1 / 16

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

aloha
Download Presentation

Partnering with Industry

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related