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National OncoVenture
http://nov.ncc.re.kr
Designated by Ministry of Health & Welfare
Supported by National Cancer Center
2
Table of Contents
1. Program summary
2. Organization
3. Operation Model & Procedure
4. Selection Process
5. Distinctive Features
6. Pipelines
7. NOV Performance
8. Alliance Models
1. Program Summary
 Mission: Support Korean global anti-cancer drug development
 Program Period : 2011~2016 (1st stage) + 2017~2021 (2nd stage)
 Budget : Ministry of Health & Welfare + Matching fund from originator
 Model:
 Select pre-clinical anti-cancer drug candidates from various sources
(Universities, National labs., Biotech & Pharmaceutical companies, etc.)
 Develop through clinical stages (PII)
 Project managed by joint development committee between National
OncoVenture and drug candidate provider
 Eventually, license out to or make partnership with domestic/global
pharmaceutical companies
 Share profit with candidate provider and collaborators
 Operation methods:
 Directed by new (anti-cancer) drug development experts
 Virtual drug development utilizing CROs, CMOs, consulting network, etc.
3
1. Program Summary
4
Expanding the area of interest in 2nd Stage
1st Stage (2011~2016) 2nd stage (2017~2021)
Development area New Anticancer drug
New Anticancer drug
Biomarker
Companion Diagnostics
Originators
Universities, National labs.,
Biotech & Pharmaceutical
companies, etc
Universities, National labs.,
Biotech & Pharmaceutical
companies, etc
Operation
Project managed by JDC,
led by NOV
Project managed by JDC,
led by NOV
Type of Drug
Small Molecule,
Monoclonal Antibodies
Small Molecule,
Monoclonal Antibodies
Cell therapeutics
Gene therapeutics
Level of Innovation Mainly Best-in-class Mainly First-in-class
Development stage Validation ↔ Phase 2a Validation ↔ Phase 2
2. Organization
President
General management
Business Development
- R&D&B trend analysis
- Identify drug candidates
- L/I, L/O, contract
- Patent/Legal management
Steering Committee
- Overall strategic decision
- Decision sub-committee
recommendations
Advisory
Committee
Advisory
recommendation
Drug Development
- Project management for
drug candidates through
preclinical & clinical stages
- Manage outsourcing studies
- Study result analysis
NCC Research Institute
- Pilot preclinical studies
- Clinical study plan
Administrative Office
- Business planning
- Personnel, Budget
- Public Relation
Network Group
- Collaborative studies: University, Nat’l Lab, Biotech/Pharma
- Outsourcing studies: CRO, CMOs
- Advisory consulting: KFDA, Global network
Scientific/Oncology
Advisory Committee
- Provide expert opinions &
recommendations throughout
drug development stages
NOV-KFDA Committee
-Provide expert opinion on regulatory strategy
-Guide requirements for efficient approval
process
5
Head & VP
Business Dev.
Kangsik
Yun
MA, Seoul National Univ.
Head of R&D Management
at Chong Kun Dang Pharm.,
Daewoong Pharm. and ToolGen
Senior Researcher at SK Corp.
Head & VP
Drug Dev.
Sung-
Sook
Lee
Ph.D., Ohio State University
Committee of KDDF
Head of Research Institute
at Chon Kun Dang Pharm.
Senior Researcher at Cerep Inc.
Head & VP
Clinical Dev.
Jung-
Yong
Kim
MD., Seoul National Univ.
Roswell Park Cancer Inst./ SUNY
at Buffalo
Practicing at Prostate Cancer
center (National Cancer Center)
President & CEO
Young-Whan
Park
Ph.D., Rutgers University
Project Leader at Merck USA
ID research center
Head of Research Institute
at Daewoong Pharm.
