By Executive Forecast, originally published at https://www.executiveforecast.com/conversation/paulo-fernandes---president-associacao-brasileira-de-organizacoes-representativas-de-pesquisa-clinica-abracro-brazil
EF: When you complete 10 years at ABRACRO, what will be your greatest pride?
PF: My greatest pride will be in expanding the institutional presence of the association. ABRABRO is made up of companies that provide services, not products. What these companies offer is the experience and work of individuals, who are often very focused on niche areas of the business sector. We work hard to make our association known to politicians, stakeholders and the general public, and I am proud of the work we are doing to increase ABRABRO’s institutional presence and increase the attractiveness of the association for new companies to join. We have reorganized the association, improved its governance, etc.
EF: What are your top 3 priorities for the rest of 2024?
PF: We are currently playing a crucial role in supporting the ongoing discussions related to the Clinical Research Bill in Brazil. This bill has been under consideration in the National Congress for the past 9 years and is now reaching a critical stage. Last year, the bill was approved by the Chamber of Deputies, and is currently being deliberated in the Senate. After this discussion in the Senate, the bill will go to the President of the Republic for approval. This is a key moment for the clinical research sector in Brazil.
Our role in these discussions is to ensure that they are based on facts and not on the sensationalism that can be found around clinical trials. It is difficult to educate people about what we do. There is a long-standing idea that clinical trials are taking advantage of people, but that is not true. Several regulations are followed for clinical trials to be implemented in Brazil. Supporting these regulations would be my top priority.
Secondly, we have an educational arm within the association that we are expanding to increase the association’s capacity 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 focused on professional services, we believe that it is part of our mission to empower individuals, and we are actively working towards this goal. We offer training courses, with plans to expand our offerings over time.
We aim to provide favourable conditions, such as scholarships and discounts, to professionals in the public sector. It is important to note that all of these efforts are carried out on a non-profit basis; the revenue generated by our educational activities is reinvested in education.
Our third goal is to continue to expand the reach and impact of the association. As the ecosystem matures and the market expands, more entrepreneurially minded individuals will emerge, seeking innovative approaches to clinical research in the country. Our goal is to expand the association to engage these individuals and support their development, unique knowledge, and experience. Interacting and learning from established market leaders will further enrich their capabilities. This interaction will drive positive outcomes for the ecosystem. This goal represents our third priority: preparing Brazil to become a leading force in clinical research in the next decade.
EF: Can you explain how law 6007/2023 is a step in the right direction for Brazil?
PF: Brazil offers an excellent environment for conducting clinical trials due to robust regulations from both regulatory authorities, such as ANVISA, and local and national ethics authorities. We benefit from well-defined rules that ensure that trials are conducted safely, while allowing the country to participate in clinical development. However, despite the mature regulatory environment, challenges remain in achieving predictability regarding trial evaluation timelines. It is essential to clarify that trials must be thoroughly evaluated and only approved if they meet rigorous safety and structural standards.
Law 6007/2023 aims to increase market predictability by simplifying the evaluation process, reducing bureaucracy and improving competitiveness compared to other countries in the world. This law will make trials safer for participants and will 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 this growth can be used to support the local environment so that more trials can be proposed in Brazil. This is an objective that aligns with our mission. In addition to 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 your association members doing to help speed up clinical trial evaluation and make Brazil a leader in this sector?
PF: ABRACRO’s membership is almost equally divided between foreign and Brazilian companies. Foreign companies include established CROs that conduct clinical trials for global biotechs and pharmaceutical companies. These organizations bring innovation to the market, especially in digital technologies designed to improve participant experiences and enable complex trials without frequent site visits. Their innovative technologies and new trial designs, such as adaptive designs, are having a significant impact on the clinical research landscape in Brazil.
This is beneficial for Brazil because, in addition to simply implementing their trials and achieving their goals, these foreign companies also contribute valuable knowledge to the Brazilian industry. Particularly in light of the pandemic, there is a global emphasis on capacity building. Conducting trials is not just about conducting them, but also about leaving behind sustainable knowledge and capabilities. These companies are playing an important role in this context. On the other hand, Brazilian companies, because they are familiar with the local market, often specialize in niche areas such as logistics, where they bring innovative solutions and highly specialized professional services.
