Workshop on “Biotechnology Commercialisation and Trade in … Docs/1342... · 2014. 3. 11. ·...

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Workshop on “Biotechnology Commercialisation and Trade in APEC Economies – Biosafety Regulatory Perspective” Le Meridien Hotel, Kuala Lumpur, Malaysia 4 - 6 September 2013 Supported by:

Transcript of Workshop on “Biotechnology Commercialisation and Trade in … Docs/1342... · 2014. 3. 11. ·...

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Workshop on “Biotechnology Commercialisation and Trade in APEC Economies – Biosafety Regulatory Perspective”

Le Meridien Hotel, Kuala Lumpur, Malaysia4 - 6 September 2013

Supported by:

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On behalf of the Department of Biosafety, Ministry of Natural Resources and Environment Malaysia,

it gives me great pleasure to welcome you to the Workshop on “Biotechnology Commercialisation

and Trade in APEC Economies - Biosafety Regulatory Perspective. To all speakers and delegates

from abroad, welcome to Malaysia!

The Department and organising committee have worked diligently to arrange an impressive

programme highlighting regional and national issues on modern biotechnology commercialisation

and biosafety. We invite you to actively participate in the conference proceedings and interact to

share knowledge and experiences. My sincere gratitude goes to all members, speakers and

delegates who have worked hard to ensure success of this workshop, and most of all we thank

you, participants for your contributions and your presence.

Thank you

I would like to extend a warm ™Selamat Datang™” to all

delegates and speakers of the Biotechnology Commercialisation and

Trade in APEC Economies - Biosafety Regulatory Perspective” workshop held in Kuala Lumpur,

Malaysia.

On behalf of the Malaysian Biotechnology Corporation (BiotechCorp), we truly welcome your

participation in this workshop. This convergence of experts and important stakeholders comes at an

opportune time where we envisage that the development of biotechnology and the importance of

adherence to biosafety regulations and protocols shall progress hand in hand for the good of

mankind.

I would like to thank APEC, the Biosafety Department of Malaysia, our knowledgeable speakers,

esteemed participants and the secretariat for making this event a reality.

Here’®s to a fruitful and exciting workshop!

Welcoming RemarksProject Co-Chairmans

Letchumanan RamathaDirector-General Biosafety Department

Ministry of Natural Resources & Environment

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Adrian Abdul GhaniSenior Vice President

BioNexus Development Division,

Malaysian Biotechnology Corporation Sdn Bhd

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TIME WEDNEDSDAY, 4TH SEPTEMBER 2013

8:00 AM Registration

9:00 AM Welcoming remarks

9:05 AM Opening remarks & Launch of the workshop

9.45 AM Coffee Break

10:00 AMRealising the Promise of Modern BiotechnologySenior Vice President, BioNexus Development Division,

Malaysian Biotechnology Corporation Sdn Bhd

10:45 AMAn Enabling Domestic Biosafety Regulatory FrameworkDirector-General Biosafety Department, Ministry of Natural Resources &

Environment

11:30 AM Coffee Break

12:00 PMCase Studies of Modern Biotechnology Commercialisation

• Aquaculture - BioValence

1:00 PM Lunch Break

2:00 PM

Case Studies of Modern Biotechnology Commercialisation

• Microbe - University of Science Malaysia

• Plant - Universiti Malaya

4:30 PM Adjourn

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Programme

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TIME THURSDAY, 5th SEPTEMBER 2013

9:00 AMBiosafety Regulatory Trends & Developments Policy and

Practice in the RegionOffice of Gene Technology Regulator, Australia

10:00 AM Coffee break

10:15 AMImplementing Biosafety Regulations in Developing

Economies: Challenges & Way ForwardChairman of GMAC Malaysia

11:15 AMBiosafety Compliance An Industry Perspectivei. Oxitec Malaysia Sdn Bhd

ii. Monsanto Singapore

1.00 PM Lunch Break

2:00 PM

Group Discussion

Topic 1: Comparative Analysis of the Biosafety

Regulatory Framework in Asia Pacific

Topic 2: Enabling Commercialisation & Easing the Cost

of Compliance

4:30 PM Adjourn

Welcoming Dinner

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Programme

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TIME FRIDAY, 6th SEPTEMBER 2013

