GAINING EFFICIENCY THROUGH PD BUSINESS PROCESSES
To better coordinate the generation and execution of an integrated development plan, a structured PD team (PDT) process was
established. Each team consists of a representative from each of the four disciplines (i.e., cell culture, purification, analytical,
and pharmaceutical development) and from manufacturing technical support. Each team has a leader and a project manager; these
individuals are responsible for driving the planning, coordinating activities, and tracking execution against the goals. The
team leader is responsible for driving decisions, mitigating problems, and representing the process develpment department
at higher level teams, such as CMC teams. One PDT is designated to champion each development program. The teams are sponsored
by PD management, who provide strategic input into the project plans, and align and prioritize resources across projects.
Figure 5: Process development (PD) team business process diagram. A structured business process allows for consistent planning,
prioritizing, and delivery on multiple programs in a resource-constrained and time-limited business. The inputs into process
development work (top box) come from a wide range of stakeholders (right tall box) and vary in scope from product development
strategy to a specific request such as responding to a regulatory question. The inputs are organized into an integrated process
development plan with key goals and milestones (beginning of cycle). The PD teams drive compilation of such goals and milestones
and integrating them into a detailed plan through iterative coordination with line functions. Work is prioritized and resources
allocated by management and executed by functions. The team updates are one of the outputs of the team, which are periodically
reviewed for strategic guidance or realignment as needed. Data, recommendations, and materials are other team outputs that
are provided to the stakeholders to complete the circle of product-development interdependencies.
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Figure 5 depicts the PDT process for planning, prioritization, execution, and communication. Based on the inputs from external
and internal stakeholders, the PDTs develop an integrated PD life cycle plan for each project, including detailed milestones
and success criteria for each stage. The plans, the status, and the decision points for all teams are reviewed and prioritized
by PD department management as the plans are being executed by the line functions. Periodic review of status and risks facilitate
timely cross-functional decision making, raise awareness of current program problems, and provide cross-functional learning.
The deliverables are also communicated or provided to external stakeholders in the appropriate forums, who might then give
additional input.
The effectiveness of PD is enhanced by establishing team structures, optimizing business processes, developing clear expectations
for roles and responsibilities, and committing the organization to build, train, and mentor strong teams as centers of excellence
in product development.
CONCLUSION
PD can be the leverage in product development performance where the speed and effectiveness of learning from each program
to develop and implement process technologies can shape the overall cost, timelines, and results of new product introductions.
PD life cycle planning enables a disciplined approach to PD for a given product and facilitates learning across programs to
minimize rework. Establishing an integrated approach among the four disciplines of PD to answer critical questions early in
the development cycle ensures timely and appropriate adjustments to the overall program plan and better use of resources.
The development and application of process platforms with small-scale models that are predictive of manufacturing-scale performance
leads to cost effective product development. Establishing a business process that facilitates integrated planning and decision
making is a precursor to well-coordinated execution. Overall, PD life cycle planning, combined with continuous business process
improvements, allows for efficient delivery within the fast-to-market complex biological product development paradigm.
ACKNOWLEDGMENTS
The evolution of process platforms has been a result of the efforts led by Yas Saotome, previous head of cell culture process
development at Shire (currently at Alexion Pharmaceuticals) and David Nichols, head of purification process development. The
analytical automation technologies were introduced by the immunoassay and bioassay group (Jeffrey vanDoren and Laura Trubiano,
led by Brian Lentrichia). The authors acknowledge the inputs into the PD life cycle by Chun Zhang (current head of cell culture
process development), David Nichols, PD project managers (Jennifer Puhlhorn and Jennifer Terew) and Walter Uchendu. The insights
of Matt Croughan, Rathmann Professor at Kegg Graduate Institute, on the process development learning modes are highly appreciated.
CURRENT AFFILIATIONS
Zahra Shahrokh is currently senior vice-president at Aurabiosciences, and Marcio Voloch is currently a biotechnology consultant.
Zahra Shahrokh* was senior director, pharmaceutical and analytical development, Stacy Price* is director, process development operations, and Marcio Voloch was vice-president, process development, all at Shire Human Genetic Therapies, Cambridge MA. *To whom correspondence should
be addressed, zshahrokh@aurabiosciences.com
or sprice@shire.com
.
REFERENCES
1. G.P. Pisano, The Development Factory: Unl.ocking the Potential of Process Development. (Harvard Business Press, Boston, MA, 1997).
2. J. Muenzer et al., Genet. Med. 8 (8), 465–473 2006.
3. Y.H. Xu, et al., PLoS ONE 5 (5) e10750, 2010.
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