Process Development: Think Like a Scientist—Behave Like a Business - Scientists should develop into leaders who are capable of determining the optimum balance between science and business. - Bio
The management and oversight of the growing number of CMC project subteams has improved by employing standardized contracts
between the CMC review committee and CMC project teams, as well as through templates for presentations, benchmarks for resources
and timelines, and more experienced mentors or sponsors for CMC teams. Various contracts cover different predefined periods
of development. The review committee business process has been particularly effective in identifying the decision points (of
a total of four from inception to launch) at which a review is needed, boundary ranges for budget and timelines, and the information
and deliverables required to move to each successive contract stage (Figure 2).
PROCESS DEVELOPMENT ACTIVITY MAPS
Figure 4
PD activity maps provide a framework for describing the development progression of molecules from inception to launch. These
maps delineate each functional area's discrete activities, the average amount of time it takes to complete each activity,
and the typical resources needed to complete the activity (in our case, at the functional-area level, Figure 3). The initial
map was based on Genentech's experience over a number of years in developing MAbs. Additional maps have been crafted for other
proteins, small molecules, device development, postmarket changes, technology transfers, and antibody-drug conjugates. The
maps are aligned with development phases and CMC contract stages and also with non-CMC research and development activities.
These have been used to identify ways to attain greatest efficiencies. The maps are updated to reflect efficiency gains during
the course of the year and are leveraged to compare year-to-year changes and their impact on long-term plans (Figure 4).
Some examples of improvements that have affected the resources or timelines for the PD activity maps include the following:
Through the use of innovative technologies, the number of resources required for viral validation studies has remained relatively
flat, even as the volume of studies has almost doubled.
By defining business processes in partnership with regulatory affairs and developing submission templates, our CMC editors
have nearly tripled their productivity.
As a result of several improvements—the application of platform technologies, an increase in pilot-plant capacity, and advances
in technology—the number of transient cell lines produced for research and the number of stable cell lines have significantly
increased per full-time employee.
By changing the stringency of methotrexate treatment earlier in cell-line development and developing serum-free cell lines,
several months have been trimmed off the cell-banking critical path.
Figure 5
At Genentech, PD activity maps have become the foundation of many useful applications and processes. The maps allow resource
forecasting at the project and portfolio levels, thereby facilitating both short-term and long-term planning. Thus, metrics
(planned versus actual resource utilization) can be tracked, transparency and alignment between teams and functions in budgeting
ensured, process improvements quantified, and project contracts simplified. In addition, these maps can be used to propose
alternatives—"what if" scenarios—for drug development before a substantial investment is made. For example, they can profile
a scenario in which resources are gated until positive Phase 3 data are available (Figure 5).
