Managing Automation - November 2008 - (Page 44)

[ INDUSTRIES ] Transformation Integration TechWatch Industries only saves money, but also, as in Boehringer Ingelheim’s case, can generate millions of dollars by extending a product’s lifecycle. “By streamlining the submission process and providing higher-quality submissions, products hit the market sooner,” says Scott Mackey, product manager at Adlib Software, a vendor of document conversion, recognition, and publishing software. “Each day gained could be worth millions of dollars in extra sales.” RACING THE CLOCK “By cutting three to six months off the submission process, drug companies can save a fairly sizable amount of money,” says Health Industry Insights’ Louie. “The pharmaceutical industr y works against the clock in regard to patent expiration dates. Pharmaceutical companies have a limited time horizon in which to recoup the investment they’ve made in new drugs. If electronic submissions save them six months on the front end of the development cycle, a new drug could potentially come to market six months earlier than if it had been submitted on paper. This has the potential to save maonline managingautomation.com RELATED ARTICLES: Rx for the FDA Jitters www.managingautomation.com/fda Pharma’s Track and Trace Challenge www.managingautomation.com/industries24 Pharma Gears Up for Supply Chain Overhaul www.managingautomation.com/pharma COMPANIES MENTIONED: Adlib Software www.managingautomation.com/adlib Image Solutions Inc. www.managingautomation.com/image Octagon Research Solutions www.managingautomation.com/image drug companies very big money, as much as a billion dollars in some cases.” With the advent of electronic submissions, federal regulators can roll out policy changes much more quickly than in the languid days of paper-based submissions. As such, experts say, it is becoming more difficult for large life sciences and pharmaceutical companies to keep up. Just when pharmaceutical manufacturers are beginning to meet the challenges of eCTD, for example, a new electronic submission standard, called Regulated Product Submission (RPS), is on the horizon. “RPS is the next electronic standard that the industry is nervous about,” Kettinger says. “The drug companies have just managed to implement eCTD, and already the powers that be are talking about this new standard” (see sidebar, p. 43). For now, eCTD is well on its way to becoming the established standard for FDA electronic submission. If that’s the case, why complicate matters by looking beyond eCTD? Some industry watchers believe RPS will provide a more flexible approach to electronic filing than eCTD. And it will allow eCTD submissions, or even other electronic formats, to be submitted and managed as regulated product submissions. This is the reason that software companies, such as Octagon, are already gearing up to support RPS. Whether RPS or another electronic submission standard emerges in the future, one thing seems clear: Paper-based product regulatory filings are quickly becoming obsolete. To accelerate that move, AMR’s McDonnell is calling for regulatory authorities around the globe to follow the FDA’s lead in accepting electronic filings as the standard for submissions. The European Union, for its part, has mandated that all 27 member countries be ready to accept eCTD by 2009. ■ ma November 44 2008 http://www.managingautomation.com http://www.managingautomation.com/fda http://www.managingautomation.com/industries24 http://www.managingautomation.com/pharma http://www.managingautomation.com/adlib http://www.managingautomation.com/image http://www.managingautomation.com/image http://www.abas-usa.com http://www.abas-usa.com

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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