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2007/SOM2/LSIF2/021
Links Between Discovery and Market- Innovative Models along the Value Chain - Public Private
Partnerships
"Research Capacities: Filling the Gaps Through Scientific Exchanges and Training to Enhance the Region's Leadership in Life Sciences Innovation"
Submitted by: Center for Drug Evaluation, Chinese Taipei
Fifth Annual APEC Life Sciences Innovation Forum
Adelaide, Australia 19-20 April 2007
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Links between Discovery and Market- Innovative Models
along the Value Chain
Public Private Partnerships "Research Capacities: Filling the Gaps through
Scientific Exchanges and Training toEnhance the Region's Leadership in Life
Sciences Innovation"
Dr. Chih-hwa Wallace LinDirector, Center for Drug Evaluation,
Chinese Taipei
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Partnerships in life sciences research …to be further activated and sustained…..the region can benefit from innovations. ….. in diagnostics and other biotechnologies, ….. traditional medicines. More attention ….. to be given to regional science capacity assessment and education and training in order to support the goals of the LSIF research agenda. ……. discuss ways of assessing research capacities in the region and how public-private partnerships should be developed in interested APEC economies to provide support for regional scientific education, training andnetworking through the development of scientific exchange, training programs and the possible development of a regional research center.
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Capacity Building and Assessment
• Readiness Assessment– Science/Technology/Regulation/Investment– Pilot project conducted in Thailand and
Chinese Taipei (2005)– Assessment Template Suggested by LSIF
(2006)– General Concern for Emerging Economics:
• Too ambitious• Spread too thin though have some fundamentals
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Life Sciences Innovation
• Knowledge-Based• Global View• Regional Concern
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Industry of Life Science
• Features along the Value Chain– Discovery: Science-based, Intense IPR issues– Development
• Regulations• Heavier Investment (Time & $)
– Market• Require1st tier product• Global View with some Regional Concern
– Diversification, Integration, Specification
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from Discovery to Market Value Chain for New Drug Development
- Collaboration- Joint Venture-Co-development-Licensing
- Collaboration- Joint Venture- Co-development- Licensing
- Joint Venture- Out-Licensing
Value Creation
-NDA-Phase IV
DevelopmentDevelopment Marketing & Sales
Marketing & SalesBasic R&DBasic R&D
- Drug Discovery -Industry/Institution.-Patent(s)
-CMC-Toxicology-Pharmacology-IND-Phase I/II-Patent(s)
-Phase III-CMC-Marketing and Sales-Patent(s)
$ Commercial $$$ $$$$ Optimize $$$$$
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Scientific Exchanges and Training
• Sectors:– Government– Academia– Industry– NGO/NPO
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PrototypeDesign or Discovery
PreclinicalDevelopment
FDA Filing /Approval &Launch
Preparation
Clinical Development
Phase 1 Phase 2 Phase 3
Industry-FDA
Interactions
During
Development
Pre-IND Meeting
Initial IND
Submissions
OngoingSubmission
End of Phase
2a Meeting
End of Phase 2 Meeting
Pre-BLA or NDAMeeting
Market ApplicationSubmission
Safety Update
IND Review PhaseApplication
Review
Phase
Cf. Critical Path Initiative of US FDA
Critical Path Program-Increase the Interaction of New Drug Development and Regulatory Agencies
•Public Health Value /Unmet Medical Needs•National Programs•Niche Products•Index Cases (23)
Approaches of Chinese Taipei
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3D-GAIN Model
GovernmentLeadership
Industry
A/N National Program
A/N Discovery and Innovation
The GoalCoordination, Integration
Pipelines of Innovation
Incubation Management:Alignment / Portfolio/Project
Screening
Infrastructure Settlement
Gaps?Gaps?
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National Programs in Chinese Taipei
Experience Sharing for:• Biotechnology and Pharmaceuticals• Genomic Medicine• Agricultural Biotech• Biotechnology Island
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NSTPBPNational Science and Technology Program for
Biotechnology and Pharmaceuticals
• Objectives– To discover and develop novel compounds
for treatment of cancer, diabetes, cardiovascular and neurological diseases.
