Download Biotech Industry in Taiwan

Biotech Industry in Taiwan
Shang‐Pwu Shia, Ph.D.
Director, NanKang Biotech Incubation Center
Development Center for Biotechnology
Taiwan
2
The Rep of China
Taiwan
P
Population:
l i 23.4Million
Area: 36,193 KM2
Official language:
Official language:
Chinese Mandarin
GDP Total (IMF)
Beijing
Seoull
Tokyo
Shanghai
Guangzhou Taiwan
HK
Bangkok H.K.
Singapore
22nd $523,006M
$523 006M Nominal
21st $1,100,198M PPP GDP Per capita
36th $22,263 $22 263 Nominal
20th $46,833 PPP
Foreign Exchange Reserves :421.5 Billion
Reserves :421.5
Global Ranking 4th
3
Taiwan - Centrally Located in East Asia
Beijing 3’00
Seoul 2’20
Tokyo 2’50
Shanghai
g
1’20
Osaka 2’15
Osaka 2
15
Chongqing 3’00
Guangzhou 1’30
Taipei
Hong Kong 1’40
Bangkok 3’45
Ho Chi Minh City 3’20
Manila 2’00
Kuala Lumpur 4’35
Singapore 4’20
Jakarta 5’00
Sydney 8’50 4
Why Taiwan Matters?
EEvaluation of Taiwan’s Global Competitiveness l i
fT i
’ Gl b l C
ii
by Major World Agencies
The Best Places for Expats No 1 /World (2016)
No. 1 /World (2016) InterNations
Innovation Index de
No. 6/World (2013) EIU ((Economist Intelligence) co o st te ge ce)
Knowledge Economy Index
No. 13 / World No. 1 / Asia (2012)
WB
(World Bank)
Competitiveness No. 3 / Asia (2016) No. 14 / World IMD (Institute for Management Development )
Competitiveness No. 14 /138Countries
No. 4 / Asia Index
((2016~2017))
WEF
(World Economic Forum)
Biotech Global No. 17 / 54 Nations
Competitiveness No. 3 / Asia (2014)
Scientific American Worldview Top 10 Safest Countries In The No.2/World (2014)
World
TheRichest
Lifestyle9.com
5
Unit
Revenue
Revenue (x1,000) (US$ M) Digital blood pressure Di
i l bl d
monitor
Global Mkt
Global
Mkt
Share (%)
7,150
209
42
160
142
30
Electronic ear tthermometer
e o ete
2,730
115
30
Electronic thermometer
h
27,500
52
60
3,300
106
50
Electrical wheelchair & scooter
Pre filled IV Auto Pre‐filled
IV Auto
Injector
The Changing World
“only thing that doesn't change is change itself”
唯一的不變，就是變! 唯
的不變 就是變
8
New
Opportunities
9
Knowledge
g
Economy
10
Smiling Curve & Value
Higher
Added Add
d
Value
Lower
Concept Design
R & D
Manufacturing
Marketing Branding
Distribution
Sales
Time
Production Chain
Biotechnology
Biotechnology & Biotech Industry
Biology
Chemistry
Agriculture
Mechanics
Electronics
Biotechnology
Pharmacology
Business
Materialogy
Medicine
Physics
Engineering
13
Taiwan BioBio-Industry in Three Sub
Sub--Sectors
Applied Biotech
• Specialty
Chemical Biotech
• Agricultural
Biotech
Bi t h
Pharmaceuticals
• API
• Synthetic Drugs
• Traditional
Chinese Medicines
• Environmental
Biotech
• Biologics
• Food Biotech
• Regenerative
Medicine
• Contract Research
Services
Medical Devices
• Medical
Electronics
• Medical Imaging
• Medical
Diagnostics
• Medical
Equipments
• Biophotonics
14
Co
ompany N
No
Re
evenue (X
X 00,000 N
NTD)
Revenue of Biotechnology
gy Industryy in
Taiwan
Applied Biotech
Pharma
ceuticals
Medicals Devices
Exports
Imports
Company No
Capital Market is Friendly to Biotech
Industry in Taiwan
Taiwan Stock Exchange (TWSE)
g (
)
Listed Biotech Co. 上市 36
Taipei Exchange (TPEx) h
(
)
Listed Biotech Co. Mainboard 上櫃 74
Emerging Stock 興櫃 54
GISA 創櫃板 23
Go Incubation Board for Startup and Acceleration Firms (GISA)
June 2016
Biotech Clusters in Taiwan
Ping--Tung Agricultural Biotechnology
Ping
Six industrial clusters
Products
Park
P k
1 Natural health and beauty industry
2
Fisheries and aquaculture biotechnology industry
Functional foods, modern Chinese medicine, biotech ,
,
cosmetics, edible and medicinal mushrooms, etc.
