Greenwich LifeSciences Builds In-House Clinical Ops Team to Enhance Efficiency and Quality

Greenwich LifeSciences is building an internal clinical operations team to manage its Phase III FLAMINGO-01 trial, reducing reliance on CROs and improving cost efficiency. The initiative aims to enhance trial management quality and facilitate the expansion of trials for GLSI-100. The team will also enable the company to conduct multiple trials simultaneously and explore new drug candidates.

Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, has announced plans to build its internal clinical trial management team for the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention. This strategic move aims to reduce dependency on Clinical Research Organizations (CROs) by hiring dedicated internal staff, which is expected to lower costs and increase efficiency in managing clinical trial operations.

The company's decision to transition from external CROs to an internal clinical operations team represents a notable operational pivot for managing its Phase III FLAMINGO-01 trial. This strategy targets two critical metrics: cost reduction and operational efficiency. By bringing clinical trial management in-house, the company is addressing the typically high expenses associated with outsourcing to CROs, which can consume 30-50% of clinical development budgets [1].

The move has multiple strategic advantages beyond simple cost savings. First, it gives Greenwich greater control over trial quality and data integrity at a critical phase in their development pipeline. Second, it positions them to potentially run parallel trials simultaneously – whether expanding the current FLAMINGO-01 study or developing new indications for GLSI-100. This capability would typically require significant additional CRO expenditures.

Most importantly, the reduced burn rate provides increased financial flexibility, extending their cash runway without additional financing. For a clinical-stage biotech without revenue, optimizing capital efficiency is paramount. While this operational change doesn't directly impact the scientific prospects of their immunotherapy candidate, it does strengthen their organizational infrastructure and potentially allows for pipeline expansion beyond their current breast cancer recurrence prevention focus.

The company has begun to hire its own staff to manage and operate FLAMINGO-01, while reducing its dependence on more expensive staffing from Clinical Research Organizations (CROs). The strategy to bring in key clinical functions inside the Company is expected to reduce costs over the remaining duration of the clinical trial and to increase efficiency and quality as the clinical trial continues to increase the number of enrolling sites and the number of approved participating countries [1].

By selecting high caliber personnel, the Company is seeking to develop the capability to conduct multiple trials simultaneously, whether it is an increase in the number of HLA-A*02 patients, the creation of pivotal treated and placebo arms for those patients who are not HLA-A*02, the pursuit of other populations and trials for GLSI-100, or the potential to develop other in-licensed drug candidates.

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally [1].

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[1] https://www.stocktitan.net/news/GLSI/greenwich-life-sciences-announces-plan-to-build-out-internal-bb5hllde6pbx.html