Global Biopharmaceutical Company – Gene Therapy Product Launch

Situation

FTI Consulting’s client is a global biopharmaceutical company specializing in creating drugs for specialty diseases with genetic underlying root causes. In advance of the client’s commercialization of a novel autologous, best-in-class gene therapy product in the US, UK, France, Italy, and Germany, FTI Consulting was engaged to ensure the success of the patient’s journey from enrollment to recovery. With a holistic view of the product launch, FTI Consulting helped the client add a level of humanity to the therapy rollout, with profiles developed for a large variety of patient types.

FTI Consulting’s task was to assist the client with refining its commercial processes and prepare both cross-functional internal teams and external partners to address launch complexities, such as regional differences, discrepancies in functional readiness and availability of core operating principles, the number of systems involved, and the vast number of supporting roles involved.

Our Role

FTI Consulting has long served as a highly trusted advisor to the client, in particular supporting optimization of the client’s supply chain logistics, operations, and functional preparedness for product launch. Our well-established relationships at all levels of the client organization, detailed familiarity with the client’s product and technology, and unique approach involving both internal and external stakeholders differentiated us from other service providers.

FTI Consulting mobilized and conducted comprehensive, end-to-end, mock operations exercises (or practice runs) to educate both internal and external stakeholders, simultaneously test people, processes and technology in a concentrated manner, and ultimately reduce risk. We performed real-life tests for different types of patients in different countries and for what happens when activities go as planned and when they inevitably go awry. Our test scenarios were performed by real actors in multiple locations, using Zoom to communicate and connect. Highlights include:

Cross-Functional Alignment and Preparation: The FTI Consulting team hosted interviews with functional representatives to gauge launch preparedness across teams. We subsequently engaged over 100 stakeholders in five countries to build and refine scripted core and exception-based, end-to-end process maps.
Process and Systems Testing: The team simulated more than 180 process steps across eight functions, including Supply Chain Planning and Logistics, Patient Enrollment, Quality Assurance, and Contract Manufacturing Management, in two sets of three-day workshops: the first a scripted workshop to validate end-to-end processes at a detailed level; the second to test the readiness of people, processes, and systems. The workshops were conducted in multiple global cities simultaneously to identify areas of opportunity.
Logistics and Materials: FTI Consulting coordinated all workshop logistics and prepared all workshop materials, including end-to-end scripts for 18 patients, data preparation, information handoffs, and more. FTI Consulting trained the facilitators so future mock operations can be led by the client’s internal stakeholders.
Process Optimization: FTI Consulting also documented workshop outcomes, improvement opportunities, and outstanding, high-risk actions to be mitigated prior to launch. The team provided support in closing a number of key gaps, including in business continuity planning for time-critical process steps.

Our Impact: Benefits of Mock Operations Exercises

Our client agrees that the value of connecting cross-functional stakeholders early to engage them in all aspects of the process cannot be overstated. In this case, it resulted in:

Participants from all cross-functional areas becoming more comfortable with the entire process (+11%), more familiar with systems (+14%), and more comfortable addressing issues (+20%)
Identification of over 200 improvement opportunities for people, systems, and processes, including over 50 high-risk actions to be addressed prior to full launch, reducing risk of failure, and increasing remediation of issues that patients may experience
Learning opportunities related to the patient’s journey to recovery, how interrelated functions connect to and rely upon each other, and improved awareness and understanding of operations
Setting the stage for the client to host future mock operations exercises for new markets, products, and people with a playbook of leading practices, lessons learned, and workshop templates.

As a result of our successful efforts, FTI Consulting has furthered its standing as a trusted advisor to the client, and we are now actively supporting launch readiness and post-launch operational robustness needs.