bioBr 2018

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Gold partners

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Dear Reader,

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elcome to the second edition of BIOBr, our annual magazine designed specially for those who come visit the Brazilian Pavilion at the BIO International Convention. This is for readers who want to know how Biotechnology and Brazil are related to one another.

Brazil is widely known for its rainforests, lit up culture and amazing diversity. But how is the country of carnival and soccer also relevant for the development of the biotechnology field worldwide? If you choose to read this magazine, you will surely have the answer.

The BIOBr magazine was created in 2017 with the purpose of elucidating the general scenario of the biotechnology sector in Brazil, increasing the visibility in the international arena of our biotech companies of the pharmaceutical production chain (human and animal health). And already with its first edition, the magazine has consolidated itself, gaining the trust, respect and credibility of readers.

This magazine is an initiative of the Internationalization Project of the pharmaceutical and pharmochemical sector in Brazil, which is coordinated by ABIQUIFI (Brazilian Pharmochemical Industry Association) in partnership with Apex-Brasil (Brazilian Trade and

Investment Promotion Agency), aiming to increase exports, exchange technology, attract investment and internationalize the sector.

The 2018 edition is brought to you in collaboration with Biominas Brasil, an institution specialized in fostering impact businesses in life sciences. Inside you’ll find a mixture of articles, interviews and columns on a wide range of biotech-related topics.

Important subjects will be addressed, such as innovation, research, technology and investment attraction to promote and enhance partnerships with Brazilian players. We intend to give you clear, sensible and reliable information from hig-level experts, entrepreneurs, company executives and government representatives.

Brazil is a growing force in the world in many areas, Biotech being one of them. The country’s strength should not be underestimated; on the contrary, it should be seized to the fullest extent. Our hopes are that you can find valuable information here, see the importance of the actions that are helping to shape Brazilian’s influence in the world of biotechnology.

Enjoy your reading and do let us know if there are any topics you’d like to see covered in future editions. ●

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SUMMARY 12 16 42 INVESTMENT Venture Capital: Brazilian Landscape

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EDITORIAL 11 Years of Brazilian Presence at BIO INNOVATION Brazil Innovates in biotech MOVING FORWARD Improvements in the Brazilian Environment for Health Innovation ANIMAL HEALTH A Giant in Animal Health RESEARCH CENTER Excellence in research all around the country TISMOO A success case of accelerated growth STARTUPS A Successful Startups Environment

BIO Br Project Management by: Reporter: BIOMINAS Brasil / Business Executive: Norberto Prestes / Planning, Control and Operation: Mariana Hentz, Carolina Sellani and Marcela Domingues Art Editor: Daniel Guedes / Contact Us at: comunicacao@abiquifi.org.br / Visit our site: bph.org.br www.facebook.com/abiquifi/

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EDITORIAL

11 Years of Brazilian Presence at BIO

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n 2018 the Brazilian Pavilion will be present for the 11th time at BIO International Convention. The first official Brazilian delegation participated in 2007 and counted with about 40 delegates.

Over the years the Brazilian presence has increased significantly. And specifically in the last couple of years, the Brazilian delegation has had a growth of about 30% in the number of participants and the business volume has folded 10 times. Of these businesses meetings conducted at the event, about 38% are related to R&D investments, 31% to technology transfer, and 31% to sales of products and services. In 2017 Brazil was represented by 194 delegates and 43 companies, apart from government, academia and other industry representatives. Over 400 meetings were held and more than USD 11 million were traded.

Many stakeholders have contributed to increase the Brazilian presence and to

Mรกrcia Nejaim Business Director of Apex-Brasil

Maria Luisa Cravo, Investment Manager of Apex-Brasil

promote the national biotechnology initiatives abroad. The Brazilian Association of APIs Industries (Abiquifi) and the Brazilian Trade and Investment Promotion Agency (Apex-Brasil) are two entities that have been fostering this process, through the “Biotechnology Sectoral Project” which is responsible for organizing the Brazilian Pavilion at the BIO International Convention.

Additionally, various Brazilian authorities usually take part in the delegation. In past years, the Brazilian Pavilion hosted the Ministry of Health (MS), Innovation Secretary from the Ministry of Industry, Foreign Trade and Services (MDIC); the Superintendent of Innovation from the Brazilian Innovation Agency (FINEP); Directors from the National Development Bank (BNDES); Directors from the Brazilian Health Regulatory Agency (ANVISA); and the President of the National Institute of Industrial Property (INPI). Likewise,

the companies typically send their high rank executives; and the representatives from research institutions attending the event are also from management level, focused on new business development.

According to Norberto Prestes, Abiquifi’s International Affairs Manager, the Brazilian presence is important because the country has expanded its portfolio of biotech products year by year, as well as being a potential consumer market for them. Consequently, it has increased its activities and consolidated itself as an important player in the sector.

The BIO International Convention reinforces this Brazilian movement, since it expands the perspectives of international business and the possibility of being in contact with what is most innovative in biotechnology.

“The Brazilian delegation is currently one of the largest of the BIO International Convention and with a diverse profile of

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EDITORIAL

participants. Annually we mobilize startups, national and multinational pharmaceutical companies installed in Brazil, representatives of the Federal Government and of some Brazilian States, as well as researchers.

One highlight characteristic of the Brazilian delegation is the expressive governmental presence, demonstrating the involvement of the government with the development of research and investment in innovation and biotechnology.” states Mr. Prestes. The main event of the Brazilian delegation this year will be the III Summit Brasil Biotech, a one-day pre-convention event which will focus on attracting international investments to Brazil.

Apex-Brasil, in collaboration with Abiquifi, has also been promoting actions to expand the Brazilian biotech sector, focus-

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Norberto Prestes, Abiquifi’s International Affairs Manager

ing on the internationalization of Brazilian companies. More recently, the Agency extended the scope of the Biotechnology Sectoral Project to attract investments and promote partnerships among companies.

Directly or indirectly, biotechnology companies have been benefiting from strategic and promotional actions of the Project, such as lectures, workshops, business rounds, the “Buyer Project”, the “Health Image Project”, international missions, among others that enable the exchange of information and attainment of businesses that positively impacts the Brazilian products’ image abroad and increase the exportation volume of national biotechnological products.

“In addition to the Agency’s business strategies for promoting the sector, we have guidelines that search solutions to non-tariff barriers and that have a positive indirect impact on Brazilian companies’ exportations.

It is an articulation movement between national and international agencies, private and public institutions and the regulated national and international sector. We also have an image project in partnership with Anvisa, which aims at improving the Brazilian products’ image between regulatory agencies.” states Márcia Nejaim, Business Director of Apex-Brasil.

For Apex-Brasil, the BIO International Convention works as a platform for networking, focusing on international strategic partnerships, technology transference, intellectual assets negotiation, investment attraction and global positioning of Brazil.

“It is very important to highlight that the Brazilian biotechnology and health market is very attractive for the foreign investors, but we believe the industry potential in Brazil is even greater than what is presented currently. Brazil has an advanced medical infrastructure and a growing community of local researchers. We are a global player that exports more than 140 biotech products to 89 different countries.” concludes Márcia. ●

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INNOVATION

Brazil Innovates in

biotech

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Brazil is a highly entrepreneur country. According to the Global Entrepreneurship Monitor Brasil 2016, for every 100 inhabitants 36 were entrepreneurs, a rate higher than many other Latin America and even some developed countries.1 This reflects in the biotechnology sector, as there are many startups being brought up that focus on projects in this area.

According to a mapping from The Brazilian Startup Association (ABStartups), there are over 4.2 million startups in Brazil2 and it is hard to estimate how many are working

with biotech. To mitigate this lack of data, Biominas Brasil, Abiquifi and Apex-Brasil are working on mapping such organizations.

This project will search for startups in Brazil that work with chemical and biological active pharmaceutical ingredients, medical equipment, digital health, human and animal pharmaceuticals, animal nutrition and biotechnology in general. It will also map the country’s main innovation clusters; the kind of proposed solutions being researched; and the products already in prototype phase.

A recent survey conducted by Biominas (2017), revealed the general profile of Brazil’s biotech companies. Most of them (about 60%) are small-sized, with up to 10

1. Sebrae, 2016. Global Entrepreneurship Monitor Brasil 2016. http://www.sebrae.com.br/Sebrae/Portal%20Sebrae/Anexos/GEM%20Nacional%20-%20web.pdf. 2. Época Negócios, 2017. Available at https://epocanegocios.globo.com/Empreendedorismo/noticia/2017/08/um-raio-x-das-startups-brasileiras-como-estao-distribuidas-e-em-que-areas-atuam.html

employees, and young, with less than 10 years old. Nearly 70% of the companies have already done some type of international cooperation and all the interviewed have interest in doing future cooperation activities.

Larger companies are also seeking innovation through biotech projects. According to Brazil’s Innovation Survey (PINTEC), the number of innovative companies using biotech has grown 41,9% from 2011 to 2014, showing that there is still room for biotechnology to grow in the country.

In the next pages, prominent companies and organizations shared with us their view about the biotechnology scenario in Brazil and examples of their innovation activities.â—?

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INNOVATION

ALBERT EINSTEIN HOSPITAL

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THE SOCIEDADE Beneficente Israelita Brasileira Albert Einstein celebrates 63 years in 2018, doing one of the things it likes the most: innovate and grow, always with excellence. For the seventh year in a row, the Einstein was ranked by the AméricaEconomía Intelligence Magazine as the best hospital in Latin America.

