In this issue, Infonomics trains its eyes on the biotechnology industry. Recognized globally as an engine of economic growth, biotechnology is linking basic research with vast new market opportunities across a broad spectrum.

And, more strictly to the point, the biotechnology industry demands the management of prodigious, ever-increasing quantities of content. Consider the Human Genome Project (HGP), a 13-year effort coordinated by the U.S. Department of Energy and the National Institutes of Health, to determine the sequences of the three billion chemical base pairs that make up human DNA.

Though the HGP is finished, analyses of the data will continue for many years. By licensing technologies to private companies and awarding grants for innovative research, the project catalyzed the multibillion-dollar U.S. biotechnology industry and fostered the development of new medical applications.

Total U.S. employment in the biosciences reached 1.3 million in 2006 (the latest year for which data are currently available), led by strong growth in the research, testing, and medical lab subsector, according to the Biotechnology Industry Organization (bio.org). The biosciences sector pays, on average, 68 percent higher salaries than the average private-sector job.

Academic bioscience R&D expenditures totaled $29 billion in fiscal year 2006, accounting for more than 60 percent of total U.S. academic R&D. And, this R&D is leading to discoveries with commercial potential. Bioscience- related patents issued totaled 82,000 during 2002 to 2007.

Bioscience employment is distributed across all 50 states and Puerto Rico.

The biotechnology, pharmaceutical, medical devices, and other life sciences have their work cut out for them when it comes to managing vast stores of information. A frantic pace of scientific advancement, highly regulated operating environment, long product lifecyles, data standardization, and other compliance issues call for impeccable content and records management.

These enterprises must do a lot more than merely create miraculous new products; to stay in business they must comply with a crushing load of government regulations like FDA 21 CFR Part 11, the U.S. Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures that define the criteria under which e-records and e-signatures are considered trustworthy, reliable and equivalent to paper records. These guidelines intersect with enterprise content management (ECM) on many levels, not the least of them the frenzy of documentation and processes required for audits, quality management, electronic signatures, and more.

Peg Mitchell, senior director of IT for the project management office and software quality at Carlsbad, Calif.-based Life Technologies, says in the last handful of years many content silos have gone away, thanks in part to improved interfaces of ECM solutions which encourage use. “There’s been an evolution of sorts in IT which has converged and become better at user interfaces and user-friendly features,” she explains.

Life Technologies is a global biotech company, recently formed by the merger of two established companies: Invitrogen and Applied Biosystems. Invitrogen is a life science company in disease and drug research, bioproduction and diagnostics. Applied Biosystems develops advanced genomic technologies that include DNA sequencing systems and chemistries to perform sophisticated DNA sequencing solutions.

Improved technologies and vigilant governance mean less searching for critical information and less trapped content that’s locked up in laptops, e-mail systems and other silos. Says Mitchell: “Governance is around the content itself that is shared: how it’s stored, how it’s tagged, etc., so that it doesn’t become just a big mess of nonsearchable, non-shareable information that once again becomes lost in a black hole.”

All ECM solutions, from basic document management to social networking tools, are rife with the regulatory and compliance issues in the life sciences field. Mitchell adds: “You want the fast exchange of ideas around the content to be agile and productive but you still have regulations, IP (intellectual property) to protect as well as the potential for litigation or e-discovery. You have to manage all that.”

Social Networking and Web 2.0 Injections
Software vendors have recently taken their regimens to the next level by combining content management with collaboration tools like voice, video and instant messaging (IM). “We’re seeing a trend where the technology is allowing us to do workflow, even audio, video, Web conferencing, exchanging documents and IM, but we haven’t reached a point where these technologies are integrated. Many vendors are acquiring niche players to gain these capabilities,” says Manoj Prasad, senior director for enterprise architecture and mobile applications at Life Technologies.

Industry insiders say social networking and other Web 2.0 applications have also influenced the management of content and collaboration inside their companies. Says Prasad: “The push is more to understand how we can use these new tools today to capture, manage, and search content, people, and communities inside the company versus just your basic document management capabilities from the storage perspective.”

Invitrogen’s late 2008 purchase of Applied Biosciences formed Life Technologies and the merger of the two companies brings the challenge of bringing employees from two different companies together to allow for seamless collaboration and communications, Prasad says. To this end, the company plans to implement an integrated content management/collaboration solution over a three-to-five year horizon. At the same time, LifeTechnologies is planning an internal social networking application which may broaden to include the outside scientific community and expand its limited internal blogging for better collaboration.

