talk 06 - biotechnology industry in malaysia, opportunities & challenge - prof. syed mohsin

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    By:Prof Syed Mohsin Sahil

    Jamalullail

    Dekan

    Penyelidikan

    Pelantar Penyelidikan Sains Kesihatan & Bioperubatan,USM

    Biotechnology Industry in Malaysia,Opportunities & Challenge

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    What is biotechnology.?

    Biotechnology

    is technology

    based on biology,

    especially when used in agriculture, food science,and medicine. United Nations Convention onBiological Diversity defines biotechnology as (1)

    Any technological application that uses biological system

    dead organisms, or derivatives thereof, to make or modi products or processes for specific use http://en.wikipedia.org/wiki/Biotechnology

    "The Convention on Biological Diversity

    (Article2. Use of Terms)."United Nations. 1992. Retrieved on February 6, 2008.

    http://en.wikipedia.org/wiki/Biotechnologyhttp://www.biodiv.org/convention/convention.shtmlhttp://www.biodiv.org/convention/convention.shtmlhttp://www.biodiv.org/convention/convention.shtmlhttp://en.wikipedia.org/wiki/United_Nationshttp://en.wikipedia.org/wiki/United_Nationshttp://www.biodiv.org/convention/convention.shtmlhttp://en.wikipedia.org/wiki/Biotechnology
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    Malaysian Planning for Biotechnology

    RM 92006-2010

    RM 8

    2001-2005

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    RM 8 (2001-2005)

    Biotechnology

    is poised to drive the next wave of knowledge-basedindustries that will contribute to growth and wealth creation, newinvestment and employment opportunities as well as deliver social and

    environmental benefits.-Biotechnology was identified as a key technology that could drive and suppor

    the nation to evolve into a knowledge-based economy.

    National Biotechnology Policy (NBP) was launched in 2005, which provided acomprehensive framework to guide biotechnology development efforts inthe country and provided for a more integrated framework of industrydevelopment, outlining a comprehensive set of goals, priorities andstrategies

    Malaysian Biotechnology Corporation was established in 2005 to act as the leaagency in facilitating the development of Malaysias biotechnology industry

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    http://www.biotechcorp.com.my/index.html

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    Human Resource Development

    The Biotechnology R&D Grant Scheme established in 2001 under the

    NationalBiotechnology Directorate approved a total of RM95.3 million for

    47 biotechnology research projects. Of this total, 11 projects were

    classified as ready

    for commercialization. In terms of intellectual capital, these R&D projects

    generated 27 patents filed in Malaysia and one filed internationally.

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    Infrastructure and Facilities (Lab)Malaysian Agricultural Research and Development Institute (MARDI),genomic

    Molecular biology at the Universiti Kebangsaan

    Malaysia (UKM) andPharmaceuticals and Nutraceuticals

    at the Universiti Putra Malaysia (UPM). Theselaboratories provided specialized facilities for the advancement

    of the countrys

    R&D in biotechnology and its applications as well as training ground for R&personnel.

    National Biotechnology and Bioinformatics Network (NBBNet) was set up in 2001.

    was initiated to promote closer collaboration and networking among researchinstitutions, universities and the industry. It also hosted databases and informationon local genetic resources and major R&D activities

    The Biotechnology Standardization and Quality Control Centre (BIOSTAQ) for herbaproducts in Kulim Hi-Tech Park began operations in August 2004. The centreprovided services related to standardization and quality control

    of natural products.

    These services, using advanced technologies, included analysis of microbial an

    heavy metals, gravimetric testing, extractive value analysis as well as toxicity anpurity testing.

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    RM 9 (2006-2010)

    Objective of RM 9

    The objective of biotechnology development during the Ninth Plan

    period will be to harvestits potential as agrowing source of wealth creation

    and enhance applications on

    biotechnology in various sectors of the economy.The target will be to at least double the number of biotechnology and biotechnology-related

    companies to 400 by 2010 . The emphasis will be on nurturing quality, high valueadded and knowledge-intensive companies and creating more job opportunities.

    The biotechnology sector faces a challenging future with increasing global competition. To becompetitive, Malaysian biotechnology companies will need to identify and build uponniche products

    and services in appropriate parts of the global biotechnology value

    chain.The Ninth Plan will focus on implementing the NBP to develop Malaysias niches in

    agriculture biotechnology, healthcare-related biotechnology, industrialbiotechnology and bioinformatics . In this regard, the promotion of foreign anddomestic investments and close collaboration with foreign entities to access newtechnolo , ex ertise and markets will be intensified.

