Mock launch: The competitive edge for successful product launch
With the advent of cell and gene therapies and personalized medicine, pharmaceutical product launches are becoming more numerous, competitive and complex. The complexity is heightened due to global product launches requiring compliance to varied country regulations, cross-functional collaborations, integration with pre-existing systems, and stakeholder expectations. These factors all have the potential to affect time to market. Launch planning is a complex strategy game that organizations don’t have the luxury of losing or enduring major setbacks by not being prepared to execute. Organizations face many challenges and barriers when bringing a drug to market that is not controllable, but companies can lessen the unease by deviation scenario planning through a Mock Launch simulation for when product approval or clearance is received
A successful product launch is the accumulation of a multitude of coordinated actions that emphasizes the importance of a strong launch strategy, consistency across functional groups, and employee confidence. Deviation planning or Mock Launch should be a key activity for your Launch Excellence team to instill confidence, highlight process and system gaps, revise mitigation plans and ensure a smooth handoff and intake process for an efficient launch to market.
Key players
A successful Launch Excellence team is global and cross-functional including representatives from commercial leadership, supply chain, patient services, channel strategy, marketing, etc. across different geographies to ensure compliance standards are being met across countries, establish a common language, and the overall alignment and goals of a company’s launch strategy. A solid governance body allows for quick decision making, focused metrics tracking against organizational goals and instilling one “voice” for clear concise communication. This team needs to be able to manage timelines, vendor relationships, and cross-functional interdependencies. A collaborative group ensures that there is a breadth of functional expertise for all components that are important for bringing a product to market.
A single integrated launch governance provides the value of shared lessons learned and best practices, reduction in duplicated efforts, consistency and common consensus on what “good” looks like. Below are three common mistakes that companies often face when organizing launch teams.
Common Mistakes
1. Lack of a singular launch resource who reaches across the organization. In Slalom’s experience, best practices show that strong leadership is important for launch success; owners of siloed workstreams “checking the box” is inefficient and leads to breakdowns in communication and project synchrony across workstreams. A program manager to ensure all cross-functional activities are aligned to the company’s overall strategic goal is integral to monitoring and tracking progress against clear KPIs. This resource should have proper sponsorship and be empowered to challenge the broader team by driving transparency and promoting accountability.
2. Fractured flow of information across workstreams. Workstream leadership often knows how to do their job well but lack awareness of parallel functions. This becomes a problem when workstreams are dependent for a common company goal but don’t know enough about other workstreams for proper intake and handoffs or to react quickly when complications arise. Shared accountability and collaboration assure that every function’s metrics is aligned to the overall company strategy.
3. Unclear tactical plan. A performance-driven tactical plan clearly outlining roles and responsibilities alongside metrics reduces any miscommunications or confusion on who does what and when. Key operational metrics should be clearly stated and routinely monitored against brand strategy and launch timeline. Metrics and benchmarks ensure capabilities are used appropriately, evaluates activity impacts and acts as a baseline for future product launches.
Practice hard, play hard.
The weeks leading up to product launch are stressful, and team alignment is of the utmost importance. Companies often account for likely scenarios and forget to plan for uncertainty and possible deviations. There are varied layered consequences for a failed or delayed launch across stakeholders. For patients, a delayed access to therapy can mean a continual decline of their quality of life; for providers, it means the inability to prescribe a therapy that might be more efficacious than the standard of care and a halt to treat based on evidence-based medicine and for companies, it may mean millions of dollars in lost revenue, especially for chronic disease therapies, and insurmountable investment costs from research and development. Managing uncertainty through deviation scenario planning is paramount due to high investment costs and low success rate of launches.
Mock launches allow your team to simulate the end to end experience of bringing a drug to market by pressure testing systems, people and process. If possible, engaging external vendors such as channel distribution or artwork partners, as part of the simulation ensures that all interacting stakeholders understand their roles and responsibilities. Mock launches tend to be multi-day workshops based on specific scenarios where personas are role-playing the critical steps involved in a drug launch lifecycle (supply chain, product on shelf, patient onboarding, field interactions, etc), by going through the ‘motions’ of the step by step launch activities. Mapping out the critical pathway highlights potential bottlenecks and provides the possibility to solve or alleviate issues in a mock and safe environment.
Investing in this activity with all key stakeholders and their interaction promotes buy-in and drives shared decision making.
1. Instills confidence in team members by pressure testing the process and understanding intakes and handoffs
2. Allows for quick reaction time and actionable next steps in the case of deviations and uncertainties
3. Deviation planning allows for contrarian thinking which promotes out of the box thinking and possible insights that otherwise wouldn’t be thought
4. Clear understanding of a deviation “trigger” and actionable next steps which reduces miscommunication, misalignment, and confusion
Sample deviation scenarios
1. Regulatory changes in prices and reimbursement label or new formulation.
2. Transportation issues, i.e. what if products can’t move due to political unrest or a courier can’t deliver against service level agreements (SLAs).
3. Change in label which necessitates new artwork & inserts.
4. Cold chain interruptions such as temperature deviations.
Mapping out these discrete deviation scenarios and mitigation actions allows for quick reactions to change and measured management responses for subsequent threats. Constant review of possible risks makes sure that leadership is sensitive to impending events that might require a course correction.
Factors of a successful mock launch
1. Incorporates all cross-functional members that are integral in the process including external stakeholders
2. Identifies key deviations and factors uncertainty into multiple scenarios with mitigation plans. Including minor investments to increase the chance of a favorable outcome
3. Provides clear and detailed notification of when a deviation is taking place, delineates roles and responsibilities and takes corrective next steps in a contingency plan to course correct
4. Proper debriefing at the end of each mock launch is key to addressing challenges, lessons learned and best practices
Repeated practice of these scenarios and continuous improvements of the deviations based on the dynamic market and feedback allows your company to be prepared for uncertainties and be comfortable and clear-headed when they arise. Though each launch plan should be unique to the current market and therapy, a mock launch exercise provides a strong foundation that can be continually assessed and modified for other products in the pipeline by leveraging previous learnings and artifacts.
Meet The Author
Slalom partners with healthcare, biotech and pharmaceutical leaders to strengthen their organizations, improve their systems, and help with some of their most strategic business challenges. Find out more about our people, our company and what we do.
Resources:
- https://www.mckinsey.com/~/media/mckinsey/industries/healthcare%20systems%20and%20services/our%20insights/the%20secret%20of%20successful%20drug%20launches/beyond_the_storm_launch_excellence_in_the_new_normal.ashx
- https://www.iqvia.com/-/media/quintilesims/pdfs/launch-excellence-v.pdf
- https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/the-secret-of-successful-drug-launches
- https://www.mckinsey.com/business-functions/operations/our-insights/launch-excellence-everything-depends-on-flawless-operations
