Project management

On completion of the business discussions and contract approval by both parties, the project is formally initiated with an on-site project kick-off meeting.

Technical subject matter experts (SMEs) representing the different departmental functions (and who supported the bidding process) are assigned as project leads.

The client also assigns corresponding SMEs to support the technical dialogue and decision making process between the respective counterparts, within the project team.

The multifunctional teams are led by a dedicated project manager and the business development manager assigned during the bidding process, provides account management support to ensure that the project team can remain focused on technical and operational activities.

Project management tools, ownership, meetings structure and frequency are all defined and agreed on a client specific basis, during the project kick-off meeting.

The success of any biologics development collaboration is often determined from the outset as a consequence of the cohesiveness and integrity through the technology transfer phase.

The demand on the client is considerable to provide a complete and correct process and analytical methods information transfer package.

ABL performs a detailed review of the client’s information, supported by several technical exchanges between the SMEs by email, in project meetings and conference calls.

From the outcome, the project objectives and deliverables are aligned and agreed by both parties, with definition of the project plan (cross referenced to technical & business proposal).

The detailed scope of initial process and analytical transfer / development activities is approved and the practical work commences.

The clients technical experts are welcome on-site at ABL as person-in-plant to support practical activities through all phases of product development.

Transparency and mutual alignment to establish a genuine collaboration, are key factors in mitigating inherent project risks and to ensure meeting a successful outcome.

All process and analytical work performed is approved upfront in development plans and protocols, with results documented in technical summary reports.

Both teams continually evaluate and determine project progression on a fully informed, data-driven basis.

Any deviations from the original project plan, including assessment of timeline and budget and impacts, are approved by both parties prior to starting any additional activities.

Higher level business risk items and alignment of corporate strategies, are tracked by senior representatives in joint steering committees (JSC).

The JSC function is to provide the infrastructure and support, to ensure that the project team can remain focused on successfully meeting the technical objectives and deliverables.

ABL’s clients are actively involved and fully integrated with their projects on a daily basis.

Frequent open communication in all formats, at all levels, on-site and off-site, is essential in order for both parties to be successful in meeting a common goal.