Korean Initiatives on Biotechnology: Challenges and Opportunities Expert Group Meeting, BINASIA...

Korean Initiatives on Biotechnology:

Challenges and Opportunities

Korean Initiatives on Biotechnology:

Challenges and OpportunitiesExpert Group Meeting, BINASIA

29-30 April, 2004

Bangkok, Thailand

Sang Ki Rhee, Ph.D. Project Coordinator, BINASIA

Korea Research Institute of Bioscience and Biotechnology

Biotechnology in Korea 2

Biotechnology Calendar Biotechnology Calendar

• In the 1980s : Implementing stageIn the 1980s : Implementing stage• 1982 Korea Biotechnology Research Association was founded.• 1983 Biotechnology Promotion Law was enacted. • 1985 KRIBB was founded.

• In the 1990s : Take-off stageIn the 1990s : Take-off stage• 1991 Bioindustry Association of Korea was founded.• 1992 HAN Project was launched.• 1994 Biotech 2000 Program (Phase I) was initiated. • 1994 “The Year of Biotechnology” was declared.• 1998 Biotech 2000 Program (Phase II) was launched

• In the 2000s : Leaping-up stageIn the 2000s : Leaping-up stage• 2000 Frontier Research Program was launched.• 2001 “The Year of Biotechnology” was

designated• 2002 Biotech 2000 Program (Phase III) was launched.


National Initiatives (I)National Initiatives (I)

• Korea recognized in early 1980s that biotechnology would emerge as a key discipline for the nation’s economic growth in the 21st century.

• Its policy makers support biotechnology with the highest priority for R&D investment in order to level up the nation’s competitiveness.

• The Korean government recently unveiled a major initiative to boost scientific R&D focusing on biotechnology.

• National technology road map (NTRM) for biotechnology was set up in 2002

• BackgroundBackground


National Initiatives (II)National Initiatives (II)

• Implementation

• The government’s investment on biotechnology has increased dramatically since 2000. (growth rate: 19.8% in 2003)

• The ratio between biotechnology and total R&D expenditure by the government has been increasing.

- Biotechnology: 3.5% (’94) → 8% (‘01) → 10% (’03) - Average growth rate (’98-’01): biotechnology 46%, total R&D 19.4%

• The implementing policy: “Selection and focus”

• The policy has changed from unit projects in small scale for application and development to long term large scale projects for platform and research since 2000.


Biotech 2000 : Overview Biotech 2000 : Overview • Set up by the Korean government

• Objective: to place Korea’s biotechnological capability at the world’s top level.

• Duration: 1994 2007 (14 years)∼

• Investment: Total US$14.3 bil.(Public US$5.5bil./Private US$8.8bil.) - Phase I (’94-’97): US$1.5 bil.(Public US$ 482mil./Private US$ 1.0bil.)

- Phase II (‘98-’01): US$2.3 bil.(Public US$ 720mil./Private US$ 1.6bil) - Phase III (‘02-’07): US$10.5 bil.(Public US$ 4.3bil/Private US$ 6.2bil)• Participating Agencies (7 Ministries, coordinated by MOST) - Ministry of Science and Technology (MOST) - Ministry of Commerce, Industry and Energy (MOCIE) - Ministry of Education and HRD (MOEHRD) - Ministry of Environment (MOE) - Ministry of Agriculture and Forestry (MOAF) - Ministry of Health and Welfare (MOHW) - Ministry of Marine Affairs and Fisheries (MOMAF)


National Committee for Biotechnology & Bioindustry

Biotech 2000 : Operating Structure (I)

Biotech 2000 : Operating Structure (I)

Industrial Applications

MOAF MOHW MOE MOMAF

Agro-Biotech

MedicalBiotech

Environ.Biotech

MarineBiotech

MOEHRD

• HRD• Creative Basic Research

R&D SupportR&D Support

MOST

• National Programs• Infrastructure• TRM

MOCIE

• Industrial Platform Technol.• Commercialization

IndustrializationSupport

IndustrializationSupport


Biotech 2000 : Operating Structure (II)

