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󴺽 2015-01-26 06:14:58
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󴺽 2015-01-26 06:14:58
[۷ιƮũ] ̱



[׸Ʈ] û ȳϽʴϱ? '۷ι Ʈũ-庸' Դϴ. ̱ CRO忡 ˾ƺ ð غ߽ϴ. ڸ GSG ǥ ȭ ֽϴ. ǥ ȳϽʴϱ?

[ ǥ] , ȳϽʴϱ?

[] ̱ CRO Ը  dz?

[ ǥ] 2014 23Ͽ ڷḦ 2014⵿ ü R&D market $245.7 Billion Dollars(245)̰ Development Market $100.1 B(100), Phase1-IV Development Market $71.3B(71) ׸ CRO Market $23.6 B(23) մϴ.

500 ȸ 2012⿡ $133 B R&D Ͽ, 2015⿡ $140 B R&D ڸ ȹԴϴ.

CRO 2012⿡ $24B 2015⿡ $25B ǰ ֽϴ.

[] ۷ι CRO Ը  Ǵ м Ź帳ϴ.

[ ǥ] 2013 1100 CRO ֽϴ. ̱ market share global share 𸣰ڽϴ.

Covance 帮ڽϴ.

2014 9 ڷῡ ϸ Covance Annual Revenue $2.4B̾ϴ. 46% ̱, EU 37%, Ÿ 17% ְڽϴ.

12500 60 Ѵ 󿡼 Ǿ ֽϴ. , Ը CRO ̻ US non US ǹ̰ ϴ.

[] ̱ ۷ι 5 CROü , ̵ CROü Ұ Ź帳ϴ.

[ ǥ] CRO 踦 ϰ ֽϴ.

1. Pfizer and Icon and Parexel

2. Astellas Pharma and INC Research

3. Sanofi and Covance

4. Takeda and Covance and Quintiles

5. Eli Lilly and Parexel

Top 10 CRO ϴ. , PRA mergeĿ top 4 rankȴٴ ǰߵ ֽϴ.

1. Quintiles : 32000. â Dennis Gillings . $1B.

2. PAREXCEL : Asia strong presence

3. PPD ( Pharma Product Development)

4. Covance : ӻ󼭺 ӻ ü.

5. ICON :׾

6. Quotient Bioresearch

7. Charles River : ӻ Ⱓ

Rising Stars

8. PHARMNET: ü CRO ߽ ϴ CRO

9. WuXi: Based CRO. ̱ ߱ Ȱ

10. Accovion: based ȸ

[] ̱ CRO ΰ ΰ?

[ ǥ] CRO market size 15% ϴ ߼ м ϰ , profits 50% پٴ Դϴ.

̷ profit ִ computer/electronic system ̿ clinical trials ߴ޵Ǿ Դϴ. system ν ӻⰣ پ, ׿ , CRA 湮 Ƚ ־, ǽð ڷ 並 ӻ ӻ ־ ӻ ̷ ֽϴ.

̷ ؼ go/no go ְ Ǿϴ.

Ը CRO 75% market share ϰ ֽϴ.

, 2007⿡ ־ 30 CRO߿ 40% ʰ ֽϴ.

Kendle inc Rsearch PharmaNet InVentiv翡 պǾϴ. Ը PRACS 2013 ĻϿϴ.

FDA ȸ翡 ϴ ӻ迡 ۵ ڷᰡ ִٴ ˰ Ǿ, ׷ ؼ Ļϰ Ǿϴ.

[] 鵵 ֱ ̱ ӻ ϰ ֽϴ. ̱ ӻ ؾ ִٸ?

[ ǥ] ӻ ؼ Ȯ ڷḦ ϰ, ڷḦ ICH guideline ִ м ؼ US FDA 䱸 ϴ format ؼ ؾ մϴ.

, ӻ󿡼 ̷ ص ǰ ص Ǵ ӻ迡 ȵǴ 찡 ϴ.

ӻ ϴµ ־ project manager/regulatory person ؼ Ȯϰ ӻ ֵؾ մϴ.

̱ ӻ GCPؼ ICH guideline / US FDA regulation ؼ Դϴ. ̷ ͵ ؼ ʰ ϰ Ǹ FDA review ˴ϴ.