Business Development Drug Development
2. Organization
Management Team of OncoVenture
6
New Paradigm: A Gov-funded Virtual Drug Development
Joint
Development
Committee
OncoVenture +
Candidate Provider
Global
Anti-Cancer
Drug
Candidate
National
OncoVenture
Candidate
Provider
Knowhow
Facility
Consulting
L/O Dev
Global
Anti-
Cancer
Drug
Joint
Development
Agreement
Supporting Networks
Nat’l Cancer Center/KFDA/
Academia/Nat’l Lab
Advisory board
CMO/CRO
3. Operation Model & Procedure
7
Knowhow/Fund
Anti-Cancer
Drug
Candidate
Expertise
Fund
3. Operation Model & Procedure
8
Receipt of application
Drop
Drop Nogo
Nogo
Due diligence
MTA/Option Agreement
(Feasibilitystudyfor development)
Co-development
Agreement
Non Clinical
development
Clinical
development
Strategic
Alliance or LO
Commercialization
Process for Project selection and Agreement↑
Process for Co-development ↓Co-development
Committee
Document
Evaluation
Oral Presentation
MTA:MaterialTransferAgreement
 Step 2. Development of Candidate :
Drug development by Joint Development
Committee
Pre-evaluation procedure
required for premature
candidates
 Step 3. License Out & Further Development :
License out for global development during or upon
completion of human clinical phase2a
 Step 1. Candidate Selection Procedure :
Accepting application all year around,
Evaluation 2~3 times/year
Project Selection and Development
4. Project Selection Statistics
9
Evaluation/Selection Development
9 programs
On going
7 programs
Stopped
Project Selection : 2011~2016
Due
diligence
Document
Evaluation
Oral
Presentation
152 81 27 16
Co-
development
Agreement
Co-development
Committee
1 program
out-licensed
5. Distinctive features
10
•Target, Hit, Lead,
Lead optimization
Discovery
•Preclinical, P1 & P2
•Translational
Research
Bridging &
Development
•P3, Approval &
•Commercialization
Development
 Develop selected pre-clinical anti-cancer drug candidates through P2 stage
 Academic candidates: 100% government fund through preclinical stage
 Commercial candidates: 50-75% financial support through clinical stage
Supported by
Ministry of Education, Science &
Technology
National OncoVenture
Supported by
Ministry of Health &
Welfare
Preclinical: 100% support
Clinical: 50-75% support
Pharmaceutical companies
(Domestic & Global)
Dept. of
Clinical
development
Candidate
Provider
Advisory:
NCC & Clinical
Oncology
committee
CRO
Central Lab
Genetic Analysis
Lab
Tumor
Assessment
PK
Analysis Lab
Other
Advisor group
Clinical
Sites
Medical
Writing
Statistics
Design
Concept
Genotyping
plan
DMPK plan Production &
Packaging
Vendor selection,
Delivery & Insurance
eCRF
Safety/
DSMB
Site due
diligence
Site contract
IRB
Clinical
Study!
KFDA
IND
An Example of Virtual Development: Clinical Development Division Interface
5. Distinctive features
 Virtual oncology drug development w/ government support
 Go/No-go milestone evaluation by global drug development experts
 Early involvement of clinical oncologist  Optimized clinical trial
 “Quick Win, Fast Fail” model  Low cost / High efficiency paradigm
11
5. Distinctive features
 Maximize candidate value by drug development experts
 Support to patent strategy and improvement
 Contract with high return to candidate provider
 Provide Korean oncology drugs & contribute to drug cost down
12
Investor
Candidate
Provider
Investor
Candidate
Provider
NOV
Return
Bridge &
Development
Representing Oncology Advisory Committee Members
5. Distinctive features
13
Yoon-Koo Kang
·Dept. of Oncology, ASAN medical
center, Univ. of Ulsan College of
Medicine
·Specialized Area :Stomach
Cancer, Hepatoma, GIST
Dong Wook Kim
·Division of Hematology, Seoul St. Mary’s
Hospital, The Catholic Univ. of Korea
·Specialized Area : Leukemia
Do-Hyun Nam
·Dept. of Neurosurgery,
Samsung Seoul Medical
Center, Sungkyunkwan
Univ. School of Medicine
·Specialized Area : Glioma,
Cancer/Neuro stem cell
Sun Young Rha
·Dept. of Medical Oncology,
Severance Hospital, Yonsei
Univ. College of Medicine
·Specialized Area : Stomach
cancer, Renal cancer,
Sarcoma
Sung-Soo Yoon
·Dept. of Internal Medicine,
Hematology/Oncology, Seoul
Nat’l Univ. Hospital
·Specialized Area : Blood
Cancer, Multiple myeloma
Soonmyung Paik
·Severance Biomedical Science Institute,
Yonsei Univ. College of Medicine
·Division of Pathology, NSABP (The National
Surgical Adjuvant Breast and Bowel Project)
·Specialized Area : Pathology, Clinical trial
design, adjuvant chemotherapy treatment /
response prediction
Yeul-Hong Kim
·Dept of Internal Medicine,
Hematology/Oncology, Korea Univ.
