Opportunities for Collaboration

Transcription

1 The 40th Joint Conference between ROC-Korea and Korea-Taiwan Business Councils Opportunities for Collaboration in Bio & Pharmaceutical Industry Leah Lo, Ph.D./ President Medical and Pharmaceutical Industry Technology and Development Center Sep. 9,

2 Outline Overview & Why Taiwan Matters Advantages of Taiwan Future Prospects 2

3 Overview & Why Taiwan Matters 3

4 Market Scale of Global Biotechnology & Pharmaceuticals The biotechnology & pharmaceutical market is growing year-on-year. Unit:billion US dollars Sales Source:World Preview 2015, Outlook to 2020 Evaluate Pharm

5 Market Scale of Global Prescription Drug Market of global prescription drug is still steadily growing. Unit:100 million US dollars,% Sales of prescription drug Growth rate Source:World Preview 2015, Outlook To 2020, EvaluatePharm, 生技產業白皮書 5

6 Geographical Advantages Centrally Located in East Asia Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

7 Competitiveness BERI (Business Environment Risk Intelligence) CEDI (The Global Entrepreneurship & Development Index) Profit Opportunity Recommendation No. 3/ World (2013) No. 2/ Asia WB (World Bank) Global Knowledge Economy Index No. 13/ World (2012) No. 1/ Asia WEF (World Economic Forum) Global Competitiveness Index No. 14/ World ( ) High Education & Training No. 12/ World Innovation No. 10/ World 2014 Global Innovation Index No. 7/ World No. 1/ Asia IMD (Institute for Management Development) Global Competitiveness No. 13/ World (2014) Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

8 BioMedical Industry in Taiwan Scope Chinese/ herbal medicines Small molecule drugs New drugs Generics Pharmaceutical ingredients Biotech/Medical Rehabilitative Service Dental implants Health equipment Orthopedic Biomedicine Biopharmacuticals Protein drugs Vaccines Monoclonal antibodies Diagnostic kit Biochips Biomaterials Test regents Tissue engineering Stem cells Gene therapy Cord blood storage Environmental biotech Specialty biotech Food biotech Agriculture biotech Source: Department of Industrial Technology, MOEA 8

9 million USD Applied COMPANY Current Status of Taiwan BioIndustry Source: : Taiwan Biotechnology Industry White Paper, MOEA (2015) 9

10 Private Investments Show Confidence in BioMedical Industry From the past 10 years, the amount of private investment in the biotech industry has significantly increased. In 2014, the investment amounts reached near 1.5 billion USD, a record high. Amount of Private Investments by Year Distribution of Investments among Different Sectors in 2014 Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. March,

11 Policies & Initiatives National program & policy 1995 Action plan for Biotech. industry 1996 Biotech. & Pharm. Industries Promotion Office, MOEA 2003 Action plan for Biotech. industry development (amended) 2005 BioTaiwan Committee BioMedical Tech Island Plan 2007 Statue for Development of Biotech. New Drug Industry Adopting PIC/S GMP regulation 2008 Tax Offsets for R&D investment, personnel training, and company shareholders 2009 Diamond Action Plan for Biotech. Take-off (1 st stage) Key Product Development Culmination Plan 2010 Human Biobank Management Act 2012 Diamond Action Plan for Biotech. Take-off (2 nd stage) 2013 Implementation PIC/S GMP Supporting Organizations Development Medical & Pharm. Center for Industry Biotech. Technology & (DCB) Development Center (PITDC) 1996 National Health Research Institutes (NHRI) 1998 Center for Drug Evaluation (CDE) 1999 Biomed. Engineering Research Center Industrial Tech. Research Institutes (ITRI) 2003 Genomics Research Center Academia Sinica (GRCAS) 2010 Taiwan Food & Drug Administration (TFDA) 2011 Supra Integration & Incubation Center (SI 2 C) 2012 Agricultural Technology Research Institute (ATRI) Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

12 Core Concepts in Promoting BioMedical Industry Basic R&D at Academic & Research Institutions Pharmaceuticals/Medical Devices Commercialization Pharmaceuticals/Medical Devices Clinical Trials Product Reaches The Market Industrialization R&D Center Builds on Upstream R&D (MOEA) Establishment of BVC to Attract Private Funding, matching with National Development Fund Promotion of the SI 2 C to Provide An Integrated Service Platform (MOST) Foster International Harmonization (MOHW) Source: Department of Industrial Technology, MOEA 12

13 Strategy for Drug Development Upstream Academic Research Midstream DoIT Nonprofit R&D Centers Downstream Industry Technology Transfer IDB Industry PITDC SI 2 C IND Patent NDA Expired Drug Discovery Opti miza tion Preclinical Testing Clinical Trials (phase I/II/III) NDA Sale Marketing Monitor DRUG PRODUCTS Process Development Test Production Process Defined/Manuf. Receive research outputs from upstream academic research and conduct value-adding preclinical research Build up infrastructure for preclinical drug development Transfer technology to downstream industry for commercialization Source: Department of Industrial Technology, MOEA 13

