Pharmaceuticals, Data Standards and XML

SAS helps pharmaceutical companies quickly adapt to an ever-changing regulatory and business environment by Patrick O'Donoghue

As business manager for the pharmaceutical industry at SAS EMEA, I work closely with pharmaceutical customers throughout Europe, the Middle East, Africa and Asia/Pacific. Among the biggest industry challenges I see at the moment are how pharmaceutical companies can rapidly address and comply with impending global regulatory change – both from the FDA with respect to 21CFR Part 11, as well as from regulatory authority adoption of the International Conference of Harmonization's (ICH) Common Technical Document (CTD) format. These changes affect companies operating in primary global markets: Japan, Europe and the United States.

The ICH Steering Committee has been modifying and aligning both the guidelines and the technologies used for submissions using the CTD and the eCTD (the electronic version), with the final goal being to create a framework for a more similar – if not identical – set of requirements for submissions into the main markets. At the same time, the Clinical Data Interchange Standards Consortium (CDISC) is actively engaged in developing new, standardized data models that are intended for use across the industry and around the world.

In light of these global changes, I have invited SAS industry experts to share their thoughts.

Kohei Suzuki is a pharmaceutical sales manager and expert on the Japanese market. Suzuki can address the status of the ICH eCTD in Japan.

Suzuki: The initiative to introduce an electronic application has been hindered by the inherent differences between Japanese and Western languages. Because of these differences, Adobe Acrobat for Japanese operates differently from the English version, making it difficult to shift to electronic procedures. However, with the popularity of XML, the situation is expected to improve in the future.

At the same time, we are working toward utilizing the CDISC models while also moving toward compliance with 21 CFR Part 11. In Japan, because drug companies are protected by various domestic regulations, progress has been slower than in the West. The Japanese Ministry of Health, Labor and Welfare has begun the process, and an overview is anticipated for release in April. Currently, companies are required to show a plan as to how they are going to achieve compliance with Part 11.

Dr. Ed Helton, as an industry veteran, has been involved in the preparation of numerous drug submissions to the Food and Drug Administration and is currently a member of the CDISC board of directors. He can speak to the benefits regarding the regulatory changes and touch upon CDISC's vendor-neutral approach.

Helton: The concept of global harmonization is something that has been in the works for some time now. It is designed to reduce the duplication of work in submission preparation in different countries. It will also provide transparency with respect to proven efficacy and safety standards, with faster review times and faster time to market for drug developers. The impact is expected to be positive for everyone, especially the individual patient.

The CDISC's vendor-neutral approach is one that SAS supports and that the entire industry can benefit from. SAS has been serving the industry faithfully for more than 20 years and we intend to remain at the forefront by adapting to its changing needs.

David Handelsman, as an industry strategist at SAS' corporate headquarters and a clinical R&D expert, can cover the effects of the new regulations on pharmaceutical companies.

Handelsman: Companies that intend to market their drugs in the United States are bound to FDA regulations, and the principles behind the regulations make good business sense. In the case of the eCTD, providing effectively the same submission to each of the primary international regulatory agencies is much more efficient than building three separate submissions. Similarly, by adopting the CDISC standards, the time-consuming processing that each company applies to transform and analyze data based on their own company standards can be replaced by efficient industry-standard processing. Pharmaceutical companies will differentiate themselves by their research programs, not by their individual information processing strategies.

Susan Flood is a scientist and strategist for SAS' new discovery research efforts. She can provide insight into data management and analysis difficulties and how SAS is uniquely positioned to address the specific needs of pharmaceutical companies.

Flood: An overwhelming volume of data has made it more difficult to identify promising targets and compounds quickly and easily. Recent mergers and acquisitions have only increased the amounts of research data, the complexity of legacy systems and variety of informatics tools. Vital knowledge is spread across channels in separate organizations, and pooling the information manually is time-consuming and ineffective, not to mention prone to human error. The throughput demands alone are pushing these organizations to revamp their internal systems to be able to handle both the scale and variety of information as well as to capture best practices that help these organizations improve their rate of success.

SAS' new solutions enable scientists to simplify data access and integrate these disparate silos of data to make this valuable information usable. The collaborative formats facilitate the cooperation between scientists and statisticians to craft experiments with sound statistical design that generate high-quality results. Combined with SAS' advanced analytics, this enables scientists to consistently uncover patterns and associations within the volumes of data. This gives organizations the power to eliminate failing projects much earlier and more effectively channel their resources into areas that will bring a better return.

Anthony Friebel, a software development manager at SAS with expertise in XML, also serves on the CDISC Operational Data Model (ODM) team. He can share what SAS has been doing and what it means for our pharmaceutical customers.

Friebel: Besides the difficulties managing the volumes of mostly relational stored data they have accumulated, now our customers are seeing new technologies that aren't always compatible with their current IT environments. My team is tasked with providing the solutions our customers need to bridge that gap and to protect their prior data investments, moving them confidently toward newer technologies. As it became clear that XML was going to become an embraced standard for data communications, we began work on an I/O engine that could consume XML mark-up content. The SAS XML LIBNAME Engine (SXLE) is a vehicle for turning XML into just another data source for SAS software. SAS functionality enables users to read and write according to CDISC data models.

Business as usual
Certainly, SAS has a long and successful history of providing the pharmaceutical industry with leading information management and analysis technologies. Our customers have come to recognize SAS not only for our rock-solid support to address the current industry issues, but also for leading the way toward the future.

New regulatory requirements and new data communications standards can present challenges for companies that are not prepared, but SAS already has solutions in place to support our customers. Some, like the XML engine, are embedded within the core of our newest SAS releases. For others, dedicated R&D teams are developing industry-specific solutions that are designed expressly to support our pharmaceutical customers. This means "business as usual" as you continue to rely on SAS to support you in the evolving pharmaceutical research industries.

Regardless of what stage your organization has reached in this process, SAS has the solutions, the technologies and the people to help you prepare for success.