Regional Higher Education Conference 3 -5 Dec 2007

Regional Higher Education Conference 3 -5 Dec, 2007 Country case: Malaysia Issues on Research, Development and Commercialization Prof Asma Ismail, Director, Institute for Research in Molecular Medicine (INFORMM), Health Campus, USM, 16150 Kubang Kerian, Kelantan and Suite 110, Eureka Complex, USM Minden, Penang

e ra dge Biotechnology era IT era wle The need to move to Keconomy Kno Increasing competition The Global agenda Technological era Agricultural era Hot Spots 21 st century (Future) Primitive era 650 © DAR 2003 1750 1950 Modified from Richard W Oliver, The shape of things to come 2000

• “As nation develop, they progress through a number of stages in terms of their characteristic competitive advantages and modes of competing” From resource-driven to Innovation-driven Resouce -driven economy Rubber, palm oil etc Investment -driven economy Multinationals at free trade zones Innovation -driven economy Knowledge-based Stages of economy for Malaysia © DAR 2002 - Porter M, Enhancing the microeconomic foundations of prosperity

New R&D challenges • Challenge for R&D in the country would be how to move towards • the requirements needed to succeed in the Innovation-led economy: Technology-driven (10 -15 years) § Dependent on our researchers • Own original scientific discoveries that will enhance the competitiveness and provides the leading edge for the country. • Set new trends in technology and create our own technology platforms • Ability to combine scientific discoveries and technology platforms to create new innovations that can create an impact to society and the global market; undergo translational research • Market-driven (3 -5 years) § Dependent on our business community/government § Dependent on funding § Buy existing technology and innovate Innovation-led economy • Technology driven • Market driven

Challenges in Innovation-led economy that affects R&D § Political will • Create policies that support R&D, innovation and entrepreneurship § Human capital • Sufficient number of innovative, creative and relevant human capital (Knowledge-workers) • Originality and IP § Must show originality and creativity in offering solutions to problems with the generation of intellectual properties/ patents • Change in the R&D approach § Harness the human capital to create an environment of innovative culture § Work with the end in mind § Funding • Funding to drive R-D-C-E • Funding to buy existing technology (market-driven)

POLITICAL WILL R&D being the National Agenda ‘Being a global player is unavoidable for a country that wants to develop’ - Abdullah • Malaysia has the political will to • • ensure that R&D is the national agenda to drive the K-economy of the country (O. 5% of GDP (6%). The government has provided a lot of national grants (at least RM 1. 7 billion from 2006 -2010) to promote R&D&C But is the amount ENOUGH to promote commercialization of research products

Moving towards successful K-economy: R&D Challenge Phase 1: Consolidating Research R PHASE 1 Making scientific discoveries Research discoveries, acquisition of technologies Applied and fundamental grants D Phase 2: Consolidating Development PHASE 2 Develop prototype Design, engineering and technology integration Development grants, pre-bridging grants C Phase 3: Consolidating Commercialization Patent, Marketing, Entrepreneurship and licensing PHASE 3 Techno fund Commercialize Smooth and continuous flow of R-D-C-E E Phase 4: Consolidating Knowledgebased enterprise (Research Park) • Spin off companies/ JV companies Venture Capitalists, Innofund PHASE 4 K-enterprise

Pitfalls and challenges: Status of Research & Development in Malaysia R Phase 1: Consolidating Research D Need to improve the number of publications Need to improve impact factor Need to improve citations Phase 2: Consolidating Development C WHY are we not there yet? Phase 3: Consolidating Commercialization/Innovation/Technology licencing Commercial arm of the University • Entrepreneurship • Spin-off companies • JV Companies • Licensing E ? ? ? ?

WHY are we not there yet? Human capital Country R&D personnel/10, 000 pop Thailand 9. 1 Malaysia 21 USA 89. 6 Singapore 83. 5 UK 61. 4 Japan 112. 8 Not sufficient K -workers! Need 60/10, 000 pop National Survey of Research and Development 2004, MASTIC

Expectations of Modern Universities in the Knowledge-era • Role of Universities include the need to train the human • capital to be relevant and support the innovative culture Expectations of Modern Universities § Generate knowledge § Disseminate knowledge § Facilitate translation of knowledge into tangible and intangible products • Universities are expected to undergo Research • Development-Commercialization of R&D and setting up of Knowledge-based enterprises in the Research Park In Malaysia, we now have Research Universities that should lead the way to generate IP and wealth for the country and enhance the quality of life of the people.

