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Organized by:

Promoted by:

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The Brazilian Pharma & Health Project is an initiative coordinated by the Brazilian Industry Association of Active Pharmaceutical Ingredient (Abiquifi) with the support of the Brazilian Trade and Investment Promotion Agency (ApexBrasil), that aims to expand the participation of companies from Brazilian pharmaceutical and APIs productive chain into the international scenario, seeking to increase exports, technology transfer, investment attraction and the internationalization of the sector.

It promotes actions in business intelligence, international marketing, prospective missions, international fairs, business rounds, and trade missions directed to different target markets, including countries from all five continents.

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https://abiquifi.org.br/projeto-setorial/ jessica.cerqueira@abiquifi.org.br +55 (11) 2638-4487

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Abiquifi (Brazilian Industry Association of Active Pharmaceutical Ingredient) was founded in 1983 to represent and defend the pharmaceutical and API industry. At the beginning of 2010, it also represented companies engaged in the production of pharmaceutical adjuvants, non-active pharmaceutical inputs, and service providers in the sector.

The main objective of Abiquifi is to stimulate production, technological development, and exports of active pharmaceutical ingredients manufactured in Brazil.

Given the nature of the provider of the drug segment, the entity brings together the various links in this chain, promoting internationalization, research and development actions, and working with the sanitary control and promotion agencies.

The Brazilian Trade and Investment Promotion Agency (ApexBrasil) works to promote Brazilian products and services abroad and attract foreign investments to strategic sectors of the Brazilian economy.

In order to achieve its goals, ApexBrasil carries out several trade promotion initiatives aimed at promoting Brazilian products and services abroad, such as prospective and trade missions, business rounds, support to the participation of Brazilian companies in major international fairs, visits of foreign buyers and opinion makers to learn about the Brazilian productive structure, among other business platforms that also aim at strengthening the Brazil brand.

www.abiquifi.org.br abiquifi@abiquifi.org.br +55 (11) 2638-4487

www.apexbrasil.com.br apexbrasil@apexbrasil.com.br +55 (61) 3426-0202

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Diamond partners

Gold partners

Silver partners

Special Partners

Exhibitors

Brazilian Delegation

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SUMMARY 20 30 48 72 76 18 bioBr

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SUSTAINABILITY Brazil’s Journey through biodiversity and Innovation REGULATION AND INCENTIVES Accelerating healthcare innovation: strategic initiatives in Brazil HEALTH INTEGRATION Brazil’s One Health innovation in the fight against neglected tropical diseases NEUROLOGICAL DISEASE A pioneering researcher learned to create ‘wired’ brain organoids — and sent them to space. Now, he’s looking to Amazonian biodiversity to discover treatments for several neurological conditions

DEVELOPMENT Healthcare sector covered: Brazil launches program to stimulate innovation and industrial production

NEO-INDUSTRIALIZATION Bridging Innovation and Industry: Brazil’s Journey Towards Sustainable Growth VACCINES Investment environment in bio and health in Brazil INNOVATION Shifting the Global Investment Path: A New Vision for Latin America

BIO Br Project Management by: Reporter: BIOMINAS Brasil / Planning, Control and Operation: Natália Araújo, Julio Neto, Jéssica Cerqueira and Gabriel Keniti Art Editor: Daniel Guedes / Contact us at: abiquifi@abiquifi.org.br / Visit our site: bph.org.br

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Brazil’s Journey through

Biodiversity and Innovation

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razil is recognized worldwide for its rich biodiversity and search for innovation and sustainability.

Ranking among the nations with the most extensive biological diversity on Earth, Brazil acknowledges the significance of investing in its natural resources. Motivated by this recognition, both public and private sectors have undertaken numerous initiatives to responsibly harness the nation’s natural heritage.

To support Brazil in understanding its own diversity, joint efforts have been made to build a central bank of bioactive molecules.

Glimpsed by the Brazilian Center for Research in Energy and Materials (CNPEM) and, with

support from the Ministry of Science, Technology, and Innovation (MCTI) and the Brazilian Company of Research and Industrial Innovation (EMBRAPII), the Central Bank of Bioactive Molecules will allow the discovery and protection of Brazilian heritage, generating significant opportunities for innovation and development of new products.

The Director of the Brazilian Biosciences National Laboratory, National Center for Research in Energy and Materials (LNBio-CNPEM), Maria Augusta Arruda, highlighted that Brazil is experiencing a crucial moment in which it can capitalize on its unique biodiversity to boost innovation in various sectors. She also emphasizes the importance

of the contribution of institutions such as the Brazilian Industry Association of Active Pharmaceutical Ingredient (Abiquifi), Emerge Brasil, and Biominas Brasil by bringing together different actors in the innovation ecosystem in favor of developing more products and businesses in the pharmaceutical area.

Doctor Arruda (LNBio-CNPEM) notices the connection between the Nova Indústria Brasil (New Industry Brazil Plan) and policies involving biodiversity, innovation, sovereignty, and sustainability. This analysis is shared by Helena Bonna Brandão, Investment Manager at the Brazilian Trade and Investment Promotion Agency (ApexBrasil). Brandão (ApexBrasil) mentions the Brazilian Government’s New Neo-industrialization Policy, which has a mission related to the Health Economic-Industrial Complex aimed to lead the ties in production chains in the sustainable and innovative use of biodiversity.

According to Brandão (ApexBrasil), the organization directs its endeavors towards facilitating foreign investments to foster Brazilian leadership through the reinforcement and backing of enterprises equipped with stateof-the-art technology. A noteworthy instance of this commitment is exemplified by the Brazilian particle accelerator project, Siri-

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us, conceptualized and financed by the Ministry of Science, Technology, and Innovation (MCTI) at CNPEM (Brazilian Center for Research in Energy and Materials). This groundbreaking initiative, a testament to innovation and cutting-edge technology, underscores Brazil’s dedication to technological advancement.

In parallel, Emerge Brasil promotes the transition of technological innovations from the laboratory bench to the market. Daniel Pimentel, Managing Partner at Emerge, points out that sustainability is a common thread in many of the projects carried out by the company, which reinforces the idea that the use of Brazilian biodiversity can be a significant opportunity for international investors. With this approach, the sustainable use of biodiversity gains strength and creates a favorable environment for foreign investments. As an example, Doctor Arruda (LNBio-CNPEM) mentioned the creation of the Drug Discovery Platform by the LNBio-CNPEM, which uses natural products from Brazilian biodiversity as support to identify drug candidates.

When using natural products at the beginning of the production chain to discover new drugs, it is possible to find a similar trend in other segments, such as cosmetics and nutraceuticals. According to Rogério da Silva Almeida, RD&I Vice-President of Laboratórios Cristália, the solutions for many unmet demands, mainly in the healthcare sector, lie in the sustainable use of Brazilian biodiversity. In line with this logic, Brandão (ApexBrasil) sees with optimism and great expectations the

Helena Bonna Brandão, Investment Manager at the Brazilian Trade and Investment Promotion Agency (ApexBrasil)

horizon of possibilities for attracting foreign investments in ​​animal and human healthcare sectors based on the alignment between innovation and biodiversity in the country.

Furthermore, Almeida (Laboratórios Cristália) highlights that there is a vast field for the discovery and exploration of Brazilian natural molecules, which can increase access to innovative treatments for the population. However, Pimentel (Emerge) warns that the financial journey is a constant challenge. According to him, it is necessary to find technological solutions that allow sustainable production at an affordable cost, thus ensuring that the benefits of innovation reach the market.

Almeida (Laboratórios Cristália) illustrates how the company achieved success by developing a finished Maria Augusta Arruda, Director of the Brazilian Biosciences National Laboratory, National Center for Research in Energy and Materials (LNBio-CNPEM)

product from a bioprospecting project in Brazilian soils. This demonstrates the logic of adding value through the conscious use of biodiversity. In the same way, according to Brandão (ApexBrasil), the work model based on inputs from Brazilian biomes offers a competitive advantage on the international scene, further strengthening Brazil’s role as a leader in sustainable innovation.

Brazil also boasts a reliable regulatory framework for phytotherapy and cosmetics, ensuring the exceptional quality of developed products. This commitment aligns with the Brazilian government’s dedication to fostering business growth through robust public policies and initiatives assembled to expand the range of sustainable products derived from the country’s rich biodiversity. Notably, this includes the herbal medicines integration into the Brazilian Unified Health System (SUS). Additionally, Brazil bears third-sector entities essential in orchestrating collaboration among stakeholders to expe-

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SUSTAINABILITY

dite the emergence of new ventures.

