January 2009

VOL. 1 ISSUE 4

BIO OUTSOURCING ASIA

Biopharmaceutical Outsourcing Opportunities and Challenges

Business in
Making strides in the
biotechnology sector

A Supportive National
Biotechnology Policy

BioNexus
Applying for BioNexus
Status in Malaysia
 Bio Outsourcing Asia©
MALAYSIA
TABLE OF CONTENTS
January 2009 Page 4
Malaysia: Emerging Biotechnology Hub
Vol. 1 Issue 4
© CanBiotech Inc. Page 10
Crafting a National Biotechnology Policy

Page 13
The BioNexus Network

Page 15
BioNexus Companies in Malaysia

Page 18
A Malaysian Entrepreneur Development Framework

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Malaysia: Emerging
Biotechnology Hub
Biotechnology has been identified as a key driver
of growth for Malaysia. The country hopes to es-
tablish itself as a knowledge economy by the year
2020. Consequently, biotechnology is seen as aug-
menting Malaysia’s current sectors such as planta-
tions and manufacturing, as well as seen as ad-
vancing new sectors such as traditional medicines
and agriculture. (www.binasia.net)
Malaysia—one of 12 countries in the world en-
dowed with rich diversity, appears to have all of
the key elements for a successful biotechnology
industry including a supportive government. The
Government has identified biotechnology as the
next engine of economic growth for the country.
Consequently, biotechnology has received strong
governmental support—with a commitment for
research and development (R&D).
(www.binasia.net)
The biotechnology industry is expected to gener-
ate RM270 billion in revenue for the country by
2020. The sector’s contribution is expected to be
approximately 2.5 % by 2010, 4.0% by 2015 and
5.0% by 2020. It is further estimated that the sec-
tor will have created 280,000 new jobs by 2020
with 100 biotechnology companies established in
Malaysia over the next 15 years.
(www.bioasianetpacific.com)
National Biotechnology Policy
As in the case for other Asian countries, govern-
ment policy has served as the primary driver for
the development of biotechnology industry. Start-
ing in the mid-1990s, the Malaysian government
launched a series of biotechnology initiatives,
known as the National Biotechnology Policy, to
strengthen the scientific infrastructure, promote
commercialization, and provide investment capi-
tal. The lead government agency for biotechnol-
ogy is the Ministry of Science, Technology, and
Environment (MOSTE), which established the
National Biotechnology Directorate (Biotek).
(Yuan, 2007) Biotek has organized biotechnology
R&D into seven sectors: molecular biology, plant,
animal, medical, biopharmacy, food, and environ-
mental. (Yuan, 2007)
Similarly, the Malaysian Biotechnology Corpora-
tion (MBC; BiotechCorp) is the lead agency for
developing the biotechnology industry. Biotech-
Corp is an agency under the purview of Ministry
of Science, Technology and Innovation and is
wholly-owned by the Ministry of Finance Incorpo-
rated. BiotechCorp is governed by the Biotechnol-
ogy Implementation Council and advised by the
Biotechnology International Advisory Panel, both
chaired by the honourable Prime Minister of Ma-
laysia, YAB Dato’ Seri Abdullah Bin Haji Ahmad
Badawi. (www.biotechcorp.com.my)
BiotechCorp acts as a central contact point pro-
viding support, facilitation and advisory services
for life sciences companies, in Malaysia. To date,
BiotechCorp has facilitated the development of 71
BioNexus-status companies in Malaysia, with total
approved investment of US$400 million (RM1.3
billion). (www.biotechcorp.com.my)
R&D Capacity
The Malaysian government also has three major
initiatives to increase R&D capacity, develop bio-
technology based human capital, and stimulate ties, MTDC has evolved to become a venture
commercialization. The Malaysia-MIT Biotechnol- capital outfit and has been the leading venture
ogy Partnership Program for example is a research capitalist in the country long before the concept
collaboration—bringing together 200 researchers became familiar and accepted in Malaysia.
in Malaysian institutes and 27 researchers at MIT. (www.biotechcorp.com.my)
The research collaboration is a five-year plan that
focuses on medicinal plants and palm oil R&D. The Malaysian Life Sciences Capital Fund
(Yuan, 2007) (MLSCF) was founded in late 2006 and is a life
sciences venture fund specializing in early stage
Another initiative is a $6.7 million program estab- investments in the areas of agriculture, industrial,
lished at the California Institute for Quantitative and healthcare biotechnology. Co-managed by
Biomedical Research (QB3), which is a consor- Malaysian Technology Development Corporation
tium of the University of California San Francisco Sdn Bhd (MTDC) and Burrill & Co., the fund has
(UCSF), UC Berkeley, UC Santa Cruz, and biotech USD140-150 million in committed capital.
companies. (Yuan, 2007) (www.biotechcorp.com.my)
The program includes visits by Malaysian scientists Malaysia Debt Ventures Berhad (MDV) was
and administrators for the purposes of being train- incorporated in 2002 and is a wholly owned sub-
ing in advanced skills and also for participation in sidiary of the Minister of Finance, Inc. MDV has
UCSF’s Center for Bioentrepreneurship. The ini- been entrusted to manage funds of RM2.5 billion
tiative further provides opportunities for students for the financing of projects in several industry
to conduct their Ph.D. thesis work or postdoctoral sectors including biotechnology. MDV provides
research in California. (Yuan, 2007) financing amounts up to RM120million.
(www.biotechcorp.com.my)
The third initiative, The Malaysian Life Science
Capital Fund, expects to raise $200 million and The SME Bank—or Bank Perusahaan Kecil &
will be jointly managed by Malaysian Technology Sederhana Malaysia Berhad—evolved into a devel-
Development and Burrill & Co. The plans are to opment financial institution in 2005 to meet the
use $140 million for investment into some 20 unique needs of small and medium enterprises
companies with an average outlay of $7 million. (SMEs). As a one-stop financial centre responding
The balance of the funds will be invested in the to the funding and business growth needs of
Burrill Life Science Capital Fund. (Yuan, 2007) Malaysian SMEs, the Bank complements existing
products and services offered by commercial
BioNexus banks through a set of comprehensive and inte-
grated financial and business advisory services.
BioNexus Malaysia is essentially a network of cen- The bank offers a dedicated biotechnology pro-
tres of excellence throughout the country— com- gramme. (www.biotechcorp.com.my)
prising companies and institutions that specialize
in specific biotech subsectors. (www.binasia.net) In 2004, the Ministry of Science, Technology and
Innovations (MOSTI) was formed after the re-
Three centres of excellence comprise BioNexus: structuring of MOSTE. In supporting the devel-
opment of biotechnology industry in Malaysia,
 The Centre of Excellence for Agro- MOSTI provides many funds for biotechnology.
biotechnology; (www.biotechcorp.com.my) (See Page 5)
 The Centre of Excellence for Genomic
& Molecular Biology; Sectors
 The Centre of Excellence for Pharma-
ceuticals & Nutraceuticals. The pharmaceutical market in Malaysia is one of
the fastest growing in Asia Pacific region with a
These three institutes are part of the BioNexus CAGR of 10.5%. According to Frost & Sullivan
initiative whose goal is to coordinate and estimates, the Malaysian pharmaceutical industry
strengthen existing universities, laboratories, and was valued at $1,027 million in 2007 and is ex-
research institutes. Agricultural biotechnology re- pected to touch $1,800 million by 2013. (Tham
search will be done in collaboration with the and Yahya, 2008)
Malaysian Agricultural Research and Development
Institute (MARDI) and Universiti Putra Malaysia. The key drivers that are anticipated to fuel this
Genomics and molecular biology will be coordi- growth are:
nated with the Universiti Kebansaan Malaysia,
while biomedical work will be located in the Medical tourism: In 2006, about 300,000 foreign
BioValley. (Yuan, 2007) patients received medical treatment in the country,
generating foreign exchange earnings of more than
Another major component of BioNexus is to con- $ 27.63 million. These visits from foreign patients
fer special status to selected domestic and foreign are likely to drive the demand for pharmaceutical
companies. BioNexus-status companies are inter- products.
national and Malaysian biotech companies that
qualify for fiscal incentives, grants, and guarantees Market for generic products: The patent expiry of
administered by BiotechCorp. blockbuster drugs, coupled with government sup-
(www.biotechcorp.com.my) port and rising healthcare costs, are likely to drive
the demand for generic products.
Funding
Specialist therapy-driven market: The increased
The Malaysian Technology Development Cor- incidence of the top five death-related diseases
poration (MTDC) was set up by the and the biotechnology industry will drive the de-
Government of Malaysia in 1992 to spearhead the mand for specialist therapies.
development of technology businesses in Malaysia.
Its initial role was to focus on the promotion and
commercialization of local research and invest in
new ventures aimed at transferring new technolo-
gies from abroad. From those investment activi-
4
FUND
MTDC-Non ICT Venture Fund
MTDC-Technology Acquisition Fund (TAF)
MTDC-Commercialization of R&D (CRDF)
Malaysian Life Sciences Capital Funds (MLSCF)
MDV- Equipment & Infrastructure Financing
MDV-Working Capital Financing
MDV-Contract/Project Financing
FUND SIZE AND MAXIMUM PURPOSE
PAYOUT (RM)
1 billion; No specific limit, range from RM3 Investment in venture capital.
million to RM50 million.
100 million; RM2 million. Acquisition of foreign technology.
115 million; RM4 million or 70% of the project Commercialization of local R&D.
cost.
USD 140-150 million; USD 7-8 million. Investment in early to mid stage companies
that are involved in healthcare, industrial,
and agricultural biotechnology
Finance acquisition and construction of
land/building, equipment and fittings for
laboratory; and R&D and/or manufacturing
facilities, including financing of interest ac-
crued during construction.
Funding and assistance to purchase business
assets, to meet business expenses, in particu-
lar to enable applicants to meet their operat-
ing expenses, purchase inventory, receivables
financing.
Financing of major inputs for projects that
are dependent on medium to long-term con-
tracts from sponsors. The facility may also
provide for short to long term financing to
companies awarded contracts to construct
and complete biotechnology infrastructure.

