| As the business world turns its attention from | | | | format, the leading players in Life Sciences and |
| back office automation to front office efficiency | | | | Pharmaceuticals were quick to make the |
| the need to streamline document and information | | | | transition; recognizing the opportunity to |
| management is starting to play an increasingly | | | | streamline their own processes and take |
| important role. This has never been more relevant | | | | advantage of the inherent cost savings. Even |
| than in the pharmaceutical industry. Enterprise | | | | companies not required to make eCTD compliant |
| Content Management applications, eCTD software | | | | submissions are seeing the advantages of an |
| and other information management tools all | | | | electronic workflow in accelerating time to market. |
| provide benefits that are designed to better | | | | They are finding ways to leverage the technology |
| manage information and streamline document | | | | and transform eCTD into suitable printed CTD. |
| workflows. As much as these applications aid in | | | | These companies have also seen the way the |
| general contributions to document management, | | | | wind is blowing with the news that the European |
| there are still further requirements in regulatory | | | | Union has mandated that all 27 member countries |
| submissions that the generalities of these | | | | be ready to accept eCTD submissions by 2009. |
| applications don’t address. The cost of | | | | Can the chapter of paper submissions be nearing |
| government and regulatory compliance leaves a | | | | its end? Can the rest of the world be far behind? |
| lot of room for improvement, a key area being | | | | There is no shortage of document workflow, |
| the document conversion and publishing process. | | | | rendering and output solutions available but the |
| The real and opportunity costs of non-compliance | | | | requirements for eCTD compliant submissions are |
| leave most companies spending an inordinate | | | | unique and require an integrated solution that puts |
| amount of time and money ensuring document | | | | the focus where it belongs, squarely on delivering |
| quality and compliance. What if there was a tool | | | | final submissions that can handle the complex, |
| that would not only automate document | | | | ever-evolving landscape of this leading edge |
| conversion and publishing but reduce the need to | | | | industry. The documents for an Investigational |
| perform quality checks and balances? Streamlining | | | | New Drug Application (IND) or New Drug |
| the sub mission process not only saves money | | | | Application (NDA) submission are always “in |
| but it can generate millions of dollars on the back | | | | play”, constantly under review, endlessly |
| end of the life cycle of the product. This article | | | | annotated and eternally being “improved”. |
| talks about real-world process improvements, | | | | These improvements must not corrupt the |
| cost reductions and the opportunities for | | | | perfection of the submission, which is often the |
| streamlining document submission processes, | | | | result of post-production re-rendering where |
| highlighted by applications with proven track | | | | critical errors are made or repeated. |
| records. | | | | Software applications, like those offered by Adlib |
| Time to market has always been a critical | | | | Software, avoid these pitfalls by focusing on |
| success factor for manufacturers and marketers | | | | document rendering quality while employing a |
| of consumer products. But when every day’s | | | | design philosophy of stable, open protocols and |
| delay can mean millions against your bottom line | | | | standards such as XML and Web services. |
| and when your product might mean the | | | | Adlib’s document transformation technologies |
| difference between life and death for millions of | | | | streamline the rendering process for documents |
| people worldwide, the stakes are that much | | | | being used in the submissions process. By |
| higher. These are the stakes that leaders of Life | | | | integrating seamlessly into the document |
| Sciences and Pharmaceutical companies must | | | | workflow, any source document can be easily |
| contend with every time a new drug or | | | | rendered automatically into a submission-ready |
| technology is faced with regulatory approval. For | | | | PDF. |
| a blockbuster drug like LIPITOR® or | | | | Robust rendering is the core |
| NEXIUM®, that are now prescribed in excess of | | | | Robust PDF rendering forms the backbone of any |
| $10 million every day, reaching the marketplace | | | | document management workflow and is the |
| quickly can make or break the financial quarter or | | | | lifeblood that flows through the entire eCTD |
| even a full fiscal year. High stakes indeed. | | | | submission lifecycle. By creating higher quality |
| The regulatory minefield | | | | renditions, quality assurance churn can be reduced |
| For Life Sciences and Pharmaceutical companies, | | | | to only minutes per document. This is a significant |
| time to market is always held hostage, to some | | | | process acceleration over traditional QA cycles, |
| degree, by the global regulatory landscape. Few | | | | searching for missing, broken and invalid |
| industries face regulation on the same scale and | | | | hyperlinks, that usually takes hours to complete. |
| level of complexity. Such intense oversight and | | | | The cost savings, projected over submissions |
| scrutiny is reasonable for an industry of such | | | | running into the hundreds of thousands or even |
| intricacy and potential impact on the health and | | | | millions of pages, have proven to be enormous. |
| wellbeing of much of the world’s population. | | | | Submission-ready PDFs are infinitely flexible and |
