Operations Excellence: The First Operational Roadmap for The Biopharmaceutical Industry

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:

1. If you were to build a biopharmaceutical operation in 2016, what would your organization's ideal operational state consist of?

2. What gaps need to be bridged in the next 10 years to reach that goal?

Marc Puich

The concept of an industry roadmap is not unique to biopharmaceuticals. In the early 1990s, advancements in the semiconductor industry were becoming prohibitively expensive and required a significant level of collaboration between the companies that excelled at designing integrated circuits, like Motorola and Intel, and those that specialized in manufacturing the precision production equipment, like Applied Materials and Nikon. In order to mature, the industry needed consensus on the future direction of technology, the materials that would be used, and the sizes and scale of manufacturing that would be available. In 1992, the first version of the National Technology Roadmap for Semiconductors (NTRS) was developed by a collaborative group of industry, government, and academic representatives, with a goal of documenting this consensus.

This NTRS roadmap has advanced and matured over the years. Now called the International Technology Roadmap for Semiconductors (ITRS), it includes working groups from Japan, Taiwan, Korea, Europe, and the United States. Significant resources from participating companies keep this 15-year plan current, and it is released annually.

The ITRS is interesting for three reasons. First, the semiconductor industry is highly competitive, where success can be measured by pennies on the dollar. Even in such an industry, each player realizes that the benefits gained from cooperation far outweigh the risks of innovating alone. ITRS demonstrates cooperative competition or "coopetition." Second, there is significant involvement from early-phase R&D resources, including those from outside of the industry. Academic researchers make up 21% of the ITRS membership, so universities are defacto extensions to the industry's R&D horsepower. Finally, the ITRS provides a clear focus for smaller industry vendors that develop supporting software, hardware, and materials for the larger manufacturing firms. By having a clearly spelled out set of requirements, vendors can make sure to develop what is needed, on-time, with less risk, but with potentially more competition. Obviously, this is of great value to those larger companies.

How is this relevant to the roadmap we are developing for the biopharmaceutical industry? First off, ours is not technology focused. Advancements in cell culture and purification technology did not fall within the scope of this discussion, although they may be relevant for future versions. This initial roadmap will be more strategic and focused on industry needs from an operations perspective. Second, it isn't nearly as detailed (and does not need to be.) Tefen and industry are not yet willing to dedicate the resources required to drive the level of depth seen in the ITRS.

Making a protein is actually much simpler than making a semiconductor chip, which may include over 600 discreet manufacturing steps. Additionally, the biopharmaceutical industry has not yet fully matured. Although there seems to be some convergence in processes and technologies, there is yet to be a true common production platform that all companies are leveraging. So the focus of the roadmap is on those things that need to be worked on over the next 10 years to bring the biopharmaceutical industry in line, from an operations perspective, with best-in-class manufacturers. In this case, operations is defined as manufacturing, quality, supply chain, and development.

Below are key goals that the group identified for their own organizations, and for the industry as a whole. The roadmap will provide more detail about the gaps to achieving these goals. These key operational goals provide the framework for the roadmap:

• Rapid transfer from lab to commercialization

• Rapid process improvement

• Flexible, multiproduct facilities

• Improved cost of goods

• Improved end-to-end cycle times

Examining the path to achieving each of these goals, we identified a number of key steps that need to be taken to close the current gaps. Included in the steps are:

• Increasing industry collaboration on issues related to regulatory oversight and common raw material suppliers

• Establishing a consistent approach to developing and manufacturing products

• Providing better product characterization and improved process understanding

• Focusing more on product lifecycle management and sales and operations planning

• Using risk analysis to support decisions across the supply chain

The final roadmap document, which will include more goals, will be summarized by the end of December as a whitepaper on www.tefen.com.

The next step is the 2007 BioPharmaceutical Operations Excellence Consortium on the outputs of the roadmap (www.tefen.com/bio). Each topic will become the theme for a meeting, with companies, vendors, and nonbiopharmaceutical speakers providing a targeted group of attendees' insights into the tools and processes that may help close the gaps.

In late 2007, another Executive Consortium meeting will be held to review roadmap status.

We hope that this approach will result in significant improvements to the industry performance overall and potentially accelerate the move from a development-focused industry to one that can call itself world-class in operations.

Marc Puich is a partner at Tefen, Ltd., 1065 E. Hillsdale Blvd., Suite 421, Foster City, CA, 94404; Tel 650.357.1120 x117, Fax 650.372.1350, marc@tefen.com