MOSTI-Science Fund 550 million; RM500,000. Development of new products or processes

up to proof-of-concept; enhancement of re-
search capability.
MOSTI-Inno Fund 80 million; Enterprises -RM3,000,000; Commu- To encourage participation from micro en-
nity groups – RM 1,000,000. trepreneurs.
MOSTI-Techno Fund 680 million; Up to a maximum of the total pro- Pre-commercialization support including
ject cost or RM5 million whichever is lower. development and up-scaling of new and
novel technologies from lab scale prototype
up to commercial readiness.
MOSTI-Agro-Biotechnology R&D Initiatives 80 million; Up to a maximum of the total pro- R&D in strategic areas of agro-biotech that
ject cost or RM2.5 million whichever is lower. will lead to modernization and transforma-
tion of the agricultural sector.
MOSTI-Genomic and Molecular Biology R&D Initia- 100 million; Up to a maximum of the total pro- Generation of intellectual property and tech-
tives ject cost or RM5 million whichever is lower. nologies for application in modern bio-
manufacturing including high value products
such as biocatalysts, fine chemicals, and diag-
nostics.
MOSTI-Pharmaceutical and Nutraceutical R&D Initia- 90 million; Up to a maximum of the total pro- To develop proof of concept products or
tives ject cost or RM5 million whichever is lower. services developed by local scientists to com-
ply with the international standards imposed
by the regulatory authorities such as good
research practice (GRP) and good laboratory
practice (GLP).
Increased demand for OTC/food supplements, herbal and traditional products: As the population ages and becomes more proactive with respect to their
health, it is anticipated there will be an increased demand for OTC/food supplement products, as well as herbal and traditional medicines.

(Tham and Yahya, 2008)

However, the Malaysian pharmaceutical industry relies heavily on imported products, which fulfill 70% of demand, with Malaysians placing higher trust in
imported brands. This reliance on imported drugs has resulted in intense competition between imported and locally manufactured products. As such, do-
mestic pharmaceutical players are now increasingly looking abroad for growth opportunities. For example, local pharmaceutical companies have been ex-
porting to over 30 countries. Major export destinations for these companies include Singapore, Vietnam, Brunei, Hong Kong, Taiwan, Japan, India, and
Germany. With the acceptance of Malaysia in the Pharmaceutical Inspection Cooperation (PIC) Scheme, Malaysian companies are now exporting pharma-
ceutical products to PIC countries including European Union, Canada and Australia. (Tham and Yahya, 2008) The total export value of drugs from
Malaysia stood at $131 million in 2004 and Frost & Sullivan estimates the value to grow at a rate of 5.4% between 2006 and 2103.

