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PHARMACEUTICAL INDUSTRY :
Technology Transfer |
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Client: |
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A
world leader (one of top five) in the pharmaceutical industry with
a global footprint, recognized as a standard-setter within the industry. |
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Problem: |
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The
client recognized that its technology transfer process was not consistent
or state-of-the art across its subsidiary companies, representing
major top-line and bottom-line opportunities in improving how to get
new products to market and move products between operational centers. |
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Approach: |
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Tunnell
Consulting was asked to work with an international team comprised
of executives and scientists from R&D, Quality, Regulatory, Operations,
and Technical Services to redesign the processes and systems that
supported technology transfer. Tunnell supplied subject matter expertise,
project management support, process and organizational design experts,
and team facilitation. As-is process maps were created for existing
processes and documentation streams, and a systems gap analysis was
done. Critical metrics were identified and existing data collected
against those metrics. Some 700 tasks were identified and catalogued
with an accompanying glossary to account for terminology differences
across the global network of operations. This was then converted into
a four-fields matrix map which served as the basis for the team's
redesign work. Functional key stakeholders were involved throughout
the project, providing critical information, data, and the identification
of problems and functional gaps that had to be addressed. The core
team was then responsible for the process redesign and implementation
plan. The resulting process redesign was validated/refined through
interaction with key stakeholders, then a subset of the core team
was given the task of supporting the follow-up implementation. |
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Results: |
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The
creation and implementation of a state-of-the-art technology transfer
process that became the standard through all divisions of the parent
company. The development of a knowledge management technology that
transformed the exchange of documentation, data, and information related
to any product throughout its development and commercialization. A
cycle time reduction of four to eight months in the transfer of product/process
from development through commercialization. Significant improvement
and restructuring of process development, resulting in more robust
processes and more successful process transfers. Significant improvement
in participation and linkages across all functional elements throughout
the technology transfer process. Identification of appropriate metrics
for tracking process/product transfers. Establishment of the basis
for on-going improvement and tracking of process/product performance
throughout lifespan of products. Provision of document trail and archive
methodology to support all regulatory filing activities, including
preparation of CMCs, PAIs, and regulatory compliance throughout the
product life-cycle. |
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