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Highlights from Axendia’s FDA e-Transformation Study - Part II

By Daniel R. Matlis

In this series of articles, we are sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study.  

We began the “FDA e-Transformation” series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics, to understand the Agency’s rationale and strategy for e-Transformation.  We also discussed how the FDA is pursuing a future where all regulated product information is electronic.

(To read the first article in the series, click on this link: FDA Pursuing a Future Where All Regulated Product Information Is Electronic )

In this installment of the “FDA e-Transformation” series, we highlight four key findings from this study:

• FDA’s e-Transformation drivers
• A new organizational e-Structure
• Don’t want to pave the cow-path
• Building  on a strong foundation: open-consensus based data standards

FDA’s e-Transformation drivers

Historically, interactions between FDA and the companies it regulates involved the creation, printing and delivery of volumes of paper documents. These documents may have been delivered as part of an application or reviewed onsite in the course of an inspection.

Over the last few years, FDA and the industry have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations.

A new organizational e-Structure

At the center of the agency’s e-transformation is the “Bioinformatics Board” (BiB).

The FDA established the BIB in order to achieve its goal for a modern, well-integrated, reliable, efficient and affordable information infrastructure to support the Agency’s administrative and regulatory business operations.

The BiB reports directly to the FDA Management Council.  The Board, in coordination with the Office of Information Management (OIM) determines the information management (IM) strategy for the agency.

•  The BiB works under a strategic framework for automation established by the Commissioner and implemented by the FDA Management Council. 
• The BiB coordinates and oversees all activities and decisions related to business automation planning, acquisition, and implementation throughout FDA, and ensure that the activities related to its charge are communicated to all levels of the Agency.
• The BiB also ensures coordination of activities among FDA representatives particularly with regard to business process planning and regulatory policies. These include the FDA Regulation Policy Council, the FDA Data Standards Council, and the Enterprise Architecture Review Board,.  The BIB also interacts with other federal health informatics initiatives such as the Federal Health Architecture program.

“We don’t want to pave the cow-path”…

…“The real promise of Electronic Review lies beyond simply receiving submissions in electronic format” commented Donna-Bea Tillman, Ph.D, Director of the Office of Device Evaluation CDRH.

The Agency is poised to provide a new target Enterprise Architecture (EA). This Target EA will provide a business-driven plan that describes the desired end-state for the FDA’s business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.

The primary purpose of the Target EA is to effectively plan a course for achieving the FDA’s strategic vision and goals. It is one element in a broader set of interrelated activities that collectively enable the FDA managers and staff to define a vision, develop strategies and plans for achieving the vision, make resource decisions, implement strategies and evaluate performance.

By defining the end-state from several distinctive perspectives (e.g. business, data, etc.), the Target EA will also provide stakeholders with a view into the complex relationships that exist among these different perspectives.

Building on a strong foundation: open-consensus based data standards

The FDA recognizes the importance of, and is committed to using open-consensus based data standards for regulatory submissions.

FDA divides data standards into two broad categories: exchange standards and terminology standards.  

• Exchange standards provide a consistent way to exchange information between organizations and computer systems. Exchange standards help ensure that the sending and the receiving system both understand unambiguously what information is being exchanged. For example, Structured Product Labeling (SPL) is an exchange standard for product information.
• Terminology standards, on the other hand, provide a consistent way to describe concepts. For example, the Unique Ingredient Identifiers (UNII), developed by FDA, provides a consistent way to describe substances in foods and drugs.

The agency is putting its money, where its mouth is

In November 2008, the FDA announced the award of up to $2.5 Billion in contracts to Modernize Information Technology over the next ten years. This award supports the cornerstone of FDA’s Information Technology and Bioinformatics initiatives, which include extensive IT modernization programs encompassing data management, data warehousing, IT infrastructure and IT security.

The benefits of FDA’s e-transformation could be “game changing”. Imagine conducting a label negotiation in real-time with FDA review staff, being able to cooperate and mark up documents in real time, or the possibility of reviewing SOPs and Batch record electronically with an investigator.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com   

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

Highlights from Axendia’s “FDA e-Transformation” Study

By Daniel R. Matlis

Axendia has recently completed a research study on FDA’s e-Transformation Initiatives. The study identified key organizational and technology initiatives the Agency is undertaking to advance ongoing electronic communication and interactions with the companies it regulates.

We will be sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study in a series of articles.  

