Challenge
A mid-sized biotechnology company lacked an integrated path from candidate selection to IND filing and Phase I supply. Clinical requirements, manufacturing work, external partners, and submission records were poorly coordinated against a seven-month commitment.
Response
PMO Partners established a strategy review board, aligned formulation and clinical requirements, and built a resource-informed schedule with risk responses. Core and functional teams maintained regular reviews, while shared plans strengthened the CMO relationship and document readiness. Contract agreement with the CMO was reached in two weeks.
Outcome
The IND was filed on time, Phase I supplies were released two weeks ahead of the aggressive schedule, and the first patient was dosed two weeks earlier than the original best-case target. The company also gained repeatable submission and partner-management practices.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.