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    The BioNexus

    concept will be employed whereby

    establishment of biotechnology companies or projects will betargeted near relevant research institutions and industrial basesto form synergistic linkages amongst these entities and hence,expedite the growth of clusters.

    Vital to the success of the implementation of the NBP will bethe follow through of plans, effective implementation of

    programs as well as constant monitoring and evaluation of outcomes and impact to society.

    Objective of RM 9.

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    Healthcare BiotechnologyBiotechnology enables the discovery and development of better healthcare products

    and

    treatments. However, given the large investments required to undertake the entire process of discovery to commercialisation, Malaysia mustdevelop niches in strategic areas

    of thevalue chain. In line with this, efforts will be focus on leveraging the countrys extensive biodiversity andlocal knowledge in traditional/complementary medicine (T/CM)to develop leads for the pharmaceutical and nutraceutical

    industries. Other niches that will be

    developed includecontract research and development of biogenerics , diagnostics andvaccines, particularly for high-incidence diseases.

    The National Institute of Pharmaceuticals and Nutraceuticals

    (NIPN) and the National Instituteof Natural Products, Vaccines and Biologicals

    (NINPVB) will be set up as centres

    of R&D

    excellence in the field of healthcare-related biotechnology. The NIPN will focus on the optimal

    utilisation

    of natural bio-resources from plant, marine and microbial origins for use innutraceuticals, cosmeceuticals

    and phytopharmaceuticals. The NINPVB will implement

    programmes

    to promote herbal medicine by harnessing local knowledge in T/CM and toincrease the production of vaccines. In addition, aBioproducts

    Validation Centre

    will also

    be established in Johor to validate herbal, nutraceutical

    and phytopharmaceutical

    productclaims for the purpose of regulatory registration and quality assurance.

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    Industrial Biotechnology

    The countrys strength in manufacturing and processing industries offers a wide range oopportunities for the development of industrial biotechnology. The identified areas ofgrowth include the development of biocatalysts

    such as enzymes for food and feed

    preparations, cleaning products, textile processing and other industrial processes.

    Bioprocessing

    is another growth area which canbe

    applied in the production of biomaterials such asbioplastics, biofuel, specialty chemicals

    such as cosmeticsingredients and electronic chemicals. The third growth area is contractbiomanufacturing .

    As part of the efforts to promote biomanufacturing, a current good manufacturing practice(cGMP) facility, designed in accordance to international guidelines and standards, will bcompleted and be fully operational by June2006. This facility will pave the way for Malaysto become a player in active pharmaceutical ingredient contract manufacturing. The multi-product facility will be used for the production of a full range

    of biopharmaceuticals based

    on mammalian and human cell culture.High crude oil prices coupled with the need to find renewable energy to replace depleting fossi

    fuel has presentedbiofuel

    as viable area of growth. The demand for biodegradable fuelsincluding palm diesel by developed countries is expected to reach 10.5 million tonnes

    by

    2007. Malaysia, with 3.9 million hectares of oil palm plantation

    and more than 360 palm oilmills has the capacity and capability to meet the increasing global demand for biofuel. In linwith the National Biofuel Policy, which was announced in August 2005, various strategie

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    Bioinformatics

    With vast amounts of data and information being generated due to

    advances in myriad of technologies, there arises a need to organise

    and manage information . The

    convergence of ICT and biotechnology, commonly known as bioinformatics, provides animportant support function to gather, store, classify, analyse and distribute biologicalinformation derived from gene sequencing as well as functional analysis of researchprojects. In addition to being a new source of growth, bioinformatics is making a significantcontribution towards discoveries and product development. Strategic initiatives will berolled out for bioinformatics and grid computing to support the countrys biotechnologydevelopment.

    The existing strength and wealth of ICT platforms in research institutions includingMIMOS,universities and the Multimedia Super Corridor (MSC)

    will be optimally utilised

    to accelerate the development of the bioinformatics subsector. Grid computing will beadopted as a means to reduce the cost of investment in R&D through the sharing of facilities. In this regard, the second phase of the Malaysian Research and EducationNetwork (MyREN) will be initiated to enhance connectivity among the various universitiesand research institutions as well as industry and international linkages to increase research

    collaboration efforts.

