Read the Conversation
EF: When you celebrate your 10th anniversary at ABRACRO, what will be your proudest achievement?
PF: My proudest achievement will be the expansion of the institutional presence of the association. ABRABRO consists of companies that provide services rather than products. What these companies offer is the expertise and work of individuals, which is often very concentrated in niches within the business sector. We work hard for our association to be known by politicians, stakeholders, and the general public, and I am proud of the work we are doing to grow the institutional presence of ABRACRO and increasing the association's attractiveness for new companies to join. We reorganized the association, improved its governance, etc.
EF: What are your top 3 priorities for the rest of 2024?
PF: We currently play a crucial role in supporting the ongoing discussions related to the Law Project for Clinical Research in Brazil. This law has been under consideration in Congress for the past 9 years and is now reaching a critical stage. Last year, the law was approved by the lower chamber, and it is currently being deliberated in the Senate. Following this senate discussion, the law will proceed to the president for approval. This represents a capital moment for the clinical research sector in Brazil.
Our role in these discussions is to ensure that they are based on the facts, not on the sensationalism that can be found around clinical trials. It is difficult to educate people about what we do. There is an old view that clinical trials are taking advantage of the people, but that is not true. Several regulations are followed for the clinical trials to be implemented in Brazil. Supporting these regulations would be my main priority.
Secondly, we have an educational arm within the association that we are expanding to enhance the association's ability to support the training of professionals. ABRACRO is advocating for a more robust ecosystem with an increase in clinical trials that are delivered with high quality. As an association centered around professional services, we believe it is part of our mission to empower individuals, and we are actively working towards this goal. We offer educational courses, with plans to expand our offerings over time.
We aim to provide favorable conditions, such as scholarships and discounts, for professionals in the public sector. It's important to note that all these efforts are conducted on a not-for-profit basis; revenue generated from our educational activities is reinvested back into education.
Our third goal is to continue expanding the association's reach and impact. As the ecosystem matures and the market expands, more individuals with entrepreneurial perspectives will emerge, seeking innovative approaches to clinical research in the country. We aim to expand the association to engage these individuals and support their development, their unique knowledge and their expertise. Interacting with and learning from established market leaders will further enrich their capabilities. This interaction will foster positive outcomes within the ecosystem. This goal represents our third priority: preparing Brazil to become a leading force in clinical research within the next decade.
EF: Can you explain how law 6007/2023 is a step in the right direction for Brazil?
PF: Brazil presents an excellent environment for conducting clinical trials due to robust regulations from both regulatory authorities such as ANVISA, as well as local and national ethical authorities. We benefit from well-defined rules that ensure trials are conducted safely while enabling the country's participation in clinical development. However, despite the mature regulatory environment, challenges persist in achieving predictability regarding the assessment timelines for trials. It is essential to clarify that trials should be assessed thoroughly and only approved if they meet rigorous standards for safety and structure.
The 6007/2023 law aims to enhance market predictability by streamlining the assessment process, reducing bureaucracy, and improving competitiveness in comparison to other global counterparts. This law will make trials safer for participants and also protect investors who take the financial risk of developing a new treatment or intervention through the implementation of clinical trials in the country. This should encourage market growth, and the results of that growth can be used to support the local environment for more trials to be proposed in Brazil. This is a goal that aligns with our mission. Beyond expanding the market for conducting global trials, we aim to foster the development of trials conceptualized and organized in Brazil that can be executed on a global scale.
EF: What are the members of your association doing to help speed up the assessment of clinical trials to make Brazil a leader in this sector?
PF: ABRACRO's membership is divided almost evenly between companies from abroad and Brazilian companies. The foreign companies typically include established CROs conducting clinical trials for biotechs and global pharmaceutical companies. These organizations bring innovation to the market, especially in digital technologies aimed at improving participant experiences and enabling complex trials without frequent site visits. Their innovative technologies and new trial designs, such as adaptive designs, are making a significant impact on Brazil's clinical research landscape.
This is beneficial to Brazil because, beyond just implementing their trials and achieving their objectives, these foreign companies also contribute valuable knowledge to the Brazilian industry. Particularly in light of the pandemic, there's a global emphasis on capacity building. Running trials is not just about conducting them but also leaving behind sustainable knowledge and capabilities. These companies are playing an important role in this context. On the other hand, Brazilian companies, being familiar with the local market, often specialize in niche areas like logistics, where they bring innovative solutions and highly specialized professional services.