The biotechnology industry likewise offers opportunities for both domestic and multinational companies. The market capitalization of biotechnology and
biotechnology-related healthcare companies listed on the Malaysian Stock Exchange has reached $857 million, with foreign direct investment close to $286
million. (Tham and Yahya, 2008) In terms of biotechnology R&D, the outcomes are visible in the genomics, health, medical diagnostics, animal, food, and
environmental biotechnology arenas. Genomics technology is being applied to studies on gene discovery, molecular diagnostics, and gene expression tech-
nology involving tropical bio-resources. Successes in medical biotechnology include the commercial production of several diagnostics kits for dengue, sev-
eral diagnostics kits for other infectious tropical diseases, and a bioenhanced formulation of artemisinin, an anti-malarial drug. Research in animal biotech-
nology has produced several recombinant vaccines for improved healthcare, applied marker assisted breeding for increased breeding efficiency, and has
provided alternative sources of livestock feed. Food biotechnology R&D has yielded several clarified juices and food enhancement products. Research in
environmental biotechnology has resulted in the treatment of industrial and agricultural waste through bio-augmentation and genetic engineering of mi-
crobes. (www.binasia.net)

Malaysia however still needs to focus on certain priorities to improve the position of its biotechnology industry such as increasing the value of its agricul-
tural products, the development of halal pharmaceuticals and food products, and exploiting biodiversity to generate new medicinal products. (Yuan, 2007)
Most of Malaysia’s agricultural biotechnology currently revolves around government institutes and large plantations. (Continued on Page 7)

5
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(Continued from Page 5)
UPCOMING EVENTS
Frost & Sullivan predicts that for example, biodiversity will be the key to the fu-
ture of the high-growth pharmaceutical and biotech industries; Malaysia's biodi-
versity holds great promise and should therefore be exploited. (Tham and Yahya,
2008)To date however, there are still few partnerships and investments with for-
eign companies and multinationals, and Malaysia is still short of the scientific and
managerial manpower needed to grow its biotechnology industry. (Yuan, 2007)

Competitive Outlook

How does Malaysia compete against the rest of Asia? Japan, Taiwan, and Korea
appear to be ahead of the curve with new start-ups and private entrepreneurial
investments. Indonesia is planning a Bio-Island, located on Rempang Island,
which was expected to be completed in 2008. Over the next five years, New Dates!
Singapore’s government will be managing around US$700 million to develop Drug Discovery and Clinical Development in India
Singapore into a biomedical Asian hub. China and India have also attracted Mumbai, India
strong interest and investment because of their sound base of scientific excellence,
February 25-February 28 2009
cost advantages, and large domestic markets. (www.malaysiamission.com)

Although Malaysia is still lagging behind some Asian countries in terms of techno- This conference will continue to serve as an international
logical development and human resources, the Malaysian government has shown and neutral forum to address current solid scientific
its determination and interest in catalyzing the biotechnology industry. The com-
panies that have already opted to invest in Malaysia have indicated their choice
research in India pertaining to global development of
was influenced by readily available bio-resources and the supporting infrastructure drugs and biologics. Global thought leaders and experts
for further R&D. As an example, Malaysia—with less red tape in dispensing across the pharmaceutical, academia, and regulatory
funds—has already attracted Singapore investors to set up a number of biotech agencies will convene to present drug discovery, global
companies. Malaysia is also partnering with multinational companies such as
Roche Diagnostics of Switzerland in developing a SARS diagnostic kit. Other for- clinical research, and scientific working groups. Keynote
eign partnerships include such countries as Korea, U.K., Russia, and Japan. lectures, workshops, and parallel discussion will highlight
(www.malaysiamission.com). (www.malaysiamission.com) the conference.
Over the years, biotech research units have been set up in most Malaysian public
universities and the private sector has engaged in some biotech R&D—largely fo- http://www.diahome.org/
cused on plant tissue culture. According to the Economic Report for 2002/2003,
some 50 Malaysian companies use biotechnological processes, (primarily in food
production, herbal products, and pharmaceuticals) but this still falls short of ex-
ploiting the country’s biotechnological potential. With 12,500 species of flowering
plants, 1,100 species of ferns, and one of the world’s most diverse coral communi- UPCOMING EVENTS
ties, Malaysia has a very diverse bio-source universe still untapped—potentially
serving as sources of treatment for many diseases. (www.malaysiamission.com)
With Malaysia’s traditional and herbal market growing at rate of 15 to 20%, ac-
cording to Frost & Sullivan, demands by local and international consumers should
continue to drive the market. (Tham and Yahya, 2008) It is also hoped that as
Malaysians turn to an increasingly healthy lifestyle, opportunities should open up
to biotechnology, pharmaceutical, and even bio-generics companies alike. It will
be up to the key industry stakeholders to take advantage of these opportunities to
meet the needs of the Malaysian population.

It is hoped that as Malaysians

turn to an increasingly healthy
lifestyle, opportunities should
open up to biotechnology,
pharmaceutical and even
bio-generics companies alike. Biotechnology Clinical Trials Outsourcing
Burlingame, CA
March 20 2009

Successful outsourcing of clinical drug development ac-

tivities is critical to smaller companies who typically lack
the infrastructure and personnel to perform these func-
References:
tions in-house. This one-day conference was designed
1) www.binasia.net and the location chosen specifically for smaller companies
2) www.bioasianetpacific.com located on the West Coast. The program will provide
3) Yuan, R. (2007) Malaysian Gov't Fosters Biotech Growth. Genetic Engi- highly interactive discussion from sponsor companies and
neering and Biotechnology News, Vol. 27(15).
4) www.biotechcorp.com.my service providers from “both sides of the fence”. Partici-
5) Tham, L.H. and Yahya, I. (2008) Malaysian Pharmaceutical Industry Out- pants can share their insights and experiences and learn
look 2008. Frost & Sullivan. how to apply outsourcing concepts and strategies to their
6) www.malaysiamission.com own projects and corporate culture.

