2010-9

140

BT

R&D 2010. 9.

www.bioin.or.kr

1. 1 2. . . . . . 3 7 10 17 26

3. . 27 . 28

4. . 29 . 30 . 32

5. . 36 . 37 . 38

6. . . . . 40 42 49 52

7. . 55 . 56 . 59

8. . 61 . 62 . 62 . 65 . 71 . 95 . 96 . 101 . 105 . 107 . 109 . 110 . 110 . 116 . 122 . 136 . 137 . 140 . 143 . 150

[ 1] 4 [ 2] 2007 8 [ 3] Global 500 9 [ 4] Pipeline () 10 [ 5] Pipeline 11 [ 6] 12 [ 7] (0508, ) 14 [ 8] (0508, ) 15 [ 9] (0508, ) 16 [ 10] 24 [ 11] 32 [ 12] () 33 [ 13] R&D 35 [ 14] 40 [ 15] 44 [ 16] 47 [ 17] 48 [ 18] () 49 [ 19] () 50 [ 20] () 51 [ 21] 52 [ 22] 55 [ 23] (1317) 59 [ 24] (1317) 60

[ 1] 1 [ 2] 2 [ 3] 3 [ 4] ( 10) , 2007 vs 2011 5 [ 5] Source (8106) 6 [ 6] Pipeline 11 [ 7] 13 [ 8] 13 [ 9] NIH-NCI DTP 18 [ 10] Scripps Florida R&D 19 [ 11] 21 [ 12] 25 [ 13] 29 [ 14] 30 [ 15] 34 [ 16] 36 [ 17] 38 [ 18] 39 [ 19] 42 [ 20] 63 [ 21] 111 [ 22] 146 [ 23] 147 [ 24] 147

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9. (). : Global Hub in Innovative Drug Industry : 16 () 10~20

. ('11~'12) 1 , 2 '12 40 ('13~'17) 6(, , , DPMK , , ) 5( , , , ) '17 200 (160 ) 1('18~'22) 50 ( 250) 2('23 ) 50 ( 300)

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- xxi -

( 250) - (5)-44 , (1)-6 ( ) - , , , DMPK - ADME/Tox - Computer - ( DMPK ) - , , - - In silico human PK - : 20-40 ( : 150, 1-3-5/project )

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2 (2023-2028)

( 300) - (1)-10, (4)-40 ( ) - , , DMPK , - - / - focused library - - / : 20-40 ( : 150 1-3-5/project ) ,

- xxii -

. (1317) : 1,750 DM/PK

(2013 2017) 1357.1 28.6 57.1 57.1 20.0 0 42.9 14.3 14.3 8.6 0 300

1460.8 31.7 60.7 58.1 21.1 0 45.0 18.6 21.2 7.8 0 325

1561.7 36.9 61.7 56.5 19.7 0 49.4 19.7 29.6 7.4 7.4 350

1662.8 41.9 62.8 53.5 21.0 7.2 51.2 21.0 37.3 9.3 7 375

1766.6 44.4 66.6 51 22.2 11.2 55.6 22.2 40.0 11.2 9.0 400

309 183.5 308.9 276.2 104 18.4 244.1 95.8 142.4 44.3 23.4 1,750

(5) (%)

201380.0 20.0

201470.0 30.0

201565.0 35.0

201660.0 40.0

201750.0 50.0

64.0 36.0

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- xxiii -

(). : : 18 () (30 21.4) 35%

. ('11~'12) 1, 2 ('13~'17) 5 (, , , DMPK , ) 7 ( , , , , , , ) '17 200 1('18~'22) 50 ( 250) 2('23 ) 50 ( 300)

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(2010 2012)

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- xxvi -

(103 ) - (45), (39), (19) - 4 - 4 - 4 - , 10-20 * 1-3-5 /project

(2013-2017) 200

(80 ) - (20), (10), (18), DMPK (25), (7) - - - DMPK - , 10-20 * 1-3-5 /project

(2018-2022) 250

(132 / 29 ) - (62), (45), (25) - 4 - 4 - 4 - , 20-40 * 1-3-5 /project

(100 / 20 ) - (28), (13), (21), DM PK (29), (9) - - - DMPK

- xxvii -

( ) - , 20-40 * 1-3-5 /project

(160 / 28 ) - (75), (53), (32) (120 / 20 ) - (34), (15), (28), DMPK (33), (10) (2023-2028) 300

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- xxviii -

. ('13~'17) : 1,750 / / DMPK

13202.2 72.1 40.3 17.6 22.6 22.7 26.9 85.8 0.5 0.3 20 20 10 10 15 10 12 300

14198.6 65.4 39.4 21.3 22.2 23.4 26.9 121.4 1 0.4 24 23 11 14 19 15 14 315

(2013-2017) 15 16 17212 70.0 38.2 20.9 24.7 28.8 29.4 131 1 1 25 24 13 15 20 16 16 335 212.9 66.6 41.6 24.2 23.5 28.8 28.2 169.1 2 2.1 32 28 17 20 24 21 23 390 217.8 67.1 42.7 24.5 25.9 30.0 27.6 183.8 3 3.8 35 30 19 22 25 22 24 410

1043.5 341.2 202.2 108.5 118.9 133.7 139.0 616.5 4.5 4 141 130 65 83 107 82 90 1,750

/ / / DMPK

(5) (%)

201367 29

201461 35

201561 35

201657 37

201756 45

61 39

*

- xxix -

10. . (1012), (1317), (18)

,

(1012)

(1317)

(18)

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. () : 384 586 (11~12) : 301 385 (13~17) : 67 171 (18~) : 16 30

(12) (17) (18)

ISI development (Intel Quad XEON)4-node () Signal processing system ADME CO2 incubator () () Water bath () electrophoresis system / Blood chemistry analyzer Fluid bed granular pilot unit LC MS/MS DDS XRD /(SAR. docking) CCL Multi reactor (GeneChip Scanner 3000 7G System (00-0212) Auto control system Cold Room

, , , , *

- xxxi -

: 684 581 (11~12) : 87 143 (13~17) : 550 346 (18~) : 47 92

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In vivo // / Virus

, Deep freezer, Liquid nitrogen tank, Flow cytometer, Biostat Q plus 6 fold Bioreactor, CO2 incubator, shaking incubator, Biostat STR Sartorius Sartoflow alpha / beta system AKTA Explorer FPLC, , Waters HPLC, CE ,, Stability Chamber, Cold lab chamber , , , Cryotome Clean Room Pass box, Air sam , , pler Autoclave , Arium water tower system, sartorius Balance, pH conductivity meter Clean Room, C02 incubator, shaking incubator, Biostat Cultibag RM, Biostat STR FACS, Cell sorter, Virus Lab, Sartobind, UVC Lab system , Biostat B plus 1L , Incubator , Gel Electrophoresis system, Image Analyzer DNA chip Incubator , Biostat B plus, Biostat D plus 50L

, URS *

- xxxii -

11. . (1317) : 3,500 : , ,

: 21,551( 860) : 1 654 : 1 897

: 1,167 : 586 : 581 17 90% ( : ) (1317) 13 14 15 16 17 2 1 (2327) (2837)

(1822)

300 300 600

325 315 640

350 335 685

375 390 765

400 1,750 410 1,750 810 3,500

2,232 2,287 4,519

2,901 2,974 5,875

3,771 3,886 7,657

10,654 10,897 21,551

(1112) (1317)

1(18)

385 143 528

171 346 517

30 92 122

586 581 1,167

*

- xxxiii -

. (1317)(1317) : 1,837.16 (2013 - 2017) 13 14 15 16 17

DM/PK

57.1 28.6 57.1 57.1 20.0 0 42.9 14.3 14.3 8.6 0 300

60.8 31.7 60.7 58.1 21.1 0 45.0 18.6 21.2 7.8 0 325

61.7 36.9 61.7 56.5 19.7 0 49.4 19.7 29.6 7.4 7.4 350

62.8 41.9 62.8 53.5 21.0 7.2 51.2 21.0 37.3 9.3 7 375

66.6 44.4 66.6 51 22.2 11.2 55.6 22.2 40.0 11.2 9.0 400

309 183.5 308.9 276.2 104 18.4 244.1 95.8 142.4 44.3 23.4 1,750

(5) (%) 2013 2014 2015 2016 2017

80.0 20.0

70.0 30.0

65.0 35.0

60.0 40.0

50.0 50.0

64.0 36.0

*

- xxxiv -

('13~'17) : 1,750 13 14 (2013-2017) 15 16 17

/ / DMPK / / / DMPK

202.2 72.1 40.3 17.6 22.6 22.7 26.9 85.8 0.5 0.3 20 20 10 10 15 10 12 300

198.6 65.4 39.4 21.3 22.2 23.4 26.9 121.4 1 0.4 24 23 11 14 19 15 14 315

212 70.0 38.2 20.9 24.7 28.8 29.4 131 1 1 25 24 13 15 20 16 16 335

212.9 66.6 41.6 24.2 23.5 28.8 28.2 169.1 2 2.1 32 28 17 20 24 21 23 390

217.8 67.1 42.7 24.5 25.9 30.0 27.6 183.8 3 3.8 35 30 19 22 25 22 24 410

1043.5 341.2 202.2 108.5 118.9 133.7 139.0 616.5 4.5 4 141 130 65 83 107 82 90 1,750