Biotech 2000 : Operating Structure (II)

National Committee for BiotecNational Committee for Biotechnology & Bioindustryhnology & Bioindustry

National Committee for BiotecNational Committee for Biotechnology & Bioindustryhnology & Bioindustry

Korea Biotechnology Research Association

Bioindustry Association of Korea

Korea Bioventure Association

Private Companies

Korea Biotechnology Research Association

Bioindustry Association of Korea

Korea Bioventure Association

Private Companies


Other governmental or public research institutions


Other governmental or public research institutions

Universities

Research Centers (SRC, ERC, RRC, MRC)

National Research Laboratories

Universities

Research Centers (SRC, ERC, RRC, MRC)

National Research Laboratories

MOST, MOCIE, MOEHRD, MOHW, MOE, MOAF, MOMAF

IndustryIndustry IndustryIndustry AcademiaAcademiaAcademiaAcademiaResearch Institutions Research Institutions Research Institutions Research Institutions


Biotech 2000 : Strategic Objectives

Biotech 2000 : Strategic Objectives

To increase the commercializing capability and expand the nation’s world market share of domestic bioproducts to 5 %

To develop platform technology and improve industrial R&D capability

To establish a scientific foundation for the development of novel biotechnology

III(2002~2007)

II(1998~2001)

I(1994~1997)

ObjectivePhase


• The government spent U$ 482 million for R&D during the Phase I, and U$ 720 million during the Phase II.

Biotech 2000 : InvestmentBiotech 2000 : Investment

(Unit : U$ mil.)

(Unit : U$ mil.) Agency Phase I(‘94-’97)

Phase II(‘98-’01)

TotalPhase III (2002-2007)

2002 2003 2004 2005 2006 2007 SubTotal

MOST 269 317 172 207 269 340 408 496 1,892 2,478MOEHRD 25 32 35 43 57 71 86 104 396 453

MOAF 90 135 48 60 79 99 119 145 550 775MOCIE 21 141 53 71 93 117 141 171 646 808

MOHW 56 5147 69 89 112 135 164 620 723MOE 11 36 10 12 16 20 24 30 112 159

MOMAF 10 8 9 12 12 16 19 23 87 109Total 482 720 377 471 615 775 932 1,133 4,303 5,505

• In the Phase III, the total investment is expected to increase substantially to U$ 4,303 million.


Ministry of Science and Technology (I)

Ministry of Science and Technology (I)

Role Supports for R&D activities from basic science to application Supports for R&D activities from basic science to application

Major Programs

G-7 Project (HAN Project) 21C Frontier Science Program

G-7 Project (HAN Project) 21C Frontier Science Program

• G-7 Project Duration: 1992-2001, Total Budget: U$ 193 million Main Area: Screening of lead compounds and commercialization

• G-7 Project Duration: 1992-2001, Total Budget: U$ 193 million Main Area: Screening of lead compounds and commercialization

• 21C Frontier Science Program Supports core science and emerging technologies for 21st century Duration: 2000-2010, Total Budget: U$ 3.6 billion Main Areas: - Functional analysis of human, microbial and crop genomes - Biodiversity of indigenous plants - Stem cell biology and therapeutic applications - Proteomics research - High throughput screening of novel compounds for bioregulators using structural biology and pharmacogenomics

• 21C Frontier Science Program Supports core science and emerging technologies for 21st century Duration: 2000-2010, Total Budget: U$ 3.6 billion Main Areas: - Functional analysis of human, microbial and crop genomes - Biodiversity of indigenous plants - Stem cell biology and therapeutic applications - Proteomics research - High throughput screening of novel compounds for bioregulators using structural biology and pharmacogenomics


Ministry of Science and Technology (II)

Ministry of Science and Technology (II)

Role Supports for R&D activities ranging basic science to application Supports for R&D activities ranging basic science to application