| At the same time, the agencies that impose | | | | contain an almost limitless set of features. These |
| these regulations, like the Food and Drug | | | | PDF outputs can be readily equipped with essential |
| Administration (FDA) in the United States, face | | | | elements like version control, downgrading, font |
| intense pressures of their own. | | | | embedding, automated Table of Contents |
| Recent media and congressional examination of | | | | creation, audit history and submission taxonomy. |
| several high-profile cases in the drug industry | | | | These PDF documents are also flexible and |
| have put the FDA and its international | | | | scalable at every stage of the submission |
| counterparts firmly on the defensive. This is not | | | | lifecycle, particularly important given the |
| good news for the industry. Scandals surrounding | | | | FDA’s increasingly aggressive use of |
| first the cardiovascular effects associated with | | | | post-marketing “risk minimization action |
| Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), | | | | plans” (RiskMAPs), including the requirement to |
| and more recently the “sleep driving” and | | | | submit additional safety information (such as |
| “sleep eating” side effects of popular new | | | | larger safety studies to screen earlier for |
| insomnia treatments are causing a significant | | | | relatively rare potential adverse reactions), after |
| retrenchment within the regulatory community. | | | | the original submission is made. |
| The FDA in particular is facing growing pressure | | | | The right instruments: powerful, flexible and nimble |
| for congressional action to address these issues | | | | When it comes to partnering with leading edge |
| but the proposals currently under consideration, in | | | | players in Life Sciences and Pharmaceuticals, Adlib |
| the opinion of many industry players, would harm, | | | | Software is uniquely positioned to supercharge |
| not improve, patient safety by making it more | | | | the submissions process with its powerful |
| difficult to get promising new drugs approved and | | | | document transformation framework anchored |
| into the hands of doctors and patients. | | | | by Adlib Express Server and Express Web |
| The FDA has also been perceived in the past as | | | | Services. For more than 10 years, Adlib has |
| “cozying up” to the industry and of | | | | enabled several key industry players to gain a |
| rushing promising new drugs and technologies to | | | | competitive advantage by maximizing the |
| market without an adequate paper trail. The result | | | | efficiency of document workflows. The difference |
| of this perception, justified or not, is heightened | | | | with Adlib Software’s solutions compared to |
| scrutiny, leading the agency to become | | | | some of the other PDF rendering engines is that |
| progressively more conservative and defensive in | | | | Adlib Software cut its teeth working with global |
| its decision-making and in its approach to | | | | Life Sciences partners to ensure that the quality |
| reviewing and approving submissions for new | | | | and fidelity of its PDF renditions not only meet but |
| medicines and technologies. At the same time, | | | | exceed the demands of regulatory submissions. |
| promising new areas of study such as the Human | | | | Several of Adlib’s customers have reported |
| Genome Project (HGP) are turbo-charging | | | | savings amounting to millions of dollars with the |
| innovation and discoveries in the research | | | | majority of the direct cost savings coming from |
| community. In fact, the Wall Street Journal | | | | substantial QA cycle time reductions due to |
| recently cataloged over $1 billion worth of | | | | unprecedented confidence in PDF rendering quality. |
| currently pending IPO filings and there is a growing | | | | QA has been reduced to a couple of minutes |
| collection of existing bio-engineering companies | | | | compared to what used to take hours. Given the |
| applying HGP concepts in the marketplace. | | | | sheer volume of document rendering that takes |
| The combination of more rigorous oversight, | | | | place for just one submission and multiply that by |
| increasing threats of litigation and the explosion of | | | | the number of submissions performed each year, |
| complex, technology-driven areas of research | | | | the numbers add up quickly. The indirect impact, |
| have created a perfect storm for companies | | | | although harder to measure may even have a |
| looking to succeed in this complicated landscape. It | | | | greater impact on the bottom line. By streamlining |
| has also led to an atomic explosion in the size and | | | | the submission process and providing higher quality |
| complexity of submissions related to new drugs | | | | submissions, product hits the market sooner. As |
| and technologies. Though this cutting edge | | | | mentioned earlier, each day gained could be worth |
| research is conducted using the latest technology, | | | | millions of dollars in extra sales. Not a bad ROI is it. |
| it is remarkable how often the key results are | | | | With its advanced publishing features and support |
| compiled and maintained on nothing more | | | | for multiple formats including MS Office-based |
| sophisticated than a series of unconnected MS | | | | sources, Adlib Express Server applications give |
| Word documents and even hand-written forms. | | | | companies all of the advanced features necessary |
| Documentation for a single research study may | | | | to significantly accelerate submission compliant |
| consist of tens of thousands of pages with a full | | | | document workflows. Some of these features |
| submission including multiple study results | | | | include automated, accurate optical character |
