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Page 1: c.jimenez@tic-spain.com-bitTEC

Organized by:

Support:

Innovationis in our DNA

GET TO KNOWTHE INNOVATIVE BIOTECHNOLOGYBRAND IN BRAZIL.

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Page 2: c.jimenez@tic-spain.com-bitTEC

BRBIOTEC BRASIL: THE BRAZILIAN DNA GENERATING INNOVATIVE BUSINESS OPPORTUNITIES.

B R A S I L

NATIONAL MANAGEMENT COMMITTEE – BRBIOTEC (brbiotec.org.br)

COORDINATION OF BIOTECHNOLOGY POLICY

National Biotechnology Centre (Centro Nacional de Biotecnologia - CNB)http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=2249

Forum on Competition in Biotechnology (Fórum de Competitividade em Biotecnologia)http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=2255

REGULATORY AGENCIES

National Agency of Health Surveillance (Agência Nacional de Vigilância Sanitária - ANVISA)http://www.anvisa.gov.br/

Ministry of Agriculture, Livestock and Food Supply (Ministério da Agricultura, Pecuária e Abastecimento - MAPA)http://www.agricultura.gov.br/

National Technical Biosafety Committe (Comissão Técnica Nacional de Biossegurança - CTNBio)http://www.ctnbio.gov.br/

Genetic Heritage Management Council (Conselho de Gestão do Patrimônio Genético - CGEN)http://www.mma.gov.br/port/cgen/index.cfm

National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa - CONEP)http://www.conselho.saude.gov.br/comissao/conep

Inter-ministerial Group for Intellectual Property (Grupo Interministerial de Propriedade Intelectual - GIPI)http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=1780

National Institute of Industrial Property (Instituto Nacional da Propriedade Industrial - INPI)http://www.inpi.gov.br/

National Institute of Metrology, Standardization and Industrial Quality (Instituto Nacional deMetrologia, Normalização e Qualidade Industrial - INMETRO)http://www.inmetro.gov.br/english/

FINANCING INSTITUTIONS

National Bank for Social and Economic Development (Banco de Desenvolvimento Econômico e Social - BNDES)http://www.bndes.gov.br/english

Financing Institution for Projects and Studies, also known as the Brazilian Innovation Agency (Financiadora de Estudos e Projetos - FINEP)http://www.fi nep.gov.br/

National Council of Scientifi c and Technological Development (Conselho Nacional de Desenvolvimento Científi co e Tecnológico - CNPq)http://www.cnpq.br/english

Coordination for the Enhancement of University Level Personnel (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES)http://www.capes.gov.br/

PUBLIC LABORATORIES

Oswaldo Cruz Foundation (Fundação Oswaldo Cruz - FIOCRUZ)http://www.fi ocruz.br/

Butantan Institute (Instituto Butantan - BUTANTAN)http://www.butantan.gov.br/

Brazilian Agricultural Research Corporation (Empresa Brasileira de Pesquisa Agropecuária - EMBRAPA)http://www.embrapa.br/english

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- CNB)ea=3&menu=22493 49

de em Biotecnologia)rea=3&menu=22553 55

gilância Sanitária - ANVISA)

da Agricultura, Pecuária e Abastecimento - MAPA)

cional de Biossegurança - CTNBio)

o Patrimônio Genético - CGEN)

nal de Ética em Pesquisa - CONEP)

ministerial de Propriedade Intelectual - GIPI)?area=3&menu=17803 7

d de Industrial - INPI)

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POLICIESTHAT ENCOURAGEINNOVATIVEACTIVITIESIN ADVANCEDBIOTECHNOLOGY.All of this activity in Brazil is aimed at establishing an environment of

cooperation between government and industry, while also strengthening the

biotechnology network within the country. One of the measures taken to advance

these goals is Decree No. 6041, passed on February 8, 2007, which implemented

the Biotechnology Development Policy, thereby establishing a sphere of

government coordination, known as the National Biotechnology Committee

(Comitê Nacional de Biotecnologia), and the Biotechnology Forum (Fórum de

Biotecnologia), providing another link to society. Law No. 11.196/2005, known as

the Good Law, was also recently passed, which “establishes tax incentives and

fi nancial subsidies for research” and offers incentives for hiring researchers with

master’s or doctoral degrees, as well as additional incentives for teaching and

research institutions.