Major Programs

National R&D Program Basic Life Science Promotion Program

National R&D Program Basic Life Science Promotion Program

• National R&D Programs Duration: 2003-2012, Total Budget: U$ 600 million Main Areas: - BioDiscovery Program (Screening and development of new drugs ) - BioChallenge Program (Preclinical studies and commercialization of biodrug

s) - BioFusion Program (Integrated technology with IT and NT) - BioInfra Program (National Genome Information Center)

• National R&D Programs Duration: 2003-2012, Total Budget: U$ 600 million Main Areas: - BioDiscovery Program (Screening and development of new drugs ) - BioChallenge Program (Preclinical studies and commercialization of biodrug

s) - BioFusion Program (Integrated technology with IT and NT) - BioInfra Program (National Genome Information Center)

• Basic Life Science Promotion Program Supports for basic life science programs Duration: 1978- Main Area: SRC, ERC, RRC, MRC

• Basic Life Science Promotion Program Supports for basic life science programs Duration: 1978- Main Area: SRC, ERC, RRC, MRC


Ministry of Commerce, Industry and Energy

Ministry of Commerce, Industry and Energy

Role Builds infrastructure for industrialization and commercialization Builds infrastructure for industrialization and commercialization

Major Programs

Industrial Platform Technology Development Industrial Platform Technology Development

• Industrial Platform Technology Development

Develops common platform technology, mid-term core technology and technology for next generation

Duration: 1992~ , Total Budget: U$ 808 million Main Areas:

- Development of processes for bioenergy production- Development of biosensors, BIOMEMS, Biomimics-Development of DNA microarrays and protein chips (Lab-on-a-chip)-Cell culture technology for therapeutic proteins- Infrastructure (GMP, Bioclusters)

• Industrial Platform Technology Development

Develops common platform technology, mid-term core technology and technology for next generation

Duration: 1992~ , Total Budget: U$ 808 million Main Areas:

- Development of processes for bioenergy production- Development of biosensors, BIOMEMS, Biomimics-Development of DNA microarrays and protein chips (Lab-on-a-chip)-Cell culture technology for therapeutic proteins- Infrastructure (GMP, Bioclusters)


Ministry of Education and Human Resources Development

Ministry of Education and Human Resources Development

Role Supports for the development of HR in biotechnology Supports for the development of HR in biotechnology

Major Programs Brain Korea 21 Program Brain Korea 21 Program

• Brain Korea 21 Program

Duration: 1999-2005, Total Budget: U$ 150 million

Major Areas:

- Human resources development in higher learning and industrial skills

- Reform of higher education programs

- Upgrade of graduate research infrastructure in biotechnology

• Brain Korea 21 Program


Major Areas:

- Human resources development in higher learning and industrial skills

- Reform of higher education programs

- Upgrade of graduate research infrastructure in biotechnology


Ministry of Health and Welfare

Ministry of Health and Welfare

Role Supports for the development of biotechnology in public health and medical sectors

Supports for the development of biotechnology in public health and medical sectors

Major Programs

Medical Biotechnology and Biopharmaceuticals Medical Biotechnology and Biopharmaceuticals

• Medical Biotechnology and Biopharmaceuticals

Duration: 1997-2010, Total Budget: U$ 900 million Major Areas: - Prevention, diagnosis, and treatments of diseases to improve public health - Development of new drugs - Development of vaccines, anti-aging and anti-cancer new drugs - Analysis of Korean genome types - Neurobiology and brain research (Braintech 21) - Gene therapy

• Medical Biotechnology and Biopharmaceuticals

Duration: 1997-2010, Total Budget: U$ 900 million Major Areas: - Prevention, diagnosis, and treatments of diseases to improve public health - Development of new drugs - Development of vaccines, anti-aging and anti-cancer new drugs - Analysis of Korean genome types - Neurobiology and brain research (Braintech 21) - Gene therapy


Ministry of Agriculture and Forestry

Ministry of Agriculture and Forestry

Role Supports for R&D in agrobiotechnology and horticulture Supports for R&D in agrobiotechnology and horticulture

Major Programs BioGreen 21 Program BioGreen 21 Program

• BioGreen 21 Program

Duration: 1994-2011, Total Budget: U$ 1 billion Major Areas:

