at the University of Minnesota Medical School.

Dr. Newman received his M.D. from Tufts University School of Medicine and his Bachelor of Arts degree in biology from Cornell University.

About BioStorage Technologies, Inc.:
BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering onsite or outsourced management of sample assets, BioStorage Technologies manages the complete life cycle of samples. With a team of global sample experts, state-of-the-art temperature-controlled storage facilities, and a real-time, web-based sample intelligence and tracking system, the company supports customers in maximizing opportunities, minimizing risk and reducing the cost of sample management. BioStorage Technologies, Inc. is privately held and headquartered in Indianapolis with an additional full-service site near Frankfurt, Germany. For more information, visit www.biostorage.com or call +1 (866) 697-2675 or +49-6155-898-1011.

Press Contact:
Michael Clark
Miller Brooks, Inc.
317-873-8100
michael@millerbrooks.com

INDIANAPOLIS (Nov. 8, 2011) – BioStorage Technologies, a global provider of comprehensive scientific management solutions, biomaterial storage and cold chain logistics for the bioscience industry, has announced the appointment of Barb Dunn as Director of Resource Management. Dunn will direct and conduct all activities for BioStorage Technologies’ biorepository facilities including space management, network infrastructure and communication services.

“We are pleased to welcome Barb to our team as her experience in operations, logistics and business intelligence will be instrumental to the growth of our company,” said Mike Reffeitt, Chief Financial Officer, BioStorage Technologies. “Her extensive knowledge in facilities, IT and information management will help us continue to address the needs of our growing global client base as we uphold our commitment to being the benchmark in comprehensive sample management.”

In her role, Dunn will oversee global real estate and capacity planning, facilities and equipment, IT infrastructure, including managing and coordinating IT operations, systems, programming and security. She will also direct business intelligence, including computer-based techniques used in identifying, extracting and analyzing business data.

With more than 20 years of experience, Dunn has held several senior management positions for companies such as Caterpillar Logistics, Rolls-Royce, and most recently at Major Tool & Machine. While at Major Tool & Machine, Dunn led the engineering and manufacturing teams in the construction of a 180,000 square-foot manufacturing facility for state-of-the-art prototype casings assembled by the customer into a uranium enrichment centrifuge. Dunn graduated from the United States Naval Academy with a Bachelor of Science degree in Engineering/Political Science and earned her Master of Business Administration degree at Chaminade University in Hawaii.

About BioStorage Technologies, Inc.:
BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering onsite or outsourced management of sample assets, BioStorage Technologies manages the complete life cycle of samples. With a team of global sample experts, state-of-the-art temperature-controlled storage facilities, and a real-time, web-based sample intelligence and tracking system, the company supports customers in maximizing opportunities, minimizing risk and reducing the cost of sample management. BioStorage Technologies, Inc. is privately held and headquartered in Indianapolis with an additional full-service site near Frankfurt, Germany. For more information, visit www.biostorage.com or call +1 (866) 697-2675 or +49-6155-898-1011.

 
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