Ư ӻ Ʈ ̱ Ʈ ѱ ľó US FDA regulation ̰ ʿ 㰡 ް ؾ ϴ.

Marketing ´ ӻ ؾ մϴ.

ϰ Ͽ ׾? 뿡 ర ӻ ؾ Դϴ.

[] 簡 ̱ ӻ , CROü ϴ Ѱ?

[ ǥ] ̱ Ը CRO 1 Ѵ Ը ȸԴϴ.

⵵ Billion Dollar Ѵ ȸ鵵 ֽϴ.

ѱ ˷ Quintile( 28000) 2013 service revenue $3.8B ̾ ݳ $4B ϴ. Parexel 1 6000 2013 revenue $1.73 B̾ϴ.

̷ ȸ ϴ ִ ༭ ϳμ ټ ֽϴ.

, üϸ protocol ۼ, site selection, conduct clinical trials, monitoring, report ϳ ü ϴϱ ϰ ̷ ִٰ Ҽ ְڽϴ.

, CRO 񽺸 ʰ ֽϴ.

Global ȸ ٹ ϰ Ǹ  ϰ ׻ ˴ϴ. ޴ 찡 ֽϴ.

 2 ӻ ؼ ۼ 10-14 η ʿ ϰ ˴ϴ. ̰ Ʈ PIԵ οԴϴ.

, ϳ ӻ Ƿϰ ִ ѱ ȸμ ޱⰡ ۿ ϴ.

ƿ﷯ CRO ؼ ڱ׵ ֽϴ. װͿ ణ̶  Ǹ ߰ ˴ϴ. ѱ ȸ ϰ Ǵ CRO ڱ׵ 䱸 ϸ鼭 ߻ϴ ߰ ϴ.

[] CRO ߿伺 ̶ Ͻó?

[ ǥ] CRO sponsor Ƿ ӻ ִ Ȯϰ protocol ° ϰ, guideline ؼؼ ִ FDA 㰡 ްų License out ϴµ service ִٰ մϴ.

Ư ѱ ȸ翡Լ Ῡǰ ִ ӻ ָ鼭 Ȯ ӻ شٴµ ִٰ մϴ.

ӻ protocolۼ ְ ְ ӻ ִ ߿ ϴ.

[] ǥԲ CRO ǥ ŵ ó?

[ ǥ] ȸ 2008 1 âϿϴ.

ѱȸ, Ϻ ȸ ׸ ̱ ȸ ѱ ̱ 1,2, 3 Ͽų Դϴ.

ȸ Global Pharma (Abbott, Eisai, Procter & Gamble, Forest Lab) 11Ⱓ ٹϸ鼭 NDA Ͽϴ.

ǥ ๰δ Humira, Omeprazole OTC, Rabeprazole, Aricept ๰ ֽϴ.

US FDA IND㰡 ˼ , US FDA IND(eCTD), ӻ 1 ۼ, ӻ2 site/pi˼, protocolۼ, dm/Stat, ͸, safety monitoring ϰ ְų Ͽϴ.

[] ӻ 赵 ƴµ, ׵ ֽ.

[ ǥ] ž Ư Ⱓ 20Դϴ. ٸ ణ ߰ ֽϴ.

ž 㰡 ޱ ؼ ӻ, IND, ӻ 1, 2, 3 ľ մϴ. 5000 ๰ (ӻܰ) 5 ž 㰡 ܰ踦 մϴ.

1. ӻ 3 6

2. IND : 1

3. Phase 1 : 1, 20 80

4. Phase 2 : 2, 100 300

5. Phase 3 : 3, 1000 3000.

6. NDA : 1

12 ð ɸ, $350 million ž㰡 Դϴ. ϴ 1000߿ ϳ ž㰡 ޽ϴ.

̱ global ȸ 1 1⵿ ϳ ϴ° ƴϰ Ѳ մϴ.

Eisaiٹ 1⿡ 45 1 ߰, Novartis Ŵ 100 Ѵ 1 ϰ ֽϴ. ӻ ϳ ϴ 쵵 , ñ⿡ ÿ Ǵ ӻ ϴ.

ѱ ȸ ϸ鼭 Ÿ Ư Ⱓ ʰ ִٴ ̴ϴ. ۾ ʹ ʰ ǰ ֽϴ.