These entities serve as conduits, facilitating connections between foreign enterprises and investors seeking to engage with Brazilian companies and innovations within the sector.

Brandão (ApexBrasil), when addressing the conjunction between innovation and conscious use of biodiversity, highlights the growing technological matuRogério rity of Brazilian comda Silva panies linked to the Almeida, healthcare sector and RD&I VicePresident of its potential for a posiLaboratórios tive impact on busiCristália ness. “Brazil has enormous potential to show the world our leadership in sustainable development combined with promising businesses” she stated. To support this movement, ApexBrasil, in partnership with Abiquifi, has been developing the Brazilian Pharma & Health project since 2011, which has as one of its work fronts the strengthening of the innovation ecosystem in biotechnology and life sciences, making it more attractive for foreign investment.

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One of the initiatives supported

by Abiquifi and the Brazilian Pharma & Health Project is InovafitoBrasil. An online platform for the phytotherapy sector. The platform facilitates connections among researchers, startups, service providers, investors, and companies interested in research grounded in Brazilian biodiversity. It operates on a tailored Technology Readiness Level (TRL) trail specifically for this sector, ensuring compliance with all Brazilian regulatory standards. By doing so, the platform enhances the project’s precision while simultaneously mitigating risks and expediting the development timeline for new products.

The initiatives mentioned previously show a robust and growing research and innovation ecosystem. Large national companie s such as Labo ratórios Cristália have Daniel shown an appetite for Pimentel, Managing research and startups Partner at that work with biodiEmerge versity, essential criBrasil

teria for the final development of new medicines and treatments.

There are also valuable research institutions with cutting-edge technologies for the initial phases of research into Brazilian bioactives and a growing number of startups and small companies emerging to take business opportunities in a national market in expansion, with opportunities also around the world.

With the synergy between biodiversity and innovation, Brazil is one of the most promising destinations for foreign capital, paving the way for solutions that use biodiversity to redefine the global sustainable business scenario. With this growing trend, the country is preparing to consolidate its position as an international investment hub focused on the sustainable and innovative use of its natural resources. As a result, Brazil can and should be one of the world leaders in developing sustainable businesses that respect its biodiversity while at the same time, driving technological progress. ●

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REGULATION AND INCENTIVES

Accelerating Healthcare Innovation: Strategic Initiatives in Brazil

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n 2023, a significant milestone for healthcare innovation in Brazil was established, with the publication of a Regulatory Ordinance by the Brazilian Health Regulatory Agency (Anvisa).

This measure established Anvisa’s Innovation Policy, outlining fundamental strategies to contribute to radical innovation in the sector, within three strategic areas: Innovation Capacity and Culture; Technology and Digital Transformation; and Regulation and Access to Healthcare.

The initiative leads innovation to meet public health challenges, deal with emergencies, and improve the population’s health, all within a transparent and ethical framework, fostering collaboration between different sectors of society.

The regulation has the following main objectives: (i) promote the achievement of institutional results, improve the efficiency and quality of work processes, and optimize the Agency’s administrative and financial burden and costs; (ii) facilitate the development and internalization in Brazil of products and services subject to health surveillance, which are innovative, based on new technologies or areas of knowledge (iii) improve Anvisa’s ability to deal with new, complex and unexpected problems.

According to Eduardo Emrich Soares, President Director of Biominas Brasil, the foremost value of the regulation was to reaffirm Anvisa’s positioning as a fundamental player in the country’s innovation environment. Through preliminary

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analysis and monitoring of applications of advanced technologies, and its willingness to establish collaboration with various actors, such as universities, startups, companies, and civil society representatives.

INCENTIVES FOR INNOVATION IN THE BIOTECH AND HEALTHCARE SECTOR

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Several entities and institutions have crucial roles in promoting innovation in the Brazilian healthcare scenario. For example, the Ministry of Science, Technology and Innovation (MCTI) articulates and implements public policies to promote radical innovation in Brazil. It encourages research, entrepreneurship, and international collaboration to boost the country’s economic and technological development.

According to Leandro Bortolozo Pedron, Director of the Department of Thematic Programs at the Ministry of Science, Technology and Innovation (MCTI) is responsible for formulating policies that encourage radical innovation, which means significant and disruptive advances in technology and processes. These policies may involve creating tax incentives, financing programs, and public-private partnerships. “Furthermore, the Ministry of Science, Technology and Innovation (MCTI) is the main promoter of R&D activities through agencies such as the National Council for Scientific and Technological Development (CNPq), the Brazilian Innovation Agency (FINEP), and the Brazilian Company of Research and Industrial Innovation (EMBRAPII), encouraging knowledge creation and innovative technologies”, as claimed by him.

The Ministry has also promoted innovative entrepreneurship and the development of startups through training programs and resources for incubators and accelerators.

Already on the international scene, Pedron (MCTI) says that the Ministry’s focus is to

seek partnerships with other countries, participating in international research and collaboration networks, thus attracting foreign investment in innovation projects. “An example of the Ministry’s initiatives is Law 14,554/23, which reduces the interest rate for obtaining loans granted by the Brazilian Innovation Agency (FINEP), changing access conditions for R&DI resources”, he exemplifies.

Another institution that has carried out this work is the Center for the Study of Venoms and Venomous Animals (CEVAP), linked to the Universidade Estadual Paulista – UNESP (São Paulo State University).

According to Rui Seabra Ferreira Jr, director at CEVAP, the institution stands out in the research of new biological medicines and, in recent years, has developed two biological drugs that are unique in the world: Fibrin Sealant and Anti-Apyl Serum. “These success stories are unique in Brazil due to the advancement of research at a public university and the innovation of healthcare products. We have also encouraged the creation of a Contract Development and Manufacturing Organization (CDMO) for biomedicines and biotechnology Eduardo Emrich Soares, President Director of Biominas Brasil

Leandro Bortolozo Pedron, Director of the Department of Thematic Programs at the Ministry of Science, Technology and Innovation (MCTI)

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companies and startups to bring some of our discoveries to the market with financial support from important institutions”, he says.

SUPERA Park also plays a relevant role in promoting the innovation ecosystem. According to Eduardo Garbes Cicconi, SUPERA’s Park Manager, the institution currently supports 80 startups, which include incubated companies and companies residing in the SUPERA Park building, while another six are planning to build their facilities in the Technological Park subdivision. “These projects are fundamental for the region due to their notable growth potential, demonstrated by the international awards received, and their ability to generate economic returns and significant benefits for human development”, he informs.

The institution also has the Container Park, the largest container complex in Brazil, a space that allows companies to grow, helping to consolidate the Ribeirão Preto (city in São Paulo state) region as an innovation hub. According to Cicconi (SUPERA Park), with 3,500 m² of built area, the new business center adopted sustainability principles by reusing shipping containers in its implementation. “Another investment attraction in the Ribeirão Preto region is the Health to Business Center, which, with an investment of almost US$4 million from the Brazilian Innovation Agency (FINEP) and the city’s City Hall, will boost innovations in healthcare”, adds Cicconi (SUPERA Park).

Emrich (Biominas) sees the fundamental role of the Government

Rui Seabra Ferreira Jr, director at Center for the Study of Venoms and Venomous Animals (CEVAP)

Eduardo Garbes Cicconi, SUPERA’s Park Manager

in developing policies and development programs for the sector.

According to him, in the last two years, public notices aimed at the interaction of universities and research centers with startups have significantly increased, preferably with the participation of medium and large companies. “The Government thus fulfills its role in the triple helix model by financing players and minimizing structural, regulatory, and fiscal obstacles, promoting economic and social development”, he informs.

are corporations such as Intrials, Hypera Pharma Group, and Libbs Pharmaceuticals, actively engaged in partnerships to increase innovation. Intrials, for instance, specializes in conducting clinical trial studies, thereby facilitating access to innovative medicines for various illnesses. Arthur Nigri, the Chief Business Officer of Intrials, underscores the pivotal role of clinical studies in granting access to innovative treatments for diseases lacking existing remedies, potentially offering therapeutic solutions or enhancing participants’ quality of life.

Nigri (Intrials) further emphasizes Intrials’ recognition of Brazil and Latin America’s potential as prime locations for conducting clinical trials. He quotes the region’s adherence to rigorous regulatory standards aligned with international norms, the exceptional caliber of research centers and investigators, and the robust capacity to recruit pa-

HOW PRIVATE INITIATIVES ARE PROMOTING INNOVATION IN THE HEALTHCARE SECTOR Private initiatives are significant drivers in fostering collaborative efforts between companies, startups, and research institutions, amplifying investments in innovation.

