Lynne A. Armiger , MSN, CRNP, JHCRN Network … · Citeline 2015. Position Company No. of Drugs in Pipeline No. of Drugs Originated 2015 1. GlaxoSmithKline: 258: 163. 2; Novartis.

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

5484

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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

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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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