The Flow of Data from Bench to Bedside: Finally Enabled by Electronic Submission.

by Dirk Karsten Beth, President of Mission3, Inc.

As with other industries, information is the substrate of Life Sciences, yet the Life Sciences have been slower to adopt information technology than other industries. Aircraft manufactures have been "virtually" test flying aircraft for decades now. The financial industry has been working with electronic regulatory submissions for about the same amount of time. But we are at a new age of life sciences, a period where discovery through bedside will be enhanced through the use of information technology.

The greater adoption of IT in Life Sciences is being driven not only through the clear benefits in quality and efficiency that we can all understand, but through market pressures and changes in the life sciences industry. Fewer blockbuster drugs and a higher failure rate in the discovery process; pharmacogenomics requires management of an ever increasing number of products in the portfolio; greater regulatory pressure; global development; biosimilar, biogeneric and generic pharmaceuticals are all affecting the way pharmaceutical and biotechnology companies operate. The response to this market pressure is a more efficient and effective industry — lead by information technology.

The true power of IT systems is first realized as the data flows freely from one system to the other and, as Life Sciences companies automate more processes internally, integration will lead to increased efficiency and quality.

Bioinformatics are significantly improving the discovery process. More data is being processed, visualized, and utilized. Business systems are supporting improved project management and collaboration as well as providing better visibility into the entire drug development process. More automated, dynamic clinical trials are providing more reliable data. And now, finally, we are seeing significant enhancements in the creation and management of international regulatory submissions in the Life Sciences. As these systems are pulled together, we will see a much more efficient Life Sciences industry.

The electronic submission process, now being fully embraced by the international regulator community, received another promising step forward as the US Food and Drug Administration withdrew all other guidance on submissions. The FDA is planning that as of 2008 submissions will all be based on the electronic Common Technical Document.

In itself the eCTD means little more than a simplified submission creation and review process. But when Life Sciences companies, large and small, evaluate what potential business advantage can be wrapped around submission management, the importance of the eCTD is incredibly significant. And again, the IT underpinnings of this technology are the driver. In accepting electronic submissions the regulatory body has gained advantages in review, approval, and archiving. Obviously, any benefit to the regulatory body translates into a benefit for the sponsor.

The tangible upside for the sponsor comes from the tools that are used to manage an eCTD. Like most computer based systems an eCTD management tool can provide huge advantages in accuracy and efficiency. It is important to consider the eCTD as an output of the submission management system and not the system itself.

Unfortunately, many submission management approaches focus only on the output, that is, achieving a eCTD compliant submission. This goal is a minor acheivement of submission management because any system can be designed to output a structured and well-specified format.

Added value of electronic submission are the features provided by your submission management system.

• The electronic submission process can cut 3-6 months off drug development time.
• Submissions to multiple regions, supporting multiple dosages and indications can be conducted in real-time.
• Compiling follow-on submissions (submission lifecycle) is greatly simplified.
• Document and link integrity is greatly improved ensuring overall submission quality.
• Submission data can flow from their source — in multiple systems — directly to the submission — increasing speed and quality. For example — clinical and document management systems. This is in essence an integrated approach.

The submission is simply the communication channel used to transmit information to the FDA and other global regulators. Regardless of the role of each member of the development team, their thoughts should focus on what is going to be communicated to the regulators. Clearly these principles are the guide for specific functions in regulatory and trial design, but what about the other groups, what about the underlying systems?

The various information systems may hold data that can flow directly into submissions. Clinical, Adverse Events, LIMs, Process Manufacturing and Document Management all have information that has a place in the submission. Increasing efficiency, quality and data integrity are all served in moving this data directly through from these systems to the submission system. Currently this data is gathered, formatted and compiled by humans that can make mistakes and take crucial time.

The eCTD submission standard is a small step in the right direction, but the giant leap comes from the IT infrastructure and integration that can really make the process flow seamlessly from bench - through regulator - to bedside.

Mission3 (an LSIT member) provides enterprise software solutions for Life Sciences companies including project-based document management, global electronic submission management, enterprise project planning, publishing, and xml content authoring. The solutions are largely web-based and are focused on integration using modern web-services. Mission3 is currently integrating their solutions with Oracle's E-business Suite and Oracle's Life Sciences Stack to enable cohesive flow of an enterprises data. For more information visit www.mission3.com.