- Collection, assessment, preservation of genetic resources of biodiversity

- Development of breeding technology for transgenic animals and plants

- Research on animal and plant genomics

- Biosafety issues on GMOs

- Biodiversity and Bioprospecting

• BioGreen 21 Program

Duration: 1994-2011, Total Budget: U$ 1 billion Major Areas:

- Collection, assessment, preservation of genetic resources of biodiversity

- Development of breeding technology for transgenic animals and plants

- Research on animal and plant genomics

- Biosafety issues on GMOs

- Biodiversity and Bioprospecting


Ministry of EnvironmentMinistry of Environment

Role Supports for R&D in environmental biotechnology Supports for R&D in environmental biotechnology

Major Programs Environmental Biotechnology Promotion ProgramEnvironmental Biotechnology Promotion Program

• Environmental Biotechnology Promotion Program


Major Areas:

- Screening and isolation of environmental microbes

- Bioremediation

- Development of biosensors for monitoring of environmental pollutants

- Conservation of natural environment and sustainable development

• Environmental Biotechnology Promotion Program


Major Areas:

- Screening and isolation of environmental microbes

- Bioremediation

- Development of biosensors for monitoring of environmental pollutants

- Conservation of natural environment and sustainable development


Ministry of Marine Affairs and Fisheries

Ministry of Marine Affairs and Fisheries

Role Supports for R&D in marine biotechnology and aquacultureSupports for R&D in marine biotechnology and aquaculture

Major Programs

Marine Biotechnology and Aquaculture Technology Promotion ProgramsMarine Biotechnology and Aquaculture Technology Promotion Programs

• Marine Biotechnology and Aquaculture Technology Promotion Programs

Duration: 1999-2010, Total Budget: U$ 100 million Major Areas: - Bioprospecting from marine bioresources - Search and utilization of polar biodiversity - Development of transgenic fishes - Development of new aquaculture technology - Screening of marine GMOs

• Marine Biotechnology and Aquaculture Technology Promotion Programs

Duration: 1999-2010, Total Budget: U$ 100 million Major Areas: - Bioprospecting from marine bioresources - Search and utilization of polar biodiversity - Development of transgenic fishes - Development of new aquaculture technology - Screening of marine GMOs


BioindustryBioindustry• Domestic biotechnology market

• Types of business

Description 1995 1997 1999 2001

Total 200 330 530 1,000

TypePharma-

ceuticalsFood Chemicals Agriculture

Process

EngineeringEnvironment

% 58 12 9 8 7 6

Description Korea USA Japan EU

Market Size (U$ mil.)

900 22,300 7,200 6,000

Growth Rate (%)

30 22 20 20

• Korea vs. World (as of 2000)

(Unit: US mil.)


Investment in BioindustryInvestment in Bioindustry

• Total R&D spending in bioindustry (Unit : U$

mil.)

• Investment plans

Description 2000 2001 2002 2003 2004

Total 447 478 525 584 676

- CJ: U$ 1.4 bil. for R&D for 5 years (2001-2005)

- Samsung Fine Chemicals: U$ 300 mil. for R&D for 3 years (2001-2003)

- LGCI: U$ 50 mil. invested to bioventures in 2000 - SK Global: U$ 35 mil. invested to bioventures in 2000 - Hanwha Chemical Co.: U$ 50 mil. for R&D in 2000 - Hansol: U$ 150 mil. for R&D from 2000 to 2006 - Isu Chemical : U$ 150 mil. for R&D in the period of 2000 -2005


BioventuresBioventures

• Government’s initiative to boost bioventure businessGovernment’s initiative to boost bioventure business

• Current status and prospects of bioventures in KoreaCurrent status and prospects of bioventures in Korea

Description 2001 2004 2007

No. of start-ups 500 700 1,000

No. of employees 6,500 15,000 45,000

Market Size (U$ bil.) 1.0 2.1 5.8

- MOCIE pushes a 5-year program to encourage the bioventure business. It earmarked a U$ 30 mil. fund in FY 2000's budget to develop the infrastructure needed by bioventure start-ups.