The hospital has become a reference in state-of-the-art treatments and humanized care, and has expanded its b orders with social responsibility actions, education, and research activities. Einstein has several initiatives regarding innovation, one of them being the recent creation of the business incubator Eretz.bio.

“Eretz.bio is an initiative started by the Sociedade Beneficente Israelita Brasileira Albert Einstein, whose main mission is to foster entrepreneurship and innovation in healthcare. For entrepreneurs and innovators, Eretz.bio is the ideal environment to develop their projects, supported by Einstein specialists and an extensive network of Brazilian and international scientific leaders, executives and startup mentors. This incubator provides coworking office space located in São Paulo/Brazil, enabling selected startups to work in a collaborative and innovative environment, and access to the laboratory and equipment infrastructure of Einstein´s research institute and specialized support from the CIT Innovation Center and the Innovation Lab in areas such as in-

Claudio Terra, Innovation Director, Hospital Israelita Albert Einstein

tellectual property, software and equipment development, project preparation, raising capital and access to grants and funding.

In addition, the startups can interact with Einstein in other diverse ways: Pilots at Einstein; Research and technical validation projects; Co-development and Investment.”

Claudio Terra, Innovation Director, Hospital Israelita Albert Einstein. ●

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INNOVATION

ANBIOTEC BRASIL ANBIOTEC BRASIL – the Brazilian Biotechnology and Life Sciences Companies Association – is the largest Brazilian network in the industry and has emerged to bring representativeness, voice, unity, support to innovation and entrepreneurship, generating competitiveness of Brazilian biotechnology companies and institutions in the global market. Anbiotec represents various areas of biotechnology such as applied technologies for human and animal health; molecular diagnosis, genetics and In Vitro (IVD); laboratory control; plant cloning; Biomaterials; Production of synthetic antibodies; hospital medical equipment; iPS cells; among others.

Vanessa Silva, Executive Manager, Anbiotec Brasil

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LIBBS is a pharmaceutical company, 100% Brazilian, with 60 years of history built with a mixture of boldness, innovation and visionary spirit that helped modeling the company’s evolution and the evolution of the national pharmaceutical sector itself.

They are a dynamic organization, engaged with exploring new frontiers in order to improve more and more the thing that inspires the corporation: taking care of people. With a team of more than 2,500 employees, Libbs has a wide portfolio of medications from several

“The biotechnology sector in Brazil is growing every year. Anbiotec’s network has more than 60 associates that operate a market of more than US $ 2.5 billion per year. With great creativity and research effort, we have quality products recognized worldwide. This year, Anbiotec is re-structuring itself to unite the main actors in the Biotechnology chain, from companies to major Brazilian research centers, strengthening the sector network in Brazil, creating connections and establishing dialogue with governmental and private institutions around the world.” Vanessa Silva, Executive Manager, Anbiotec Brasil. ●

specialties, and invests 10% of its income in Research, Development and Innovation.

“Libbs’s innovation strategy is to pursue innovation networks as much as possible all over the world and engage with them so that we can leverage our internal resources and accelerate the delivery of both new products and services to patients.” Alcebíades Athayde Junior, Executive President, Libbs. ●

Alcebíades Athayde Junior, Executive President, Libbs

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INNOVATION

SEBRAE/RJ SEBRAE is the Brazilian Micro and Small Business Support Service, a non-profit national private entity with the mission of promoting the sustainable and competitive development of small businesses. Sebrae’s role is to foster entrepreneurship, providing guidance to help small businesses to grow and generate more employment, helping to develop the Brazilian economy. In 2017, Sebrae completed 45 years of existence, focusing on strengthening entrepreneurship and accelerating the process of formalization of the economy through partnerships with the public and private sectors, training programs, access to credit and innovation, encouragement of associativism, fairs and business rounds. Sebrae/RJ is the office of Sebrae in the State of Rio de Janeiro.

“The challenges that humanity faces in this century lead us to a race for the development of solutions, innovative processes and disruptive technologies. Micro and small companies with technological and scientific base position themselves as agents of

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Miriam Ferraz, International Affairs, Sebrae/RJ

transformation as they manage to generate these solutions. Sebrae/RJ, as a strategy to support innovation and technological development, aims to support these companies to transform knowledge and research into profitable, scalable business models, and consequently to insert their technologies in the international market. This support has allowed us to achieve quite expressive results, with several licensing, investment and export operations carried out in the first two years of the project. Therefore, the support of Sebrae/RJ allows the development of businesses of high impact and global scale.”

Miriam Ferraz, International Affairs, Sebrae/RJ. ●

SERVIER SERVIER is a French pharmaceutical Foundation, founded in 1954, with more than 21,000 employees, 3,000 of them in R&D. Present in 148 countries, Servier has activities in Brazil for over 40 years, with three business units installed in the country (Manufacturing, Research & Development and Business Administration).

“Brazil is a strategic country with great potential for innovation and excellence in scientific research. We are developing several partnerships with both public and private sectors. This includes, for example at the public sector, we have stablished a technology transfer of modified release micropellets

with FarManguinhos, which allows the manufacturing of the third generation of an innovative medicine to the treatment of Cardiac Ischemia. Also, there is a natural products research project focused on Oncology with Fiocruz. At the private sector, we are scouting Brazilian startups for investment partnerships specially focused on eHealth solutions.

We expect to continuously grow over the years our local innovation projects partnerships in Brazil.” Sandro Albuquerque, Head of Patient Access & Public Affairs, Servier. ● Sandro Albuquerque, Head of Patient Access & Public Affairs, Servier

SUPERA SUPERA Park is an innovative environment that promotes knowledge transfer in several types of activities. It is responsible for attracting and retaining technology-based companies, with noteworthy mention to the Health, Biotechnology, Information Technology and Bioenergy industries. SUPERA Park is the result of a consortium between the University of São Paulo (USP), Ribeirão Preto City Hall and the Department of Economic Development, Science, Technology and Innovation of the State of São Paulo.

SUPERA Incubator, one of the anchors of the Technology Park, houses startups and further the integration between them and Brazilian established companies and international companies that provide technology-driven solutions. It supports businesses

Saulo Rodrigues, Business Incubator Manager, SUPERA

in creating new business, providing basic infrastructure for the endeavor, consulting, training, and networking opportunities. The result has been recorded in the socioeconomic development of the city of Ribeirão Preto and its surrounding area, by creating new job opportunities, in the expansion of the technological districts and in the acceleration of startups in Brazil.

“Nowadays it is impossible to think in a world with biotechnology outside the scope of possible and probable challenging solutions for science.” Saulo Rodrigues, Business Incubator Manager, SUPERA. ●

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ABBVIE ABBVIE is a highly focused research-driven biopharmaceutical company, capable of achieving sustainable performance through a consistent flow of innovative medicines that raise the standard of care for some of the world’s most serious diseases. But we do more than treat diseases – we aim to make a remarkable impact on people’s lives. We bring together the resources, the knowledge and the experience of a pharmaceutical company with

ACHÉ

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ACHÉ LABS, a 100% Brazilian company with more than 50 years of experience in the pharmaceutical market, has the mission to meet the needs of healthcare professionals and consumers worldwide in an innovative way.

To do so, it offers a portfolio of approximately 300 products in Brazil and reaches, through international agreements, 25 countries in the Americas, Africa and Asia.

According to Stephani Saverio, Innovation and Business Development Director, the company has innovation in its DNA and invested, only in 2017, around USD 30 million in technology, research and development of products. “In 2015 we created an Innovation Center that gathers over 300 professionals and scientists divided into five units (Business Development, Alliances & Internationalization; Radical Innovation; Incremental Innovation; Analytical & Pharmaceutical Development; and Medical Affairs), which acts exclusively in the generation of portfolio renewal projects, incremental and radical innovation, exploring

the flexibility and focus afforded by a biotech enterprise to explore more significant health opportunities for our patients, where we are” In Brazil we are over than 350 employees committed to bring innovative treatments to Brazilian patients. We focus on initiatives that can positively impact the Brazilian healthcare system, focused on three major pillars: Training & Education, Innovation & Research and Innovative Healthcare Solutions. ●

internal development and partnership opportunities”, emphasizes Saverio.

As a result of the Innovation Center initiatives, in 2015 the first Design and Molecular Synthesis laboratory of Brazil was inaugurated, with the purpose of bringing new treatment options in different therapeutic areas.

In the new molecular entities pipeline the most promising assets that stands out are the ACH24 (for vitiligo) and ACH36 (for anxiety). The inauguration of this laboratory also made possible for the company to enter,

Stephani Saverio, Innovation and Business Development Director - Aché

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INNOVATION

in the beginning of 2016, into the Structural Genomics Consortium (SGC), with head offices in Toronto (Canada) and Oxford (United Kingdom). It is an international partnership between universities, governments and industries to accelerate the development of new medicines. “Aché was the first Brazilian pharma invited to be part of the consortium and has been contributing to high impact research, published in international scientific journals. The focus of this collaboration is the research in kinases, enzymes directly connected to several kinds of cancer”, explains Saverio.

In 2017 Aché opened, in partnership with the Swiss multinational Ferring, the Nanotechnology Innovation Laboratory Enterprise (NILE), the first laboratory of Latin America dedicated to research and develop-

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AMGEN was founded in 1980 with a “biology first” approach, employing cutting-edge science and technology to study the biological mechanisms of complex diseases and create innovative therapies. The company opened its Brazilian branch in 2009 to coordinate clinical research for South America.

