Country Profile

Brazil

SYNBIO MAP

SynBio Map identifies and locates companies, universities, research institutions, laboratories and other centers across the globe that are active in the synthetic biology research ("Synthetic biology project"). It is a good tool to compare the development of synthetic biology all around the world. This map was created by the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars.

In Brazil there are three organizations registered on Synbio Map, all located in São Paulo. Two of them at the University of São Paulo (USP), and the third one is on a company.

Source

PARTICIPATION IN THE iGEM COMPETITION

Universities in Brazil has attracted increasingly to participate in iGEM competition. The first team to participate in the competition was the State University of Campinas, in 2009, and by 2012 there were only a Brazilian representative per year. However, this year we already have the presence of four teams in Brazil.

The four Brazilian teams that participate in the competition in 2014 are the University of São Paulo (USP) together with the Universidade Estadual Paulista (UNESP) and Federal University of São Carlos (UFSCar); the second team belongs to the Federal University of Minas Gerais (UFMG); the third to the Federal University of Amazonas; and the latest belongs to the Federal University of Pernambuco (UFPE). The University of Pernambuco is the newest member in the group of Brazilian universities, participating for the first time in 2014, while UFAM and UFMG participate for the second time and USP goes to 3rd participation.

BIOTECHNOLOGY INDUSTRY AND FUNDS

The industries of Biotechnology in Brazil are in the growth stage, and the capacity and infrastructure in this area vary from sector to sector. According to a survey conducted in 2011, Biominas identified 143 biotechnology companies (Biominas, 2011). By contrast, the work of BrBiotec (2011) estimates that there are 237 biotech companies, a significantly higher number. Bianchi (2013), in a new survey, divided biotech companies in Brazil in three categories and found 92 companies that are solely engaged in biotechnology, as shown in the figure below:

In this set, we consider companies dedicated to Biotechnology and others that belong to this broad universe of companies dedicated to bioscience activities, which carry out activities related to biotechnology. This number also includes companies that operate with other technical bases, for example, the pharmaceutical industry that keeps the central body of its activities in the production of chemical basis, but that has embedded business units dedicated to biotechnology (Bianchi, C. 2013). According to data from CEBRAP, the average age of Brazilian companies is low: 63% of them were founded after 2000; 40% of them after 2005 and most of the companies (77.4%) is in the Southeast (40% in São Paulo, 24% in Ontario and 13% in Rio de Janeiro). This is achieved by a logistics issue, since the industry is highly dependent on imports: 76.9% of Brazilian companies import reagents, 64.3% and 20% care equipment care services.

In general, one of the main strong points of biotechnology in Brazil is the use and development of crops genetically modified organisms (GMOs), biofuels and the development of agricultural biotechnology, where for many years Brazil is a pioneer. However, its capacity is less developed when it comes to health biotechnology (Pugatch Consilium, 2014).

Companies dedicated to agricultural biotechnology are generally more active than those of other areas of the activity scale. These companies have strong ties with various agents, such as the Brazilian Agricultural Research Corporation (Embrapa), Universities and, in particular, are associated with Local Productive Arrangements (APLs) with producers who use the products or services they offer. Among companies in the agricultural area, include the dedicated biotechnology applied to the production of crops for energy generation, mainly sugar cane. In 2013, Brazil had 40.3 million hectares of biotech crop corn, soybeans and cotton; behind the United States (ISAAA, 2013). Brazil also has biofuels (ethanol from cane sugar) as the main source of energy for transportation since 1975 and the introduction of the National Alcohol Program (ProÁlcool).

The conditions for the success of biotech companies in the biofuels and agricultural biotechnology sector are directly linked to strong government leadership. For example, the Brazilian government, through EMBRAPA, is intimately involved in R&D (Production and development) and marketing of agricultural biotechnologies.

In Brazil there is a great importance of public support for the biotechnology industry: BrBiotec according to a study (2011), 78% of the surveyed firms receiving some sort of federal or state support, as shown in the table below. On the other hand, 14.3% of these companies finance projects with the support of firms or venture capital funds, according to data from CEBRAP (Brazilian Center for Analysis and Planning). Although this is a much smaller percentage than the companies that received public capital and it is not possible to know if they are the same companies, it is a relatively high percentage for the Brazilian context and the development of its capital market to enterprises of this type.

According to data from CEBRAP, 56% of businesses are small, with annual revenues of up to $ 140 000; 20.6% of Brazilian companies in the industry have no profit, since their products are still under development and research. Currently, FINEP is a leading provider of research grants to biotech companies. BNDES provides a significant amount of funds for research, manufacturing and innovation in biomedical and biopharmaceutical. This entity provides direct financing, loans and seed capital. In 2013, BNDES has also announced the funding of a specific part of the branch of biotechnology, PROFARMA , biotechnology dedicated to the advancement of health and capability of the national R & D.