, 3 6 ؾ ϴ ӻ 5-6⾿ ϰ ְ(10⵵ ֽϴ), 1̸ ϴ 1 2 Ȥ 3⾿ ϰ ֽϴ.

proof of concept study (phase 2a) 2 ̻ ɷ մϴ.

̷ ӻ, 1, 2 ϴ 10 ̶̻ ɸ, global ȸ翡 compound ߰ 1 ߰ 2, 3 ؾ ϰ, Ⱓ ƹ ߰ 6-7 ɸ ˴ϴ. , ѱ ȸ翡 10̶ Ⱓ 1 2-3, 2 ϳϴµ Ҹ Ͽ, Global ȸ翡 ߰ 6-7 ɸ Ǹ ̹ 16-17̶ ž㰡 ޴µ ƯⰣ Դϴ.

, Global ȸ翡 ѱȸ簡 ๰ ž㰡 ް ȼ ִ Ⱓ 5⵵ ʽϴ.

ӻ Marketing ο ΰ ؾ մϴ. ϴ ž Ȯ ˾ƾ մϴ. ܼϰ ϸ ʹ ֽϴ. о̶ ϸ ̹ ִ ü ؾ մϴ.

, ̷ ְ, ־ ̹ ִ Global ȸ ǰ ٴ ˸ ִ ӻ ؾ մϴ.

Proof of concept̶ غؼ potential license out company ִ ǹ 亯 Ҽ ־ մϴ.

̾ block buster ȿ ִٰ Ѵٸ ̴ϴ.

ຸ  ִٴ ӻ ؼ ؾ մϴ.

ѱ ȸ ӻ ʹ ϰ ϰ ֽϴ.

׷ ؼ ӻ ȭǾ մϴ. , ̹ Ǿ 㰡 ӻ ڷ Ȯ ϰ ľؼ market ϴ ӻ protocol ۼؾ ϴ.

ӻ GCP ´ ӻ ؾ ϰ ICH ´ غؾ մϴ.

Global ȸ system ٲ, ڷ ü ٲϴ.

ϰ 2008 Ǿ ص ȴٴ µ ٲپ մϴ. մϴ.

2008 1ڷ ٲ US FDA requirement ʴ , ڷ FDA ʽϴ. , license ϰ ; ϴ ȸ鵵 ڷḦ 䱸 ͽϴ.

ӻ Ȱؾ մϴ.

ȸ λ̷ ô Pfizer翡 joinϼż global block buster Nexium OTC project ̽ϴ.

̺ Nexium ๰Omeprazole OTC, Rabeprazole ӻ 10 Ѱ Ͽ 缭 Pfizer翡 ̽ϴ.

, Pfizer Ŵ GI ٰ ̷ ʺؼ ϴ.

, ѱ ӻ Ȱ뵵 ϴ.

Protocol ۼ ̱ Ѱ (study director) ڰ protocol ۼմϴ.

̰ Test Ȯ protocol ۼϰ ˴ϴ. ̱ FDA method ϰ װͿ ǰ ÿ ǰ ֽϴ.

[] ֱ ߱ CRO ϱ޼ Ŀ ִٰ µ, ̱ ߱ CRO ?

[ ǥ] δ ߱, εε ̹ FDA ̱ ȸ翡 ٹϿ, ̵ ׳׵ ư CRO ϴ ҽϴ.

10 ο Ű , ڰ ε̾, ׷ ε head hunter ȭ ޾Ҵ ϴ.

ε ȸ ҳ CRO joinϰڳİ ȭ ޾Ҵ ϴ.

ٹϿ Eisai DM/StatѰ λ ߱̾ϴ. Sanofi R&D Scientific Platforms å ߱̾ϴ.

ֺ ̱ ȸ翡 ٹϿ ߱, ε CRO ߰, ̵ ̱Ӹ ƴ϶ ߱, ε ӻ󿡵 Ȱϰ ϰ ־ϴ.

Covanceλ Rick Cimino ߱ ӻ site Pi ׿ ִ Ұ, Bayer, AstraZeneca, GSK, Roche Global ȸ ߱ Ը center ϰ ִٰ ߽ϴ. ߱ ȸ鵵 ̱ ž 㰡 ؼ ̱ ֽϴ.

[] ߱ CROü ۷ι CRO ֽϴ. ǥԵ ̽Ű?

