초록 ▼

◾ N of 1 trial, stemcell, genomics, imaging biomarker 관련 임상시험 수행 및 기술개발
◾ 신약재창출을 통한 기술이전 및 신약개발 컨설팅 서비스 수행
◾ 임상연구 지원 시스템 구축과 인프라 강화
◾ 국내제약사 임상 1상과 외자사 임상 2상 점유율 증가
◾ 혁신적 pipeline의 확보 및 제약사의 신약개발 연구와 병원의 clinical practice 연계
◾ 임상연구자의 아이디어를 숙성 멘토링하여 다국적제약사 대규모 grant 획득
◾ 인적역량 강화를 위한

◾ N of 1 trial, stemcell, genomics, imaging biomarker 관련 임상시험 수행 및 기술개발
◾ 신약재창출을 통한 기술이전 및 신약개발 컨설팅 서비스 수행
◾ 임상연구 지원 시스템 구축과 인프라 강화
◾ 국내제약사 임상 1상과 외자사 임상 2상 점유율 증가
◾ 혁신적 pipeline의 확보 및 제약사의 신약개발 연구와 병원의 clinical practice 연계
◾ 임상연구자의 아이디어를 숙성 멘토링하여 다국적제약사 대규모 grant 획득
◾ 인적역량 강화를 위한 수요자 중심의 융합형/맞춤형 인재양성 시스템 구축

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
◯ Research and development of personalized clinical trial based on Research tool
- Personalized & precision specialized global clinical trial and clinical trial support
- Expansion of market through diagnosis technology and re-creation of new drugs and new drug development

Purpose&Contents
◯ Research and development of personalized clinical trial based on Research tool
- Personalized & precision specialized global clinical trial and clinical trial support
- Expansion of market through diagnosis technology and re-creation of new drugs and new drug development consulting service
- Development of original technology such as panomics, stemcell, biomarker, M&S and Full-Cycle Clinical Trial Support Platform service

◯ Organizing and operating the general consortium Working group
- Establish consortium joint research and cooperation platform (Associate human/physical infrastructure, research resources central management system, data standardization)
- Consortium integrated CRO, business and training functions for educational functions
- Self-inspection, progress management, policy & SOP establishment

Results
◯ Research and development of personalized clinical trial based on Research tool
- Conducting clinical trials and developing technologies related to N of 1 trial, stem cell, genomics, imaging biomarker
- Conducting technology transfer and drug development consulting service through drug repositioning
- Increased orders for domestic and foreign clinical trials by securing research personnel and constructing spaces optimized for performing early stage of clinical trial
- Suggest the possibility of self-development by exceeding the project goal of the proposed field and the center

◯ Establishment and stabilization of clinical trial support system
- Produce profits by conducting various joint projects, including support for joint research and training of expert personnel, based on the consortium working group matrix organization
- Establish a support plan and cooperate to meet the mutual needs of consortium organizations
- Conducted new drug development consulting for small and medium sized biopharmaceutical companies in Korea through P-CREATS service
- Securing the revolutionary pipeline and connecting the new drug development of pharmaceutical companies with clinical practice of hospital(SMC)
- Mentorized the ideas of clinical researchers and acquired a large grant from multinational pharmaceutical companies
- Establish a convergent/customized human resources development system centered on demand to enhance human capacity
- Establish patient pool DB of target disease
- Conduct technical/business value evaluation of retained patent

Expected Contribution
- Achieve national R&D promotion strategy by carrying out research for commercialization of bio-pharma fields such as genome business and new drug development
- Shorten the cost and duration of new drug development and increase the probability of success through Personalized & precision clinical trials
- Gain global competitiveness that enables consortiums to achieve self-sustaining capabilities based on Total innovation
- Proposal of successful clinical trial consortium model that can be win-win through pharmaceutical industry ecosystem control tower

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• 목차 ... 7
• Ⅰ. 연구개발과제의 개요 ... 8
• 1. 과제정보 ... 8
• Ⅱ. 국내외 기술개발 현황 ... 16
• Ⅲ. 연구수행 내용 및 결과 ... 36
• 1. 연구개발 성과 및 자체평가 ... 36
• 2. 연구 성과 ... 52
• Ⅳ. 목표달성도 및 관련분야 기여도 ... 487
• 1. 목표 달성도 ... 487
• 2. 관련분야 기여도 ... 499
• Ⅴ. 연구결과의 활용계획 ... 509
• 1. 연구결과 활용 계획 ... 509
• 2. 수요기반 발전방안 ... 514
• 3. 계량적 예상 성과 ... 518
• Ⅵ. 연구과정에서 수집한 해외과학기술정보 ... 530
• Ⅶ. 연구개발성과의 보안등급 ... 542
• Ⅷ. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 542
• Ⅸ. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 542
• Ⅹ. 연구개발과제의 대표적 연구실적 ... 543
• Ⅺ. 기타사항 ... 543
• Ⅻ. 참고문헌 ... 544
• [별첨 3] 실적 증빙자료 ... 545
• [별첨4] 사업성과 요약서 ... 610
• 끝페이지 ... 611