National onco venture_introduction_2017_march_v33
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Transcript of National onco venture_introduction_2017_march_v33
National OncoVenturehttp://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 & Korean
pharmaceutical industry
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 domestic/global pharmaceutical companies
Share profit with candidate provider and collaborators
Operation methods:
Directed by new (anti-cancer) drug development experts
Virtual drug development operation utilized by 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 DrugSmall 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
AdvisoryCommittee
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/OncologyAdvisory 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 & SVP
Young-WhanPark
Ph.D. Rutgers UniversityProject Leader at Merck USA
ID research centerHead of Research Institute
at Daewoong Pharm. Co.ltd.
Head & VPDrug Dev.
Sung-SookLee
Ph.D., Ohio State University Committee of KDDFHead of Research Institute
at Chonkundang Pharm. Co.ltd.Senior Researcher at Cerep Inc.
Head & VPClinical Dev.
Jung-YongKim
MD. Seoul National Univ.Roswell Park Cancer Inst./ SUNY at Buffalo Practicing at Prostate Cancer center (National Cancer Center)
President & CEO
In-Chull Kim
Ph.D. University of Illinois CEO at LG Life ScienceHead Researcher at Glaxo USResponsible Developer of Factiv”
Business Development Drug Development
2. Organization
Management Team of OncoVenture
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New Paradigm: A Gov-funded Virtual Drug Development
Joint Development CommitteeOncoVenture +
Candidate Provider
Global Anti-Cancer
Drug Candidate
National OncoVenture
Candidate Provider
KnowhowFacility
Consulting
L/O Dev
GlobalAnti-
Cancer Drug
Joint Development Agreement
Supporting NetworksNat’l Cancer Center/KFDA/
Academia/Nat’l LabAdvisory board
CMO/CRO
3. Operation Model & Procedure
7
Knowhow/Fund
Anti-Cancer Drug
Candidate
ExpertiseFund
3. Operation Model & Procedure
8
Receipt of applicationDrop
Drop No go
No go
Due diligenceMTA/Option Agreement(Feasibility study for 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: Material Transfer Agreement
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
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Evaluation/Selection Development
9 programsOn going
7 programsStopped
Project Selection : 2011~2016
Due diligence
Document Evaluation
Oral Presentation
152 81 27 16
Co-development Agreement
Co-development Committee
5. Distinctive features
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•Target, Hit, Lead,
Lead optimizationDiscovery
•Preclinical, P1 & P2
•Translational
Research
Bridging &
Development
•P3, Approval &
•CommercializationDevelopment
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 LabGenetic Analysis
Lab
Tumor Assessment
PK Analysis Lab
Other Advisor group
Clinical Sites
Medical Writing
Statistics
DesignConcept
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
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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
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InvestorCandidate Provider
Investor
Candidate Provider
NOVReturn
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
ChemistryBiologyProject
Management
ManufacturingProcess
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
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Toxicology /Pathology
6. Pipeline (As of March 2017)
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Project ID Description Indication Project non-GLP GLP Ph 1 Ph 2
NOV1601 TRK inhibitor Solid tumors
NOV1502KRAS/WNT inhibitor
Solid tumors
NOV1501Anti-VEGF/DLL4 bispecific mAb
Gastric cancer, Solid tumors
NOV1402PARP/Tankyrase
InhibitorSolid tumors
NOV1401 PARP 1 Inhibitor Breast, Ovarian
NOV1105 Anti-HGF mAbGBM, Ovarian,
Melanoma
NOV1204Oral Vascular
Disrupting Agent
Solid tumors Mono
CRCCombo w/ IRT
NOV1301 TGF-b R1 inhibitorSolid tumors
MDS
NOV1201Next Gen Pan-Her
inhibitor
Breast cancer Salvage
NSCLC1st line
2nd line
MFDS
MFDS
MFDS
FDA
MFDS
MFDS
MFDSLO
FDA
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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 betweenNOV & 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
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 oversea project◈
8. Flexible Alliance Model
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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 [email protected]
Lee, Mina
Sr.Director, [email protected]
82-31-920-2772 (O)
Park, Young-Whan
SVP, [email protected]
82-31-920-2780 (O)
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