(5) (%) 2013 2014 2015 2016 2017

67 29

61 35

61 35

57 37

56 45

61 39

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- xxxv -

1. / 1

1. , (5 , 2007.6.4) BRICs [ 1]

, (15 ; 14, 1)

2 / R&D

[ 2]

(, )

2010-9

2. / 3

2. . 2020 2007 50% 1.3 , [ 3]

: Burrill & Company, "Biotch 2008 Life Sciences: A 20/20 Vision to 2020", 2008

8 3 (2010~2012) 21 2010 6 131,

4 / R&D

2011 6(2 2 ) 352 , 2012 9 256 3 739 14% 41% 10 16 [ 1] (2010~2012) 2010 2011 2012 (%)

Astra Zeneca BMS GSK Eli Lily Merck Novartis Pfizer Sanofi -Aventis Total

Arimidex Advair Cozaar/ Hyzaar Femara Aricept

$22 $38 $32 $11 $8

Seroquel Plavix Avapro Zyprexa Lipitor Xalatan Plavix Avapro

$47 $48 $13 $48 $121 $16 $38 $21 $352

Symbicort Abilify Avandia Singulair Diovan Viagra Detrol Geodon Lovenox 9products

$37 $21 $25 $45 $60 $17 $8.6 $11 $31 $256

38 30 23 22 22 14 41

Taxotere 6 products

$20

34 -

$131 6products

: AXA Framlington 2009

, , , , , 2011 5

2010-9

2. / 5

[ 4] ( 10) , 2007 vs 2011

* All ranks based on constant US$ : IMS Health, "IMS Market Prognosis International., sep 2007

81~06 ( , ), ( ), ( ) (48%) > (34%) > (18%) , 28% 80 ,

6 / R&D

[ 5] Source (81~06)

* B: Biological; usually a large (>45 residues) peptide or protein either isolated from an organism/cell line or produced by biotechnological means in a surrogate host. N: Natural product, ND: Derived from a natural product and is usually a semisynthetic modification, S: Totally synthetic drug, often found by random screening/ modification of an existing agent, S*: Made by total synthesis, but the pharmacophore is/was from a natural product, V: Vaccine, NM: Natural product mimic : Natural Products as sources of New Drugs over the Last 25 years: Journal of Natural Products 2007 70(3) 461-477

2010-9

2. / 7

. , , 2010 () 10~11 Top3 , 2014 Top10 1 80% , , , , IT , , , (Novartis), (GSK), (Pfizer) 2015 Top R&D , ,

8 / R&D

07 Pfizer 80 1 , 2 Roche 70 R&D Merck Co. 20.2% , Roche Eli Lilly 18% R&D [ 2] 2007 ( : , %)

1 2 3 4 5 6 7 8 9

Pfizer GlaxoSmithKline Sanofi-Aventis Novartis AstraZeneca Merck Co. Roche Eli Lilly Wyeth

484 455 384 381 296 242 384 186 224

80.9 66.6 62.2 64.3 51.6 48.8 69.9 34.9 32.6

R&D 16.7 14.6 16.2 16.9 17.5 20.2 18.2 18.7 14.5

: http://www.reuters.com/finance/ : Johnson & Johnson

12 500 , 4 Merck, Wyeth, BMS(Bristol-Myers Squibb), Pfizer Eli Lilly 10% Global 1 Johnson & Johnson 455 Bristol-Myers Squibb(BMS)

2010-9

2. / 9

09 Big-Deal, Pfizer/Wyeth Merck/ Schering Plough 10

[ 3] Global 500 Royal Ductch Shell Toyota Motor Samsung Electronics LG Hyundai Motor Johnson & Johnson Pfizer GlaxoSmithKline Roche Sanofi-Aventis Novartis AstraZenca Abbott Laboratories Merck Wyeth Bristol-Myers Squibb Eli Lilly

Global Rank1 10 40 69 87 103 152 168 171 181 183 263 294 378 401 435 455

($M)458,361 204,352 110,350 82,082 72,542 63,747 48,296 44,654 44,268 42,179 41,459 31,601 29,528 23,850 22,834 21,366 20,378

($M)26,277 -4,349 5,027 830 780 12,949 8,104 8,439 8,288 5,637 8,195 6,101 4,881 7,808 4,418 5,247 -2,072

(%)5.7 -2.1 4.6 1.0 1.1 20.3 16.8 18.9 18.7 13.4 19.8 19.3 16.5 32.7 19.3 24.6 -10.2

: Fortune magazine, 2009 issues

10 / R&D

. 09 (32) 159 2, 45, 49, 63 3 9 12 , 25 49 [ 4] Pipeline ()(: )

3 2 1/2 1

2 12 16 1 16 45 49 63 159

2 9 10 1 9 29 25 21 32

2010-9

2. / 11

[ 6] Pipeline Pipeline 70 60 50 40 30 20 10 0 1 1/2 2 3

63 ( 39.6%) 49 ( 30.8%)

16 ( 10.1%) 1 ( 0.6%)

16 ( 10.1%)

12 ( 7.5%)

2 ( 1.3%)

:

, 159 (42, 26%) > (31, 19%), (23, 14%)

[ 5] Pipeline 3 2 1/2 1

0 0 0 1 0 0 1 0 0 2

0 3 1 1 1 3 0 0 3 12

2 1 1 1 0 7 1 0 3 16

1 0 0 0 0 0 0 0 0 1

6 1 2 0 2 3 0 0 3 16

11 5 0 4 4 13 1 2 9 49

11 13 9 1 2 17 1 1 8 63

31 23 13 8 9 42 4 3 26 159

: : (, , , , ), (, ), (/, )

12 / R&D

, (, ) , [ 6] ()

/ 1~2 12 6 (3%) 2 1 2~3 30 (15%) 20~25 1~3 46 (23%) 5,000~ 10,000

: ( ), ,

64%(08) 80%(13) 10% 4% * : 64%(08) 59.7%(13)

2010-9

2. / 13

[ 7]

: 2008 -90 (08),

bottleneck , , ( ) , , [ 8]

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14 / R&D

3 (, , ) 4(05~08) 3 3,912 , * : (19%), (21%), (23%), (12%), (15%)

10 >>> [ 7] (05~08, )(%)

0515,239,526 20 14,623,800 20 18,309,000 25 16223000 22 10,053,000 14 74,448,326

0618,871,199 19 19,759,000 20 25,142,700 26 17,828,000 18 15,714,000 16 97,314,899

0718,608,356 19 23,444,000 24 16,153,200 16 24,253,000 24 17,245,000 17 99,703,556

0822,361,716 19 25,453,327 21 31,012,030 26 24,710,000 21 16,147,000 13 119,684,073

75,080,797

(%)

83,280,127

(%)

90,616,930

(%)

83,014,000

(%)

59,159,000 391,150,854

2010-9

2. / 15

[ 8] (05~08, )

054,233,144 10,288,000 7,455,000 3,445,000 5,461,000 1,060,000 5,862,000 1,321,000 2,861,000 1450000 20,959,182

065,232,000 14,050,900 7,861,300 10,362,000 5,240,000 1,214,000 7,160,000 1,302,000 1,770,000 1335000 26,073,699

075,607,440 15,976,716 9,660,900 3,479,000 5,010,000 1,740,000 8,349,000 2,022,000 5,970,000 1,815,000 25,828,500

086,475,000 20,793,246 15,367,830 4,319,000 5,530,000 1,815,000 8,451,497 1,372,000 2,486,000 2,362,000 31,565,500

(%)17 15 15 14 21 13 18 18 14 20 18

(%)22 20 16 42 20 15 22 18 9 19 22

(%)23 23 20 14 19 22 25 28 30 25 22

(%)27 30 32 17 21 23 25 19 12 33 26

21,547,584 61,108,862 40,345,030 21,605,000 21,241,000 5,829,000 29,822,497 6,017,000 13,087,000 6,962,000 104,426,881 331,991,854