Noteworthy among these entities

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tients/participants as key factors contributing to its appeal for clinical research endeavors.

Libbs, on the other hand, seeks to expand its portfolio and promote access to new treatments, investing in partnerships with Brazilian startups and researchers. Projects, such as the development of Vivaxxia and Elovie, in collaboration with foreign companies, highlight the company’s commitment to innovation in the Brazilian pharmaceutical sector. Anna Paula Sheppard Guembes Lilla, Business Development Director at Libbs Pharmaceuticals, highlights that since 2014, the company has invested in radical innovation projects both with foreign companies and Brazilian startups. “We have already invested more than US$15 million in innovation and have intensified investments in the last three years, having invested US$5 million in this period alone in partnerships with startups and early-stage companies to support the research and development of innovative treatments”, she informs.

The Hypera Pharma Group has also worked on innovation as one of the main drivers of its sustainable growth and access to healthcare in Brazil. To this end, the company established Hypera Ventures, a corporate Venture Capital program, and HyperaHub, a startup acceleration program. Furthermore, the company is leading the largest operational complex in Latin America in Anápolis (Goiás-Brazil), together with the modern Hynova innovation center in Barueri (São Paulo-Brazil).

The Hypera Pharma Group recently launched a Business Unit focused on the Institutional Market, requiring investments in innovative and disruptive projects, and has been working on building an RD&I center in Jundiaí (São Paulo-Brazil) focused on synthetic and biological medicines. The group seeks strategic partnerships, and the implementation of a production-industrial platform reflects the group’s vision of re-

Arthur Nigri, the Chief Business Officer of Intrials

ducing dependence on the external market and promoting the transformation of innovative ideas into essential products for the health of the Brazilian population.

Carolini Kaid, CEO of Vyro Biotherapeutics

ATTRACTING INVESTMENTS FOR RADICAL INNOVATION IN BRAZIL Despite the favorable course of Brazilian legislation, Brazilian startups continue to encounter significant hurdles in attracting investments, particularly within the biotechnology sector. Carolini Kaid, CEO of Vyro Biotherapeutics, elucidates the challenges her startup faces in securing investment for its groundbreaking biotechnological innovation projects. “Our primary obstacle stems from the company’s geographical location.

Despite possessing technology with profound global implications, Brazil is frequently perceived as an unsuitable investment environment within this sector,” she asserts.

Anticipating this chalAnna Paula lenge, Biotimize prepared Sheppard to open a company in the Guembes Lilla, Business United States, in case the Development investment came from Director at Libbs abroad. According to Pharmaceuticals

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Fernando César Barbosa, Co-founder and CEO of Biotimize, when looking for investment for deep techs in Brazil, there is still difficulty for investors in understanding that their return time is different from other startups.

“However, in our case, we overcame this challenge and obtained a national investor who is very aligned with our purpose”, he informs.

Vyro Biotherapeutics, to stand out on the international scene and attract foreign investors, adopted strategies such as presenting solid data and a robust scientific base. According to Kaid (Vyro), they sought to demonstrate that it is possible to develop biotechnological technologies at more affordable prices here in Brazil if compared to costs in the United States. “At the company’s beginning, we opted for a hybrid model, combining best international practices with local advantages, until we found a model that offered clear advantages”, she highlights.

Other companies use their founders’ experiences and track records in the pharmaceutical sector to attract investments for radical innovation projects in the biotechnology sector. That is the case of Nintx – Next Innovative Therapeutics. According to Miller Nunes de Freitas, CEO-Founder of the company, Nintx seeks resources from various sources, including investment funds and private investors, partnerships with companies, and public-private partnerships with support from the Brazilian Company of Research and Industrial Innovation (EMBRAPII) and development agencies. “About investment funds and private investors in Brazil, we have few in the biotech sector. Although there is an appetite for investments focused on other verticals, such as impact (financial return with high socio-environmental impact). They are increasingly interested in understanding the universe of biotechs in Brazil, especially those that innovate based on Brazilian biodiversity”, he highlights.

Nintx also invests in active collabora-

tion with other Brazilian companies and research institutions, promoting a collaborative and decentralized R&D environment. “We aim to advance the biotechnology sector in Brazil by generating projects based on our biodiversity and licensing it to large global pharmaceutical companies.

Thus, we share value with patients, with our partners and investors, with society and the environment”, informs Cristiano Ruch Werneck Guimarães, CSO-Founder at Nintx.

Emrich (Biominas) adds that the work done by the Brazilian Trade and Investment Promotion Agency (ApexBrasil), the Brazilian Industry Association of Active Pharmaceutical Ingredient (Abiquifi), and Biominas Brasil to prepare startups with investment potential to participate in international events, such as the BIO Convention, has contributed to greater business maturity Fernando César Barbosa, Co-founder and CEO of Biotimize

Miller Nunes de Freitas, CEO-Founder at Nintx – Next Innovative Therapeutics

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and generation of investment opportunities. “By doing this consistently over the next few years, success stories in foreign investment will certainly be seen”, he concludes.

SAIL for Health also emerged from this desire to strengthen the innovation ecosystem in Brazil. According to Marina Domenech, founder of the company, the reflection on the dependence of more than 95% on external technologies was the first provocation. “We asked ourselves: how can we change this scenario and develop innovation locally, from start to finish, generating real impact in the sector? This analysis revealed a major challenge in the technologies’ scalability in Brazil, especially when observing the failure of many of them in the clinical phases”, she recalls.

Domenech (SAIL for Health) says that, with this knowledge of the market, SAIL established an operating strategy that already brought critical and disruptive analysis from the initial phases of projects, with a long-term look at the viability of innovation. “Understanding the level of maturity of the project and drawing up a personalized action plan is a premise that needs to be clear from the beginning. It is with this vision that we outline a strategy to attract investments, combining impact on health with financial return.

It is a disruptive approach that we bring to our partners”, she informs.

The knowledge barrier has also been a concern for Biominas Brasil. Emrich (Biominas) points out that there are few Marina people and instituDomenech, tions in the country founder of the with knowledge of SAIL for Health

Cristiano Ruch Werneck Guimarães, CSO-Founder at Nintx

production scheduling following good research or production practices. According to him, “Most startups are led by researchers who have had little training in product development; therefore, cases of startups that had to, for example, repeat their preclinical studies are still relatively common.” To solve this problem, in addition to training, expand the activities of institutions such as accelerators, incubators, CROs (Contract

Research Organizations), and CMOS (Contract Manufacturing Organizations) can support entrepreneurs.

All these reports show that promoting radical innovation in the Brazilian healthcare sector and attracting investments to boost it crucially depends on intelligent collaboration between the government, research institutions, companies, and startups.

This synergy allows not only the development of innovative technologies but also the creation of an environment conducive to economic growth, improving the population’s quality of life and inserting Brazil into the global scenario of health innovation.

Therefore, these actors must continue to work together, sharing resources, knowledge, and expertise to face challenges and explore opportunities that arise on the path to innovation. Collaboration between these sectors strengthens Brazil’s ability to compete in the international market and also contributes to building a solid and tainable innovation ecosystem that benefits society as a whole. ●

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Brazil’s One Health Innovation in the Fight Against Neglected Tropical Diseases

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he notion of One Health embodies a pioneering paradigm in healthcare, acknowledging the intricate interplay among human health, animal health, and environmental health. This concept emerged prominently in the early 2000s and has regained importance amidst the global SARS-CoV-2 pandemic and escalating concerns regarding global warming. The significance of this approach has become increasingly apparent,

underscoring its pivotal role across various domains of health and scientific research.

In addition to being a strategy to combat pandemics, One Health is a valuable tool for addressing sustainability and climate change issues, which directly impact on the health of humans, animals, and the environment. The focus is on prevention, early intervention, and coordinated response, showing that a collaborative approach, combined with an analysis of social determinants, is the key to solving com-

The importance of preventive actions is because Brazil

REPRESENTS 90% OF THE incidences of Neglected Tropical Diseases (NTDs) in Latin America and the Caribbean

plex healthcare challenges in today’s world.