Overall, I see that our member companies actively support the ecosystem. Furthermore, there has been a recent trend, particularly in 2023, of healthcare technology companies specializing in the clinical trials domain showing interest in joining ABRACRO and collaborating with Brazilian companies. These companies are developing tailored software solutions for clinical trials. All of our members are, in one way or another, supporting a better structured market.
EF: How would you describe the current state of data management in terms of ensuring clean and reliable data? Also, what do you envision the future of data management, especially AI and language models?
PF: We have a board made up of representatives from our member companies. Within this board, we have a management structure where people like Fernando Rezende, our CEO, and myself help to facilitate internal activities. Most of the internal work is carried out by dedicated volunteers from the member companies. These volunteers engage with the leaders and representatives of their companies to participate, deliberate and contribute to the association.
We have committees within the association covering a variety of areas, including clinical operations, regulatory affairs and imports. In 2024, we have created two additional internal committees: one focused on real-world evidence and one on digital technologies. These committees will serve as forums to deepen our understanding and develop expertise in these critical areas of technology, both now and in the future.
As our association grows, internal committees will also take on the responsibility of educating our executives with the knowledge needed to engage 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 substantive discussions on emerging trends, particularly in areas such as artificial intelligence and machine learning (AIML), which are poised to become commonplace in clinical development.
AIML will soon become an essential tool, similar to electricity, and we are actively exploring ways to automate data extraction from electronic medical records to minimize transcription errors and maximize data generation efficiency. This is a very innovative area that still lacks solutions worldwide, not just in Brazil.
In Latin America, including Brazil, there is still a significant reliance on paper-based medical records, necessitating advances in optical character recognition (OCR) technology to effectively digitize and process this data. While these trends are still emerging, we are committed to leveraging innovative solutions and technologies to drive progress across 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 represents a significant advantage for the country and the region. The need to generalize results and control development costs will drive the industry to look for locations where large trials can be conducted efficiently with diverse populations. There is a lot of pressure in clinical development regarding timelines, and Brazil, like Latin America as a whole, offers ample opportunities to conduct large trials with diverse populations. Rather than conducting trials in multiple locations around the world and aggregating statistics later, why not incorporate Brazil into all Phase 2 and Phase 3 trials? This approach is not only cost-effective due to lower labor costs in Latin America, but also facilitates generalization of data across a wide range of indications.
Brazil has an ICH-compliant regulatory authority and is an ICH council member, creating an enabling environment with robust regulations and skilled professionals – an unmatched combination in my experience.
EF: What are the economic benefits of Brazil becoming a hub of innovation in life sciences?
PF: The clinical trials value chain goes beyond conducting the trials themselves. It requires a comprehensive ecosystem involving logistics, specialized companies and advanced laboratory capabilities for diagnostic tests beyond standard-of-care biomarkers. Developing these aspects is crucial to effectively support clinical research. Furthermore, creating pathways for academia to enter the pharmaceutical sector will bridge the gap between research and practical applications, allowing Brazilian innovations to move from the bench to the bedside more efficiently – a transition that is often lacking in Latin America.
By expanding clinical research, we expect positive impacts across multiple industries. For example, despite a strong clinical research ecosystem, few colleges offer dedicated clinical trials courses in their curricula. 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, healthcare technology, and software solutions.
We are currently witnessing significant government initiatives and funding for biotechnology, exemplified by FINEP’s investment in innovation across different sectors, including biotechnology. Deepening clinical research in Brazil 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 proposed legislation that aims to further support our clinical trials environment. Brazil is already a strong location for clinical trials, with respected clinicians and researchers who have a proven track record in the region. While improvements in the speed of assessment are crucial, we are already well positioned in the sector.
Despite the challenges posed by the COVID-19 pandemic, Brazil has played a significant role in several vaccine and treatment development projects, demonstrating high performance and quality. We recognize the need for continuous improvement and agility, especially in the rapidly evolving technology domain. Brazil’s healthcare system is vast, overseen by a government that spans a continent. As we strive to grow and improve, we recognize the importance of adapting quickly to technological advances and maintaining our strong foothold in the clinical research landscape.
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