National onco venture_introduction_2013_mar_v19
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v.19
National OncoVenture http://nov.ncc.re.kr
Designated by Ministry of Health & Welfare
Supported by National Cancer Center
Table of Contents
1. Mission & Objectives
2. Organization
3. Business summary
4. Operation Model & Procedure
5. Selection Process
2
6. Distinctive Features
7. Pipelines
8. Alliance Models
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Mission: Global Anti-Cancer Drug Development
Objective: Produce 4 Global Drug Candidates with PIIa completion within 5 years
1. Mission & Objective
National OncoVenture
Drug value↑
Drug Candidate
University Biotech
Nat'l Lab Domestic Pharma Global pharma
Global drug candidate Korean / Global
Pharmaceutical companies
License Out
Expert Network
Outsourcing CRO, CMOs
Global drug
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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
Center for Drug Dev. Assistance(KFDA)
-Provide expert opinion on regulatory strategy -Guide requirements for efficient approval process
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President & CEO
In-Chull Kim
Ph.D. University of Illinois CEO at LG Life Science Head Researcher at Glaxo US Responsible Developer of Factiv”
Head & SVP
Young-Whan Park
Ph.D. Rutgers University Project Leader at Merck USA ID research center Head of Research Institute at Daewoong Pharm. Co.ltd.
Head & VP Biologic drugs
Kiwon Jo
Ph.D. UNC-Chapel Hill Research Director at KRIBB Head, Cancer Team at LG Life Sciences
Head & VP Chemical drugs
Moon-hwan Kim Ph.D., Seoul National Univ. Director at Exelixis USA Research Advisor at New Drug dev. at Medical school of Stanford Univ.
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)
Business Development Drug Development
2. Organization
Management Team of OncoVenture
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Advisory Board
2. Organization
Jungshin Lee
President,
Institute of Innovative
Cancer Research
President(ex),
Seoul ASAN Medical Center
Prof.(ex), Fox Chase Cancer Center
YungJue Bang
Prof.
Dept. of Internal Medicine
Seoul Nat’l Univ.
College of Medicine
Scientific Council Member ,
WHO /IARC
Jaekyung Rho
Prof.
Dept. of Internal Medicine
Yonsei Univ. College of
Medicine
Fellow (ex),
Medical Oncology, Vincent Lombardi Cancer
Research Center
Jinsoo Lee
President,
National Cancer
Center of Korea
Prof, (ex),
MD Anderson Cancer Center
Hoogeun Chun
Director,
Catholic Comprehensive
Cancer Inst. at Seoul St.
Mary's Hospital,
Catholic Univ. of Korea
President,
Korean Assoc. for Clinical Oncology
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Paul A. Bunn
Prof & Head, Division of
Medical Oncology , State Univ.
of Colorado
President of ASCO, IASLC,
and AACI (ex)
Chairman of the FDA
Oncology Drug Advisory
Committee (ex)
Eric K. Rowinsky
CMO & EVP Stemline Therapeutics Boards of directors of Biogen Idec, Inc. Founder/CEO,Primrose Therapeutics (ex) CMO & EVP ImClone System Inc. (ex) Associate Professor Johns Hopkins University School of Medicine (ex)
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Dong Wook Kim
Division of Hematology
Seoul St. Mary’s Hospital
The Catholic University of Korea
Specialized in :Leukemia
2005- Tasigna P1/2, Sprycel P2
2007- Bosutinib P2, Tasigna P3
2008- Sprycel P3, Bosutinib P3
2008- Supect P1/2
Sun Young Rha
Dept. of Medical Oncology
Severance Hospital
Yonsei Univ. College of Medicine
Specialized in : Stomach cancer ,
Renal cancer, Sarcoma
2004~ RPR109881 P2
Epothilone P3
2008~ Sutent GIST P3
2010~ Votrient vs. Sutent
Do-Hyun Nam
Dept. of Neurosurgery
Samsung Seoul Medical Center
Sungkyunkwan Univ. School of
Medicine
Specialized in : Glioma, Cancer
/Neuro stem cell
2006~Temodal P2
2009~Cilengitide P3
2009~INNOCELL Immuncell-LC P3
2010~GBM-BO21990 P3
Oncology Advisory Committee
Center for Lung Cancer;
National Cancer Center, Korea
Specialized in: Lung cancer,
Esophagus cancer
2006~ Alimta P3
2007~ Aflibercept P3
2008~ TS-1 (TSIP) P1/2
2010~ Avastin P3 ,Belotecan P2b
Jungsil Ro
Center for Clinical Trials
Center for Breast Cancer
National Cancer Center, Korea
Specialized in: Breast cancer
2002~ Herceptin P3
2006~ Tykerb P3
2008~ Tykerb P1b
2009~ Afnitor P3
Sung-Soo Yoon
Dept of Internal Medicine,
Hematology/Oncology
Seoul Nat’l University Hospital
Specialized in : Blood Cancer ,
Multiple myeloma
2008~Velcade P3
2008~Vorinostat P2
2010~ GSK 220183 P1
2010- Panobinostat P3
Yoon-Koo Kang
Dept of Oncology
ASAN medical Center
Univ.of Ulsan College of Medicine
Specialized in: Stomach cancer,
hepatoma, GIST
2007~ Avastin P3
2008~ Sutent P3
2009~Tasigna P3
2010~ Regorafenib P3
Heung Tae Kim
2. Organization
Yeul-Hong Kim
Dept of Internal Medicine,
Hematology/Oncology
Korea University Anam Hospital
Cancer Center
Specialized in : Stomach cancer ,
Gastrointestinal cancer
2008~ KT&G-MB40 P1
2008~ Nimotuzumab P2
2009~ RAD001 P3
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Soonmyung Paik
Director, Division of Pathology,
NSABP
1995 ~ : NSABP breast B27-51:
tratuzumab, lapatinib, pertuzumab,
bevacizumab, TDM1, etc. : P3
1995 ~: NSABP colon C06-11: UFT,
oxaliplatin, bevacizumab: P3
1995~ : NSABP rectal R04:
capecitabine, bevacizumab: P3
2004: OncotypeDx breast cancer
2010: OncotypeDx colon cancer
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Scientific Advisory Committee
2. Organization
Pre/Formulation
DMPK Regulatory Affairs
IP/Legal Affairs
Chemistry
Biology
Toxicology/Pathology Project Management
Manufacturing
Process Development
Clinical Design & Development
Marketing
Consists of >30 nationally & globally well-known cancer drug R&D
experts
Provide expert opinions & recommendations throughout drug development process
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3. Business Summary
Name : National OncoVenture
Business Period : 2011~2015 + 5 yrs (if confirmed)
Total Budget : $200MM (Private funds 50%) for 5 years
Business Model:
Select early stage anti-cancer drug candidates from various sources
(Universities, National labs., Biotech & Pharmaceutical companies, etc.)