[ ǥ] ߱ global ü CRO ־ ߿ Դϴ.

, ʹ ٷο ؼ ü ް ֽϴ. , ӻ Ʈ ϴµ ־ 㰡 ޾ƾ ϰ ̷ 㰡 ӻƮ 400 ۿ ʽϴ.

ӻ ϰ ִ ڵ մϴ.(Paraxel Chief operation office Mark Goldberg) ߱ ӻ Ǵ µ, ٷο ߱ ؼ ž㰡 ̷ ʰ ֽϴ.(INC Research, Mr. Macdonald)

, 5Ⱓ ߱ ֽϴ.

 ο 鼭 , ߱ ̱ ̷ ϰ ذ մϴ.

߱ε ü ڱ ƴѵ joinϴ ƿԽϴ. ߱ε globalȸ翡 ־ϴ.

[] 츮 CROü ð ĺ ۷ι £ Ƴ  ұ?

[ ǥ] ȸ ӻ 󿡼 ϴ ٲ ֽϴ.(Mr. Macdonald, INC Research).

ֽϴ.

globalȸ ϰ ֽϴ.

մϴ.

׳׵ Կ̾ block buster޵ Ư ᰡ Ǿ, ο ž Դϴ.

, Key global market ӻ Ϸ ϰ ְ, ѱ key global market ϱ ؼ Global Standard ´ ؾ մϴ.

Global Standardization ̷ ʰ ִ ѱ CRO global £ Ƴ ϴ.

ICH guideline ִ ׵ Ȯ ؼ ̱ CRO鿡Լ ֵ FDA ް ǰ ᱹ Ļ ۿ ϴ.

, ICH guideline US FDA guideline ؼϰ sponsor service ϰ Ǹ preferred vendor Ư츦 ް ˴ϴ.

 ȸ ٹ ȸ翡 preferred vendor proposal proposal ϰ ˴ϴ.

, ǿ 츦 ֽϴ.

2008 ķ guideline US FDA ȵǾ, װ ؼϱ ؼ ȸ ϰ ֽϴ.

US FDA 䱸ϴ ׵ ؼϿ ӻ ϰ ۼ ˾ƾ߸ globalȸ簡 ѱ CROԼ service 䱸 Ұ Դϴ.

ICH 䱸 ϴ м, ӻ , FDA 䱸ϴ data file ͵ غؾ մϴ.

[] ǥ, մϴ.

[ ǥ] , մϴ.

[Ŭ¡] ۷ι Ʈũ-庸. Դϴ. ð پ ҽ غؼ ãƺ˰ڽϴ. û ֽ ϴ.