In this context, multidisciplinary efforts are necessary to understand and address problems effectively. The Drugs for Neglected Diseases Initiative (DNDi) is an international, non-profit pharmaceutical R&D organization that develops new treatments for neglected patients. According to Jadel Müller Kratz, Head of Discovery and Partnerships LATAM, at DNDi, the organization adopts an open approach that relies on collaborators, from public and private sectors, to accelerate the development of solutions for endemic and emerging diseases.

In line with this, Vagner Simões, Country Manager at Illumina Brazil, believes that the collaborative approach between sectors facilitates the global monitoring of diseases, the identification of early outbreaks, and the understanding of pathogens spread at an international level. The importance of preventive actions, such as this, is because Brazil represents 90% of the incidences of Neglected Tropical Diseases (NTDs) in Latin America and the Caribbean. Thus, this coordinated work ensures more comprehensive and efficient surveillance in preventing threats to public health.

In short, One Health represents an interdependent system extremely relevant when talking about climate change and social-

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ly determined diseases. Since neglected diseases are directly influenced by environmental factors, it is necessary to pay attention to climate change’s effects on the Brazilian basic sanitation systems, and on vector redistribution. To this end, the Ministry of Health highlights the need to anticipate and implement actions to combat climate change: “Adapting to climate change is not a choice, it is a necessity. It is essential to increase the Brazilian Unified Health System (SUS) and communities response and resilience capacity, particularly those with greater vulnerability”.

Chagas disease, dengue, chikungunya, leishmaniasis, and helminthiasis, among others, are among more than 20 Neglected Tropical Diseases (NTDs) listed by the World Health Organization, prevalent in the Americas.

Many of these diseases are endemic in Brazil, where the nation boasts a rich history of research in this field, presenting an unparalleled opportunity to lead the battle against NTDs. For instance, the Butantan Institute is currently developing a dengue vaccine in collaboration with the United States National Institute of Allergy and Infectious Diseases (NIAID), with completion anticipated later this year. This endeavor not only signifies a significant stride in combating dengue but also opens avenues for foreign investors and collaborators. This is especially pertinent in a global context where Brazil’s substantial research efforts in NTDs have positioned it as a frontrunner, and diseases such as dengue are no longer confined to tropical regions but have extended their reach to the global north.

In addition to its research history, Brazil is at a strategic moment to promote and strengthen its international cooperation. As a country that assumes the presidency of the G20 in 2024, Brazil is positioned to stand out in several areas, with a particular emphasis on healthcare. The Working Group dedicated to health within the G20 has as its primary objective the construction of healthcare sys-

tems, in which prevention, preparation, and response to pandemics, together with climate change, constitute focuses of attention.

Brazil’s main proposal for the G20 Healthcare GT is the creation of an Alliance for Regional Production and Innovation. This initiative aims to establish a cooperation network with the main actors involved, including States, academic institutions, the private sector, and international organizations, to research, develop, and produce vaccines, medicines, diagnostics, and strategic inputs to combat serious diseases, especially those that affect the most vulnerable populations.

Simultaneously, Brazil is on the brink of hosting the Conference of the Parties (COP-

Vagner Simões, Country Manager at Illumina Brazil

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30) in 2025, a crucial gathering aimed at addressing sustainability, biodiversity, and healthcare on a global scale. This forum will serve as a remarkable platform for the country to reaffirm its dedication to advancing health and well-being within the framework of environmental conservation and sustainable development.

The favorable scenario for international collaborations in Brazil suggests that investors can expect a relatively quick return on their investments, thanks to the cutting-edge scientific knowledge already existing in the country. As an example, the Japanese company Takeda included Brazil in its Aspirational Plan for expansion in 2021. In 2023, 2 years later, its dengue vaccine became part of the National Immunization Plan, entering the commercial stage in Brazil. Simões (Ilumina) believes that initiatives such as investment in laboratory infrastructure and international collaborations represent a significant step towards overcoming challenges in Brazil.

Visualizing opportunities, Kratz (DNDi) reports that support for scientific exchange between different pharmaceutical actors expands the translational research capacity in the country. To this end, he mentions the consortium of drug discover y called Lead Optimization Latin America (LOLA), which is responsible for identifying and developing new treatments for neglected parasitic diseases. In this project, DNDi collaborates closely with the State University of Campinas (UNICAMP) and the University of São Paulo (USP), connecting local partners to a global R&D network that makes it possible to advance new candidates until the clinical stages of development.

The concept of One Health serves as a conduit bridging science, policy, and community engagement. This convergence fosters the emergence of innovative and impactful solutions to global health challenges, thereby cultivating an environment conducive to foreign investment and the sus-

Jadel Müller Kratz, Head of Discovery and Partnerships LATAM at DNDi

tainable expansion of Brazil’s healthcare industry. Consequently, these advancements solidify Brazil’s standing as a beacon of scientific innovation, particularly in combating neglected diseases (NTDs), and also highlight the potential of strategic partnerships in advancing cutting-edge technologies. Thus, Brazil emerges poised at the threshold of numerous opportunities, offering a conducive landscape for the proliferation of startups in the sector and for portfolio diversification for established enterprises.●

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DEVELOPMENT

Healthcare sector covered:

Brazil launches program to stimulate innovation and industrial production

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he industry plays a crucial role in the Brazilian economy, contributing significantly to the country’s Gross Domestic Product (GDP).

According to recent data from the National Confederation of Industry (CNI), in 2023, the industry represented around 26.3% of GDP and was responsible for an impressive 66.8% of business investment in research and development. These numbers highlight the importance of the industrial sector as a driver of innovation and economic growth, emphasizing its influence on various aspects of the national economy.

Faced with this scenario, the Federal Government launched the Nova Indústria Brasil - NIB (the New Industry Brazil Program), intending to revitalize the industry, boosting investments in technology and innovation, improving competitiveness, and accelerating the transition to a more sustainable

economy. With approximately US$58 billion allocated to the new industrial policy until 2026, the NIB Program (New Industry Brazil Program) aims to stimulate productive and technological development in Brazil, with a particular focus on healthcare.

According to Uallace Moreira, Secretary of Industrial Development, Innovation, Commerce and Services at the Ministry of Development, Industry, Commerce and Services (MDIC), industrial development policies are aligned with healthcare policies, promoting the supply of innovative products in the Brazilian Unified Health System (SUS) and reducing the system vulnerabilities. “NIB’s (New Industry Brazil Program) healthcare mission is largely focused on increasing local production, expanding access to healthcare and promoting more highskilled, high-income jobs, and also strengthening the Brazilian domestic market and

reducing social inequalities,” he highlights.

Furthermore, the government has acted on other vital fronts to improve competitiveness and the business environment. Moreira (MDIC) lists the Tax Reform, the reactivation of the internal market with income transfer policies, and the stimulus to increase exports as some of the measures taken to reduce bureaucracy, time, and costs for entrepreneurs.

“The Estratégia Nacional para o Desenvolvimento do Complexo Econômico-Industrial da Saúde (National Strategy for the Development of the Health Economic-Industrial Complex) was also launched. With planned investments of approximately US$8 billion to expand national production and reduce the country’s dependence on foreign inputs and products, this strategy aims to strengthen the supply of innovative products in the Brazilian Unified Health System (SUS) and promote access to healthcare”, he informs.

Currently, the government is delineating the priority chains within the six strategic missions for its industrial development policies (Nova Indústria Brasil – NIB), notably including the Health Economic-Industrial Complex. As elucidated by Moreira (MDIC), this endeavor encompasses not only the Ministry of Development, Industry, Commerce and Services (MDIC) but also various other ministries and programs. A suite of significant policy instruments is being mobilized alongside the industrial sector to stimulate domestic production within the healthcare domain.

On the financing side, for example, there is the Mais Produção Plan (More Production

Plan). Besides, soon the government should launch the details for the revised the Programa de Parcerias para o Desenvolvimento Produtivo – PDP (Partnership Program for Productive Development) and the Programa de Parceria para o Desenvolvimento e Inovação Local – PDIL (Partnership Program for Local Development and Innovation) “Both provide support for the sector and have relevant resources. Furthermore, Brazil has the Programa de Aceleração do Crescimento – PAC (a National Growth Acceleration Program) for the healthcare sector, with resources of approximately US$6 billion, and should function as a lever for national production”, he highlights.

The Ministry of Health reinforces this vision, as it will launch the PDIL (Local Development and Innovation Program) to promote the local development of innovative solutions aimed at healthcare challenges. The Ministry will also launch the improved PDP (Partnership Program for Productive Development)​ , which will link the government with the private sector for technology transfer, reinforcing actions to reduce the vulnerabilities of the Brazilian Unified Health System (SUS) and expanding access to healthcare for the population with economic development.

