Challenge
A cancer-immunotherapy company faced its first IND with limited internal regulatory capacity and a two-month deadline. Multiple programs competed for attention, while document control and development processes needed structure.
Response
PMO Partners linked CMC, nonclinical, clinical, vendor, and submission activities in an integrated plan. The consultant coordinated reviews and third parties, then supported the response when unclear protocol language triggered a clinical hold. Mentoring strengthened the internal project manager’s capability.
Outcome
The first filing arrived five days early, although it subsequently required work to lift the hold. A more complex second IND, involving three drug substances, was submitted near its target date without a clinical hold. The company gained reusable processes and a clearer understanding of submission dependencies.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.