Best practices
Organizational commitment
. Partners should be committed, have aligned goals, and communicate with the functions involved. It is imperative to have
key stakeholders' support and organizational resources. The negative consequences of a lack of organizational commitment to
success are obvious, but they are more pronounced if issues arise in the project that require quick decision making and additional
resources. For example, if a licensed product is being transferred from the licensor to a CMO and during the process, the
CMO receives observations from the FDA that will not be resolved quickly, it may become necessary to engage a different CMO.
To do so requires not only additional resources, but possible time delays depending on the stage of the process.
Communication.
High-level communication between dedicated alliance managers on each side is critical. The alliance manager liases with the
different parts of the organization, whether it be development, manufacturing, commercial or legal, to ensure the partnership
runs as smoothly as possible. The importance of constant communication and dedicated project management cannot be overstated
as they help to manage deliverables and expectations of all parties involved. Furthermore, unexpected obstacles are more easily
overcome. For example, if during the crucial stage of exhibit batch manufacturing, issues arise that require mutually agreeable
decisions, they can be made rapidly if excellent communication exists between parties.
Project management.
Dedicated project management (which can be performed by alliance managers) is a key strategy in helping alliances stay on
track and meet timelines. This approach is especially critical in the age of virtual teams with multiple partners handling
complex projects such as CMC development with numerous moving parts, where functional involvement of all is required for successful
completion
Strategic partnership.
Companies with successful past collaborations should consider extending mutually beneficial relationships to expand opportunities
for reaching shared goals. Companies that excel in alliance management will position themselves to attain partner-of-choice
status and win new deals.
Conclusion
Alliance management will continue to become an important component of not only in-licensing partnerships leading to successful
CMC package development but also to other partnerships within the pharmaceutical industry. It is important to manage these
alliances as effectively as an in-house research team to reap the full reward. Working with partner companies can be difficult
and, at times, frustrating, but with adequate planning, forward-looking agreements, pitfall avoidance, and insistance on adoption
of best practices, the benefits of successful partnerships can be tremendous.
Sumeet Dagar* is manager, alliance management and new business development, and Sean Brynjelsen is vice-president, new business development, both at Akorn Inc., sumeet.dagar@akorn.com
, tel: 847.353.4902.
*To whom all correspondence should be addressed.
|
