Hutchmed, a global biopharmaceutical company, is at the forefront of advancing innovative therapies for cancer and immunological diseases. With a pipeline of transformative treatments targeting significant unmet medical needs, Hutchmed is committed to improving patient outcomes worldwide. As the company prepared for the commercialization of one of its groundbreaking therapies, it faced the critical task of building a robust operational and technological foundation to ensure future success.
The Challenge
Launching a product in the biopharmaceutical industry is a highly complex endeavor, especially for a company with a global footprint. For Hutchmed, the challenge lay in building the foundational systems, processes, and infrastructure necessary to support a seamless transition from development to commercialization. Key hurdles included:
Enterprise Systems Implementation: Designing and integrating systems such as ERP, Quality Management Systems (QMS), CRM, BI, and Master Data Management (MDM) to manage operations effectively.
Regulatory Readiness: Establishing compliant processes and systems to meet stringent global regulatory requirements.
Cross-Functional Coordination: Ensuring alignment and collaboration across clinical, regulatory, manufacturing, commercial teams, and the Chinese headquarter teams.
Scalability and Growth: Building systems and processes that could scale with Hutchmed’s expanding global operations.
The Solution
Tailwinds Advisory partnered with Hutchmed to develop and execute a comprehensive plan for launch readiness, working closely with their global teams, including their headquarters in China. Our efforts ensured seamless alignment across regions and functions. Key initiatives included:
Developing a Multi-Year IT Strategy and Roadmap: We crafted a visionary, multi-year IT strategy that aligned Hutchmed's immediate objectives with its broader vision for long-term growth. The roadmap detailed milestones and prioritized alignment with commercial goals, serving as a guiding framework for both regional and global initiatives.
Leading Program Management: Tailwinds provided expert program management, ensuring cross-functional coordination between teams in the U.S. and China. By proactively managing risks, resolving challenges in real time, and maintaining alignment across regions, we ensured the project remained on track and efficient.
Conducting Solution and Vendor Evaluation: Through a rigorous evaluation process, we worked with Hutchmed's global teams to identify and select the best-fit solutions and vendors. By understanding the unique demands of the U.S. market, we ensured the adoption of reliable, cutting-edge technologies that supported regional and global operations.
Designing a Robust IT Architecture: We developed a scalable IT architecture from the ground up, tailored to meet Hutchmed’s operational complexities. This included integrating systems for patient engagement, prescribing workflows, sales operations, and supply chain management. Collaboration with the China headquarters ensured the architecture supported both regional compliance and global consistency.
Implementing IT Governance and Security: Recognizing the importance of compliance and security in a global context, we established an IT governance framework that met international regulatory standards while addressing local requirements in China and other regions. This framework ensured data protection, operational transparency, and trust across all markets.
Planning and Managing the IT Budget: We developed a detailed IT budget that balanced cost efficiency with the need for advanced solutions. Collaboration with the China headquarters allowed for strategic resource allocation, ensuring sustainability and scalability across both regions.
Building the IT Organization: To ensure long-term operational success, we established a dedicated IT organization for Hutchmed, working closely with teams in both the U.S. and China. This included defining roles, hiring key personnel, and creating workflows to empower global teams to manage and scale IT operations independently.