http://www.diahome.org/

7
8
9
Crafting a National Biotechnology cine and on the production of vaccines. In addi- MESDAQ, will take into consideration the special
tion, a Bioproducts Validation Centre will also be characteristics of biotech companies with its long
Policy established in Johor to validate herbal, nutraceuti- gestation periods and higher risk profiles. (Badawi,
cal, and phytopharmaceutical product claims for 2005)
Commitment to Biotechnology the purposes of regulatory registration and quality
Biotechnology has been identified as a new source assurance. (Ninth Malaysia Plan) Thrust 7: Legislative and Regulatory Frame-
of economic growth for Malaysia. To drive the work Development
development of this industry a new biotech policy Thrust 3: Industrial Biotechnology Develop- Under this thrust, the country’s regulatory frame-
was created, focusing on key concepts and meas- ment work and processes will be brought in line with
ures offered by the government of Malaysia. The This thrust will ensure growth in the application global standards and best practices. As well, the
new policy was unveiled by the Prime Minister at of advanced bio-processing and bio- country will further move to develop a strong in-
the opening ceremony of the BioMalaysia 2005 manufacturing technologies. The identified areas tellectual property protection regime.
conference at the Putrajaya International Conven- of growth include the development of biocatalysts Recognizing the necessity of a strong regulatory
tion Center. The Prime Minister outlined nine ma- such as enzymes for food and feed preparations, framework for the development of biotechnology,
jor initiatives to realize the country’s potential in cleaning products, textile processing, and other the Government is in the process of formulating
this sector. (www.ita.doc.gov) industrial processes. Bioprocessing is another and enacting a number of legislations. These in-
growth area which can be applied in the produc- clude the Biosafety Bill and the Access and Benefit
Speaking at the opening, the Prime Minister also tion of biomaterials such as bioplastics, biofuel, Sharing (ABS) Bill. The ABS Bill seeks to ensure
announced the newly created Malaysian Biotech specialty chemicals such as cosmetics ingredients, fair and equitable sharing of benefits from the use
Corporation (MBC) to oversee the implementa- and electronic chemicals. The third growth area of Malaysia’s biological resources and to protect
tion of the new policy and initiatives. MBC is a under this thrust is contract biomanufacturing. against biopiracy. To foster innovation and safe-
dedicated and professional one-stop agency with (Ninth Malaysia Plan) guard investments in biotechnology, efforts will be
the main objective of developing the country’s strengthened to improve the intellectual property
biotech industry. It is overseen by an Implementa- The Prime Minister explained in his speech that (IP) regime. Guidelines on IP sharing for research-
tion Council and advised by an International Advi- the above three thrusts will leverage the country’s ers in public research institutions and in business
sory Panel, both under the leadership of the Prime existing capabilities and to move them up the collaborations as well as for local and foreign ven-
Minister of Malaysia. MBC coordinates biotech value chain. (Badawi, 2005) tures will be developed. Related standards such as
initiatives from all relevant government minis- good laboratory practice (GLP) and good manu-
tries—all under the purview of the Ministry of Thrust 4: R&D and Technology Acquisition facturing practice (GMP) will be augmented to
Science, Technology and Innovation. MBC aims As part of this thrust Centres of Excellence will be develop the contract research and contract manu-
to not only enhance biotech R&D, but also im- established, in existing or new institutions, to facturing sectors. (Ninth Malaysia Plan)
prove the regulatory environment. bring together multidisciplinary research teams in
(www.ita.doc.gov) coordinated research and commercialization initia- Trust 8: Strategic Positioning
tives. To further boost research productivity and Under this thrust, global marketing strategy will be
Biotechnology has been shorten the time required to bring products to developed to build brand recognition for
market, the acquisition of platform technologies Malaysian biotechnology.
identified as a new will be a key initiative under this thrust. For this
source of economic purpose, a special RM100 million fund for bio- Trust 9: Government Commitment
technology acquisition has been established. It is Under this thrust the Malaysian Biotechnology
growth for Malaysia. anticipated that international collaborations will be Corporation was established. The Malaysian Bio-
encouraged to facilitate both knowledge and tech- technology Corporation works closely with all
nology transfer. (Ninth Malaysia Plan) relevant agencies and ministries, such as the Minis-
try of Health, the Ministry of Agriculture & Agro-
Thrusts of the Policy Trust 5: Human Capital Development Based Industries and the Ministry of Commodities
Under this thrust, biotech human resources will be & Plantation Industries. Malaysian Biotechnology
The National Biotechnology Policy comprises of developed through special schemes, programmes, Corporation works under the purview of the Min-
nine thrusts: (www.binasia.net) and training. Institutions of higher education will istry of Science, Technology and Innovation to
augment their undergraduate and post-graduate enhance biotech R&D and to help improve the
Thrust 1: Agriculture Biotechnology Develop- courses in order to expand scientific and special- regulatory environment.
ment ized skills, especially in the fields of genomics, mi-
This thrust includes enhancing value creation of crobiology, bioprocessing as well as in related en- The Government also developed a network or
the agricultural sector through biotechnology. The gineering and business fields. Colleges and skills nexus of centres of excellence from existing insti-
knowledge and expertise of institutions such as development training centres will be charged with tutions around the country—known as BioNexus
MARDI, Malaysian Palm Oil Board, and the the responsibility of meeting demands for techni- Malaysia. (Badawi, 2005)
Malaysian Rubber Board will be used to develop cal human resources such as biotechnology re-
niche areas. New technologies, spearheaded by search assistants, GMP personnel, and technicians
these institutions as well as the newly designated in biomanufacturing, metrology, and quality con- The Government
Malaysian Genome Institute, will include bioinfor- trol. (Ninth Malaysia Plan) anticipates that these nine
matics, genetic engineering, functional genomics
and proteomics to discover new applications not Trust 6: Financial Infrastructure Development thrusts and supporting
only in agriculture biotechnology, but also those in Prime Minister Badawi explained that as an initial initiatives will steer the
healthcare and industrial biotechnologies. (Ninth step, the Government would be structuring dedi- growth of a competitive
Malaysia Plan) cated matching grants for biotech R&D and com- biotechnology industry.
mercialization, including financial support for pat-
Thrust 2: Healthcare Biotechnology Develop- ent applications. To assist R&D ventures even fur-
ment ther, a fund would be established to assist in the The Government anticipates that these nine
This thrust involves capitalizing on the strengths training of skilled workers and the hiring of re- thrusts and supporting initiatives will steer the
of biodiversity to commercialize discoveries in searchers in key areas. (Badawi, 2005) growth of a competitive biotechnology industry
natural products as well as position Malaysia in the that not only leverages existing strengths but de-
bio-generics market. The National Institute of Biotech businesses can also benefit from prepack- velops new ones in Malaysia.
Pharmaceuticals and Nutraceuticals (NIPN) and aged tax incentives currently provided by the Gov-
the National Institute of Natural Products, Vac- ernment, including 10 year tax exempt pioneer References:
cines and Biologicals (NINPVB) will be set up as status, exemption of import duties on approved 1) www.ita.doc.gov
centres of R&D excellence in the field of health- equipment and materials, and double tax deduc- 2) www.binasia.net
care-related biotechnology. The NIPN will focus tions on qualifying expenses and R&D invest- 3) Biotechnology for Wealth Creation. Ninth
on the utilization of natural bio-resources from ments. To increase access to funds for biotech Malaysia Plan 2006-2010.
plant, marine, and microbial origins for use in companies, venture capital participation will be 4) Speech by Yab Dato’ Seri Abdullah Bin Haji
nutraceuticals, cosmeceuticals, and phytopharma- strengthened and entry to capital markets will be Ahmad Badawi Prime Minister of Malaysia,
ceuticals. The NINPVB will focus on herbal medi- further enabled. For example, entry criteria into BioMalaysia 2005.
10
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The BioNexus Network
Objective
The Government developed a network or nexus of centres of excellence
from existing institutions around the country known as BioNexus Malaysia. 
Resources were initially dedicated to the development of three Centres of
Excellence. The Centre of Excellence for Agricultural Biotechnology is fo-
cused around MARDI and Universiti Putra Malaysia. The Centre of Excel-
lence for Genomics and Molecular Biology is focused in Universiti
Kebangsaan Malaysia. The Centre of Excellence for Pharmaceuticals and
Nutraceuticals is anticipated to be built in the original BioValley site in
Dengkil. These Centres of Excellence will be used to attract other institu-
tions and companies in related areas of expertise. Furthermore, it is antici- 
pated that these Centres of Excellence will connect with other BioNexus
centres in the country as part of a network of collaboration and information
exchange. (Badawi, 2005)
BioNexus Status Companies
Another major component of BioNexus is to confer special status to se-
lected domestic and foreign companies that are then eligible for financial
support, tax incentives, and access to equipment and facilities. BioNexus
status is essential to accessing major government funding and eventual list-
ing on MESDAQ. (Yuan, 2007) Approximately 100 companies are in the
pipeline to obtain the BioNexus status, which will make them eligible for
privileges contained in the BioNexus Bill of Guarantees according to chief
executive officer Datuk Iskandar Mizal Mahmood. (www. biomalay-
sia.com.my)
Key incentives available for qualified biotechnology companies with
BioNexus status include several tax incentives. These fiscal incentives are
further strengthened by a set of privileges granted under a Malaysian
Government Bill of Guarantees. (biomalaysia.com.my;
www.bionetasiapacific.com)
 A company that invests in its subsidiary, which is a BioNexus status
company, is granted a tax deduction equivalent to the amount of invest-
ment made in that subsidiary provided that the investing company owns at
least 70% of that subsidiary.
A BioNexus company is given concessionary tax rate of 20% on in-
come from qualifying activities for 10 years upon the expiry of the tax ex-
emption period.
 A company or an individual investing in a BioNexus company is given
a tax deduction equivalent to total investment made in seed capital and
early stage financing.
A BioNexus company undertaking a merger and acquisition with a
biotechnology company is given exemption of stamp duty and real prop-
erty gains tax within a period of 5 years until 31 December 2011.
 Buildings used solely for the purpose of biotechnology research activi-
ties are given an Industrial Building Allowance over a period of 10 years.
(www.biotechcorp.com.my)
BioNexus Companies
BioNexus companies include those from the agricultural biotechnology, di-
agnostics, genomics, drug discovery and development, medical product de-
velopment, animal health, and research services arenas. (See Page 15)
Approximately 100
companies are in the
pipeline to obtain the
BioNexus status.

