Information quality is always important. In the life sciences sector, however, information quality, or its absence, can be a matter of life and death. Even if poor quality information can be worked around, it is draining precious time and resources away from other activities that might improve the efficiency and effectiveness of the care being given.

With there being an accelerating movement towards digital healthcare information the targets for both minimal and optimal levels of information quality are in fact being raised. The issue to be weighed is the fact that achieving even minimal levels of information quality can be expensive and can require a deliberate program of investment in content technologies. Fortunately, the movement towards digital healthcare information and services is happening at a time when there is a substantial body of knowledge and experience that has already been built up, typically within the contexts of other industries where information quality is critically important.

Among the most important of the lessons learned from past investments is the importance of leveraging intelligent automation to assist in the creation, management and delivery of high quality information resources and services. One of the areas of particular interest for the life sciences sector will be the role automation can play in validating content and facilitating the progressive elimination of errors and their sources. As has been illustrated, especially within the Aerospace and Defense sector, extraordinarily high levels of information quality can be achieved and sustained in ways that save time and money even when compared to activities that had been performed in order to meet far less exacting quality measures.

This presentation will introduce some of the background about the science of content validation and verification that is available to companies in the life sciences industry in its quest to achieve ever higher levels of quality. 

Expiring patents, increasing shareholder and customer expectations, rising competition, and expanding regulations put pressure on Life Sciences’ firms to find effective ways to produce reliable content. Developing a repeatable process for creating, managing, and delivering content efficiently saves time and money, strengthens the bottom line, and builds a solid foundation for future growth.

Life Sciences organizations create huge amounts of content. They put a lot of time and effort into creating this content—both from a regulatory perspective, and from sales, marketing, and customer perspectives. Yet, much of the business critical content is locked away in silos. It does not provide maximum value to the organization because it is not easily discoverable, is hard to share, lacks consistency and structure, and costs much more to create than it should. It doesn’t have to be that way. Content can be aligned to business goals and strategies—even across silos—by adopting a unified enterprise content model.

Learn how companies in various regulated industries:

• Manage content through the development, manufacture, approval and marketing of a product
• Maximize intellectual capital while satisfying regulatory requirements
• Reduce time to market
• Address a global market

This session provides an understanding of a unified content model and identifies both the roadblocks and the reality of a common model. Topics include:

• Understanding a unified content model
• Steps required to achieve a unified content model
• Roadblocks and realities of moving to a unified model

How do you get through to consumers bombarded by so many marketing messages? Hear Michael Silverman, CEO of Duo Consulting discuss Marketing in an Connected World - using content to drive results when the customer is in control.

In this cluttered world, people wait until they need information, and then search for it - putting the customer in control. Because of this new reality, you need to make it easy for the customer to find you, and provide a way for them to talk about you.  Learn why the best marketing involves a dialogue with your customer and get tips on how to encourage such dialog to take place.

Silverman will discuss what to do, and not to do, when bringing your brand online, and he will explain why you should focus on solutions, not products. You will also learn how to be open and “share” your brand by interacting with clients to gain credibility online. You will come away from this session with an understanding of the new rules of Marketing in a Connected World.

Developing medical devices that run on embedded systems is a regular practice in the life science industry. Very often these embedded platforms are single-purpose, proprietary systems, built from the ground up with little to no dependence on common programming frameworks or operating systems. For local markets, the product typically works as intended. However, when those devices get into the hands of global users, a said company can be inundated with urgent requests to create versions of the product into various languages in order to comply with international regulatory requirements. Panic quickly ensues once it is realized that the devices, more often than not, fail to completely support the language scripts, formats and conventions for the requester, be it users in Western Europe, Brazil or Japan.

The process of creating “global-ready” medical devices to support languages and conventions outside of one’s local norms always seems to inevitably fall into the realm of afterthought, leading to painful, costly and time-consuming efforts to retrofit products to support each subsequent language release. It does not have to be this way.

