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Table 2 Assessment of translatability for eight drugs according to [2].

From: Translatability scoring in drug development: eight case studies

Compound

Dabigatran

Ipilimumab

Gefitinib

Gefitinib*

Vilazodone

Latrepirdine

Semegacestat

Torcetrapib[37]

Varenicline[37]

Aspect

         

Starting evidence

         

In vitro data Including animal genetics

0.1 [4]

0.06 [38]

0.1 [6, 7, 39, 40]

0.1 [6, 7, 39, 40]

0.08 [41]

0.06 [42–44]

0.1 [12]

0.1

0.1

In vivo data Including animal genetics

0.15 [4]

0.06 [45, 46]

0.15 [6, 7, 14]

0.15 [6, 7, 14]

0.12 [41, 47, 48]

0.06 [42, 49]

0.15 [12, 50]

0.15

0.15

Animal disease models

0.09 [51]

0.06 [1, 52]

0.09 [1]

0.09 [1]

0.06 [41, 47, 48, 53]

0.06 [49]

0.03 [18]

0.12

0.15

Data from multiple species

0.15 [4]

0.09 [46]

0.06 [54]

0.06 [54]

0.06 [41, 55]

0.03 [42]

0.15 [12]

0.03

0.15

Human evidence

         

Genetics

0.05

0.05

0.05

0.25 [8–10, 22, 28]

0.05

0.05

0.25 [56–59]

0.05

0.05

Model Compounds

0.52 [60]

0.52 [61]

0.13 [54]

0.13 [54]

0.65 [62–64]

0.13 [42, 43, 65, 66]

0.13

 

0.65

Clinical trials

0.52 [31, 67]

0.65 [68–74]

0.26 [24, 25, 75–78]

0.65 [8, 9, 24, 25, 75–81]

0.26 [15, 82]

0.13 [15, 42, 83]

0.39 [50, 84, 85]

0.26

0.52

Biomarkers for efficacy and safety prediction

         

Biomarker Grading

0.96 [35, 36]

0.96 [5]

1.2 [24, 25]

1.2 [8, 9, 24, 25]

0.72 [26, 27]

0

0 [23]

0.48

1.2

Biomarker development

0.26

0.52 [5]

0.13 [24, 25]

0.65 [8–10, 22, 28]

0.13 [26, 27]

0

0 [23]

0.26

0.52

Proof-of-mechanism, proof-of-principle and proof of concept testing

         

Biomarker strategy

0.2 [35, 36]

0.2 [5]

0.05 [24, 25]

0.25 [8–10, 22, 28]

0.15 [26, 27]

0

0 [23]

0.1

0.25

Surrogate or endpoint strategy

0.4

0.4 [5]

0.24 [24, 25]

0.32 [8–10, 22, 28]

0.24 [26, 27]

0

0 [23]

0.16

0.32

Personalized medicine aspects

         

Disease sub-classification and responder concentration

0.12

0.03

0.03

0.15 [8–10, 22, 28]

0.03

0.03

0.03

0.09

0.03

Pharmacogenetics

0.25

0.05

0.05

0.25 [8–10, 22, 28]

0.05

0.05

0.05

0.15

0.05

Sum

3.77

3.65

2.54

4.25

2.6

0.60 (0)

1.28 (0)

1.95

4.14

  1. Data for torcetrapib and varenicline are taken from [37].
  2. *after the development of the pivotal biomarker (EGFR mutation status)