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Good information management is essential to help pharmaceutical companies efficiently translate large amounts of data into drug market applications, achieve fast time to market and reduce costs and in Europe, many companies and regulatory agencies are actively assessing the potential of the EMEA's XML-based Product Information Management initiative.
Global pharmaceutical companies are increasingly competing in the strategies and processes they employ for the management and exchange of information, which are critical to product development, delivery and quality, customer service, business‑to‑business relationships and competitive positioning. Although most industry sectors are under the same pressure to develop in this area, it is the pharma industry, which is faced with dozens of commercial pressures, that shows the greatest need for information management.
The constantly evolving knowledge of disease, biology and genetics demands increased R&D, which is already inherently expensive; research-based pharma companies typically spend 1020% of their revenues on R&D. In addition, the length of product market exclusivity, competitive pressure and rigorous regulatory procedures means that companies must carefully examine costs to increase their chances of a good return on investment. As such, managers must look at how information is managed internally and how efficiently it is translated into drug market applications.
To meet the industry’s considerable needs for information management, new standards and procedures have been developed. The first initiatives in this area, Europe’s Product Information Management (PIM) initiative and the US’s Structured Package Labelling (SPL) initiative, relate to requirements for labelling and product information. These initiatives are essentially the same in design and goal, and are becoming increasingly important to the pharma industry as well as to overstretched agencies charged with reviewing the millions of pages of information associated with drug submissions.
The status in Europe
PIM was established by the European Medicines Agency (EMEA) to develop a better and faster way of handling pharmaceutical regulatory information, covering the practical requirements of Summary of Product Information, Labelling and Package Leaflet. Although the system is still in the pilot stage, it has already been used by GlaxoSmithKline (UK) for new active substance submissions, and by Genzyme (MA, USA) and Merck Serono (Germany) for submissions for post‑authorization procedures.
PIM describes how the exchange of electronic information in regulatory submissions is conducted and validated between companies and regulatory bodies, and is based on Extensible Markup Language (XML), which enables the dynamic exchange of information across multiple documents, reports and publications at many levels in a company’s activities and reporting. XML can also manage a variety of structured and semistructured inputs, link with databases and internet portals, and allow navigation and the dynamic re-use of information.
Today, the pharma industry is actively reviewing XML-based PIM for delivering operational needs in the area of information management, as well as its potential to meet future requirements. However, although the system offers considerable potential for companies working towards more efficient and streamlined information management, it demands expertise and care in the design and translation of product information into the XML environment and interaction with other information systems.
The industry must be patient when it comes to getting products to market, which can take up to 10 years and hundreds of millions of dollars in R&D per successfully launched product. By increasing control and improving the way information is managed, however, there is the potential to increase efficiency, and reduce costs and time to market. Better information management systems would also enable companies to better manage their audit trails.
Ultimately, time to market is crucial and a key factor to a product’s success; for example, with blockbuster drugs such as Pfizer’s Lipitor or Merck’s Zocor achieving global sales of $100200 million per week, even small improvements in the efficiency of information management could add hundreds of millions of dollars to the bottom line for many companies.
The benefits of information management also feed through to regulatory agencies that are under pressure to streamline the review process and increase efficiency. In the cancer field alone there are more than 2000 drugs or drug candidates in the development pipeline, creating a mountain of information that will eventually be reviewed. At a time when regulatory agencies are expected to have better control of marketed products (and are themselves under increasing scrutiny), growing pressures from the burgeoning drug pipeline, the need for greater rigour and the threat of litigation have increased the volume and complexity of regulatory submissions.
New biopharma drugs in the post‑genomic era also add complexity because companies seek not only to prove the case for their own submission, but to differentiate them from their competitors’ submissions as companies compete both for regulatory and reimbursement approval. Initiatives to improve the regulatory application process are largely being pushed forward by the regulatory agencies themselves.
Moving into the electronic era
For most companies, regulatory submissions are based on conventional word processor files and consist of thousands of pages of information. The demands this created more than a decade ago were unacceptable, but the IT capabilities available today make change essential to address the deficiencies of the system. In conventional systems, the need for duplication because of navigational deficiencies, and the time‑consuming and repetitive nature of manual updates make this system prone to error and expensive.
The need for development in this area has led to the Electronic Common Technical Document (eCTD) for the exchange of regulatory information between the industry and regulatory agencies. The FDA announced that it would handle all submissions as eCTDs by the end of 2007 and, likewise, the European Union has mandated that all 27 member countries should be ready to accept eCTD submissions by 2009.
Where do companies go from here?
Implementation of PIM systems must be carefully managed and meet the individual needs of companies. In particular, a holistic view of the information exchanges and dependencies across the regulatory submissions process must be developed to ensure that information solutions are applied to greatest effect.
Although the final phase of PIM is not yet completed, the EMEA has said that companies beyond the six or seven within the EMEA programme are actively assessing PIM. “This is also being pushed by the development of SPL in the US and by companies focusing on ways to manage information worldwide,” explained a senior PIM manager at the EMEA. “PIM is about improving information management and re-using information to improve the quality of the documentation. However, PIM also involves changing processes and using new technologies that people need to get used to. It is also about managing that change,” they added.
The disadvantage of not using PIM/SPL is that information is not reused, leading to inconsistency, manual input errors, repetition and delay. This problem, however, is not just limited to the step of exchange between the regulator and the pharma company. In fact, PIM/SPL should not be treated as a project that is wholly the domain of regulatory affairs.
Recommendations for improving information management are as follows:
Dr Bruce Sharpe
is Head of Technology at JustSystems.
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