National onco venture_introduction_2013_mar_v19
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  • 1. National OncoVenture http://nov.ncc.re.kr Designated by Ministry of Health & Welfare Supported by National Cancer Centerv.19
  • 2. Table of Contents1. Mission & Objectives2. Organization3. Business summary4. Operation Model & Procedure5. Selection Process6. Distinctive Features7. Pipelines8. Alliance Models 2
  • 3. 1. Mission & Objective  Mission: Global Anti-Cancer Drug Development  Objective: Produce 4 Global Drug Candidates with PIIa completion within 5 years Expert Network Drug Candidate National License Out University Global drug Biotech OncoVenture candidate Korean / Global Natl Lab Drug value↑ Pharmaceutical Domestic Pharma companies Global pharma Outsourcing CRO, CMOs Global drugv.19 3
  • 4. 2. Organization Advisory President Committee General management Advisory recommendation Steering Committee Administrative Office - Overall strategic decision - Business planning - Decision sub-committee - Personnel, Budget recommendations - Public Relation Scientific/Oncology Center for Drug Dev. Assistance(KFDA) Advisory Committee - Provide expert opinion on regulatory strategy - Provide expert opinions & - Guide requirements for efficient approval recommendations throughout process drug development stages Business Development Drug Development NCC Research Institute - R&D&B trend analysis - Project management for - Pilot preclinical studies - Identify drug candidates drug candidates through - Clinical study plan - L/I, L/O, contract preclinical & clinical stages - Patent/Legal management - Manage outsourcing studies - Study result analysis Network Group - Collaborative studies: University, Nat’l Lab, Biotech/Pharma - Outsourcing studies: CRO, CMOs - Advisory consulting: KFDA, Global networkv.19 4
  • 5. 2. Organization Management Team of OncoVenture President & CEO In-Chull Kim Ph.D. University of Illinois CEO at LG Life Science Head Researcher at Glaxo US Responsible Developer of Factiv” Business Development Drug Development Head & SVP Head & VP Head & VP Head & VP Biologic drugs Chemical drugs Clinical Dev. Young- Kiwon Moon- Jung- Whan Jo hwan Yong Park Kim Kim Ph.D. Rutgers University Ph.D. UNC-Chapel Hill Ph.D., Seoul National Univ. MD. Seoul National Univ. Project Leader at Merck USA Research Director at KRIBB Director at Exelixis USA Roswell Park Cancer Inst./ SUNY ID research center Head, Cancer Team at LG Life Research Advisor at New Drug dev. at Buffalo Head of Research Institute Sciences at Medical school of Stanford Univ. Practicing at Prostate Cancer at Daewoong Pharm. Co.ltd. center (National Cancer Center)v.19 5
  • 6. 2. Organization Advisory Board Jaekyung Rho YungJue Bang Hoogeun Chun Prof. Prof. Director, Dept. of Internal Medicine Dept. of Internal Medicine Catholic Comprehensive Yonsei Univ. College of Seoul Nat’l Univ. Cancer Inst. at Seoul St. Medicine College of Medicine Marys Hospital, Fellow (ex), Scientific Council Member , Catholic Univ. of Korea Medical Oncology, Vincent Lombardi Cancer WHO /IARC President, Research Center Korean Assoc. for Clinical Oncology Jungshin Lee Jinsoo Lee Eric K. Rowinsky President, CMO & EVP Stemline President, Institute of Innovative National Cancer Therapeutics Cancer Research Center of Korea Boards of directors of Biogen Idec, Inc. President(ex), Seoul ASAN Medical Center Prof, (ex), Founder/CEO,Primrose MD Anderson Cancer Center Therapeutics (ex) Prof.(ex), Fox Chase Cancer Center CMO & EVP ImClone System Inc. (ex) Associate Professor Johns Paul A. Bunn Hopkins University School Prof & Head, Division of of Medicine (ex) Medical Oncology , State Univ. of Colorado President of ASCO, IASLC, and AACI (ex) Chairman of the FDA Oncology Drug Advisory Committee (ex)v.19 6
