By Deb Borfitz
October 20, 2009 | Moonbay Technology entered the field of regulatory document management and electronic submissions in June with an option affordable even to small biotechnology firms heretofore reliant primarily on homegrown, error-prone systems. With the release of Pipeline EDM, beta tested in 2007 and completely validated last year, all the relevant advantages of large enterprise document management systems are now within financial reach of emerging companies, says Jill Iacopi, Moonbay’s founder and CEO.
Iacopi previously worked as an independent regulatory affairs consultant and saw firsthand the problems small companies encountered when depending on their own self-styled file system, including lost documents and no version control. Someone inevitably started digging through boxes. Meanwhile, pressure was mounting from U.S. and European regulatory agencies to submit documents electronically. Absent better document management, her clients were wholly unprepared. “Document management and electronic publishing go hand in hand,” says Iacopi.
Pipeline EDM allows cash-strapped life science companies to obtain needed document management and submission services via outsourcing to Moonbay in exchange for a monthly subscription fee, lowering the total cost of ownership, says Iacopi. The only IT requirements are an Internet connection and a browser. Unlike most similar products on the market, “the application was built from the ground up with software-as-a-service [SaaS] in mind,” says Iacopi. Its chief competitors (including Image Solutions and Octagon Research Solutions) offer a submission publication service but interface with different document management systems. Pipeline EDM is an “all-in-one application,” so upgrades to its individual parts also happen simultaneously without unexpected technical interference.
Modules of Pipeline EDM include Research, Nonclinical, Clinical, Safety, Quality, Chemistry Manufacturing and Controls, and Regulatory Affairs.
Electronic submissions made by Pipeline EDM utilize the electronic Common Technical Document format, as mandated by the U.S. Food and Drug Administration (FDA), says Iacopi. “We can also manage legacy paper submissions and do paper submissions until a customer is ready to convert [to an electronic system].” More than 50% of all NDAs submitted to the FDA are currently being submitted in eCTD format.
Moonbay’s first few customers are, as expected, small companies, says Iacopi. “But we did get a couple of unexpected requests for proposals from big pharma,” which have increasingly been eying cloud computing (or SaaS) as a cost-cutting strategy. Pipeline EDM complies with 21 CFR Part 11 requirements. But to address any outstanding security concerns, Moonbay is willing to house and manage its server at the worksite of its customers. For companies disposed to web hosting, but desiring a bit more security, Moonbay will put its application on a private server.
“The take-home message is that regulatory agencies…are all moving toward a paperless world and, in order to accommodate [that reality], companies need more robust systems in place,” says Iacopi. Every member of Pharmaceutical Research and Manufacturers of America—representing more than three-fourths of the $65.2 billion invested industry-wide in discovering and developing new medicines last year—already submit their New Drug Applications electronically.
Pipeline EDM can help smaller companies cost effectively attain that goal and “be better prepared for acquisition due diligence and out-licensing,” says Lee Knoch, Moonbay’s vice president of sales and marketing.