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     FRAMEWORKS & CHALLENGES ASSOCIATED WITH
BIO-PROSPECTING & TECHNOLOGICAL DEVELOPMENT IN THE
         BRAZILIAN AMAZON & SIMILAR REGIONS
                            Boston, June 18, 2012


     Sponsorship & Organization                         Promotional Support
OBJECTIVES

 Provide an overview of the genetic & human assets, the
ongoing bio-prospecting and technological development
                 in the Brazilian Amazon


Stimulate cross-pollination of best practices in the Amazon
                 and other similar regions


    Develop a framework to minimize bio-prospecting
                     challenges


    Discuss bio-prospecting as a key strategy towards
technological development and the sustainable growth of
                   the global economy.
AUDIENCE
 About 80 attendees
 Countries represented
   – Brazil, Canada, United States, United Kingdom,
     Sweden, Switzerland
 Companies represented
   – Abbott; AstraZeneca R&D Lund; Bioamber, Inc.;
     Bristol-Myers Squibb; Burrill & Company;
     Debiopharm AS; DuPont; Eli Lilly & Company;
     FIOCRUZ; FKBiotec; GlaxoSmithkline; INCT
     (National Institute of Science & Technology)
     Nanobiotecnologia; Johnson & Johnson; Keller
     and Heckman LLP; Leonardos & Licks
     Advogados; MedStar Cleveland Clinic
     Innovation Alliance; Merck-Serono; Monsanto
     Company; Nanodynamics; Pfizer, Inc.; Sanofi;
     SinoVeda Canada; Synthetic Genomics, Inc.;
     TransLegal, LLC; UBS Financial Services
AUDIENCE
 Institutions represented
    – ABDI - Brazilian Agency for Industrial
      Development; ANPROTEC; Biotechnology Industry
      Organization; BrBIOTEC; BIO-RIO Foundation;
      MPEG - Museu Paraense Emílio Goeldi; National
      Research Council Canada; IP Network of the
      Minas Gerais State; René Rachou Research Center
      - CPqRR – Fiocruz, Minas Gerais; SENAI
      Innovation Institute CETEC-SENAI; State
      Secretariat of Science, Technology & Higher
      Education, Government of Minas Gerais; State
      Secretariat of Science, Technology and
      Innovation, Government of Pará; UFAM -
      Universidade Federal do Amazonas; UFMG -
      Universidade Federal de Minas Gerais; UNB -
      Universidade de Brasília.
Opportunites & Challenges
By Stakeholder Group

DISCUSSION HIGHLIGHTS
INVESTORS & COLLABORATORS
                    OPPORTUNITIES                                                    CHALLENGES
1. Early access to matchless molecules and compounds in      1. Complexity of access
various sectors                                              a. The extract collections are spread in several storage
a. Massive collections of extracts to be screened;                areas, which reduces the efficiency of access and
b. Natural compounds with biological activity already             scalability;
     identified.                                             b. Need to boost the screening / characterization of
                                                                  Amazon molecular wealth and compounds;
                                                             c. Platform fragmentation – a centralized, automated and
                                                                  controlled lab will require large investments.

