StemSight is on a mission to cure blindness through regenerative cell therapies. The goal is to accelerate tissue regeneration and simplify cell delivery for patients suffering from corneal blindness.
Moving into the Clinic
Charlotta joins StemSight at the time when the company starts preparing for its transition into clinical development.
“The early clinical development stage has been my focus for many years. This is where I feel at home,” says Charlotta.
Charlotta joins StemSight from Valo Therapeutics, where she played a key role in the transition from the pre-clinical setting to the clinic. She was responsible for launching Valo’s first-in-human (FIH) study, which was the second time in her career that she led a product into FIH trials. Her first experience was with Oncos Therapeutics (now Targovax). At both companies, Charlotta led Regulatory Affairs and Clinical Operations, managing all aspects of clinical trial initiation.
Clinical Operations and Regulatory Affairs from Multiple Perspectives
Charlotta brings a broad perspective on clinical development, having worked on both the sponsor and service provider sides. Before moving into sponsor roles, she gained extensive experience in the Clinical CRO industry at Remedium and Encorium where she acted as the liaison between sponsors and clinical trial sites.
“During my career I have managed the start-up, conduct, and close-out of trials from Phase I to Phase IV across various indications, including vaccines, hypertension, dermatology, and oncology, and with various products, including products classified as ATMPs, or Advanced Therapy Medicinal Products. This gave me a deep understanding of how to ensure smooth trial operations at the site level and capture clean, complete data for the sponsor,” she explains.
Looking Ahead
Charlotta is very enthusiastic about what’s ahead for StemSight.
“The concept is brilliant. Unlike many cell therapies, this product doesn’t require genetic engineering. We’re simply replacing what has been lost.”
She also shares her excitement about joining the team:
“I’m thrilled to work with such an expert group of colleagues who are all driven by the same mission to make a real difference for patients.”
StemSight’s first product advancing toward clinical trials is STE-101, developed for the treatment of partial or total unilateral or bilateral limbal stem cell deficiency (LSCD). LSCD may result from various congenital or acquired causes, such as congenital aniridia, Stevens-Johnson syndrome, thermal or chemical burns, microbial infections, or even prolonged contact lens wear.
STE-101 has the potential to target a large variety of patients with a high unmet medical need. The program also benefits from the regulatory opportunities offered under frameworks for Advanced Therapy Medicinal Products (ATMPs) and Orphan Drug Designation.