| documents. Extend this over multiple jurisdictions, | | | | recognition (OCR) to create searchable files from |
| different languages, add in the complexity of joint | | | | images and PDFs, stamping to create headers, |
| ventures, patent laws, sub-contracting and | | | | footers, volume numbers and cross-references |
| outsourcing research and it is hardly surprising that | | | | from hyperlinks, as well as dynamic Tables of |
| some FDA and EMEA (European Medicines | | | | Contents generation capabilities. Importantly, Adlib |
| Agency) submissions were traditionally delivered | | | | Express also normalizes hyperlink styles to meet |
| not by the box load but by the truck load. | | | | FDA standards and includes advanced |
| Electronic submissions: technology to the rescue? | | | | bookmarking control with the ability to merge and |
| When every day is critical, ensuring that you have | | | | or volumize PDFs based on page count, size or |
| effective electronic regulatory submission | | | | other variables. Adlib solutions are XML-ready with |
| processes and technologies in place is “table | | | | XML Job Ticket support and Web services. A |
| stakes”. Having leading-edge document | | | | truly complete solution. |
| management technologies coupled with | | | | Adlib Software then takes things to the next level |
| collaborative document transformation tools, on | | | | with its Exhibit product. Exhibit enables |
| the other hand, is a significant competitive | | | | organizations to leverage existing XML backbones, |
| advantage. The effective implementation of these | | | | as well as folder structures for Rest of World |
| technologies can significantly accelerate submission | | | | (ROW) submissions in either paper or volumized |
| lifecycles that contributes directly to the bottom | | | | PDF formats. Exhibit works with eCTDs as well as |
| line. | | | | other submission formats (e.g. 510k) and with |
| Preparing submission compliant documents, | | | | other applications to provide the ultimate in |
| typically in PDF, is a time-consuming and highly | | | | flexibility and interoperability. |
| iterative process critical to successful submissions. | | | | Exhibit was developed in partnership with several |
| As discussed earlier, the highly collaborative and | | | | world leading pharmaceutical companies to |
| fractured nature of the research and | | | | automate the process of creating paper-based |
| development process means that many of the | | | | submissions from eCTDs. It’s a collaborative |
| original source documents that make up the | | | | browser-based solution that optimizes the |
| submission need to be manually reworked. The | | | | capabilities of Adlib Express Server to prepare |
| rework stems from deficiencies inherent in MS | | | | electronic submissions for print or volumized PDF |
| Word, particularly the inability to retain key | | | | destinations. It includes the ability to convert |
| navigation information during conversion to PDF. | | | | electronic hyperlinks into paper-based bookmarks |
| This kind of manual rework is time-consuming, | | | | and references as well as automated features |
| prone to error and, not surprisingly, very | | | | that allow for intelligent document assembly; |
| expensive. These deficiencies can be overcome | | | | modifying Tables of Contents, page scaling, the |
| during the PDF creation process by having the | | | | application of headers and footers, page numbers |
| right technology in place. | | | | and the insertion of tabs and slip sheets. All of |
| Not all solutions are created equal | | | | these advanced operations are available with |
| The excessive size of these submissions is also a | | | | Express Server but leveraged through applications |
| significant burden for the agencies themselves. For | | | | like Exhibit. |
| its part, the FDA plans to streamline and simplify | | | | The benefits of a solution like Adlib Express |
| the process by moving all submissions to an | | | | Server is that the scalable conversion, publishing |
| automated electronic platform by the end of | | | | and OCR functionality can be leveraged for not |
| 2007, with the caveat that this may be pushed | | | | only regulatory submission processes but it can |
| out to a later date. The standard, known as | | | | also be applied across the entire enterprise to |
| eCTD (electronic Common Technical Documents) | | | | create a complete rendering framework for all |
| is an interface between industry and agency for | | | | sorts of document workflows. The robust |
| transferring regulatory information while at the | | | | infrastructure of Adlib Express Server is designed |
| same time taking into consideration the facilitation | | | | to be a foundation for growth that allows Life |
| of the creation, review, lifecycle management and | | | | Sciences and Pharmaceutical organizations to take |
| archival of the electronic submission. The | | | | advantage of existing investments in skills and |
| specification has set criteria that make electronic | | | | technology to achieve document management |
| submissions technically valid, and any | | | | efficiencies that truly support the critical work |
| eCTD-compliant submission prepared in any | | | | they do on behalf of humanity and their |
| compliant environment can be transferred to | | | | shareholders. These solutions are also flexible and |
| another environment built on technology from | | | | scalable enough to act as the launching pad for |
| another vendor. In theory it sounds ideal, | | | | adopting innovative new methods of information |
| however in practice it should be remembered that | | | | management to achieve competitive advantages |
| not all technologies are created equal. | | | | over time. |
| With the FDA demanding the use of the eCTD | | | | |