Fiscal incentives are Agricultural Biotechnology includes: Plant genomics, fertilizer & soil en-
hancer, plant propagation via tissue culture, animal breeding and reproduc-
further strengthened by a tion technology, nutraceuticals, and orchid tissue culturing.
set of privileges granted
under a Malaysian govern- Industrial Biotechnology includes: Bioremediation, enzymes/catalysts,
biodiesel production, microbes technologies, and biocatalysts.
ment Bill of Guarantees.
References:

Specifically the BioNexus’ Bills of Guarantees (BOG) allows: 1) Speech by Yab Dato’ Seri Abdullah Bin Haji Ahmad Badawi Prime
Minister of Malaysia, BioMalaysia 2005.
 Freedom of ownership; 2) Yuan, R. (2007) Malaysian Gov't Fosters Biotech Growth. Genetic
 Freedom to source funds globally; Engineering and Biotechnology News, Vol. 27(15).
 Freedom to bring in knowledge workers; 3) www.biomalaysia.com.my
 Eligibility for competitive incentives and other assistance; 4) www.bionetasiapacific.com
 Eligibility to receive assistance for international accreditations and 5) www.biotechcorp.com.my
standards;
 Strong intellectual property (IP) regime;
 Access to a supportive information network linking research cen-
tres of excellence; For Information on Investment
 Access to shared laboratories and other related facilities;
 Access to BiotechCorp as the one-stop agency. Opportunities:
BioNexus status companies may apply for the following tax incentives from
the Malaysian Government:
Malaysian Biotechnology Corporation Sdn. Bhd.
 100% income tax exemption for 10 years commencing from the first Level 23, Menara Naluri
year the company derives profit OR Investment Tax Allowance of 100% 161 Jalan Ampang
on the qualifying capital expenditure incurred within a period of 5 years.
50450 Kuala Lumpur
 Tax exemption on dividends distributed by a BioNexus company.
Tel : (603) 2116 5588
 Exemption of import duty and sales tax on raw materials/components
and machinery/equipment. Fax : (603) 2116 5577
 Double deduction on expenditure incurred for R&D. E-mail : info@biotechcorp.com.my
 Double deduction on expenditure incurred for the promotion of ex-
ports.

13
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 BIONEXUS COMPANY FOCUS
All Cosmos Industries Sdn Bhd Agricultural Biotechnology
ar-Raudhah Bio Tech Farm Sdn Bhd Agricultural Biotechnology
Asia Pacific Special Nutrients Sdn Bhd Diagnostics
Asiatic Centre for Genome Technology Sdn Bhd Genomics

Asma Agro Malaysia Sdn Bhd Genomics

Aurigene Discovery Technologies (M) Sdn Bhd Drug Discovery

Autoimmune Sdn Bhd Drug Discovery

Bio Molecular Industries Sdn Bhd Drug Development
Biotech Alliance International Sdn Bhd Industrial Biotechnology
Biotec International Asia Sdn Bhd Industrial Biotechnology
BioFact Life Sdn Bhd Drug Development
Bio-Fertilizers Sdn Bhd Agricultural Biotechnology
BioSmart Sdn Bhd Industrial Biotechnology
Biovic Sdn Bhd Medical Product Development
Borneo Plant Technology Sdn Bhd Drug Development
CellSafe International Sdn Bhd Biotechnology
Chakra Biotech Sdn Bhd Drug Discovery
DNA Laboratories Sdn Bhd Diagnostics
First Base Laboratory Sdn Bhd Contract Research
GENERTI Biosystems Sdn Bhd Diagnostics
Genetic Improvement and Farm Technologies Agricultural Biotechnology

Granulab Sdn Bhd Medical Product Development

Healol Melaka Biotech Sdn Bhd Drug Development
Holista Biotech Sdn Bhd Health Services
Hopematic Sdn Bhd Drug Development
Inno Biologics Sdn Bhd Research Services
Inno Intergrasi Sdn Bhd Agricultural Biotechnology
InQpharm Asia Sdn Bhd Drug Discovery/Development
IPT Kosmo BioTechnology Sdn Bhd Industrial Biotechnology
KL Biotech Manufacturing Sdn Bhd Drug Development
Malaysian Agri Hi-Tech Sdn Bhd Agricultural Biotechnology
Malaysian Bio-Diagnostics Research Sdn Bhd Diagnostics