If patents indicate originality/creativity Indigenous Technology Country % GDP (Amount USD) Patents per 100, 000 pop Efficiency Mil (USD)/patent Malaysia 0. 5 (440 mil) 1. 7 259 Thailand 0. 2 (306 mil) 2. 6 118 S. Korea 2. 9 (12 bil) 456 26 Japan 2. 9 (142 bil) 820 175 Fadzilah Ahmad Din. National S&T Indicators in Malaysia: Where are we now? . MASTIC, MOSTE, National Symposium on S&T, July 28 -30, 2003. We lacked efficiency in producing patents We lacked originality in performing R&D

Patents • Are people aware about IPR? • We need to encourage IPR awareness and the patent culture. • We should not view patents as a number game. • When we patent we should use it to design and develop new innovations. Patents must be used to generate income. It is used to generate K-based industries for the country. The iceberg phenomenon

Commercialization of research products • Commercialization of R&D products is not • a simple process It is a complex exercise that must address several issues before we can take the technology/product/process to the market

Commercialization of Knowledge Idea (scientific discovery) + Innovative Technology Lab model DISCOVERY COMPANY’s ROLE Issues: Since industry not ready, univ has to do both roles • Undergo translational Research • Research theses • Patents and IPRs • Commercial viability • Business plan • Win awards UNIVERSITY’s ROLE Evaluate (lab-level) Prototype Packaging • Business plan • Win awards Product DEVELOPMENT AND INNOVATION Evaluation (multi-centres) Courtesy of Sam Teng Wah, USAINS Technology Licencing

Benchmark with UK 2004 UK Patent-Investment ratios for 11 sectors http: //www. innovation. gov. uk/rd_scoreboard/patents_ratio. asp No of disclosures differ For different areas of focus Ave 2. 8 million pounds/patent RM 20 million/patent Investment of RM 1760 million, Malaysia should have 88 patents But only 25 patents in biotech Most expensive!

Reality check: Patent vs licencing • In USA the ratio of commercialization to patent is • 1: 3. 5 Since we are spending RM 1, 760 we should hypothetically produced 88 patents ( 25 technology licencing for the country or 7 biotech licencing for the country) • Hence the lack of technology licencing and the setting up of K-based industries due to insufficient funding.

Reality check: Financial investment • Business community: § Must believe that knowledge can be turned into a business § Must have strong network of angel investors § Must perform research as the basic building block for any K-based industry

Reality check: Financial investment • Currently Malaysian business communities lack the • • knack for K-based industries. Majority are still into property and manufacturing. They will only come in at the latter part of research when you have developed § a product or devise or services or a process to undergo technology licensing or direct selling Venture Capitalists as investors are also not adventurous (does not take risks).

Reality check: Need to change paradigm to do research • We must meet the industry half way. • We must understand that in the new economy, a discovery has no value until it can benefit the public. Publishing and winning gold medals for the products created are not enough. It has to be commercialised. • Compromise: Work with the end in mind. • Cater for the needs of the client. • R&D product would be more commercially viable • Experimental design strategy must be from Z to A rather than A to Z.

Paradigm shift: The New Research approach • Strike a balance between fundamental and applied in order to undergo Translational Research (Move R to D to C) • Work in multi-disciplinary clusters Generate Produce relevant • Generate new industries scientists and Patents postgraduates to Create new • Publications be drivers of K-economy Scientific Enhance discoveries STRATEGIC quality INNOVATIONS A FUNDAMENTAL Z of life RESEARCH Work with end in mind Check market/client requirements + Develop Advances in Technology • Incentives for scientists • Incentives for industries To ensure products remain technologically competitive Consolidate existing industries Z

The Innovation system at USM • • • R Research Development D Commercialisation C Enterprises (knowledge-based) E Research Park (P) (in-campus ‘industrial alliances’) Global vs Local © DAR 2003 innovation -driven