- Focusing on commercialization of biotechnology, the Korean government announced a package that envisages to create 600 bioventures by 2003 and to expand the number to 1,000 by 2007.


• Amino acids : 20 % share of world market in 2000 (U$ 75 million)

Facts and Status : the Success Story

Facts and Status : the Success Story

• Ryfamycin : 10% share of world market in 2000 (U$ 7.5 million)

• Hepatitis B Vaccine : Developed in 1987 by Korea Green Cross Corp. World market share was rapidly increased (40% in 1999)

• Recombinant human growth hormone : Developed by LG Chemical Ltd. Technology transferred to SmithKline Beecham of U.K. in 1990.

• First domestic new drug, Sunpla, for anticancer: Developed in 1997 by SK Chemicals and approved by KFDA. Technology transferred to Johnson & Johnson Co.

• First global new drug, Factive, for anti-infectious diseases : Developed by LGCI and approved by FDA in 2003.

• About 300 new drugs are under development. Among them, 23 new drugs are in progress or in completion of clinical trials for FDA approval.


Manpower in BiotechnologyManpower in Biotechnology

• By degreesDescription 1994 1996 1998 2000

Total Number 7,595 8,230 8,485 9,392

Ph. D. (%) 43.7 44.7 46.3 47.1

M. S. (%) 35.4 38.0 37.4 36.5

B. S. (%) 20.9 17.3 16.3 16.4

Description 1994 1996 1998 2000

Total Number 7,595 8,230 8,485 9,392

Universities (%) 50.4 52.3 54.0 55.4

Private Companies (%) 28.7 27.8 27.1 25.0

Government Research Institutions (%) 20.9 19.9 18.9 19.6

• By distribution


Patents & PublicationsPatents & Publications• Publications in SCI journals ( in genomics and proteomicPublications in SCI journals ( in genomics and proteomic

s)s) Description 1994 1998 1999 2000

Korea 21 135 157 185

USA 2,871 4,004 4,318 4,500

Japan 643 1,147 1,238 1,236

Korea/USA (%) 0.7 3.4 3.6 4.1

Korea/Japan (%) 3.3 11.8 12.7 15.0

• US patents registeredUS patents registeredDescription 1991-1995 1996-2001

Korea 20 83

USA 2,993 10,480

Japan 741 1,153

Korea/USA (%) 0.7 0.8

Korea/Japan (%) 2.7 7.2


• BackgroundBiosafety IssuesBiosafety Issues

• Governmental agencies in chargeGovernmental agencies in chargeAgency Role / ActivitiesMOFAT Focal point

MOSTPreparation of regulatory guidelines to oversee recombinant DNA plants

MOHW Providing guidelines for recombinant DNA experimental research

MOEProposed to the National Assembly to enact a law regulating research with an environmental impact and industrial applications

MOCIEPreparing a draft law to supervise the National Assembly with biosafety management and the import and export of LMOs for enactment

- In 2000, more than 130 countries including Korea reached an agreement to adopt the Biosafety Protocol which applies to the transboundary movement, transit, handling and use of all LMOs.

- The Korean government set up an interministrial committee to assess the safety of LMO products in 2000.

- The Act for trans-boundary movement of LMOs was enacted in 2001.


International CooperationInternational Cooperation

Description

All Areas Biotech. Areas

No. of Projects

Spending (A) (U$ mil.)

No. of Projects

Spending(B)

(U$ mil.)Percentage

(B/A)

MOST 133 6.9 34 1.5 21.5

KOSEF 187 2.4 52 0.7 27.8

MOCIE 52 5.2 3 0.4 5.8

RDA 21 0.4 9 0.2 50. 0

• International joint research projects in 2000International joint research projects in 2000

