Round Table on Harmonisation of Global Regulatory Framework Chair Mr. Narayanan Suresh Group Editor BioSpectrum - India & Asia #9, UNI Building, 3rd Floor Millers Tank Bund, Thimmaiah Road Vasanth Nagar, Bangalore - 560 052, India Email: [email protected] ------------------------------------------------------------------------------------------------------------------Panelists Mr. Razwin Sulairee Hasnan Termizi Chief Operating Officer Malaysian Biotechnology Corporation Sdn Bhd Level 23, Menara Atlan, 161B, Jalan Ampang , 5045, Kuala Lumpur, Malaysia Email: [email protected] Profile : Razwin Sulairee is the Chief Operating Officer of Malaysian Biotechnology Corporation Sdn Bhd. Razwin has joined Biotechcorp in 2007. He was the Vice-President in Industrial Business Development and Investment Division (2007-2010), Senior Vice President in Industrial Business Development and Investment Division (2010-2011), Executive Senior Vice President in Business Development and Investment Division (2011-2012) before promoted to current position Chief Operating Officer of Malaysian Biotechnology Corporation Sdn Bhd. Prior to his appointment to BiotechCorp, he was the Senior Deputy Director of the Malaysian Rubber Export Promotion Council (2000-2007). Manager of Sime Darby (1995 – 2000) and responsible for strategic planning, investor relations and business development. Razwin attended a Senior Executive Programme in Asia-Hong Kong at Michigan Ross School of Business (2012). Razwin received his Master of Business Administration from Universiti Teknologi MARA in 2004. In 1995 Razwin received a Bachelor’s Degree of Industrial Chemistry from University Putra Malaysia and Diploma in Plastic & Rubber from Plastic and Rubber Institute of Malaysia (PRIM). Razwin Sulairee brings to BiotechCorp his expertise in investment, business development and strategic planning. He leads and oversees implementation of industrial biotechnology initiatives. Leads business development and client partnerships to attract biotechnology companies to set up operations in Malaysia and showcase Malaysia’s value proposition. ******************* Panelists Dr. Yang-woo Kim Chief of International Export & Trade Promotion Center; Korea Health Industry Development Institute (KHIDI) Osong Health Technology Administration Complex, 187 Osongsaengmyeong2(i)-ro, Osong-eup, Cheongwon-gun, Chungcheongbuk-do, 363 Email: [email protected] Profile: Education Ph.D., Public health, Korea University B.S., Pharmacology, Chosun University Professional Experience Chief of Center, Korea Health Industry Development Institute(KHIDI) National Health Insurance Corporation(NHIC) Health Insurance Review and Assessment Agency(HIRA) Research Interests RA & Health Insurance Reimbursement Drug pricing Pharmaco-economics Policy of health industry Publications KHIDI Report(2013) Scandinavian Journal of infectious Disease(2012) Journal of pharmaceutical society of Korea(2010) ISQua Journal(2005) Dr. Andrew Milner MD & CEO, Neurosciences Victoria Ltd. Melbourne Brain Centre 30 Royal Parade (corner Genetics Lane) Parkville, Melbourne, 3010 Victoria, Australia Email: [email protected] Sessions : Round Table on Harmonisation of Global Regulatory Framework Developing Strategic Relationships in Neuroscience between Melbourne and India Profile: Neurosciences Victoria Ltd (NSV) is a Victorian company established in 2001 whose member organisations comprise Victorian universities, medical research institutes and hospitals. NSV’s primary goal is to market major neuroscience programs to industry and government. NSV works closely with the Melbourne neuroscience community to offer a single access point to a range of neuroscience platforms and disease specialisations, backed by leading neurology and psychiatry resources and clinical expertise. A key strategic aim for NSV is to develop international linkages to generate and facilitate major research and development programs. Dr Milner is on the advisory and management committees of a number of major neurology, psychiatry and technology programs and is a member of the Advisory Board for the Melbourne Neuroscience Institute. ******************* Panelists Dr. Ash Ramzan Managing Director / Principal Consultant Woodley BioReg Ltd. Midland Mill, 9-11 Hillhouse Lane, Huddersfield, HD1 6EF, UK Email: [email protected] Sessions: Round Table on Harmonisation of Global Regulatory Framework Biosimilars Attaining Global Standards Profile : Dr Ramzan is Managing Director / Principal Consultant of Woodley BioReg Ltd, a Regulatory and Quality consultancy based in the UK specialising in the registration and maintenance of pharmaceuticals (particularly biologics and generics)in the EU and US for a range of global companies. Dr Ramzan has worked in the biopharmaceutical industry for around 25 years with companies including Ipsen, Wyeth, Novartis, Sanofi-Aventis, Eli Lily, and Medeva. Dr.Ramzan’sholds aPh.D in Protein Biochemistry and a BSc. (Honours) in Biochemistry from the University of Liverpool, UK. *************** Panelists Dr. P.M. Murali President, Association of Biotechnology Led Enterprises (ABLE); MD, Evolva Biotech 401 - 405, 4th Floor, Ticel Bio Park Ltd. Taramani Road, Taramani