정책/기획 보고서
총서140권_-신약개발지원센터_기능설정및수행방안에 관한 연구....
개요
1. 추진배경 및 경과
가. 수립배경
우리나라 신약개발 단계 중 선도물질의 평가 및 최적화 기능이 취약함에 따라 국가 차원에서 지원의 필요성 제기(제5차 의료산업선진화위원회, ʼ07.6)
첨단의료복합단지 입지 선정(대구경북단지, 충북오송단지)에 따른 신약개발지원센터 설립 계획 추진(ʼ09.12)
우리나라 신약개발 프로세스 중 취약한 것으로 나타난 후보물질도출 지원 인프라(인력, 시설 등)를 글로벌 수준으로 구축하여 혁신신약 개발을 가속화 할 필요
나. 추진 경과
ʼ10.4 : 신약개발지원센터 기능설정 및 수행방안에 대한 기획연구 추진(교과부)
※ 한국생명공학연구원 생명공학정책연구센터(연구책임자 : 현병환센터장)
ʼ10.4∼8 : 총괄기획위원회, 실무기획위원회(바이오와 합성신약 분과), 지자체 의견 수렴 회의 개최(총 8회)
※ 총괄기획회의 개최(3.19, 4.8, 9.8), 실무기획회의 개최(4.23, 5.6, 7.9), 지자체간 의견 수렴 회의(7.27, 8.11)
ʼ10.8 : 초안보고서에 기반한 지자체별 추가 자료 작성, 검토 및 수정 보완
ʼ10.9 : 공청회 개최
...................계속
목차
1. 추진배경 및 필요성 ······················································ 1
2. 국내외 동향 및 사례 분석
가. 국외 신약개발 동향 ·············································································· 3
나. 글로벌 제약기업 ··················································································· 7
다. 국내 신약개발 동향 ············································································ 10
라. 유사기관 사례 분석 ············································································ 17
마. 시사점 ·································································································· 26
3. 신약개발지원센터 비전과 목표
가. 비전과 목표 ························································································· 27
나. 추진전력 ······························································································ 28
4. 센터 설립 목적과 기능
가. 센터설립의 목적 ················································································· 29
나. 센터의 주요 기능 ················································································ 30
다. 기존사업과의 차별성 및 연계성 ······················································· 32
5. 센터 운영 기본 방향 및 조직 구성 체계
가. 운영 기본 방향 ··················································································· 36
나. 센터 위상 및 추진 방향 ···································································· 37
다. 조직 구성 체계 ··················································································· 38
6. 센터 운영 시스템 구축 방안
가. 센터장 선임 및 역할 ·········································································· 40
나. 센터 지원 사업 운영 방안 ································································· 42
다. 센터 평가 방안 ··················································································· 49
라. 장비 확보 기본 방향 및 추진 계획 ·················································· 52
7. 소요예산
가. 전체예산 ······························································································ 55
나. 예산 소요 근거 ··················································································· 56
다. 지원센터별 소요예산 ·········································································· 59
8. 신약개발지원센터별 지원 사업
① 합성신약개발지원센터
가. 비전과 목표 ························································································· 61
나. 추진전략 ······························································································ 62
다. 단계별 조직 구성 체계 ······································································ 62
라. 사업목적 및 주요 연구내용 ······························································· 65
마. 주요 지원사업 분야별 세부 내용 ····················································· 71
바. 소요예산 ······························································································ 95
사. 주요 장비 구축 계획 ·········································································· 96
아. 우수인력 유치 계획 ·········································································· 101
자. 국내외 의료연구개발기관과의 연계․협력 활성화 방안 ············· 105
차. 단지 입주기관 지원 방안 ································································ 107
② 오송바이오신약개발지원센터
가. 비전과 목표 ······················································································· 109
나. 추진전략 ····························································································· 110
다. 단계별 조직 구성 체계 ···································································· 110
라. 사업목적 및 주요 연구내용 ····························································· 116
마. 주요 지원사업 분야별 세부 내용 ··················································· 122
바. 소요예산 ····························································································· 136
사. 주요 장비 구축 계획 ········································································ 137
아. 우수인력 유치 계획 ·········································································· 140
자. 국내외 의료연구개발기관과의 연계․협력 활성화 방안 ············· 143
차. 단지 입주기관 지원 방안 ································································ 150
지식
동향