Links Between Discovery and Market- Innovative Models ...mddb.apec.org/documents/2007/LSIF/LSIF2/07_lsif2_021.pdf · Regulation, for Life Drug Discovery Preclinical Trial Clinical

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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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Regulation, for Life

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


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


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


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


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?


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.


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

Regulation, for LifeNSTPBP Collaborative Virtual Team

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


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


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


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


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)


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”


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

34


Regulation, For Life

http:// www. cde.org.tw

Documents

Links Between Discovery and Market- Innovative Models ...mddb.apec.org/documents/2007/LSIF/LSIF2/07_lsif2_021.pdf · Regulation, for Life Drug Discovery Preclinical Trial Clinical