Develop through preclinical & clinical stages (PIIa)
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.
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Joint Development Committee OncoVenture +
Candidate Provider
Global Anti-Cancer
Drug Candidate
Candidate Provider
National OncoVenture
Substance/ IP Knowhow
Fund
Fund Expertise
Knowhow Facility
Consulting
L/O Dev Global
Anti-Cancer Drug
Joint Development Agreement
Supporting Networks CMO/CRO
Nat’l Cancer Center/KFDA/ Academia/Nat’l Lab
Advisory board
4. Operation Model & Procedure
New Paradigm: A Gov-funded Virtual Drug Development Program
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Business Operation Procedure
Step 1. Candidate Selection Procedure
: Accepting application all year around, Evaluation 3 times/year
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
2 page simple application
Evaluation by new drug R&D experts
Document Evaluation
Oral Presentation
Evaluation by clinical oncologist
Clinical Evaluation
Confirm integrity of data &
development capability
Due Diligence
Rapid agreement contract within 2
months
Joint Development Agreement
4. Operation Model & Procedure
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5. Selection Process
Drop Drop
Go
No Go
Conditional Go
Pre-Evaluation (Written document)
Development track
Application
Bridging track
Confidentiality is guaranteed for entire process.
Peer Review (Oral presentation)
CDA/ Due Diligence
CDA/ Due Diligence
Term Negotiation
MTA/ Substance Evaluation
Peer Review (Oral presentation)
Joint Development Agreement
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Joint Development Committee Nat’l OncoVenture + Candidate Provider
Commercializing
Global Cancer Drug
Global Cancer Drug
Candidate
Non Clinical Evaluation
Clinical Evaluation
( I /IIa)
Joint Development Agreement
Originator
Drop
Licensing Out
Further Dev. & Licensing Out
Go
No Go
Conditional Go
5. Selection Process
Confidentiality is guaranteed for entire process.
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Supported by Ministry of
Education, Science & Technology
Discovery
Development
Target, Hit, Lead, Lead optimization
P3, Approval & Commercialization
Bridging & Development
Preclinical, P1 & P2 Translational
Research
Develop selected drug candidates through human clinical PII stage
Support 100% government fund through preclinical stage
6. Distinctive features
National OncoVenture Supported by Ministry of
Health & Welfare Preclinical: 100% support
Clinical: 50% support
Pharmaceutical companies
(Domestic & Global)
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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
6. Distinctive features
Fast decision making throughout development
“Quick Win, Fast Fail” model Low cost / High efficiency paradigm
Continuous involvement of clinical oncologist Personalized medicine
Virtual oncology drug development w/ government support
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6. 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
Investor Candidate Provider
Investor
Candidate Provider
NOV
Return
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7. Pipeline (As of Dec. 2012)
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Project ID Description MOA Indication Project non-GLP
GLP Ph 1 Ph 2
NOV1203 Anti- AITR (Human Activation-Inducible TNF Receptor) antibody
Inducing cytotoxic effector T cells
Solid tumors
NOV1105 Anti-HGF antibody Neutralizing HGF Sarcoma
NOV1205 Bcl-abl inhibitor Inhibition of Bcl-Abl RTK
CML
NOV1101 DLK1 antagonist Anti DLK1 antibody
Neutralizing DLK1
DLK1-Fc fusion protein
DLK1 decoy Liver, Pancreas, Colon, Ovarian Cancer
NOV1103 FLT3 inhibitor Inhibition of FLT 3 RTK
AML
NOV1204 Anti-tubulin Vascular disruption Solid tumors Oral
IV
NOV1201 Pan-Her inhibitor Inhibition of Her1,2&4
Gastric cancer
NSCLC 1st line
2nd line
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Collaboration between NOV & Global/Domestic Pharmaceutical Company
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 company’s in-house project ◈
Company can join the NOV’s oncology project as a co-development partner or matching fund provider, or can license in the project
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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Thank You!
Mina Lee
Director, Business Development
National OncoVenture
Bd.nov@ncc.re.kr
82-31-920-2772 (O)
Home page
http://nov.ncc.re.kr
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