Malaysian Genomics Resources Centre Genomics/Contract Research

Nimura Genetic Solutions Sdn Bhd
Nova Laboratories Sdn Bhd
Olipro Biotechnology Sdn Bhd
Orchid Life Sdn Bhd
Power Biotechnologies Sdn Bhd
Profound Vaccine Sdn Bhd
Renogenic Sdn Bhd
StemLife Berhad
Stevian Biotechnology Corporation Sdn Bhd
Contract Research
Drug Development (Animal Health)
Diagnostics
Agricultural Biotechnology
Agricultural Biotechnology
Animal Health/Vaccines
Biotechnology
Research Services
Agricultural Biotechnology

Stempeutics Research Malaysia Sdn Bhd Medical Product Development

Success Nexus Sdn Bhd
Sunzen LifeSciences Sdn Bhd
TSH Biotech Sdn Bhd
Vivantis Technologies Sdn Bhd
Industrial Biotechnology
Drug Development (Animal Health)
Agricultural Biotechnology
Research Services
15
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 PROGRAMME COMPONENTS
A Malaysian Entrepreneur Development Framework
The Malaysian Biotechnology Corporation (BiotechCorp), the lead agency to The Biotechnology Entrepreneur- Six-month intensive and structured
develop the biotechnology industry in Malaysia, is stepping up efforts to en- ship Special Training (BeST) retooling programme for biotech-
sure that human capital development is ready to meet the requirements of the Programme nology/life-sciences graduates.
next phase in the Malaysian biotechnology industry. California Institute for Research, human capital, and bio-
(www.biomalaysia.com.my) Quantitative Biomedical Research entrepreneurship development.
(qb3)
―In fact, the growth and success of the biotechnology sector in the commer- Mentor in Residence Programme Connection with international men-
cialization phase— hinges on our success in expanding the capability and tors.
competency of our people in biotechnology. Thus, we have a very ambitious BioNexus Partner Programme Network creation with Malaysian
target of expanding the pool of knowledge workers in biotechnology from universities, research institutes, gov-
40,000 in 2011 to 80,000 by 2015‖, said Datuk Iskandar Mizal Mahmood, the ernment linked companies, technol-
Chief Executive Officer of BiotechCorp. (www.biomalaysia.com.my) ogy parks, and incubators.
BiotechCorp has developed the Biotechnology Entrepreneur Development BioNexus Partner Programme (BNP)
Framework. The Biotechnology Entrepreneur Development Framework pro-
vides a comprehensive approach to developing new entrepreneurs, facilitating The BioNexus Partner Programme will leverage on existing facilities, infra-
the creation of new biotechnology start-ups/business ventures, and trans- structure, and capabilities within Malaysian universities, research institutes,
forming ideas/business concepts into those ready for commercialization. A government linked companies, technology parks, and incubators. As of No-
series of programmes have been developed to enable entrepreneurs along the vember 2008, the Forest Research Institute Malaysia (FRIM) and seven lo-
various stages of development. These programmes cover entrepreneur devel- cal public universities signed an agreement under the BioNexus Partners
opment workshops, entrepreneur development conferences, and mentoring (BNP) programme to strengthen their research and development (R&D)
programmes. (www.biomalaysia.com.my) capacity. (FRIM, 2008) BNP partners include: The International Islamic
University Malaysia, Universiti Teknologi Mara, Universiti Malaya,
The Biotechnology Entrepreneurship Special Training (BeST) Pro- Universiti Malaysia Terengganu, Universiti Putra Malaysia, Universiti Sains
gramme Malaysia, Universiti Teknologi Malaysia, and Forest Research Institute Ma-
laysia. (Yunus, 2009)
BeST is a six-month intensive and structured retooling programme for bio-
technology/life-sciences graduates wishing to enter the biotechnology indus-
try and other industries in general. References:

BeST combines classroom-based instruction, with laboratory work and an 1) www.biomalaysia.com.my

industry internship. The programme is aimed at equipping graduates with es- 2) www.biotechcorp.com.my
sential skills and knowledge for entry-level positions within biotechnology 3) qb3.org/malaysia.htm
companies or biotechnology-related companies. (www.biotechcorp.com.my) 4) Yunus, K. BioNexus firms can capitalise on woes. Business Times,
January 24 2009.
California Institute for Quantitative Biomedical Research (qb3)

BiotechCorp has also established a five-year partnership with the California

Institute for Quantitative Biomedical Research (qb3) to collaborate in the ar- “..we have a very ambitious
eas of research, human capital, and bio-entrepreneurship development. The
partnership enables collaborations on research projects and classroom train-
target of expanding the pool
ing to equip Malaysian scientists with the latest multi-disciplinary and bio- of knowledge workers in
technology entrepreneurship skills. biotechnology from 40,000 in
All the students in this program attend QB3 with the anticipation of forming 2011 to 80,000 by 2015.”
networks with each other as well as with QB3 scientists. After the formal
training, all the students return as staff to the new National Institute for Phar-
maceuticals and Nutraceuticals. It is hoped that the trainees should be able to
transfer the entrepreneurial skills they have acquired back to Malaysia.
(qb3.org/malaysia.htm)

Mentor in Residence Programme

For Information on Investment
Opportunities:
The Mentor-In-Residence Programme is a part of the Mentoring Programme.
Under the Mentor-In-Residence Programme, BiotechCorp intends to engage
the services of experienced CEOs/industry leaders from around the world to Chemical & Life Sciences Industries Division
serve as mentors. These mentors are envisioned to bring a wealth of industry Malaysian Industrial Development Authority
expertise and experience that will be shared with companies/individuals par-
ticipating in the mentoring programme.
Block 4, Plaza Sentral, Jalan Stesen Sentral 5,
Kuala Lumpur Sentral, 50470 Kuala Lumpur,
Malaysia
“In fact, the growth and success
of the biotechnology sector in Tel : (603) 2267 3633
the commercialization phase— Fax : (603) 2273 4192
hinges on our success in ex-
panding the capability and Website : www.mida.gov.my
competency of our people in E-mail : lifesc@mida.gov.my
biotechnology. ..”