A particularly swift deployment of an internal company platform for employee communications was successfully launched by Life Technologies once the merger was official in November 2008. The intranet collaboration space, complete with document sharing and video updates by the CEO, is still used today. “It was a big concerted effort by the CEOs and research and development (R&D) scientists who came out of the starting gate to share information,” Mitchell says, noting that other Web 2.0 tools include wikis, internally faced to both companies.

The life sciences industry tends to thoroughly evaluate technologies before making a move, says Cheryl McKinnon, director of program management for the Enterprise 2.0 group at Open Text, an ECM solutions provider in Waterloo, Ontario. Caution must be taken with Web 2.0-style technologies that don’t fly in highly controlled environments. Nevertheless, she says, companies are increasingly looking at lightweight collaboration tools that are quick to deploy for fast return on investment (ROI).

“Most of the uses of collaborative tools are around drug discovery, not so much about clinical trials, which require highly controlled documentation,” adds Therese Harris, program manager for life sciences with Open Text. However, one contract research organization that Harris is aware of uses a Microsoft SharePoint interface to manage documents in an Open Text repository to manage a drug trial research project which includes inputs from patients, physicians and other members outside of a drug company’s four walls. The online solution greatly aids FDA 21 CFR Part 11 compliance, bypassing the need to move paper around physically via courier, mail, fax or e-mail. “These types of solutions for drug trials are very elegant and very forward, aiding compliance,” Harris notes.

The French-owned life sciences company bioMerieux uses Open Text’s ECM solutions for basic document management involving its broad content-control, says Eric Himel, business systems analyst with bioMerieux in Durham, N.C. As well, customers use convenient pull-down menus to access information they need such as material safety data sheets, package inserts, and product labels on an Open Text ECM interface (formerly LiveLink).

A world leader in the field of in vitro diagnostics (medical tests conducted in a test tube), bioMérieux, headquartered in Lyon, France, develops diagnostic solutions including reagents, instruments and software that determine the source of disease. Its products are used in the area of cardiovascular health, cancer screening, and monitoring as well as detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

The company is in the process of setting up an online collaborative community for its R&D function across several alliance partners. “Scientists will be able to collaborate and share information between our sister companies in the Merieux Alliance using blogs, wikis, and other tools,” Himel says.

On the realm of quality management and safety for managing its Corrective and Preventive Actions (CAPA), Maya Ramachandran, information services and technologies manager in quality assurance and regulatory affairs, also at bioMerieux’s Durham office, says once an upgrade to the latest Open Text Enterprise Services release is complete along with an enterprise SAP implementation, the company looks forward to routing quality and change controls documentation electronically, bypassing today’s manual processes for routing documentation across facilities and country borders.

As Himel notes, the biggest changes behind these automated workflow initiatives come in the form of re-engineering company processes worldwide. “The problem is aligning the processes, not the technology.”

The Challenge: Using Web 2.0 Beyond Its Social Aspects
Bruce Johnson, business advisory board member at Eden Prairie, Minn.-based Infobionics, a provider of platform solutions for knowledge mining and managing director of data architecture at Boston-based Recombinant Data Corp., a healthcare data warehousing provider, says even Facebook-style profile pages within an enterprise can facilitate better research by allowing scientists to connect and collaborate. “The challenge is how do you adequately get notified when something is pertinent to you and how do you validate the accuracy of that information?”

User-friendly, intuitive interfaces are the hallmark of social networking and Wikipedia-style knowledge sharing, notes Harris of Open Text, citing legions of under-30 biotech workers. “This Web 2.0 generation grew up on Facebook and MySpace and wants to share information. They don’t want to have to learn a new client server architecture or Web interface. They want to work the way they work the Web.” But Mitchell says the challenge is to provide value with Web 2.0 tools beyond their social aspects to harness information in a way without allowing collaboration to become an unfettered Wild West. “You need the right amount of governance without stifling the intent of these tools. How do you ensure that the usage is appropriately targeted for moving our business forward?”

Life Technologies is looking at hosting instant messaging-enabled white pages of sorts to create its own social networking platform where employees can put up profile pages allowing them to list their professional interests as well as to pick and choose what areas by topic or management groups from which they want to receive communications.

Prasad predicts the ECM market will soon see four or five players with end-toend collaboration, communication, and content management functionality, ultimately enabling employees to become more efficient and for companies to interact. Biotech may be a cautious adopter of some ECM technologies—but early test results show it’s an innovator.

Marcia Jedd is a Minneapolis-based marketing consultant and writer and frequent contributor to Infonomics. Her website is www.marciajedd.com.

Please read the two sidebars to this article:

Anatomy of an ECM Solution

RX for Medical Advances

For more information contact the Biotechnology Industry Organization . BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.