Jane Koo’s Leadership in Regulatory Affairs at CTMC: Transitioning from mAbs to Cell-Based Therapies

With a background in monoclonal antibodies and now cell therapies, she adeptly maneuvers through the intricate regulatory environments to provide life-changing solutions for patients. Her enthusiasm for science, leadership in regulatory strategies, and dedication to advancing cancer treatments motivate her efforts each day.

Can you provide a summary of your work?

CTMC stands out as an innovative therapeutics development partner, where scientific discovery and advancement drive progress, prioritizing swift patient access to cellular therapies. This acceleration involves moving from laboratory research to clinical application while also focusing on future commercialization. As the head of regulatory affairs at CTMC, my primary responsibility includes establishing a solid foundation for promising early-stage products to facilitate their swift transition to human studies. Additionally, I aim to ensure their readiness for commercial flexibility by strategically managing interactions with the FDA. This involves maintaining continuous dialogue during clinical studies through activities like requests for designation, implementing manufacturing enhancements, and conducting meetings. I find great satisfaction in collaborating with our technical teams to convert their extraordinary scientific innovations and data into actionable regulatory strategies, ultimately enhancing patient access to these potentially curative solutions.

When did your interest in science spark – was it in childhood, adolescence, or later in life?

My passion for science truly flourished when I recognized its significant real-world implications. My journey kicked off in the monoclonal antibody (mAb) sector, where I proudly contributed to the approval of the first-ever mAb biosimilar. This experience opened my eyes to how science can broaden patient access to transformative therapies. Collaborating with MD Anderson Cancer Center through CTMC continually reinforces my belief in research’s ability to save lives and make a difference in the battle against cancer.

Can you share your personal journey that led you to your current role?

Starting my career in the mAb field, I worked on a biosimilar that would become the first of its kind approved by the FDA. The process was challenging, especially given the absence of a clear regulatory framework for biosimilars in the U.S. at that time. We navigated this uncertainty with the FDA closely. With mAb biosimilars, significant focus is placed on Chemistry, Manufacturing, and Controls (CMC), where proving interchangeability with an FDA-licensed product necessitates a profound understanding of the product and extensive scientific data.

This experience, while challenging and immensely enjoyable, was invaluable, equipping me with the necessary skills and insights to face the unique challenges posed by cellular therapies. The regulatory landscape for cell therapies mirrors the path pioneered by mAb biosimilars nearly two decades ago. The similarities in regulatory complexities and the scientific rigor required in both fields have empowered me to tackle the evolving demands of cellular therapies.

What challenges have you encountered, particularly as a woman, and what key lesson have you learned?

One significant challenge I faced was discovering my voice. Naturally reserved, I seldom spoke in larger group settings early in my career in Korea. This wasn’t due to being discouraged but rather the culture not fostering it. Transitioning to work in the U.S. was a different experience, where I was encouraged to share my thoughts, particularly in my current leadership role. My perspective contributes to discussions, enriching insights and overall dialogue. While I enjoy imparting knowledge when it can aid others, building confidence in my voice and honing my communication skills has been essential. The most important lesson I’ve learned is that confidence in your expertise is vital for meaningful contributions and effective leadership. I continue to work on this, and that’s an ongoing journey.

What fuels your enthusiasm in your current position?

What drives my passion at CTMC is the opportunity to engage in efforts that could lead to curing cancer. Each day, I witness innovative science’s remarkable potential to transform lives, and being able to contribute even incrementally to the fight against cancer is highly rewarding.

How would you characterize your work ethos and style?

My work ethos centers on a steadfast commitment to excellence, strategic thought, and making a tangible difference in patients’ lives.

My work style emphasizes attentiveness to FDA guidelines and recommendations during product development, recognizing FDA alignment as pivotal. However, advocating for alternative strategies based on our product and developmental insights is sometimes necessary for success. In these cases, I collaborate closely with our technical teams to advocate for the best outcomes for our products while maintaining constructive communication with the FDA.

I aspire to promote collaboration across functions and with partners, including the FDA. Engaging with colleagues from various disciplines and our academic and biotech collaborators is crucial for fostering innovation and working toward our shared mission of combating cancer.

What advice would you offer to young women interested in science or pursuing a career in your field?

The field of science is impactful and diverse, offering many opportunities beyond common perceptions. While I initially pursued a major in biological sciences and participated in lab work during graduate studies, I soon discovered that lab environments weren’t the right fit for me. Joining the biotech sector unveiled my passion for regulatory affairs, where I could merge scientific understanding with problem-solving and strategic analysis. My journey taught me that there is no singular path in science – by exploring different opportunities, you will eventually find what truly inspires you.