BeiGene Details Its Approach To Expanding Oncology Trials Into Brazil
By Lígia Campos, director, clinical operations head Brazil and LATAM, BeiGene
BeiGene has found recent success in expanding oncology clinical research trials into Brazil — a country greatly impacted by cancer prevalence and lagging treatment (and funding thereof). In part one of this series, BeiGene details the country’s cancer treatment landscape and details the benefits of expanding oncology trials in the country. In this second and final article, BeiGene details its journey to setting roots in the country, sharing its beginnings there and highlighting its approach to study start-up and patient recruitment and enrollment.
Building The Brazilian Foundation
BeiGene’s journey to establish itself in Brazil began in 2021 with the acquisition of its legal entity and a three-person team, with Alex Carvalho as general manager for Brazil, Alaeddin Homsi, head of Americas, GCO, and, later, Lígia Campos as clinical operations head for Brazil. While the team initially operated with significant support and coordination from the global structure, they desired to establish a fully operational company in Brazil, capable of conducting clinical trials and preparing for the launch and commercialization of upcoming products. This expansion was approached with an end-to-end strategy in mind, ensuring that each operational component supported BeiGene’s broader mission in the region. Seamless coordination across clinical operations, regulatory affairs, legal teams, and local sites is vital for accelerating timelines and ensuring Brazil's active participation in key trials. The openness to discussions, agility in evaluations, and support provided by the Brazilian Health Regulatory Agency (ANVISA) have all been essential to our success. One of our first strategic steps was to engage with ANVISA, presenting an overview of BeiGene’s mission, pipeline, and plans for regional expansion.
Within the LATAM region and beyond, the Brazilian team has established and nurtured partnerships with renowned leaders and healthcare institutions. Much of our success is rooted in these collaborations with distinguished physicians and investigators in hematology and oncology, as well as partnerships with public and private institutions.
The Brazil team has also initiated a partnership program that offers mutual benefits and a tailored agenda. By providing a dedicated point of contact for investigators and site staff, we facilitate improved communication and customized solutions. This approach enables strategic planning for future studies through pipeline meetings and enhances study management with operational dashboards from clinical study meetings.
In addition to effectively engaging with external stakeholders, assembling a top-performing, diverse team from within the pharmaceutical industry has been a key factor in our success. Our team is composed not only of highly experienced clinical trials management professionals but also of specialists in areas such as medical affairs and market access. The blend of complementary backgrounds has been crucial in shaping our business strategy for rapid expansion and maintaining a high level of quality.
Our Strength: Unparalleled Start-Up Capabilities
BeiGene employs a strategic feasibility process that initiates discussions at the earliest possible stage, both internally across all regions and externally, leveraging insights from our partners and national KOLs. This integration of internal and external prerequisites at a preliminary stage directly influences the development of more precise study designs and a streamlined approval timeline that aligns with the needs of the company, investigators, and, most importantly, patients. This integration, coupled with a comprehensive grasp of our local needs and the specific profiles of patients and institutions, has enabled us to make more informed selections of clinical centers. This, in turn, is having a direct impact on patient recruitment and the success of ongoing trials.
The Brazil Study Start-Up (SSU) structure also supports submissions in other Latin American countries, ensuring high-quality submissions to local and central ethics committees (LEC and CEC) as well as health authorities (HAs) by leveraging their expertise in local regulations and site-specific requirements. These professionals customized informed consent forms (ICFs) to meet local requirements, prepared documentation for LEC/CEC and HA submissions, and collaborated with sites to streamline the process. Furthermore, SSU managers had developed regulatory strategies that accelerated approvals, particularly for rare diseases in Brazil. They managed submissions at the LATAM level, coordinated with both local and global teams to resolve issues, and ensured that BeiGene’s processes were harmonized across the region. They also provided guidance and oversight to the local SSU team.
Even though Brazil has historically been known for its lengthy approval timelines for both ethics and regulatory submissions, we have consistently secured direct approvals much faster than traditional timelines. We have seen particular success in clinical trials involving rare diseases. The Brazilian HA, ANVISA, considers rare diseases when the incidence is one patient per 65,000 habitants (resolution 205 of 2017). The streamlined analysis processes have enabled us to commence studies without significant delays and without receiving inquiries from ANVISA and LECs.
Our success can be attributed to our comprehensive understanding of the LEC/CEC and HA’s requirements and the HA’s simplified analysis based on a model that relies on or recognizes regulatory decisions made by trusted international health authorities (members of ICH), such as the FDA, Health Canada, and the United Kingdom, which facilitates faster approvals by leveraging evaluations from other health agencies.
Furthermore, the regulatory environment in Brazil is increasingly favorable, with the introduction of Law 14874 of 2024, which brings more predictability to timelines and requirements in a safer regulatory environment. Therefore, we are confident that Brazil will become a stronger contributor to new global studies, positively impacting oncologists and patients as the number of studies increases in the region. In addition, the main HA resolution for medication in clinical trials, RDC 9 of 2015, is also being updated to comply with this new law, among other changes.
Exceeding Recruitment Expectations
The high incidence of cancer, combined with a diverse population and access-related challenges, underscores the necessity for precise identification of clinical sites that align with each trial's patient profiles. BeiGene’s success in LATAM has been driven by the expertise of its team, the active engagement of PIs, strong partnerships with clinical sites, and a commitment to quality. This collaborative approach, combined with expedited start-up activities, has significantly enhanced patient recruitment efforts.
From the outset, the strategy reflected the philosophy of “changing the wheels while still moving,” as the first trial was submitted even before a dedicated ClinOps structure was fully established. This initial wave focused on late-phase hematology trials, while also including studies on lung cancer — both cornerstone indications of BeiGene’s clinical program. Additionally, a few early-phase trials explored more niche disease indications, reflecting the company's dedication to broadening therapeutic impact.
In just two years, BeiGene initiated over 10 clinical studies, successfully enrolling more than 200 patients — an impressive achievement that establishes a new industry benchmark. Despite this rapid progress, challenges that are common in such complex operations have arisen and continue to pose risks to timelines and trial execution overall. The key internal challenges include timely importation of clinical supplies, sourcing comparators, and contract negotiation and execution timelines at the clinical sites. On the other hand, BeiGene’s biotech-like lean structure offers a critical advantage: agility. This flexibility enables the company to swiftly overcome operational hurdles by adapting internal processes to meet the evolving demands of a new market.
What’s Next For BeiGene In Brazil
In addition to ongoing efforts to bring late-phase studies and recruit — and potentially benefit — an increasing number of patients due to the strength of its pipeline, the next exciting challenge is to effectively scale up the ClinOps operation. With at least 10 new molecules projected to enter the clinical stage each year, the challenge of scaling up brings with it an incredible opportunity to drive the execution of Phase 1 studies in Brazil. The country currently lacks a significant role in this type of study, and BeiGene plans to help Brazil join the ranks of countries with extensive Phase 1 expertise.
About The Author:
Lígia Campos has over 17 years of experience in clinical research and operations in the pharmaceutical industry. As director, clinical operations head for Brazil and LATAM at BeiGene, she has played a key role in establishing and expanding the company’s clinical operations in the region.
Previously, Lígia held leadership roles at Novartis Oncology, where she oversaw clinical operations, real-world evidence initiatives, and strategic evidence generation to support product launches and market access. Her expertise includes regulatory submissions, patient recruitment strategies, and building collaborations with key stakeholders across LATAM. With a background in pharmacy, Lígia has worked across diverse therapeutic areas, particularly oncology, driving clinical trial efficiency and operational excellence.