In 2011, Amgen acquired the local pharmaceutical company Bergamo, reacquired products licensed to other companies in the country and started its commercial operations. Currently, the company offers 11 therapies for Oncology & Hematology, Bone Diseases, Cardiovascular and Nephrology.

In Brazil, the company invests around US$12 million per year in clinical trials and

ment of products based on the use of nanotechnology in drug delivery systems. The laboratory counts on cutting-edge equipment to develop technologies that can be transferred to industrial scale. That is a successful partnership with a substantial project pipeline that already represents a great accomplishment for both enterprises.

The structured investments made by the company over the last years, combined with the process of thinking innovation collectively, have been generating consistent outcomes.

Thirty new drugs were launched last year and 34 are expected to 2018. Aché has a pipeline with 145 projects in different development stages and stands watchful to the global pharmaceutical market and the best opportunities for research and development. ●

coordinates research initiatives for eight countries in Latin America. This contributes to validate therapies with a multiethnic group, train healthcare professionals, increase scientific development and anticipate medical innovation in Brazil. In addition to this continuous investment, Amgen recently reinforced its Real-World Evidence area in Brazil, with resources fully focused on real world data generation, bringing to stakeholders more information for better decisions in the Brazilian healthcare system.

For the next years, our strategy in Brazil is to focus on the approval of new therapies and indications, as well as launching a portfolio of biosimilar medicines. Biotechnology provides sophisticated ways to attack disease, and Amgen was among

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INNOVATION

the first companies to recognize the potential of modern biotechnology in developing valuable medicines for patients. Now, nearly four decades later, Amgen is leveraging its biotechnology experience also to the development of biosimilars with the same highest standards in quality and supply.

We strive towards the approval and launch of our portfolio of nine biosimilars, including molecules in oncology, inflammation and rare diseases; we look forward to adding new chapters to our story, while maintaining Amgen’s commitment to connect patients with vital medicines. ● Mauro Loch, General Manager Amgen Brasil

BIOLAB

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INNOVATION! This is what drives Biolab and directs its efforts. With about 10% of our revenue being invested in Research, Development and Innovation (RD&I), innovative medicine amounts to over 50% of our revenue.

Biolab maintains solid partnerships with pharmaceutical industries and the main universities and research centers, both in Brazil and abroad. Our strong activity in radical innovation as well as incremental innovation has led to the development of Dapaconazole, the first radical molecule of the Brazilian pharmaceutical industry and a new anti-fungal compound in phase 3 clinical

study, as a contribution to global science.

As for incremental innovation, some examples are Photoprot®, a protective sunscreen with nanotechnology, and Vonau Flash® - ondansetron with an exclusive oral dissolution technology and the first topical use anesthetic with nanotechnology, also in phase 3 clinical study.

In the Biotechnology area, our partnership with Eurofarma goes on at the Orygen joint venture, directed at biotechnological products.

Amongst the largest national pharmaceutical companies, Biolab is currently placed 5th in prescriptions and 6th in sales in the Brazilian prescription medicine market.

In order to maintain our focus on innovation, the company faces and overcomes challenges that are inherent to Brazil, mainly

regarding bureaucracy and national regulation, which are a part of the learning process related to new procedures at a relatively young nation. On the other hand, the genetic and biodiversity and inherent creativity of the Brazilian people are opportunities and resources that the company wishes to enlist, generating sustainable novelty, in line with all applicable rules.

Despite all challenges, Biolab keeps believing and moving forward in a continuous evolution process to provide health and quality of life to people, now and for the years to come. â—?

Dante Alario Jr., Chief Scientific Officer - Biolab FarmacĂŞutica

EUROFARMA AT EUROFARMA innovation is not limited to the discovery of new drugs, it pervades all areas of the organization as we understand that this is a fundamental value for the perpetuation of our business. The R&D area, focused on drug discovery and innovations related to the core business of the company, invested 6% of the company’s net sales in 2017. With the expansion plan, the goal is to reach up to 15%.

In parallel, we created a corporate venture area, and as a first project we started an acceleration program called Synapsis, in partnership with Endeavor. The main purpose of the program is to create a healthy path to work and learn with startups in all areas within the company, from Human Resources to R&D. We believe that a corporate venture area inside a pharmaceuti-

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Paulo Braga, Corporate Venture Capitalist - Eurofarma

INNOVATION

cal company doesn’t necessarily mean just investing in biotech startups (which is also great when you look with the perspective of outsourcing R&D), but also an opportunity to explore and create new businesses and help to shape the future of the sector from industrial processes to different ways of relating with stakeholders (medical doctors, consumers and partners).

The development of this ecosystem in Brazil is a huge opportunity but also came with some challenges. One of them is trying to reduce the gap between the academia and the companies, creating a path based on good communication and building strong relations

JANSSEN

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AT JANSSEN, a Pharmaceutical Company of Johnson & Johnson, we collaborate with the world for the health of everyone in it. It would be impossible to accomplish this mission without an audacious model for innovation and a robust presence in Brazil.

Janssen Brazil is currently the 2nd pharmaceutical company in number of clinical studies in progress and it is working to be the first one by 2020. More than USD 27.7 million have been invested locally in clinical trials over the past three years. The studies involved more than 2,000 researchers in over 800 institutions, which have already benefited more than 4,500 patients. Since 2012, 11 molecules were launched and 10 new will enter the regulatory review process in the coming years. The Johnson & Johnson in Brazil has over 6,000 direct and 25,000 indirect employees.

At same time, health challenges are in-

between them. In our country we have a big number of scientists who produce very innovative research, and we believe that exists a big opportunity developing technology transfer areas inside universities. This will lead to better products to the consumers, a new revenue stream to fund further scientific research for the scientists and the University and growth to the economy in a broader sense. â—?

creasing in Brazil and more people are counting on healthcare services. Janssen impacts thousands of patients and healthcare professionals every year, through its support and educational programs. We understand that to collaborate with the system’s sustainability and to strengthen the industrial capabilities of the country are as much important as to help improving lives through innovation.

Seeking to fill out the gaps in Brazilian innovation ecosystem, the company is extending the J&J Innovation (JJI) approach to Brazil, through initiatives with local entrepreneurs, universities and institutes developing innovations across the pharmaceutical area. Three Brazilian companies have

already received awards, which include incubation periods at the JLABS in USA, where they have access to world-leading resources, guidance to fully develop their projects, and grants. The companies, working on pointof-care molecular diagnostics, expression of recombinant proteins for Zika Virus diagnostics and treatment, and AI-based recognition

MSD OPERATING in Brazil since 1952, MSD is a world leader in healthcare. MSD has worldwide strategic partnerships for production in order to increase patient access to its products, bringing medicines and vaccines for human and animal health clients in over 140 countries and expanding its productive capacity.

MSD has a strong Biotech operation in Brazil mainly concerned to oncology and vaccine distribution. Its core initiative in this sense is the Productive Development Partnership (PDP) with the Butantan Institute. This partnership relates to the national production of the HPV and Hepatitis A vaccines and the development collaboration for new products.

Since Brazil has one of the best immunization programs in the world, the country is an important part of the MSD’s biotech strategy.

The partnership has supplied more than 50 million doses for both vaccines to the Ministry of Health in the last 5 years with significant impact in the Brazilian population quality of life. Besides the Butantan partnership, MSD is currently evaluating additional opportunities with other public labs to increase the company presence in the vaccine market.

of facial expressions applied to wellness and health solutions, were the winners of innovation challenges dedicated to Latin America.

Moreover, a dedicated Innovation Ambassador for Janssen was hired in the country to scout and screen projects, guarantying that the most promising initiatives are detected and receive support to advance. â—?

Moreover, it is expected that these productive partnerships, current and future, should attend not only the Brazilian demand, but also other Latin America countries or even other continents.

The company invests in partnerships, consulting and training with Brazilian institutions. MSD aims at the development of local production lines with international standards of quality, seeking line expansion and possible future product exportation, especially for other Latin American countries.

Another line of investment includes clinical and epidemiological studies in Brazil together with local reference institutions focusing on clinical development and patient database. â—?

Guilherme Leser, Access, Communications, and Government Relations Director - MSD

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Venture Capital:

Brazilian Landscape

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he Brazilian venture capital industry is being consolidated rapidly. In 2016, investments in the private equity (PE) and venture capital (VC) industry in Brazil totaled USD1 3.3 billion and approximately 76% of this volume was available for new investments or expenditures. This index has shown a peak in 2015 of USDยน 5,4 billion, due to large deals in the health and pharmaceutical sectors that significantly increased the average value of transactions

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in that year. In 2016, 73 companies received PE while 84 received VC. The average deal value was USDยน 42 million for PE and USDยน 2.6 million for VC. Over 200 companies are expected to receive investment in the coming years in a wide range of sectors. The sectors with the largest number of investments include: IT, agribusiness, health and pharmacy, and financial services2.

Apart from its recent development, Brazil has the largest VC market in Latin America, in terms of volume invested: USD 279 million which represents 56% of the total invested in the region, through 64 transactions. The second position belongs to Mexico, with 73 deals but only USD 130 million invested.

In Brazil the investments are still directed towards more traditional sectors of the economy, such as trade and heavy construction.

This fact evidences the preference of the investors who operate in the country towards more conservative sectors, reinforcing the difficulty of technology-based companies to fund their activities3. Nonetheless, the life

science sector often appears as an area of interest to venture capitalists in the country.