Ornamental fish, aquaculture products, aquatic peripheral products, etc.
3 Bioagricultural materials industry
Bi
i lt l t i l i d t
Bi f tili
Biofertilizers, biopesticides, plant nutrients, etc.
bi
ti id
l t ti t t
4 Animal biotechnology industry
Animal vaccines, feed additives, livestock probiotics, etc.
5
Biotech testing and OEM/ ODM Biotech
testing and OEM/ ODM
service industry
Energy conservation, 6 environmental control and environmental control and
agricultural facilities industry
Animal and plant virus testing, food safety testing, biotech Animal
and plant virus testing food safety testing biotech
OEM/ODM services, etc.
Solar/wind energy cultivation, environmental control facilities for aquaculture, etc.
Hsinchu Biomedical Science Park
NanKang BioPark
Taipei Technology Corridor
Taipei Biotech Cluster
(Planning)
Expected: (In 5‐8 Years)
240,000 M2 Floor Area
Attracting 37 Billion NTD Investment from Private
5,800
,
Employees
p y
B.O.T. (Build–Operate–Transfer)
National NanKang Bio Research Park
(Under Construction)
(Under Construction)
National NanKang Bio Research Park
(Under Construction)
Comprehensive Basic Talent Training
f Taiwan
for
T i
Bio
BioBi -industry
i d t
More than 400 bio‐medical related More than 400 bio medical related
departments
More than 20,000 College Graduates + Masters + Ph D /year
+ Masters + Ph.D. /year
156
Universities and G d t
Graduate Schools Pilot Educational Programs in g
Translational Medicine and Agriculture
Ph.D. On‐the‐job Training Program
R&D Expenditure for Biotechnology: 0.2% of GDP (2012)
Biotech
Basic Science
Regulation, Patent, and P t t
d
Marketing
I d t i lC
Industrial Case Studies
Practical Training
Medical Medical
Device
Pharmaceuticals
Partnership between University & Industry
Short of top management and international marketing professionals 28
The Government is Actively Promoting
Bi t h industry
Biotech
i d t
National Program & Policy
1982
Taiwan government identified
identified Biotechnology as 8 key technologies
1995
Action Plan for Biotech Industry Government‐
supported
supported Organizations
1984
Development Center for Center for
Biotechnology (DCB)
1993
Pharmaceutical Industry Industry
Technology and Development Center (PITDC)
1996
Biotech and Pharmaceutical Industries Promotion i
Office (BPIPO), MOEA
2003
2005
Action Plan for BioTaiwan Biotech Committee Industry (BTC)
Development l
BioMedical
i
di l
(amended)
Tech Island Plan 2007
Statute for the Development of Biotech New Drug Industry
2009
Diamond Action Plan for Biotech Takeoff k ff
(First Stage)
2012
Biotech Industry Takeoff Action Plan (Second l (
d
Stage)
Government Measures
1996
National Health Health
Research Institutes
(NHRI)
1998
Center for Drug Drug
Evaluation (CDE)
1999
Biomedical Engineering Engineering
Research Center, Industrial Technology Research
Research Institute (ITRI)
2004
NanKang
Biotech Biotech
Incubation Center (NBIC) 2010
2011
2014
Taiwan Food & Drug &D
Administration
(TFDA)
Supra Integration I t
ti
& Incubation Center (Si2C)
Agricultural Technology T h l
Research Institute (ATRI)
29
Governmental Framework for
Promoting BioBio-industry in Taiwan
Th E
The Executive Yuan
ti Y
BioTaiwan Committee
Ministry i i
of Education
Ministry of Ministry
of
Science and Technology Science & Technology Science
& Technology
Advisory Group (STAG)
Council of Agriculture