9.00 AM

Group Discussion (Continue)

Topic 1: Comparative Analysis of the Biosafety

Regulatory Framework in Asia Pacific

Topic 2: Enabling Commercialisation & Easing the Cost

of Compliance

10.00 AM Coffee Break

10.30 AM Presentation by 4 Groups

11.30 AM Closing & Presentation of Certificates

12.00 PM End of Event

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Programme

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About the Workshop

The workshop will provide a platform where international biosafety experts and

regulators from APEC economies will be sharing their knowledge and experiences

with regards to regulatory challenges in the commercialisation of modern

biotechnology. The workshop will also provide valuable opportunity for

networking and to be updated with the current developments in biosafety

uniquely to the Asia-Pacific region.

The workshop will consist of presentations by international biosafety experts and

regulators from APEC economies. They will be sharing their knowledge and

experiences with regards to regulatory challenges in the commercialisation of

modern biotechnology. Selected participants will be present their experiences in

dealing commercialisation of modern biotechnology.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

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Speakers

Dr. Joe SmithOffice of the Gene Technology Regulator, Australia

Adrian Abdul GhaniMalaysian Biotechnology Corporation Sdn Bhd

Ung Eng HuanBioValence Malaysia

Prof. Dr. Rofina Yasmin OthmanUniversiti Malaya, Malaysia

Wan Izzuddin Wan SulaimanOxitec Malaysia

Dr. Harvey GlickMonsanto Singapore

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Letchumanan RamathaDepartment of Biosafety, Ministry of Natural Resources & Environment

Dr. Ahmad Parveez Ghulam Kadir Malaysian Palm Oil Board

Prof. Dr. K. Sudesh KumarUniversiti Sains Malaysia

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Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Letchumanan RamathaDepartment of Biosafety, Ministry of Natural Resources & Environment

Letchumanan Ramatha has been the Director General, Department of Biosafety at

the Ministry of Natural Resources and Environment, Malaysia since 2010. He

graduated with a Master in Public Management from the National University of

Singapore (2003), and a Bachelor of Engineering (Chemical) (Hons) from the

University of Malaya (1981).

As a senior government officer, Letchumanan has acquired vast experience and

expertise in policy analysis and planning covering broad areas such as Energy,

Communications, Multimedia, Environment, Biodiversity (including Wildlife

Protection, Marine Parks, Forestry), Biosafety, Biosecurity, Toxin and Biological

Weapons etc.

He has also represented the government in various capacities at numerous forums

organized locally, as well as at the ASEAN and international levels in particular in

relation to Multilateral Environmental Agreements such as the Convention on

Biological Diversity, the Cartagena Protocol on Biosafety and the Supplementary

Protocol on Liability and Redress.

Since his appointment as the Director General of Biosafety he has been

instrumental in setting up the institutional, scientific and legal frameworks for the

implementation of the Malaysian Biosafety Act 2007.

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Adrian Abdul Ghani is the Senior Vice President for Bionexus Development at the

Malaysian Biotechnology Corporation (BiotchCorp), an agency established by the

Government of Malaysia under the auspices of the Ministry of Science

Technology and Innovation to drive the development of biotechnology in the

country.

Specialising in policy formulation, regulatory and developmental advocacy, prior to

BiotechCorp Adrian was an advocate and solicitor of the High Court of Malaya

before serving as a Director with the Malaysian Communications and Multimedia

Commission, the regulators for the converged communications and multimedia

industry in Malaysia.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Adrian Abdul GhaniMalaysian Biotechnology Corporation Sdn Bhd

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Dr. Joe SmithOffice of the Gene Technology Regulator, Australia

Dr Joe Smith has been Australia’s Gene Technology Regulator since March 2009.

In this role, he is the statutory office holder responsible for administering the

national regulatory system for gene technology. He is committed to delivering a

transparent, scientifically robust, effective and internationally respected system for

the regulation of gene technology in Australia. Joe has a diverse background

spanning over thirty years in both the public and private sectors involving

scientific research, services and regulation.

