CASE STUDIES

TECHNOLOGY TRANSFER CHARTER, TECHNOLOGY TRANSFER GOVERNANCE AND

COMMUNICATION PLAN
PRODUCT LIFECYCLE PHASE: COMMERCIAL – COMMERCIAL
TT PROCESS STAGE: PLANNING
SITE TYPES: INTERNAL-EXTERNAL, EXTERNAL-EXTERNAL

Case

To reduce costs, Company A made a business decision to consolidate outsourcing of drug product packaging,
expecting to achieve savings quickly.

Company A awarded a multiproduct bundle to a contract manufacturing organization (CMO), Company B,

transferring packaging of 15 drug products from other contract providers. These products are new to the facility of
Company B, the RU. This external-external TT was performed over a 2 years period. The TT goal is to complete
the transfer of the first product in 7 months with a new product in place each month thereafter, requiring all TTs to
occur in parallel.

As Company B worked to achieve the TT goals, Company A continuously changed the knowledge requirements,
including the labels, component design, preferred vendors and the qualification of backup sources. In addition,
Company A asked the TT team to change the planned order of products being transferred. These changes
prevented Company B’s TT team from meeting project timelines, a situation Company A escalated to senior
management in both the companies.

With senior leadership from both companies involved, a formal process for the TT was implemented. This process
included steering committee and governance oversight, a communication plan, additional staffing and improved
TT Project Management (PM) tools to allow greater visibility of the project progress and risks. The changes
specifically included the following:

1. Additional resources were provided to enable key functions to focus on their specific workstream for a
cluster of products based on process similarities and timelines.
2. Following an all-day workshop, workstream meetings were held weekly to allow each function from both
Company A and Company B to maintain alignment of their activities across the entire portfolio,
3. The TT PM implemented as weekly progress meeting across the workstreams during which the project
timeline, needs, and risks were discussed and reported to Company A. The use of improved visual tools
for these updates allowed for better alignment with the project goals.
4. A steering committee of one-level-higher management from both the companies was formed. A weekly
steering committee meeting allowed timely feedback, risk management and escalation support from
both Company A and Company B.
5. Using input from the steering committee, the senior management of both companies met monthly and
held face to face meetings on a quarterly basis throughout the project to provide overall governance.

Company B learned the value of establishing a TT charter and of ensuring that Planning stage activities
were completed before moving to the next stage. After implementing the governance structure and a
 communication plan, Company B encountered significantly fewer change requests from Company A,
allowing the TT team to complete Knowledge Transfer (KT)

Two events jeopardized the TT timeline, but the new timeline risks were quickly communicated to the steering
committee for risk mitigation and the information related to the governance team. First a vendor delay was
resolved by negotiating a payment to the vendor to expedite the material. Second, a competing priority arose
with another commercial activity using shared equipment. With the involvement of the steering committee, the
TT team was able to reach an alignment on managing changes to the project scope and ensure that projects
received priority in order to meet the launch needs.