Managing Automation - November 2008 - (Page 43)

[ INDUSTRIES ] Transformation Integration TechWatch change of regulatory filings increases the consistency of the documentation and, hence, the transparency of information,” says Hans van Bruggen, president of The Netherlands-based eCTD Consultancy, a firm that advises pharmaceutical and biotech companies on time-tosubmission strategies. “Further, using the same exchange standards and structure of information, drug companies can work internally to gradually increase the amount of information and detail in their filings throughout the submission process.” eCTD has rapidly moved from the FDA’s preferred submission method to the mandated format for product regulatory filings in the United States, according to Alan Louie, research director at Health Industry Insights, an IDC company. Louie calculates that at least 50% of current pharmaceutical product regulatory submissions are delivered electronically. Eventually, as the FDA issues fewer exemptions to the rule, the compliance rate will likely climb. QUANTUM LEAP Since the eCTD mandate went into effect, technology vendors’ electronic filing capabilities have progressed beyond supporting paperless filings and electronic submissions to integrated software suites that support electronic data capture, content management, publishing, and tracking. According to Wayne McDonnell, research director at AMR Research, a good example of a vendor making progress with software that suppor ts electronic regulator y submissions, including eCTD submissions, is Octagon Research Solutions, a provider of software designed for the life sciences industr y. The company recently unveiled ViewPoint Quantum, its latest set of applications to help manufacturers manage the drug development lifecycle, from data collection to submission. ViewPoint Quantum combines electronic publishing capabilities with enterprise process management, allowing users to pull cross-functional content toward finalization and submission, according to David Kettinger, senior director of product management at Octagon. The software lets drugmakers manage processes such as data standards governance, data lifecycles, document management, and eCTD compilation and submission management. ViewPoint helps pharmaceutical manufacturers improve process efficiency as well as comply with eCTD mandates, Kettinger says. “By tracking and monitoring information electronically, drug companies can use the knowledge gleaned from their data to transform and improve their Industries manufacturing processes,” he says. “The software is designed to help companies alleviate bottlenecks during the process of compiling data for submission to the FDA.” ViewPoint is intended to replace the piecemeal tools and homegrown utilities that many drug companies implemented when filing FDA submissions electronically was voluntary, an option that has been available since the late 1990s. For instance, many drug companies used — and still use — spreadsheets to track documentation as it flows among various departments. By placing submission data in a centralized repository such as ViewPoint, drugmakers can more quickly manage and organize their submission content and scientific resources. Another company, Image Solutions Inc., an enterprise content management systems integrator and SaaS software provider, offers drug manufacturers a suite of services designed to streamline the drug development and regulatory approval process. In 2007, Boehringer Ingelheim, a German developer and manufacturer of pharmaceutical products for human and animal health, deployed eCTDXPress, ISI’s flagship offering for managing and reviewing electronic submissions. Using eCTDXPress, the company submits information about its products to regulators across the globe. By choosing eCTDXPress, the drugmaker has cut its internal support costs by approximately 40%. ISI’s service for supporting electronic submissions has enabled Boehringer Ingelheim to cut at least two weeks from its submission cycle. In the case of a blockbuster drug, worth $1 billion a year, a two-week time-to-market acceleration can mean dramatically increased profits. Streamlining the FDA submission process not RPS: One Standard for All he FDA’s eCTD standard is designed specifically for the submission of applications for human pharmaceutical products. It does not, therefore, meet the needs of submissions related to other regulated life sciences products. Another standard under development, the Regulated Product Submission (RPS), is intended to create one standard that can be used for the submission of any regulated product, encompassing those things not covered by eCTD, including, but not limited to, food additives, human therapeutics, veterinary products, and medical devices. The RPS would create a framework that allows life sciences manufacturers to send regulatory information using pre-defined parameters to identify and catalog their content submissions to the FDA and other governmental regulatory bodies. In this way, government reviewers, regardless of their regulatory authority, will be able to easily and consistently locate discipline-specific information. The RPS project was started in 2005, as the FDA leveraged its experience with eCTD. A draft of the standard was approved for trial use in 2006, and the first test submission using the RPS standard was submitted to the FDA in September of that year. T 43 November 2008

Table of Contents Feed for the Digital Edition of Managing Automation - November 2008

Managing Automation - November 2008 Contents Take 1 At One-Year Mark, Wonderware President Focuses on Empowering Plant Operators Oracle Demos Fusio Apps, Reveals Delays Baan Founder Says BPM Will Replace ERP Emerson Talks Wireless at Annual User Group Event Merger Complete, Intercim Focuses on Collaboration Notes Cover Story: The New Supply Chain Reality Special Report: Keep Out Integration: The On-Demand Interchange Industries: Ending the Endless Waves of Paper Product Scan Advertiser Index Next

Managing Automation - November 2008

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