David Kiklis, a seasoned IT leader in the pharmaceutical industry, shares his experiences and challenges in integrating technology at Replimune Group, a pre-commercial pharmaceutical company. With a rich background in various industries, Kiklis brings a unique perspective to the critical role of technology in pharma, especially in a company transitioning from the entrepreneurial phase to becoming commercial-ready.
Q1: Can you share a brief overview of your role and how technology shapes your organization's strategy?
David Kiklis: At Replimune Group, where I've been involved in IT leadership, technology underpins every aspect of our operations, from clinical data management to drug manufacturing. My role has largely been about implementing robust systems and processes to prepare the company for commercial scalability and compliance with stringent regulatory standards. This involves everything from SaaS platforms for data management to systems ensuring manufacturing and quality processes meet the required guidelines.
Q2: What is one significant challenge you're currently facing in technology, and how are you addressing it?
David Kiklis: A major challenge in our industry is managing third-party risks and ensuring data integrity across various platforms. Most of our critical systems are managed through third-party SaaS providers, which poses risks in cybersecurity and data integration. To address this, we emphasize stringent vendor selection processes and continuous monitoring. Furthermore, we've taken steps to centralize our data through an internal data warehouse, which allows us to maintain control over data integrity and streamline compliance with regulatory requirements.
Q3: Can you highlight a recent tech initiative or project that you're excited about? What impact do you anticipate it will have?
David Kiklis: One of the most significant projects underway is the complete build-out of our supply chain and distribution processes as we prepare for commercial launch in 2025. This involves creating end-to-end systems for demand planning, product delivery, and revenue recognition—a first for Replimune. The successful implementation of these systems will not only enable us to start generating revenue but also ensure efficiency and compliance across our operations.
Q4: How do you foster a culture of innovation within your team or organization?
David Kiklis: Innovating within a heavily regulated industry like pharmaceuticals is challenging. However, not all our operations are under strict regulatory watch, which allows some room for creative technological solutions, particularly in areas like IT process automation and cybersecurity. We encourage a culture where new ideas are valued and tested, and where continuous education and partnerships keep us abreast of emerging trends and technologies.
Q5: Looking forward, what technology trend do you think will have the most significant impact on your industry in the next few years?
David Kiklis: While AI is a buzzword across many sectors, in pharmaceuticals, the impact of advanced analytics and data warehouse technologies is more immediate. These technologies are transforming how we manage clinical and commercial data. With the evolution of user-friendly analytical tools, we're moving towards more direct data manipulation by end-users, reducing the need for specialized skill sets like SAS programming and enhancing our ability to derive actionable insights more efficiently.
Conclusion
David Kiklis's insights reveal a sophisticated approach to IT in the pharmaceutical industry, highlighting the critical balance between innovation and compliance. As Replimune Group moves towards commercialization, the strategic use of technology not only supports its business objectives but also ensures it remains compliant and competitive in a rapidly evolving market.