64,395,326

81,600,899

85,458,556

100,537,073

: 59,159,000( : 17,992,000, : 39,392,000, : 1,775,000)

16 / R&D

[ 9] (05~08, ) (%)

8,574,184 40 13,255,132 22 8,624,800 21 0 4,540,000 21 2,344,000 40 8,142,000 27 1,039,000 17 894,000 7 452,000 7 27,215,681 26 89,477,204

7,632,400 35 5,680,000 9 6,654,230 17 3,070,000 14 7,862,000 37 1,200,000 21 4,900,497 16 3,394,000 56 3,838,000 29 0! 39,049,000 37 95,500,877

2,498,000 12 21,915,730 36 10,938,000 27 11,924,000 55 6,614,000 31 1,885,000 32 9,830,000 33 240,000 4 1,730,000 13 820,000 12 21,922,200 21 109,867,650

2,843,000 13 20,258,000 33 14,028,000 35 6,611,000 31 2,225,000 10 400,000 7 6,850,000 23 1,344,000 22 6,625,000 51 5,390,000 81 16,240,000 16 89,546,000

21,547,584 61,108,862 40,245,030 21,605,000 21,241,000 5,829,000 29,722,497 6,017,000 13,087,000 6,662,000 104,426,881

(%)

(%)

(%)

(%)

(%)

(%)

(%)

(%)

(%)

(%)

331,492,952

: 59,159,000( : 17,992,000, : 39,392,000, : 1,775,000)

2010-9

2. / 17

. []NIH (NCI, National Cancer Institute) DTP (Developmental Therapeutics Program) 50 DTP , DTP RAND(Rapid Access to NCI Discovery Resources) (Discovery) RAND (Discovery) , , , , , DTP CTEP(Cancer Therapy Evaluation Program) DDG(Drug Development Group) RAID(Rapid Access to Interventional Development) RAID(Rapid Access to Interventional Development)

18 / R&D

1 RAID RAID GMP, formulation, , , , , , , , , validation NCI RAID DTP (Developmental Therapeutics Program) [ 9] NIH-NCI DTP

2010-9

2. / 19

Scripps

Florida

(Translational

Research Institute, TRI) Lead 7 7 : , , , , X-ray , , Scripps Florida , , , , 5 Scripps Florida (Commercialization gap) [ 10] Scripps Florida R&D

20 / R&D

[]10

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:

2010-9

2. / 21

, , 3 : , , : , , : , , [ 11]

22 / R&D

[] Innovative Medicine Initiative (European Technology Platform) Innovative Medicine Initiative FDA CDER Critical Path Initiative 4 , , , 4 ( The Innovative Medicines Initiative Research Agenda, 2008) (drug safety evaluation) in-silico (evidence base) -

(drug efficacy evaluation) in-vitro in-vivo (translational medicine)

(Knowledge Management) KM

2010-9

2. / 23

KM (text mining tools) ,

& (Education, Training and Communication), European Medicines Research Academy(EMRA) R&D , ,

Medical Research Council (MRC) MRC , , , ,

08 14 1,600 08 (Developmental Pathway Funding Scheme ,DPFS) , , ,

24 / R&D

[ 10] ( )

()34,643,808 5,371,592 2,117,276 1,985,092 1,753,504 45,871,272

56 7 4 1 1 69

BioValley 3 (CNRS, INSERM, INRA), 2 , 3 , 200 BioValley BioValley

Lyon Biopole (ADERLLY) Isere (AEPI) , ,

[] , 2010-9

2. / 25

, 10 , , , , , , , GLP , / NMR, LC-MS, ArrayScan, KineticScan, , [ 12]

26 / R&D

. , (Cost), (Speed), (Experience) , ,

2010-9

3. / 27

3. . : : R&D

28 / R&D

. [ 1] - : DB ,

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2010-9

4. / 29

4. . (, , ) [ 13]

30 / R&D

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2010-9

4. / 31

-- CDO(Corporate Development Officer)

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32 / R&D

. (, ) [ 11] (GEM) , GEM , GEM // , GEM GEM R&D ( ) ()

(, ) in vivo/vitro, , PK CDO

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2010-9

4. / 33

[ 12] ()

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34 / R&D

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2010-9

[ 13] R&D 21C

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2010-9

5. / 37

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38 / R&D

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2010-9

5. / 39

: , 1 2, 2 : , , 1 : , , 2 : , 2 : , [ 18]

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2010-9

6. / 41

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42 / R&D

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2010-9

6. / 43

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44 / R&D

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2010-9

6. / 45

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46 / R&D

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2010-9

6. / 47

, [ 16] - : , :

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48 / R&D

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- : 30% + 70% - + : - go/stop :

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- : 100%

(, , )

2010-9

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. R&D (, , ) [ 18] ()

() , , , , ,

, 3 , MBO()

3 /, R&D 3

50 / R&D

[ 19] () 3 10 10 20 20 20

10

10 100

2010-9

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[ 20] ()

- R&D - - (Patent) - R&D( ) - Needs - - - , - , - ( ) - () ( ) - - - - - -

15

25

25

20

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100

52 / R&D

. ((1012), (1317), (18)

, , ,

, , [ 21] (1012) (1317) (18)

2010-9

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(12) (17) (18)

() ADME

ISI development (Intel Quad XEON)4-node Signal processing system CO2 incubator Water bath electrophoresis system Blood chemistry analyzer Fluid bed granular pilot unit LC MS/MS XRD /(SAR. docking) CCL Multi reactor

() () () /

DDS

(GeneChip Scanner 3000 7G System (00-0212) Auto control system Cold Room

, , ,

54 / R&D

*

(12)

(17)

(18)

/ In vivo // / Virus

, Deep freezer, Liquid nitrogen tank, Flow cytometer, Biostat Q plus 6 fold Bioreactor, CO2 incubator, shaking incubator, Biostat STR Sartorius Sartoflow alpha / beta system AKTA Explorer FPLC, , Waters HPLC, CE ,, Stability Chamber, Cold lab chamber , , , Cryotome Clean Room, , Pass box, Air sampler Autoclave , Arium water tower system, sartorius Balance, pH conductivity meter Clean Room, C02 incubator, shaking incubator, Biostat Cultibag RM, Biostat STR FACS, Cell sorter, Virus Lab, Sartobind, UVC Lab system , Biostat B plus 1L , Incubator , Gel Electrophoresis system, Image Analyzer DNA chip Incubator , Biostat B plus, Biostat D plus 50L

2010-9

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7. . (1317) : 3,500 : 1,750 : 1,750 : ++

: 21,551( 860) : 1 654 : 1 897

: 1,167 : 586 : 581 17 90%

[ 22] ( : ) 13 (1317) 14 15 16 17 1 2 (1822) (2328)

(2938)

300 300 600

325 315 640

350 335 685

375 390 765

400 410 810

1,750 1,750 3,500

2,232 2,287 4,519

2,901 2,974 5,875

3,771 3,886 7,657

10,654 10,897 21,551

(1112) 385 143 528

(1317) 171 346 517

1(18) 30 92 122

586 581 1,167

*

56 / R&D

. 0408 961 231 4 , 47 MRC 14 5,00010,000 550 , 1 0.060.11 1 0.09

100 47 4,700 , 4,700 0.09 = 423 100 4 400

(34%) 1(1822) 3% , ( 2(2327), (2837)) 3% 13 300 13 300 84, 45 171 ( , )

2010-9

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1 : 0.7 ( 300 1.5, 1, 0.6 )

(1112) (1317) 1 (1822) 1822 2 (2327) 23

() () () ()

11 20 14 20 14

12 40 28 40 28

13 120 84 120 84

14 140 98 140 98

15 160 112 172 121

16 180 126 190 133

17 200 140 200 140

250 875 250 875

300 980 300 980

: + 15%

(, , ) 100% (1112) :

(1317):

(18) :

58 / R&D

(1112) (1317) (18)

301 385 87 143

67 171 550 346

16 30 47 92

2010-9

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. (1317)(1317) : 1,750 [ 23] (13~17) DM/PK

(2013 - 2017) 1357.1 28.6 57.1 57.1 20.0 0 42.9 14.3 14.3 8.6 0 300

1460.8 31.7 60.7 58.1 21.1 0 45.0 18.6 21.2 7.8 0 325

1561.7 36.9 61.7 56.5 19.7 0 49.4 19.7 29.6 7.4 7.4 350

1662.8 41.9 62.8 53.5 21.0 7.2 51.2 21.0 37.3 9.3 7 375

1766.6 44.4 66.6 51 22.2 11.2 55.6 22.2 40.0 11.2 9.0 400

309 183.5 308.9 276.2 104 18.4 244.1 95.8 142.4 44.3 23.4 1,750

(5) (%)

