Small Biotech Companies Handle Most Regulatory Filings on Paper, Study Shows

Most small and mid-size biopharmaceutical companies still handle most regulatory filings on paper, recent industry research shows, despite the fact that larger companies and regulators are rapidly shifting toward an electronic environment. Executives at many of these companies, however, are seeking electronic options that can be implemented quickly and cost-effectively, but which also can be scaled up as the company grows and submits regulatory filings in more regions of the world.

These findings were some of the results of a series of focus group sessions conducted by Image Solutions, Inc. (ISI, Whippany, NJ), in which ISI asked growing biopharmaceutical companies about their business models, processes, and strategies, and their corresponding technology needs. The focus groups, which were conducted during the summer and fall of 2007, included executives from organizations in the biotechnology clusters in Boston, San Francisco, and San Diego.

Across the board, participants said that regulatory forces are driving change and are having a significant impact on how their organizations operate. Participants were queried on a range of challenges with a focus on how organizations are managing the huge amounts of documentation collected throughout the product development life cycle and their progress toward transitioning to an electronic environment.

Although participants recognized that building integrated processes is ideal, the reality is that this is difficult to achieve, they said.  The creation of cross-functional teams made up of staff from information technology, regulatory, and clinical departments-and supported by integrated technologies-remains elusive for most companies, according to the participants.

When asked about software solutions to help with the transition, participants in all three regions agreed that the scalability of a regulatory submission system was the highest priority.  A scalable system would allow them to comply with the electronic common technical document (eCTD) format for submissions. Such a system, they said, should allow them to easily assemble and review of eCTDs for submission to any region of the world, merge submission modules to create new submissions from existing data, and automatically rename files to meet regional guidance and naming conventions.

 Because these companies have limited resources and personnel, they need solutions that can be implemented quickly and at a low cost, focus group participants said. There were many divergent opinions, however, when the firms discussed any combination of software purchasing, renting, or blending, or, alternatively, outsourcing regulatory functions.

“Decisions on whether to buy software or outsource key functions are often dependent on a number of factors, including the number of compounds in development, stage of development, business model, or whether the company is partnering with a large pharma company that has already invested in submission software,” said Sue Simpson, managing director of West Coast operations for ISI.

Varied Regional Results

During the discussions, some regional differences emerged. The Boston focus group showed a strong predilection for outsourcing regulatory functions, while also looking for modular document management systems that can expand and contract as the company’s pipeline grows.  San Francisco participants showed the same tendency to outsource, but companies in that region are more likely to outsource data management.

The San Diego-area companies interviewed agreed with the Boston focus group, expressing a desire for expandable life-cycle management systems-often referred to as the “Lego brick” model-that fit to the changing needs of drug pipelines.  The most pressing need for these companies is finding ways to manage the large amounts of raw data that come in from disparate sources.