2. Capitalize on the biotech momentum                        2. Investment risks
a. Bring technology and funds to create a unique,            a. Must establish clearer policies and priorities towards
     centralized and automated storage and research lab in         investment in biotechnology innovation;
     the Amazon region;                                      b. Regulations must be harmonized / streamlined in order
b. Boost the screening of extracts through technology              to make the country competitive;
     transfer and collaborative partnerships;                c. Bureaucracy - lengthy timelines to import research
c. The sprouting bio-industry in Brazil and the untapped           materials, to obtain patents, registration and licenses
     R&D potential offer vast opportunity to the                   for both research and clinical trials, to register products,
     establishment of new, innovative enterprises.                 to access the bio assets;
                                                             d. The establishment of biotechnology university spinoffs
                                                                   is embryonic which makes it challenging to identify
                                                                   those of attractive investment grade.
INSTITUTES OF SCIENCE & TECHNOLOGY
                     OPPORTUNITIES                                                        CHALLENGES
1. Increase R&D activities                                        1. Legal framework
a. Characterize million compounds and molecules;                  a. Unclear policies to access Brazilian biodiversity;
b. Bring thousands of compounds in early stages of                b. Increased risk to investors: massive fines and litigation for
      development to clinical.                                         an unclear regulatory system;
                                                                  c. Patent Office genetic resource patent filing requirements
                                                                       greatly increase risk of investment:
                                                                         i.    Compliance mechanisms should not be in the
                                                                               Patent Office as genetic resource is not yet
                                                                               invention.
                                                                  d. A new regulatory framework is under discussion:
                                                                         i.    Regulations must be harmonized / streamlined in
                                                                               order to attract R&D private investments.
2. Boost R&D partnerships                                         2. Infrastructure & Bureaucracy
a. Benefit from the increased demand of national                  a. Lengthy timelines to import research materials;
     corporations for new technologies;                           b. Complex and lengthy clinical trials approval process;
b. Capitalize on the current interest of transnational            c. Risks to invest due to current policies and bureaucracy
     organizations to build or increase presence in Brazil;             (refer to topic I. Investors & Collaborators);
c. The larger share of biodiversity assets are in the Brazilian   d. Although the Brazilian Amazon region is the core of the
     Amazon region:                                                     biodiversity in the planet, its characteristics make it a
       i.   This may confer the region the status of a                  challenging place to develop a biotech cluster.
            potential biotechnology ST&I valley in the globe.
3. Fuel the establishment of university spinoffs                  3. Scarce private / venture capital
a. New regulatory framework in place to register biological       a. Mechanisms to encourage the creation of new spinoffs
     products and stimulate startup creation.                          need to be further expanded or even created in some
                                                                       states:
                                                                         i.    Boston biotechnology cluster is an example.
STARTUPS
                   OPPORTUNITIES                                                 CHALLENGES
1. Accelerate the growth of startups                      1. Infrastructure & Bureaucracy
a. The developing bio-industry, and the number of         a. Need to further improve the approval process of bio-
     compounds and molecules to be characterized embody         based projects;
     vast opportunity to the establishment of new         b. Current infrastructure of public agencies do not support
     businesses.                                                the growing demand for new projects and start-ups
                                                                approvals;
                                                          c. Not enough auditors and consultants specialized in the
                                                                assessment of bio-based projects:
                                                          d. Dedicated educational programs have been recently
                                                                launched.

2. Partner with tech-based local and international        2. Lack of resources for internationalization
organizations and institutions, to combine knowledge,     a. International expertise in early stages:
resources and fill technology gaps.                              i.     The Triple Helix innovation model locally
                                                                        adopted in some states of Brazil needs to be
                                                                        further stimulated in other regions;
                                                                 ii.    And further stimulated at the international
                                                                        scope.
Prof. Dr. Carlos Gustavo Nunes, M.Sc., Ph.D.
UFAM, Manaus, AM, Brazil
cgustavo@ufam.edu.br | cgustavo@biotechamazonia.com


PRESENTATION
A BRIEF MESSAGE

 Brazil will grant 75,000 scholarships over the next four-year period, five
  times the current number.
    – Goal: to promote the consolidation and expansion of ST&I in Brazil by means of
      international exchange and mobility.


 The strategy aims to:
    – Increase the presence of students, scientists and industry personnel from Brazil in
      international institutions of excellence;
    – Encourage young talents and highly qualified researchers from abroad to work
      with local investigators in joint projects;
    – Induce the internationalization of Brazilian universities and research centers.
Over 55% Brazil’s land
Amazon river holds about
  17% of all fresh water

It pours millions cubic feet
 of water into the Atlantic
      EVERY SECOND
The most extraordinary
  attribute of life is its
       diversity…
The Amazon rain forest
  is the pinnacle of it.
THE BIODIVERSITY IN
              NUMBERS
 Plants
    – 300 different species in one ha.
 Animals
    – ~3,000 different fish species
    – 30% of the birds in the world
    – Most of the small poisonous
      amphibians
    – New insects species being discovered
      every day
 Microorganisms
    – Beyond reasonable assessment
 Unique ecological relationships
    – Physiology
    – Behavior
    – Biochemistry
CONVENTIONAL USE OF TROPICAL FORESTS


–Agriculture
–Pasture
–Extraction
  •Minerals, gas and petroleum
  •Wood
RATIONAL USES OF TROPICAL FORESTS
 Establishment of Research & Innovation Parks
   –   Bio-prospecting /discovery
   –   Bio and nanotechnologies
   –   Bio and environmental engineering
   –   Technology transfer


 Management and sustainability
   –   Forest-based management
   –   Non wood materials
   –   Agro energy
   –   Ecotourism
   –   Social inclusion
A NEW GEOGRAPHY OF SCIENTIFIC COLLABORATIONS
      Brazilian Amazon: the yet unknown profile
                                                                        UFAP
                                                     UFRR
                                                                        EMBRAPA
                           UFAM                      EMBRAPA

