Thermo Fisher Scientific
Advancing Cell and Gene Therapies with Purpose and Precision
Tine Vander Sype
Through this article, Tine Vander Sype, Senior Manager of Cell, Gene & Advanced Therapies, EMEA at Thermo Fisher Scientific, shares her journey from the lab to leadership, highlighting the evolving landscape of cell and gene therapy. She explores key industry shifts—from regulatory acceleration and supply chain resilience to the rise of AI and automation in manufacturing. Tine emphasises the importance of crossfunctional collaboration, customer engagement, and staying informed to drive innovation. For aspiring professionals, she offers practical advice on blending scientific, regulatory, and business expertise to build a successful career in this dynamic field.
A Journey Beyond the Lab
After obtaining my master's degree in biomedical sciences, I soon realised that life in the lab was not in the cards for me. So, I oriented myself towards jobs where I could leverage my scientific education in a business environment. I worked for two years in technical support, learning the ropes of working in a corporate environment. When I joined Thermo Fisher Scientific, I quickly felt at home with our Mission to enable our customers to make the world healthier, cleaner and safer. Thermo Fisher’s Mission and the company’s culture and values deeply resonated with my passion for science. Over six years, I have held various commercial roles before moving into people leadership. During the pandemic, I coached young sales professionals. I have been part of the cell, gene and advanced therapies business for the past three years, leading a team of experienced business development managers to support therapy developers and manufacturers in EMEA. These therapies represent a new category of treatments that can potentially cure human diseases instead of merely alleviating their symptoms. Hence, it’s an exciting time to work in this business.
Strengthening Links in Advanced Therapy Supply
Supply chain resilience is essential for securing critical cell and gene therapy manufacturing materials. This requires thoroughly evaluating suppliers' material quality, manufacturing processes, and quality management systems. Helping to ensure suppliers have business continuity plans, regulatory experience, and proper documentation like certificates of analysis (CoA) and drug master files is crucial in delivering these therapies to those who need them most. Focusing on detailed Certificate of Analysis documentation helps maintain regulatory compliance and mitigate variability, strengthening supply chain resilience.
I would encourage aspiring professionals to focus on gaining a well-rounded understanding of both the scientific and regulatory aspects of cell and gene therapy. Building strong industry relationships, staying informed about emerging trends, and developing business skills are also important.
Thermo Fisher constantly communicates with customers, helps them visualise potential disruptions and collaborates to establish a healthy inventory of materials. We employ these strategies to minimise supply chain disruptions.
Staying in the Loop, Leading at the Bench
Our team stays current with the rapidly evolving cell and gene therapy landscape by ensuring we remain connected to the latest data and technologies from sources such as leading industry publications and conferences across the globe. As a company that values partnership and collaboration, our team always engages and connects with customers to hear their challenges and current workflows firsthand. As part of this work, we also have regular touchpoints with our internal R&D teams, which are the technical subject matter experts, and we work with our customers to refine their research and development processes for therapies.
Innovating Within the Lines
To support our customers in navigating the expanding regulatory landscape in the EMEA region while maintaining innovation speed, we leverage rigorous regulatory expertise and provide robust documentation to aid in regulatory filings. Our cross-functional teams, comprising regulatory and R&D professionals, help integrate compliance considerations into the innovation process. Additionally, we maintain transparent communication with our customers throughout their workflow development to enable seamless support and compliance. To further enhance our efforts, we invest in regular compliance training and awareness programs to help ensure all employees are well-versed in compliance protocols.
Between the Bench and the Boundaries
Academic customers generally have more flexibility in process development and testing, allowing them to experiment and modify their workflows as needed. This adaptability is crucial for research and innovation. In contrast, commercial customers are often constrained by regulatory approvals and clinical trial requirements. Once a process is approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), changing unit operations without additional regulatory scrutiny becomes challenging. This rigidity ensures consistency and compliance but limits the ability to make adjustments.
Powering the Next Wave of Therapies
The cell and gene therapy industry is rapidly growing, with nearly 2,000 clinical trials underway worldwide. Key trends in the industry include:
1. Therapeutic Expansion: The field is expanding beyond oncology to include new therapeutic areas such as autoimmune diseases, neurology, and rare genetic disorders.
2. Regulatory Landscape: Accelerated approvals by regulatory bodies like the U.S. Food and Drug Administration and the European Medicines Agency are increasing accessibility to cell therapies, moving these therapies into earlier lines of treatment while becoming more of a standard of care.
3. Leveraging AI and Automation: AI and automation address manufacturing and scalability challenges, enhancing efficiency and consistency in therapy production.
Thermo Fisher is dedicated to continually innovating our cell and gene therapy products and solutions to help our customers accelerate their development processes and speed to market. We have designed a portfolio of modular instruments that efficiently scale to commercial manufacturing and support a diverse range of cell therapy manufacturing workflows, automating unit operations. These instruments are compatible with the Gibco Cell Therapy Systems portfolio of cell therapy products, which are current Good Manufacturing Practices manufactured, safety tested, backed by regulatory documentation, and supported globally by field-based experts. Our comprehensive offerings help ensure that our customers can achieve consistent, highquality results while navigating the complexities of cell and gene therapy development.
From Lab Smarts to Boardroom Starts
I would encourage aspiring professionals to focus on gaining a well-rounded understanding of both the scientific and regulatory aspects of cell and gene therapy. Building strong industry relationships, staying informed about emerging trends, and developing business skills are also important. Additionally, gaining experience in cross-functional roles and the ability to lead teams through complex projects will be valuable for advancing to commercial and business development leadership positions.
