Egetis Therapeutics is a pioneering biopharmaceutical company dedicated to addressing the profound unmet needs of patients with ultra-rare diseases. With therapies targeting these highly specialized conditions, the stakes for operational excellence are incredibly high. Successfully launching and scaling operations in such a challenging field requires not only scientific innovation but also a robust and compliant IT infrastructure.
The Challenge
As Egetis prepared to scale its business and deliver transformative therapies, the company faced a unique challenge: no IT infrastructure was in place. To support the launch and growth of its therapies, Egetis needed to build everything from scratch, including:
Enterprise and Commercial Systems: ERP, QMS, serialization, Veeva, Websites, and other critical platforms.
Compliance and Security: Systems need to adhere to stringent healthcare regulations and ensure the security of sensitive data.
Standard Operating Procedures (SOPs): Establishing operational processes to meet regulatory and business needs.
IT Governance: Creating a governance framework to ensure alignment, accountability, and compliance across all IT initiatives.
This wasn’t just about building systems—it was about creating an entire IT strategy and organization to support both the immediate needs of a product launch and the company's long-term vision.
Tailwind Advisory led the charge to establish a comprehensive IT strategy and execute a multi-year roadmap that addressed the company’s current and future needs. Key activities included:
Multi-Year IT Strategy and Roadmap: Defined and executed a phased plan to align IT initiatives with business goals.
Program Management Support: Ensured that all IT projects were delivered on time, within scope, and met quality standards.
Solution and Vendor Evaluation: Identified and selected the best solutions and vendors to meet Egetis’s unique requirements.
Enterprise IT Architecture: Designed an IT infrastructure that was scalable, compliant, and tailored to support enterprise and commercial needs.
IT Governance and Security: Established governance frameworks and security protocols to safeguard sensitive data and ensure regulatory compliance.
IT Budget and Organization Setup: Developed and managed the IT budget while building an IT team to support ongoing operations and growth.
The implementation of this strategy transformed Egetis into a fully operational, future-ready organization capable of meeting the demands of ultra-rare disease therapies. Key outcomes included:
Comprehensive IT Ecosystem: Successfully implemented enterprise systems (ERP, QMS, serialization) and commercial platforms to support product launches and scaling.
Regulatory Compliance: Established processes and systems to meet global healthcare and data security regulations.
Operational Readiness: Built an IT organization and governance framework to ensure long-term sustainability and alignment with business goals.
Scalable Infrastructure: Designed and implemented systems that could grow with the company’s needs, ensuring continued success in the ultra-rare disease space.
At Tailwinds Advisory, we’re proud to have played a pivotal role in helping Egetis establish the technological and operational foundation needed to deliver life-changing therapies.