National Institute for Natural Products, Vaccines & Biologicals

1. National Institute for Natural Products, Vaccines & Biologicals 9BIO 9BIO

2. Why Vaccines

3. “Vaccines are weapons of mass protection” ~Heidi LARSON (UNICEF)

5. Malaysian Budget Dialogue 2004 • 21 May 2003 • Announcement of “Stimulus Package” for new sources of growth and decreasing reliance on outside resources • National Institute for Natural Products and Vaccinology (NINPVB) specified in items 43,44, 45 under the MOH

6. THE EXCHANGE & EXISTING VALUE CHAIN OF NATIONAL R&D • Feedback on learning • Feedback on actions The EXCHANGE • Strategic Intent • Resource Allocation STRATEGY • MARKET • Branding • Logistics • Packaging GAPS GAPS • Market • Technology INDUSTRY RESEARCH Weak Link DEVELOPMENT PRODUCTION Commercialization phase DESIGN ENGINEERING

7. MOH • Global trader • Malaysian Brand National Institute for Natural Products Vaccines & Biologicals (NINPVB) Cutting edge technology Shared responsibility Public Sector Biotechnology R & D Ideas to products Marketplace Government Industry Research Institutions Universities

8. About the NINPVB…… • Launched by the Minister of Health as the 7 National Institute of Health (NIH) • August 2003 • Corporatised arm of MOH R & D • National Vaccine Security • Exploit and Commercialise R &D of NIHs • Major focus : Vaccines, Natural Products • ( Herbal Medicines, Nuetraceuticals), Biologicals

9. STATUS IN THE NEW MILLENIUM Vaccine supplies for Malaysia currently are still entirely from foreign manufacturers: The implications on this entire dependence are as follows: • Global shortage of vaccines.Spread of vaccine preventable infectious diseases if vaccines supply not met • Allocation of vast amounts of funds to purchase vaccines and control infectious diseases endemic in Malaysia • Need to consider vaccines of regional interest ( SARS, Nipah, Dengue, Avian Flu, Chikungunya)

10. 1. Global shortage of vaccines and implications • This state of entire dependence on importation of basic childhood vaccines has serious implications in times of geopolitical emergencies • It has been well documented that vaccine shortages havebecome global, affecting industrialized and developed countries alike, due to significant changes in the vaccine market and the industry’s focus on profitability ( eg OPV,measles)

11. The lack or insufficient supply of vaccines will result in the rampant spread of vaccine preventable infectious diseases such as poliomyelitis, diptheria ,pertussis ,tuberculosis ,hepatitis B ,measles etc • Increase the morbidity and mortality rates of these diseases • Massive health costs and burden to the economy and overall productivity of the nation

12. 2. Allocation of vast amounts of funds to purchase vaccines and control infectious diseases endemic in Malaysia • The Ministry of Health Malaysia , the largest health care provider spends annually more than RM 16 million in vaccine costs • The vaccine costs are expected to rise dramatically with the introduction of newer vaccines including combination vaccines such as MMR , HiB and inactivated polio vaccines • The anticipated increase in vaccine expenditure to the Government with this new vaccine policy is about RM 32 million . Hence the annual costs of vaccination will be in the region of RM 48 million.

13. MOH: Responsibility to ensure adequate supply of vaccines • The MOH has the responsibility to ensure adequate supply of safe and efficacious vaccines for the nation • The MOH needs to respond to constant emerging diseases which pose as a threat to the nation • The MOH needs to be able to protect the population in the event of a biological weapon attack eg.Smallpox ,Anthrax

14. Largest Healthcare provider • Responsible for the provision of safe and efficacious vaccines as well as medicines to the population • Define the requirements for registration and usage of vaccines and medicines • Have clear regulations and guidelines (accordance to FDA ,EMEA, TGA practices )in place to achieve safe and efficacious use of vaccines and medicines • Have technical expertise in ensuring products are of required standards

15. Strengths • Vaccine producing capabilities from 1976 -1990 • Designated as the coordinator and focal point of R & D biotechnology in ‘halal’ vaccine production by OIC vaccine producing countries as part of the Self Reliance Vaccine Program among OIC • ( Tunisia ,March 04) • Drive and chair a Cabinet approved National Committee for Herbal Medicine R & D to ensure research and commercialisation of Malaysian Herbal Medicines • Sets strategy for healthcare research

16. We are not alone… • Neighbouring countries are already manufacturing their own vaccines • Indonesia (PT Biofarma), • India (Serum Institute of India, Bharat Biotech Int. Shanta BiotechPvt Ltd), • Hong Kong (Hong Kong Institute of Biotech Ltd), • Korea ( Korea Green Cross), • China

19. MISSION • Play a key role in healthcare security against vaccine-preventable diseases as well as national/regional security against bioterrorism • Bring to market, potential herbal medicinal products besides prioritizing research in natural products with medicinal potential • Help to drive product development and technology commercialization in natural products , vaccines and biologicals • Create a conducive environment for development of critical mass in R & D and inculcating entrepreneurship among researchers

20. Drive and develop linkages and smart partnerships with industry and appropriate centres of excellence • Serve as a national resource for knowledge and understanding of the medical use of vaccines&natural products and their applications in public health

21. BUSINESS MODEL NINPVB GLC PPP Government majority shareholder Design, Build, Equip, Maintain Natural Products Biologicals Vaccines • Diagnostic kits • Generic medicines • Personalised medicine • Childhood vaccines • Dengue, Nipah • Bioterrorism vaccines • Hepatitis B • HIV • Breast cancer • Diabetes mellitus

22. Infrastructure NINPVB R & D FILL AND FINISH SUITE MANU- FACTURING INTERIM LAB

23. Malaysia’s R & D vision • By the year 2020, our global competitiveness will be led by new frontier technologies driven by technological innovations created by our institutions~

24. National Biotechnology Policy • Brand Statement • Biotechnology for Wealth Creation and Social Well Being • Policy Statement • Innovation to create wealth by utilising and advancing biotechnology for socio-economic benefits of the nation in accordance with established social and ethical norms

25. National Biotechnology Policy • Vision: • Position Biotechnology as the New Economic Engine to enhance prosperity and wellness of the Nation by 2020

26. Agricultural Biotechnology Development Healthcare Biotechnology Development Industrial Biotechnology Development Financial Industrial Development Legislative and Regulatory Framework Development Strategic Development Government Support and Commitment R & D Technology Acquisition Development Human Capital Development Policy thrusts

27. Position Biotech Economic Engine National Biotechnology Policy Investment requirements Public and Private (2006-2020) RM 30 billion 60% (RM 18 billion) private Higher GDP, high value employment & Knowledge workers Stronger R & D capacity Leading Global companies Improve Prosperity, Healthcare & Wellness by 2020 Biotechnology contribute To 5 % of GDP by 2020 • >28,000 jobs( 2% of national job markets)

28. Thank you