This session aims to briefly outline the most common globalization issues found in medical devices through visual examples and case studies. By outlining best practices of global product development, participants will gain awareness of methods for avoiding – or at least minimizing – globalization issues from the start. With these concepts in mind, design of new “global-ready” product lines or a full revamp of a popular device can allow for faster, more efficient, lower cost and nearly painless global release efforts.

During this presentation, a comparison will be made with the most recent advances in the IT space for embedded product interfaces, what lessons life science companies can learn, and the common platforms that exist for embedded devices today. The session will also provide a bigger picture of how localization of embedded products fits into the overall globalization cycle including the testing of localized embedded products. As a take-away, a “Dos and Don’ts” checklist will be provided that developers or technical writers can use to determine how well their devices stack up against existing globalization best practices, and as a guide for future medical device development efforts.

There is no prior knowledge of the subject required to attend. This session is aimed at all those involved or interested in globalizing medical devices to make an efficient and repeatable process.

Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.

A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.

The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review. 

However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.

The impact to the company’s stock price over three years is shown in the chart below.

This presentation will describe:

• Regulatory and business drivers behind the eCTD format
• Technical components of an eCTD
• Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
• Global picture for adoption of the eCTD format
• Future direction for the eCTD format
• Role of electronic document management in the eCTD lifecycle
• Top 12 Issues FDA Has with eCTD and how to avoid them
• Preparing submission-ready source documents and data for submission in eCTD
• Whether to purchase an eCTD publishing system or to outsource.
• How to prepare for the technical challenges of eCTD

The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.

Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.

Join this session, which will explore new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.

As companies increase their investments in emerging markets, Web globalization has crossed-over from luxury to necessity. But successfully taking a website global isn’’t easy. Every new market and language poses a host of new cultural and technical challenges.

This session provides attendees with a solid grounding in web globalization best practices through profiles of real-world medical and pharmaceutical websites, including Eli Lilly, Pfizer, and Johnson & Johnson.

Yunker will share key findings from his recent study, The 2008 Web Globalization Report Card, in which he rated more than 200 global Web sites across a dozen industries.

Attend this session if you want to learn about:

• Global navigation: Tips on improving user traffic to your localized websites.
• Global design: How to design a global website that is both globally consistent yet locally flexible.
• Global content management: Trends in managing websites across brands and borders.
• Translation memory and machine translation: How companies are using these technologies to improve customer support on the web (and lower costs).

Every organization struggles with how to store, tag, and search for their documents. In a hospital corporation, the need is particularly critical. Hospital staff need to be able to quickly find the latest policies and procedures. Auditors need to be able to track who made what changes and when. Lawyers want to know which protocols were in place on a particular date. In this session you’ll learn a practical approach to putting a document management system in place that can help address these needs and reduce your exposure to legal, regulatory, and even human health risks.

Based on lessons learned during a real-world project, the session shows that getting your documents under control doesn’t have to be a multi-year, multi-million dollar effort. The session will outline how a hospital corporation in New England used a “start small and grow” approach to piloting and rolling out a document management solution across the corporation.

Topics covered include:

• Business benefits of getting your documents under control
• Document management concepts such as metadata, versioning, and workflow
• A high-level methodology for document management implementations
• Common pitfalls
• Leveraging the benefits of open source software

A 15 month-old law extends the current XML prescription drug labeling requirements to OTC, medical device, and veterinary manufacturers. The FDA has not established a date for compliance yet, but it is a major topic of discussion with many observers expecting early2009 as a possible implementation date. The good news is that SPL no longer represents unknown territory. The experience of prescription drug companies to date has provided lessons-learned and sound tactical or strategic approaches to SPL.

In.vision is the leading provider of SPL authoring software, with a client list that includes major pharmaceutical companies and the FDA. This session is designed to provide both a survey of the SPL requirements, and a walk-through of the actual authoring experience of creating SPL compliant labels in Microsoft Word.