The Brazilian government has engaged many efforts and resources to foster this industry in the country. Therefore, the participation of the Brazilian public sector as an investor has been extremely important for the promotion and development of this national industry. The National Development Bank (BNDES), the Brazilian Innovation Agency (FINEP), and the Brazilian Trade and Investment Promotion Agency (Apex-Brasil), as well as regional development banks and other funding entities, play a key role in the entrepreneurial capital ecosystem. Historically, these institutions were responsible for attracting several investors to the country. In addition, they provide resources to encourage the investment in companies from sectors that are not very attractive for private investors, but of singular importance for the development of the national technological scenario.

The focus of Apex-Brasil is to support the attraction of foreign capital to Brazilian investment funds, as well as to support the access of Brazilian companies to this type of capital. In this context, Apex-Brasil has been developing for the past eight years specific programs to support financial investors, such as sovereign funds, corporate and individual investors, Endowments, Pension Funds and Funds. Apex’s goal is to help locate opportunities in partnership and investments in Brazilian funds, both Private Equity and Venture Capital. The Agency also supports foreign venture capital managers, both traditional or corporate managers, to connect with the Brazilian innovation and investment ecosystem. For this purpose, customized service is provided to facilitate quality opportunities for investors’ evaluation or to foster meetings

and networking. In 2015 the Agency started to develop the “Corporate Venture in Brazil” project, which aims to facilitate the interaction of corporate entrepreneurship programs of large companies with the local entrepreneurial ecosystem. Among the priority sectors supported - both from the company and the investor side - are biotechnology and health.

“In Brazil, although the venture capital industry is very recent, we have noticed a growing movement in the sector. Day after day, large Brazilian companies create their own accelerators or, also, programs of selection of entrepreneurs contemplating structural and financial benefits. Importantly, most foreign companies still have their VC arms only in the US and Europe, with few exceptions in Asia and the Middle East.

One of the great challenges of Apex-Brasil is to show global investors that we have innovative solutions in several sectors, including the health and biotechnology sector. Under the corporate venture initiative, Apex-Brasil is mapping and segmenting startups in the healthcare sector, so that we can have a portfolio of innovative companies for presentation to foreign investors.” tells us Maria Luisa Cravo, Investment Manager of Apex-Brasil.

BNDES, another relevant player in the Brazilian investment scenario, first invested in seed capital funds in 19994. But its most emblematic case is the Criatec Fund. Criatec 1 main goal was to capitalize startups with high potential in strategic areas. The first round of investment in 2007 was so promising that there were two others, Criatec

1. Originally in Brazilian Reais. Exchange rate USD 1 = BRL 3,4263 (Source: Brazil Central Bank in 04/16/2018 – Available at http://www4.bcb. gov.br/pec/conversao/conversao.asp) 2. Abvcap, 2018. Inside VC 2018. Available at: http://www.abvcap.com.br/pesquisas/estudos.aspx?c=pt-br 3. Biominas Brasil, 2016. Cenário de investimentos em empresas de ciências da vida em Minas Gerais. Available at: http://conteudo.biominas. org.br/cenario-de-investimentos

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2 launched in 2013 and Criatec 3 in 2016.

The evolution of Criatec is a parallel with the industry’s evolution itself. Criatec 1 had an amount of USD¹ 29.2 million capitalized from only two investors, BNDES and a regional bank, in which the first invested 80% of the capital. Criatec 2 was able to attract more investors, including six other regional banks and development agencies and Criatec 3 counted with 15 quota holders, this time including private investors. These funds have raised USD¹ 54.3 million and USD¹ 63.3 million respectively. With the diverse profile of Criatec 2 and 3, BNDES reduced its participation to about 60% of the total volume, indicating that the bank’s role of attracting new players to the national market worked.

“BNDES is the main investors in VC in Brazil. Today it has USD¹ 291.1 million capital committed in 16 funds, 10 of them are currently in investment phase. Almost half of this amount is invested at the Criatec funds. Criatec has originated many success cases, including in the health area, such as Magnamed, a producer of medical equipment that originated from the university and now exports to many countries. Before Criatec there was a vacuum, we did not have a well-developed VC scenario in Brazil.” states Gabriel Gomes, Head of Venture Capital and Private Equity Investments of BNDES. The history of Criatec comes together with the maturing of the Brazilian innovation and entrepreneurship ecosystem. More and more projects and companies are being originated from the university and entrepreneurs are increasingly searching for new business opportunities and launching new ventures. On the other hand, many investors started looking at this market, such as foreign investors and funds that have installed in Brazil looking for this potential.

BNDES has some new VC initiatives. One

of them is the Primatec fund, in partnership with FINEP and other regional institutions.

It has available USD¹ 29.2 million for companies that have undergone an incubation process. BNDES contributed with 40% of the fund’s total value. Another initiative is a fund of venture debts, a new instrument for Brazil but already established in other countries. It focuses in companies that already received VC and have proven its business model, but do not want to further dilute its capital to finance its expansion. Lastly, a new fund of co-investment with angel investors will be created, to provide smaller tickets directed at companies at even earlier stages than seed capital.

The fund and the angels will invest between USD¹ 29.1 and USD¹ 145.9 thousand in each supported company.

“BNDES focus on market gaps. Many investors come to Brazil looking for IT or incremental innovation, for example. BNDES foster more technological knowledge, it tries to make these investors also open to other areas such as health, equipment, Internet of Things, and others. Biosciences is important because the country has a strong technical knowledge-base in it. From the market side, Brazil has industries in this area that can absorb this innovation and we have one of the biggest health markets in the world. Brazil is a very interesting barn for new investment and technologies.

Investors should pay more attention, specially to the biotechnology market, both because of the ideas generated and the country’s market potential.” concludes Mr. Gomes.

FINEP also plays a key role in structuring the VC market in Brazil. Its first initiative was the Inovar Program in 2000 that aimed at developing this industry and has brought together

4. BNDES, 2015. Capital de risco e o desenvolvimento de empresas de base tecnológica no Brasil – a experiência dos fundos Criatec e perspectivas. Available at: https://web.bndes.gov.br/bib/jspui/handle/1408/9619

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17 investors. Since then, FINEP has invested in 33 funds, and 28 of them are still operating.

The Agency has committed USD¹ 191.2 million in these funds and was able to leverage USD¹ 1,36 billion from other investors. This amount has been put into over 200 companies, but more than 400 have been reached in the process. FINEP has also provided direct investment in 4 companies and collaborated with corporate venture funds.

Recently FINEP gave a special attention to startups. The FINEP Startup program offered resources of up to USD¹ 291.9 thousand to companies, through convertible notes, that already have a marketable prototype or at least are validating it in a relevant scale, preferably already in sales. FINEP aims at filling the gap between the prototype and the expansion phase of the startups. The first round received applications from multiple sectors, including biotechnology, in which the proposals were related to bioinformatics, biochips, biosensors, but mostly cell therapy and recombinant proteins. This round was able to attract a complementary amount of USD¹ 1.6 million from angel investors and two biotechnology companies were selected of a total of 25.

“FINEP comes from a long cycle of investment in biotechnology that focused in medium and large companies, with Inova Saúde, a program created to support R&D and Innovation activities in projects of public and private institutions that work within the scope of the Health Economic and Industrial Complex. It also has supported most companies working with biological medicines in the country and the structuring of the national network in advanced cell therapy, which is a frontier, future-bearing area.” tells us Rodrigo Secioso, Manager for Health and Life Quality at FINEP. Advanced therapy products are a great therapeutic promise in complex clinical settings and where there are no medical alternatives available. Considering the potential and importance of advanced cellular ther-

apy, tissue engineering products and gene therapy products, FINEP together with the Ministry of Health launched in 2008 a public call for Cell Technology Centers. Thus, 9 Cell Technology Centers (currently known as Cell Processing Centers) were structured to isolate, cultivate and produce human cells under Good Manipulation Practices, according to the criteria established by the Brazil Regulatory Agency (ANVISA).

The centers are already producing results and one of them has contributed to combating the recent Zika virus epidemy that rushed the country.

Of FINEP’s 33 funds, one is totally focused in the health industry in general, including biotech, medical equipment and even specialized service providers. There are other investments in biotech at the portfolio, but they originate from non-specific funds or direct investments. “From its experience in multisectoral funds, FINEP has learned that biotechnology is different from the other sectors mainly because of the product and the entrepreneur’s characteristics. In other words, it requires great specific knowledge from the fund manager and a long investment time.

Also, it is important to attract investors experienced in this profile.” states Guilherme Luis Mantovan, Substitute Manager for Investment in Funds and Participations at FINEP. Examples of investments in this area are the company Recepta, that develops drug treatments based in monoclonal antibodies, and Myleus, a company that works with food safety through DNA analysis. ●

The FINEP Startup program offered resources of up to

USD 291.9

THOUSAND to companies

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Improvements in the Brazilian Environment for Health Innovation

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razil has been working hard to improve its life sciences business environment to fully explore the potential the country has in this sector. The government, together with other stakeholders, has acted fiercely to move forward and remove any barrier that might hinder innovation and social development.

In the health segment, the main orchestrator of such movements is the Ministry of Health - MoH, since it is responsible for the “Sistema Único de Saúde – SUS”, Brazil’s universal public health system and one of the largest in the world. And technology is key to the recent developments, both in fostering technological innovation, technology transfer and local production, and in improving the care quality of SUS through digital innovation.