201380.0 20.0

201470.0 30.0

201565.0 35.0

201660.0 40.0

201750.0 50.0

64.0 36.0

*

60 / R&D

('13~'17) : 2,056 [ 24] (13~17) / / DMPK

(2013-2017) 13202.2 72.1 40.3 17.6 22.6 22.7 26.9 85.8 0.5 0.3 20 20 10 10 15 10 12 300

14198.6 65.4 39.4 21.3 22.2 23.4 26.9 121.4 1 0.4 24 23 11 14 19 15 14 315

15212 70.0 38.2 20.9 24.7 28.8 29.4 131 1 1 25 24 13 15 20 16 16 335

16212.9 66.6 41.6 24.2 23.5 28.8 28.2 169.1 2 2.1 32 28 17 20 24 21 23 390

17217.8 67.1 42.7 24.5 25.9 30.0 27.6 183.8 3 3.8 35 30 19 22 25 22 24 410

1043.5 341.2 202.2 108.5 118.9 133.7 139.0 616.5 4.5 4 141 130 65 83 107 82 90 1,750

/ / / DMPK

(5) (%)

201367 29

201461 35

201561 35

201657 37

201756 45

61 39

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2010-9

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8. (). : Global Hub in Innovative Drug Industry : 16 () 10~20

62 / R&D

. Solution Provider , , , License-out

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. ('11~'12) 1 , 2 '12 40 ('13~'17) 6(, , , DPMK , , ) 5( , , , )

2010-9

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'17 200 (160 ) 1('18'22) 50 ( 250) 2('23 ) 50 ( 300)[ 20]

('17) 200 1 12('28) 300

64 / R&D

() ( 300)

(1) (19) (4) (4) (5) (6) (178) (40) (30) (40) DMPK(33) (20) (15) (102) (34) (20) (28) (10) (10) ()

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2010-9

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.

Gate 10 ( 1) , (1012) : CDO (1317) : , , , , 1(1822) : , , 2(2328) : , , ,

66 / R&D

( 200) - (6)-118, (5)-82 ( ) - - , , DMPK - - ( DMPK ) - in vitro in vivo - - ADME/Tox - : 20-40 ( : 150 , 1-3-5/project )

(2013-2017)

( 250) - (5)-44 , (1)-6 ( ) - , , , DMPK - ADME/Tox - Computer - ( DMPK ) - , , - - In silico human PK - : 20-40 ( : 150 , 1-3-5/project )

1 (2018-2022)

,

2010-9

8. / 67

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68 / R&D

(1317) G ate DMPK 1 (1822) DMPK

- // - / - // - / , - / - // ( ) - /in vivo DM/PK - / / - // - - / - // - / - in silico - / - - preformulation/salt form - /, (DDS) - // - / - // - / , - / - // ( ) - /in vivo DM/PK - / / - // - - / - // - / - in silico - / - - preformulation/salt form - /, (DDS) - - /

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2 (2328) DMPK

- // - / - // - / , - / - // ( ) - /in vivo DM/PK - / / - // - - - / - / - // - / - in silico - / - - preformulation/salt form - /, (DDS) - - /

13 : 80%, 20% 17 : 20%, 80%

70 / R&D

(10~12)

(40 ) - - - : / / / (,) / / - I (160 /200) - (/ ) : 20 - / 1) (30) 2) (20) 3) (30) 4) DMPK (23) 5) (10) 6) (5) 7) (25) 8) (10) 9) (18) 10) (5) 11) (4) (50 /250) - () 1) (10 ) 2) (10 ) 3) DMPK (9 ) 4) (5 ) 5) (10 ) 6) (6) (50 /300) - () 1) (10 ) 2) (15 ) 3) (10 ) 4) (5 ) 5) (10)

(13~17)

1 (18~22)

2 (23~28)

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. 1) // // 2) , , 3) : // / (, , ) : , : , Dye ELISA: / , : :

72 / R&D

: , Reporter Assay: Promoter / / / : , , migration, invasion : NK , T-, B- , : , , synaptic transmission

2010-9

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4) ()

2013 2014 2015 2016 2017

11.2 11.3 11.4 11.3 10.5 55.7

30 27.2 24.9 22.9 19.8 124.8

4.5 4.1 3.7 3.4 3 18.7

(23.0) (7.0) (-) (-) (-)

45.7 42.6 40 37.7 33.3 199.3

: 1 0.7( 300 1.5, 1, 0.6 ) 30 15 2

13 20

14 3

16 2

17 3

1) - 04-08 () 0.95, 64% - 1.5 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 . - 100 4 400 : 15%

74 / R&D

1) : 2) : , 3) : , (Genoype-driven) (transgenic) (knock out ) (Phenotype-driven) / (Genoype-driven) vector ES (on/off ) (Phenotype-driven) phenotype Database

2010-9

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4) ()

2013 2014 2015 2016 2017

5.6 5.9 6.8 7.6 7 32.9

15 14.2 15 15.3 13.2 72.7

2.3 2.1 2.2 2.2 2 10.8

(-) (-) (-) (-) (-)

22.9 22.2 24 25.1 22.2 116.4

: 1 0.7( 300 1.5, 1, 0.6 ) 20 13 10 14 2 15 3 16 3 17 2

1) - 04-08 () 0.95, 64% - , 3 2) - 5,00010,000 550 . 1 0.060.11 1 0.09 - 100 2 200 : 15%

76 / R&D

1) : in vitro in vivo 2) : FDA , 3) CHO BALB/3T3 (MTT assay) ATP contents (Ames test) (Micronucleus test) (hERG) Ikr hERG binding assay patch clamp assay QT-prolongation Action Potential Duration(APD) assay : Cyp () / : / LD50 , MTD ( ) /

2010-9

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: , , , , , (Core Battery): , , / 4) 2013 2014 2015 2016 2017 11.2 11.3 11.4 11.3 10.5 55.7 30 27.2 24.9 22.9 19.8 124.8 4.5 4 3.8 3.5 3 18.8 () (21.0) (1.2) (-) (-) (-) 45.7 42.5 40.1 37.7 33.3 199.3

: 1 0.7( 300 1.5, 1, 0.6 ) 30 13 20 14 3 15 2 16 2 17 3

1) - 04-08 () 0.95, 64% - 1 2) - 5,000~10,000 550 1 . 0.06~0.11 1 0.09 - 100 8 800 : 15%

78 / R&D

DM/PK 1) : in vitro in vivo 2) : . , 3) in vitro (mouse, rat, dog, monkey, human) LC/MS microsomes in silico in vitro Caco-2 MDCK / LC/MS / in Silico in vivo DM/PK / (, )/(, ) Rat / Dog pGP efflux / Blood/Plasma (B/P) ratio / source : S9,

2010-9

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Phase 1 / Phase 2 , , , , in vivo / Cyp 4) ()

2013 2014 2015 2016 2017

11.2 10.8 10.5 9.7 8.1 50.3

30 26 22.9 19.5 15.1 113.5

4.5 3.8 3.4 2.9 2.3 16.9

(21.0) (7.0) (-) (-) (-)

45.7 40.6 36.8 32.1 25.5 180.7

: 1 0.7( 300 1.5, 1, 0.6 ) 23 13 20 14 2 15 1 16 0 17 0

1) - 04-08 () 0.95, 64% - 1.5 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 5 500 : 15%

80 / R&D

1) : 2) : , , (profiling) . 3) in silico / logP pKa in silico

2010-9

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4) ()

2013 2014 2015 2016 2017

3.9 3.9 3.6 3.8 3.5 18.7

10.5 9.5 8 7.7 6.6 42.3

1.6 1.4 1.2 1.1 1 6.3

(10.0) (14.8) (-) (-) (-)

16 14.8 12.8 12.6 11.1 67.3

: 1 0.7( 300 1.5, 1, 0.6 ) 13 14 15 16 17

10

7

1

0

1

1

1) - 04-08 () 0.95, 64% - 1.5 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 3 300 : 15%

82 / R&D

1) : in vitro in vivo 2) : , / , 3) : HTS 3 live cell imaging cytometry / : MRI MRS CT / PET SPECT micro-PET / 4) ()

2013 2014 2015 2016 2017

(-) (-) (-) 1.3 1.8 3.1

(-) (-) (-) 2.5 3.4 5.9

(-) (-) (-) 0.4 0.5 0.9

(-) (-) (-) (-) (-)

(-) (-) (-) 4.2 5.7 9.9

2010-9

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: 1 0.7( 300 1.5, 1, 0.6 ) 13 14 15 16 17

8 0

0

0

3

5

1) - 04-08 () 0.95, 64% - 1 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 2 200 : 15%

