Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product - Pharmaceutical Technology

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Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product
The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

Pharmaceutical Technology
Volume 35, pp. s50-s52

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.


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.,
, tel: 847.353.4902.

*To whom all correspondence should be addressed.


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