Unlocking Value: Why Latin America is the Strategic Choice for Phase 1 Trials. S1E12 скачать в хорошем качестве

Unlocking Value: Why Latin America is the Strategic Choice for Phase 1 Trials. S1E12

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, interviews Sara Tylosky, CEO of Farmacon Global, about the Latin American market for clinical trials. Farmacon Global, a strategic partner with a network of physicians, focuses on rare diseases, oncology, and immunology in Latin America. Sara highlights the region's diversity, cost savings, and fast recruitment, noting that Latin America represents 0.7% of global phase 1 studies but has a population of more than 660 million and 30+ qualified sites. She addresses misconceptions about slow recruitment and regulatory issues, emphasizing the region's alignment with international guidelines and the potential for collaboration with CROs. Farmacon Global aims to expand its phase 1 research opportunities and educate biotechs on the region's benefits. Interested in learning more about clinical trials in Latin America? WEBINAR: Early Clinical Trials in LATAM: A Sustainable Data Strategy September 18, 2025. 12 Noon EST WEBINAR registration via RARE DIEM ALLIANCE Introduction and Overview of Court Square Group ● Keith Parent introduces himself as the CEO of Court Square Group, a managed service firm specializing in managing infrastructure for life science companies. ● The Driving the Business of Science podcast aims to explore innovative practices in the industry and features guests who are doing unique things. ● Keith introduces Sara Tylosky, CEO of Farmacon Global, to discuss the Latin American market from a CEO and CRO perspective. ● Sara Tylosky introduces herself and explains that Farmacon Global is a strategic partner with a network of physicians, focusing on Latin America and rare diseases. Farmacon Global's Focus on Latin America ● Sara explains that Farmacon Global has a presence in the United States but focuses primarily on Latin America. ● The company works with smaller biotechs to help them get started and assists larger pharmas in rescuing situations, often related to enrollment or regulatory challenges. ● Keith recalls meeting Sara at an ADDF event in Boston and discusses the significant work Farmacon Global is doing in Latin America. ● Sara highlights the diversity of Latin America, which is crucial for clinical trials, and mentions the region's potential for conducting early phase trials. Misconceptions About Latin America ● Keith and Sara discuss common misconceptions about Latin America, such as thinking it consists only of rural populations and jungles. ● Sara emphasizes the sophistication of the medical community in major cities like Mexico City and Sao Paulo as large urban centers. ● Sara shares examples of companies Farmacon Global has worked with, including a recent approval for a liver condition product. ● Keith and Sara discuss the misconceptions about slow recruitment, logistical issues, and IND filing in Latin America, which is not necessary to conduct early phase trials. ● Enrollment is always so fast and so strong that often there are FDA audits and that could be perceived as a negative, when in fact, it shows strong enrollment! Advantages of Conducting Early Phase Trials in Latin America ● Sara explains the cost advantages of conducting trials in Latin America, which are about 30-60% less than in the US, Europe, or Australia. ● The region offers fast recruitment due to large cities and treatment-naive patients. ● Sara mentions the regulatory improvements and alignment with international guidelines, making Latin America a viable alternative to other regions. ● Keith and Sara discuss the importance of time zones and the alignment with the US East Coast, which facilitates communication and coordination. Farmacon Global's Strategic Partnership and Site Engagement ● Sara explains Farmacon Global's approach of being a strategic partner rather than just a CRO. ● The company has a network of experienced physicians and sites, which helps in engaging with sites and overcoming challenges. ● Sara highlights the importance of site engagement, where medical leads maintain regular communication with principal investigators (PIs) to address any issues. ● Farmacon Global ensures that clinical sites have the necessary infrastructure and support for conducting trials.