84 / R&D

1) : () 2) : , 3) : : / / Fragment / Privileged Scaffold / , , - (Structue-Activity Relationship) // / / // 4) ()

2013 2014 2015 2016 2017

8.4 8.4 9.1 9.2 8.8 43.9

22.5 20.1 20 18.7 16.5 97.8

3.4 3 3 2.8 2.5 14.7

(1.5) (-) (-) (-) (-)

34.3 31.5 32.1 30.7 27.8 156.4

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: 1 0.7( 300 1.5, 1, 0.6 ) 13 15 14 2 15 3 16 2 17 3

25

1) - 04-08 () 0.95, 64% - 2 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 3 300 : 15%

86 / R&D

1) : /, . 3) : Docking : ; Scoring - Pharmacophore De novo Design Fragment in silico DM/PK in silico 4) ()

2) : ,

2013 2014 2015 2016 2017

2.8 3.4 3.6 3.8 3.5 17.1

7.5 8.4 8 7.7 6.6 38.2

1.1 1.2 1.2 1.1 1 5.6

(-) (-) (71.0) (-) (-)

11.4 13 12.8 12.6 11.1 60.9

2010-9

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: 1 0.7( 300 1.5, 1, 0.6 ) 13 5 14 2 15 1 16 1 17 1

10

1) - 04-08 () 0.95, 64% - 1 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 5 500 : 15%

88 / R&D

1) : 3) : preformulation free form salt form / Storage Stability / polymorphism (DDS) , 4) ()

2) : ,

2013 2014 2015 2016 2017

2.8 3.9 5.5 6.7 6.3 25.2

7.5 9.5 12 13.6 11.9 54.5

1.1 1.4 1.8 2 1.8 8.1

(-) (-) (-) (-) (-)

11.4 14.8 19.3 22.3 20 87.8

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: 1 0.7( 300 1.5, 1, 0.6 ) 13 5 14 3 15 4 16 4 17 2

18

1) - 04-08 () 0.95, 64% - 1.5 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 5 500 : 15%

90 / R&D

10 1) : 2) : , //// 3) , , (SAR), , , Clustering , HTS ADME / Tox , homology modeling / - , , NMR , , , homology modeling 4) ()

2013 2014 2015 2016 2017

1.7 1.5 1.4 1.7 1.7 8

4.5 3.6 3 3.4 3.4 17.9

0.7 0.5 0.4 0.5 0.5 2.6

(-) (-) (-) (-) (-)

6.9 5.6 4.8 5.6 5.6 28.5

2010-9

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: 1 0.7( 300 1.5, 1, 0.6 ) 5 13 3 14 0 15 0 16 1 17 1

1) - 04-08 () 0.95, 64% - 1 2) - 5,000~10,000 550 . 1 0.06~0.11 1 0.09 - 100 3 300 : 15%

92 / R&D

11 / 1) : 2) : 3) / / : , , 4) ()

2013 2014 2015 2016 2017

(-) (-) 1.4 1.3 1.4 4.1

(-) (-) 3.0 2.5 2.7 8.2

(-) (-) 0.4 0.4 0.4 1.2

(-) (-) (-) (-) (-)

(-) (-) 4.8 4.2 4.5 13.5

2010-9

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: 1 0.7( 300 1.5, 1, 0.6 ) 13 14 15 16 17

4

0

0

3

0

1

1) - 1 2) - 5,000~10,000 550 1 . 0.06~0.11 1 0.09 - 100 2 200 : 15%

(1317) : 1,032.38(++ )

( : ) (2013 - 2017) 13 14 15 16 17 //// 45.7 42.5 40.1 37.7 33.3 22.9 22.2 24 25.1 22.2 in vitro in vivo 45.7 42.5 40.1 37.7 33.3 in vitro in vivo 45.7 40.6 36.8 32.1 25.5 16 14.8 12.8 12.6 11.1 in vitro in vivo 4.3 5.6 () 34.3 31.5 32.1 30.7 27.8 11.4 13 12.8 12.6 11.1 11.4 14.8 19.2 22.4 20 6.9 5.6 4.8 5.6 5.6 4.8 4.2 4.5 240 227.5 227.5 225 200 199.3 116.4 199.3 180.7 67.3 9.9 156.4 60.9 87.8 28.5 13.5 1,120

94 / R&D

1) : , , ( ) 2) //// in vitro in vivo in vitro in vivo in vitro in vivo () 3) (1317)(: ) / / / / in vitro in vivo in vitro in vivo in vitro in vivo () 2013 11.4 5.7 11.4 11.4 4 8.6 2.9 2.9 1.7 60 2014 18.2 9.5 18.2 17.5 6.3 13.5 5.6 6.3 2.4 97.5 2015 21.6 12.9 21.6 19.7 6.9 17.3 6.9 10.4 2.6 2.6 122.5 2016 25.1 16.8 25.1 21.4 8.4 2.9 20.5 8.4 14.9 3.7 2.8 150 2017 33.3 22.2 33.3 25.5 11.1 5.6 27.8 11.1 20 5.6 4.5 200 109.6 67.1 109.6 95.5 36.7 8.5 87.7 34.9 54.5 16 9.9 630

, ,

2010-9

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. (1317) : 1,750 13 14 (2013 - 2017) 15 16 17

DM/PK

57.1 28.6 57.1 57.1 20.0 0 42.9 14.3 14.3 8.6 0 300

60.8 31.7 60.7 58.1 21.1 0 45.0 18.6 21.2 7.8 0 325

61.7 36.9 61.7 56.5 19.7 0 49.4 19.7 29.6 7.4 7.4 350

62.8 41.9 62.8 53.5 21.0 7.2 51.2 21.0 37.3 9.3 7 375

66.6 44.4 66.6 51 22.2 11.2 55.6 22.2 40.0 11.2 9.0 400

309 183.5 308.9 276.2 104 18.4 244.1 95.8 142.4 44.3 23.4 1,750

(5) (%) 2013 2014 2015 2016 2017

80.0 20.0

70.0 30.0

65.0 35.0

60.0 40.0

50.0 50.0

64.0 36.0

96 / R&D

. (//) (11-12) (13-17) (18 )

(Full Op.)

, , ,

2010-9

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, , : 384 58,560 (1112) (1317) (18)

301

67 170.38

16 30.4

384.82

98 / R&D

(11~12)

- Validation , , Global Top-tier ()

()

301 ISIS development 11 (Intel Quad XEON)-4node 16 Ion analyzer 39

38,482 336 540 9,010 2,958 978 2,353 293 1,329 3,317 1,571 1,800 5,808 1,013 601 123 1,552 1,700 3,200

ADME / HTS-ADME 22 / 2011 ~ 2012 10 Cell Pemeability 25 Electrophoresis system 7 Blood chemistry analyzer 29 Fluid bed granulator pilot unit 30 GC-MS 22 CCL 11 Lasentec Crystallization 22 24 8 5 (Immunoassay(protein quantitation) ) 4 Auto control system 17 Cold Room 3

2010-9

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(13~17)-

- Target Validation Best in Class Best in class Best in Class License Out First in Class

()17,038 7,638 1,700 50 2,045 180 2,102 996 150 415 2,300 700 120 1,480 7,100 7,100

() 2013 () / Bio Informatics

67 48 Signal Processing system 15

ADME / Isolated organ perfusion system / High Troughput Screening System 8 shadow free light(surgery) 3 Auto Patch Clamp 16 Channel 9 GC 10 60L Reactor GeneChip Scanner 3000 7G System(00-0212) 11 LAS System 4 Physiological analyzer 2 NMR spectroscopy 5 8 8

2014

2015

100 / R&D

('18 )- First in Class

Target First in Class - , , , Nano Technology ()

()

() lyophilizer 7 2018

16

3,040 1,130 1,350 50 200 90 220

High Troughput Screening System 3 Nephelometer

/ Auto DNA sequencer Low temperature centrifuge 3 160L Reactor

2010-9

8. / 101

. Global Star , , , , , , Global Grade

102 / R&D

DB Profile Contact Global Network, Headhunt, < Network >KASBP KSEA KOLIS KSEAUK BLSA NEBS Korean American Society in Biotech and Pharmaceuticals Korean American Scientists and Engineers Association Korean Life Scientists in the Bay Area Korean Scientists and Engineers Association in the U.K. Baltimore Life Scientists Association New England Bioscience Society

Approach Incentive

- -

Global Global Mentorship Post-Doc. - ( ) Network Global Mentorship Website - / Port-Doc. Global - MNC

2010-9

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- - - Global - Global - - / - - Internship - Life Science - Position - - -

Internship

( )

- / 1.5

(, ) - / 1 - : 0.6(, )

