Operations Excellence: The Art of Improvement

The concept is not new. Companies comparing performance and practices and then mutually identifying the best solutions to common operational challenges has been a part of business for years. What is different is that this is happening in the biopharmaceutical industry, which, until recently, has been primarily focused on filling the pipeline and on improving the manufacturing processes themselves. This focus was not misguided- the biggest challenge facing biopharmaceutical companies until the last five years was convincing everyone that they were legitimate players that can develop and supply therapeutics consistently, and not isolated success stories.

Now biopharmaceutical companies are facing what their older brother, the pharma industry, has already faced — competition, price controls, and talk of generics. With these emerging threats comes the realization that, in their haste to meet clinical and investor needs and bring products to market quickly, companies did not focus on becoming world class manufacturers. No longer can a company strictly be an innovator — it must also find ways to make its downstream operations more competitive. Companies are looking at reducing cycle times, controlling costs and headcount growth, improving process consistency, and reducing the overall time-to-market.

Several years ago, Tefen Ltd., an operations consulting firm specializing in the biopharmaceutical industry, hosted a Life Science seminar on Operations Excellence. Feedback from this seminar motivated Tefen to initiate and facilitate a regular forum within the industry. Thus, the Biopharmaceutical Operations Excellence Consortium was born. The first meeting was hosted by Genentech in April 2002 with 25 attendees from the leading biopharmaceutical companies on the West Coast of the United States. The group has grown to include meetings on the East Coast and in Europe, with a contact list of nearly 300 professionals from 40 different companies. Over 10 meetings have been held with attendance levels of up to 50 individuals — enough to generate good discussion without being overwhelming. Motivation from this meeting also resulted in the Biopharmaceutical BioBenchmark™ study, completed at the end of 2003.

Through the past few years, the activities in the meetings have included presentations, panels, plant tours, and workshops. In all cases, the key desire was to allow enough time for off-line discussion and real, face-to-face benchmarking. Attendance has been limited to high-level professionals from within the industry. Vendors were only included when the topic was consistent with their specialization (for example, a specific IT system). There have even been some interesting guests — Joe Dillon, an executive at a contract semiconductor manufacturer, provided an interesting perspective on outsourcing in a hypercompetitive industry. His presentation may have been a look into the future of biopharmaceuticals.

As you will see, the subjects are wide ranging — technology transfer, continuous improvement in manufacturing, and quality outsourcing. In all cases, the theme of the forum is operations excellence — driving waste out of the system and becoming more efficient. You can get further information on this topic by reading BioPharm International's quarterly Operations Excellence column, which summarizes meetings and highlights industry trends. Please contact excellence@tefen.com to join the mailing list. I look forward to seeing you at future meetings.