This session is designed to give those responsible for delivering and maintaining web content a look at the best approaches to create and serve relevant and personalized copy to providers and patients derived from any advertising channel. Discover how savvy marketers are using the latest tactics to coordinate cross-media campaigns, track results, and generate follow up communications without needing support across multiple departments or firms. 

Real time data profiling can serve unique web content to visitors referred from static or variably printed pieces with amazing accuracy. Virtually any media (including TV, radio, billboards, magazine ads and more) can be used to drive web traffic to a site that captures both demographic and psychographic information that gets the right message, to the right customer, at the right time.

The topics to be covered in this session include:

• Comparing traditional shotgun marketing (web, print, etc) to highly targeted methods
• Developing world class 1:1 marketing campaigns in virtually any media without busting the budget
• Understanding the various methods for generating personalized content including purls and real time profiling
• Creating highly targeted marketing campaigns using integrated micro-sites and personalized url (purl) landing pages
• Segmenting prospects and conducting real time personalization to serve web visitors specific content regardless of their entry point
• Providing personalized and highly relevant content from database analysis, web content, list and market procurement, and list and market analytics
• Improving response rates by capturing “soft responses”
• Decreasing cost per response by coordinating media messages
• Collecting and comparing metrics across all media
• Implementing automated follow up and fulfillment processes
• Winning new clients by combining media outlets without investing in new lines of business

Ever have a project fail? You met with your project team, you talked with the customer, you reviewed technical requirements. But did you talk to your users? Just as one diagnosis doesn’t fit all patients, one application’s approach doesn’t work for all users. Know who accesses your information and uses your applications. Only then choose your features. Using a case study of a multinational project covering four countries, 10 business units, and tens of thousands of content elements, we’’ll explore personas, scenarios, and other user-centered techniques. We’ll look at identifying users as well as segregating content according to users and regulatory needs.

What was involved in this cases study?

First we analyzed the 10 business units and their approaches and definitions of business goals. Next we analyzed industry standards for medical devices and their usage.

But that wasn’t enough. We interviewed 40 people in 4 countries, and created an information architecture prototype. We then tested this prototype in hospitals, doctors’ offices, and on site where medical devices were in use.

Based on this contextual inquiry, we refined the architecture and our understanding of the users. Decisions were then made on what type of content would be both appropriate and legal for each user and in each country.

Only with a solid understanding of the users and their goals could we define a flexible, extensible, and usable information and content architecture.

Most of an organization’s information is stored in unstructured medical records with cursive handwriting. By using a new technology that understands how the documents are used and what role they play, you can classify and extract more information from both handwritten and machine-printed documents. Courtney Rand will focus his discussion around the toughest challenges in optimizing forms processing and medical records management today—unstructured document processing and handwritten cursive recognition—and the new generation of technology available to solve these problems. This presentation will explain the state of current automatic classification technologies, how they interact with recognition technologies, and explain how to implement such a system with maximum functionality and results.

Rand will discuss Intelligent Word Recognition (IWR), a lies at the heart of his company’s recognition software products and is optimized for processing data on real-world documents that contain mostly free-form, hard-to-recognize handwriting. The best use of IWR is to eliminate a high percentage of the manual entry of handwritten data on documents that otherwise could be keyed only by humans. IWR differs from Intelligent Character Recognition (ICR) primarily in that conventional ICR technology recognizes data fundamentally at the character level, while IWR recognizes data at the word or “field” level. A2iA’s IWR engine is capable of extracting all types of field-based information from a form - either constrained (machine print, hand-printed capitals) or unconstrained (freeform hand print, cursive) from virtually any type of document.

The IWR process of converting a written word into computer-usable data occurs in a series of top-down stages. IWR provides a competitive advantage for operations that rely on the conversion of paperwork into computer-usable form, such as data entry departments of big government agencies, large financial institutions, and service bureaus. In many cases, IWR can automate data entry at a cost so low that it enables A2iA customers to successfully compete against offshore service bureaus located in countries such as India and China

Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects’ human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process.

• Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management – from regulatory, financial, and efficiency perspectives.
• Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.

Inspired by an open letter blog post by diabetes advocate, Amy Tenderich, asking Steve Jobs to bring his design genius to the medical device industry, Adaptive Path created an experience design concept known as Charmr. The concept was created based on research with diabetics and diabetes experts. Since the project was announced, the video showing Charmr has been seen at diabetes conferences around the world, and has been viewed by nearly 20,000 people on YouTube.

The most important objective of this project was to NOT approach it as an “engineering or technical problem”. As an experience design firm, we wanted to approach it from the users’ perspective: what is it like to live with diabetes? The idea was to show with our user centered design process that it is possible to make devices that fit the lives of their customers more comfortably and naturally.

In this presentation, attendees will learn about the Adaptive Path approach to this challenge and how medical manufactures, technical writers, information architects, and interaction designers might adopt this approach to improve their products, writing and training.

The web has changed how people interact with healthcare. Like most self-service experiences on the web, people are looking to exert more control over their healthcare…but what does this mean in terms of the design of your website? How is the web responding to this evolutionary paradigm of self-service?  What is your visitor’s mindset and what motivates them?

Mona Patel will discuss current trends in healthcare website usage and explore what innovation means in the healthcare vertical. She’ll address Web 2.0, enhanced navigation techniques, the benefits of mash-ups, and how social networking impacts the healthcare community. Healthcare websites are becoming more persuasive and emotionally engaging, taking users beyond basic usability principles. Mona will discuss these trends and innovations, and provide an overview of applicable research findings. Attendees will learn how this research is impacting healthcare website design. Topics to be explored include: content personalization, mobile access, communications and interactions with healthcare professionals (meeting HIPAA requirements) and new navigation techniques for finding content. This session will help attendees improve their ability to serve website visitors, in the present and in the future. 

Bring your own anecdotes to share! This is an ideal opportunity to network with peers who share the desire to promote customer experience within their organizations.

The experiences of two distinctly different communities to bring their healthcare information online will be explored in these case studies. In one case, the protagonist is a major institution responsible for setting healthcare standards and distributing funding for innovative public health programs. This institution set out to establish a web portal that would provide an integrated view of useful health information for the public. This particular undertaking immediately ran into a tangled web of issues ranging from jurisdictional sensitivities through to the technological challenges of aggregating, into some kind of useful and authoritative view, tens of millions of pages of health information.

In the second case, an independent agency in the pharmaceutical sector determined that it needed to modernize its venerable compendium of pharmaceutical products and to deliver, using the accumulated content and editorial wisdom, a new generation of intelligent drug look-up tools. In this effort, one of the immediate issues encountered was the fact that information suited to print published will not exist in a form suitable for driving intelligent online behavior.

In both of the cases, a number of key lessons emerged that should resonate with everyone interested in applying modern content technologies to the management, improvement and deliver of effective health information as a digitally accessed service. These case studies illustrate, graphically, the types of challenges that need to be addressed and the magnitude of the benefits that can be realized when these challenges are overcome.

The Structured Product Labeling (SPL) era is drawing closer as FDA prepares to require SPL for divisions beyond CDER. SPL is a format for Labeling based on XML that allows better (more complete) and faster communication of the content of labeling to FDA, NLM, and consumers. Just as Pharma was grasping for solutions three years ago (before the October 2005 mandate for SPL), OTC, Veterinary, Devices, Biologics, etc. are asking the same questions now that the mandate is on the horizon. Hoping to leverage past pharma experience, this panel discussion is a unique opportunity to learn the basics of preparing an Structured Product Labeling (SPL) strategy and answering the basic question of “what do I need to know about SPL”.

Each sponsor will cover:

• Company background/situation
• SPL approach decision
• hat you wished you had known before the SPL era that you didn’t know

Then it’s the attendees turn to ask questions.