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Project Management
One project manager accountable for the timeline, across every workstream in the program.
Where the time goes
Time is lost in the gaps between workstreams: the analytical method that arrives after the batch it was meant to release, the formulation work that waits on an API delivery that waits on customs, the dossier section that cannot be written because the data is at a third supplier.
Each supplier is doing its job, and none is accountable for the date, because none can see the whole program.
What a client observed
A US consultant who has placed several programs with us put the saving at around three months and attributed it to something structural rather than to effort: drug substance, drug product, and toxicology in one organization, with a single project manager accountable for the whole timeline rather than three suppliers each accountable for a piece of it.
What the project manager can do
The difference between a coordinator and a project manager is the authority that comes from the work being in one place.
- Schedule across workstreams. Drug substance, drug product and analytical are scheduled together rather than negotiated between organizations. When a campaign moves, everything downstream of it moves with it in the same schedule.
- Start work before the handover. IND-enabling activity begins when the preclinical candidate is confirmed. Dossier templates go out at project initiation and sections are written as data arrives.
- Run steps in parallel that would otherwise queue. Clinical supply activities align with CMC rather than waiting for it — worth about a month on its own to first patient dosing.
- Skip the technology transfer. The team that developed the process runs the campaign. There is no transfer, so there is no transfer risk and no reconciliation of impurity profiles between organizations.
Accountable for the date
The distinction is between a single point of contact and a single point of accountability, and the test is what the project manager can move without asking anyone outside the organization.
At WuXi Chemistry, the project manager can move a manufacturing slot, pull an analytical method forward, or start dossier sections before the data is final, because drug substance, drug product and analytical are one organization.