18
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Safety Reporting
Dr. Izabela Slowik
PharmaVigilance Consulting Group, Warsaw
& Dr. Anjali Shukla
Accure Labs Pvt. Ltd., India
How well-prepared are we to monitor, report,
document, and evaluate adverse drug reactions /
events (ADRs/AEs) arising from clinical trials as
well as from the marketed new medicinal prod-
ucts? Monitoring and reporting adverse events
from clinical trials may be relatively a simpler
process, considering the given settings and envi-
ronment that are ensured by GCP. But the same
cannot be assumed for marketed drug products.
First of all, we have to admit that it is essential to
report ADRs. Several questions arise in context
with safety reporting requirements. These are:
1. What to report?
2. Why to report?
3. When to report?
4. How to report?
What to Report
Periodic Safety Update Reports (PSURs) for mar-
keted products form the mainstay of traditional,
post marketing surveillance activities throughout
the pharmaceutical world. US FDA’s MedWatch
forms & MHRA’s Yellow Cards have almost be-
come synonymous with spontaneous reporting.
While the US FDA recommends voluntary spon-
taneous reporting of all serious suspected ADRs
through Form 3500A for health care profession-
als, it makes such reporting mandatory for the
Marketing Authorization Holders (MAHs) and
draws very stern timelines and reporting obliga-
tions.
All other ADRs/AEs, which are not reported to
regulators, in an expedited manner are included in
periodic clinical trial reports (in case of pre-
marketed development phase) and in PSURs for
marketed products.
A PSUR is intended to provide an update of the
worldwide safety experience of a medicinal prod-
uct to Competent Authorities (CA) at defined
points post-authorization. At these times, MAHs
are expected to provide concise summary informa-
tion together with a critical evaluation of the risk-
benefit (R/B) balance of the product in the light
of new or changing information. This evaluation
should determine whether further investigations
need to be carried out and whether changes
should be made to the marketing authorization
and product information.
Why to Report
At the time of authorization, the safety profile of
the product is not complete. Clinical trials
conducted during the pre-authorization phase Situations where less frequent submission of
were limited to the special group of patients, in PSURs may be appropriate include:
terms of age, gender, and ethnicity. There were
also a small numbers of subjects enrolled to the Products authorized through line-extensions to
clinical trials. Restricted conditions were used in existing medicinal products.
the protocols regarding co-medication, duration of
exposure (relatively to short), and lack of follow Newly authorized generic medicinal products.
up.
Situations where more frequent submission of
PSUR is intended to provide an update of the PSURs may be required include:
worldwide safety experience of a medicinal prod-
uct to Competent Authorities at defined time Variations introducing new indications, dosage
points during the post-authorization phase. PSUR forms, and routes of administration.
for marketed medicines is a stand-alone docu-
ment. It is completed according to the ICH tem- An API which is a different salt/ester or deriva-
plate. Data from the MAH observations as well as tive (with the same therapeutic moiety).
results from the clinical trials and published in the
literature are all presented. This enables for the The presence of an inactive substance without an
evaluation of all available worldwide safety data of established safety profile.
marketed drugs.
A Risk Management Plan (RMP) in place for a
When to Report corresponding originator product requiring spe-
cific monitoring of a safety concern.
Once a medicinal product is authorized in the
European Union (EU), even if it is not marketed,
the MAH is required to submit PSURs at 6- European PSUR Work Sharing Project
monthly intervals. When launch dates are planned,
this information should be reflected in the forth- Companies have proposed dates for substances
coming PSUR. for which they considered their product to be the
originator, and this was used as a basis for compil-
PSURs should be submitted at the following times ing a list of EU HBD and DLPs for active sub-
from the time of authorization, for all medicinal stances. This list has now been adopted by all na-
products unless the marketing authorization tional agencies and is published on the HMA web-
makes different provisions: site.
 Immediately upon request.
 At least 6 monthly after authorization and un- Under the scheme all products involving the same
til placement on the market. API will have the same EU HBD and DLP and
therefore the same PSUR submission cycle. This
 At least 6 monthly for the first two years after
will allow sharing of the PSUR assessment work
being placed on the market.
load across the EU. Each API will be allocated a P
 Annually for the subsequent two years. -RMS (Reference Member State for the PSUR)
 Thereafter at three-yearly intervals. who will take the lead in the assessment. For mu-
The first PSUR should have a data lock point tually authorized licenses the P-RMS and RMS
(DLP) within 6 months after granting of the mar- may not be the same EU member state. There is
keting authorization. European agreement that the PSUR cycle for ge-
neric products may move directly to the three-
For nationally authorized products, including yearly cycle in line with the brand leader rather
those authorized through mutual recognition or than start with six-monthly PSURs, unless poten-
decentralized procedures, initiatives have been tial safety issues that may require monitoring are
taken by the National Competent Authority identified in the Safety Assessment included
(NCA) to synchronize PSUR submission sched- within the registration dossier.
ules for products containing the same Active
Pharmaceutical Ingredient (API). For many APIs, The request to amend the PSUR cycle should be
harmonized ―virtual‖ birth dates, known as EU included in the registration dossier and supported
Harmonized Birth Dates (EU HBDs) and related in the Safety Assessment. This will be agreed as
harmonized DLPs for the following PSURs have part of the marketing authorization approval. If a
been agreed upon by the relevant MAHs for origi- request to amend the PSUR cycle is not received
nator products and NCAs. These harmonized then the PSUR cycle will default back to 6
birth dates and related data lock points are pub- monthly reports for two years, annually for two
lished by the Heads of Medicines Agencies years, and then every three years thereafter.
(HMA). MAHs for generic products are encour-
aged to use the same PSUR submission schedules The focal point of the PSUR should be the pres-
as those agreed for originator products. entation, analysis, and evaluation of new or chang-
ing safety data received during the period covered
Medicinal products, which are also authorized out- by the PSUR. So the following things should be
side EU, will have an International Birth Date adequately addressed in the PSUR:
(IBD). In order to harmonize PSUR submissions
internationally, the MAH may use the IBD to de- 1. Analysis of adverse reaction reports.
termine the dates of the DLPs for the PSUR sub- 2. An overview of cumulative data.
mission schedule, provided that the first DLP falls 3. Safety data from studies.
within the 6 months following the EBD (EU Birth 4. Other relevant safety information.
Date). 5. Follow-up of any Risk Management.
6. Reports of lack of efficacy, specifically for me-
The periodicity of PSUR submission may be dicinal products used in the treatment of life-
amended, as required by the CA or proposed by threatening conditions and for certain other me-
the MAH. This may result in more or less frequent dicinal products (contraceptives and vaccines).
submission of PSURs. However, submission of
PSURs at a lower frequency than once every 3 (Continued on Page 22)
years is not possible.
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(Continued from Page 21) Strengths Weaknesses
Aggregate data (to better identify Does not explain all prior safety issues.
Information on all indications, dosage forms, routes of admini-
new safety signals).
stration and dosages for a given API for medicinal products au-
Worldwide data (safety signal Line-listings provide limited information
thorized to one MAH should be included in a single PSUR, with
strengthened if seen in more than for assessing a case.
a single DLP common for all aspects of product use to facilitate
one country).
a consistent, broad-based examination of the safety information
Multiple sources of information (also No set numerator or denominator to cal-
for the API in a single document.
strengthens the safety signal). culate incidences.
Opportunity for re-assessment of Retrospective, potentially biased.
In exceptional cases, EMEA (European Medicines Agency), the
safety profile.
CA or the MAH may consider it appropriate to have a separate
Assessment and rationale for updat- Safety signal not verified.
PSUR. For example:
ing Company Core Data Sheet /
Company Core Safety Information
Products authorized through line extensions to existing medicinal
[(CCDS/CCSI] (Driving updates of
products (e.g. an API in two or more different formulations for
Package Inserts worldwide).
systemic versus topical administration) with cross-reference be-
Interim snapshot of safety reports. Causality for events cannot be deter-
tween PSURs, if appropriate.
mined based on information in a PSUR
(The pivotal problem for pharmacovigi-
Fixed combinations, where options include either a separate
lance: What events are really due to use of
PSUR for the combination with cross-reference to the single-
the drug product?)
substance PSUR or inclusion of the fixed combination data
within one of the single-substance PSURs.
UPCOMING EVENTS
The benefits of a
particular medicine should DIA’s 1st Workshop on Pre-market Evaluation
exceed the risks by the of Quality and Bioavailability
greatest achievable margin Hyderabad, India
for the individual patient 05/02/2009 - 06/02/2009
and for the target
population as a whole. This workshop will clarify the approval requirements for
drugs developed in India for global markets.

