Driving Innovation in Cell Therapy: A Major Step Forward with Andrew Willis, StemSight’s Chief Development Officer
- verakroger2
- Mar 19
- 3 min read
StemSight is advancing cell therapy with a clear mission: to bring innovative induced pluripotent stem cell (iPSC) treatments to patients. At the heart of this effort is Andrew Willis, our Chief Development Officer, whose decades of experience in drug development, regulatory affairs, and cell therapies help shape our journey from research to clinical application. We sat down with Andrew to discuss his background, vision, and priorities for StemSight.
A Career Built on Experience and Impact
With over 35 years in the pharmaceutical and cell therapy industries, Andrew has held leadership positions at multiple companies, including roles as Chief Development and Regulatory Officer and Senior Vice President in regulatory and quality affairs. His expertise spans clinical trial strategy, regulatory approvals, CMC development, and investor engagement.
“StemSight was of particular interest to me for a number of reasons. Firstly, it matched my experience, and I believed I could bring value by applying my knowledge in drug development and regulatory affairs. It’s a young company with immense potential, and I saw an opportunity to contribute meaningfully to its growth.”
Throughout his career, Andrew has played a pivotal role in securing FDA Breakthrough Designation status, overseeing global regulatory strategies, and scaling ATMP (Advanced Therapy Medicinal Product) manufacturing processes. His experience will be instrumental in guiding StemSight through critical regulatory and development milestones.
The Excitement of Joining StemSight
When asked what excites him most about StemSight’s mission and technology, Andrew points to both the science and the people.
“A number of factors excite me. Firstly, the team—our CEO and leadership are deeply passionate about bringing this project to reality. Their commitment is inspiring. Beyond that, the opportunity to influence all aspects of quality, regulatory, and development at such an early stage is incredibly rare. It’s a challenge I couldn’t pass up.”
StemSight’s innovative use of iPSC technology to create limbal stem cells (LSCs) presents complex but exciting challenges in manufacturing and delivery. “The work we’re doing isn’t just groundbreaking—it has the potential to transform how patients receive treatment. That’s what drives me.”
Charting the Path Forward
As Chief Development Officer, Andrew’s immediate priorities are clear: securing regulatory approvals, advancing StemSight’s preclinical and CMC (Chemistry, Manufacturing, and Controls) plans, and preparing for the company’s Series A fundraising.
“We have already initiated plans to increase interaction with major regulatory agencies like the FDA. This year, we intend to have an INTERACT meeting and obtain Orphan Drug status. My initial goal was to become fully familiar with the product and team and ensure, through advanced evaluation techniques, that we are ready for clinical trials.”
With clinical trials on the horizon, Andrew emphasizes the importance of a well-structured strategy. “We need a plan that meets regulatory expectations, ensures a high-quality product, and provides key inflection points for investors and stakeholders. Every step must be deliberate and well-executed.”
Shaping the Future of Cell Therapy
Andrew sees his role as a bridge between research, regulatory expectations, and commercial viability.
“My role is critical in ensuring our overall strategy aligns with regulators, quality standards, and investor expectations. Working closely with the CEO, CSO, CCO, and the entire team, we are collectively driving toward the clinic in a timely and responsible manner. Above all, we are committed to delivering safe, high-quality treatments to patients.”
StemSight operates in a complex and rapidly evolving field, but Andrew is confident in the company’s positioning. “The landscape for cell therapies is challenging—investor expectations, quality standards, and regulatory requirements must all align. But iPSC-derived products are becoming better understood, and StemSight has taken these considerations into account from the earliest research stages. We are now in an excellent position to meet those expectations and bring our therapies to patients.”
As StemSight continues its journey toward clinical trials and beyond, Andrew’s leadership will be instrumental in navigating the road ahead. His expertise, combined with the dedication of the StemSight team, ensures that the company remains at the forefront of regenerative medicine.