FINANCING AND SUPPORT FOR INNOVATION Financing and supporting innovation are of significant importance in the development of the healthcare industry in Brazil. In this context, institutions such as the Brazilian Develop-

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Uallace Moreira, Secretary of Industrial Development, Innovation, Commerce and Services at the Ministry of Development, Industry, Commerce and Services (MDIC)

Carla Reis de Souza Neto, Head of the Health Industry Department at BNDES

ment Bank (BNDES) and the Brazilian Innovation Agency (FINEP) have been fundamental in promoting research and development projects aligned with the needs of the healthcare sector.

The Brazilian Development Bank (BNDES), for instance, launched the Programa BNDES Mais Inovação (BNDES More Innovation Program), with approximately US$1 billion annually for R&D projects aligned with industrial policy missions.

According to Carla Reis de Souza Neto, Head of the Health Industry Department at BNDES, a predominant competitiveness factor for companies in the health industry is product differentiation, achieved through innovative projects. Reis (BNDES) highlights that the Brazilian healthcare industry presents expenditure indicators on innovative activities above those of the manufacturing industry as a whole.

But it is still a low level compared to the international standard for the sector. “It is necessary to encourage companies in the sector to raise their level of investment in in-

health sector in 2024. According to Rodrigo Rocha Secioso de Sá, Innovation Superintendent at FINEP, the institution seeks to strengthen partnerships between companies, research institutions, and government to boost the development of fundamental technologies and therapies. “We have public notices of economic subsidies for companies, and research centers. In addition, FINEP has measures to improve the Health Science and Technology institutes infrastructure. Through this group of initiatives we seek to give a new impetus to the sector with new technologies in areas such as Active Pharmaceutical Inputs, Advanced Therapies, Biological Products, Clinical Research, and healthcare devices, for example, expanding access to healthcare in Brazil and providing fundamental technologies and therapies for the technological independence of the Brazilian Unified Health System (SUS)”, he informs.

FINEP’s actions encourage interaction between companies, research centers, and government,

novation in Brazil”, she points out.

BNDES is one of the historic actors in financing the modernization and expansion of productive capacity. According to Reis (BNDES), the main biotechnology factories in the country had credit from BNDES in their list of financiers. Recently, a factory was inaugurated, which included an investment of approximately US$20 million from BNDES. Since 2023, within the scope of the program (BNDES More Innovation Program), the bank has credit lines encouraged for the expansion of the biotechnology sector. “In the case of the healthcare sector, it is understood that biotechnology and active pharmaceutical inputs units can be considered pioneering factories in Brazil, being eligible for the program (BNDES More Innovation) resources”, she adds.

The Brazilian Innovation Agency (FINEP) is working with economic subsidy resources, refundable and non-refundable credit, totaling more than US$400 million in innovation investments in the

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whether through strict alignment of the Ministry of Development, Industry, Commerce and Services (MDIC), the Ministry of Health, or the Ministry of Science, Technology and Innovation (MCTI) public policies within the scope of the Mais Inovação (the More Innovation Program). Furthermore, when granting subsidies, credit, and non-refundable resources to science and technology institutes, the institution considers predominantly the technological risk associated with the specific project, the positive externalities to promote access to healthcare, and strengthening the Brazilian Unified Health System (SUS).

“Thanks to FINEP’s support within the scope of the Inova Saúde (Health and Innovation Program), we have R&D capabilities for biological products, illustrated by the registration of the first biosimilar developed by a Brazilian company. We also have the registry of photodynamic therapy for skin cancer developed by a Brazilian research center, and the development of critical Active Pharmaceutical Inputs for medicines supplied to the Brazilian Unified Health System (SUS). We hope with FINEP Mais Inovação (FINEP’s More Innovation Program) to start another new cycle of high standard technological research and development in the country”, Secioso (FINEP) highlights.

The Ministry of Science, Technology and Innovation (MCTI) also plays a fundamental role in enhancing the healthcare sector. In addition to innovation incentive programs, such as FINEP’s Economic Subsidy – a mechanism that supports research, development, and innovation projects in different sectors of the economy and allows companies to receive resources for the development of innovative products, processes or services –, The institution also launched a broad set of programs aimed at boosting scientific, technological research and innovation in Brazil.

According to Leandro Bortolozo Pedron, Director of the Department of Thematic Pro-

Rodrigo Rocha Secioso de Sá, Innovation Superintendent at FINEP

grams at the Ministry of Science, Technology and Innovation (MCIT), the projects range from the recovery and expansion of research infrastructure in universities and institutes to the promotion of sustainable industrialization and digital connectivity across the country.

Furthermore, initiatives such as talent repatriation, support for public policies based on scientific knowledge, and preservation of historical and cultural collections are also among the priorities. “These programs aim not only to strengthen the country’s scientific and technological base, but also to promote economic and social development, with special attention to food security, national defense, and the eradication of hunger”, he informs.

The Brazilian Company of Research and Industrial Innovation (EMBRAPII) has joined efforts in structuring and developing a more resilient Economic-Industrial Complex to support technological solutions that improve access to and treatment of diseases for the Brazilian population. According to Igor Nazareth, Director of Planning and Management at Embrapii, in 2023 the institution announced the Embrapii Competence Center in Advanced Therapies. “The Center represents an advance about our traditional model, as its objective is to create a knowledge

Leandro Bortolozo Pedron, Director of the Department of Thematic Programs at the Ministry of Science, Technology and Innovation (MCIT)

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base on technological frontier topics, attract companies, and train people from the Center’s ecosystem in advanced therapies, which adds value to the country”, he comments.

With the mission to generate an environment conducive to industrial technological development, Embrapii works by sharing the cost and risk inherent to the innovation process, in addition to connecting scientific research with the private sector. Nazareth (Embrapii) informs that in healthcare, for example, the institution has more than US$60 million in supported projects. “Given that the model works on demand from the industrial sector, there are several types of supported projects, from the development of a new generation of molecules with anti-cancer action based on natural products to exam report verification software based on techniques from Artificial Intelligence to the development of Equipment for Extracorporeal Patient Oxygenation (ECMO)”, he exemplifies.

ROLE OF RESEARCH AND DEVELOPMENT INSTITUTIONS IN HEALTHCARE INNOVATION Saulo Simoni Nacif, Executive Director at Butantan Foundation

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On the other side of the scale, research and development institutions also play a fundamental role in this scenario, working to strengthen the capacity to invest in research and production of vaccines and biological products.

At the Butantan Institute, for example, to ensure efficiency and the best possible management of resources, they work with a focus on governance, longevity, and effectiveness. According to Saulo Simoni Nacif, Executive Director at Butantan Foundation, the institution adopts guidelines to improve processes. “Concerning R&D, the Foundation has invested in technological platforms and routes for products and processes development, from those developed internally to those resulting from technology transfers.

We are thinking and working strategically to strengthen the country’s autonomy in the area and transform Butantan Institute into

Igor Nazareth, Director of Planning and Management at Embrapii

the main international hub for immunobiological production and development in Latin America. We are well positioned geographically and institutionally for this”, he informs.

In recent years, the Butantan Foundation has been investing in implementing pilot laboratories, laboratories with level 3 security, and specialized platforms. There are also multi-purpose laboratories, which carry out various stages, from initial research to pre-clinical trials, including the development of scalable processes to be transferred to the production sector. “We are constantly investing in structuring new factories”, highlights Nacif (Butantan).

As a science and technology institution, Butantan has generated knowledge, trained people, and focused efforts, following its mission to be a global player in science and technology. Nacif (Butantan) underlines that the Institute is an organization that is modernizing in technology and management, using global tools and seeking to bring together qualified and committed people in many sectors. “At Butantan, management is a science”, he states.

Butantan collaborates with partners around the world in the development of vaccines and biopharmaceuticals. One example is the dengue vaccine, licensed by the American National Institute of Health in 2009.

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The institution quickly advanced the technology and went to phase three studies, which attracted MSD to a cooperation agreement. Since 2018, they have been sharing clinical data to drive the project. In addition, there is a partnership for the production of vaccines against hepatitis A and HPV and the ButanVac, a vaccine against COVID-19, developed together with the International Consortium led by PATH, with contributions from the Icahn School of Medicine and the University of Texas. Butantan is advancing to phase three of the development of this vaccine, having production capacity and autonomy.