Anam Hospital Cancer Center
·Specialized Area : Stomach cancer,
Gastrointestinal cancer
·Unit of Biomolecular Function
Research, Center for Gastric
cancer, National Cancer Center,
·Specialized Area : Stomach
Cancer, Diagnostic Markers
and Anticancer Drug
Susceptibility Predictors
Kim Hark Kyun
·Dept. of Clinical Pharmacology
and Therapeutics, ASAN
medical center, Univ. of Ulsan
College of Medicine
·Specialized Area : Clinical
Pharmacology and
Therapeutics
Lim Hyeong-Seok
Scientific Advisory Committee
5. Distinctive features
Pre/Formulation
DMPK
Regulatory AffairsIP/Legal Affairs
ChemistryBiology
Project
Management
Manufacturing
Process
Development
Clinical Design &
Development
Marketing
 Consists of ~100 nationally & globally well-known cancer drug R&D experts
 Provide expert opinions & recommendations throughout drug development
process
14
Toxicology
/Pathology
6. Pipeline (As of June 2017)
15
Project ID Description Indication Project non-GLP GLP Ph 1 Ph 2
NOV1601 TRK inhibitor Solid tumors
NOV1502
KRAS/WNT
inhibitor
Solid tumors
NOV1501
Anti-VEGF/DLL4
bispecific mAb
Gastric cancer,
Solid tumors
NOV1402
PARP/Tankyrase
Inhibitor
Solid tumors
NOV1401 PARP 1 Inhibitor Breast, Ovarian
NOV1105 Anti-HGF mAb
GBM, Ovarian,
Melanoma
NOV1204
Oral Vascular
Disrupting Agent
Solid tumors Mono
CRC
Combo
w/ IRT
NOV1301 TGF-b R1 inhibitor
Solid tumors
MDS
NOV1201
Next Gen Pan-Her
inhibitor
Breast cancer Salvage
NSCLC
1st line
2nd line
MFDS
MFDS
MFDS
FDA
MFDS
MFDS
MFDSLO
FDA
16
7. Area of Interest
□ Common Requirements
1. Anticancer drug candidates being developed between nonclinical and clinical phases
2. Substances that have no problems in securing IP for global anti-cancer drug development or
global technology transfer
3. Materials with innovative molecular targets or medical unmet needs
□ Areas of Primary Interest
1. First-In Class chemicals and Biologics including antibodies, antibody-drug conjugate
2. Targeting cancer signaling pathway, metabolism, epigenetics, etc.
3. Novel immunotherapeutic agents (Immune checkpoint, Immune cell modulator, etc.)
4. Gene therapy or cell therapeutics that is feasible due to a new mechanism for action or
differentiation.
5. Targeted therapy that can be developed simultaneously with accompanying companion diagnostics
□ Areas of Secondary Interest
1. A cancer metastasis inhibitor with a clear mechanism of action that can produce synergistic effects
when used in combination with a NOV pipeline
2. Anticancer drug using targeted drug delivery system
Collaboration between
NOV & Global/Domestic Pharmaceutical Company
Company can join the NOV’s oncology project as a co-development partner or
matching fund provider, or can license in the project
Global/Domestic company can join the NOV’s project◈
NOV can join domestic company to develop in-licensing oncology project from global
bio/pharmaceutical companies as a co-development partner.
NOV can join domestic company to develop in-licensing overseas project◈
8. Flexible Alliance Model
17
NOV develops/co-develops the company’s in-house project (pre-clinical or clinical) with
the research infra (NCC), extensive networks, expert’s know-how as well as development
fund
NOV co-develops the domestic company’s in-house project◈
Thank You!