According to the federal government, the new policy will allow an investment of

some R$ 10 billion in biotechnology over the next ten years. Out of the total, 60%

of funding will be provided by the federal budget and resources from the National

Bank of Economic and Social Development (Banco Nacional de Desenvolvimento

Econômico e Social - BNDES), as well as from investment funds for research,

science and technology. It is expected that the remaining 40% will be invested by

the private sector.

The development of the biopharmaceutical and food sectors has been further

encouraged by the work of the National Agency of Health Surveillance (Agência

Nacional de Vigilância Sanitária - ANVISA), the National Commission for Ethics

in Research (Comissão Nacional de Ética em Pesquisa - CONEP), the National

Technical Biosafety Committee (Comissão Técnica Nacional de Biossegurança

- CTNBio) and other governmental agencies. The Biosafety Law was passed

fi ve years ago, and it sets in place controls and standards for compliance with

biosafety requirements following the principle of precaution.

In relation to the transfer of technology and the protection of intellectual property

of biotechnology products, the National Institute of Industrial Property (Instituto

Nacional da Propriedade Industrial - INPI) actively participated in creating the

Productive Development Policy for the biotechnology sector, and it has worked

to strengthen the intellectual property system in Brazil, considering all of the

relevant issues within this sector. At the same time, INPI is working to improve

the effi ciency of the patent process, reducing the necessary processing time.

Development in the biotechnology sector has always been

of strategic importance to the country, presenting countless

opportunities for the generation of new businesses and

solutions for the demands made by Brazilian society.

This situation has led to the establishment of BRBIOTEC

BRASIL, a biotechnology business network. Its main goal is

to establish technical and business cooperation, integrating

companies, investors, teaching and research institutions,

science and technology institutes, entrepreneurs, supporting

agencies and government.

There are several challenges that confront the areas of

biotechnology research and innovation. Starting with the

effective cooperation of all those involved resulting in

productive work, breaking through barriers and joining efforts

so that the results may indeed be transformed into products

and services, thereby generating capital for the country and

bringing Brazil onto the world stage as a biotechnology leader.

THE FUTURE OF BRAZILIAN BIOTECHNOLOGY.THE FUTURE OF BRAZILIAN BIOTECHNOLOGY.

• Strengthening micro and small businesses, which are at the

base of the biotechnology production chain in the country.

• Encouraging and promoting cooperation between national and

foreign companies; and among key actors, such as research and

teaching institutions, government institutions, investors, etc.

• Disseminating products and services of network

companies within Brazil and abroad, through participation

in trade fairs and missions.

• Providing technical skills training at various levels to ensure

the excellence of human resources within the sector in Brazil,

and thereby expanding the scope of activities.

• Creating a national observatory of biotechnology in all fi elds

(business and technical) to help guide national policies of

promotion and to encourage development in this area.

• Making relevant legislation available to all organizations involved,

so that Brazilian industry, as well as institutions related to federal

and state governments, may take an appropriate position.

• Informing the general public about partnership among

institutions that already carry out this kind of activity in the country.

• Encouraging scientifi c and commercial agreements

between partners in industry, research institutions

and national and international universities.

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BRAZIL: BIODIVERSITYTHAT BOOSTS INVESTMENT AND RETURNS.

As a result of the minimal impact felt from the 2009 world

economic crisis, Brazil has consolidated a stable economic

standing, which has enabled the country to maintain and, in

some cases, even increase investments in new technologies,

including biotechnology.

Biotechnology companies, most of them small to medium-

sized businesses, are organized around institutions and

associations, in order to increase their representational

capacity vis-à-vis society, government, companies and

universities. Consequentially, since 2007, the Brazilian

government has adopted a national public policy aimed at the

development of biotechnology.

More than R$ 511.4 million (approximately US$ 255 million)

has been invested in programs to support R&D activities,

develop technological and/or investment infrastructure,

through loans made directly to biotechnology companies.

Between 2009 and 2010, some US$ 1.2 billion will be invested.