Chennai - 600 113, India Email: [email protected], [email protected] Session: Round Table on Harmonisation of Global Regulatory Framework Profile: Dr. P M Murali, President, Association of Biotechnology Led Enterprises (ABLE) & is the CEO & Managing Director of Evolva Biotech which is a subsidiary of a Swiss headquartered, listed Biosynthtic company and also the President and CEO of Evolva Inc, USA. He established Evolva Biotech in Hyderabad in 2005 with India's unique public private partnership with CSIR and presently operating the whole facility since 2010 from Chennai. He has a PhD in Microbiology from Madurai University and a D.Sc. He has over 20 years of experience in Pharmaceutical/FMCG R&D. He was the Founder and Director of the Dalmia Centre for Research and Development for 16 years and presently serves their Governing Board. Earlier he worked as an Indo-US Researcher at the Battelle-Kettering Research Centre, Ohio and also was a senior fellow in the Hindustan Lever project. He is a visiting faculty in many national & international institutions and also serves as Adjunct Professor at Deakin University, Australia. He is presently involved in creating a unique "eco-system" to build a cost-effective discovery pipeline in India and also serves as the Chairman of the Biotech panel for Tamil Nadu in the CII. He is also the General Secretary for Association of Biotech Led Enterprises (ABLE) and the Vice-President and Treasurer of the Indian Red Cross Society of the Coimbatore District. ************************* Panelists Dr. Ajay Sharma Director Research Organisation of Pharmaceutical Producers of India (OPPI) Session: Round Table on Harmonisation of Global Regulatory Framework Profile: Functional Expertise Close to 13 years of healthcare industry knowledge, including 7 plus years of consulting expertise focusing on the pharmaceutical and biotechnology sector. Industry expert in pharmaceuticals/healthcare biotechnology with particular expertise in: - Business viability assessment for new business opportunities - Market entry strategy and design of viable business models - Regulatory framework harmonization - Market / business performance assessment for new product or service development, market / distribution channel penetration, market repositioning, and competitive benchmarking Industry Expertise Experience base covering broad range of sectors, leveraging past experience across various industry verticals Pharmaceuticals and Biotechnology : Oncology, Pain therapy and Infectious diseases - Medical Services: Primary & Tertiary healthcare services, Healthcare Insurance, Wellness, Medical & Allied Health Education, Medical Waste Management - Medical Devices: Clinical Imaging & Diagnostics, Medical Consumables, Patient Monitoring - Life Science & Medical Technologies: Biotechnology & biomedical engineering, Healthcare IT Career Highlights Acclaimed for completed market studies through publications, interviews and articles in sources, such as BBC World, Biospectrum, NTV7, Biz Journals, AOL Money News and Fox Business News Previous tenures in Africa, Middle East and South East Asia gives complete Asia view Education MBA (S.P.Jain), M.B.B.S - Panelists Mr. D.A. Prasanna Chairman & Managing Director Ecron Acunova Mobius Towers, SJR-I Park, EPIP Whitefield, Bangalore, India Email: [email protected] Profile: As a founder, he has mapped the vision and strategy for the organization. He has experience in leveraging Asian competitiveness building successful global business in medical technology for GE and software for Wipro. As Exec Chairman of the Manipal Group, his focus was on developing a research thrust for the Group. Considered a thought leader in Health care and Life Sciences, he has worked in global leadership positions in GE and was Vice Chairman of Wipro. He serves on the board of various Pharma companies and Research institutes. Prasanna is acknowledged in the healthcare sector as the pioneer in creating a market for high tech. medical equipment and delivering clinical excellence at low patient fees in Asian Hospitals, through innovative strategies. As the startup CEO of GE Medical in India, he also developed a $330 m Global Business in healthcare for GE Medical Systems (GEMS) by leveraging India's competitiveness taking the company from no 5 to No 1. He has also been a founding member of Wipro's team that initiated the company's entry into IT and was Vice Chairman of Wipro Ltd. He is an independent Director of Take Solutions Ltd. He serves on the Governing Council of Center for Policy Research, India's leading Think Tank and of T A Pai Management Institute, a reputed Business School. He is a Trustee on Shriram Ownership Trust, which shapes the strategy of Shriram group of companies. He has served as Chairman of GEBEL, GEMS IT Ltd and GE X-Ray(South Asia) and Director of GE Yokogawa Medical Systems Ltd, Japan and GE Samsung Ltd, Korea, Wipro GE Medical Systems Ltd, India and Shasun Chemical & Drugs Ltd India. He brings rich experience in pharma and healthcare. Mr. Prasanna is an alumnus of IIM Ahmedabad & GE Global Business Leadership Program at Crotonville. ***********
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