“Happy Reporting” Clinical Research Outsourcing in Asia at

Outsourcing Asia Summit 2009
All said and done, there are both strengths and weaknesses of
PSURs.
Singapore
The benefits of a particular medicine should exceed the risks by
18/02/2009 - 20/02/2009
the greatest achievable margin for the individual patient and for Share knowledge and practical experience of
the target population as a whole.
outsourcing business processes.
When the new risk is identified and benefit is still positive the
following actions can be proposed by MAH:
Clinical Trials in Emerging Markets
1. Supplementation of the Summary of Product Characteristic
and Patient Information Leaflet.
InterContinental Hotel, Vienna, Austria
2. Active surveillance under identified risks (non-interventional 24/02/2009 - 25/02/2009
study, letter to the doctors requesting for additional reports, edu-
cational materials etc.). Co-located with Clinical Trial Supply and Cold Chain
3. Risk minimization plan preparation and risk minimization Storage and Distribution.
strategy development.
4. Risk communication.
New Dates! Drug Discovery and Clinical
Development in India
Mumbai, India
25/02/2009 - 28/02/2009
Discuss solid scientific research in India pertaining to
global development of drugs and biologics.

BioMedical Asia 2009

Singapore
16/03/2009 - 19/03/2009
Explore partnership and investment opportunities and
discuss best operational strategies and successful
business models.
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BioMalaysia
BioMalaysia is Malaysia’s premier and largest biotechnology
conference and exhibition. Held annually, this significant
event attracts the best of Malaysian and global biotechnol-
ogy participants.
BioMalaysia 2008 surpassed the success of BioMalaysia
2007—with over 7,800 participants including 60 biotechnol-
ogy experts from 30 countries speaking at the conference,
1,100 conference participants, 85 international and local ex-
hibitors, and 6,555 trade visitors.
Visit BioMalaysia to learn more about the 2009 conference
to be held at the Kuala Lumpur Convention Centre from
November 17th to November 19th 2009.
www.biomalaysia.com.my
Malaysian Healthcare Industry Set to Grow this Year
The Malaysia’s healthcare industry is expected to grow at a
rate of 8% in 2009 and is being supported by a RM 13.7 bil- Source: Barnes, K. Outsourcing-Pharma.com, April 8
lion budget (RM 13 billion in 2008). This is an increase of 2008.
5.35% from previous year, which represents 2 percent of
GDP.
Both healthcare providers and pharmaceutical companies
are expecting increases in their market shares in 2009.
Healthcare companies see the global economy crisis as an
opportunity in emerging markets. Companies are prepared
to take bold steps with acquisitions or joint ventures with
niche medical technology players in China and India. The
pharmaceutical industry anticipates opportunities for invest-
ment by foreign companies in the form of clinical research
outsourcing and clinical trials.
Source: BioSpectrum, January 16 2009.
Malaysia Pharmaceuticals Expand into China
China has agreed to facilitate the easy entry of Malaysian
medical and pharmaceutical products, according to Health
Minister Datuk Liow Tiong Lai.
Following a bilateral negotiation recently, Liow said, China
had agreed to give a greenlight to Malaysian products al-
ready approved by the ministry without too much bureauc-
racy and second testing.
Source: The Star Online, January 27 2009.
A Rising Star: Malaysia’s Pharmaceutical
Industry
According to Lin Hui Tham, consultant of Healthcare
Asia Pacific at Frost & Sullivan, the boost in Malaysia’s
pharmaceutical industry is being driven by the increas-
ing numbers of pharmaceutical manufacturers that
have sought to outsource to or in-license their opera-
tions from the country.
For example, pharmaceuticals firms are increasingly
outsourcing some of their clinical work to contract
research organisations (CROs) within Malaysia.
The Malaysian government has played a significant
role in providing initiatives to the pharmaceutical
industry including the provision of grants and financ-
ing schemes to support R&D initiatives. The country
also recently established the Penang Science Park at
Bukit Minyak.
The park’s first tenant is a preclinical CRO—the first
of its kind in Malaysia—and is part-funded by a UK
venture capital fund. Called Progenix, the CRO is of-
fering toxicology services to the global biopharma
market and houses a range of mammalian species for
the purpose, from mice through to primates. Accord-
ing to the firm, it has a particular area of expertise in
inhalation toxicology.
Penang Halal Park
Two local halal firms with investments totalling over
RM200 million will be the tenants at Penang’s Halal
Industrial Park next year.
Penang Chief Minister Lim Guan Eng said the coun-
try’s sole halal gelatine maker for pharmacies, Halagel
(M) Sdn Bhd, will invest RM130 million and create
200 new jobs, while Granulab (M) Sdn Bhd, a member
of Johor Corp, will invest between RM50 million and
RM100 million for its synthetic bone graft material
operations.
Lim also said for the first phase in developing the
Penang Halal Industrial Park, a 52.4ha plot which is
adjacent to the Penang Science Park has been identi-
fied by the state government. The Penang Science
Park at Bukit Minyak has attracted investments of
over RM100 million to manufacture biotechnology-
related products and medical devices.
Sources: Emmanuel, M. Business Times, February
5th 2009; investPenang, July 4th 2008.
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