Overall, I observe our member companies actively supporting the ecosystem. Additionally, there has been a recent trend, particularly in 2023, of health tech companies specializing in the clinical trial domain showing interest in joining ABRACRO and collaborating with Brazilian companies. These companies are developing software solutions tailored for clinical trials. All of our members are in one way or another supporting a more well-structured market.
EF: How would you describe the present state of data management in terms of ensuring clean and reliable data? Additionally, how do you envision the future of data management, especially AI and language models?
PF: We have a council comprising representatives from our member companies. Under this council, we have a management structure where people like Fernando Rezende, our Executive Manager, alongside myself, assist in facilitating internal activities. Most of the internal work is carried out by dedicated volunteers from member companies. These volunteers engage with their company leaders and representatives to participate, deliberate, and contribute to the association.
We have committees within the association covering various areas such as clinical operations, regulatory affairs, and imports. In 2024, we established two additional internal committees: one focused on real-world evidence and the other on digital technologies. These committees will serve as forums for deepening our understanding and developing expertise in these critical areas of technology, both presently and in the future.
As our association grows, the internal committees will also take on the responsibility of educating our executives with the necessary knowledge for engaging in discussions with regulators. For example, ANVISA is interested in topics such as software for medical devices or digital interventions. We are preparing our internal environment to engage in substantial discussions about emerging trends, particularly in areas like artificial intelligence and machine learning (AIML), which are poised to become common in clinical development.
AIML will soon become an essential tool, similar to electricity, and we are in the field actively exploring ways to automate data extraction from electronic medical charts to minimize transcription errors and maximize data generation efficiency. This is a very innovative area, which still lacks solutions globally, not only in Brazil.
In Latin America, including Brazil, there is still a significant reliance on paper medical records, necessitating advancements in optical character recognition (OCR) technology to digitize and process this data effectively. While these trends are still emerging, we are committed to leveraging innovative solutions and technologies to drive progress within our association and the broader healthcare ecosystem.
EF: Why is investing in clinical trials in Brazil more valuable than anywhere else?
PF: The diversity of the population presents a significant advantage for the country and the region. The need to generalize results and control development costs will drive the industry to seek locations where large trials can be conducted efficiently with diverse populations. There is a lot of pressure in clinical development regarding timelines, and Brazil, along with Latin America as a whole, offers ample opportunities to conduct extensive trials with diverse populations. Instead of conducting trials in various locations globally and aggregating statistics afterwards, why not incorporate Brazil into every Phase Two and Phase Three trial? This approach is not only cost-effective due to lower labor costs in Latin America but also facilitates data generalization across a wide range of indications.
Brazil boasts a regulatory authority that is ICH-compliant and a member of ICH’s council, creating a conducive environment with robust regulations and skilled professionals—an unparalleled combination in my experience.
EF: What are the economic benefits of Brazil becoming a life sciences innovation hub?
PF: The value-added chain for clinical trials involves more than just conducting the trials themselves. It requires a comprehensive ecosystem involving logistics, specialized companies, and advanced laboratory capabilities for diagnostic tests beyond regular care biomarkers. Developing these aspects is crucial to support clinical research effectively. Additionally, creating pathways for academia to enter the pharmaceutical sector will bridge the gap between research and practical applications, allowing Brazilian innovations to transition from the bench to the bedside more efficiently—a transition that is often lacking in Latin America.
By expanding clinical research, we anticipate positive impacts across various sectors. For instance, despite having a strong clinical research ecosystem, few colleges offer dedicated subjects on clinical trials within their curriculum. Strengthening the clinical research industry will create a beneficial feedback loop with academia, benefiting both sides. Furthermore, this growth will extend to other sectors such as logistics, diagnostics, health tech, and software solutions.
We are currently witnessing significant government initiatives and funding for biotech, exemplified by FINEP's investment in innovation across different sectors, including biotech. As clinical research deepens in Brazil, it will undoubtedly have a substantial and positive economic impact—a direction we are actively pursuing.
EF: Is there any final message you would like to share with the rest of the healthcare industry?
PF: A key aspect of our discussion today focused on the law project aimed at further supporting our clinical trial environment. Brazil already stands as a strong location for running clinical trials, with respected physicians and investigators who have a proven track record in the region. While improvements in assessment speed are crucial, we are already well-positioned within the industry.
Despite the challenges posed by the COVID-19 pandemic, Brazil played a significant role in multiple projects developing vaccines and treatments, demonstrating high performance and quality. We acknowledge the need for continuous improvement and agility, especially in the rapidly evolving field of technology. Brazil's healthcare system is vast, overseen by a government that spans like a continent. As we strive for growth and enhancement, we recognize the importance of adapting quickly to technological advancements and maintaining our strong foundation within the clinical research landscape.
