출장개요 - 2 -

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1 미국출장보고서 - Clinical Research Center (CRC)/ NCATS 방문 ~ 한국보건산업진흥원 Korea Health Industry Development Institute 의료산업정책단

2 출장개요 - 2 -

3 출장목적 m m 1) Rare Diseases and Orphan Products Coordinating Committee 2) Trans-NIH Rare Diseases Working Group - 3 -

4 일자별주요일정 출장자 - 4 -

5 기관방문및조사결과 - 5 -

6 1 NIH CLINICAL CENTER 장소 Medical Board Room Building 10;

7 기관성격 m m m m 3) 4) 5) 질병의자연경과에서밝혀진특성을적합한실험대상 ( 환자 ) 에서규명하여, 질병이해를위한과학적토대를제공하는연구 6)

8 기관명 설립년도 National Cancer Institute (NCI) 1937 National Eye Institute (NEI) 1968 National Heart, Lung, and Blood Institute (NHLBI) 1948 National Human Genome Research Institute (NHGRI) 1989 National Institute on Aging (NIA) 1974 National Institute on Alcohol Abuse and Alcoholism (NIAAA) 1970 National Institute of Allergy and Infectious Diseases (NIAID) 1948 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 1986 National Institute of Biomedical Imaging and Bioengineering (NIBIB) 2000 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 1962 National Institute on Deafness and Other Communication Disorders (NIDCD) 1988 National Institute of Dental and Craniofacial Research (NIDCR) 1948 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1950 National Institute on Drug Abuse (NIDA) 1974 National Institute of Environmental Health Sciences (NIEHS) 1969 National Institute of General Medical Sciences (NIGMS) 1962 National Institute of Mental Health (NIMH) 1949 National Institute on Minority Health and Health Disparities (NIMHD) 1993 National Institute of Neurological Disorders and Stroke (NINDS) 1950 National Institute of Nursing Research (NINR) 1986 National Library of Medicine (NLM) 1956 Center for Information Technology (CIT) 1964 Center for Scientific Review (CSR) 1946 John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) 1968 National Center for Complementary and Alternative Medicine (NCCAM) 1999 National Center for Advancing Translational Sciences (NCATS) 2011 NIH Clinical Center (CC)

9 임상센터설립관련법적근거 m m m m 임상센터비젼및미션 m 7) 밑줄친부분은 2004 년추가삽입된문구임 8) 밑줄친부분은 2008 년추가삽입된문구임 9) 2009 년현재의비젼내용으로수정 - 9 -

10 m 기관설립경과 m 10) 굵은글자체는각연도구간에서변경된내용임 11) 1930, Ransdell Act 에따라 National Institute of Health(singular) 설립

11 m m 12) "the golden years" of NIH expansion 13) adenosine deaminate deficiency 14) National Cancer Institute 15) National Institute of Allergy and Infectious Diseases

12 m m m m

13 16) 직원및환자를감염성이높은질환으로부터보호할수있도록병실의공기가밖으로나가지않도록함 (preventing air from exiting, to shield staff and other patients from exposure to highly infectious diseases such as SARS) 17) 면역력이저하된환자를감염성질환으로부터보호할수있도록공기흐름을바깥으로함 (blowing air out, to protect patients with severe immune deficiencies from exposure to infectious diseases) 18)

14 기관배치도 m

15 m

16 임상센터관리및자문단 (Governance and Advisory Groups) m m m m 19) 20) National Institutes of Health(NIH) Reform Act of 2006 에따라 NIH 의기관권한사용을재확인하기위하여설치된위원회

17 m m 그림임상센터의관리구조

18 NIH Clinical Center, Organizational Chart(April 2013)

19 기관인증 (Accreditation) 21) 획득현황 m 21) 22) ttp:// -

20 m m 23) bsearchpgflow%2fprocess_searchcriteria&_windowlabel=alsearch_3_1&_pagelabel=accrlabsearch_page 24)

21 예산 (Budget) m m m

NIAID 4,491 15% NHLBI 3,079 10% NIGMS 2,430 8% NIDDK 1,947 6% NINDS 1,626 5% NIMH 1,480 5% OD 1,459 5% NICHD 1,321 4% NCI 5,072 16% NIA 1,103 4% B&F 125 0% FIC 70 0% NINR 145 0% NCCAM 128 0% NIMHD

22 NIAID 4,491 15% NHLBI 3,079 10% NIGMS 2,430 8% NIDDK 1,947 6% NINDS 1,626 5% NIMH 1,480 5% OD 1,459 5% NICHD 1,321 4% NCI 5,072 16% NIA 1,103 4% B&F 125 0% FIC 70 0% NINR 145 0% NCCAM 128 0% NIMHD 276 1% NLM 338 1% NIDCR 411 1% NIBIB 338 1% NIDCD 416 1% NIAAA 460 1% NHGRI 513 2% NIAMS 536 2% NEI 703 2% NCATS 575 2% NIEHS 764 2% NIDA 1,053 3% m m 25)

