associate prof dr nor fadilah hj rajab ......1. the malaysian medical device act (2012) will require...
TRANSCRIPT
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Opportunities for Commercialisation of R&D Findings by Universities, Courses Offered for Pharmaceutical & Medical Devices Industries;
Collaboration between university and industry in Pharmaceutical & Medical Devices Industries.
ASSOCIATE PROF DR NOR FADILAH HJ RAJAB
UNIVERSITI KEBANGSAAN MALAYSIA
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University and industry collaboration can be defined as “bi-directional linkages between university and industry entities, established to enable the diffusion of creativity, ideas, skills and people with the aim of creating mutual value over time” (Plewa et al., 2013). For the sustainable development of the innovation ecosystem, collaborative work undertaken by both the university and industry is the mechanism that drives the success of the outcome. Collaboration can be in many ways such as funding for knowledge and technology developments by the universities, vice versa, university linkages are important for innovative activities of the firms . Additionally, The changing role of universities beyond teaching and research to commercialisation contributes significantly for the success of commercialisation and innovation. In addition, industrial linkages also create the so-called combinative capabilities (Kogut and Zander 1992) or the degree of technological opportunity. Besides, collaboration benefits universities in terms of revenue, licensing, equity, sponsored research, donations and technology development. (Chandran et al. 2013)
Collaboration between university and industry
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Motivation for collaboration
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Motivation for collaboration
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Collaboration Barriers
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Solution to overcome barriers
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Interaction between university and industry usually requires some sort of technology transfer from either side or each side of contracting parties. According to (Lee and Win, 2004) among the mechanisms of technology transfer are as follow: 1. Collegial interchange, conference and publication. 2. Consultancy and technical services provision. 3. Exchange program and expertise or employee secondment. 4. Joint venture of research and development. 5. Licensing (transfer of intellectual property rights to a third party) of university intellectual property to the
industry 6. Contract research by the industry to university or research centre and usually industry provides the fund. 7. Training/ Internship 8. Practical training where students are exposed to the working methods and requirements of jobs at industry
Collaboration between university and industry
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Courses Offered for Pharmaceutical & Medical Devices Industries
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Universities should employ a different approach to their programmes and activities to suits the market demands by the industries. An initiatives should be put together by the institutions, through various knowledge exchange and business-matching activities to enhance the collateral understanding on the requirement by the industries to fulfil their needs. Additionally, universities is also suggested to produce industry-ready graduates by offering professional courses as add-on to the fundamental based knowledge.
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Masters of Health Science (Biomedical Science) Coursework Programme
The taught-course Masters in Health Science (Biomedical Science) programme at UKM is the first to be offered in Malaysia. It provides opportunities to graduates, especially those in biomedical science, to enhance their knowledge and skill in biomedical sciences. (Specialization III: Toxicology) Code Course Name Unit NNNB6124 Natural Product Development 4 NNNB6144 Toxicology Laboratory Placement 4 NNNB6164 Toxicology Laboratory Techniques 4 NNNB6624 Research Project in Biomedical Sciences 4 Total Units 16 units
Courses Offered for Pharmaceutical & Medical Devices Industries At the Faculty of Health Sciences, UKM
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Universities have been identified as the key to wealth creation of a country since they are the centre for the best mind of a country. University’s profile as a non-profit organization has made the experts of certain fields of knowledge unknown to the industry and thus, their expertise were not fully utilised for the betterment of the society. However, there has been dramatic increase in awareness of the importance of university’s involvement with industries, and this development has called forth the emergence of entrepreneurial university. Traditional university system was built for the purpose of disseminating knowledge which later on evolve to have dual mission of dissemination of knowledge and production of new knowledge through research (Morphew, 2003), (Atkinson &Blanpied, 2008) and (Cheng, 2011). Recently universities have again expanded to embrace ‘third mission’ (Wong, Ho & Singh, 2011) as laid down by (Etzkowitz, 2002) that is university involvement in regional economic development through capitalization of knowledge produced at the university. One of the approach is by providing services based on the expertises, knowledgeable minds and skills produced by the institutions or universities to serve the need of the industries.
Entrepreneurial University
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SHARING EXPERIENCE
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Makmal Bioserasi –
Biocompatibility Laboratory
www.makmalbioserasi.com
Makmal Bioserasi
Centre for Research
and Instrumentation
Management (CRIM),
Universiti Kebangsaan
Malaysia,
43600, UKM Bangi,
Selangor Darul Ehsan.
03-8921 4280 (Phone)
03-8921 4281 (Fax)
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Location of Makmal Bioserasi, UKM
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What is Makmal Bioserasi?
Makmal Bioserasi is a BIOCOMPATIBILITY and TOXICITY TESTING
LABORATORY established in 2003 offering support services to manufacturers
and distributors. We specialize in the field of BIOMEDICAL SCIENCES, especially in the area
of toxicology, microbiology and biochemistry, and are committed to
helping customers (sponsors) deliver safe products and devices to patients and
the general public.
Biological testing (non-clinical) usually takes place at several logical points in the
development of new materials and products. Assessment of chemicals or material interactions in cell and animals
forms the basis in determining the safety of products.
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What is Makmal Bioserasi?
MS ISO/IEC 17025 accredited since October 2010.
We undertake studies using standard methods and guidelines of the ISO, US
FDA, ASTM and OECD.
All studies are performed to standard methods and protocols adhered to
principles of good laboratory practice (GLP). #
Since 2010, Makmal Bioserasi has been awarded Bionexus - partnership by
Malaysian Biotechnology Corporation (BiotechCorp) on enhancement of our capacity
building programs.