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    Building a Malaysian BrandConcerted efforts will be undertaken towards making Malaysia a preferred

    destination for investments in biotechnology. The Malaysian BiotechnologyCorporation will focus on attracting investment, sourcing partnership

    opportunities as well as supporting local biotechnology entrepreneurs insetting up their businesses. Towards this end, the brand BioNexus

    will bepromoted to market Malaysia's biotechnology initiative to investors andpotential partners. To strengthen the brand, an attractive package of incentives

    will be offered to domestic and foreign BioNexus-status

    companies.

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    Financial Infrastructure The Opportunities

    Biotechnology projects are confronted with issues such as high risk, long gestation periosubstantial upfront investment and stringent regulatory compliance. In order to transformthe nascent biotechnology industry into a vibrant one, access to

    financing across the entire

    value chain will be a critical factor for success. Towards this end, acomprehensive

    funding structure and financial incentives

    will be put in place to address the gaps infinancing. Increasing emphasis will be placed on R&D and commercialisation, stratetechnology acquisition, business and entrepreneurship development as well as the buildinof the requisite infrastructure. In this regard, the public sector will complement

    private sector financing and investment efforts, with an allocation of RM2.0billion , which include a number of programmes

    to improve access to financing by

    the private sector.

    Funding for R&D in biotechnology will be provided through existing sources as well as nefunds such as the ScienceFund

    and TechnoFund. To support commercialisation of research

    findings, applications for matching grants can be made via the Commercialisation of R&Fund (CRDF) under the Malaysian Technology Development Corporation (MTDC). Tocomplement these sources, a dedicated Biotechnology Commercialisation Fundwith an allocation of RM100million will be set up to provide matching grants toR&D companies or companies conducting in-house R&D.

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    The Investee companies of MTDC

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    Human Capital Development

    The institutions of higher learning will enhance undergraduate and post-graduate courses inorder to expand scientific and specialised skills , especially in the fields of genomics, microbiology, bioprocessing

    as well as in related engineering and business

    fields. The colleges and skills development training centres

    will concentrate on matchingthe demand for technical human resource such as biotechnology research assistants, GMPpersonnel and technicians in biomanufacturing, metrology and quality control.

    To create greater synergy and collaboration between the research institutions ,universities and the industry, measures will be undertaken to create highly dynamic andmotivated R&D personnel. A mechanism to facilitate IP ownership and IP sharing amongvarious stakeholders will be put in place. Avenues will be provided to enable theparticipation of public sector scientists and researchers in private sector biotechnologyprojects and clinical trials. The National Brain Gain Programme will be implemented toenhance domestic technology capacity and capability as well as fill the gaps in skills anexpertise. To address the issue of brain drain and attract overseas talent, theremuneration and reward system will be reviewed and made more attractive andperformance-driven.

    A biotechnology entrepreneur development programme, with an initialallocation of RM50 million,

    will be implemented to develop core competencies in

    business negotiations, technology and financial due diligence, preparation of viable business plans and business management. Efforts will also be directed at disseminatinginformation on business opportunities, sources of funding and incentives for the

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    R&D and Technology Acquisition

    R&D programmes

    will cover a range of research areas including improvement of productivityin agriculture and animal husbandry, medical diagnostics and pharmaceuticals. Increasedresources will be made available to develop domestic R&D capacity and capability in number of research institutions and universities. In downstream commercialisation and

    marketability of potential products, collaboration with the industry will beenhanced through a variety of modalities such as joint-ventures, sharing of high-technology facilities and specialists as well as equity participation.Research scientists and engineers from research institutions and

    universities will be given

    opportunities to participate in and, develop new ventures as well as manage and marketIPs.

    To boost research productivity and shorten the time required to bring products to market,

    the acquisition of platform technologies

    will be given emphasis. In this regard, thestrategic acquisition of biotechnology-related IP and technologies in key areas will badopted to fast-track developments. For this purpose,a special RM100 million fundfor biotechnology acquisition

    will be established. Potential acquisition will undergo

    a stringent process of due diligence and will be licensed to selected companies or researchinstitutions. International collaboration will also be enhanced to facilitatetechnology transfer and expertise as well as improve access to a wider pool of knowledge

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    For the period covering the Ninth Plan, an allocation of RM2.0 billion will beprovided for biotechnology development. Of this total, 45.9 percent willcater for physical infrastructural development while the remaining 54.1perallocated for soft infrastructure development including R&D andcommercialisation as well as business development programmes.

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    T h a n k y o u

    .