* RDA: Rural Development Administration

• Overseas Cooperation Programs & joint research centers Overseas Cooperation Programs & joint research centers - Joint Research Center at the Fred Hutchinson Cancer Research Center, USA - Korea-UK Bioindustry Collaboration Program (HGMPRC, Bio-Nano IRC) - Korea-France S&T Focal Points Program (focal point in biotech area) - Korea-China Bioscience and Biotechnology Cooperation Center (Shanghai Institutes

for Biological Sciences, CAS) - Korea-Israel Biotechnology Collaboration Program (Weizmann Ins. of Science) - Bioventure Incubating Centers (Germany, USA)


• Strengths

Challenges and Opportunities : SWOT Analysis (I)

Challenges and Opportunities : SWOT Analysis (I)

• Weaknesses

- Strong drive policy by the government - Good R&D infrastructure in industry, universities and research institu

tes - Booming bioventure business - Skilled manpower - Strong knowledge and industry bases

- Shortage of innovative R&Ds for platform technology - Comparatively insufficient R&D expenditure - Weak link between industry and academia - Small domestic market and limited marketing power for global sales - Poor biodiversity and bioresources


• Opportunities

Challenges and Opportunities : SWOT Analysis (II)

Challenges and Opportunities : SWOT Analysis (II)

• Threats

- Paradigm shift in biotechnology for post genomic era

- Top priority in national R&D projects

- Increase of public awareness in health and welfare

- Emerging new technology innovation

- Growing competition worldwide

- Depression of local investment atmosphere

- Regulatory issues: biosafety and bioethics


CompetitivenessCompetitiveness

Description Technology Competitiveness(% of Top Level)

Basic Technology

• Genetic Engineering/Genomics• Protein Engineering/Proteomics• Cell Engineering/Immunology• Transgenic Animals/Plants

80/50

70/50

80/60

85/70

New Drug Development

• Screening• Structure Analysis• Efficacy/Valuation• Biosafety Evaluation

70

50

30

30

Process Development

• Fermentation/Process• Cell Culture Technology• Bioreactor Design• Separation/Purification

90/80

75

40

65

Overall (%) 60-70

(as of 2002)


Vision 2010Vision 2010

–현재–현재

종 합 13th in the world

2000

Competitiveness –선진–선진 –7–7–개국–개국

2010

G-7 level

5% of total governmental

R&D spending종 합R&D Spending

종 합R&D Capability (% of top level)

-Basic: 70%-NDD: 50%-Process: 70%

종 합MarketSize: - World: U$ 54 bil. - Korea: U$ 0.9 bil.

Share: 1.7 % of world market

20% of total governmental R&D spending

-Basic: 90%-NDD: 90%-Process: 90%

Size: - World: U$150 bil. - Korea: U$ 10 bil.

Share: 6.6% of world market


SummarySummary

• Biotechnology is a key platform to accelerate the national economic growth in Korea.

• Korea has set up a solid strategy to achieve international competitiveness by leveraging existing capabilities and creating new strengths.

- “selection and focus” on the areas with high international

competitiveness

- implementation of inter-ministerial coordination for biotechnology

development

- promotion of international cooperation and strategic alliances


Thank you !Thank you !


What should be put in BINASIA?

What should be put in BINASIA?

• Science and Technology Related Data National Science and Technology Policies

National Policies on Biotechnology

Biotechnology R&D Activities

Status of Biological Diversity

Biosafety Protocol

Manpower Training Centers / Programs

International Cooperation in Biotech Area

Bilateral Cooperation with Member Countries and beyond

Biotechnology Infrastructure

National Budget for the Promotion of Biotechnology


• Key Factors

- Part A: Basic Data – Land Area, Population, GNP

- Part B: R&D – National R&D Expenditures in Total, National R&D Expenditures in Biotech

- Part C: Human Resources – Number of Scientists in Biotech Area in Total, Number of Scientists in Biotech Area by Sector

- Part D: Biotechnology Development and Diffusion – Bioindustry Market (in Total and by Sector), International Trade in Bioproducts, Number of Biotechnology Companies (Venture, Established), Number of Patents(in Total, by Field), Number of Publications (Domestic and Overseas), etc.

- Part E: International Cooperation – Number of Bilateral & Multinational Agreements (MOU), Number of International Cooperation Centers, Number of International Joint Research Projects

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