FRAMEWORKS & CHALLENGES ASSOCIATED WITH

BIO-PROSPECTING & TECHNOLOGICAL DEVELOPMENT IN THE

BRAZILIAN AMAZON & SIMILAR REGIONS

Boston, June 18, 2012

Sponsorship & Organization Promotional Support

roundtable

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

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.

AUDIENCE

DISCUSSION HIGHLIGHTS

Opportunites & Challenges By Stakeholder Group

INVESTORS & COLLABORATORS

OPPORTUNITIES CHALLENGES

1. Early access to matchless molecules and compounds in various sectors a. Massive collections of extracts to be screened; b. Natural compounds with biological activity already

identified.

1. Complexity of access a. The extract collections are spread in several storage

areas, which reduces the efficiency of access and scalability;

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 a. Bring technology and funds to create a unique,

centralized and automated storage and research lab in the Amazon region;

b. Boost the screening of extracts through technology transfer and collaborative partnerships;

c. The sprouting bio-industry in Brazil and the untapped R&D potential offer vast opportunity to the establishment of new, innovative enterprises.

2. Investment risks a. Must establish clearer policies and priorities towards

investment in biotechnology innovation; b. Regulations must be harmonized / streamlined in order

to make the country competitive; c. Bureaucracy - lengthy timelines to import research

materials, to obtain patents, registration and licenses for both research and clinical trials, to register products, 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 a. Characterize million compounds and molecules; b. Bring thousands of compounds in early stages of

development to clinical.

1. Legal framework a. Unclear policies to access Brazilian biodiversity; b. Increased risk to investors: massive fines and litigation for

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 a. Benefit from the increased demand of national

corporations for new technologies; b. Capitalize on the current interest of transnational

organizations to build or increase presence in Brazil; c. The larger share of biodiversity assets are in the Brazilian

Amazon region: i. This may confer the region the status of a

potential biotechnology ST&I valley in the globe.

2. Infrastructure & Bureaucracy a. Lengthy timelines to import research materials; b. Complex and lengthy clinical trials approval process; c. Risks to invest due to current policies and bureaucracy

(refer to topic I. Investors & Collaborators); d. Although the Brazilian Amazon region is the core of the

biodiversity in the planet, its characteristics make it a challenging place to develop a biotech cluster.

3. Fuel the establishment of university spinoffs a. New regulatory framework in place to register biological

products and stimulate startup creation.

3. Scarce private / venture capital a. Mechanisms to encourage the creation of new spinoffs

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 a. The developing bio-industry, and the number of

compounds and molecules to be characterized embody vast opportunity to the establishment of new businesses.

1. Infrastructure & Bureaucracy a. Need to further improve the approval process of bio-

based projects; b. Current infrastructure of public agencies do not support

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 organizations and institutions, to combine knowledge, resources and fill technology gaps.

2. Lack of resources for internationalization a. International expertise in early stages:

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.

PRESENTATION

Prof. Dr. Carlos Gustavo Nunes, M.Sc., Ph.D. UFAM, Manaus, AM, Brazil cgustavo@ufam.edu.br | cgustavo@biotechamazonia.com

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

UFAM INPA EMBRAPA FIOCRUZ UEA SUFRAMA HEMOAM PCTIS

UFPA UFRA MEG EMBRAPA PCTG

UFOPA

UFRR EMBRAPA

UFAM

UFAM

UFAM

UFAM PETROBRAS

VALE

UFAM

UFAM

UFAP EMBRAPA

UFMA UEMA

UFTO EMBRAPA

UFMT UEMT

UNIR IPEPATRO FIOCRUZ EMBRAPA

UFAC EMBRAPA

Collections Petro/mining Tech Industry Universities R&D Inst. R&D in Health

A NEW GEOGRAPHY OF SCIENTIFIC COLLABORATIONS

Brazilian Amazon: the yet unknown profile

REALGENE

PROTEAM

REDEBIO Amazonian Genome and Transcriptome network Guarana transciptome

+ 10 other genomes/transcriptome About 120 researchers from

several institutions of all Amazon States

Guarana (Paullinia cupana) Chromobacterium violaceum

Biodiversity, Conservation & Biotechnology network

22 institutions 20 Projects (ongoing)

Doctoral Program with 100 projects (begining)

www.bionorte.org.br

Dermatology & Cosmetic Development

FEDERAL UNIVERSITY OF AMAZONAS UFAM

SCIENCE AND TECHNOLOGY PARK FOR SOCIAL INCLUSION

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

EDUCATION

Management

Environmental protection

Technology

transfer

Innovation

Social inclusion

Government Industry People

PCTIS proposal

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

Rede NIT Amazônia Ocidental

Rede NIT Amazônia

Oriental

FIOCRUZ