Jane Koo on leading regulatory affairs at CTMC: A journey from mAbs to cellular therapies

With a career spanning monoclonal antibodies and now cell therapies, she expertly navigates complex regulatory landscapes to bring life-changing treatments to patients. Her passion for science, leadership in regulatory strategy, and commitment to advancing cancer cures drive her work every day.

Could you give us an overview of your work?​

CTMC is a unique therapeutics development partner, where science and innovation drive development with accelerating patient access to cellular therapies as our highest priority. While accelerating transition from lab to clinic is a part of this, so is keeping an eye towards commercialization. Therefore, a key responsibility, as the head of regulatory affairs at CTMC, is to lay down the groundwork for promising, early-stage products to not only accelerate path to first-in-human studies, but also to position them for flexible transition to commercialization by strategically integrating FDA interactions and managing ongoing dialogue with FDA during conduct of the clinical study (e.g., requests for designation, implementation of manufacturing improvements, meetings). The fun part of my job is working with our technical teams and translating their amazing scientific innovations and data into effective regulatory strategies for implementation, to ultimately increase patient access to these therapies with curative potential.

When did you realize you were interested in science - as a young child, teen, or older?​

I didn’t fully develop a passion for science until I realized its profound practical impact. My journey began in the monoclonal antibody (mAb) field, where I had the privilege of contributing to the approval of the very first mAb biosimilar. That was the moment I saw firsthand how science can expand patient access to life-changing therapies. Through CTMC’s collaboration with MD Anderson Cancer Center, I continuously witness groundbreaking science moving the needle in the fight against cancer, reaffirming my belief in the power of research to save lives.

Could you describe your personal journey bringing us to where you are now?​

When my career began in the mAb field, I worked on a mAb biosimilar that would become the first in its class approved by the FDA. It was a challenge, especially because at the time, there was no established regulatory pathway for biosimilars in the US, and we were navigating the process alongside the FDA. With mAb biosimilars, a great deal of scrutiny is placed on Chemistry, Manufacturing, and Controls (CMC), and demonstrating that a mAb is interchangeable with an FDA-licensed product requires extensive product understanding and scientific data.

Though it was challenging (and so much fun), the experience I gained was invaluable and positioned me to succeed in my current role, giving me the tools and insight needed to navigate the unique challenges of cellular therapies. Cell therapies are paving a similar path that was initially paved with mAb biosimilars almost 20 years ago. The parallels between these fields, particularly in terms of regulatory complexity and the scientific rigor required, have given me the confidence to approach and address the evolving needs of cellular therapies.

What challenges did you face - as a woman or otherwise - along the way and what is the most valuable lesson you have learned?​

One of the biggest challenges I’ve faced is finding strength in my voice. I’ve never been naturally talkative and early in my career in Korea, I rarely spoke in larger group settings – not because I was discouraged, but because the environment didn’t push me to. Transitioning to work in the U.S. has been a different experience, where I’ve been encouraged to speak up, especially now in a leadership role where sharing my insights is expected. My experience rounds out the discussion, provides valuable input and enriches the conversation. While I love to share knowledge if it can help others, I’ve had to build confidence in my own voice and learn how to communicate effectively with audiences. The most valuable lesson I’ve learned is that having confidence in your knowledge is crucial to contributing meaningfully and leading others. I’m still working on this today, and that’s perfectly fine because growth is a continuous process.

What ignites your passion in your current role?​

What truly fuels my passion in my role at CTMC is the opportunity to contribute to something as transformative as curing cancer. Every day, I see the potential of innovative science to change lives, and being able to make even a small dent in the fight to cure cancer is deeply fulfilling.

What is your current work ethos/style?​

My work ethos is defined by a deep commitment to excellence, strategic thinking, and the ability to impact patient lives.

My work style involves carefully considering FDA guidance and recommendations during development, as FDA alignment is crucial to success. However, there are instances where advocating for a different strategy based on our own product and process understanding accumulated over development is vital to a product’s success. In those cases, I work closely with the technical teams to push for what is best for the product while ensuring open and constructive communication with the FDA.

I truly value collaboration and strive to foster collaboration both cross-functionally and with partners, including the FDA. Working together with colleagues across disciplines and our academic and biotech partners is key to driving innovation and achieving our shared goal of eliminating cancer.

Could you share some advice for young women starting to develop an interest in science or wanting to pursue a career like yours?​

Science is not only an impactful field but also a broad one offering a wide range of opportunities beyond what you might expect. I majored in biological sciences and did lab work in graduate school and quickly discovered that I really did not like working in the lab as it was a poor fit for my personality and interests. It wasn’t until I joined the biotech industry that I discovered my love for regulatory affairs, which allows me to combine science with problem solving and strategic thinking. My journey showed me that there’s no one path in science – you can explore different areas and will eventually find what truly excites you.