National OncoVenture contact:
Business Development at
BD.NOV@ncc.re.kr
Mina Lee
Sr.Director, minalee@ncc.re.kr
82-31-920-2772 (O)
Kangsik Yun
VP, ksyun@ncc.re.kr
82-31-920-2778 (O)
Write a success story
together with you ..

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National onco venture_introduction_2017_june_v34

  • 1. National OncoVenture http://nov.ncc.re.kr Designated by Ministry of Health & Welfare Supported by National Cancer Center
  • 2. 2 Table of Contents 1. Program summary 2. Organization 3. Operation Model & Procedure 4. Selection Process 5. Distinctive Features 6. Pipelines 7. NOV Performance 8. Alliance Models
  • 3. 1. Program Summary  Mission: Support Korean global anti-cancer drug development  Program Period : 2011~2016 (1st stage) + 2017~2021 (2nd stage)  Budget : Ministry of Health & Welfare + Matching fund from originator  Model:  Select pre-clinical anti-cancer drug candidates from various sources (Universities, National labs., Biotech & Pharmaceutical companies, etc.)  Develop through clinical stages (PII)  Project managed by joint development committee between National OncoVenture and drug candidate provider  Eventually, license out to or make partnership with domestic/global pharmaceutical companies  Share profit with candidate provider and collaborators  Operation methods:  Directed by new (anti-cancer) drug development experts  Virtual drug development utilizing CROs, CMOs, consulting network, etc. 3
  • 4. 1. Program Summary 4 Expanding the area of interest in 2nd Stage 1st Stage (2011~2016) 2nd stage (2017~2021) Development area New Anticancer drug New Anticancer drug Biomarker Companion Diagnostics Originators Universities, National labs., Biotech & Pharmaceutical companies, etc Universities, National labs., Biotech & Pharmaceutical companies, etc Operation Project managed by JDC, led by NOV Project managed by JDC, led by NOV Type of Drug Small Molecule, Monoclonal Antibodies Small Molecule, Monoclonal Antibodies Cell therapeutics Gene therapeutics Level of Innovation Mainly Best-in-class Mainly First-in-class Development stage Validation ↔ Phase 2a Validation ↔ Phase 2
  • 5. 2. Organization President General management Business Development - R&D&B trend analysis - Identify drug candidates - L/I, L/O, contract - Patent/Legal management Steering Committee - Overall strategic decision - Decision sub-committee recommendations Advisory Committee Advisory recommendation Drug Development - Project management for drug candidates through preclinical & clinical stages - Manage outsourcing studies - Study result analysis NCC Research Institute - Pilot preclinical studies - Clinical study plan Administrative Office - Business planning - Personnel, Budget - Public Relation Network Group - Collaborative studies: University, Nat’l Lab, Biotech/Pharma - Outsourcing studies: CRO, CMOs - Advisory consulting: KFDA, Global network Scientific/Oncology Advisory Committee - Provide expert opinions & recommendations throughout drug development stages NOV-KFDA Committee -Provide expert opinion on regulatory strategy -Guide requirements for efficient approval process 5
  • 6. Head & VP Business Dev. Kangsik Yun MA, Seoul National Univ. Head of R&D Management at Chong Kun Dang Pharm., Daewoong Pharm. and ToolGen Senior Researcher at SK Corp. Head & VP Drug Dev. Sung- Sook Lee Ph.D., Ohio State University Committee of KDDF Head of Research Institute at Chon Kun Dang Pharm. Senior Researcher at Cerep Inc. Head & VP Clinical Dev. Jung- Yong Kim MD., Seoul National Univ. Roswell Park Cancer Inst./ SUNY at Buffalo Practicing at Prostate Cancer center (National Cancer Center) President & CEO Young-Whan Park Ph.D., Rutgers University Project Leader at Merck USA ID research center Head of Research Institute at Daewoong Pharm. Business Development Drug Development 2. Organization Management Team of OncoVenture 6
