2 Treatments, 1 Timeline

Managing the Unexpected in Commercial Launch Planning

Service Areas: Commercial Launch, Supply Chain, Quality, Enterprise IT Solutions, Commercial Systems-CRM-Medical Affairs

Lifecycle Stage: Clinical

Our client was formed to commercialize a rare disease treatment in late-stage clinical trials. Essentially a startup, the company was scrambling to build the commercial operations and infrastructure needed to launch the treatment on an accelerated timeline and bring it to patients in need.

About 6 months before the PDUFA date, Converge was invited to conduct a Launch Readiness Assessment, identifying any risks that may have been missed. Our quick-moving and structured approach identified risks to and gaps in the launch preparations across the supply chain, quality, commercial, medical, IT, accounting, finance and manufacturing functions.

The assessment resulted in recommendations for addressing each area’s specific needs. Converge worked closely with the client’s own commercial team to accelerate internal preparation while maintaining the original launch schedule.

Working with the Converge Commercial Launch team

Our Commercial Launch advisors helped the client form an integrated, cross-functional Launch Readiness Team with a mandate to ensure remediation and preparation in the time available.

Together we established a unified launch plan that highlighted the critical tasks and inter-dependencies across functions, as well as conducted Day 1 and Contingency Planning sessions to synchronize the steps involved in producing and distributing the product within hours of receiving approval.

We also ran walkthroughs of both the patient and product pathways, invaluable exercises since the treatment involved complex logistical challenges in moving, storing and administering the product, along with a high-touch patient services model focused on ensuring patient outcomes.

Adjusting to Unexpected Events

As launch preparations were taking shape, our client suddenly inherited a second late-stage treatment – a drug anticipating approval on the same timeline.  Suddenly the company was planning a second launch to occur within 3 months of their first.

With little infrastructure in place and few internal resources – all currently focused on the initial product launch, the client engaged Converge to build commercial supply capabilities for the second treatment.

Providing experienced project managers for CMO and 3PL management, along with subject matter experts in cold chain logistics, global trade and commercial systems, we helped the client establish the supply chain. This included downstream order-to-cash processes, patient-focused CRM, and commercial and medical affairs analytics systems.

As the launch date for both products drew closer, our support across both workstreams shifted to execution support to be launch ready.

Status today

Our client successfully launched both treatments in countries where they received respective approvals, bringing the transformative treatments to patients and driving revenue and market value for the emerging company.

Converge continues to serve as a trusted partner, supporting the commercial teams, technical operations, quality, finance and IT as the company expands access into new markets and grows their internal organization.

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