Health informatization is one of the priorities of the MoH to qualify the service provided to the citizen and, at the same time, improve information management. Therefore, the MoH is implementing strategies that make it possible to expand and qualify the health service. One of these initiatives is the e-SUS, a strategic action that integrates

electronically the medical records of SUS users. This tool enables system integration, allowing the user to resolve schedules, appointments and exams without going to the hospital. The MoH has also invested in Big Data for strategic areas of health, Artificial Intelligence and Internet of Things, to make the basic attention of the public system more efficient and thus with better care.

With the support of the Brazilian Health Regulatory Agency (ANVISA), the traceability of medicines is already a reality and, soon, the drugs will be fully monitored in the delivery process between the industry and the patient. The current MoH management implemented solutions to improve the purchase processes, distribution and batch control of medicines acquired and distributed by the MoH to the States. The lack of informatization in this process was creating some difficulties of control and opened gaps for waste. The National Data Base, a system implemented to fill this gap, allows all health secretariats in the country to transmit the information to the MoH, unifying the data. It is almost inestimable the value that this computerization brings

to the Brazilian health system through better planning and use of public resources.

Another highlight from the Brazilian MoH, focused in encouraging innovation, is the support of the Research, Development and Innovation Centers in Science and Technology Institutes (ICTs), which function as incubators of several health startups. These ICTs are designed with a framework for manufacturing, on a pilot scale, various medicines, synthetic and biological, and conducting research and development of biomaterials.

“We know that technology is a great ally to prolong lives, improve and expand our capacity to serve and bring economic sustainability to the country. We have the largest public health system in the world and we know our capacity as an inducer of new technologies. Therefore, the Ministry of Health has been working to make the national environment conducive to innovation. We have expanded the regulatory frameworks, which allows the State to act more strongly in Health, Science, Technology and Innovation. We have reformed and structured more intelligently our partnerships to produce strategic technologies for the SUS, optimiz-

ing our resources and supporting, more effectively, public and private institutions with production potential. As a result, we have increased competition between manufacturing laboratories, which has reduced the purchase costs of 103 medicines and 12 health products. Our focus is to expand the productive capacity of the country and, thus, to tread the path of technological and scientific autonomy.” stated Mr. Marco Fireman, Ministry of Health’s Secretary for Science, Technology and Strategic Inputs (SCTIE).

The Brazilian industrial property system is also in the process of modernization led by the Ministry of Industry, Foreign Trade and Service (MDIC) to position the National Institute of Industrial Property (INPI) in a global standard of productivity. 2017 was marked by impressive achievements: the examiners analyzed the largest volume of patents applications and industrial designs in the history of the Institute and the largest number of trademarks in the last 10 years. This outstanding result occurred after INPI’s staff increase by 25% in the last 2 years with the hiring of 210 new examiners, simplifying of procedures and

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improving IT systems, resulting in reducing the backlog in the three areas.

Also in 2017, the Patent Directorate (DIRPA) reached the number of 55 technical decisions per patent examiner, an increase of almost 60% compared to 2015. Such increase was possible due to optimizations in flow and process control, as well as initiatives of automation of procedures. Also contributing to this result is the expansion and consolidation of policies to encourage productivity, such as telework. Today, more than 100 patent examiners are already working home-based.

INPI has recently implemented new priority examination programs: Health products, ICTs (Science and Technology Institutions), SMEs and Priority BR. The number of Patent Prosecution Highway (PPH) agreements has also been expanded: currently the institute has bilateral PPH pilot projects with the American (USPTO), Japanese (JPO), European (EPO), Chinese (SIPO), Danish (DKPTO) patent offices and with PROSUR (Argentina, Chile, Colombia, Ecuador, Paraguay, Peru and Uruguay) which covers the pharmaceutical area. Through the PPH, Brazilians can use the result of the examination of the patent application in the INPI to anticipate the analysis in other partner offices and use the results of the examination of these offices to prioritize the analysis in the INPI. Another interesting initiative is the INPI’s Green Patent Program, which was built on a benchmarking study conducted with other IP offices and sought to identify and to fast-track green patent applications.

During the pilot project, the pendency for a final decision fell to 16 months in average, with 87% of applications decided within the 2-year intended deadline. Remarkably, 85% of the patents granted are national, showing the importance of this service as an incentive to Brazilian innovation. The success of the program motivated the establishment of the accelerated examination of green

Mr. Marco Fireman, Ministry of Health’s Secretary for Science, Technology and Strategic Inputs (SCTIE)

patent applications as a permanent service.

Currently, new actions are being planned to develop the Green Patent Program, such as the dissemination of deposited green technologies, the training of Patent Examiners and the creation of an environment for the dialogue between investors, inventors and entrepreneurs. The collaborative examination program with South American institutes using e-PEC – Electronic Platform for Collaborative Examination – was also implemented. The goals of the e-PEC are to ensure efficiency, quality and transparency to patent examination among participants.

Through the e-PEC system, examiners can exchange information and opinions concerning patent applications that are analyzed simultaneously in various nations.

In 2017 a great advance was also made in the pharmaceutical area, with the publication of the Examination Guidelines for Patent Applications in the Chemistry Area,

and the Joint Ordinance between INPI and ANVISA – defining the procedures adopted by the institutions for the analysis of patent applications for pharmaceutical products and processes. An also important aspect was the creation of the Interinstitutional Articulation Group (GAI) between INPI and ANVISA, aiming to establish procedures and minimize divergence. Within the framework of this Joint Ordinance, the previous consent from ANVISA has been maintained, and this process has gained in efficiency.

From January 2017 to March 2018, 12,547 patent applications were sent to ANVISA and 2,575 were returned: 65% of them received prior consent; 29% did not fall under law article 229-C, which determines the previous consent; and 6% did not receive prior consent. This is extremely important in this area, in view of the impact on the society of the extended pendency of pharmaceutical patents, besides legal insecurity.

In the Biotechnology field, the 2015 version of the INPI Guidelines is currently being updated, to further clarify issues and enhance some topics, e.g. stem cell usage, monoclonal antibodies, proper characterization of biolog-

ical sequences. The new version of this INPI Guidelines will continue to ensure harmonization and greater examination efficiency and will soon be available for public consultation, projected for the second semester of 2018.

Finally, as part of the continuous effort to enhance its efficacy, INPI, MDIC and the Brazilian Agency for Industrial Development (ABDI) are working together to increase its IT infrastructure, which will allow the revision and updating of their processes, generating competitive intelligence and the analysis of new opportunities in industrial property.

According to Mrs. Claudia Magioli1, General Patent Coordinator of INPI, these results show that the Institute is committed to enhancing its services, to further stimulate an innovation environment through the granting of industrial property rights affirmed.

ANVISA has also stablished several measures to improve its regulatory efficiency.

“The end of 2017 and the year 2018 could

Ms. Claudia Magioli, INPI’s General Patent Coordinator

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be a period marked by ANVISA’s actions and attempts to reduce bureaucracy and improve its regulatory environment, aiming for a better quality in normative acts and decision-making by the agency. The new regulatory framework created by ANVISA, and still to be improved, did not go unnoticed by Kasznar Leonardos. The office maintained itself in constant contact with its clients, actively participating in the process of understanding the new regulations, as well as representing them in the presentation of their perspectives to the Agency.” told us Anderson Ribeiro and Lucas Calabria, from Kasznar Leonardos.

For example, recently the Agency carried out a “guillotine” in its regulatory inventory.

The term was used by the Agency itself when it revoked 128 obsolete normative acts. ANVISA explained that the revocation promoted by the “guillotine” simplifies access and guarantees more clarity to the regulatory stock, which now represents the set of acts really in force.

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Regarding new regulations, at the end of 2017 and beginning of 2018, ANVISA issued new rules which reduce bureaucracy and streamlined procedures. The new fast track procedures for drugs register (Resolution RDC 204/2017) and drugs for rare diseases (Resolution - RDC 205/2017), together with the simplified process for import products subject to sanitary surveillance (Resolution - RDC 208 / 2018) can be highlighted.

However, there is still much room for progress. ANVISA, as others Brazilian regulatory agencies, is preparing guidelines to conduct a Regulatory Impact Analysis - RIA. This measure aims to bring greater regulatory quality to the Agency, through a deep evaluation of costs and benefits of its actions. Considering the Agency’s lack of experience with this kind of evaluation, the challenge will be to combine the complexity of preparing RIA reports with the variety of subjects under ANVISA’s competence

and the great number of acts and rules issued per year (only in 2017 were 91).

In addition, it is important to highlight that, with ANVISA’s entry into the International Conference on Harmonisation - ICH, the Agency is now responsible for adhering to its various guides and technical standards. Specifically, ANVISA has a five-year term to suit itself to the ICH guides regarding: Pharmacovigilance, Clinical Research, Common Technical Document (CTD), and MedDRA implementation. ● 1. With acknowledgments to Daniel Golodne, Gisele Lara de Almeida, Bruno Leonardo Bozaquel Morais and Diego Musskopf, also from INPI, for their contributions to this article.

The INPI’s Green Patent Program, which was built on a benchmarking study conducted with other IP offices and sought to identify and to fast-track green patent applications

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ANIMAL HEALTH

A Giant

in Animal Health

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razil is one of the biggest world players in the livestock market.