BIOTECHNOLOGY IN BRAZIL: A DEVELOPING SECTOR.

This sector relies on scientifi c and technical support from

institutions of higher learning as well as public and private

research centers, which actively participate in generating

biotechnology products and services, mainly in the areas of

agriculture, bio-energy, human health, animal health and

the environment.

A study conducted by Global Bio-Economy Consulting LCC

in 2006 ranks Brazil in 5th place worldwide in terms of the

number of employees working in the biotechnology sector.

Financing of activities in the innovation sector illustrates

an equilibrium in national investments in research and

development. Data released by the Ministry of Science and

Technology demonstrates that 53% of investments came from

the public sector and 44% from private enterprise.

Government investment has also been responsible for the skill

of highly qualifi ed labor throughout the country. Presently,

Brazil has some 122 National Science and Technology

Institutes (Institutos Nacionais de Ciência e Tecnologia -

INCTs – www.cnpq.br/programas/inct/_apresentacao), while

some 10,000 doctors graduate annually. These fi gures indicate

that scientifi c production has tripled over the last 30 years in

Brazil, accounting for 2.12% of the total scientifi c production

worldwide in 2008.

The country with the 5th largest mass in the world, Brazil

has a signifi cant competitive advantage with respect to the

development of agricultural and environmental activities.

The country’s potential is vast, ranging from genetic exploration

aimed at agricultural advancements to the use of molecular

markers and applications of genetic engineering in bio-

informatics. With regard to the environment, promising results

include a potential reduction in the use of pesticides, lower

risks of contaminating rivers and underground waters, as well

as potential applications for degraded lands.

In the area of human health, one of the principal Brazilian

milestones has been the development of interdisciplinary

research with opportunities for forming strategic partnerships

between the areas of diagnostics/ therapy and biomolecular

materials. At the current stage of development, the Brazilian

biomedical industry seeks partners for the large-scale

production of biotechnology products. In this area of industry,

the greatest demand is for enzymes and therapeutic proteins

derived from recombining DNA (biosimilar) technology,

resulting from incentives that the pharmaceutical industry has

recently received for the development of new biotechnology

products and for biopharmaceutical production platforms.

In the bioenergy sector, Brazil is one of the most important

producers in the world, and it is a leader in the development

of related technologies and in consistent investments

in RD&I in this sector. Compared to all alternative fuels,

bioethanol is, without a doubt, the most important and the fuel

demonstrating the best commercial potential.

MEDICINE AND HEALTH • Technological development of recombining proteins• Biomaterials using a rapid creation technology for prototypes used to form models• Biomaterials for regeneration, repair and reconstruction of bone tissue• Biomaterials for dermatological and cosmetic use• Reagents for in vitro diagnosis• Reagents for immunochemistry• Immunoassay, fl ow cytometry, autologous quick anti-cancer cell vaccine, human vaccines, diagnosis kits

ANIMAL HEALTH• Animal feed and products for animal health• Biopharmaceutical and biotechnological processes• Vaccines

BIOPHARMACEUTICALS• Technology for the production of human recombining insulin and other therapeutic proteins• Biopharmaceutical and biotechnological processes for human health• Monoclonal antibodies for use in cancer treatment and antibodies for clinical use

BIOENERGY AND BIOFUELS• Technology for the production of enzymes and second-generation ethanol (cellulosic ethanol)• Technology for the production of enzymes to produce biofuels

AGRICULTURAL INDUSTRIES• Biodegradable plastics, such as PHB and PHB-HV, made from sugar cane• Genomics, post-genomics and proteomics• Cloning and heterologous expression of proteins• New technologies aimed at agriculture and livestock• Agricultural biotechnology, improvement of foodstuffs and nutraceuticals• Biological fi xation of nitrogen

THE ENVIRONMENT• Bioremedies;• Use of waste for the production of biomaterials• New platforms for biological pest control• Bioprospection of biodiversity and genetic inheritance• Treatment of water, landfi ll gases, solid waste and industrial residue

FOCUSED ON THE MARKET, BRBIOTEC BRASIL ACTS IN A SEGMENTED MANNER:

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