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Partnering with Industry

Partnering with Industry. Katherine Y. Look M.D. Medical Fellow I Eli Lilly. NCI/GCIG Panel Discussion May 29, 2009. What we Bring Novel Molecules Global Presence Advocacy Links Financial support. What we Need Timeliness Concept →PA→FPV Regulatory Quality Data Collection

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Partnering with Industry

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  1. Partnering with Industry Katherine Y. Look M.D. Medical Fellow I Eli Lilly NCI/GCIG Panel Discussion May 29, 2009

  2. What we Bring Novel Molecules Global Presence Advocacy Links Financial support What we Need Timeliness Concept→PA→FPV RegulatoryQuality Data Collection Cooperation with CTR Requirements Partnering Industry Perspective

  3. Pfisterer J et al JCO 2006

  4. Pfisterer J et al JCO 2006

  5. Pfisterer J et al JNCI 2006

  6. Pfisterer J et al JNCI 2006

  7. TFI ³ 12 mos Ferrero JM et al Annals Oncology 2007

  8. Ferrero JM et al Annals Oncology 2007

  9. CALYPSO Sponsors and Collaborators: ARCAGY/ GINECO GROUP Schering-Plough ArbeitsgemeinschaftGynaekologischeOnkologie Austria AGO Ovarian Cancer Study Group ANZGOG European Organization for Research and Treatment of Cancer NCIC CTG NSGO ClinicalTrials.gov Identifier: NCT00189553 • Standard Carboplatin AUC 5 every 3 or 4 weeks Paclitaxel 175 mg/m² at day 1 every 3 weeks • Experimental Carboplatin AUC 5 every 3 or 4 week Pegylated liposomal doxorubicin 30 mg/m² every 4 weeks 6 cycles or until progression

  10. CALYPSO Eligibility Criteria Measurable disease (RECIST) or CA125 assessable disease (GCIG) or Histologically proven Dx of relapse Progression > 6 m after 1st or 2nd Platinum based therapy. Prior taxane derivative required. ECOG PS < 2 Adequate organ function Exclusion Criteria LMP tumors Prior RT Prior other malignancy Pre-existing NCI CTCAE neurotox > G1 Severe hypersensitivity to Cb, Pac, Caelyx 1• Outcome Measure: PFS 2 • Outcomes Measure(s): Toxicity, QOL, OS Enrollment: 976 Start Date: April 2005 Estimated Completion Date: November 2012 http://www.clinicaltrials.gov/ct2/show/NCT00189553 accessed May 4, 2009

  11. Intellectual Property Biomarker-Pt Segmentation Contracting Data NDA sNDA Timeline(s) Stakeholder dialogue Safe harbor Common Clauses Streamlined Optimized Standardized/caBIG Surrogate Endpoints (PFS -Ind/Review-EBM) Challenges Opportunities Curt G; McClellan M, Benner JS; Niederhuber JE The Oncologist 2009 in press

  12. Discussion Common Goals OS, PFS, QOL Gains Rapid Accrual Lessons Learned What is working…. What is slowing us down.. Examples (if desired) -Platin resistant - Front Line therapy

  13. Registration Endpoints: Industry Perspective

  14. Platinum Resistant Recurrent Ovary Cancer

  15. Platinum Resistant Ovary Cancer: Proposals UD GOG Phase 3: 2 X 2 Factorial design Docetaxelvs LD with concurrent randomization w/wo VEGF Trap SGCTG‡: RP2 N = 250 1○EP PFS ddCb3T80 3/4wk X 18 vs LD 50 Q4 EORTC‡ Picoplatin phase 2/3 (Poniard) EORTC‡ HDAC Inhibitor phase 2 ‡ discussed at GCIG November 2008

  16. GCIG Proposals UD Nov 08 Has FPV Occurred? AGO 12: Cb5T175 vs Cb5T175 BIBF 1120 200 bid N = 1300 1○EP: PFS 2○ EP: OS, PFI, CA125, QOL AGO 16: DC lst line +/- Pazopanib (GSK) 1○EP: PFS Schedule: CA125 Q3m X 18 m: CT Q6 FPV = First Patient Visit

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