In the year 2015, Brazil ranked as the largest cattle herd, currently with over 218 million heads. Brazil is the second largest world consumer and the second largest exporter of beef. Cattle and beef already accounts for 3% of Brazilian exports and generates revenues of USD1 1,8 billion and, in terms of gross domestic product (GDP), represents 6% of the Brazilian GDP and 30% of the national agribusiness GDP. Brazil’s beef export has increased by almost

45% in the last 5 years2. Brazil also is a top market player in other livestock farming animals. It is the third world producer of chicken, with a production volume of 12.6 million ton per year3 and is the fourth world producer of swine with 3,3 million ton per year4.

This massive production together with a strong science-base in the life sciences area has originated a flourishing animal health industry. In 2016 this sector in Brazil has had revenues of USDš 1.5 billion.

The main therapeutic class is antiparasitic (31%). Biologics have a significant share of

21%, followed by therapeutics, antimicrobials, supplements and others5.

Apart from production animals, 18% of the animal health output is dedicated to pets. The Brazilian pet industry was responsible for a turnover of more than USD¹ 5.5 billion in 2016, with a growth of 4.9% over 2015. It has the third place in the world market, behind only the United States and the United Kingdom, and in exports it traded USD 236.3 million in 2016.

Therefore, Brazil has many important companies working in this field, and several of them are present at the BIO International Convention. For example, Farmacore has participated in the event since 2007 and every year it obtains better results, with new business and updates with the latest technologies available in the market. “By 2018, we hope that the event can bring new partnerships focused on the area of activity of the company, the veterinary sector. The company has already established a partnership with a US company to develop a new product, sharing the proprietary technology between the two

companies.” tells us Helena Faccioli Lopes, Executive Director of Farmacore.

Farmacore is a technology-based company created to conduct R&D&I of biotechnological processes and products for the human and veterinary area. It develops and adds value to innovative biotechnological and immunobiological products throughout their development phases, from projects conception to biomolecules production.

Based on immunomodulatory and adjuvant activities, Farmacore has developed its first DNA vaccine. Now the company is expanding the technology as a technological platform for insertion of new gene sequences that encode antigens important for inducing specific and more effective immune response.

This platform has great potential for R&D of new vaccine products, immunomodulators and/or adjuvants for the veterinary sector. Several products are already in pre-clinical phase, some being contracted by multinationals companies: DNA-01 – for use in dog; DNA-02 - for use in fish; DNA-03 - for use in goats and cattle; DNA-04 – for use in cows.

1. Originally in Brazilian Reais. Exchange rate USD 1 = BRL 3,4263 (Source: Brazil Central Bank in 04/16/2018 – Available at http://www4.bcb. gov.br/pec/conversao/conversao.asp) 2. https://www.embrapa.br/documents/10180/21470602/EvolucaoeQualidadePecuaria.pdf/64e8985a-5c7c-b83e-ba2d-168ffaa762ad 3. http://abpa-br.com.br/setores/avicultura/mercado-mundial 4. http://abpa-br.com.br/setores/suinocultura/mercado-mundial 5. http://www.sindan.org.br/sd/base.aspx?controle=8

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Brazil is the second largest world consumer and the second largest exporter of beef. Cattle and beef already accounts for 3% of Brazilian exports

Another good example of a Brazilian animal health company is BioCamp. The company was founded almost 20 years ago and develops biotechnology products, based on the normal animal microbiota for the poultry sector. Its products include probiotics and others known technically as “competitive exclusion products”, and they are benchmark in the Brazilian market. They aim to promote animal health, zootechnical gains, food safety for the consumer, all through sustainable methods that guarantee less impact on the environment. These goals are in line with the company’s mission “to offer natural solutions based on the principle of a single chain of health, from animal to human.”

Nowadays, in addition to intense research in the poultry area, the company is expanding its investments for swine and aquaculture. There is a tremendous worldwide concern to reduce the unnecessary use of antibiotics throughout livestock pro-

Helena Faccioli Lopes, Executive Director of Farmacore

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duction. For this reason, with its experience gained in poultry products, BioCamp wants to be also a partner of producers and other agribusiness players in these two new segments. In poultry farming, the company has several pioneering projects not only for Brazil but worldwide. One project focuses in embryo nutrition of birds from 18 days of incubation (3 days before birth) through distribution of defined microbiota probiotics known as delivery “in ovo”. Another project allies the use of the company’s probiotics with modern technological tools of machine learning aiming to facilitate the health surveillance of flocks. Sanitary control of pests, which affect the health of poultry farms, through biological and non-chemical tools, are also part of developing products, always counting on the support of national institutions of education and research.

“National and international fairs have made it possible to show our company, conquer new commercial partners in Latin America and expand our business to other continents, which has led to the expansion of our facilities and staff.” tells us Paulo Cesar Martins, BioCamp’s Technical and Commercial Director.

Apart from the domestic players, multinational companies are also present in Brazil. Zoetis is the leading global animal health company and has an R&D hub in the country. It is focused on the need for development of specific products for the local market or adjustments to the global products to address the specific customers’ needs of the region. Many projects for different species and therapeutic areas are part of the company’s portfolio, although vaccines are Zoetis’ main focus in Brazil. Zoetis’ R&D or-

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ganization is comprised of scientific experts across numerous disciplines in science and veterinary medicine. There are approximately 1,000 researchers focused on R&D at Zoetis.

In addition to the global R&D headquarters in Kalamazoo, Michigan, the Zoetis research and development network includes teams in the United States (Nebraska and North Carolina), Europe (Belgium, Norway, Denmark and Spain), Australia, and in key emerging markets (Brazil, India, China and Vietnam).

Zoetis is globally recognized for its disruptive innovation that shapes the animal health sector. A recent example of biotechnology application is the development and licensing of the first long-lasting monoclonal antibody therapy for canine allergy and atopic dermatitis. This novel therapy targets canine interleukin-31, an important cytokine involved in sending the itch signal to the brain in chronic atopic dermatitis. Biotechnology is also part of the development

of highly efficient manufacturing processes, through cell engineering or bioprocesses.

Zoetis was the first Animal Health company to surpass USD 5 billion in annual revenue, reaching USD 5.3 billion in 2017. The company’s investment in highly productive innovation, USD 380 million in 2017, resulted in more than 200 approvals during the year for groundbreaking new products and enhancements to the current product portfolio. Through R&D, Zoetis achieves a continuous flow of new products that make a real difference for animals and the people who raise and care for them.

The presence of the company at the BIO International Convention validates the relevance of this event for the animal health sector. Zoetis is an annual attendee at the BIO International Convention. The company typically makes over 200 contacts during every meeting, with several leads that materialize as active collaborations and/or licensing opportunities6. It is expected the same or more in 2018. ●

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Carla Freitas, Zoetis

6. To learn more about Zoetis’ approach to partnering and to the company’s research alliance areas of interest, visit www.zoetis. com/innovation/strategic-partnerships.

Paulo Cesar Martins, BioCamp’s Technical and Commercial Director

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Excellence in research all around the country

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razil has a strong science base, especially in biosciences. It has over 60 thousand publications indexed in Scopus which corresponds to 2,5% of the world’s production. These are the results of a growing trend - since 1996, Brazil has seen a growth of over 700% in its scientific production and has more than tripled its global share (in 1996 the country produced about 8,7 thousand publications that accounted for 0,76 of the world’s total output). The country is even with other BRICs countries like Korea and Russia in this index. Brazil has over 4,000 post graduate programs, more than 90,000 scientists and approximately one third of them are related to the life sciences area.

The country traditionally developed its scientific capacity in basic research dedicated to fields such as agricultural and biological sciences. But recently, supported by its strong technical base, the maturing of its life science industry and governments incentives, Brazil has been moving forward to more complex research fields like drug discovery and development, crops genetical enhancement, among others.

In this context, several specialized hightech centers have been consolidated, with

support from federal and local governments. The Brazilian Innovation Agency (FINEP, in Portuguese, Financiadora de Estudos e Projetos), linked to the Ministry of Science, Technology, Innovation and Communication, has played an important role in this. “FINEP, together with the Ministry of Health, supported the creation and maintenance of CIEnP and NPDM/UFC. These actions are strategic for the country, as they attack bottlenecks of the Brazilian innovation chain in drugs and medicines and allow a situation of greater autonomy in the development of clinical studies considered strategic.” states Rodrigo Secioso, Manager for Health and Life Quality at FINEP. We have interviewed three of such centers that focus on different stages of drug development: NPDM, LNBio/CNPEM and CIEnP, located in the northeast, southeast and south region of the country, respectively. They have complementary activities and all of them are open for international cooperation.

Brazilian Biosciences National Laboratory / Brazilian Center for Research in Energy and Materials

Drug Research and Development Center – Federal University of Ceará

› Núcleo de Pesquisa e Desenvolvimento de Medicamentos da Universidade Federal do Ceará – NPDM/UFC (Drug Research and Development Center – Federal University of Ceará) www.npdm.ufc.br/ NPDM was created to concatenate the several competencies in clinical and non-clinical trials that already existed inside the university. “It is harder to have specialized human resources than physical infrastructure. So, we decided to bring together this research excellence in an institution able to provide innovation and services for the industry” states Dr. Odorico Moraes, Director of NPDM. “The Center works from bioprospecting and synthesis of molecules, drug formulation, pre-clinical tests in animals and clinical trials, the latter being the Center’s greatest expertise – NPDM has conducted over 300 clinical trials”.