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ֽż ݴ
౹ Ϲݾ Top 100(03)
ǰ Ƚ Ǹűݾ
1 Ÿ̷500mg(10) 23638 33104 101,505,000
2 Ȱť 13391 83427 97,389,700
3 Ǹť 10902 91595 73,069,159
4 ݿ 11997 88325 71,846,700
5 ũũ 4431 4720 52,151,000
6 뽺ī 20g 2332 2418 49,544,700
7 319 12291 44,946,300
8 Ź ĸ(10ĸ) 10732 15961 42,562,800
9 S 676 1227 42,429,350
10 ݴ ť÷ 8546 11210 42,423,060
11 ̰źĸ(60ĸ) 1292 2602 37,202,100
12 ġ 8140 41776 36,792,300
13 öŸ(34) 2501 3833 35,705,600
14 ׶÷ ƮŸ 3353 4312 35,035,660
15 Ʒγΰ̾(120) 657 810 34,246,900
16 ġ̽Ʈġ120g 2388 3282 34,107,490
17 öŸ(40) 2100 2586 34,093,300
18 ٿ 30g 2899 5594 33,943,700
19 (120) 1218 2384 32,914,000
20 ڶ-(40) 1737 3804 28,306,900
21 Ժ 5110 8423 27,914,600
22 Ź 3783 5019 27,081,000
23 ƽŸ 434 825 26,872,500
24 ׶÷ ݵ& Ʈ 1824 2172 25,848,300
25 (10) 8429 12233 25,619,101
26 ȲûɿŹ50ml(õ) 1192 2335 25,361,000
27 ݴ ݵť÷ 5324 6920 25,224,900
28 Ÿ̷500mg(30) 2468 3258 24,699,390
29 Ľõ򿬰10׶ 3091 3369 24,306,500
30 6089 25744 24,196,461
31 Ʒ 3226 7806 24,186,252
32 6̺(30ĸ) 2737 3245 23,701,750
33 ġ̽Ʈġ150g 1401 1754 23,469,900
34 ũ 1907 1963 23,302,401
35 λ絹÷(100) 671 1981 22,752,400
36 ݿ 5552 7933 22,665,600
37 ťýȾ0.5ml*60 1158 1319 22,004,000
38 D-׳ 2074 2207 21,799,902
39 Ľõ򿬰5g 3700 3954 20,580,200
40 뽺ī 10g 1603 1663 20,406,600
41 ӽ÷ 1879 2250 20,176,000
42 öŸ 3232 7567 19,371,321
43 ȲûɿŹ50ml() 1585 3803 19,128,000
44 Ȳûɿȯ() 255 1579 19,058,500
45 ƽƮ(150) 195 351 18,535,100
46 Ÿ̷8ð̾˼ 4493 6574 18,407,000
47 ʽ÷÷ 2748 3217 18,376,001
48 īɾ10g 2552 2817 18,221,600
49 Ʒγΰ(100) 525 1187 18,136,800
50 (10) 2814 3718 18,035,700
51 6̺꿬ĸ(10ĸ) 4711 6546 17,234,600
52 ھ ߽20ml 1500 1754 17,208,900
53 ƽŸ 313 594 16,459,972
54 ݴŰ÷ 3393 4385 15,960,800
55 ̵Ⱦ 14ml 2463 2769 15,949,650
56 ǥȲûɿ 50ml 1061 3758 15,544,646
57 ڷƮ 2mg (Ʈ) 693 1630 15,516,200
58 Ź 2643 3839 15,388,600
59 ѺŸC1000mg 814 2828 15,249,703
60 λ絹÷(270) 194 737 15,225,500
61 밢()(18) 1795 2220 15,094,100
62 ̵Ⱦ 14ml 2416 2576 14,910,600
63 λ絹(100) 491 907 14,826,800
64 ׺ƽĸ 294 546 14,789,500
65 翬ĸ(120ĸ) 372 387 14,722,300
66 Ź̵ 3100 3837 14,720,200
67 Ʈ0.1%й 1182 1495 14,673,700
68 ȭ 4074 18105 14,639,465
69 Ʒ 2856 4634 14,629,300
70 ѽŻ÷(10) 3458 5196 14,582,200
71 ׺ǵ 1246 7135 14,399,712
72 ݴŰ÷ 3107 3696 14,384,750
73 ÷ 3969 4682 14,254,868
74 ƼǪīŸö󽺸 2531 4745 13,924,700
75 ̵Ⱦ׼ 14ml 2151 2411 13,871,800
76 īٿĸ(60ĸ) 299 427 13,498,500
77 ΰ 155 206 13,325,000
78 2480 9352 13,106,010
79 ξ 487 5011 13,096,210
80 ƼǪ Ŀ 1714 3762 13,033,911
81 īɾ 6g 2647 2864 12,758,350
82 10 1610 2720 12,753,338
83 ƽúŰ÷(10) 2340 2566 12,706,610
84 ġĸ(60ĸ) 452 984 12,697,600
85 տ翬ĸ(80ĸ) 349 449 12,559,600
86 Ǫ÷ 3092 4079 12,536,300
87 īڿ;(300) 425 459 12,408,600
88 Ÿ̷ݵ忡 2519 3686 12,349,800
89 2% 120ml 683 707 12,166,600
90 ġĸ(120ĸ) 241 251 12,094,000
91 ȯ 1945 2815 12,000,300
92 Ŭƾ 972 1013 11,992,500
93 ƼǪ Ŀ 1949 4686 11,989,100
94 ݴ ť÷ 2523 3104 11,948,900
95 ǥȲûɿ50ml(õ⺯) 584 1190 11,875,100
96 1100 1463 11,805,800
97 ؽ 1141 1198 11,802,000
98 ڸŰĸ 2134 2516 11,677,500
99 Ⱦ0.5ml 573 659 11,636,000
100 ƮƮŰ& 1615 2330 11,516,140
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