Essential Elements of Commercial Mock Launch for Emerging Biotech Companies

By Mike Ciaccio Alexander Spivak

Every emerging biotech company has the unique opportunity to establish itself as a reliable partner to patients, physicians, and payers by executing impeccable product launches.

As emerging companies gear up for commercial launch, however, it’s common for departments to concentrate on their specific tasks, often as isolated efforts.

Functional silos and a fragmented approach can create gaps that significantly impact launch readiness. Such gaps may hinder the seamless flow of data, compromise business processes, and affect partner readiness – all of which are critical elements for launch success.

A commercial mock launch is an important way to rigorously assess the organization’s cross-functional preparedness for delivering essential therapies to patients. We emphasize two distinctive elements when working with our clients on commercial launch readiness:

1. Cross-Functional Preparedness: Many organizations focus on individual functions or departments, but we underscore the significance of ensuring that all relevant teams work in harmony to prepare. This applies to both upstream (manufacturing, supply chain, logistics) and downstream (sales, marketing, market access, customer support) areas.
2. Alignment Based on Business Assumptions: It is essential for leadership to not only identify and understand key organizational planning assumptions, but also ensure that every function is in sync with those assumptions. This approach promotes a more comprehensive and well-rounded readiness for delivering therapies to patients.

There are many other important objectives of a commercial mock launch, such as confirming:

• System readiness for data flow and patient and physician interactions.
• Completeness and accuracy of business processes.
• Partner readiness to execute in compliance with their service contracts.

The value of a mock launch goes beyond the sum of its parts. It ensures that every part is coordinated to achieve the desired outcome – a successful commercial launch.

Integrated Cross-Functional Commercial Mock Launch

An emerging company was preparing to commercially launch an orphan therapy for a genetic disorder. They engaged the Converge team prior to the anticipated PDUFA date to assist with ensuring launch readiness. Given the intricate product profile and the inclusion of a black box warning, the therapy demanded a comprehensive program of high-touch patient and physician services to facilitate patient identification, prescription, and treatment procedures effectively.

To ensure a seamless launch, we orchestrated a mock launch that encompassed product and information flows, physician interactions, and external partner engagement. We meticulously designed tailored scripts and scenarios aligned with core business processes along both the patient and product journeys. These scripts covered prescription processing, financial support, REMS program adherence, and physical supply to the last mile of the product’s supply chain journey.

During the two-day session, the cross-functional client team rigorously assessed real-world materials, systems, and platforms to verify aspects such as:

• Confirming integrations/interdependencies between the systems tested.
• Identifying functional and systems gaps, accompanied by developing concrete action plans.
• Exploring non-standard and exception case scenarios.
• Defining clear ownership for addressing any identified deficiencies.

The mock launch exercise proved pivotal in recognizing and addressing gaps that would be very difficult to identify in isolated functional plans.  For example, the session identified a need to develop templates for electronic enrollment into the REMS process.  It also highlighted the need for defining business rules for exception cases, such as when the copay program limit is exceeded. This proactive approach ensured a smooth launch and the client’s vision of delivering an exemplary customer experience. Ultimately, the company successfully launched its product commercially.

Key Takeaways

• A well-structured mock launch session serves to not only rigorously assess the organization’s cross-functional preparedness for launch, but also foster cohesion and establish a shared understanding of launch assumptions and readiness.
• In addition to proving out the standard business processes and systems, the Mock Launch session should explicitly evaluate system interdependencies and explore non-standard scenarios and variations. Ownership should be defined for addressing any gaps or issues identified.
• Conduct a mock launch 2-4 months ahead of the anticipated PDUFA date, as this timing ensures that most preparations are complete, and still provides time for adjustments and corrections where necessary.
• Create lasting value by applying the insights garnered from the mock launch exercise in future commercial launch initiatives to enhance their efficiency and effectiveness.

If you are interested in running a commercial mock launch for your own preparation purposes, contact our team of experts today at 1.857.245.7025 or info@convergeconsulting.com.