The Center was funded by the Ministry of Science, Technology, Innovation and Communication, by the Ministry of Health, and mostly by the National Development Bank (BNDES) and started operations in 2015. The research structure of the NPDM occupies an area of 10,000m2 with 22 preclinical research laboratories (both pharmacology and toxicology), a hospital unit with 64 beds and 13 clinics exclusively for

clinical trials, as well as a dental office for the study of oral health and a special ward to test new protocols for cancer. The vivarium occupies an area of 2.000m2 adjacent to the main building and consists of an area to produce high standard mice and rats, and another area exclusively for animal experimentation. All animals are kept in racks with microisolators to ensure the Specific Pathogen Free sanitary standard.

NPDM currently has more than 48 researchers, having produced over 286 scientific publications and continues working on human resources training, both in basic and applied research. Some success cases have already come from the Center. An example is a technology using tilapia fish skin that is being registered at the Brazilian Health Regulatory Agency (ANVISA) for the treatment of skin burns and already has a private partner to produce it. Another example is the Center collaboration with Sanofi on the development of a dengue vaccine and will conduct Phase IV studies for this project.

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› Laboratório Nacional de Biociências / Centro Nacional de Pesquisa em Energia e Materiais – LNBio/CNPEM (Brazilian Biosciences National Laboratory / Brazilian Center for Research in Energy and Materials) www.lnbio.cnpem.br/ LNBio/CNPEM is also dedicated to cutting-edge research and innovation focused on biotechnology and drugs development with an especial emphasis on the early stages of the drug development process.

The laboratory activities are organized into four areas: Open Facilities; Thematic Programs; Innovation Core; and Training & Education. This organizational strategy was designed to foster interactions with the academic and industrial sectors.

The laboratory was created in 2009 to perform research in biosciences and to support innovation in strategic areas such as, structural biology, drug discovery, biotechnology and materials for healthcare and life sciences. During the last four years, the laboratory has expanded, modernized and diversified its open facilities for external users.

LNBio/CNPEM has also established an Innovation Core to meet the national policies for innovation and development.

One highlight project is the Molecular Power House – MPH. It is a nucleus of drug discovery based on natural products from plant extracts from Brazilian biodiversity.

“This project is differentiated because it uses Brazilian biodiversity. Historically, new drugs have been discovered mostly based on synthetic chemistry. Natural products, recognized as a potential source of new medicines, have been neglected because of complexity and intellectual property issues.

Moreover, Brazilian biodiversity has been very underexploited due to restrictive regulations. However, Brazil has the largest vegetable biodiversity in the world with one fifth of all world’s plant species. In 2015, a new

“research friendly” regulation was adopted, making it easier to use the biodiversity for industrial applications, such as drugs, herbal medicines, cosmetics and functional foods. LNBio/CNPEM works in all these areas.” highlights Dr. Eduardo Pagani, Drug Development Manager of LNBio/CNPEM. The MPH project is a partnership with Phytobios, a company with tradition in sustainable exploration of the Brazilian biodiversity. Phytobios collects and catalogues vegetable samples and produces the dry extracts. The LNBio/CNPEM fractionate the extracts by preparative chromatography and identifies some compounds with mass spectrometry. The project’s collection already has samples from 600 plants, originated from the biomes Amazon, Atlantic Forest, Cerrado and Caatinga. Afterwards, LNBio/CNPEM runs High Throughput Screenings for selected targets and/or phenotypes, identify the active compounds and performs lead optimization through medicinal chemistry.

Partners interested in accessing this collection can contact LNBio/CNPEM. The Brazilian pharmaceutical company Aché already established two partnerships, one for an anticancer drug and another for a dermocosmetic with antiaging activity.

And there are negotiations in course with other national and international players.

“This collection of Brazilian natural compounds is our main differential. Other similar initiatives do not have the same size or curatorship. We can deliver an isolated natural substance optimized for a given therapeutic effect or an optimized natural extract” concludes Dr. Pagani.

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Another line of work of the laboratory is the project “Human on a Chip” that aims at developing improved invitro tests for new drugs, using human cultivated cells to substitute animal experimentation with higher predictive accuracy. Finally, the Center also nationalizes tests that are available internationally.

LNBio is part of the Brazilian Center for Research in Energy and Materials (CNPEM).

CNPEM is a non-profit organization funded mainly by the Brazilian Ministry of Science, Technology, Innovation and Communications (MCTIC). The Center has four national laboratories: The Brazilian Synchrotron Light Laboratory (LNLS); The Brazilian Biosciences National Laboratory (LNBio); The Brazilian Nanotechnology National Laboratory; and The Brazilian Bioethanol Science and Technology Laboratory (CTBE).

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› Centro de Inovação e Ensaios Pré-Clínicos – CIEnP (Center of Innovation and Preclinical Studies) www.cienp.org.br Funded by Brazilian Federal Government (Ministry of Science, Technology, Innovation and Communication, and the Ministry of Health), through FINEP and locally by the State Government of Santa Catarina, CIEnP was designed to act and comply with the requirements of national and international regulatory guidelines, contributing to the Brazilian pharmaceutical industry and insert Brazil among the countries capable of developing and exporting drugs in the near future. In addition, CIEnP provides the development of high-level scientific research, being able to act in both training of human resources (doctorates and postdoctoral) and the development of research aligned with the country’s objective of increasing the production of patents and innovative products.

Opened in 2013, CIEnP was idealized in the same context as the previous institutions

mentioned in this article, nonetheless it has some unique characteristics. From conception it was required that CIEnP should be located in the south of Brazil inserted in a technological park and should be constituted as an independent private nonprofit institution. “We are fully dedicated to innovation since the beginning We were created to work in Good Laboratory Practice – GLP, a Brazilian gap at the time. During the planning phase, we have many specialized international consultants to help us build state of the art facilities. Also, we trained our staff abroad, through international postgraduate projects, in a partnership with some big pharmas. We work both with drugs and cosmetics development and all our projects are conducted in partnership with the industry. Our strongest feature is our technical and scientific capability” states Dr. Calixto, CEO of CIEnP. CIEnP has a constructed area of 5,300m², divided in 24 research laboratories containing modern equipment necessary to conduct non-clinical studies of efficacy and safety of pharmaceuticals, plus a high technology vivarium to bread and maintain specific pathogen free rodents. The laboratory can meet demand of non-clinical trials of high quality standard necessary for he analysis of synthetic, biological, phytomedicinal and other molecules. In addition, within this innovation environment, CIEnP has an area of approximately 1,000m2 for the incubation of technology-based companies focused on human and animal health. The current staff has 40 professionals, including twelve PhDs. “The Center is open for international partnerships and is able to work in the highest international standards with a competitive price. Together with the projects in partnership with the industry, CIEnP has some proprietary developments. The CEO of CIEnP has already transferred technologies to the industry. Brazil has a great potential in this field” concludes Dr. Calixto. ●

Dr. João Calixto, CEO of CIEnP

Center of Innovation and Preclinical Studies

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TISMOO

Tismoo A success case of

accelerated growth

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tartups live in a dynamic environment and are defined for its exponential growth.

Tismoo is one of Brazil’s finest example – the company, already featured in the 2017 edition of the BIOBr Magazine, has seen its revenues triple in the last couple of years. And this is just the beginning.

Tismoo is the first company in the world exclusively dedicated to genetic analysis, focused on personalized therapeutic perspectives for the Autism Spectrum Disorder and other genetic neurological disorders. The company was founded in 2015 by a group of Brazilian researchers, headed by the molecular biologist Dr. Alysson R. Muotri, who is currently a Professor at the School of Medicine at the University of California – San Diego (UCSD).

The project which originated the company was to recreate in the laboratory the stages of neural development by using cells from the patient himself – mini-brains created from induced pluripotent stem cells – capable of reflecting the unique genetic distinctiveness of each person. This work is of great interest to the pharmaceutical companies since it allows the development of personalized pharmacological treatments.

Today the main services the company provides are genetic tests for personalized medicine for autism spectrum disorders (ASD). The company combines genomics, mutations analysis, cloud computing and genetic interpretation of clinical conditions.

This is the main driver of the company’s revenue, which has grown from USD1

175,000 in 2016 to USD 0,5 million in 2018.

Now the company wants to move from the implementation phase, when it focused on finishing its product development and setting up its laboratory facilities, to the phase of sales traction and expansion to international markets. The company already has offices in San Diego and Miami – USA, apart from its headquarters in São Paulo Brazil, and is negotiating new operations in Europe. “Tismoo is a Brazilian company with a global relevance” states Gian Franco Rocchiccioli, Co-Founder and Chief Strategy Officer. Mr. Rocchiccioli also says that one of the company’s main challenges is the fact that it operates in a large and complex social issue, so it is important to design its solutions in business units or steps that can deal with the specificities of each part of the demand and deliver the best answers to patients and their families.

Considering this, the company keeps developing new projects to tackle different needs. One of the highlights, according to Dr. Graciela C. Pignatari, Co-Founder & Executive Director, is the project 1000 Brazilian Genomes, a partnership between the University of São Paulo – USP and the University of California San Diego – UCSD. The main objective of this initiative is to create the largest genomic database of Brazilian autistic population, which will help to better understand the genetic profile of autism in the country, making this information available for scientists around the world and further accelerating the innovations in this area. This project is special also because it relates to one of the company’s core features – its social impacts “The genetic sequencing is very valuable, both to develop a broader knowledge base, to provide genetic counselling and to stratify patients for clinical trials so they can be

Gian Franco Rocchiccioli, Co-Founder and Chief Strategy Officer

Graciela C. Pignatari, Co-Founder & Executive Director Dr. Alysson R. Muotri, molecular biologist, professor at the School of Medicine at the University of California

classified in subgroups, in order to have an improved personalized medicine for these individuals in the future. Brazil has a very diverse genetic profile, so this project is important to elucidating it and promises very interesting results” says Dr. Pignatari.

