Throughout the product development and commercialization life cycle, life science companies need to serve two masters: regulatory requirements and business requirements. Integrating the interests of both requirements into one business practice increases productivity, improves time-to-market, and provides a higher quality product.
True information integration, from the lab bench all the way through final manufacturing, labeling, and FDA clearance/approval, can lower costs and produce operating efficiencies that result in a faster response to government regulators and customer needs.
These days, however, most life science firms are bogged down with processes that were created back in the early 1970s, when in response to expanding FDA requirements, companies focused on building quality systems that were separate from their other business practices. Designing the business around meeting the FDA mandates may have been a well-intentioned strategy at first, but it also led to additional burdens and more overhead.
Revamping operations requires an integrated approach that centers around sharing information to take advantage of other departments’ knowledge and skills. Information integration allows departments to enhance their performance by functioning like a true team, while taking full advantage of each person’s expertise.
For example, a device company’s regulatory staff’s work comes at the end of the R&D chain, when they write the new product application for the FDA. But if the information from R&D and clinical trials was integrated, productive discussions during early product development might benefit final regulatory submission and ultimately help to get the product to market quicker and with fewer post-market problems.
Many organizations talk about how they are team-oriented. But in my experience the talk at team meetings is often really informal business conversation, sharing information but not resolving issues. A collaborative integration tool can help colleagues share information electronically before coming together for the meeting. As a result, when they do assemble as a group, their preparation makes the meeting more effective and provides better efficiency for the entire project.
Life science companies that do not integrate their various groups often struggle to resolve issues. One department might purchase software on their own to respond to an immediate problem. Another will do something different to deal with a similar issue. Eventually, the IT folks are called in to knit these programs together, but they often do not have the ability, time, or expertise to make it all work.
Product-related problems such as recalls and drug safety issues rarely result from scientific negligence. They typically arise from a lack of information during the development process. Issues such as a drug design flaw that are discovered but not properly shared with other divisions of an organization might be avoided with better management of information.
Similarly, drug manufacturing groups that determine the quality of raw materials needed to fill production specifications, often do not talk to the R&D teams that developed the compound and know it best. Yet, these researchers often have the most knowledge about what is needed to assure long-term performance.
Project management where everyone involved in a team understands what is going on, what the issues are, and how the project is moving forward is a solution to the problem. For example, if researchers electronically share information gathered from their early experiences developing the product, manufacturing, and operations, people can find appropriate suppliers more efficiently. At the same time, development groups can gain information about new sources of raw materials from the manufacturing and operations groups.
Integrated enterprise software allows research organizations to fully leverage their knowledge assets across the entire organization. Modules for knowledge management and project management can lead to more effective collaboration with colleagues. By using electronic lab notebooks, automating the process for conducting clinical trials, and automating quality management and training management, life science companies can become true quality leaders.
There are signs that life science companies are starting to rethink their team-building strategies. Some have progressive thinkers at or near the top of management who appreciate the adept management of information. Look for this trend to continue. The competitive advantage that life science companies can capture through integrating information technology will accelerate the adoption of these systems in the next few years.