  • 7. New Paradigm: A Gov-funded Virtual Drug Development Joint Development Committee OncoVenture + Candidate Provider Global Anti-Cancer Drug Candidate National OncoVenture Candidate Provider Knowhow Facility Consulting L/O Dev Global Anti- Cancer Drug Joint Development Agreement Supporting Networks Nat’l Cancer Center/KFDA/ Academia/Nat’l Lab Advisory board CMO/CRO 3. Operation Model & Procedure 7 Knowhow/Fund Anti-Cancer Drug Candidate Expertise Fund
  • 8. 3. Operation Model & Procedure 8 Receipt of application Drop Drop Nogo Nogo Due diligence MTA/Option Agreement (Feasibilitystudyfor development) Co-development Agreement Non Clinical development Clinical development Strategic Alliance or LO Commercialization Process for Project selection and Agreement↑ Process for Co-development ↓Co-development Committee Document Evaluation Oral Presentation MTA:MaterialTransferAgreement  Step 2. Development of Candidate : Drug development by Joint Development Committee Pre-evaluation procedure required for premature candidates  Step 3. License Out & Further Development : License out for global development during or upon completion of human clinical phase2a  Step 1. Candidate Selection Procedure : Accepting application all year around, Evaluation 2~3 times/year Project Selection and Development
  • 9. 4. Project Selection Statistics 9 Evaluation/Selection Development 9 programs On going 7 programs Stopped Project Selection : 2011~2016 Due diligence Document Evaluation Oral Presentation 152 81 27 16 Co- development Agreement Co-development Committee 1 program out-licensed
  • 10. 5. Distinctive features 10 •Target, Hit, Lead, Lead optimization Discovery •Preclinical, P1 & P2 •Translational Research Bridging & Development •P3, Approval & •Commercialization Development  Develop selected pre-clinical anti-cancer drug candidates through P2 stage  Academic candidates: 100% government fund through preclinical stage  Commercial candidates: 50-75% financial support through clinical stage Supported by Ministry of Education, Science & Technology National OncoVenture Supported by Ministry of Health & Welfare Preclinical: 100% support Clinical: 50-75% support Pharmaceutical companies (Domestic & Global)
  • 11. Dept. of Clinical development Candidate Provider Advisory: NCC & Clinical Oncology committee CRO Central Lab Genetic Analysis Lab Tumor Assessment PK Analysis Lab Other Advisor group Clinical Sites Medical Writing Statistics Design Concept Genotyping plan DMPK plan Production & Packaging Vendor selection, Delivery & Insurance eCRF Safety/ DSMB Site due diligence Site contract IRB Clinical Study! KFDA IND An Example of Virtual Development: Clinical Development Division Interface 5. Distinctive features  Virtual oncology drug development w/ government support  Go/No-go milestone evaluation by global drug development experts  Early involvement of clinical oncologist  Optimized clinical trial  “Quick Win, Fast Fail” model  Low cost / High efficiency paradigm 11
  • 12. 5. Distinctive features  Maximize candidate value by drug development experts  Support to patent strategy and improvement  Contract with high return to candidate provider  Provide Korean oncology drugs & contribute to drug cost down 12 Investor Candidate Provider Investor Candidate Provider NOV Return Bridge & Development
  • 13. Representing Oncology Advisory Committee Members 5. Distinctive features 13 Yoon-Koo Kang ·Dept. of Oncology, ASAN medical center, Univ. of Ulsan College of Medicine ·Specialized Area :Stomach Cancer, Hepatoma, GIST Dong Wook Kim ·Division of Hematology, Seoul St. Mary’s Hospital, The Catholic Univ. of Korea ·Specialized Area : Leukemia Do-Hyun Nam ·Dept. of Neurosurgery, Samsung Seoul Medical Center, Sungkyunkwan Univ. School of Medicine ·Specialized Area : Glioma, Cancer/Neuro stem cell Sun Young Rha ·Dept. of Medical Oncology, Severance Hospital, Yonsei Univ. College of Medicine ·Specialized Area : Stomach cancer, Renal cancer, Sarcoma Sung-Soo Yoon ·Dept. of Internal Medicine, Hematology/Oncology, Seoul