He has over twenty four years experience in senior government regulatory and

related roles, including as Chief Executive of the Australian Pesticides and

Veterinary Medicines Authority, Director of the Therapeutic Goods Administration

Laboratories and as Australian Government Analyst. He has been actively

engaged in international collaborative and standards setting activities through

forums such as the OECD, FAO/WHO and ISBR, and in building cooperation with

counterpart regulators in other countries.

He has a PhD and BSc (Hons), is a Fellow of the Royal Australian Chemical

Institute and a Graduate of the Australian Institute of Company Directors.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

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Dr. Ahmad Parveez is a Senior Principal Research Officer at the Advance

Biotechnology and Breeding Centre, Malaysian Palm Oil Board and involved in

research related to genetic engineering of oil palm and its biosafety. His main

focus is to change the fatty acid composition and synthesizing novel metabolites

such as biodegradable plastics.

He is involved in designing of biosafety screenhouses for planting of transgenic

oil palm. He also involved in biosafety studies, such as effects on insect and

environment, horizontal gene flow and pollen viability. He also supervising a

number of Research Officers and Post-graduate students on their research related

to genetic engineering of oil palm or other species.

He is involved in the drafting of Malaysia Biosafety regulations and guidelines

besides becoming a resource person for Department of Biosafety events. He has

attended many biosafety related courses and workshops locally and internationally

including workshops on issues related to risk assessment of GMO plants

sponsored by CBD Secretariat/UNEP and ICGEB, in Cambodia and Italy in 2010,

respectively.

He was appointed as the Genetic Modification Advisory (GMAC) Chair by the

Minister of Natural Resources and Environment in May 2010 and reappointed in

the year 2012.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Dr. Ahmad Parveez Ghulam Kadir Malaysian Palm Oil Board

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Prof. Dr. Rofina Yasmin Othman is currently Acting Dean, Health and

Translational Medicine Cluster, University of Malaya. She has previously served as

Under-Secretary of the National Biotechnology Division of the Ministry of Science,

Technology & Innovation (MOSTI) and was Head of Centre for Research in

Biotechnology for Agriculture (CEBAR) also in UM.

She obtained her Bachelor’s degree in the year 1984 from University of Surrey,

UK in the year 1984. In 1990 on completion of an MSC at the University of

Malaya, she was awarded a Chevening Scholarship to pursue a Ph.D in Plant

Virology. She obtained her Ph.D. in Plant Virology from the John Innes Institute

of Plant Science (UK) in the year 1994. She has been awarded numerous

fellowships and international exchange links grants which gave her the

opportunities to work at Cornell University (USA), Scripps Research Institute (USA),

Nara Institute of Science & Technology (Japan), University of Derby (UK) and the

University of Leicester (UK).

Her professional affiliations include being a Member of the International Banana

Genomics Consortium and the United Nations Industrial Development

Organization (UNIDO) Consortium on Biosafety; Associate Fellow of the Asia-

Pacific International Molecular Biology Network (A-IMBN), Member of the

Malaysian Genetic Modification Advisory Committee (GMAC) and she currently

serves as President of the Malaysian Society for Molecular Biology &

Biotechnology and an expert member to the National Biosafety Board. She also

sits on the Board of Governors of the International Centre for Genetic Engineering

and Biotechnology (ICGEB) and is Malaysia’s representative to the Asean

Subcomittee on Biotechnology.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Prof. Dr. Rofina Yasmin OthmanUniversiti Malaya, Malaysia

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Dr. Glick has been actively involved in agricultural research and development for

over 35 years. He studied agronomy at McGill University in Montreal where he

received a Bachelor of Science in Agriculture. He obtained his Masters degree

in plant physiology at the University of Manitoba and received his Ph D at the

University of Manitoba on full scholarship in plant physiology and biology. He

has also completed an executive business management program at the University

of Western Ontario.

After completing his formal education he joined the Canadian Wheat Board, an

organization involved in international grain marketing. In 1985, after three years

with the Wheat Board, he joined Monsanto as it was beginning to develop crop

biotechnology programs.