23 m

24 Clinical Center 제공서비스구성 m

25 임상센터의중점사항 (Major Emphasis) m m m m 임상센터의인력구성 (Workforce) m 26) 미국내희귀질환환자규모는약 백만명으로임상센터에서약 400 이상의코호트, 700 건의프로토콜적용중 27) 드러그리포지셔닝 (Drug Repositioning 또는 Repurposing, Re- profiling, Re-tasking) 은개발완료된의약품또는개발단계에있는신약후보물질의새로운적응증을찾아내는연구

26 m m m

27 m 임상연구현황 m

28 m 과학적성과 (Clinical Center's Scientific Discovery/breakthrough) 28) 28)

환자진료실적 m 6,535 6,782 6,944 6,619 6,096 5,825

9,494 10,733 9,718 9,263 9,435 9,460 4 5 6 10,696

57,783 57,718 0 5 5 9 1 4 2 56,594 54,971 91,96

29 환자진료실적 m 6,535 6,782 6,944 6,619 6,096 5,825 6,105 6,426 6,000 6,082 5,916 10,31 10,31 10,08 9,494 10,733 9,718 9,263 9,435 9, ,696 10,694 49,91 53,72 51,57 51,18 51,31 55,66 56,50 57,783 57, ,594 54,971 91,96 98,76 108,07 105,00 95,15 105, m

임상연구교육훈련 (Clinical Research Training) 29) m m m m 29) http://www.cc.nih.gov/researchers/training.

30 임상연구교육훈련 (Clinical Research Training) 29) m m m m 29) 30) Modules - Module 1: Critical Infrastructure/ Module 2: Support Services/ Module 3: Legal & Regulatory Infrastructure/ Module 4: Communications and Outreach/ Module 5: Strategic Management/ Module 6: Funding Opportunities Popular Electives - Protocol Writing & Tracking, Clinical and Translational Science Awards, Planning & Budget Development, Patient Recruitment, Quality and Performance Metrics, Food & Drug Administration, Office of Human Subjects Research Protections

31 m 전산시스템운영 m m 31)

32 m

33 부대시설 m m 32) Children s Inn at NIH, Financial Statements and Supplemental Information and Report Thereon(2012). 33)

m 환자등록 (Registry) m m 34) NIH Guest House 는

34 m 환자등록 (Registry) m m 34) NIH Guest House 는 1996 년 Building 20 근처에 6 실 (6-unit Guest House) 를시작한후 1998 년 Bethesda 지역으로이전하여, 현재의형태로운영중 35) 36) $4.75 million donation from The Edmond J. Safra Philanthropic Foundation

35 - 35 -

36 임상센터에대한성과평가 m 임상센터의연구자, 연구환경, 환자, 연구역량측면의강점 (strengths)

37 2 National Center for Advancing Translational Sciences 장소 Floor Boardroom-9800 Medical Center Dr. Rockville, MD

기관성격 m m m m m 37) http://www.ncats.nih.gov/about/about.html 38) http://www.ncats.nih.gov/files/factsheet.

38 기관성격 m m m m m 37) 38) 39) 미국 public Health Service 법제 4 편 (TITLE IV), 제 E 장 (Part 1), 제 1 절 (Subpart 1) 제 479~481B 조 (Section 479~481B)

39 m NCATS 설립근거법 m 40) 관찰하기힘든어려운상태, 희귀질환유병률 2 만명이하의질환또는현ㅇ재의치료법이나진단법이개발되지않아치료제가존재하지않는질환

40 NCATS 의미션 m 설립배경 m m

41 m m m m

42 NCATS 설립경과 m m m m NCATS 자문위원회 (NCATS Advisory Council) m m 예산 (Budget) 41) m m 41) NIH 내기관별예산자료

43 NCATS 의조직구성 m

44 m

45 NCATS 의주요프로그램 m m

46 42) 중개및임상연구에서연구자들이직면하고있는문제점은고비용의연구비, 연구과정의복잡성, 정보시스템의부족, 엄격한규제, 환자모집및보유어려움, 자격을갖춘연구자모집등이있음. 이러한이유로기초연구부터치료법개발또는신약개발까지소요되는시간이늦어지고있음

47 m m 43) The National Center for Advancing Translational Sciences Status and Prospects(CHRISTOPHER P. AUSTIN, M.D. DIRECTOR, NCATS, AUGUST 14, 2013)

48 m 44) The National Center for Advancing Translational Sciences Status and Prospects(CHRISTOPHER P. AUSTIN, M.D. DIRECTOR, NCATS, AUGUST 14, 2013) 45) 임상시험승인신청 (Investigational New Drug Applications) 이란동물시험까지의전임상자료와임상시험계획서를취합하여임상시험승인을신청하는절차를의미

49 m m

50 m New NCATS Initiatives m

51 3 기관방문시사점 m

목차 제1장최종연구개발목표 / 15 제2장최종연구개발내용및방법 / 17 제3장최종연구개발결과 / 22

목차 제1장최종연구개발목표 / 15 제2장최종연구개발내용및방법 / 17 제3장최종연구개발결과 / 22 제4장연구결과고찰및결론 / 143 제 5 장연구비사용내역및연구원분담표 / 146 제 6 장참고문헌 / 148 부록 표목차 그림목차 Ⅰ. 연구개발결과요약문 최종결과보고서요약문 Summary Ⅱ. 학술연구용역과제연구결과 제 1 절배경및필요성 제 1 절연구내용및방법