104 / R&D

( : ) (1112) 11 12 13 (1317) 14 15 16 17 1 (1822) 1822 2 (23) 23

20

40

120

140

160

180

200

250

300

: 2,387( '17 602)(, 10 ) (11-2 8) 11 12 13 (13-17) 14 15 16 17 18 1(18~22) 19 20 21 22 2 23-2 7

2,387

14

28

84

98 112 126 140 147

154

161

168

175

980

2010-9

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. R&D Resource, R&D , ,

106 / R&D

,

(/) IR , DB , (Job Fair ) (/) R&D

2010-9

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. , , , R&D R&D R&D () One-Stop

108 / R&D

, , (), (), (), (BT,NT) , , , , , , Science Village , ,

2010-9

8. / 109

. : : 18 () (30 21.4) 35%

110 / R&D

. - -

bottleneck bottleneck

. ('11~'12) 1, 2 ('13~'17) 5(, , , DMPK , ) 7( , , , , , , ) '17 200

2010-9

8. / 111

1('18~'22) 50 ( 250) 2('23 ) 50 ( 300)[ 21]

(2010 ~ 2012) : , , , 4, 17 : CDO(Coporate Development Officer)* *

,

112 / R&D

() ( 300)

(1) (20) (6) (5) (4) (5)

, , , , , , , , , , / ,

(160) , , (42) (18) (15) (28) (15) (10) / , , , , , , (, , , ) , , (, , , ) , , (, , , )

/(32) (preformulation), (120) in vivo /,, DMPK (34) (15) (28) DMPK (33) (10) , , , , , , , , ,

2010-9

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A. A-1. A-2. A-3. 2013 60 23 4 2 16 4 2 9 49 16 5 8 17 3 11 3 3 2 3 120 2014 73 26 5 2 19 6 3 12 51 17 6 8 17 3 16 4 4 4 4 140 2015 85 30 8 3 21 6 3 14 70 20 7 12 25 6 17 5 4 4 4 172 2016 98 31 8 3 23 6 5 18 75 20 8 16 25 6 17 5 4 4 4 190 2017 103 32 8 5 27 7 5 19 80 20 10 18 25 7 17 5 4 4 4 200

A-4. A-5. A-6. A-7. B.

B-1. B-2. B-3. B-4. DMPK B-5. C. C-1. C-2. C-3. C-4.

* /

114 / R&D

() 17 103 32 8 5 27 7 5 19 80 20 10 18 25 7 17 3 3 2 3 250 22 132 38 14 10 28 9 8 25 100 28 13 21 29 9 18 5 4 4 5

A. A-1. A-2. A-3. A-4. A-5. A-6. A-7. B. B-1. B-2. B-3. B-4. DMPK B-5. C. C-1. C-2. C-3. C-4.

* /

2010-9

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() 22 132 38 14 10 28 9 8 25 100 28 13 21 29 9 18 5 4 4 5 300 27 160 42 18 15 28 15 10 32 120 34 15 28 33 10 20 6 5 4 5

A. A-1. A-2. A-3. A-4. A-5. A-6. A-7. B. B-1. B-2. B-3. B-4. DMPK B-5. C. C-1. C-2. C-3. C-4.

* /

116 / R&D

. Valuation , , feedback

, (1012) : CDO (1317) : , , in vivo 1(1822) : , 2(2328) : , 5 ,

2010-9

8. / 117

(2013-2017) 200

(103 ) - (45), (39), (19) - 4 - 4 - 4 - , 10-20 * 1-3-5 /project (80 ) - (20), (10), (18), DMPK (25), (7) - - - DMPK - , 10-20 * 1-3-5 /project (132 / 29 ) - (62), (45), (25) - 4 - 4 - 4 - , 20-40 * 1-3-5 /project (100 / 20 ) - (28), (13), (21), DMPK (29), (9) - - - DMPK

1 (2018-2022) 250

118 / R&D

- , 20-40 * 1-3-5 /project (160 / 28 ) - (75), (53), (32) (120 / 20 ) - (34), (15), (28), DMPK (33), (10) - , - - - , 20-40 * 1-3-5 /project

2 (2023-2028) 300

2010-9

8. / 119

60% In vivo DMPK

- - - - - / - Bioreactor feeding medium feeding strategy perfusion - - Protein A - - , , , - Leachate - Viral clearance - 1, 2, 3 - - 4 ( , , , ) - (QC) - - In vivo - - DMPK

(13~17)

In vivo 40% DMPK : 10-20 : 10-20

120 / R&D

Lab - : , 20 pcd 40% - - : , 2 g/L 1(18~22) - : 4 ( , , , , ) (QC) In vivo 60% In vivo DMPK DMPK - : : 20-40 GLP : 20-40 40% - : , 30 pcd - : , 5 g/L - : In vivo 4 ( , , 60% , ) (QC) DMPK In vivo : 20-40 DMPK : 20-40

2(23~28)

2010-9

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- - - : / , , ( , ), / - CDO - ,

(10-12)

CDO

(13-17)

(, , , ) : 17 , 103 - : 3, 45 - : 3, 39 - : 19 , 80 - : 20 - : 10 - : 18 - DMPK : 25 - : 7 (, , , ) : 18 , 132 - : 3, 62 - : 3, 45 - : 25 , 100 - : 28 - : 13 - : 21 - DMPK : 29 - : 9

1 (18-22)

2 (23-28)

(, , , ) : 20 , 160 - : 3, 75 - : 3, 53 - : 32 , 120 - : 34 - : 15 - : 28 - DMPK : 33 - : 10

122 / R&D

. (1317) . , () (:) 2013 2014 2015 2016 2017

61.3 20.3 41 10.8 (7.2)

55.6 23.1 32.5 9.8 (6.5)

59.2 28.7 30.5 10.8 (7.0)

56.6 30.1 26.5 10.0 (6.7)

57 31.5 25.5 10.1 (6.7)

289.7 133.7 156 51.5 (34.1)

2010-9

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: = x 0.7 / 1- / 2- / 3- 4- / 5- 6- 7- 2013 5 8 2 8 2 2 2 29 2014 5 10 3 8 3 2 2 33 2015 5 12 3 10 5 3 3 41 2016 5 14 3 10 5 3 3 43 2017 5 14 3 10 5 3 5 45

: 1- / / / 2- / Fed-Batch Perfusion 3- 4- / FPLC Virus 5- Cell Sorting 6- 7- 2013 8 2 5 1 12 6 6 2 2 10 3 5 2 4 2 2 0 3 3 2 2 41 2014 6 1 4 1 8 4 4 1.5 1.5 9 2 5 2 4 2 2 0 2 2 2 2 32.5 2015 3 0 3 0 8 4 4 1.5 1.5 5 1 4 0 5 3 2 0 4 4 4 4 30.5 2016 3 0 3 0 6 3 3 1.5 1.5 4 1 3 0 5 3 1 1 3 3 4 4 26.5 2017 3 0 3 0 6 3 3 1.5 1.5 4 1 3 0 4 3 1 0 3 3 4 4 25.5

: 15% : 10% .

124 / R&D

, , , in vivo () / 1, 2, 3 (, ) (Process-related impurity, Product-related impurity) , , , (Cell-based assay) (ELISA, Biacore) FACS 2013 2014 2015 2016 2017 (:)

34.4 15.4 19 5.9 (4.0)

33.6 19.6 14 5.8 (4.0)

32.5 21.0 11.5 5.7 (4.0)

35.4 25.9 9.5 6.2 (4.2)

36.3 27.3 9 6.4 (4.3)

172.2 109.2 63 30 (20.5)

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: = x 0.7 / 1- / 2- 3- 4- 5- 6- 2013 10 4 2 2 2 2 22 2014 12 4 3 3 3 3 28 2015 14 4 3 3 3 3 30 2016 16 6 5 3 3 4 37 2017 16 7 5 4 3 4 39

: 1- / MASS HPLC CE 2- // (Cell-Based Assay) 3- / 4- FACS 5- 6- 2013 7 3 1 2 1 3 2 1 3 1 1 1 2 2 2 2 2 2 19 2014 5 2 1 1.5 0.5 3 2 1 2.5 0.5 1 1 1 1 1 1 1 1 14 2015 4.5 2 1 1 0.5 2 1 1 2 0.5 0.5 1 1 1 1 1 1 1 11.5 2016 3 1 0.5 1 0.5 2 1 1 1.5 0.5 0.5 0.5 1 1 1 1 1 1 9.5 2017 3 1 0.5 1 0.5 1.5 1 0.5 1.5 0.5 0.5 0.5 1 1 1 1 1 1 9

