Winter 2006
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Content, Publishing and Knowledge Management Trends in Context
In This Issue
Welcome
Welcome to our third issue of KNOWLEDGEWISE, as we continue our mission to give you our perspective on the latest trends in Content, Knowledge and Publishing. In this issue, we’re providing an update on the efforts of pharmaceutical companies to meet the FDA’s SPL mandate. We also interview Michael Anobile from LISA (Localisation Industry Standards Association) on what they’re doing to help organizations compete in the global village. And we cover an emerging dilemma for many organizations, how to archive critical documents in a way that will enable them to be accessed in future years. As always, we welcome your feedback and suggestions on how we can make KNOWLEDGEWISE even better. Enjoy.
The Editors, KNOWLEDGEWISE
Pharmaceutical Companies Meet First SPL Hurdle
While the initial deadline has already passed, many pharmaceutical companies still have much to do before they meet the full requirements of the Food and Drug Administration’s (FDA) Structured Product Labeling mandate.
Nonetheless, while the industry has yet to fully embrace the new format, industry observers Patrick Gary, Harry Fisher and Jake Nadler say that companies still have time to fully comply with the spirit of the mandate, and not just the letter of the law.
"One of the challenges is that SPL is still a moving target," says Gary, a consulting engineer for Innodata Isogen, noting that a second phase of the project, dubbed SPL 2B, is set to begin in 2006.
"SPL 2B will help with some other initiatives, like the e-prescriptions and tool searches to help doctors," Gary says. "It also contains what they'll send to the FDA, but they haven't finished the dictionary of what content it will contain yet, so companies obviously can't comply with it in full."
Perhaps the strongest motivation, Gary notes, for companies to adopt a system that creates content in XML is that submissions in Microsoft Word documents and Excel spreadsheets will no longer be accepted from companies seeking approval of new prescription drugs or updates of data on previously approved drugs. Therefore, companies that have so far complied with the mandate by converting documents from Word or another format to XML as a last step will now need to convert those documents to XML each time they file a revision with the agency.
Fisher, who serves as a consultant on XML and other issues to pharmaceutical companies, adds that global pharmaceutical companies also have to address another issue: the differences between XML documentation required by the FDA and its overseas counterpart, the European Agency for the Evaluation of Medical Products (EMEA).
The EMEA's labeling program is pushing companies to evolve toward the electronic common technical document (eCTD) framework, while the FDA is currently basing SPL as a stand-alone guideline, although that will change down the road.
"SPL is focused on labeling requirements," says Fisher, a leading industry analyst for PQ Consulting, "and the FDA recognized the opportunity to set a very specific deadline that would require companies to take that first step. On the other hand, EMEA is taking a longer-term approach by encouraging companies to comply with the eCTD requirements.
EMEA's PIM (Product Information Management) requirement will have a huge influence on which companies decide to embrace the full potential of XML to overhaul their entire content supply chain, says Jake Nadler of Intrasphere.
"The PIM requirements are more demanding," Nadler says. "Instead of just a single label for a product required in the U.S., EMEA requires companies to submit separate documents for every strength, formulation and package size, yet much of the content is identical. PIM is to designed to leverage efficient content reuse in just this situation. Some companies use as many as 1,500 product information documents to support a single trade name."
That's why it makes sense for multinational companies to start planning for the eCTD guidelines, Gary says. The guidelines do not have a deadline, but ultimately they will require companies in the United States, Europe, Japan and Canada to adopt a common format for all drug-related documentation.
At this point, however, few multinational pharmaceutical companies have taken the step of adopting a company-wide approach to converting key points in their content supply chain to XML.
"Pharmaceuticals may be a bit reluctant, because they've been burned before by going with a standard when it's not 100 percent finalized," Fisher says. "However, as the DailyMed program expands to its full size, adopting SPL company-wide will gain increasing importance."
The FDA is currently building a repository on drug labeling information that includes warning notices, indications and contraindications. Next to come will be a library of basic medical information to help doctors and pharmacists in diagnosing and treating illnesses. Finally, the agency plans to establish a repository of patient data. Once the three XML-tagged libraries are in place, physicians and patients will have a powerful resource for diagnosing and treating ailments based not just on research and clinical trials but on actual use of drugs as well.
XML tagging will ease updating the libraries, since the FDA will scrutinize only the proposed revisions, which can be easily sorted from the original document. New products often require many revisions throughout the approval process, so companies that tag data from the outset can greatly streamline the time required to bring a product to market.
Fisher compares the adoption of XML with investing in an infrastructure. "If you pay now, you'll get the benefits. But if you jury rig just to get by, you'll always be chasing to catch up."
For more information on SPL, read Innodata Isogen's white paper "Turn SPL into a Business Advantage... Three Pitfalls to Avoid on the Road to SPL Compliance."