Industrial Development Bureau (IDB)
( )
Ministry Ministry
of Health and Welfare Ministry of i i
f
Economic Affairs
Environmental i
l
Protection Administration
Department of Industrial
Technology (DOIT)
gy (
)
Ministry of Finance
National i
l
Development Council Department of
Investment Services ((DOIS))
Development Center for Biotechnology
(DCB)
30
Biotech Industry Hub in Taiwan - DCB
Development Center for Biotechnology
R & D Group
& G
BD Group G
300 Scientists in New Drug Discovery
80 Professionals for Bio‐Business Promotion 31
New Drug
N
D
Discovery
32
Trillion Dollars Business
Development Time - Activities
New
Molecule
Idea
File
IND
Drug
Di
Discovery
Period
Chemical Candidate
Lead FoundCompound
Chosen and
Additional
Tests Run
Synthesis Additional
& testing Compounds
of New are Made
chemical
Clinical
Studies
Planned
IND
Enabling
Activities
30
Day
Wait
File
NDA
Drug
D
Development
l
t
Period
Formulation
Development
Scale-up &
manufacturing
Clinical
Supplies
Approval
Agency
Review
Advisory
Committee
Meetings
response to
Agency
g
y ?s
Data
Management
Pharmaceutical
Production
Clinical Phase I, II, III
Drug Marketing &
Line Expansion
Registration
Dossier
Launch
Advertising
Marketing
Promotion
Pre-Launch
Activities
Annual
Reports
Line Extensions
Other Indications
Other Studies
Phase IV
Toxicology
Commercial
Market Research
Manufacturing
g
Pharmaceutical
Patent
Competition
Process evaluation
Planning
Scale-up
Scale up
Production
Opinion Leaders
Launch
Facilities Planning
Expansion
Pre-formulation, Formulation/Analytical, Tox Supplies, Clinical Supplies, Production
US Filing Foreign Filing Other Inventions
5.8 Years
Infringement
7.4 Years
Process/Formulations
Post-Marketing
Line Extensions
Enforcement
1.5 Years
Uses
Pre--clinical Safety Study
Pre
’ Purposes
• Estimation of an initial safe starting dose f h h
for the human trials
l
• Identification of parameters for clinical p
monitoring for potential adverse effects
’ Goals of the study design
Goals of the study design
• To characterize the toxic effects with respect to target organs
respect to target organs
Genotoxicity Testing
ICH Standard Battery
• A test for gene mutation in bacteria
• An in vitro
An in vitro test with cytogenetic evaluation of test with cytogenetic evaluation of
chromosomal damage with mammalian cells or an in vitro mouse lymphoma tk
or an in vitro
mouse lymphoma tk assay
• An in vivo test for chromosomal damage using rodent heamtopoietic cells
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
DCB (Development Center for
Biotechnology)
Preclinical Toxicology Laboratory
• Nine Laboratories
• three cell culture rooms
three cell culture rooms
• Two microbial culture rooms
• One radioisotope room
• QAU office
QAU office
• Two archives rooms
• Laboratory animal Laboratory animal
facilities (two floors)
DCB PrePre-clinical Testing Services
•
•
•
•
•
•
•
•
Genetic Toxicology
General Toxicology
General Toxicology
Reproduction Toxicology
Immunotoxicity Tests
Biocompatibility Tests
p
y
ADME Studies
D
Drug Screening
S
i
Functional Assays
ADME and Tox
Toxicology Testing
 Genetic Toxicology
G
i T i l
 General Toxicology
 Reproductive Toxicology
Reproductive Toxicology
 ADME
‡
‡
‡
‡
‡
‡
‡
‡
General Toxicology
General
Toxicology一般毒理試驗
般毒理試驗
Reproductive Toxicology生殖毒理試驗
Genetic Toxicology 遺傳毒理試驗
Other Tests 其他毒理試驗
Other Tests 其他毒理試驗