: 15% : 10%

126 / R&D

, () , (:) 2013 2014 2015 2016 2017

7 8 2.6 17.6 1.8

9.1 9 3.2 21.3 2.1

9.8 8 3.1 20.9 2.1

12.6 8 3.6 24.2 2.4

13.3 7.5 3.7 24.5 2.5

51.8 40.5 16.2 108.5 10.9

: = x 0.7 / 1- 2- / 2013 6 4 10 2014 8 5 13 2015 9 5 14 2016 12 6 18 2017 13 6 19

: 2010-9

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1- Preformulation Cycle Development 2- /

2013 5 2 2 1 3 2 1 8

2014 6 2 2 2 3 2 1 9

2015 6 1.5 1.5 3 2 1 1 8

2016 6 1 1 4 2 1 1 8

2017 6 1 1 4 1.5 1 0.5 7.5

: 15% : 10% ,

128 / R&D

/// in vivo , ( ) (///) (: ) 2013 2014 2015 2016 2017

11.2 8.0 3.5 22.7 2.3

11.9 8.0 3.5 23.4 2.3

17.5 7.0 4.3 28.8 2.9

17.5 7.0 4.3 28.8 2.9

21 4.5 4.5 30 3.0

79.1 34.5 20.1 133.7 13.4

: = x 0.7 / 1- 2- 3- 4- in vivo 2013 10 2 2 2 16 2014 11 2 2 2 17 2015 18 2 3 2 25 2016 18 2 3 2 25 2017 21 3 3 3 30

:

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1- (///) 2- / 3- 4-

2013 5 5 1 1 1 1 1 1 8

2014 5 5 1 1 1 1 1 1 8

2015 4 4 1 1 1 1 1 1 7

2016 4 4 1 1 1 1 1 1 7

2017 3 3 0.5 0.5 0.5 0.5 0.5 0.5 4.5

: 15% : 10% ,

130 / R&D

/// in vivo , (: ) 2013 2014 2015 2016 2017

11.28.0

11.97.0

147.0

146.0

17.54.5

3.4 22.6 2.3

3.3 22.2 2.2

3.7 24.7 2.5

3.5 23.5 2.4

3.9 25.9 2.6

68.6 32.5 17.8 118.9 12

: = x 0.7 / 1- 2- 3- 4- DMPK 2013 10 2 2 2 16 2014 11 2 2 2 17 2015 14 2 2 2 20 2016 14 2 2 2 20 2017 16 3 3 3 25

:

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1- 2- / 3- 4-

2013 5 5 1 1 1 1 1 1 8

2014 4 4 1 1 1 1 1 1 7

2015 4 4 1 1 1 1 1 1 7

2016 3 3 1 1 1 1 1 1 6

2017 3 3 0.5 0.5 0.5 0.5 0.5 0.5 4.5

: 15% : 10% ,

132 / R&D

DMPK /// DMPK , FACS ELISA (: ) 2013 2014 2015 2016 2017

11.9 11 4.0 26.9 2.7

11.9 11 4.0 26.9 2.7

17.5 7.5 4.4 29.4 2.9

17.5 6.5 4.2 28.2 2.8

17.5 6.0 4.1 27.6 2.8

76.3 42 20.7 139 13.9

: = x 0.7 / 1- DMPK 2- 3- ELISA 4- DMPK 2013 7 4 3 3 17 2014 7 4 3 3 17 2015 12 5 5 3 25 2016 12 5 5 3 25 2017 12 5 5 3 25

:

2010-9

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1- DMPK 2- FACS 3- ELISA ELISA 4-

2013 3 3 4 2 1 1 2 2 2 2 11

2014 3 3 4 2 1 1 2 2 2 2 11

2015 3 3 2.5 1 1 0.5 1 1 1 1 7.5

2016 2 2 2.5 1 1 0.5 1 1 1 1 6.5

2017 2 2 2.5 1 1 0.5 1.0 1.0 0.5 0.5 6.0

: 15% : 10% ,

(1317) ; 1,043.5(++ )

( : ) (2013-2017) 13 14 15 16 17

/ / DMPK

72.1 40.3 17.6 22.6 22.7 26.9 202.2

65.4 39.4 21.3 22.2 23.4 26.9 198.6

70.0 38.2 20.9 24.7 28.8 29.4 212

66.6 41.6 24.2 23.5 28.8 28.2 212.9

67.1 42.7 24.5 25.9 30.0 27.6 217.8

341.2 202.2 108.5 118.9 133.7 139.0 1,043.5

134 / R&D

/// in vivo , DMPK (: ) 2013 2014 2015 2016 2017

/ / In vivo DMPK

0.5 0.3 20 20 10 10 15 10 85.8

1.0 0.4 25 24 12 15 20 15 112.4

1.0 1.0 27 26 13 16 22 16 122

1.0 1.1 32 28 14 20 24 19 139.1

1.0 1.2 37 32 16 22 26 22 157.2

4.5 4 141 130 65 83 107 82 616.5

2010-9

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/ : 20-40 - (250 / ) x 20-40 - 1.6 -3.3 / (5-6) : 20 - /, : 10-20 - CMO (0.5-1 / ) x 10-20 - (2 /) x 5 : 10-20 - (1 / ) x 10-20 - (0.4 /) x 10-20 - CMO (QC) (0.1 / ) x 10-20 / : 5-7 - CRO (1 /Preformulation )x 5-7 - CMO 12 (1 /) x 5-7 in vivo ( //DMPK ) : 10-20 - 1/ x 10 x 3 - Nude (10 ) x200 x10x 3 - (500 ) X 200 x 3x 3 - / (1, 2)X200 x10x 3

136 / R&D

. ('13~'17) : 1,750 (2013-2017) 13 14 15 16 17

/ / DMPK

202.2 72.1 40.3 17.6 22.6 22.7 26.9 85.8 0.5 0.3 20 20 10 10 15 10 12 300

198.6 65.4 39.4 21.3 22.2 23.4 26.9 121.4 1 0.4 24 23 11 14 19 15 14 315

212 70.0 38.2 20.9 24.7 28.8 29.4 131 1 1 25 24 13 15 20 16 16 335

212.9 66.6 41.6 24.2 23.5 28.8 28.2 169.1 2 2.1 32 28 17 20 24 21 23 390

217.8 67.1 42.7 24.5 25.9 30.0 27.6 183.8 3 3.8 35 30 19 22 25 22 24 410

1043.5 341.2 202.2 108.5 118.9 133.7 139.0 616.5 4.5 4 141 130 65 83 107 82 90 1,750

/ / / DMPK

(5) (%) 2013 2014 2015 2016 2017

67 29

61 35

61 35

57 37

56 45

61 39

2010-9

8. / 137

. (//) ('11-'12) ('13-'17) (Full Op.) ('18 )

,

, ,

138 / R&D

: 684 58,0292 (1112) (1317) (18)

87 143.07

550 345.58

47 91.64

(11~12)

- Validation Built-in , , Global Top-tier ()

87 Autoclave(CISA 550L) 3 Built in

14,307 700 2,215

Blood chemistry analyzer (2011 , 1,329 29 ~ Built in 2012) Autoclave(CISA 75L) 1 75 DMPK

( ) Built in 3

Ion analyzer 39 10

,

9,010 978

2010-9

8. / 139

(13~17) - - Target Validation Best in Class Best in class Best in Class License Out First in Class

BIOSTAT CultiBag 1000(Sartorius) 94 FLIPR (Fluorescence System) 182 Flowcytometer 41

( )

(2013 ~ 2017)

550 34,558 STR 11,752 Imaging 16,504 2,066 2,865 310 1,061

Animal activity meter 36 DMPK CAT, MRI, PET 8

HTS(High Content Cell Imaging Analysis System) - Roche 183

('18 ) - First in Class Target First in Class - , , , Nano Technology

DMPK

46 HPLC(IMS) 4 HPLC(MS-MS) waters 31 Molecular modeling software 1 , ,

( )9,164 1,100 6,735 110 495 724

(2018~)

Confocol laser scanning microscope 5 MRI(3T) 1

140 / R&D

. : 2010~2017 : 435 : 40(1), (1), (13), (15), (10)

: 4 395(1, 1, 2, 12 200) (1, 1 4, 12 112) (1, 3 9 35) (1 4 1 48)

( ) ( CEO, 3) ( , 3) : 3 , ,

2010-9

8. / 141

() [ ]

201018 3 3 3 3 6

201139 15 7 5 5 7

201278 22 13 14 20 9

2013300 160 89 26 7 18

(17)435 200 112 48 35 40

(Searching Committee) , , , , R&D

142 / R&D

, , , KOTRA, IRO(International Recruit Officier) , , , ()