XML Cuts Through Archiving Record Dilemma
Companies and public sector organizations struggling to develop long-term strategies for archiving materials and records are increasingly beginning to view the creation of XML-based content repositories as a solution. In fact, standards associations for both the United States and Europe are now actively encouraging member organizations to embrace a common standard, which includes XML, for archiving documents.
Federal, state and local regulations that increase demands on retaining records for heightened scrutiny for security and legal processes are adding to the exponential growth in archiving. Just one subpoena for an historic document could send a company on a costly search of records and the software to interpret them, and failing to find that document could result in fines and other penalties.
XML’s primary advantage is that the file format contains the self-describing markup language or metadata that is independent of hardware and operating systems. Therefore it is able to store data in a format that is always readable by a generic reader. Once records are tagged in XML, retaining legacy software to interpret aging files is no longer a problem.
Federal agencies are increasingly requiring industries to file reports on medicine, consumer protection and accounting procedures in XML, and phasing out accepting reports on proprietary platforms such as Microsoft Word and Excel programs. Microsoft, meanwhile, is taking steps to maintain its Office Suite programs as the industry standard for generating business documents and reports. An open XML format supposedly provides the foundation for Microsoft’s new Office 12. The recently released beta version is to be refined into a commercial version in late 2006.
While XML can help solve the problem of deciphering archived records in the future, storing data still challenges existing technology. Tapes, which can hold vast amounts of data, can be time-consuming to search and can disintegrate from wear even when stored in an ideal environment. Compact disks can be searched quickly, but their capacity is limited and they too break down over time. Data stored on these media must be periodically migrated to new media.
Many businesses are opting to archive records on banks of hard disks, especially the new advanced technology attachment disks, which provide high speed access to stored data and have a mean reliability of 1.2 million hours. But even these provide only a temporary solution, since they too must be migrated to new disks as older ones age.
Where to keep the data is another problem in archiving. On-site storage allows immediate access, but no protection from catastrophic loss, such as a fire or a flood. For this reason, businesses generally turn to companies that specialize in archiving records to guarantee that the data they need will be there when needed.
No matter what the long-term storage solution, however, it’s clear that archivists will view XML as one of their primary tools to extract and access archived files.
LISA Director Recounts Growing Global Demand for Localization
What is LISA and how does it help support the goals of its members?
As the leading forum for globalization, at one time or another, we’ve helped many large multinationals, especially those who do more than 50 percent of business globally. We give organizations a head start in complying with international standards, help them integrate localization activities into their workflow and assess emerging technologies. The member archives on our Web site contain more than 1,000 articles addressing the full range of issues faced by our members. We also provide an index of best practices, what’s worked before and why. And we offer software packages like the LISA QA Model which is available for download off our Web site http://www.lisa.org/products/qamodel/ (and at a discount to members), to help companies manage the localization quality assurance process for all the components in a localized product.
What similarities do companies face in pursuing global expansion?
They all share a common goal of wanting to sell products and support their customers outside their home market. One common mistake many companies make at first is to view globalization as being just about translation. Once they learn what localization is really about, however, they generally begin to develop a grasp for what they need to do. At this point, most companies also begin to recognize the importance of product design, creating the look and feel of a product that’s produced nationally, not shipped in from the United States or another country. That’s when they really start to begin shaping strategies that will resonate in local markets, from advertising to customer support.
How many companies are pursuing global expansion?
I’d estimate that there are about 10,000 companies that know what it’s like to do business globally. You can see it in their products, and customer support policies. Much of the ground work is done internally, and then it makes its way to the Web. The company building blocks are the descriptions, definitions, procedures, the way they articulate their business, customer support strategies, and the way they express what their product does. When companies see the building blocks as words, policies and procedures and align them in open standards, they can repeat success and go into other markets with more success.
How have the challenges changed in past 15 years?
Everything is better, faster and cheaper. Frankly, scalability has never been more important. What people are doing now in industry, they didn’t even imagine 10 years ago. Today’s consumers are more sophisticated. There is more emphasis on getting to the market as quickly as possible. Because of the sophistication in the product development, companies can accomplish a lot more than they did years ago. Technology is solid, and standards are getting widely accepted. And more companies are thinking globally. The Internet has become part of the globalization focus and momentum. It’s powerful, and it’s encouraging.
How many companies are looking to coming in to America?
A fair amount, but the numbers are going to multiply rapidly over the next 3-5 years. For example, we’re hosting a workshop in Shanghai, April 18-21 on China turning its eyes to the West. Globalization is really becoming a two-way street. You’ll see more companies readily approaching globalization and learning the importance of language, as their sites, their products and their processes become cross-cultural. Open standards are becoming much more robust with more support and ROI.
News Briefs
Wikipedia Adds Hurdle To Posting New Entries
Users now are required to register before they can create articles for the on-line encyclopedia. However, existing articles can be modified without registering.
The change occurred less than one week after John Seigenthaler, who had served as an administrative assistant to Robert Kennedy, complained that a Wikipedia biography on him claimed that he had been suspected of the assassinations of the former attorney general and his brother, President John F. Kennedy.
