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

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

3. Pfisterer J et al JCO 2006

5. Pfisterer J et al JNCI 2006

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

9. CALYPSO Sponsors and Collaborators: ARCAGY/ GINECO GROUP Schering-Plough Arbeitsgemeinschaft Gynaekologische Onkologie Austria AGO Ovarian Cancer Study Group ANZGOG European Organization for Research and Treatment of Cancer NCIC CTG NSGO ClinicalTrials.gov Identifier: NCT00189553 Standard Standard Carboplatin AUC 5 every 3 or 4 weeks Paclitaxel 175 mg/m² at day 1 every 3 weeks Experimental Experimental Carboplatin AUC 5 every 3 or 4 week Pegylated liposomal doxorubicin 30 mg/m² every 4 weeks Pegylated liposomal doxorubicin 30 mg/m² every 4 weeks 6 cycles or until progression 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 1 st or 2 nd 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/NCT0 0189553 accessed May 4http://www.clinicaltrials.gov/ct2/show/NCT0 0189553 accessed May 4, 2009 http://www.clinicaltrials.gov/ct2/show/NCT0 0189553 accessed May 4

11. Challenges Opportunities Intellectual Property Biomarker -Pt Segmentation ContractingDataNDAsNDATimeline(s) Stakeholder dialogue Safe harbor Common Clauses StreamlinedOptimizedStandardized/caBIG Surrogate Endpoints (PFS -Ind/Review-EBM) 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 Agent/Dose Author/YRRR%M PFS (m)M OS (m) Alimta 500Vergote 099.32.811.9 Alimta 900Vergote 0910.42.810.3 Alimta 900Miller 09212.911.4 L. Doxil 50 vs Topo Gordon 04122.38.9 L. Doxil 50 vs gemcitabine Mutch 0711.73.113.5 L. Doxil 50 vs Trabectedin + L Doxil Monk 08* ESMO, IGCS abstract only 12.23.7NA

15. Platinum Resistant Ovary Cancer: Proposals UD GOG Phase 3: 2 X 2 Factorial design Docetaxel vs 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: Cb 5 T 175 vs Cb 5 T 175 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