Garten's talk highlighted what CEOs must do to lead their companies, and in some cases, he said, some of the discarded activities could be assigned to someone else. If we try to apply this idea to any role, however, it raises an interesting question. If you had the obligation—or privilege—to discard 25% of your current activities, what would be on the list?
For biopharmaceutical companies, the items would vary by function, of course. Yet if we imagine the discard lists of managers leading biopharmaceutical process development and manufacturing operations, some of the items probably would include extensive filing requirements for manufacturing changes; scale-up problems; old-style process validation procedures that do not have real value; lengthy investigations into out-of-specification (OOS) test results; inefficient, slow, and manual processes for lot sampling and analysis; and effort and time spent trying to make automated systems communicate with each other.These activities, of course, are all things that companies would gladly give up. The challenge, thus, is not in coming up with the list of activities to discard, but in finding a feasible way to stop doing them.
Some of the above items require technological solutions. Because companies generally find it most feasible to implement new technology only early in development, the benefits of technological advances tend to be felt slowly, as new systems are used in the development of new products. And implementing such changes demands an effort and investment that are not trivial, and thus may increase workloads until the transition is complete. But automating process sampling, analysis, and other laboratory work could have benefits beyond speed by lowering headcount requirements for certain tasks.
Other activities mentioned above, such as scale-up problems, inefficient process validation, and lengthy OOS investigations, can be reduced as companies increase their process knowledge. But achieving such knowledge, like implementing automated solutions, probably requires a short-term increase in work, for example, to apply approaches like design of experiments and multivariate data analysis.
Progress in manufacturing science, however, can help reduce some of regulatory requirements. The FDA has been saying for several years that if manufacturers demonstrate in-depth process understanding, there should be some regulatory relief—particularly through the concept of design space—that allows companies to make manufacturing changes easier, with less red tape. The agency is expected to take important next steps in this direction later this year, by announcing reduced filing requirements for manufacturing changes, and by starting a Quality by Design pilot program for biotech operations.
Thus, it certainly seems difficult, in development and manufacturing operations, to find ways to give up current activities to liberate resources for future efforts. In many cases, the short-term result may be an increase in work, instead of a decrease. Yet such short-term efforts promise long-term relief, and progress in one area can have additional benefits in others. Given these reasons, such work may be worth it, and allow for future progress.
Laura Bush is the editor in chief of BioPharm International, [email protected]