                                                                 UFAM    UFOPA


                                                               UFAM
                                                                                                   UFMA
                                   UFAM             UFAM                                           UEMA
                    UFAM                                                               UFPA
                                   PETROBRAS        INPA
                                                                                       UFRA
                                                    EMBRAPA                                    VALE
                                                                                       MEG
                                                    FIOCRUZ
                                            UFAM                                       EMBRAPA
                UFAC                                UEA
                                                                                       PCTG
                EMBRAPA                             SUFRAMA
                                           UNIR     HEMOAM                        UFTO
                                           IPEPATRO PCTIS                         EMBRAPA
                                           FIOCRUZ
                                           EMBRAPA

                                                                      UFMT
                                                                      UEMT




Collections   Petro/mining Tech Industry R&D Inst.                           Universities R&D in Health
PROTEAM
                                          Biodiversity, Conservation &
 Guarana (Paullinia cupana)
                                            Biotechnology network
Chromobacterium violaceum
                                                 22 institutions
                                             20 Projects (ongoing)
                                       Doctoral Program with 100 projects
                                                     (begining)
                                             www.bionorte.org.br
         REALGENE
      Amazonian Genome and
       Transcriptome network                            REDEBIO
       Guarana transciptome
 + 10 other genomes/transcriptome                  Dermatology & Cosmetic
    About 120 researchers from                         Development
  several institutions of all Amazon
                 States
SCIENCE AND TECHNOLOGY PARK
    FOR SOCIAL INCLUSION




FEDERAL UNIVERSITY OF AMAZONAS
            UFAM
PCTIS: A NEW APROACH
     FOR SUSTAINABILITY

 Modern concept:
  Innovation Network
  ~500 researchers in
    networking
  ~100 projects
  – Over 100 partners
     • Government
     • Companies
     • NGOs
  – Traditional communities
    (over 1,000)
BIOTECHNOLOGY IN THE PCTIS
 Biocentro focus
  – Biotechnology development
  – Working on Amazon biodiversity
  – Innovation
  – Sustainability
  – Training of traditional communities,
    researchers, graduates and
    postgraduate
BIOCENTRO: R&D

 New enzymes
 Antibiotics
 Anti-cancer molecules
 Pigments, dyes
 Biocides (pesticides,
  fungicides)
 Diagnosis and tests
 Challenges
   – Million compounds and
     molecules waiting for
     characterization
   – Incipient bio-industry
   – Scarce private / venture
     capital
 Tackling it
   – Develop and attract key
     expertise
   – Accelerate the creation of
     startups
   – Attract bio-industry
   – Encourage private
     investment and partnerships
PCTIS proposal

                                 Management




         Innovation


                       Social inclusion                Technology
                                                       transfer




  Government                   Environmental protection
  Industry
  People



                      EDUCATION
Partnering Institutions
(Technology development, technical, material & financial support, consulting)

                                                               Rede NIT Amazônia
                                                               Oriental


           Rede NIT Amazônia Ocidental




                                         FIOCRUZ

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Roundtable Bioprospecting at Brazilian Amazon, Boston, June18, 2012 - Discussion highlights & presentation