Nat’l Univ. Hospital ·Specialized Area : Blood Cancer, Multiple myeloma Soonmyung Paik ·Severance Biomedical Science Institute, Yonsei Univ. College of Medicine ·Division of Pathology, NSABP (The National Surgical Adjuvant Breast and Bowel Project) ·Specialized Area : Pathology, Clinical trial design, adjuvant chemotherapy treatment / response prediction Yeul-Hong Kim ·Dept of Internal Medicine, Hematology/Oncology, Korea Univ. Anam Hospital Cancer Center ·Specialized Area : Stomach cancer, Gastrointestinal cancer ·Unit of Biomolecular Function Research, Center for Gastric cancer, National Cancer Center, ·Specialized Area : Stomach Cancer, Diagnostic Markers and Anticancer Drug Susceptibility Predictors Kim Hark Kyun ·Dept. of Clinical Pharmacology and Therapeutics, ASAN medical center, Univ. of Ulsan College of Medicine ·Specialized Area : Clinical Pharmacology and Therapeutics Lim Hyeong-Seok
  • 14. Scientific Advisory Committee 5. Distinctive features Pre/Formulation DMPK Regulatory AffairsIP/Legal Affairs ChemistryBiology Project Management Manufacturing Process Development Clinical Design & Development Marketing  Consists of ~100 nationally & globally well-known cancer drug R&D experts  Provide expert opinions & recommendations throughout drug development process 14 Toxicology /Pathology
  • 15. 6. Pipeline (As of June 2017) 15 Project ID Description Indication Project non-GLP GLP Ph 1 Ph 2 NOV1601 TRK inhibitor Solid tumors NOV1502 KRAS/WNT inhibitor Solid tumors NOV1501 Anti-VEGF/DLL4 bispecific mAb Gastric cancer, Solid tumors NOV1402 PARP/Tankyrase Inhibitor Solid tumors NOV1401 PARP 1 Inhibitor Breast, Ovarian NOV1105 Anti-HGF mAb GBM, Ovarian, Melanoma NOV1204 Oral Vascular Disrupting Agent Solid tumors Mono CRC Combo w/ IRT NOV1301 TGF-b R1 inhibitor Solid tumors MDS NOV1201 Next Gen Pan-Her inhibitor Breast cancer Salvage NSCLC 1st line 2nd line MFDS MFDS MFDS FDA MFDS MFDS MFDSLO FDA
  • 16. 16 7. Area of Interest □ Common Requirements 1. Anticancer drug candidates being developed between nonclinical and clinical phases 2. Substances that have no problems in securing IP for global anti-cancer drug development or global technology transfer 3. Materials with innovative molecular targets or medical unmet needs □ Areas of Primary Interest 1. First-In Class chemicals and Biologics including antibodies, antibody-drug conjugate 2. Targeting cancer signaling pathway, metabolism, epigenetics, etc. 3. Novel immunotherapeutic agents (Immune checkpoint, Immune cell modulator, etc.) 4. Gene therapy or cell therapeutics that is feasible due to a new mechanism for action or differentiation. 5. Targeted therapy that can be developed simultaneously with accompanying companion diagnostics □ Areas of Secondary Interest 1. A cancer metastasis inhibitor with a clear mechanism of action that can produce synergistic effects when used in combination with a NOV pipeline 2. Anticancer drug using targeted drug delivery system
  • 17. Collaboration between NOV & Global/Domestic Pharmaceutical Company Company can join the NOV’s oncology project as a co-development partner or matching fund provider, or can license in the project Global/Domestic company can join the NOV’s project◈ NOV can join domestic company to develop in-licensing oncology project from global bio/pharmaceutical companies as a co-development partner. NOV can join domestic company to develop in-licensing overseas project◈ 8. Flexible Alliance Model 17 NOV develops/co-develops the company’s in-house project (pre-clinical or clinical) with the research infra (NCC), extensive networks, expert’s know-how as well as development fund NOV co-develops the domestic company’s in-house project◈
  • 18. Thank You! National OncoVenture contact: Business Development at BD.NOV@ncc.re.kr Mina Lee Sr.Director, minalee@ncc.re.kr 82-31-920-2772 (O) Kangsik Yun VP, ksyun@ncc.re.kr 82-31-920-2778 (O) Write a success story together with you ..