INFORMM’s Technology development and design strategies at MITD for diagnostics

Working from Z to A (end in mind): Market foresight requirements for rapid diagnostics Criteria for Design and development • Rapid • Specific • Sensitive • Easy to perform • Cost effective • Can be transported without cold chain Scientific discovery Technology platform Patent separately • Dot EIA • Dipstick • Sensor technology • Thermostabilised PCR • PCR DNA chip

Contribution to K-economy: Molecular Diagnostics Rapid protein or DNA - based diagnostics for the following diseases • • • Typhoid Cholera Campylobacteriosis Filariasis Tuberculosis Dysentery Paratyphoid Nosocomial infections Pharmacogenomics (Drug response to TB) Focus on diseases relevant to S. E Asia

Commercialization Track record: Antibody-based Biotech kits 6 kits commercialised ORIGINAL DISCOVERIES 2002 1996 2005 1994 Bancroftian filariasis -2005 Pan filariasis -2006

Planned strategic approach for creation of technology platforms ( Road map for typhoid diagnosis ) Scientific Discovery 50 k. Da Dot EIA (Require cold chain) Immunochromatography (No cold chain) Thermostabilised PCR EZ Universal PCR Chip (Nanotechnology) TYPHI carrier DNA TYPHIrapid™ 15 min 1986 -1991 1998 2005 1994 1997 2004 TYPHOID DIAGNOSIS

Commercialization of TYPHIDOT – a rapid diagnostic test for typhoid R&D is necessary to make the product technologically competitive Pakistan India Philippines South Africa Guam Papua New Guinea Thailand Vietnam Egypt Turkey United Arab Republic Indonesia Bangladesh China Sudan Cameroon Nigeria USA Outputs • 33 Publications • 7 Patents • Creation of 500 jobs • Supported local industries • Generated income Global Distribution of Typhoid Fever • Won >50 awards

Thermostabilised PCR Boil sample to obtain DNA Create new technology platforms for molecular diagnostics 3 min USM invention M. Ravichandran et al 40 min 80 min 100 bp DNA ladder marker Sample DNA + water Add 2 ul lysate + 18 ul water (2 steps) ¯No cold storage two pipetting steps ¯Does not need PCR skilled personnels ¯Cheap (USD 10 to now USD 1) ¯Only Duration: Approx 2. 5 to 3 hours PCR product 415 bp Amplication of target genes Gel electrophoresis analysis Require collaboration of strengths

Thermostabilised PCR kits 2003 2004 EZCholera Amp ITEX 2003 Silver Medal EZEBV Amp ITEX 2004 Gold medal WIPO Gold Medal KASS Award 2004 Geneva 2005 Gold Medal 2005 EZVRE Amp ITEX 2005 Gold medal Geneva 2006 Gold Medal 2006 DNA ITEX 2005 Silver Medal 2007 EZDysentry Cholera Genosensor A total solution LD SO EZDNA Amp Expo S&T 2003 Silver medal Commercialized by MBDr M’sian Patent: PI 20051471 EZTB Amp ITEX 2004 Silver medal Commercialized by MBDr EZAmp Octaplex Cholera ITEX 2004 Gold medal WIPO Gold Medal Geneva 2005 Gold Medal EZTyphi Carrier DNA ITEX 2005 Gold medal ITEX 2005 Best Invention in Biotechnology Geneva 2006 Silver Medal EZCampy DNA Expo S&T 2005 Silver Medal Geneva 2006 Silver Medal SO LD Courtesy: M Ravichandran, USM

Conclusion n. Development of technologically competitive product/device/process/expertise is no longer a luxury. n. It is a necessity n. It would require collaboration with other strengths on a global scale to stay ahead of the game n. Malaysian R&D must be relevant, accessible, bring in respect and profits and not an economic drain ICT quad scan Universal PCR chip Genosensor

Acknowledgements • Committee for National Strategies for • • Biotechnolgy Committee for Human capital development – ASM Committee for Strategic plans for KPT on R-D-C Issues

THANK YOU ISO 9001: 2000 certified UK, France, Malaysia, Italy, Germany INFORMM Health campus INFORMM Main campus asma@kb. usm. my Http: www. informm. usm. my Institute for Research in Molecular Medicine