  • 1. roundtable FRAMEWORKS & CHALLENGES ASSOCIATED WITH BIO-PROSPECTING & TECHNOLOGICAL DEVELOPMENT IN THE BRAZILIAN AMAZON & SIMILAR REGIONS Boston, June 18, 2012 Sponsorship & Organization Promotional Support
  • 2. OBJECTIVES Provide an overview of the genetic & human assets, the ongoing bio-prospecting and technological development in the Brazilian Amazon Stimulate cross-pollination of best practices in the Amazon and other similar regions Develop a framework to minimize bio-prospecting challenges Discuss bio-prospecting as a key strategy towards technological development and the sustainable growth of the global economy.
  • 3. AUDIENCE  About 80 attendees  Countries represented – Brazil, Canada, United States, United Kingdom, Sweden, Switzerland  Companies represented – Abbott; AstraZeneca R&D Lund; Bioamber, Inc.; Bristol-Myers Squibb; Burrill & Company; Debiopharm AS; DuPont; Eli Lilly & Company; FIOCRUZ; FKBiotec; GlaxoSmithkline; INCT (National Institute of Science & Technology) Nanobiotecnologia; Johnson & Johnson; Keller and Heckman LLP; Leonardos & Licks Advogados; MedStar Cleveland Clinic Innovation Alliance; Merck-Serono; Monsanto Company; Nanodynamics; Pfizer, Inc.; Sanofi; SinoVeda Canada; Synthetic Genomics, Inc.; TransLegal, LLC; UBS Financial Services
  • 4. AUDIENCE  Institutions represented – ABDI - Brazilian Agency for Industrial Development; ANPROTEC; Biotechnology Industry Organization; BrBIOTEC; BIO-RIO Foundation; MPEG - Museu Paraense Emílio Goeldi; National Research Council Canada; IP Network of the Minas Gerais State; René Rachou Research Center - CPqRR – Fiocruz, Minas Gerais; SENAI Innovation Institute CETEC-SENAI; State Secretariat of Science, Technology & Higher Education, Government of Minas Gerais; State Secretariat of Science, Technology and Innovation, Government of Pará; UFAM - Universidade Federal do Amazonas; UFMG - Universidade Federal de Minas Gerais; UNB - Universidade de Brasília.
  • 5. Opportunites & Challenges By Stakeholder Group DISCUSSION HIGHLIGHTS
  • 6. INVESTORS & COLLABORATORS OPPORTUNITIES CHALLENGES 1. Early access to matchless molecules and compounds in 1. Complexity of access various sectors a. The extract collections are spread in several storage a. Massive collections of extracts to be screened; areas, which reduces the efficiency of access and b. Natural compounds with biological activity already scalability; identified. b. Need to boost the screening / characterization of Amazon molecular wealth and compounds; c. Platform fragmentation – a centralized, automated and controlled lab will require large investments. 2. Capitalize on the biotech momentum 2. Investment risks a. Bring technology and funds to create a unique, a. Must establish clearer policies and priorities towards centralized and automated storage and research lab in investment in biotechnology innovation; the Amazon region; b. Regulations must be harmonized / streamlined in order b. Boost the screening of extracts through technology to make the country competitive; transfer and collaborative partnerships; c. Bureaucracy - lengthy timelines to import research c. The sprouting bio-industry in Brazil and the untapped materials, to obtain patents, registration and licenses R&D potential offer vast opportunity to the for both research and clinical trials, to register products, establishment of new, innovative enterprises. to access the bio assets; d. The establishment of biotechnology university spinoffs is embryonic which makes it challenging to identify those of attractive investment grade.
  • 7. INSTITUTES OF SCIENCE & TECHNOLOGY OPPORTUNITIES CHALLENGES 1. Increase R&D activities 1. Legal framework a. Characterize million compounds and molecules; a. Unclear policies to access Brazilian biodiversity; b. Bring thousands of compounds in early stages of b. Increased risk to investors: massive fines and litigation for development to clinical. an unclear regulatory system; c. Patent Office genetic resource patent filing requirements greatly increase risk of investment: i. Compliance mechanisms should not be in the Patent Office as genetic resource is not yet invention. d. A new regulatory framework is under discussion: i. Regulations must be harmonized / streamlined in order to attract R&D private investments. 2. Boost R&D partnerships 2. Infrastructure & Bureaucracy a. Benefit from the increased demand of national a. Lengthy timelines to import research materials; corporations for new technologies; b. Complex and lengthy clinical trials approval process; b. Capitalize on the current interest of transnational c. Risks to invest due to current policies and bureaucracy organizations to build or increase presence in Brazil; (refer to topic I. Investors & Collaborators); c. The larger share of biodiversity assets are in the Brazilian d. Although the Brazilian Amazon region is the core of the Amazon region: biodiversity in the planet, its characteristics make it a i. This may confer the region the status of a challenging place to develop a biotech cluster. potential biotechnology ST&I valley in the globe. 3. Fuel the establishment of university spinoffs 3. Scarce private / venture capital a. New regulatory framework in place to register biological a. Mechanisms to encourage the creation of new spinoffs products and stimulate startup creation. need to be further expanded or even created in some states: i. Boston biotechnology cluster is an example.
