In response, the company's management established a dedicated technology transfer organization to determine transfer needs
of all key stakeholder groups and to formally manage transfer activities. The new transfer organization consisted of representatives
from diverse groups: regulatory, quality, clinical, pharmaceutical sciences, marketing, and commercial manufacturing. It defined
value-added activities and deliverables, established cross-functional transition teams that represented both send and receiving
sites, identified hand-off points, established responsibilities, and formalized performance measures. Ultimately, the transfer
organization provided a much clearer view of accountability for transfer activities across early- and late-stage development,
along with a better alignment with stakeholders and decisions makers. In addition, the organization established a formal feedback
mechanism to drive continuous improvement and increase the efficiency of subsequent transfers.
To survive in the increasingly complex and competitive pharmaceutical industry, companies must maximize their full arsenal
of capabilities, using both internal and external resources. Technology transfer provides companies with efficient access
to external technology and knowledge, enables them to achieve global reach, and allows them to optimize their own resources.
Achieving transfer success during the first attempt is particularly important because it saves money. Early success also helps
companies mitigate the risk of supply interruptions, it gives them prompt access to low-cost manufacturing, and reduces companies'
regulatory compliance risk. It also helps them meet aggressive filing and launch targets.
However, to implement technology transfer successfully is challenging—even within a single organization, let alone across
companies, geographies, and cultures. The benefits of a holistic best–practice approach are well proven. Considering the size
of the prize, changing the organization's mindset and behaviors takes a lot of effort—but is well worth it.
Scott J. Mahoney is a principal at PRTM Management Consultants, 1050 Winter St., Waltham, MA 02451, 781.434.1351, firstname.lastname@example.org
Anser F. Qureshi is a manager at PRTM Management Consultants, Stamford CT, 203.905.5604, email@example.com