This article is the second in an ongoing series intended to share insight and provide guidance to the pharmaceutical industry through a proven set of best-practices and case studies within the strategic consulting, business intelligence, data warehousing and data management disciplines. My first article described the current environment for pharmaceutical drug discovery and development.

Drug Discovery and Development is a business process supported by several line functions, including Research, Pre-Clinical Safety, Clinical Pharmacology, Clinical Research and Development, Drug Regulatory Affairs, Clinical Safety, Epidemiology and Marketing. Their high-performance teams must—throughout the entire cycle—continually cooperate with the highest precision when finding information and sharing results from countless sequential and parallel tasks.  As demanding and sophisticated as they seem, the teams’ greatest challenges are in the application architecture they use when processing the operation. Drug Discovery and Development architectures consist of numerous applications storing data in different physical formats, as well as in diverse DBMS/storage technologies. While these architectures deliver rich functionality on the front end, they are flawed with resulting silos of data on the back end. These silos are neither integrated nor easily accessible. This “data rich, but information poor” paradigm is overcome through the determination of highly-motivated team members who exhaust every option for extracting data, consolidating information, and formalizing results for review and distribution. The work gets done, but at a significant cost to the operational environment! Here, the value of data warehousing, with an accompanying self-service analytic and reporting environment, is gaining traction in the pharmaceutical industry. It is viewed not only as a proven, experience-based approach to empower teams with insight and necessary information, but also as a conduit for increasing operational efficiencies, reducing costs and accelerating decision-making processes.  

This article, as well as the next two in the series, is taken from case studies that demonstrate how these supporting line functions of the Drug Development and Discovery process have taken strategic steps to reengineer their processes. They have also increased operational efficiencies within their standard operating procedures (SOPs) and business operations.   

Drug Regulatory Affairs

In an effort to comply with national and international health authorities, Drug Regulatory Affairs is the primary contact for all correspondence. They ensure that drugs under development, as well as those currently on the market, comply with all worldwide regulatory requirements. Within their domain, they are responsible for the submission of the initial and annual updates for the Investigational New Drug, the New Drug Application and other key regulatory documents. The Investigational New Drug must be submitted to the Food and Drug Administration (FDA) before the drug can be evaluated in humans, while the New Drug Application (also known as the Registration Dossier) must be submitted to the FDA before the drug can be marketed. Both are significant undertakings which fully stretch all line functions as the amount of information accessed, assembled and then formatted—according to FDA regulations—is immense. As stated in last month’s article, it was common for a New Drug Application to be significantly greater than 100,000 pages.  Moreover, the mandatory copies oftentimes weighed half a ton or more! 

Most importantly, these regulatory documents are always prepared and delivered under strict, well-defined operating procedures with underlying, repeatable sub-processes. Consequently, a solid foundation exists where respective line functions can take proactive steps in expediting these repeatable sub-processes. This can be done under a data warehousing, self-service, analytic and reporting environment. 

This case study involves an innovative, global pharmaceutical company who recognized the previously mentioned foundation. Consequently, there was a golden opportunity to profoundly impact the business operation. The company needed to accelerate the preparation of the FDA-required Investigational New Drug annual update. Their preparation for individual clinical study and summarized clinical safety sections of the report was a manual process—taking   weeks and sometimes even months to complete. This preparation was needed because of unnecessary time and resource consumption and justifiable scrutiny for lack of validity due to manual compilation and assembly. Another problem was that information was occasionally submitted after the regulatory deadline. In fact, their greatest challenges were extracting data, consolidating information and formalizing results from at least seven applications and their respective data silos. 

The pharmaceutical company took proactive steps, and designed, developed and deployed a data warehouse with a web-enabled, self-service, business intelligence reporting solution. This now generates, formats, versions and even integrates the clinical study and summary clinical safety sections of the FDA-required Investigational New Drug report into their enterprise document management system. The reporting environment delivered several analytical views for a submitted Investigational New Drug and can be generated simply by pushing the enter key. These include:         

• A summary of Individual Clinical Studies, including the status of each study whether it is in progress or completed during the current year.
• A summary of the most frequent Adverse Events (AE), according to frequency and body system. 
• A summary of the most Serious Adverse Events (SAE), according to frequency and body system.
• A list of subjects who died during their participation in the “evaluation,” as well as their cause of death.
• A list of subjects who discontinued their participation in the “evaluation” as a result of an adverse event, whether or not it was considered drug related.
• Clinical Studies not conducted under the submitted Investigational New Drug.
• A summary of Safety Reports submitted to the FDA.

The qualitative and quantitative benefits produced a superior return on investment. As a result, these benefits built creditability, generated support for further investment in data warehousing and explored other opportunities to increase operational efficiencies across the entire business operation.

Recent articles by Tim Furey

• Quality Assurance Framework Lowers Total Cost of Ownership
• Spending Trends Demonstrate Value of Business Intelligence and Data Warehousing
• The Business Value for Investing in Pre-Clinical Safety Data Warehousing
• Pharmaceutical Drug Discovery and Development: Serious Adverse Events