  • 7. 2. Organization Oncology Advisory Committee Yoon-Koo Yeul-Hong Soonmyung Dong Wook Heung Tae Kang Kim Paik Kim Kim Dept of Oncology Division of Hematology Center for Lung Cancer; Dept of Internal Medicine, Director, Division of Pathology, ASAN medical Center Seoul St. Mary’s Hospital National Cancer Center, Korea Hematology/Oncology NSABP Univ.of Ulsan College of Medicine The Catholic University of Korea Specialized in: Lung cancer, Korea University Anam Hospital 1995 ~ : NSABP breast B27-51: Specialized in: Stomach cancer, Specialized in :Leukemia Esophagus cancer Cancer Center tratuzumab, lapatinib, pertuzumab, hepatoma, GIST 2005- Tasigna P1/2, Sprycel P2 2006~ Alimta P3 Specialized in : Stomach cancer , bevacizumab, TDM1, etc. : P3 2007~ Avastin P3 2007- Bosutinib P2, Tasigna P3 2007~ Aflibercept P3 Gastrointestinal cancer 1995 ~: NSABP colon C06-11: UFT, 2008~ Sutent P3 2008- Sprycel P3, Bosutinib P3 2008~ TS-1 (TSIP) P1/2 2008~ KT&G-MB40 P1 oxaliplatin, bevacizumab: P3 2009~Tasigna P3 2008- Supect P1/2 2010~ Avastin P3 ,Belotecan P2b 2008~ Nimotuzumab P2 1995~ : NSABP rectal R04: 2010~ Regorafenib P3 2009~ RAD001 P3 capecitabine, bevacizumab: P3 2004: OncotypeDx breast cancer 2010: OncotypeDx colon cancer Do-Hyun Sung-Soo Sun Young Jungsil Yoon Nam Rha Ro Dept. of Neurosurgery Dept. of Medical Oncology Dept of Internal Medicine, Samsung Seoul Medical Center Center for Clinical Trials Severance Hospital Hematology/Oncology Sungkyunkwan Univ. School of Center for Breast Cancer Yonsei Univ. College of Medicine Seoul Nat’l University Hospital Medicine National Cancer Center, Korea Specialized in : Stomach cancer , Specialized in : Blood Cancer , Specialized in : Glioma, Cancer Specialized in: Breast cancer Renal cancer, Sarcoma Multiple myeloma /Neuro stem cell 2002~ Herceptin P3 2004~ RPR109881 P2 2008~Velcade P3 2006~Temodal P2 2006~ Tykerb P3 Epothilone P3 2008~Vorinostat P2 2009~Cilengitide P3 2008~ Tykerb P1b 2008~ Sutent GIST P3 2010~ GSK 220183 P1 2009~INNOCELL Immuncell-LC P3 2009~ Afnitor P3 2010~ Votrient vs. Sutent 2010- Panobinostat P3 2010~GBM-BO21990 P3v.19 7
  • 8. 2. Organization Scientific Advisory Committee  Consists of >30 nationally & globally well-known cancer drug R&D experts  Provide expert opinions & recommendations throughout drug development process Project Management Toxicology/Pathology Pre/Formulation IP/Legal Affairs Chemistry DMPK Manufacturing Regulatory Affairs Process Clinical Design & Biology Marketing Development Developmentv.19 8
  • 9. 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.v.19 9
  • 10. 4. Operation Model & Procedure New Paradigm: A Gov-funded Virtual Drug Development Program Joint Candidate Development Agreement Provider Substance/ IP Knowhow Fund Joint Development Global National Fund Anti-Cancer Global Dev OncoVenture Expertise Committee Drug L/O Anti-Cancer OncoVenture + Drug Candidate Candidate Provider Knowhow Facility Consulting Supporting Networks CMO/CRO Nat’l Cancer Center/KFDA/ Academia/Nat’l Lab Advisory boardv.19 10
  • 11. 4. Operation Model & Procedure Business Operation Procedure  Step 1. Candidate Selection Procedure : Accepting application all year around, Evaluation 3 times/year Joint Document Clinical Oral Presentation Due Diligence Development Evaluation Evaluation Agreement Confirm integrity Rapid agreement 2 page simple Evaluation by new Evaluation by of data & contract within 2 application drug R&D experts clinical oncologist development months capability  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 phase2av.19 11
