Bioprospecting

‘‘Adding value to Indigenous Knowledge through Scientific Innovation’

INTERNATIONAL WORKSHOP ON INDIGENOUS KNOWLEDGE

Benoni, South Africa

9-11 February 2005

Marthinus HorakMarthinus HorakBioprospecting ProgrammeBioprospecting Programme

CSIR Bio/CSIR Bio/ChemtekChemtekPretoriaPretoria

THE WORLD BANK

Bioprospecting

• Local knowledge• Unique to every culture or society• Basis for local-level decision making in :

– Agriculture, health care, food preparation, education, natural resource management, etc.

• Provides problem solving strategies for communities

• Community rather than individual knowledge• Tacit knowledge, difficult to codify,

embedded in community practices, etc.

IKS definition (World Bank)

Bioprospecting

• IKS is different, but equal, to ‘Western’ knowledge systems

• IKS may have ancient origins, but is relevant in day-to-day lives of people

• Continues to evolve• Is highly validated in context of

community/local use

IKS – some thoughts

Bioprospecting

• Millenium Development Goals:– Eradicate poverty and hunger, improve

education, gender equality, health issues, environmental sustainability and partnerships for development

• IKS can contribute significantly to development– Must be leveraged with other knowledge

resources– Value addition to IKS through scientific

innovation can create new benefits for society– Requires partnerships

IKS in context of Global Development

Bioprospecting

The search for valuable chemical and genetic constituents of

biodiversity

What is Bioprospecting?

Bioprospecting

Add maximum value to bio-resources and indigenous knowledge through

consortium-based research, thereby creating economic and social benefit

for all stakeholders

Vision for Bioprospecting

Bioprospecting

Bioprospecting strategy

Scientific Innovation

Biodiversity

Indigenous Knowledge

Bioprospecting

• 19 500 indigenous plant species• 8% of all plant species on earth• 60% endemicity• Mainly unexplored as source of natural

medicines– 25% of world’s pharmaceuticals are

derived from plants

S A’s plant biodiversity

Bioprospecting

• 200 000 Traditional Healers in SA• >70% of population regularly consult a

Healer• Possibly 3 000 - 5 000 plants may have

biological activity

Indigenous Knowledge …

Bioprospecting

CSIR signs agreement with Traditional Healers (1999)

Bioprospecting

Bioprospecting

Drug Development Cycle

DiscoveryDevelopment: Phase I, II, III

and regulatory approval

Commercial Sales

Time

Multinational companies

Cum

ulat

ive

Inve

stm

ent

CSIR Bioprospecting

Lead Discovery

Early ProofOf Concept

Bioprospecting

Classic, rational approach to drug discovery

Therapeuticconcept

EfficacyAssay (HTS)

Screencompounds

In vitro models

In vivo Pharmaco-dynamics

Toxicology

NDAsubmission

New druglaunch

PreclinicalDevelopment

compound

patent

analytical

production

Pharmacokinetics

Phase 1Clinical study

Phase 2Clinical study

Phase 3Clinical study

n-th NCE First NCE,iterate

Evolve SARand MC concepts

INDClinical

Developmentcompound

Bioprospecting

Bioprospecting in partnership with Traditional Healers

Therapeuticconcept

EfficacyAssay (HTS)

Screencompounds

In vitro models

In vivo Pharmaco-dynamics

Toxicology

NDAsubmission

New druglaunch

PreclinicalDevelopment

compound

patent

analytical

production

Pharmacokinetics

Phase 1Clinical study

Phase 2Clinical study

Phase 3Clinical study

n-th NCE First NCE,iterate

Evolve SARand MC concepts

INDClinical

Developmentcompound

Bioprospecting

• High-throughput plant collection and extraction

• Data and information management• Nuclear magnetic resonance, mass

spectrometry, high-pressure liquid chromatography, gas chromatography

• Plant biotechnology including tissue culture laboratories

• Clinical Supplies Unit, Botanical Supplies unit

• Good Farming Practice, Good Manufacturing Practice, Good Laboratory Practice

CSIR Bioprospecting facilities

Bioprospecting

• No research group, company, country or region can control full value chain inBioprospecting

• CSIR Consortium consists of:– Traditional Healers– Universities– Research institutes– Communities– Micro-enterprises

Consortium-based research: key component of Bioprospecting

Bioprospecting

CSIR Bioprospecting partners

Bioprospecting

• The needle is hidden in a very big haystack– Nearly 250 000 plant species– 50 years of ‘modern’ research data – Centuries of experiential learning of Traditional

Healers • Data and information security• Communication between representatives of

different knowledge systems• Stimulate scientific innovation• Support quality assurance procedures e.g.

Good Laboratory Practice

Knowledge management challenges in Bioprospecting

Bioprospecting

• Artificial neural networks may be constructed to assist recognition of patterns such as ecosystem-species-biological activity relationships

• Aimed at implementation in southern African region, based on experimental data from South African species

Artificial Intelligence

Bioprospecting

Intellectual Capital

Protection of intellectual assets:what are intellectual assets?

•intangible: learning, experience, capability to innovate•People based

Intellectual Assets

Intellectual Property

•information, technology, Indigenous Knowledge •Product/technologybased

•Unique and highlyvaluable productor technology

Bioprospecting

Intellectual Capital

Creation and protection of intellectual assets

•Involve owners of knowledge as partners in Bioprospecting

Intellectual Assets

Intellectual Property (IP)

•Keep secret•Trademark/brand•Develop into IP

•Patent

Search, record and add value

Innovate

Bioprospecting

• Creation and licensing of patented Intellectual property– Very long development periods– Difficulty typically underestimated– Rewards can be very high

• Production and sale of biodiversity products e.g. self-medication products (not patented)– Regulatory environment is complex– Requires strong brand identity

Commercialization of Bioprospecting products

Bioprospecting

Risk vs. Return in Bioprospecting

Degree of value added

Profitpotential

Low

Low

High

High

Patenteddrug leads

Herbalproducts

Bioprospecting

Anti-obesity agent from Hoodia

Bioprospecting

Hoodia in its natural habitat

Bioprospecting

Hoodia: cultivation site

Bioprospecting

Anti-obesity agent (P57): structure elucidation

Bioprospecting

• Establishment of community-owned businesses, based on agro-processing

• Focus on alternative crops e.g. aromatic and medicinal plants

• Technology transfer and skills development allow value-adding processing

• Communities become partners in commercialization of bioprospecting successes

Community involvement

Bioprospecting

Bioprospecting

Current activities• Signed benefit-sharing agreements with

owners of Indigenous Knowledge (San Council and Traditional Healer Trust)

• Signed bioprospecting agreement with Namibia (2005)

• Collected one-third of SA’ plant biodiversity (>8 000 plant species)

• Investigating more than 400 ethnobotanical leads provided by Traditional Healers

Bioprospecting

IKS-led drug leads under development

• Asthma and allergies• Inflammation• Arthritis• Benign prostatic hyperplasia• HIV• Wound healing• Malaria

Bioprospecting

THE WORLD BANK

Challenges for this IKS Workshop• Establish framework for collaboration:

World Bank, GRA and Traditional Healers• Identify pilot projects aimed at validation

of IK• Develop roadmap for the partnership, aimed

at implementation of IK in support of sustainable development

• Present outcomes at 4th Annual Meeting of GRA Principals and future World Bank Conference

Bioprospecting

THE WORLD BANK

Thank you for your attention