FUTURE PERSPECTIVES

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As expressed by the Secretary of Science, Technology and Innovation and the Health Economic-Industrial Complex at the Ministry of Health, Carlos Gadelha: “Health is development. The Health Economic-Industrial Complex agenda recognizes it as a vector of development, reconciling the economy and the right to life, allowing the structuring of a set of public policies in a systemic and integrated way to strengthen the Brazilian Unified Health System (SUS)”.

To achieve those goals, the connection between the various actors involved in the health innovation ecosystem plays a fundamental role in driving research, development, and implementation of effective solutions. According to Norberto Prestes, president of the Brazilian Industry Association of Active Pharmaceutical Ingredient (Abiquifi), collaboration between pharmaceutical companies, research institutions, regulatory authorities, and investors is essential

Carlos Gadelha, Secretary of Science, Technology and Innovation and the Health Economic-Industrial Complex at the Ministry of Health

to identify gaps, overcome challenges, and promote significant advances.

In this sense, the association acts as a facilitator in this process, promoting events and discussions that encourage interaction between these stakeholders. Prestes (Abiquifi) emphasizes that for this connection to be truly effective, they must also address fundamental issues, such as the culture of technology translation in universities, the improvement of interaction tools between universities and companies, the adjustment of government incentive funds and strengthening the Brazilian Health Regulatory Agency (Anvisa) regulatory structure.

For Prestes (Abiquifi), by solving these problems, collaboration between the various actors in the healthcare innovation ecosystem can occur more naturally and productively. To this end, Abiquifi has worked with initiatives such as the Brazilian Regulatory Guide for Startups, training for science and technology institutions and pharmaceutical companies, and

the convergence agenda between public and private entity creation. “In partnership with the Brazilian Trade and Investment Promotion Agency (ApexBrasil), Abiquifi is also working on creating a channel for attracting foreign and national resources to further boost technological development in Brazil”, he points out.

Given this panorama, it is safe to say that Brazil is following a promising path toward strengthening the industry and innovation in healthcare. With the Nova Indústria Brasil - NIB (New Industry Brazil Program) program and funding and research support initiatives, the country is taking significant steps to boost innovation in healthcare. With continued support from the government, engagement from the private sector, and investment in research and development, Brazil is prepared to face the challenges that lie ahead and reach new levels of excellence, benefiting not only Brazilians but also positively impacting the lives of millions of people around the world.●

Norberto Prestes, president of the Brazilian Industry Association of Active Pharmaceutical Ingredient (Abiquifi)

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A pioneering researcher learned to create ‘wired’ brain organoids — and sent them to space. Now, he’s looking to Amazonian biodiversity to discover treatments for several neurological conditions

By Erin Prater, University of California San Diego Sanford Stem Cell Institute

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lysson Muotri has never been satisfied with the limitations of human brain models.

Postmortem tissues are not ideal, as the cells they contain are dead and their tissue degrades quickly. Mouse models – the gold standard in neuroscience – are evolutionarily too distant from people to be useful.

In fact, nearly all drugs found effective for the treatment of neurological disease in mice have failed in patients.

Desiring a more faithful model, Muotri – a native Brazilian – began hatching a plan to create human brain organoids, from stem cells derived from the skin cells of patients, in 2013.

Developing a pioneering, patented protocol wasn’t enough for the intrepid researcher, who now serves as the director of the University of California San Diego’s Integrated Space Stem Cell Orbital Research Center (ISSCOR) – a revolutionary research laboratory aboard the International Space Station (ISS), and part of the Sanford Stem Cell Institute (SSCI).

In 2019, he sent the first brain organoids to space. There, the stress of microgravity mimics the aging process on Earth, but in an accelerated

fashion. And he’s continued to push boundaries. Earlier this year he launched the first brain organoids with neurodegenerative diseases – created from the cells of patients with Alzheimer’s disease and amyotrophic lateral sclerosis (ALS) – into the cosmos for 30 days. His goal: to witness the equivalent of several years of disease progression, including potential changes in protein production, signaling pathways, oxidative stress and epigenetics.

Muotri’s latest research has him pushing the limits of science even further – this time, into the depths of the Amazon rainforest. He and fellow researchers in Brazil are teaming up to record Amazonian tribal remedies for age-related neurological conditions – created with native plants, many of which are unknown to Western scientists.

Muotri will test these potential therapeutics in space, of course – on brain organoids he creates with his pioneering new model. Doing so, however, will require complex technical knowledge that astronauts aboard the ISS don’t have. Said Muotri: “There is an urgent need to train our

scientists to become astronauts. This is the next neuroscience frontier.”

AN ‘INBOX FULL OF REQUESTS’ After Muotri published his first journal article using his cutting-edge brain organoids – in the scientific journal Cell Stem Cell in 2019 – he was stunned to find an inbox full of requests from researchers around the world who wanted to replicate the protocol for use in all kinds of experiments.

“The requests kept coming, and even today, I still get several inquiries every week,” he said. “We tried to help everyone, but at one point, this was no longer practical. I felt in debt with this community, and that was the motivation to publish a very detailed protocol, including some of the electrophysiological analyses we performed in the lab.”

The recent publication of the protocol – May 3 in Nature Protocols – will allow scientists worldwide to perform more advanced research regarding autism, schizophrenia and other neurological disorders in which the brain’s structure is usually typical, but electrical activity is altered.

Two other protocols for creating

brain organoids were publicly accessible before the May publication.

Neither allowed researchers to study the brain’s electrical activity. The first, developed in 2008, allows scientists to create miniature versions of the brain’s cortex and other areas of interest – but only one area at a time, and, thus, without any neural connections between regions. Researchers must assemble different region-specific organoids and create circuits that do not necessarily mimic how the brain is formed. A second protocol, developed in 2013, leads to the production of multiple regional brain cell types at once but does not necessarily form natural circuity.

Muotri’s method, however, mimics the natural development of the brain in utero, allowing researchers to study neural networks created from the stem cells of patients with various neurodevelopmental conditions.

“You no longer need to create different regions and assemble them together,” said Muotri, adding that different brain areas – like the cortex and midbrain – “co-develop as naturally observed in human development. I believe we will see many derivations of this protocol in the future for the study of different brain circuits,” he added.

The protocol is considered a “semi-guided” one “due to its transient exposure to factors, giving the cells the freedom to differentiate in nearby brain regions,” according to Muotri. Such protocols help researchers study the emergence of complex neural network formation in the human brain – a remarkable breakthrough in the field.

Some disorders involving the brain – like Congenital Zika syn-

Dr. Alysson R. Muotri, Director, Stem Cell Program. Professor of Pediatrics and Cellular & Molecular Medicine, UC San Diego

drome, a condition characterized by severe microcephaly in the offspring of those who contract the Zika virus during pregnancy – don’t require the study of the neural network because they involve significant structural changes in the brain that can be seen with the naked eye. When Muotri created brain organoids that mimicked those with the syndrome, they were visibly smaller than normal, explaining symptoms experienced by those with the condition.

When it comes to autism and other neurodevelopmental disorders, however, “it’s all about the neural network,” he said. “Having a model that mimics the embryonic development of such a neural network is important when studying these types of conditions because it allows for more precise therapeutics.”

Dr. Lena Smirnova, Ph.D., an assistant professor at the Johns Hopkins Bloomberg School of Public Health, has been working for the last decade to develop a human-relevant model of brain development. A long-term collaborator with Muotri, Smirnova said her lab plans to use the new protocol to study the physi-

ology of learning in brain organoids.

What stands out about Muotri’s protocol, in Smirnova’s opinion: the top-tier level of functioning among the brain organoids it produces.

“This type of high-level complexity of the electrophysiological functionality makes the organoids even more physiologically relevant, and suggests the use of them for therapeutic development for diseases,” she said.

The new protocol, which will allow for the mass production of brain organoids with electrical activity, “significantly pushes research forward on human brain organoids,” said Andrea Lavazza, a philosopher and neuroethicist with the University of Milan in Italy. Because of Muotri’s protocol, “there will be advancements both in the clinical field and in research on the developmental processes of the human nervous system,” said Lavazza, adding that such brain organoids could eventually “replace animal models in laboratories.”

“From an ethical point of view, the presence of complex electrical activity in cortical organoids will have to be closely monitored to produce research that is responsible and sensitive to the needs and concerns of all stakeholders,” he added.