Clinical Pathology 臨床病理分析
Toxicological Pathology
藥物組織病理評估
Biocompatibility Tests 生物相容性試驗
Pharmacokinetics/Absorption, Distribution, (
)
Metabolism & Excretion (ADME) 藥物動力學/吸收、分佈、代謝、排除
39
Ames Test for Mutagenesis
Crystal violet sensitivity (rfa mutation)
Bacteria growing on histidine ‐biotin plate (histidine requirement)
Bacteria growing on biotin plate (histidine requirement)
UV sensitive/resistant (uvrB mutation)
Ampicillin sensitive/resistant (R factor)
Toxicological Screening for
Potential Genotoxic Compounds
Chromosome Aberration Chromosome
Aberration
Assay
CHO cells, V79 cells, Human lymphocytes
In Vivo Micronucleus Assay
In Vivo
Micronucleus Assay
Pre--clinical Toxicology Laboratory
Pre
• GLP for Non‐clinical L b
Laboratory Study
S d
• Taiwan Accreditation Fundation (TAF)
• American Association for Accreditation of Laboratory Animal y
Care (AAALAC)
SPF Animal Facility
SPF Animal Facility
Good Laboratory Practice (GLP)
• To support application for research or gp
p
g
y
marketing permit for products regulated by FDA
• GLP compliance is intended to assure the GLP compliance is intended to assure the
quality and integrity of the safety data.
• GLP is for non‐clinical safety study, not applied to clinical lab.
to clinical lab. 45
45
46
46
Passingg Box
Animal Handling
Toxicity Study in Animals
Toxicity Study in Rodents
Toxicity Study in Dogs
Acute Test
Acute Test
‐P.O., I.V., I.M., S.C., I.P., Dermal, Infusion
‐P.O., I.V., I.M., Infusion
Sub‐acute Test
Sub‐acute Test
‐P
P.O., I.V., I.M., S.C., I.P., O I V I M S C I P Dermal, Infusion
Dermal Infusion
‐P
P.O., I.V., I.M., Infusion
O I V I M Infusion
Sub‐chronic Test
Sub‐chronic Test
‐P.O., I.V., I.M., S.C., I.P., Dermal, Infusion
‐P.O., I.V., I.M., Infusion
Toxicityy Studyy in Rabbits
Intra‐cutaneous
Intra
cutaneous Test
Skin Irritation Test
Eye Irritation Test
y
Physical Examinations
Ophthalmology
EKG
EKG Necropsy in Animals
Rodents
Dogs
Clinical Pathology
gy
Histology
Histopathology
R
Reproductive
d ti T
Toxicity
i it Study
St d
ADME Study
•
•
•
•
Absorption
Distribution
Metabolism
Excretion
Distribution
Species
‐Rat
R
Route
‐I.V.(catheterization)
Cryomicrotome
‐(Bright) Sample Analysis
‐Electronic Autoradiography
‐Electronic
Autoradiography
(Packard InstantImager)
Distribution and Excretion
Species
‐Rat
Metabolic Cage
Sample Oxidizer ‐Packard 307
Route
‐I.V.(catheterization)
Urine & Feces
Collection
‐Metabolic Cage
Blood & Organs
C ll i
Collection
Sample Analysis
‐Sample Oxidizer and β‐Counter
S
l O idi
dβ C
t
β‐Counter ‐ Beckman LS6500
Dissolution
60
Protein Drugg
62
63
64
cGMP Biopharmaceutical
p
Pilot Plant
z A mammalian cell culture biologics clinical Phase I/II production facility
z CGMP certificate issued by DOH, TAIWAN
z FDA Drug Master File (No. 19164) z PIC/S international CGMP compliance
High Quality Product with Asian Advantages!
65
65
66
67
68
Medical Devices
69
Wearable Medical Devices
70
Wearable Monitor
Electrocardiogram
Phonocardiogram
71
Laser for Skin Treatment
73
Patient Care Products
Patient Bed
Respiratory Therapy
CPAP
continuous positive airway pressure
Wound Management
Nebulizer
74
Patient Lift
Mobile lift
Mobile lift
Ceiling lift
Ceiling lift
75
Applied Biotech
76
Genetically Modified
Organism
77
80
Herbicide Tolerant Crops
Genetically Modified Organism, GMO
Ornamental Fish
82
Biopharming
Is Biopharming
p
g Worth The Risk?