To understand the Agency’s rationale and strategy for e-Transformation, we begin this series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics.  During our conversation, Dr. Oliva discusses transformational activities that promise to usher a new era of electronic interactions between the Agency and its constituents. 

The Janus Initiative

In Roman mythology, Janus was the god of gates, doors, doorways, beginnings and endings.  He was frequently used to symbolize change and transitions such as the progression of past to future, of one condition to another, of one vision to another.

This is a very fitting name, based on FDA’s intent for the Janus Initiative.

Axendia’s Life-Science Panorama Journal (LSP): What is the FDA’s Janus Initiative?

Dr. Oliva: Janus is a high level strategy to better manage structured scientific data for all FDA regulated products. Janus is an Agency-wide initiative to be used by all the centers at the FDA.

A key goal for Janus is to standardize data as they come in though the FDA’s electronic submission gateway.

The initial phase of Janus is to build a study data warehouse to host subject level data about clinical trials.

LSP: How will the Janus initiative impact electronic interactions between FDA and the companies it regulates?

Dr. Oliva: The goal for Janus is to provide a single repository for study data.  Sponsors would submit study reports as well as the data sets of the study used in human trials (be it a drug, biologic, device trial).

Janus will also provide standard modern and user friendly visualization, data mining and analytics tools. These tools will enable FDA to analyze data not only within a particular study, but across studies and applications as well as perform comparative analyses be it across multiple devices in the same therapeutic class or drugs across pharmacological class.
Janus will enable the FDA to:

• Establish an enterprise-wide data architecture and standards that facilitate the integration of structured scientific data from a wide variety of internal and external sources to create large-scale data-sharing infrastructures to support clinical trials, post-marketing, registration activities, and manufacturing life-cycle activities;

• Develop the standards-based scientific data exchange networks that are needed to ensure the quality, safety, and efficacy of medical and consumer products as defined by FDA’s regulatory mandate;Create structured scientific data repositories that support the acquisition, validation, integration, and extraction of data from the increasingly large and complex datasets received by the Agency;
• Make use of enhanced analytical, mathematical, visualization, and other computational tools and techniques that enable reviewers to search, model, and analyze data to conduct better safety and efficacy analyses.

LSP: Today, FDA Centers use different structures and formats for their applications, how will Janus work with these differing formats?

Dr. Oliva: Regardless of how the data come into FDA, (e.g. NDA, BLA, PMA) every center and each application type will have its own structure and format, but the study data will look the same across all the centers once standardized.  The Agency is relying very heavily on standards from organizations such as CDISC and HL7.
 
LSP: What is FDA’s involvement in the development of these standards?
 
Dr. Oliva: FDA is actively involved in the development of standards. We want these standards to be useful, not just for FDA, but for the regulated industry. Standards should meet industry’s business needs and processes so that they work for everybody not just FDA.

These Standards must support electronic reporting of information utilizing common variable name and, terminology code lists of observations. The standards must be flexible enough to model or represent study data that is generated across different studies type, whether it be for a device, drug, biologic or dietary supplement.

The Agency is also working on global applications harmonization with organizations like ICH and GHTF.

LSP: We can’t discuss Electronic interactions between industry and the FDA without touching on Part 11. How will FDA incorporated part 11 into some of the initiatives we have been discussing?

Dr. Oliva: Part 11 is very much in a state of flux. Part 11 only provides for voluntary submission of electronic data. In other words, companies may chose to submit electronically instead of paper, but we still receive study data on paper, and study data submitted on paper is very difficult to review.

Part 11 is not adequate to support Janus. We are proposing new regulation to require electronic submission of study data in a standardized format. The first application of the proposed rule we already announced would cover studies on drugs and biologics.

The long term goal is for all study data across the entire Agency to come in electronically and in a standardized format.

To realize the Janus vision, FDA must require all Industry/Agency interactions be electronic and that’s where additional regulation beyond Part 11 would be required.

LSP: What does the future hold for electronic interactions between FDA and Industry?

Dr. Oliva: I think it’s fair to say that Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn’t tell when that is going to happen, but certainly there are active discussion underway to move to an all electronic submission environment for all FDA regulated product information whether it be, Product quality, Manufacturing, Pre-market, Post market data.

Janus promises to usher a new era where interactions between the agency and its constituents (i.e. industry, and consumers) will be conducted primarily through electronic means.

The promise of electronic interaction would benefit everyone, but “the proof is in the pudding”.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc. 

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.