Lynne A. Armiger , MSN, CRNP, JHCRN Network … · Citeline 2015. Position Company No. of Drugs in...
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Lynne A. Armiger, MSN, CRNP, JHCRN Network Coordinator
Transcript of Lynne A. Armiger , MSN, CRNP, JHCRN Network … · Citeline 2015. Position Company No. of Drugs in...
Lynne A. Armiger, MSN, CRNP, JHCRN Network Coordinator
Networking◦Colleagues◦Pharmaceutical & Device
Representatives
Internet-Based Resources◦CenterWatch◦CRO / Sponsor Websites
Investigational Databases◦ CROs◦ Sponsors◦ Study Brokers
Preferred Partner Relations◦ JHCRN / CRO Partnerships◦ JHCRN / Sponsor Partnerships
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PreClinical Phase 1 Phase 2 Phase 3 Launched
2014
2015
Citeline 2015
Position Company No. of Drugs in Pipeline
No. of DrugsOriginated 2015
1 GlaxoSmithKline 258 1632 Novartis 245 1823 Roche 234 1584 AstraZeneca 222 1215 Johnson & Johnson 204 1006 Merck & Co 199 1307 Pfizer 199 1328 Sanofi 184 849 Takeda 130 68
10 Eli Lilly 119 93
Citeline 2015
Position Company No. of Drugs in Pipeline
No. of DrugsOriginated 2015
11 Bristol-Myers Squibb 118 8812 Daiichi Sankyo 104 6013 Bayer 99 4314 Amgen 94 7215 Teva 92 4316 AbbVie 85 1617 Actavis 84 3418 Astellas 83 4419 Eisai 82 4720 Boerhringer Ingelheim 82 56
Citeline 2015
$4.10
$2.60 $2.00
$1.60 $1.60 $1.30 $0.80 $0.70 $0.60 $0.50
2014 Revenue in U.S. Billions
54
29 26 26 2519 18 14
9 8 8 8 8 7 7 5 6 3
Onc
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Neu
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Pulm
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Endo
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Card
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Pedi
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IM/F
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Der
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Nep
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Ort
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Psyc
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Rheu
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Hem
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OB/
GYN
Oth
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Wou
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2014 Trials = 284 Opportunities
70% Site Start-Up Delays
◦ $50,000 CRO/Sponsor Costs
◦ $13,000 Site-Level Costs
45% Studies Completed Late
20% Sites Recruit Zero Patients
Experience
Patient Population
Investigator Interest
Process & Capabilities
Historical Performance
Increase Utilization◦ Active Trials – Goal > 20 (JHU = 30)◦ Subjects Contributed - Goal > 100 (JHU 2014 = 47)
Reduced Cycle Time◦ CDA <20 Days (JHU 2014 = 36)◦ CTA - <133 Days (JHU 2014 = 212)
Quality Metrics - Site and Study Specific◦ JHU Overall Trending 94%◦ Partner Site Trending 96.3%◦ Non-Partner Site Trending 94.2%
Elibility & Entry Criteria Deviations
Patients with ICF Deviations
Patients with IP Deviations
Patients with Source Doc Criteria Deviation
Patients with SAE Deviations
1 1 0 0 00 1 0 0 00 0 7 0 00 1 2 0 00 0 2 0 00 0 8 0 00 0 1 0 00 1 4 0 0
No. of PtsRandomized
No. of PtsScreened
No. of PtsComplete
No. of PtsEnrolled
Avg. GCP & Protocol Compliance
1 1 0 1 0.61 1 0 1 0.87 10 0 7 0.8294 4 0 4 0.853 3 0 3 0.86713 13 1 13 0.8772 2 0 2 0.913 18 12 13 0.933
300 Alliance Sites Globally◦ 100 – US/Canada
10% “Better” Start-Up
20% Better Patient Enrollment – Than Country Avg.
JHCRN Investigator Database Handout
Research Resources Handout
http://ictrweb.johnshopkins.edu/ictr/jhcrn/investigator.cfm
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