REGULATIONS FOR SYNTHETIC BIOLOGY

The regulation is not the same for all industries and biotechnology sectors. Biofuel manufacturers do not face the same challenges of R & D, as well, are not within the same rules as companies seeds.As the biotech industry in Brazil is mainly regulated by ANVISA and by CTNBio. ANVISA is responsible for regulation of biologics and biosimilars (input was introduced in 2010/11) (T Kirchlechner, 2013). CTNBio is responsible for the regulation of all activities (including research and marketing) of GM technologies or products and biotechnological (CTNBIO, 2014).

More recently, in 2003, biotechnology was identified as a national strategic priority, which culminated in 2007 in Decree No. 6041 (Biotechnology Development Policy). This decree focuses on building the international competitiveness of Brazilian biotechnology and contains policies relating to direct support to R & D, construction of infrastructure for R & D, training and human capital development, and the improvement of other existing regulatory frameworks policies (Pugatch Consilium, 2014).

The decree also established the National Biotechnology Committee to coordinate the implementation of government policies biotechnology. The Committee is composed of 23 federal agencies and ministries, all geared to the growth of biotechnology industries in Brazil.

Regarding clinical studies, although the total number of studies in Brazil is relatively high, 3804currently in Brazil , a total of 5,606 regional Latin America (clinicaltrials.gov), the environment is quite challenging and clinical research in Brazil is below expected levels. Less than 2% of clinical centers in the world who are conducting research in Brazil and, according to local scientists and clinicians, the country is losing potential studies for other countries due to their regulatory requirements (Folha de S. Paulo, 2014). Clinical trials need to have the endorsement of two distinct organisms (CONEP, National Commission on Research Ethics, and ANVISA), a process that can extend over more than a year, unlike the three months in the USA and the European Union

Unlike many OECD economies and a growing number of middle-income countries, Brazil only provides regulatory protection of clinical trial data submitted to fertilizers, agrochemicals and pharmaceuticals for veterinary use. Pharmaceuticals for human use are not covered by existing regulations (Pugatch Consilium, 2014).

RESEARCH, PEOPLE AND ORGANIZATION

In Brazil, according to a study held by IPEA (SIGLA) in 2008 (Mendonça and Freitas, 2008) 290 research groups linked to R&D&I activities in biotechnology were identified. The agricultural, biological and health sciences are the most important, accounting for 79% of the identified groups. The main biotechnological applications listed by the research groups are agriculture, human health and animal health. Data from the Brazilian Center for Analysis and Planning (CEBRAP) indicated that 57% of searches are funded directly by the Federal Government, and 46% of the total is linked to federal universities. States are responsible for approximately 31% and 26% coming from universities. The research and organizations are clustered in the Southeast, primarily in the states of São Paulo, Minas Gerais and Rio de Janeiro, where it usually is focused research groups, located in the most prestigious universities, leading to the formation of companies dedicated to biotechnology with various forms of collaboration with research groups.

Partnerships between Research Institutions and University, as well as universities and private sector have been carried out slowly in Brazil. While there are still challenges in transforming this support into concrete biopharmaceuticals and fully commercialized technologies, this is, however, an increasingly prioritized by the Brazilian government area. Brazil has various policies and regulations to promote technology transfer. As an example, we have the Innovation Act of 2004, which aims to encourage the transfer and commercialization of technology through incubation services to public and researchers greater stimulus to activities of start-ups (OECD, 2012).

Between 2000 and 2007, the patents filed by universities increased five more times than expected, from 60 to 325 patents (WIPO, 2011). During this same period, the patents filed by public research organizations increased from 20 to 39 Likewise, a survey of 2011 with seven universities in Brazil found that there was patenting, licensing and cooperation between universities and industry, but this step was in early stage incipient (G Dalmarco, 2011).

EVENTS RELATED TO SYNTHETIC BIOLOGY

Congresso Brasileiro de Biotecnologia (National Biotechnology Congress)

This meeting aims to encourage interactions between scientists and professionals from different fields of research, promote scientific exchange and discussion and establish collaborations between scientists and entrepreneurs. The target audience is composed of Brazilian scientists educational public research and private entrepreneurs in the area of biotechnology institutions, graduate students and undergraduate private companies healthcare, industrial, environmental and agricultural

I Workshop of Synthetic Biology and Technological Innovation

The event is an initiative of the CESAR team LIKA-BRAZIL-as a way of dissemination for Synthetic Biology and the integration of Robotics, Health Information Technology, and will feature lectures by experts who are working directly with innovative projects on the issues involved. The event is primarily designed for students and professionals in health care, information technology and computing. One of the highlights is the design of biosensor that is in development to revolutionize the treatment of breast cancer.