14 Industrialization R&D Center Enhance Drug Translational Research and Medical Device Prototyping (MOEA, MOST, MOHW) Basic Research Early Stage Drug Development Late Stage Drug Development Sales & Marketing -$ to +$ Tech Transfer & Service/Value Generation $$$ $$$$ Profit Maximizing $$$$$ License out Academia Sinica License in Value-Adding Services Nonprofit Organizations Development Delivery of over 10 drug leads per year for optimization and preclinical testing starting from 2010 Source: Department of Industrial Technology, MOEA 14

15 Globalization of Drug Products Problem encountered Few patented APIs with market potentials Few specialty pharmaceuticals Limited capacity for manufacturing specialty pharmaceuticals Few FDA-caliber statisticians Insufficient international regulatory experience for approval of generics Promotion program (IDB) GMP mock inspection CTD documentation International conference Exhibition Taiwan Pharmaceutical Alliance Globalization of Pharmaceuticals Approved projects includes: 40 items 22 generic drug submissions worldwide 3 approved in Japan 1 paragraph IV granted in US 721 million USD investment Estimated value: 1.35 B (USD) Development Strategies (DoIT) Develop Niche APIs/ Integrate with special formulation Develop Special-formulated generic products Develop specialty pharmaceuticals Training of Patent/ Statistics/ Regulatory personnel Source: Department of Industrial Technology, MOEA 15 15

16 Taiwan BioMedical Industry GMP accredited for API & Finished Products -US FDA -EMA -Australia TGA -Japan MHLW -KFDA -Others 16

17 Advantages of Taiwan 17

18 Talent Pool Advantages 5,000+ undergraduates/year in life science Basic Science Medical Device Biotech 160 Universities and Graduate Schools Pilot Educational Programs in Translational Medicine and Agriculture Ph. D. On-the-job Training Program Regulation, Patent, and Marketing Industrial Case Studies Practical Training Pharmaceuticals Partnership between University & Industry Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

19 Building Blocks for Success Talent Pool Capitalization Investors Botech companies Regulatory Environment Regulatory agents Innovation Ability Academic institutes Government incentive Government Policy Pharmaceutical companies Industry Infrastructure Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

20 Opportunities Post-ECFA & Cross-Strait Cooperation Agreement Chinese market becomes a major Taiwan has more culture, language, attraction to global BioIndustry geographic advantages than other country to entering Chinese market. ECFA creates more interactive trading opportunities cross-straits. Unmet medical needs of chronic diseases Growing expenditure on healthcare 1.3 billion population M&A Joint venture Formation of affiliated companies product launch production sites marketing R&D Collaboration R&D production marketing Taiwan company Foreign company Source: Biotechnology & Pharmaceutical Industries Promotion Office, MOEA. May,

21 Taiwan Biotech Company International Cooperation Lotus Pharmaceutical Co., Ltd. Fountain Biopharma Company, Ltd. Genovate Biotechnology Co., Ltd.. ScinoPharm Taiwan., Ltd Medigen Biotechnology Corporation PharmaEngine Inc R&D Investment Factories Global distribution Standard Chem. & Pharm. Co., Ltd. TDW Pharmaceuticals, Inc Lotus Pharmaceutical Co., Ltd channel AnnCare Bio-Tech Center Inc. Timing Pharmaceutical Co., Ltd. Bionime Corporation Synmosa Biopharma Corporation Orient Europharma Co., Ltd YungShin Group Coland Holdings Limited PharmaEssentia Corporation Product license technology licensing TaiGen Biotechnology Co., Ltd. Sinphar Group Orient PHARMA Co., Ltd Taiwan Liposome Company, Ltd others SynCore Biotechnology Co., Ltd Swissray Global Qisda Corporation Ref: DCB/PITDC Development Center for Biotechnology 21

22 Taiwan & Korea Cooperation Taiwan Clinical trials has Quality system, Low cost of clinical development Regulations fellow international standards and IP protection Ethnographic research with Asian energy specific diseases Aiming for Global Success Korea Innovation and development of new drugs Pharmaceutical companies with strong capital can be invested Taiwan will be the good partner to the global market 22

23 Taiwan and South Korea establish strategic partnership to explore the international market Operating from Asia- Pacific Advancing across the Strait Aiming for Global Success Win-win Strategy Biotech API Excipients Small Molecular Drug TPP Cosmetic Medical Device 23

24 Mission and Role of PITDC Mission: Offer guidance and advice on relevant technology to the domestic medical and pharmaceutical industry Strive to develop key technology for new products Realize the industrial development of high quality products; and open up the international market Promote government decrees Promote industrial upgrading and globalization 24

25 R&D Power R & D of new pre-clinical herbal medicine Natural Drug New drug formulation desgin Drug delivery technology Formulation R&D Medical Device Medical consumables Complex medical mater ials development Regulation GMP Internationalization 25

26 Future Prospects 26

27 Future Prospects Develop distinctive products and quality technologies to enhance industrial competitiveness. Use R&D capabilities for pharmaceutical dosage forms to create a base of drug delivery systems, to cooperate with international pharmaceutical companies, and to expand the global market. Combine interdisciplinary science, technology and industry, creating new value of products, for more effective treatment modalities and convenient health care services. 27

28 ~ Working together for the development and prosperity of the pharmaceutical industry ~ Cooperating to share the global Bio & pharmaceutical market! 28

29 Thank you for your attention! 29