Over the past 29 years at Monsanto, Harvey has lived and worked in Canada,

Belgium and the US and currently is based in Singapore. He has held a variety

of positions in the technology, commercial development and marketing

organizations. He has been fortunate to visit and work in agricultural production

systems in many different regions of the world with the objective of bringing new

agricultural technology to producers. He helped introduce the first biotech crop

to Canadian farmers in 1995 and has been actively involved in the development

of biotech crops for Europe, Asia and the Americas. Currently he is head of

Regulatory Policy and Scientific Affairs for Asia and is directly involved in

bringing the next generation of plant biotechnology products to farmers in Asia.

He is a frequent speaker at conferences focused on agricultural biotechnology

and sustainable food production systems. He serves on the Board of Directors

for the International Life Sciences Institute (ILSI) in Asia.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Dr. Harvey GlickSenior Director, Asia

Regulatory Policy & Scientific Affairs

Monsanto [email protected]

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Prof. Sudesh®’s main research interest is in the design and synthesis of

biodegradable polyhydroxyalkanoates (PHAs) using microbial systems. He started

doing research in this area in 1992 and obtained his Masters in Biotechnology

from University Malaya. Then, he continued research in this area for his PhD,

which was sponsored by Japanese Government (Monbusho). His research project

was on the cloning and characterization of the genes involved in the production

of bioplastics. The research was conducted at RIKEN Institute, Japan.

He obtained his PhD in 1999 and then continued as a Special Postdoctoral

Researcher at RIKEN. He returned to Malaysia under the Brain Gain program and

joined the School of Biological Sciences, Universiti Sains Malaysia as a lecturer in

2001 and became a full professor 10 years later.

In the past 12 years in USM he has significantly contributed to the research and

development of biodegradable plastics in Malaysia. In addition to the numerous

scientific publications in both local and international journals, he has 4 granted

patents, one of which has been successfully licensed.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Prof. Dr. K. Sudesh KumarUniversiti Sains Malaysia

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Ung has over 25 years commercial sector experience and has worked in the

aquaculture field in Malaysia, Indonesia, India and the Maldives. He is a

Consultant for mariculture biotechnology representing ASEAN in the ASEAN-

Republic of Korea joint programme.

He also teaches both undergraduate and M.Sc. students in the University of

Malaya as a Visiting Lecturer in Biotechnology. He is currently in charge of

managing Global Satria Group’s ‘spin-off’ biotech companies of which BioSatria

Sendirian Berhad is the first.

He has a First Class Honours from the University of London and a Masters with

Distinction from the University of Stirling in Aquaculture and is the winner of the

Royal Highland Agricultural Award of Scotland.

Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Ung Eng HuanBioValence Malaysia

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Workshop on "Biotechnology Commercialisation and Trade in APEC Economies - Biosafety Regulatory Perspective“, 4 -6 September 2013. Kuala Lumpur, Malaysia

Currently, Wan Izzuddin is the Acting Chief Executive Officer of Oxitec Sdn Bhd

which is the subsidiary of Oxitec Ltd. (UK). The company was involved in a

collaboration with Malaysian Government on evaluation of Genetically Modified

Mosquitoes technology in Malaysia. He is also the CEO and Principal Consultant

of Team BioVision Sdn Bhd.His experience range from technical to management

with him contributing his expertise to several companies such as Technology Park

Malaysia and Kelantan Biotech Corporation. He was also the Vice President in

Malaysia Biotechnology Corporation (BiotechCorp) with excellent contributions to

the company.

He obtained his first degree, Bachelor of Science (Biology) in 1984 and Masters of

Natural Science (Biology), Southeast Missouri State University, USA in 1986.He

even continued to further his knowledge in the field of parasitology and

entomology from Institute of Medical Research in 1990. In 1992, he obtained the

Advanced Diploma in Statistical, Epidemiological and Operational Methods

Applied in Medicine and Public Health from , Universite Libre de Bruxelles,

Belgium.

Wan Izzuddin Wan SulaimanOxitec Malaysia