‘NOBODY HAS SENT SUCH A MODEL INTO SPACE’ So far, Muotri has been using his brain organoids to witness the effects of time and aging on neural networks.

But they can also be used to test potentially therapeutic drugs and even a gene therapy approach before patient use, as well as to screen for efficacy and side effects, according to Muotri.

Other research possibilities for

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the brain organoids include disease modeling, understanding human consciousness and additional space-related experiments. In March, Muotri – in partnership with NASA – sent to space a number of brain organoids made from the stem cells of Alzheimer’s disease and ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease) patients.

Because microgravity mimics an accelerated version of Earth-based aging, Muotri should be able to witness the effects of several years of disease progression during the month-long mission, including potential changes in protein production, signaling pathways, oxidative stress and epigenetics.

His work dovetails perfectly with that of ISSCOR. Launched in 2022

by SSCI Director Dr. Catriona Jamieson, M.D., Ph.D., the extraterrestrial lab aims to facilitate breakthroughs to aid in the diagnosis and treatment of cancer and other age-related degenerative diseases.

“We’re hoping for novel findings – things researchers haven’t discovered before,” Muotri said of his space-based experiment on neurodegenerative conditions. “Nobody has sent such a model into space, until now.” The diseased brain organoids returned from space in May. Muotri will detail his findings in a future journal publication.

UNCHARTED TERRITORY Muotri’s brain organoids are crucial to so much of his research, including an expansive project involving researchers at the Federal University of Amazonas in Manaus, Amazonas, Brazil – in particular Dr. Spartaco Astolfi Filho, a professor of genetic engineering and biotechnology there.

Muotri hatched a plan for the study after meeting with a shaman in the Amazon rainforest in 2022.

There, isolated tribal members live long and healthy lives. Very few experience age-related neurological decline. This is in contrast with tribal members who have more contact with Western civilizations, in whom such diseases are more common.

The reason, Muotri posits: a combination of lifestyle factors and, perhaps, the protective properties of the myriad plants that surround them, most of which are unknown to Western medicine. If plants are indeed protecting the Amazonians, the study of their medicines based on knowledge of these tribes – known as ethnic pharmacology – could benefit Alzheimer’s patients around the world, according to Muotri.

Eventually, Muotri plans to again create brain organoids derived from patients with Alzheimer’s disease,

INCUBATE THEM AT THE ISS AND TREAT THEM WITH SELECTED TRIBAL THERAPEUTICS, in a bid to more quickly determine their efficacy and, ideally, usher them into clinical trials.

What’s more, they could even be corrective, meaning that they reverse the damage that has already occurred due to the aging process.

Recognizing that ancient shamanic wisdom is dying off as younger, Westernized generations abandon tradition, Muotri began cataloging plants detailed to him by the Amazonian shaman. He now has a list of over 200, most unknown to science.

Muotri works in tandem with Filho and his researchers, who study and experiment with each plant’s extracts, determining whether they can pass through the blood-brain barrier, among other properties. They also use AI modeling to predict receptor bindings and eventual therapeutic benefits.

Eventually, Muotri plans to again create brain organoids derived from patients with Alzheimer’s disease, incubate them at the ISS and treat them with selected tribal therapeutics, in a bid to more quickly determine their efficacy and, ideally, usher them into clinical trials.

A recent Humans in Space grant – awarded by Boryung, a leading healthcare investment company based in South Korea – will help fuel the intrepid research project, which spans multiple continents and habitats, from the depths of the Amazon rainforest to a lab on the coast of California – and, eventually, to outer space.

“This is the type of interdisciplinary experiment that is, unfortunately, super rare in modern science,” Muotri concluded. “We hope to leverage the knowledge from our ancestors and cutting-edge technology to help humanity cope with complex diseases such as Alzheimer’s and dementia.” ●

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Bridging Innovation and Industry: Brazil’s Journey Towards Sustainable Growth Raquel Goes, technical analyst at Biominas Brasil

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s a reflection of the urgency to regain the Brazilian industry’s leading role, the federal government implemented the concept of neo-industrialization and launched, through the Ministry of Development, Industry, Commerce and Services (MDIC), the Nova Indústria Brasil program. This initiative proposes the modernization and evolution of the industry by stimulating the revitalization of the industrial sector by committing to innovation, sustainable development, and environmental commitment and, finally, promoting integration between sectors.

The new policy, launched in January 2024, contains six missions consisting of strategic planning, with objectives to be achieved by 2033, focused on agroindustry, healthcare, urban infrastructure, information technology, bioeconomy, and defense. The healthcare area, in particular, was included in Mission 2, called “Resilient health-industrial Economic Complex to reduce the Brazilian Unified Health System (SUS) vulnerabilities

and expand access to healthcare.”

After the evident dependence on imports of pharmaceutical ingredients in the COVID-19 pandemic, the goal is to increase the share of production in the country from 42% to 70% of national demands, such as pharmaceuticals, medicines and advanced therapies. In addition, the Mission 2 includes vaccines, serums, blood products, equipment, medical devices and, finally, information and connectivity technologies. Therefore, to sustain increased production, both cost reduction legislation and policies aimed at a grander absorption of the country’s innovation capacity.

PROMISING SEGMENTS In this sense, Biominas Brasil, a reference institution in the Brazilian bio sector, has expanded its crucial role in the market in 2001 with the creation of its Think Tank. Since that, Biominas Think Tank compiles various sector information and manages a specialized database for mapping startups in the field. Biominas cur-

rently monitors more than 900 innovative bio startups and 300 lines of research. In addition, it has a public database, available on its website, of more than 500 registered startups.

The database’s purpose is to provide analyses and insights that serve as a basis for knowledge production, market intelligence, and strategic content for companies and policy structuring for governmental agents.

It further serves as a platform to promote opportunities for startups and research projects. The database brings together essential information about the performance of startups, making it possible to analyze the most promising segments in Brazil.

By evaluating global trends in health innovation and the information available in the database, combined with our knowledge of the health sector in Brazil, we identified these sectors as promising: ● Sustainability and biodiversity: Brazil has one of the richest biodiversity on the planet, however, it has

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a record of voucher specimens up to only 15% to 25% of plant species. This low representation exposes an opportunity since, according to the annual medicinal chemistry report, during the period 1989-1995, more than 60% of compounds approved as drug candidates came from natural products. The promotion of research, investments, and partnerships serves to foster competitiveness within the industrial sector. These initiatives play a pivotal role in bolstering Brazil’s expertise in various endemic plants abundant in valuable chemical compounds. These plants boast a wide array of applications ranging from medicinal uses to industrial products, including biofuel.

Through the database, it is possible to observe a notable growth of around 66% of new startups linked to the themes of sustainability, biodiversity, and phytochemistry in recent years. Sustainability has been reported in startups related to herbal products, cosmetics, and also, agroecological solutions, such as biofertilizers. This result accurately reflects the wave of development in this strategic sector in Brazil. Based on a sustained boost in Brazilian biodiversity and the rational exploitation of natural sources, according to many experts, phytochemistry represents significant potential with the capacity to contribute to innovation and the country’s bioeconomy. More than ever, investment in ​​natural products emerges as a strategic possibility for Brazil to reduce its dependence on critical inputs and to promote a green and sustainable economy. ● FemTechs: Female Technologies are solutions aimed at women’s health and well-being. Previously,

the lack of a comprehensive and accurate definition of women’s health which goes beyond just the concept of birth control - was a frequent reality in the Brazilian and international markets. Within this perspective, there is a tendency in the market to explore possibilities in disease prevention, as significant efforts have been recorded by startups working with preventive ​​ health, from physical and rehabilitative medicine, and nutrition. The database shows a noteworthy increase of 59% in the emergence of new technologies in this area in the last three years alone.

The FemTechs have experienced a significant boost in terms of venture capital investments and, consequently, access to the market, resulting in a boom in the sector since the pandemic. In line with international market trends, Brazil is experiencing progress in new startups dedicated

to this topic. Given the recent expansion of the segment, the perspective is of a favorable environment for both startups already consolidated before the investment boom, as for those in early stages, which seek to add value to the healthcare ecosystem. ● Digital MedTechs: The digitalization of medical technology and digital tech models emerge as highly promising themes, bringing optimism to the market. In this scenario, new disruptive technologies for diagnosis, homecare, genetic mapping, clinical data storage, and, mainly, technologies involving healthcare process optimization through generative artificial intelligence fit into these segments.