  • 12. 5. Selection Process Confidentiality is guaranteed Pre-Evaluation for entire process. Application (Written document) Peer Review (Oral presentation) Bridging track Development track CDA/ CDA/ Drop Drop Due Diligence Due Diligence MTA/ Substance Evaluation Peer Review Term (Oral presentation) Negotiation Go Joint Conditional Go Development No Go Agreementv.19 12
  • 13. 5. Selection Process Confidentiality is guaranteed Joint Development for entire process. Agreement Drop Joint Development Committee Nat’l OncoVenture + Candidate Provider Global Non Clinical Cancer Global Licensing Evaluation Drug Commercializing Cancer Out Candidate Drug Clinical Evaluation ( I /IIa) Originator Go Further Dev. & Conditional Go Licensing Out No Gov.19 13
  • 14. 6. Distinctive features  Develop selected drug candidates through human clinical PII stage  Support 100% government fund through preclinical stage Discovery Supported by Ministry of Target, Hit, Lead, Education, Science & Lead optimization Technology Bridging & National OncoVenture Development Supported by Ministry of Health & Welfare Preclinical, P1 & P2 Preclinical: 100% support Translational Clinical: 50% support Research Development Pharmaceutical P3, Approval & companies Commercialization (Domestic & Global)v.19 14
  • 15. 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 An Example of Virtual Development: Clinical Development Division Interface KFDA IND IRB Medical Clinical Writing Site contract Sites Statistics Site due diligence Dept. of Candidate Design CRO Clinical Provider Concept Safety/ development DSMB Clinical Genotyping Study! eCRF plan DMPK plan Production & Vendor selection, Packaging Delivery & Insurance Advisory: NCC & Clinical Genetic Analysis Tumor PK Other Central Lab Analysis Lab Advisor group Oncology Lab Assessment committeev.19 15
  • 16. 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 Return Investor Investor Candidate Provider Candidate Provider NOVv.19 16
  • 17. 7. Pipeline (As of Dec. 2012) Project ID Description MOA Indication Project non- GLP Ph 1 Ph 2 GLP NOV1203 Anti- AITR (Human Inducing cytotoxic Solid tumors Activation- effector T cells Inducible TNF Receptor) antibody NOV1105 Anti-HGF antibody Neutralizing HGF Sarcoma NOV1205 Bcl-abl inhibitor Inhibition of Bcl-Abl CML RTK NOV1101 DLK1 antagonist Anti DLK1 Neutralizing DLK1 antibody DLK1-Fc DLK1 decoy Liver, Pancreas, fusion protein Colon, Ovarian Cancer NOV1103 FLT3 inhibitor Inhibition of FLT 3 AML RTK NOV1204 Anti-tubulin Vascular disruption Solid tumors Oral IV NOV1201 Pan-Her inhibitor Inhibition of Gastric cancer Her1,2&4 NSCLC 1st line 2nd linev.19 17
  • 18. 8. Flexible Alliance Model Collaboration between NOV & Global/Domestic Pharmaceutical Company ◈ Company can join the NOV’s project Company can join the NOV’s oncology project as a co-development partner or matching fund provider, or can license in the project ◈ NOV co-develops the company’s in-house project 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 can join domestic company to develop in-licensing oversea project NOV can join domestic company to develop in-licensing oncology project from global bio/pharmaceutical companies as a co-development partner.v.19 18
  • 19. Write a success story together with you .. 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.krv.19