Anthony Strattner, Special Project Editor
August 18, 2004 | Two years ago, Endo Pharmaceuticals made the strategic decision to enter the electronic age of regulatory submissions. The Chadds Ford, Pa.-based company electronically submitted two new drug applications (NDAs) to the FDA for two different versions of its pain-management drug, oxymorphone. While the submissions themselves were largely successful (the FDA has deemed the drug "approvable" pending further efficacy testing), the demands of automating this core business process were eye-opening, says Rebecca Platt, Endo's supervisor of e-publishing, regulatory affairs.
Tracking all components of a regulatory submission along with the documents themselves using only Microsoft Project Manager and Excel spreadsheets "was a nightmare," Platt says. Despite having a document-management system in place, Platt quickly discovered that Endo's e-submission process was automated only at the margins. "We were, in effect, building the plane as we flew it," she recalls, "which I would not recommend doing."
| "We were building the plane as we flew it, which I would not recommend doing."
- REBECCA PLATT, ENDO PHARMACEUTICALS
As the submission deadline for oxymorphone approached, thousands of files needed to pass through Endo's regulatory department very quickly. During this crunch time, Platt's team had to focus on publishing compliant documents rather than tracking activities. Data tracking was set aside until there was a lull in the process, and then the regulatory team would estimate the metrics retroactively. The result: No one in the organization had a clear picture of the e-compliance process, its components, or how it could be improved.
Then Platt received a demonstration of ViewPoint, a process-management tool developed by Octagon Research Solutions to manage its own electronic submissions services business. Octagon had been helping Endo with the oxymorphone submissions. Even though ViewPoint was still in beta development, Platt immediately wanted to test the software as a possible solution.
For its part, Octagon was eager to do a "real-world" implementation of ViewPoint inside a pharmaceutical organization. So the two companies set up a pilot project designed to mirror a complex, multiformat, multitask e-submission process requiring different skill sets and resources. The subsequent success of the project, including the clear metrics defined and achieved, enabled Endo to win a Best Practices Grand Prize in Regulatory Compliance from Bio·IT World.
Two teams were created to execute similar tasks. "We wanted to draw people out of their comfort zone, as far as whom they'd normally interact with in the company," Platt says. "Mainly, however, we needed to compare the times taken for task completion to tell us how accurate our metrics were and the skill-level differences of users."
Endo mapped the workflow associated only with Item 5, the preclinical section of an NDA submission. They discovered 58 discrete tasks associated with that one section. ViewPoint captured all these tasks and deliverables, and integrated the data in a workflow engine designed to run bundles of workflows simultaneously.
In addition to keeping users up to date with data entry and all intended tasks, the software also provided guides to completing predefined tasks. Customizable metrics let Platt and her two pilot teams know if they were actually on track toward their goals.
Other benefits included access to real-time process information so that managers could redirect resources or alter strategy; task-level data that provided feedback on bottlenecks; the tracking and management of problems, from identification through resolution, so "broken processes" could be repaired quickly; and the ability to design future projects based on real organizational experience.
The next step is companywide deployment of ViewPoint. Endo will use the software for entire submissions, not just individual sections. Among those to be included are the project-management group, which will be able to monitor timelines, and the scientific communications group, which can solve content problems through the system.
Endo Pharmaceuticals' e-publishing, regulatory affairs team: (l-r) Bob Barto, Erika George, Mary Alice Raudenbush, Phil Wydro, Rebecca Platt, Jennipher Truesdale, and William Renn.
PHOTO of team by Michael Branscom