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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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kmbioserasi@ukm.edu.my

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

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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

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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