2010-9

8. / 143

. 1)

() , , () , ()

144 / R&D

()

, , , - - - , - , 150 2010-9

8. / 145

, , - , - , -, - , TF 3 , 3 , 3 3 , 3 3, 5

- , -, - , , 3 3 3 , 5

146 / R&D

+ (), 3 3 [ 22]

, , ,5+2 , ,

2010-9

8. / 147

[ 23]

2)

( ET ) [ 24]

148 / R&D

ET(Exploit Technologies), NSTB NSTB Holdings - - A*STAR (TDF) - TDF(Technology Development Fund) (technology-based) , ( ) - , TDF - 1995 9 5000 2 25150 - , A*STAR , TDF Management Pte Ltd

UniServices (R&D 50) 30 5 2007 8,700 550 , 2,500 20 15%

2010-9

8. / 149

150 / R&D

. 1) : 120 ( 20 100) : : 570,098(172)

: 2010~2020

(10. 1. 1. ) (5,000, ) MOU , (, ) ( 3) LG, CJ 15 (6. 30) : , 8 (6.28-29, 500 ) DB ( 200 ) (7. 2)

(10. 10~11)

2010-9

8. / 151

(50 ) MOU : : ()

2) ( 18) ( 20) ( ) 1 5( 2~5) ( 21) ()

( 22)

( 23)

152 / R&D

( 24) ( 26) 1826

: 50 ( 11, 25) ( 12, 26) ( 13) ( 15, 19) , ( 15, 19) ( 27) , ( 16, 20) ( 23) : 20 1 6 50 ( 60)( 17, 21) : 20 50 ( 60) ( 17, 22) 11~17 19~28

2010-9

8. / 153

5 , 5 ( 61 3) 5 100%, 2 50% (3) ( 632 1, 2) 61, 632

, (5) ( 276) 5 , 3 50% 28

( 282) 276, 282, 28

: 85 : 3 30 : (, ) 70% : , , 10 5% 28 ( 2008-239) 9, 9 2

: 50 : 3 50

154 / R&D

: , 5% 3 50% 2 : (), 10 5% 50 : , , 10 5% 50 29

: 50 : 3 50 : (), , 10 5% : , 10 5% 30

: 300 , 1,000 : : 1 10 3 31

2010-9

/ 155

[]

/ () () / /

KIST

156 / R&D

()

()

2010-9

No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1 2 3 4 5 6 7 8 9 / (Cyanobacteria) Cytokine cervical cancer 2004-1 2004-2 2004-3 2004-4 2004-5 2004-6 2004-7 2004-8 2004-9 2004-10 2005-1 2005-2 2005-3 2005-1 2005-2 2005-3 2005-4 2005-5 2005-1 2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-06-30

10 Peptide drug 11 Metabolic engineering Biocatalysis 12 13 14 15 16 17 18 19 Embryonic stem cell Xenogenic organ Organogenesis (, , ) BT 1

2005-06-30 2005-06-30 2005-06-30 2005-06-30 2005-07-19 2005-07-19 2005-07-19 2005-07-19 2005-08-12 2005-09-13

20 , MEMS 2005-10-7 21 2005-12-31 22 2005-12-31

2005-6 2005-4

22

2005-5

23 24 25 26 27 28

23 2005-12-31 24 2006-02-10 25 2005 2006-02-22 26 BT 27 28 2006-02-28 2006-02-28 2006-05-04

2005-6 2006-1

2006-1 2006-1 2006-1

29 30

29 30

31

31

32

32

33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51

33 34 35 36 37

( ) ( ) Status of Biotechnology in Korea

2006-06-06 2006-07-10

2006-2 2006-2

2006-09-10

2006-2

2006-09-10

2006-3

2006-09-10 2006-10-20 2006-12-29 2006-12-30 2006-12-30 2007-04-30 2007-06-14 2007-06-30 2007-07-18 2007-07-20 2007-07-25 2007-08-31 2007-09-01 2007-09-01 2007-10-10 2007-10-10

2006-4 2006-1 2006-3 2006-4 2007-1 2007-1 2007-2 2007-1 2007-2 2007-3 2007-1 2007-3 2007-1 2007-2 2007-3 2007-4 2007-5

(GLP/GMP) 38 BT 39 40 41 42 43 44 2007 / 45 46 1989~1997 FDA 21 47 -(, , , , (algae) ) 21 48 -(Genom ics, Proteom ics, GMO ) 49

2007-10-11 () 50 2007-10-16 51 2007-10-16

52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85

52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85

( ) BT 3 ( ) (,) 2005 Biotechnology in Korea ('07~'16) 2 "Bio-Vision 2016" Bio-Vision 2016 1 (94 06) 2007 2007 2 (Biorem ediation ) R&D (2008~2017) 2008 R&D 2008 2008 2 1(07.7-08.6) 2008 ( ) ( )

2007-11-27 2007-12-15 2007-12-20 2007-12-31 2008-01-14 2008-01-31

2007-4 2008-1

2005-12-31 2006-02-08 2006-07-10 2006-12-15 2007-02-01

2007-03-12 2007-02-15 2007-04-04 2007-12-28 2008-01-06 2008-01-31 2007-5 2008-03-10 2008-03-31 2008-03-31 2008-04-04 2008-04-07 2008-04-28 2008-06-30 2008-07-25 2008-07-25 2008-07-31 2008-07-31 2008-07-31 2008-08-31 2008-10-22 2008-10-31 2008-10-31 2008-10-31 2008-1 2008-1 2007-6 2008-1 2008-1 2008-2 2008-3 2008-1 2008-2 2008-1 2008-2 2008-2 2008-3 2008-2 2008-3

86 87 88 89 90 91 92 93 94 95

86 R&D 87 OECD 88 89 90 91 92 93 94

2008-10-31 2008-11-25 2008-11-28 2008-12-30 2008-12-31 2008-12-31 2008-12-31 2009-01-13 2009-02-10 2009-02-10

2008-4 2008-5 2008-4 2008-5 2008-6 2008-2

Bioin BT ( )

Bioin 2008 2008-4 2009-1 2009-1

96 97 98 99 100 101 102 103 104 105 106 107 108

95 3 3P(Paper, Patent, Product) 96 97 BT 98 - Fraunhofer Center for 99 Biopharmaceutical Research(CBR) 100 101 bottleneck 102 103 2009 Biotechnology in Korea 104 (08~17) Approaches to International 105 Collaboration in Korean Biotechnology 106 2009 107 2009 108 2009 Bioin &()

2009-02-12 2009-03-31 2009-03-31 2009-04-10 2009-04-20 2009-04-25 2009-04-25 2009-05-25 2008-06-01 2009-09-04 2009-08-30 2009-08-30 2009-11-07 2009-11-18 2009-11-25 2009-11-25 2009-11-25 2009-11-25 2009-12-22

2009-2 2009-1 2008-5 2009-1 2008-6 2009-2

2009-2

2009-3 2009-3 2009-4 Bioin 2009-1 2009 2009-5 2009-6 2009-1 2009-7 2009-1

109 109 2009 110 111 112 113 114 110 111 112 113 114 2 R&D 2009 MD-Ph.D

115 115 2009 Bioin 116 116 2009 117 117 118 118 Bioin & 2009_ 119 119 BioWatch BT(Monthly) 120 120 ( ) ( 121 121 ) 122 122 123 123 ( ) (TRIZ) R&D 2010 2010

2009-12-30 2009-12-31 2009-12-31 2010-01-15 2010-01-15 2010-02-10 2010-02-10 2010-02-10 2010-02-10 2010-03-17 2010-04-01 2010-04-10 2010-06-25 2010-08-10 2010-08-10 2010-09-30 2010-10-08 2010-11-15 2010-11-30 2010-12-15 2010-12-30

Bioin 2009-2 2009-5 Bioin 2009-3 Bioin 2009-4 2009-2 2009-3 2009-4 2009-5 2009-6 2010-1 2010-2 2010-1 2010-3 2010-4 2010-5

124 124 125 125 126 126 127 127 128 128 129 129 130 130 131 131 132 132 133 133

: 2010 Bioin

2010-1 2010-6 Bioin 2010-1 Bioin 2010-2 Bioin 2010-3

134 134 2010 Bioin & 135 135 2010 BioINdustry 136 136 137 137 ( ) 138 138 139 139 R&D 140 140

2011-01-31 2010-1 2011-01-31 2010-2 2011-02-10 2010-7 2011-02-10 2010-8 2011-02-10 2010-9

BioIn(http://www.bioin.or.kr) .

2010-9

R&D 2011 2011 2 08 2 10 / / 52 3 : (042) 879-8366 ISBN978-89-93675-60-3 2011