  • 8. STARTUPS OPPORTUNITIES CHALLENGES 1. Accelerate the growth of startups 1. Infrastructure & Bureaucracy a. The developing bio-industry, and the number of a. Need to further improve the approval process of bio- compounds and molecules to be characterized embody based projects; vast opportunity to the establishment of new b. Current infrastructure of public agencies do not support businesses. the growing demand for new projects and start-ups approvals; c. Not enough auditors and consultants specialized in the assessment of bio-based projects: d. Dedicated educational programs have been recently launched. 2. Partner with tech-based local and international 2. Lack of resources for internationalization organizations and institutions, to combine knowledge, a. International expertise in early stages: resources and fill technology gaps. i. The Triple Helix innovation model locally adopted in some states of Brazil needs to be further stimulated in other regions; ii. And further stimulated at the international scope.
  • 9. Prof. Dr. Carlos Gustavo Nunes, M.Sc., Ph.D. UFAM, Manaus, AM, Brazil cgustavo@ufam.edu.br | cgustavo@biotechamazonia.com PRESENTATION
  • 10. A BRIEF MESSAGE  Brazil will grant 75,000 scholarships over the next four-year period, five times the current number. – Goal: to promote the consolidation and expansion of ST&I in Brazil by means of international exchange and mobility.  The strategy aims to: – Increase the presence of students, scientists and industry personnel from Brazil in international institutions of excellence; – Encourage young talents and highly qualified researchers from abroad to work with local investigators in joint projects; – Induce the internationalization of Brazilian universities and research centers.
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  • 15. Amazon river holds about 17% of all fresh water It pours millions cubic feet of water into the Atlantic EVERY SECOND
  • 16. The most extraordinary attribute of life is its diversity… The Amazon rain forest is the pinnacle of it.
  • 17. THE BIODIVERSITY IN NUMBERS  Plants – 300 different species in one ha.  Animals – ~3,000 different fish species – 30% of the birds in the world – Most of the small poisonous amphibians – New insects species being discovered every day  Microorganisms – Beyond reasonable assessment  Unique ecological relationships – Physiology – Behavior – Biochemistry
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  • 19. CONVENTIONAL USE OF TROPICAL FORESTS –Agriculture –Pasture –Extraction •Minerals, gas and petroleum •Wood
  • 20. RATIONAL USES OF TROPICAL FORESTS  Establishment of Research & Innovation Parks – Bio-prospecting /discovery – Bio and nanotechnologies – Bio and environmental engineering – Technology transfer  Management and sustainability – Forest-based management – Non wood materials – Agro energy – Ecotourism – Social inclusion
  • 21. A NEW GEOGRAPHY OF SCIENTIFIC COLLABORATIONS Brazilian Amazon: the yet unknown profile UFAP UFRR EMBRAPA UFAM EMBRAPA UFAM UFOPA UFAM UFMA UFAM UFAM UEMA UFAM UFPA PETROBRAS INPA UFRA EMBRAPA VALE MEG FIOCRUZ UFAM EMBRAPA UFAC UEA PCTG EMBRAPA SUFRAMA UNIR HEMOAM UFTO IPEPATRO PCTIS EMBRAPA FIOCRUZ EMBRAPA UFMT UEMT Collections Petro/mining Tech Industry R&D Inst. Universities R&D in Health
  • 22. PROTEAM Biodiversity, Conservation & Guarana (Paullinia cupana) Biotechnology network Chromobacterium violaceum 22 institutions 20 Projects (ongoing) Doctoral Program with 100 projects (begining) www.bionorte.org.br REALGENE Amazonian Genome and Transcriptome network REDEBIO Guarana transciptome + 10 other genomes/transcriptome Dermatology & Cosmetic About 120 researchers from Development several institutions of all Amazon States
  • 23. SCIENCE AND TECHNOLOGY PARK FOR SOCIAL INCLUSION FEDERAL UNIVERSITY OF AMAZONAS UFAM
  • 24. PCTIS: A NEW APROACH FOR SUSTAINABILITY  Modern concept: Innovation Network ~500 researchers in networking ~100 projects – Over 100 partners • Government • Companies • NGOs – Traditional communities (over 1,000)
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  • 26. BIOTECHNOLOGY IN THE PCTIS  Biocentro focus – Biotechnology development – Working on Amazon biodiversity – Innovation – Sustainability – Training of traditional communities, researchers, graduates and postgraduate
  • 27. BIOCENTRO: R&D  New enzymes  Antibiotics  Anti-cancer molecules  Pigments, dyes  Biocides (pesticides, fungicides)  Diagnosis and tests
  • 28.  Challenges – Million compounds and molecules waiting for characterization – Incipient bio-industry – Scarce private / venture capital  Tackling it – Develop and attract key expertise – Accelerate the creation of startups – Attract bio-industry – Encourage private investment and partnerships
  • 29. PCTIS proposal Management Innovation Social inclusion Technology transfer Government Environmental protection Industry People EDUCATION
  • 30. Partnering Institutions (Technology development, technical, material & financial support, consulting) Rede NIT Amazônia Oriental Rede NIT Amazônia Ocidental FIOCRUZ