The cultivation of genetically engineered plants for industry may save money, but many are being developed in secret and there are already many cases of environmental contamination
and there are already many cases of environmental contamination
83
Gaucher‘s disease
lysosomal storage diseases. bruising, fatigue, anemia, low blood platelets, and
enlargement of the liver and spleen. deficiency of the enzyme glucosylceramidase.
84
Molecular Pharming
g
85
AG-bio
86
Agriculture Biotech in Taiwan
Orchid Biotechnology
gy
Aq ac lt re
Aquaculture
88
Cage culture
90
91
Green Biotech
92
Biodegradable Plastic
Polyhydroxyalkanoates (PHAs)
Poly 3 hydroxybutyrate (PHB)
Poly‐3‐hydroxybutyrate
Polyhydroxyvalerate (PHV) Polyhydroxyhexanoate (PHH)
Polyglycolic acid (PGA)
acid (PGA)
Polylactic acid (PLA) Polybutylene succinate(PBS) Polycaprolactone (PCL)
Polyanhydrides
Polyvinyl alcohol Polyglycolic acid (PGA)
Polylactic acid (PLA)
Polyethylene (PE)
93
Bio
pesticide
94
Insect Resistant Crops
Plant Factory
97
Plant Factory
98
Agriculture Biotechnology
• Biotechnology is used in many ways in agriculture.
Agricultural biotechnology companies work to supply
farmers with tools to increase the yield of plant and
animal products, while lowering the costs of production.
• Agricultural biotechnology can also include production of
plants such as orchids for ornamental purposes and plants
that can be used for fuel production (biofuels).
Bio Fuel
生質燃料
質燃料
100
Internal combustion engine
g
101
Biodiesel
Biodiesel refers to a vegetable oil ‐ or animal fat‐based diesel fuel consisting of long‐chain alkyl (methyl, ethyl, g
g
y (
y,
y,
or propyl) esters. Biodiesel is typically made by chemically reacting lipids (e.g., vegetable oil, soybean oil, animal fat (tallow)) with an alcohol producing fatty acid esters.
S b
Soybean
S fl
Sun flower R
Rapeseed
d
102
102
麻瘋樹（Jatropha curcas
麻瘋樹（Jatropha curcas
Jatropha curcas L
103
103
Biodiesel
T
Transesterification
t ifi ti
Methanol
Biodiesel Production Process
105
Bioethanol
C6H12O6 → 2 C
→ 2 C2H5OH OH + 2 CO
2 CO2
107
The Usefulness of Ethanol
1. Edible
2. Medical
3. Industrial
H2SO4 conc.
CH3CH2OH
Ethanol
△
CH2=CH2↑ + H2O
Ethylene
108
Bio fuel Production
PhotoBioReactor
110
Green
Biotech
I
Integration
i
Sea water for algae
Solar Energy
3 D Photo Bioreactor
Algae Absorbs CO2
Harvest
Biomass for Biomass
for
Electricity
Sewage provides Se
age pro ides
N、P、K for algae growing
algae
Extract oil from Algae
Bio diesel
111
Building
u d g Blocks
oc s oof Success
Capitalization
Biotech
Companies
p
Regulatory
Environment
Regulatory
Agencies
Investors
Innovation
Ability
Talent
Pool
Academic
Institutes
Government
Policy
Government
Incentives
Pharmaceutical
Ph
ti l
Companies
Industry
Infrastructure
112
Your Biotech Partner in Asia
and Gateway to the World
Taiwan
Development Center for Biotechnology
113
Shang‐Pwu Shia, Ph.D., Director
NanKangg Biotech Incubation Center
Development Center for Biotechnology
Tel: +886‐2‐2655‐8633
Tel:
886 2 2655 8633 X8001
X8001
Cell:+886‐952‐790‐900
[email protected]
[email protected]