Startups focused on the Digital MedTechs, which represent almost 30% of the Biominas Brasil database, are the most prevalent and continue to expand. Some technologies

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also deserve greater attention due to the number of related startups.

To this end, machine learning and software creation emerge prominently through artificial intelligence to construct laboratory analyses and execute user-friendly interfaces in data management in healthcare.

The increase in the creation of startups that invest in these technologies reinforces two premises: the reflection of the escalation in demand attributed to innovation in the healthcare sector and the dependence between the new Brazilian policy and the advancement of logistics 4.0. The incorporation of big data, the automation of daily healthcare processes, and the storage/capture of data represent contributions from the so-called logistics 4.0 to expand the field of neo-industrialization. It is vital to understand these two topics in a parallel and integrated manner, understanding that the implementation and advancement of neo-industrialization require digital transformation model scenarios.

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BRAZIL AND THE INTERNATIONAL MARKET Given the ongoing market trends, it is possible to anticipate relevant perspectives for Brazil, considering the international scenario. Over the last four years, the theme of sustainability has been highlighted prominently around the world, especially in the European Union.

Sustainability and FemTechs can be driven by the impact generated by the Digital MedTechs. One reason for this advancement is the global demand for expanding access to healthcare services. And what would be the most agile and efficient way to provide this expansion? Through Dig-

ital MedTechs. Mainly in the area of​​ diagnostics, the possibility of streamlining processes, whether technical or administrative, in the healthcare field, allows the production of a personalized and high-reach strategy.

Moreover, Digital MedTech startups possess the capacity to significantly impact other sectors of the market.

In the domain of women’s health and wellness, as highlighted by Deloitte, the global market is projected to attain a valuation of $75 billion by the year 2025.

By embracing these emerging trends, Brazil stands poised to not only address present demands but also to pave the path toward a greener, technologically advanced, and diversified economy. We firmly believe Brazil is positioning itself as an appealing destination for investors seeking global solutions within the biotechnology and healthcare sectors. Given its cost competitiveness relative to developed nations and the presence of world-class researchers and companies, Brazil offers significant potential for startups of considerable relevance within these sectors to originate within its borders. ●

In the domain of

WOMEN’S HEALTH AND WELLNESS, as highlighted by Deloitte, the global market is projected to attain a valuation of $75 billion by the year 2025.

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VACCINES

Bio-Manguinhos and Brazil’s role as a provider of RNA technology vaccines to Americas and Caribbean Mauricio Zuma CEO - Bio-Manguinhos / Fiocruz / Brazilian MOH

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n September 21, 2021, the Institute of Technology on Immunobiologicals of Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz) was selected by the World Health Organization (WHO) as the Center for the Development and Production of RNA Technology-based Vaccines for Latin America and the Caribbean.

The selection is the result of a global call, which aims to increase production capacity and expand access to vaccines in the Americas. Through it, Bio-Manguinhos is now part of an international network of institutions with the same purpose. The Institute is working on developing mRNA vaccines, with technology developed internally by Bio-Manguinhos.

Nucleic acid-based vaccine approaches have been in development for many years and have become a reality during the COVID-19 pandemic. RNAbased vaccines licensed for the prevention of COVID-19 have achieved the highest efficacy rates among all those evaluated in phase III clinical trials.

The RNA platform has several advantages, including the ability to acti-

vate the innate immune system without the need for adjuvants, as well as less complexity in terms of production and flexibility in promoting changes in nucleic acid sequences when necessary.

These characteristics allow a rapid response in the fight against epidemics or even the acceleration of the process of developing therapeutic options for medical needs. This makes the RNA platform ideal for responding to health emergencies, in addition to being considered the frontier of knowledge for third-generation immunobiologicals.

Bio-Manguinhos’ RNA platform development projects use both the messenger RNA and self-amplifying RNA approaches, and the plasmid used to build the platform was fully designed by the Institute’s team. In this plasmid, a multiple cloning site has been created, which means that genes can be inserted according to the interest and the disease in question, allowing the platform to be used not only for the development of preventive vaccines against infectious diseases, but also for immunotherapies for chronic diseases, such as cancer.

Considering the competencies

and technological capabilities of Bio-Manguinhos as well as its installed infrastructure, including not only the RNA platform for vaccines and immunotherapeutics but also the knowledge absorbed from the COVID-19 vaccine technology transfer from the pharmaceutical company AstraZeneca, the establishment of advanced therapy platforms, such as gene therapies, is the direction for a new segment of activity for the Institute.

Related to Bio-Manguinhos’ RNA platform project, the GMP facilities are ready, and we expect to make the first engineering batch of the mRNA COVID-19 vaccine by June. During this year we also expect to make our first clinical batch for registration with the National Health Surveillance Agency (ANVISA) and carry on the clinical studies.

The success of this project will enable Bio-Manguinhos to expand access to cutting-edge therapies for Brazilian citizens, as well as support health systems throughout the Latin American and the Caribbean region, thus contributing to the initiatives of the Pan American Health Organization ( OPAS). ●

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INNOVATION

Shifting the Global Investment Path: A New Vision for Latin America Marina Domenech Founder of SAIL for Health, CEO of Intrials Clinical Research. and vice-president of ABRACRO.

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s the world moves towards an increasingly digital and technological economy, it becomes crucial to redirect global investment flows to areas with high potential for growth and innovation. Latin America, historically seen as volatile in terms of investments, now presents itself as a promising territory for growth of disruptive technologies, and strategic investments can transform the region into a hub of innovation and technological development.

The first step to changing the investment route is to understand and address the structural and knowledge gaps faced in the region.

Local governments, together with international partnerships, should invest in technological infrastructure and training, creating a conducive environment for innovation.

The SAIL for Health Global Chair in Global Health and Clinical Development was created at the University of Oxford to advance this strategy, recognizing the need for robust investment in research and development and positioning Brazil and Latin America as key players in the global health scene.

Collaboration between the public sector, private companies, non-profit institutions, and academia is crucial to conducting research that can be quickly transferred to clinical and commercial applications, benefiting both regional and global populations.

In Brazil, we are experiencing a unique window of opportunity in articulating links between players in the new product development chain, connecting basic research to industry and investment. And the country, which is already one of the ten largest healthcare markets in the world, is taking more robust steps to become self-sufficient at all stages of this chain, strengthening the ecosystem, attracting foreign investments, and producing innovation that can benefit the population more quickly and at lower costs.

To exemplify this advancement, I mention the recent collaboration between SAIL for Health, Biotimize, and Vyro Biotherapeutics, aimed at producing a clinical pilot batch of an innovative treatment using laboratory-modified Zika virus to combat brain tumors. This union combines complementary technical skills, robust and

promising technology, appropriate infrastructure, and processes, with a well-defined and elaborate regulatory and development strategy. We are witnessing a powerful case of disruptive innovation led by Brazilian companies – something unprecedented until now.

The inauguration of Biotimize’s CDMO, the first in the country to operate as a service and in compliance with Good Laboratory Practices (GLP) for the development of biological Active Pharmaceutical Ingredients (API), represents significant progress in promoting innovation and excellence in this type of manufacturing in Brazil. And the promising technology developed

by Vyro Biotherapeutics shows the high level of Brazilian researchers and the need to strengthen the internal ecosystem to reverse the current logic - in which Brazil exports raw materials and knowledge at a low cost while importing the final product at a high price.

SAIL’s contribution to this process was unprecedented, as it fills a strategic gap that used to lead to the failure of promising projects even in the pre-clinical phases.

Our starting point is to understand the level of technological maturity, so the company can have an objective overview of the regulatory journey necessary to advance the development of the technology. Through this detailed look, we define the required guidance for them to complete the steps to scale the technology.

With a clear vision of its maturity, viability, and reliability, we actively contribute to the company experiencing translational research, being able to raise funding according to the project’s current situation and being able to advance to the clinical and registration phases, always aiming to ensure these new technologies’ availability in the market and the population’s broad access to them.

Placing Brazil on the global path for clinical development is a fundamental movement already underway. Working synergistically on all fronts of the health innovation tripod – technology, infrastructure, and regulatory strategy – is essential to advance and become a global reference in innovation. This will allow more technologies to be scaled, more products to reach the market and, finally, more and more Brazilians having access to quality healthcare. ●

The first step to changing the investment route is to understand and address the structural and knowledge gaps faced in the region.

Local governments, together with international partnerships,

SHOULD INVEST IN TECHNOLOGICAL INFRASTRUCTURE AND TRAINING, creating a conducive environment for innovation

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