• Operation– To integrate research activities of
government agencies, academic and pharmaceutical companies focused on drug discovery and development.
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Drug Discovery Preclinical Trial Clinical Trial Commercialization
UniversitiesResearch Institutes
(NHRI)
Corporate Institutes(DCB, BMEC, PDC)
Medical CentersPharm. companies
Pharmaceutical &Biotechnology
Companies
National Science Council (NSC)
Ministry of Economic Affairs (MOEA)
Department of Health
(DOH)
Enterprises
Scheme of NSTPBP:from discovery to development
BiotechnologyChemical Synthesis
Natural Products
LeadCompounds
Pharmacology
Animal Toxicology Safety Pharmacology
INDI
Phase IIIII
NDA DrugMarketing
Phase IV
Formulation / CMC
ADME
Center for DrugEvaluation
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Regulation, for LifeNSTPBP Organization
Industry Promotion Unit
Cancer Unit
Diabetes Unit
Neurological Disease Unit
Cardiovascular Disease Unit
Preclinical Evaluation Unit
Academia-Industry Bridging OfficeChemical Core Laboratory
Industrial Technology Research Institute (ITRI)
Development Center for Biotechnology (DCB)
Pharmaceutical Industry Technology and Development
Center (PDC)
National Health Research Institutes
Clinical Trial Unit
Government Agencies
NSCMOEADOH
Steering Committee
Advisory Committee
NSTPBP OfficeProgram Leader
Associate LeadersAdministration
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Drug Screening
• General Pharmacology• Acute/subacute Toxicology • Early Pharmacokinetics• Chemical synthesis (scale up)
Safety Pharmacology, Toxicology, ADME
Phase I, II, III
• Cancer Unit• Cardiovascular Disease Unit • Diabetes Unit• Neurological Disease Unit
• Preclinical Evaluation Unit
• Clinical Trial Unit
Research and Development Programs
Industry-Academia Collaboration
Successful Cases
Lead optimization
Candidate drug
Translation medicine
•Academia-Industry Bridging Office
•Industrial Promotion Unit
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NSTPBP-Major Accomplishments
1) More than 20 lead compounds active in cancer, diabetes, cardiovascular and neurological disease areas have been identifies.
2) The first Successful Biotech Investment Case of NSTPBP “Development of microfluidic biochip systems” has been selected:
• by Microfluidic Biochip Research Group at National Cheng Kung University
• an enabling platform technology for fast diagnosis for virus and bacteria infections.
Regulation, for LifeNSTPBP-Major Accomplishments (Cont.)
3) The herbal databank of 300 Chinese herbal medicines has been established:
• open for data searching (http://www.herbemed.org.tw)• promote the quality control of Chinese herbal medicine
and subsequently help the globalization of Chinese medicine.
4) The cGMP pilot plants for small molecules, botanical drugs and protein drugs have been established to provide drugs of GMP grade for clinical trial in Taiwan and international use.
5) 18 clinical trials have been supported by NSTPBP in four years.
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National Science and Technology Program for Biotechnology and Pharmaceuticals (NSTPBP)
http://www. mc.ntu.edu.tw/~npbp/Program Leader: Dr. Che-Ming TengAssociate Leaders: Dr. Jui-Lien Huang
Dr. Biing-Jiun UangDr. Ming-Chi WuDr. Yu-Sheng Chao
We welcome international collaborations and development
partners
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Genomic MedicineNational Research Program for Genomic Medicine
The 1st 5 years• Platforms:
– Genomic medicine– Proteomics and structural
genomics– Bioinformatics
• Ethical, legal, and social implications, ELSI)
• Core Facilities
The 2nd 5 years• Disease-oriented
– Liver Cancer– Lung Cancer– Infectious Diseases– Highly Heritable Diseases
• Ethical, legal, and social implications, ELSI)
• Core Facilities
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Executive Yuan
Advisory Group
Cross-Ministry Platform
Biotech Island
DOH
Clinical Res. System
Feasibility for Biobank
NHIP
HR
臨床試驗合作網絡Network
3專科卓越中心
國家級卓越臨床試驗中心NCRC
CP
ELSIInfrastructure for Value-added Applications
ProgressPolicy
臨床試驗環境之建構驗證與加速臨床能量產業化計畫
Industrial-ization
Academia SinicaMOEA DOH
SCRC
IT Ind.