Workshop de parceria trans-atlântica em biologia sintética

The workshop is a threefold initiative of the University of Warwick (UK), Boston (USA) and USP to promote international cooperation in the emerging field of Synthetic Biology and reaffirm the partnership between the institutions. The event program includes discussion groups in key areas of synthetic biology. It is intended to foster the development of new approaches to address issues of global relevanc

Jamboré Brasil

Meeting of Brazilian Teams Competition of the International Genetically Engineered Machines in order to exchange experiences, to network and discuss Synthetic Biology.

BIOEN Workshop on Synthetic Biology

Coordinated by FAPESP Bioenergy Research Program, aims to discuss the rise of Brazilian research on bioenergy and the need for investment in synthetic biology

References

Pugatch Consilium. Construindo a Bioeconomia: Analisando as estratégias nacionais de desenvolvimento da Indústria Biotecnológica, 2014, 120p.

Bianchi, C. (2013). “A Industria Brasileira de Biotecnologia: montando o quebra cabeça” Revista Economia e Tecnologia. 9, 2:99-116.

Biotecnologia, Iniciativa Nacional de Inovação. Panorama da Biotecnologia no Mundo e no Brasil. (Link)

IPEA: Instituto de Pesquisa Econômica Aplicada. (Link)

Bianchi, C. (2012). “O papel das políticas públicas no regime de inovação de biotecnologia para saúde humana. Brasil 2002-2010”. Tese de Doutorado. Instituto de Economia, UFRJ. Rio de Janeiro.

Biominas. (2011). “The Brazilian life science industry: pathways for growth” PwC-BIominas. Belo Horizonte

BRBIOTEC (Associação Brasileira de Biotecnologia) CEBRAP (Centro Brasileiro de Análise e Planejamento) (2011) “Brazil Biotech Map 2011”.BIBIOTEC-CEBRAP, São Paulo.

Bianchi, C. (2013). “A Industria Brasileira de Biotecnologia: montando o quebra cabeça” Revista Economia e Tecnologia. 9, 2:99-116.

Cebrap (Centro Brasileiro de Análise e Planejamento) . (Link)

Pugatch Consilium. Construindo a Bioeconomia: Analisando as estratégias nacionais de desenvolvimento da Indústria Biotecnológica, 2014, 120p.

BRBIOTEC (Associação Brasileira de Biotecnologia) CEBRAP (Centro Brasileiro de Análise e Planejamento) (2011) “Brazil Biotech Map 2011”.BIBIOTEC-CEBRAP, São Paulo.

Cebrap (Centro Brasileiro de Análise e Planejamento) .(Link)

FINEP (Financiadora de Estudos e Projetos). (2008) Inovar.Link

BNDES, Press Room, News, “BNDES renews Profarma and expands support to biotechnology”, November 4. 2011.

R. Rezaie et al (2008), “Brazilian health biotech—fostering crosstalk between public and private sectors”, Nature Biotechnology, VOLUME 26 NUMBER 6 JUNE 2008

SANTANNA, M.F. E. et al. (2006). Perfil da Biotecnologia no Brasil: Investimentos, Recursos Humanos e a Indústria de Biotecnologia. In: Gestão de biotecnologia. Rio de Janeiro: E-papers, 2006.

T Kirchlechner (2013), “Biosimilar Regulatory Overview ANVISA biosimilars workshop”, Brasilia, 25 June 2013, Sandoz, slide presentation, slide CTNBio. (Link)

Pugatch Consilium. Construindo a Bioeconomia: Analisando as estratégias nacionais de desenvolvimento da Indústria Biotecnológica, 2014, 120p.

Clinicaltrials.gov, Home, Find Studies, See Studies on a Map. (Link)

Folha de S. Paulo (2014), “Grupo lanca iniciativa para fomentar testes clinicos no Brasil”, April 10 2014. (Link)

MENDONÇA, M.A.A.; e FREITAS, R. E. (2008). Biotecnologia: perfil dos grupos de pesquisa no Brasil. IPEA. In: Anais do XLVI Congresso da Sociedade Brasileira e Sociologia Rural. Rio Branco, AC, 20 a 23 de jul 2008.

Cebrap (Centro Brasileiro de Análise e Planejamento). (Link)

WIPO, (2011), World Intellectual Property Report 2011, The Changing Face of Innovation, WIPO Geneva p. 151.

G Dalmarco (2011), “Universities’ Intellectual Property: Path for Innovation or Patent Competition?”, Journal of Technology Management & Innovation, 2011, Volume 6, Issue 3