Callidatas US faced a formidable task: launching Nefecon, an orphan drug designed to treat the rare disease IgA Nephropathy (IgAN), in the highly competitive US market by November 2021. This was no ordinary launch. As a treatment for a rare condition, success hinged on precise targeting and meticulous execution. Adding to the complexity, they also needed to lay the groundwork for the future launch of Fruquintinib in 2023.
The hurdles were significant. Callidatas US had no established IT strategy or systems in place to support the intricate needs of the launch. They needed to build infrastructure from the ground up, with tight timelines and high stakes.
Commercialization posed additional challenges. The market focused on approximately 3,000 high-value nephrologists and hospitals—specialists who could unlock access to patients. Finding and identifying these patients was critical, as the drug's orphan status demanded precise and targeted outreach. Furthermore, distribution relied on an exclusive specialty pharmacy, requiring seamless coordination and robust systems to ensure patient access.
This wasn’t just about launching a product—it was about navigating uncharted waters to bring life-changing treatment to those who needed it most.
The Tailwinds Advisory Solution: Transforming Challenges into a Seamless Launch
Faced with the immense challenge of launching an orphan drug for a rare disease with no existing IT foundation, Tailwinds Advisory delivered a groundbreaking transformation that laid the groundwork for success—not just for the immediate Nefecon launch but for the company's long-term vision.
Developed a Multi-Year IT Strategy and RoadmapTailwinds Advisory designed a comprehensive, forward-looking IT strategy that aligned with the organization's unique needs and ambitious goals. This roadmap was more than a plan—it was a blueprint for operational excellence, scalability, and resilience.
Led Support Program ManagementWith meticulous attention to detail, Tailwinds ensured every component of the launch was executed flawlessly. By driving program management, they kept timelines on track, stakeholders aligned, and potential roadblocks swiftly addressed, ensuring the Nefecon launch met its critical deadlines.
Conducted Solution and Vendor Evaluation and SelectionTailwinds identified and onboarded best-in-class solutions and vendors tailored to the requirements of a rare disease drug launch. This strategic selection process ensured that every piece of the IT ecosystem—from patient identification to distribution logistics—was robust, reliable, and efficient.
Designed an Enterprise IT ArchitectureBuilding an IT foundation from scratch, Tailwinds crafted a scalable and secure enterprise IT architecture that supported not only Nefecon's complex requirements but also laid the groundwork for the future Fruquintinib launch.
Established IT Governance and SecurityRecognizing the sensitive nature of healthcare data and regulatory requirements, Tailwinds implemented industry-leading IT governance and security frameworks. These measures ensured compliance, minimized risk, and instilled confidence across stakeholders.
Planned and Managed IT BudgetTailwinds delivered a detailed and realistic IT budget, carefully balancing cost control with the need for cutting-edge technology investments. This financial discipline ensured resources were optimized for maximum impact.
Set Up the IT OrganizationUnderstanding that technology is only as effective as the team behind it, Tailwinds built and structured a capable IT organization from the ground up. This included defining roles, responsibilities, and workflows to create a seamless operational backbone for the company.
Through these efforts, Tailwinds Advisory turned an overwhelming challenge into a remarkable success story, enabling Callidatas US to confidently launch Nefecon on time while preparing for future milestones. Their leadership and expertise not only addressed the immediate need but also empowered the organization with a lasting foundation for growth and innovation.