Seigenthaler, 78, the former USA Today editorial page editor and founder of Vanderbilt University’s Freedom Forum First Amendment Center, was falsely said to have lived in the Soviet Union from 1971 to 1984.
The misinformation was posted for 132 days before it was removed after Seigenthaler’s son, John, a journalist with NBC News discovered the Wiki entry. The person who posted the false information has since come forward and admitted responsibility.
Wikipedia founder Jimmy Wales concedes that the new registration rules will not prevent people from submitting false information. However the process will make it easier for the Web site’s 600 active volunteers to review and remove errors.
Victims of misinformation have little recourse. Persons who submit or edit Wikipedia entries do not have to provide their e-mail addresses. Privacy laws governing telephone companies and internet service providers protect the identities of their customers.
Technology Companies Show Prominence
Google led the pack of technology companies in the public’s mind in the Harris Interactive and Reputation Institute list of the world’s more prominent companies.
Google ranked third in the list of 60 companies, not bad for an organization that is less than 10 years old and a fraction of the size of Johnson & Johnson and Coca-Cola, which ranked first and second. Other technology companies in the top 10 were Sony, Microsoft and Intel. Dell Computer landed at 15, just below Walt Disney. IBM climbed to 19 from last year’s 25 while Apple Computer rose to 27 from 34.
The two-part study was based on a poll of 7,000 respondents who were asked to name two companies with the best reputations and two with the worst. It then surveyed more than 19,500 additional participants to evaluate the 60 most frequently named companies based on the quality of their products and services, financial performance, workplace environment, social responsibility, leadership and emotional appeal.
Innodata Isogen News
Innodata Isogen Among EContent 100
Innodata Isogen has been named to EContent Magazine’s EContent 100 as a leading provider of content management, knowledge management and digital content production. The award recognizes leadership in the marketplace.
"Innodata Isogen is a leader – having assembled a broad range of content-related IT and BPO services, that, taken together, deliver unique and distinct value to the market,” Michelle Manafy, EContent editor, said. “The company’s energetic advocacy of structured information standards like XML and standards-based content management and publishing systems distinguish it from the crowd.”
EContent editors compile the list from companies representing a wide range of digital content disciplines. Others selected along with Innodata Isogen include ProQuest, Reed Elsevier, Wolters Kluwer, EBSCO, Google, Yahoo, IBM and Socialtext.
Innodata Isogen Hosts Digitization Webinar
The latest Innodata Isogen Webinar, “Maximizing Economic Value from Large-Scale 
Digitization Projects,” detailed many of the key lessons the company has gained over the past 15 years digitizing content for leading publishing, media and information services providers.
An archive of Webinar is available at www.innodata-isogen/resources/digitization.
Partner Corner
Forbes Honors FAST CEO
FAST chief executive officer John Markus Lervik was named to the seventh annual EGang list of Forbes magazine. The EGang – Masters of Information – are those entrepreneurs and companies that are figuring out how to separate the gold from the gravel on the Web, the magazine said. Search technology has grown so broad and deep that it is the basis for a range of new businesses, delivering intelligence via computers, cell phones and other smart devices.
TEMIS Takes Two Honors
TEMIS and TOTAL received the “Big Company / Small Company best relationship 2005” award of the Competitive Intelligence French Club or IE-Club. The honor was presented at the second annual Observatory Prize event attended by a representative of the French Ministry of Economy. Some 5,000 French and European companies comprise the Observatory, and the TEMIS-TOTAL partnership was selected from 13 finalists in the dual-team category.
Gilles Pouzenc, president and chairman of TEMIS, also received the "Entrepreneur of the Year" award in the "Realizing Business Potentials – Ile de France region." Ernst & Young honors entrepreneurs at the regional, national and world levels in more than 100 cities in 40 countries.
Topic Map Technology Is Framework For Ontopia’s Office Net Portal
By integrating topic map technology into Office Net Portal, Ontopia has created a Web-based framework for electronic cooperation and sharing of information that can be tailored to meet the size, demand and budget of a specific company.
Traditional company portals allow for sharing articles. With Office Net, communities and channels of important topics can be created within the company’s portal, such as news, calendar, discussion, documents, search, booking and CMR. This allows access to any authorized user with access to an Internet browser. Articles from other sources can be incorporated effortlessly, and content published through Office Net can be sent to other systems.
X-Hive Challenges Industry to Publish Test Suite Results
X-Hive Corp. became the first company to publish the results of the W3C’s XQTS Xquery test with its recent release of X-Hive/DB version 7.0
The new version is designed for organizations that manage large volumes of content. Key new features include path indexes that allow more detailed specification of nodes to index and allow multiple values to be used as index keys. It also has improved Lock acquisition priority and deadlock victim selection, versionable BLOBS and XQuery update statements.
XQTS test suite results for version 7.0 can be found at http://www.x-hive.com/static/XQTSReport.html.
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