The Tismoo goal is to create a better collaboration process with parents, physicians, therapists and scientists to help them diagnose, treat and care for patients, making it faster, easier and less painful. Our vision is to change the current situation using a combination of science and technology. For example, Tismoo24/7 is a service based on a continuous update using the scientific knowledge because one unknown data today could be very important in the future. Our updates includes two reanalyzes and two additional semi-annual reports for a year.

Like many other startups, Tismoo has many challenges ahead. However, it paves its path with a robust scientific and clinical base, and this, combined with the company’s persistence and will to succeed, shows that there is an important place for this Brazilian startup in the global scenario. ●

1. Originally in Brazilian Reais. Exchange rate USD 1 = BRL 3,4263 (Source: Brazil Central Bank in 04/16/2018 – Available at http://www4.bcb.gov.br/pec/conversao/conversao.asp)

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STARTUPS

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A Successful Startups Environment

B

razil has several other interesting biotech success cases to show. In the next pages we feature three promising startups from different areas and with diverse backgrounds: Beone Technologies – that developed a photobiomodulation technology; Epigen Biosciences – specialized in early stage drug development; and Phytobios – a high technology company focused on the Brazilian biodiversity.

BEONE TECH Caio Guimarães, the company’s Founder and CEO

BEONE TECH has developed a solution for diabetic foot, a disease that is important due to both its prevalence – diabetes is one of the most common noncommunicable diseases – and its outcomes – it can lead to the limb’s amputation. The company has developed a solution using photobiomodulation. “Different light wavelengths send generic commands to the cells that can control the inflammatory process and stimulates cicatrization” tells us Caio Guimarães, the company’s Founder and CEO. The company history is linked to the entrepreneur’s journey. Mr. Guimarães did part of his electrical engineering course at Hofstra University in New York, supported by Brazilian public funds for student mobility, and later started researching at Harvard and MIT Laboratories in Boston at the Wellman Center for Photomedicine Research Center. He was awarded the Harvard MIT People’s Choice Award 2015 for the excellence in his work developing innovative medical

equipment based on light applications.

Mr. Guimarães came back to Brazil and in 2015 founded Beone Tech together with a multidisciplinary team from the University of Pernambuco, located in the Northeastern region of Brazil. The team chose to work with diabetic foot because of its relatively lower regulatory requirements – the technology has many applications, including the substitution of antibiotics, that would take a much longer effort and time to come to market. The company keeps a close relationship with the university, its main source of knowledge. Also, Beone Tech has a strong social calling and focus on developing products that can change people’s life, even glimpsing a new way of doing medicine. “We foresee a new medicine, less invasive, with a physics approach, and less chemical, more modern”, says Mr. Guimarães.

The company is currently finishing its product development and will submit it to approval by the Brazilian Health Regulatory Agency – ANVISA, the US Food and Drug Administration – FDA, and the European Medicines Agency – EMA, with the market entry estimated to be on May 2019. Although this is a critical phase, the company is confident in its clinical trial’s results that revealed to be better than expected. The technology was able to completely close within 15 and 90 days wounds that had been open for more than 2 years without showing improvement. The clinical trial, the first product prototype and the structuring of the treatment protocol were funded by a successful crowdfunding round that raised over USD1 23,000. Beone Tech also counts with angel investors and venture capital funds and has received several awards and recognitions as a promising startup, including the “Hello Tomorrow Global Challenge” and the “Brazil Campus Party Best Startup Award”. ●

1. Originally in Brazilian Reais. Exchange rate USD 1 = BRL 3,4263 (Source: Brazil Central Bank in 04/16/2018 – Available at http://www4. bcb.gov.br/pec/conversao/conversao.asp)

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STARTUPS

EPIGEN BIOSCIENCES

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EPIGEN BIOSCIENCES is another startup where the entrepreneur’s personal history mingles with the company’s own. Co-founder, Fabio Tucci, is an experienced medicinal chemist who has worked in the field of drug development with several pharmaceutical companies, and has contributed to many projects, including the development of Elagolix, a small-molecule GnRH antagonist that recently completed phase III clinical trials for endometriosis and uterine fibroids. The FDA is expected to issue a decision about its approval for clinical use by July of 2018.

The recession of 2010 in the US proved to be the right time to seek new opportunites. In 2010, Dr. Tucci and a group of other preeminent drug development scientists decided to harness their broad knowledge base and founded Epigen Biosciences, a company dedicated to the early stages of drug development, operating under a differentiated business model. “Our model is flexible and adaptable to each client’s need. In contrast to other similarly sized companies that work with drug development, medicinal chemistry is Epigen’s core asset,” states Dr. Tucci.

The company has its own laboratory and dedicated staff, so it is able to synthesize compounds and conduct physicochemical analyses. Epigen brings biological expertise through partnerships with leading universi-

originated as a joint venture between Epigen and the original entrepreneurial group, Curtana Pharmaceuticals. The technology has almost reached the stage of human clinical ties and other research institutions trials and has received up to USD 12 to conduct further pharmacological million in public and private funds.

The company’s main challenge investigations. In other words, Epigen Biosciences works from lead is funding, given that it operates in identification and optimization up the so called “valley of death of drug development,” as private investors to the phase I clinical trials stage. are more interested in One of the compaless risky projects that ny’s most mature projhave already undergone ects is a small molecule some stages of clinical modulator for renal development. This exfibrosis, a condition plains why the company which occurs in the latrelies mostly on public est stage of chronic kidfunding, especially from ney disease, leading to the National Institutes progressive loss of renal of Health (NIH) – which function and eventufosters high-risk really end-stage renal Fabio Tucci, search projects in drug failure. The project, iniCo-founder development in the US. tiated in 2012, through a partnership with Yale University Nevertheless, Epigen’s model has and UCSD (University of California, proven sustainable, as the company San Diego), received about USD 5 mil- is already 8 years in the market.

“Pharmaceutical inlion in grants from the novation, although risky, US government’s Small is an activity that can genBusiness Innovation Reerate a lot of wealth and search (SBIR) program. progress for humanity.

The candidate comIt is still hard to do it in pound is going through Brazil, as few companies focus on this, the final stages of preclinical efficacy and safety studies and is expected to but is time to be more forward thinking. go into clinical trials in two years. The Creating a culture of pharmaceutical project has generated significant in- innovation and building a complete innovation ecosystem is something terest from big Pharma companies.

In addition to its own drug discov- that it is going to be highly beneficial ery portfolio, the company also accel- for the country. We need to start now erates external projects and technol- to be able to see results in 20, 30 or 50 ogies. One example is a technology years; therefore, it is important to take for the treatment of glioblastoma that the first steps,” concludes Dr. Tucci. ●

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STARTUPS

PHYTOBIOS Dr. Cristina Ropke, CEO of Phytobios

The new improvements in the biodiversity access law have reduced the juridical insecurity, especially for foreign investors

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PHYTOBIOS has already featured in the first edition of the BIOBr Magazine as one of Brazil’s highlight biotech startups. Phytobios is a 100% Brazilian company focused on the development and commercialization of technologies based on biodiversity through research, licensing, intellectual property, regulatory support and innovation management.

The company operates in the development of technologies for the pharmaceutical, cosmetic, food and natural technology areas, from the research phase to the development of prototypes. The startup explores Brazilian biodiversity in a sustainable manner, always respecting the legislation on access to genetic heritage.

One of the company’s latest news is a project together with the Brazilian Biosciences National Laboratory (LNBio) part of the Brazilian Center for Research in Energy and Materials (CNPEM) that consists of a library of compounds originated from different Brazilian biomes. In the collection, there are extracts and fractions derived from hundreds of plant species of the Cerrado, Caatinga, Atlantic Forest and Amazonian Forest, and new expeditions are being planned. These samples will be screened and tested for their pharmacological activity.

“This project is a revolutionary Brazilian initiative not only from a technological perspective, given that it uses state of the art techniques such as Molecular Networking that improves considerably the process of biodiversity screening, but also in its business model, that was based in similar international drug discovery centers and is relevant and encouraging both for Brazilian and foreign companies” states Dr. Cristina Ropke, CEO of Phytobios.

A proof that the model works is a partnership recently signed with Brazilian pharma

company Aché, one of the biggest domestic players in the market. Aché already invested in two projects from the platform, and Phytobios expects to expand the number of partnerships.

The new improvements in the biodiversity access law have reduced the juridical insecurity, especially for foreign investors. “It is a unique moment to launch such project as it brings together cutting-edge technology and the Brazilian technical capacity, the largest biodiversity in the planet and a favorable legal framework.

The potential of this is the development of disruptive herbal medicines and synthetic drugs, based on the discovery of new natural structures” tells us Dr. Ropke.

In parallel, the company has other exciting activities.

Most of the extracts used in Brazil originates from other countries, especially from Europe, as it is hard and costly to conduct clinical trials for natural extracts locally. But the company is being successful in the clinical validation of Brazilian natural extracts, in partnership with national universities.

Phytobios and its projects are great examples of initiatives that can translate Brazil’s huge potential into real impacts, not only for the country, but also for the global life sciences scenario. ●

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