Genomics
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Biotech Parks and Cluster in Chinese Taipei
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ELSI issues for Life Science Innovation
• Communication for trust of the public• Could be community based
– Consent– Mobilization
• Cohort study for welfare state formation– Prevention and early detection
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Partnership in Harmonization –Experience from
“APEC Network on Pharmaceutical Regulatory
Science” 2000~2006
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APEC Network under ISTWG, since 1999
Chinese Taipei (2000, 2001, 2003, 2005, 2007)
(2004)
(2002, 2006)
Partnership inPartnership inHarmonizationHarmonization
with ICHwith ICH
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Theme and Topics
02000 2002 2004 2006
Clinical Trial
Bridging Study
Global Drug Development
ICH GCGFDAEMEA
Level of Emphasis
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Proposal for APEC Cooperation
• APEC Network on Pharmaceutical Regulatory Science Forum
• Joint Training Program on Regulatory Science
• Information Sharing – “Revival of Pharmaceutical Evaluation Report Scheme”
• “Last Cohort” Project Cooperation
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APEC Network on Regulatory Science Forum
• APEC-Forum website (http://www.apecpharm-forum.org)– APEC Symposium, 2000~2007– News Issues & Forum – Country Profile– Links, Site Map
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Partnership in Harmonization (I) Revival of PER Scheme?
• Pharmaceutical Evaluation Scheme (PER)• A model once very well accepted before
EMEA under EFTA• Set up the standard of Good Review
Practice for members • Exchange assessment reports, CMC/CTD
issues• Training program on regulatory science
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Partnership in Harmonization (II) Revival of PER Scheme?
• Trust but verify without duplication of the whole review process- Verification of Assessment
• A platform involving regulatory agency and industries to improve regulatory affairs
• Interest from CMR, WHO, Swissmedic, TGA, Brazil, Roche, Novartis, GSK, AstraZeneca, CDE, PhRMA, EMEA, FDA
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Last Cohort Cooperation
• Biomarker: Dr. Lee Hartwell as keynote speaker for annual meeting of “Formosa Medical Association”, Nov. 11, 2006
• Last Cohort: Dr. John Potter Roundtable discussion with related key opinion leaders, Nov. 10, 2006
• 2007 in US (a few days ago)
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Proposal to Harmonization Session, APEC LSIF
• Adopt “APEC Network” project as a vehicle for information exchange – Build up existing momentum– Not interject more bureaucracy into the
process– Willingness for FDA’s participation– Output endorsed by leaders of member
economies
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LSIF Working Group on Harmonization
• Steering function : set the agenda for information exchange
• Supervise and suggest contact window for APEC forum Website
• Organizing “PER Scheme in APEC”
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MORE MORE IInternational nternational CooperationCooperation
Projects are Welcome!Projects are Welcome!
Welcome to Taipei for the “2007 Symposium on APEC Network of Pharmaceutical Regulatory
Science” in Taipei, Nov. 27-28, 2007
Evolving Models of Regulatory Agency in APECCritical Path Initiatives in APECRegulatory Dialogue and PartnershipPharmacogenomics - Co-development of New Drug and IVD
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MORE MORE IInternational nternational CooperationCooperation
Projects are Welcome!Projects are Welcome!
Welcome to Taipei for the “2007 Symposium on APEC Network of Pharmaceutical Regulatory
Science” in Taipei, Nov. 27-28, 2007
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http:// www. cde.org.tw