2 A new department of global manufacturing science and technology (GMSAT) was created. Like some other growing biopharmaceutical
companies, Genentech finds itself manufacturing the same product at multiple sites in the internal and external network. The
role of GMSAT was created to ensure that processes, problem resolution, and improvements are treated in a synchronous manner
across sites. It mitigates risk and ensures long-term success in delivering products to patients, despite the growing complexity
of the pipeline. Moreover, the new GMSAT group both drives and benefits from Genentech's Product Operations initiative to
become a Class A organization.1 (Class A is a standard of world-class performance, independent of industry class.)
3 R&D expanded to Oceanside, California. This opportunistic expansion was made possible by the purchase of two manufacturing
sites (a bulk manufacturing facility and a clinical operations facility) from Biogen Idec. The opportunity the expansion presents
to PR&D is two-fold. First, the intent was to have the Oceanside PR&D department organized by cross-functional teams focused
on early stage development to handle the growing pipeline. This provides an immediate increase in the capacity for process
development. Second, the Oceanside site serves as an "incubator" for new ideas that can be tested with a team that is small,
but still has all the elements of a complete PR&D department. This department has been piloting novel technologies, innovative
information-technology systems, and new equipment.
4 The role of the process economics group was expanded. Even if there is an opportunity to make improvements in a process, it
does not necessarily follow that those improvements should be implemented into manufacturing. It is critical to identify the
opportunities and solutions that will have the greatest impact on the business. The process economics group easily pays for
itself in multiples. Some of the ways in which this group supports decision-making in PR&D at Genentech include the following:
- Evaluating crystallization versus chromatography for a new product
- Maximizing the value of developing a version 1.x of an existing product
- Analyzing the value of developing an alternative device to eliminate vial overfill
- Choosing among dozens of new technologies for long-range impact.
One of the underlying benefits accrued through a centralized business-modeling group within PR&D is the assurance of common
assumptions—"apples to apples" comparisons—across projects.
CMC REVIEW COMMITTEE AND CMC CONTRACTS
When organizations strive for efficiencies in the drug development process, they sometimes overlook the time and effort that
executives spend learning and making decisions. As a pipeline grows, the amount of time spent by senior executives per molecule
must decrease. Through the judicious use of functional-area committees and agenda-driven membership review, we were able to
reduce by half the number of executives required to serve on the CMC Review Committee (Figure 1). These efficiencies were
made possible by clearly defining roles and responsibilities (a component of Class A methodology) and by following Genentech's
standard decision-making model. This model identifies a single point of accountability—who is the decision maker for any given
decision? This individual is accountable for making the decision and for seeking the appropriate, informed input from others.
The discussions leading up to a decision can consist of vigorous debate, but once the decision is made, all stakeholders are
responsible for supporting and implementing the decision.