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Certificate of
Accreditation
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Scope of
Accreditation
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Permanent
Contract
Organisation
Chart
IN VITRO
CYTOTOXICITY
• MEM Elution Test
• MTT Assay
• Agar Diffusion Assay
IN VITRO
GENOTOXICITY
• Reverse Mutation Assay (Ames)
• Comet Assay
• Micronucleus Assay
IN VIVO
• Dermal Sensitization
• Primary Skin Irritation
• Skin Corrosion and Irritation
• Rabbit Pyrogenicity
• Intracutaneus Reactivity
• Acute Toxicity
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Services Provided by Makmal Bioserasi
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Operational Activity
1. Conduct in vitro Tests. 2. Conduct Animal Tests. 3. Training in Regulatory Testing.
4. Teaching, Consultation and Learning Facilities.
5. R&D on Food Ingredients, Implant Material & Herbal Formulations.
BIOCOMPATIBILITY TEST MATRIX
GUIDELINES FOR THE APPLICATION OF SPECIAL MANAGEMENT OF SCHEDULED WASTE – DOE
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Market Segment
1. Medical Devices
2. Industrial Chemical
3. Herbal Formulations
4. Food Ingredients
5. Cosmetic Ingredients
6. Scheduled Waste materials
7. Biologics
8. Cytotherapy
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Company Types
Micro enterprise & SME 34%
Large enterprise 16%
Multinational corporation/enterprise (MNC/MNE)
32%
Government agency
9%
Institutions 9% Micro enterprise & SME
Large enterprise
Multinationalcorporation/enterprise(MNC/MNE)
Government agency
Institutions
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Test Material Received
Category 2010 (%) 2011 (%) 2012 (%) 2013 (%) 2014 (%)
Medical Device 40 73 71 49 63
Food 3 0 8 7 4
Herbal and pharmaceutical
products
7 4 2 1 11
Cosmetic products 1 0 0 1 5
Chemicals 43 15 14 25 16
Pesticides 0 0 0 0 0
Waste materials 3 6 6 1 2
Biologicals 1 0 0 0 0
Other 3 1 0 16 0
For 2015, 32% Medical Device, 36% Manufactured Product, 9% cosmetic product, 6% chemical product and 6% others
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Makmal Bioserasi-At A Glance
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Makmal Bioserasi-At A Glance
MOVING FORWARD
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MD Sales Exceeded the Forecast
Forecast sales value
Actual sales value
2013 2014 2015
Medical devices sales export revenue
RM 6.24 billion RM13.5 billion RM15.11 (forecast)
Source: Association of Malaysian Medical Industries 2015
Asean Economic Community
AEC will transform ASEAN into a region with free movement
of goods, SERVICES, investment, skilled labour, and freer
flow of capital.
Big potential in biocompatibility and toxicity testing
services.
ASEAN MD market = USD 27 billion/year
.
FMM, MMDA
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With GLP Certification;
1. The Malaysian Medical Device Act (2012) will require biocompatibility
data of medical devices to be evaluated under GLP regulations.
a. The need to have a local GLP facility is imminently critical in giving out
services at par as the world standards.
2. Market conditions.
a. Testing required for market approval.
b. New devices and products being introduced.
c. No other local labs with similar capacity & expertise
3. Safety regulations on other products.
4. Active R&D activities from institutions require safety assessment data.
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Market Advantage
1. Our services are recognized by industries, institutions, and MoH Malaysia.
2. Test reports accepted by international regulators e.g. USFDA, CE Marks
3. No significant local competition.
4. Have the know-how. 5. Ahead in infrastructure, capacity and expertise. 6. Safety testing business is perpetual.
. Sales value of own manufactured products (2013)
Category Sales value of own manufactured products
RM Billion
Medical device 12104353000 12.1
Food 18456410000 18.5
Chemicals 1.79722E+11 180
Pesticide 1341992000 1.3
Pharmaceuticals 1594011000 1.6
Sales value of local manufactured products
Sales value of local manufactured products (2013)
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Asean Economic Community
AEC will transform ASEAN into a region with free movement of goods, SERVICES,
investment, skilled labour, and freer flow of capital.
Big potential in biocompatibility and toxicity testing services.
Malaysian MD export = USD 2.5 billion/year
Malaysian MD consumption = USD 1.3 billion/year
ASEAN MD market = USD 27 billion/year
Cosmetic & Skincare products = USD 2.4 billion/year
Herbal supplements = USD 1.2 billion/year
.
FMM, MMDA
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hTERA (Human Toxicology And Health Risk Assessment
Center Of Excellence)
Health Technopolis
Makmal Bioserasi - Involved In Providing
Testing Facilities for Health Risk Assessment and Safety Evaluation.
1. Mechanistic Toxicology
2. Genetic Toxicology
3. Clinical toxicity
4. Neurotoxicology
5. Chemical Toxicology 6. Environment and Ecotoxicology
7. Reproductive Toxicology
8. Natural Product Toxicology
9. Food Toxicology
10. Occupational and Industrial Toxicology
Risk Assessment
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Makmal Bioserasi
1. Mechanistic Toxicology
2. Genetic Toxicology
3. Clinical toxicity
4. Neurotoxicology
5. Chemical Toxicology
6. Environment and
Ecotoxicology
7. Reproductive
Toxicology
8. Natural Product
Toxicology
9. Food Toxicology
10. Occupational and Industrial
Toxicology
Health Technopolis
hTERA (Human Toxicology And Health Risk
Assessment Center Of Excellence)
Makmal Bioserasi Will Be Involved In Providing Testing Facilities Of Health Risk
Assessment For Safety Evaluation.
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Thank you