Marc Puich

Marc Puich is Partner at Tefen Ltd., 1065 East Hillsdale Boulevard, Suite 112, Foster City, CA 94404, 650.357.1120, ext. 117 Office 415.290-4580 Mobile marc@tefen.com.

A true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations

In the April issue of BioPharm International, the article "BioPharmaceutical Operations Roadmap," provided a summary of the key industry gaps executives would like to close in the next 10 years. These goals came to my mind while I was attending Interphex this April in New York.

Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.

All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.

Recently, 22 vice presidents of biopharmaceutical operations met in Boston to develop the first operational roadmap for their industry. This special executive-level consortium was organized to discuss two key questions.

Better supplier management can begin in parallel to production-related improvements.

The overhead expense that comes along with each new enterprise application adds up quickly, and can be somewhat invisible to owners of the system.

. . . Popular consortium meetings have focused on successful use of tools to drive improvement in cycle time reduction, deviation reduction, and improved production efficiency.

As with any partnership, working with a CMO can be complex. The level of trust and cooperation between both organizations needs to be extremely high.