MS STRUCTURES
The MS models can be similar to these of PD, with the exception that the MS groups by definition are colocated with their
corresponding manufacturing units. Therefore, the fully centralized model (see Figure 4) is not applicable. Although individual
MS groups are ultimately focused on supporting their local manufacturing units, global coordination between them in terms
of business processes, priorities, best practices, and instrumentation is essential. As such, the models in Figures 2 and
3 are appropriate, and their features apply fully to MS. Tight harmonization is particularly critical for multisite production
of the same drug.
Tangible benefits should be associated with the symmetrical organization of PD and MS, which would enable simplified coordination
and communication to better handle the typical push–pull dynamics between the two functions. It is easy to imagine and implement
additional organizational tools that link PD and MS, including teams, committees, task forces, and a global project management
function. These supporting elements are simpler to construct when the PD and MS organizations are compatible and structured
the same way.
CONCLUSIONS
The dynamics of the biotechnology business imposes challenging demands on the individual sites and on the global multisite
functions. Achieving a simultaneously high level of site autonomy while maintaining global coordination is a difficult task
that requires proper organizational structure for PD and MS. However, these objectives are not mutually exclusive. The PD
models outlined in Figures 2 and 3 provide a reasonable balance between the conflicting needs. These structures can incrementally
evolve, reflecting the maturity of the entire organization. The proposed models also enable the smooth integration of newly
acquired companies within the existing structures, without the negative effect of a complete reorganization or relocation
of the new entities. Variations of the proposed models can be found in the biopharmaceutical industry today. In most real
cases, however, the organizational structures are complicated by exceptions caused by historical or other reasons. Despite
the model diversity, there is a clear trend towards globalization of the distributed PD function.
Missing the opportunity to strike a balance between site autonomy and global coordination entails a significant cost. If the
PD groups are left disconnected, there will be a growing drift in direction, which will eventually result in inefficiencies,
technology platform misalignments, and lost opportunities. The opposite is also true: overwhelming central control may stifle
the creativity and innovation at individual sites. The organizational structure itself is an essential, but not sufficient,
requirement for these models to work. Active management using the power of global reporting lines is necessary to promote
common goals, priorities, learning, and standards.
Properly aligned global PD organizations have the following:
- Fast corporatewide distribution of best practices and technology platforms across the PD network
- Ability to globalize innovation sourced from different sites
- Flexible resource allocation, rapid responses to changing priorities
- Less internal competition
- Focus on external competition
- Improved efficiency through standardization of scale-down models, data- and knowledge- management systems, instrumentation,
and business practices
- Minimized redundancy and common priorities
- Global PD management shifted to a lower level in the hierarchy.
In addition to the right organization of PD, a symmetrical structure of MS can provide additional benefits, making a step
forward to the truly agile, ambidextrous enterprise capable of optimal management of short-term urgent projects, incremental
improvement, and disruptive innovation (2, 3).
ACKNOWLEDGMENTS
The authors appreciate the open discussion with the management of several leading biopharmaceutical companies. The support
of Dr. Eliana Clark of Genzyme is acknowledged with gratitude.
Konstantin Konstantinov* is vice-president of commercial process development and Steve Sofen is vice-president of project management, both at Genzyme. Konstantin.Konstantinov@genzyme.com
.
REFERENCES
1. K. Konstantinov et. al., presentation at the IBC Bioprocess International Conference (Anaheim, CA 2008).
2. M. Tushman and C. O'Reilly, Winning Through Innovation, (Harvard Business School Press, 1997).
3. C. Christensen, The Innovator's Dilemma, (Harper Business, 2000).
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