The company faced a monumental challenge: scaling its operations to support the US sales expansion of very rare orphan drugs, while simultaneously preparing for multiple high-stakes product launches in international markets.
Among the critical milestones were:
The launch of a new breast cancer treatment, fast-tracked with an NDA priority review and a PDUFA date in Q1 2023.
The introduction of a multiple myeloma drug in Q3 2022, set to roll out in both the US and licensed international markets.
Despite these ambitious goals, the company had significant operational gaps. They lacked a defined IT strategy and the portfolio of commercial solutions essential to enable and support these launches. Without a robust technological and organizational foundation, the global expansion and complex launches risked falling short of their potential.
Compounding the challenge was the need to establish new and expanded go-to-market organizations in both US and international markets—requiring swift scaling of resources, processes, and systems to meet the demands of a rapidly growing portfolio and global reach.
The stakes were immense, with success dependent on overcoming the lack of infrastructure and aligning every aspect of the business with the demands of these transformative product launches.
The Tailwinds Advisory Solution: Empowering Global Expansion and Multi-Year Product Launches
Faced with the immense challenge of launching new treatments across the US and international markets while scaling operations for global success, Tailwinds Advisory delivered a transformative solution, equipping the company with the infrastructure and strategy required for its ambitious goals.
Assigned Leadership to Drive Global Commercial Operations: Tailwinds provided a seasoned resource to serve as Associate VP, Global Commercial Operations & Analytics, taking charge of developing a robust organizational structure and actionable business plans. This leadership ensured alignment across global teams, supporting the company’s long-term commercial vision and multi-year product launches.
Developed a Multi-Year IT Strategy and Roadmap: Tailwinds crafted a forward-looking IT strategy that aligned with the company’s rapid growth and complex launch timeline. This roadmap ensured a strategic approach to scaling operations and integrating technologies to meet immediate and future business needs.
Implemented Program Management Offices (PMOs): To streamline execution and ensure seamless coordination, Tailwinds established Program Management Offices (PMOs) dedicated to overseeing product launches and the deployment of critical technology solutions. These PMOs ensured timelines were met, risks were mitigated, and cross-functional teams operated in unison.
Executed Data Strategy and Analytics Solutions: Recognizing the pivotal role of data in driving global expansion, Tailwinds developed a comprehensive Data Strategy, encompassing data acquisition, management, and the implementation of informatics and analytics solutions. These initiatives provided actionable insights to drive informed decision-making and market success.
Implemented Veeva CRM, Vault, and Salesforce Marketing Cloud: Tailwinds spearheaded the deployment of Veeva CRM, Veeva Vault, and Salesforce Marketing Cloud platforms. These cutting-edge tools were integrated to support global commercial operations, enhance customer engagement, streamline regulatory processes, and enable scalable marketing strategies.
Planned and Implemented Data Privacy Solutions: Tailwinds prioritized data privacy, ensuring compliance with global regulations by implementing advanced data privacy processes and solutions. These measures safeguarded sensitive patient and commercial data, reinforcing trust with stakeholders across markets.
The Result
Through these targeted initiatives, Tailwinds Advisory transformed the company’s commercial and IT landscape, enabling the successful launch of multiple high-priority treatments while establishing the foundation for sustained global growth. From equipping the organization with industry-leading technology to aligning teams under a clear strategic vision, Tailwinds empowered the company to overcome its operational gaps and emerge as a leader in rare disease and oncology markets worldwide.