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미국 바이든 행정부에서 발표한 행정명령 중 "바이오 의약품 관련" 주요 내용 정리 자료 입니다.
| Category | 주요 내용 |
| 바이오기술을 활용한 공급망 강화 (Leverage biotechnology for strengthened supply chains) |
The Department of Health and Human Services will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics...(후략)... 미국 보건복지부(HHS)는 필수 치료제 생산 및 팬더믹 대응을 위한 API, 항생제, 핵심 기초 원료의 바이오 제조 영역 확장을 위해 4천만달러 투자 예정. 미국 국방부(DoD)는 향후 5년간 2.7억달러 투자를 통해 연 료, 내화성 복합재료, 폴리머, 레진 등 방어 체계 생산망 내 바이오 기반 소재의 고도화를 위한 TriService Biotechnology를 출범할 예정..(후략)... |
| 미국 내 바이오제조 확장 (Expand domestic biomanufacturing) |
The Department of Defense(DoD) will invest $1 billion in bioindustrial domestic manufacturing infrastructure over 5 years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. This support will provide incentives for private-and publicsector partners to expandmanufacturing capacity for products ...(후략)... 미국 국방부(DoD)는 5년 동안 10억 달러를 투자해 미국 내 바이오 산업 생산 인프라 발전을 지원할 예 정. 새로운 설비 증설 목적의 투자에 인센티브를 지급하는 식으로 진행할 계획...(후략)... |
| 미국 전지역 혁신 촉진 (Foster innovation across the United States) |
The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines throughout the United States. These Engines will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy. Investments in New Hampshire, Virginia, North Carolina, Oregon, and Alaska will help expand the bioeconomy by advancing regional biotechnology and biomanufacturing programs...(후략)... ...(전략)... 1,780만 달러를 투자해 생명공학, 바이오의약품, 바이오소재 관련 연구 시상 계획을 발표할 계 획. 10억 달러를 New Hampshire, Virginia, North Carolina, Oregon, and Alaska 5개 지역에 투자해 지역 생명공학 및 바이오 생산공정 프로그램을 지원해 확장시킬 계획...(후략)... |
| 바이오의약품 시장 확대 (Bring bio-products to market) |
…The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by the DoD) and NIIMBL (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals. For example, NIIMBL will launch a biomanufacturing initiative that will engage the institute’s 200 partners across industry, academic, non-profit, and Federal agencies to mature biomanufacturing technology needed to improve patient access to gene therapies. BioMADE will launch hubs supporting equitable regional development, create jobs nationwide, and enhance American economic competitiveness. BioFabUSA is standing up the BioFab Foundries, a first-of-its-kind U.S. facility that integrates engineering, automation, and computation with biology. BioFab Foundries will be accessible to U.S. innovators to enable manufacturing of preclinical and early-stage clinical products. …(전략)… 천만 달러 규모의 바이오제품 파일럿 프로그램을 통해 바이오의약품의 스케일업 및 연구 지원 계획. 바이오 의약품 제조 관련 상용화를 위해 산업과의 협력을 확대할 계획. 예를 들어 유전자 치료제 제 조 관련 지원이나 전임상 및 초기 임상 의약품 제조 지원 등을 시작할 계획 |
| 차세대 바이오텍 인력 양성 (Train the next-generation of biotechnologists) | The National Institutes of Health (NIH) is expanding the I-Corps program, a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, that connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. NIH에서 바이오기술 관련 차세대 인력 양성 및 창업 프로그램 다수 진행 예정 |
| 바이오텍 규제 혁신 촉진 (Drive regulatory innovation to increase access to products of biotechnology) |
The Food and Drug Administration is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance and increased engagement with industry seeking to leverage these emerging technologies These efforts will increase medical supply chain resilience and improve patient access to new medical products. NIH’s Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium will support up to six new clinical trials, each focused on a different rare disease, to streamline manufacturing and regulatory frameworks. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products. FDA에서는 산업과 협력을 통해 제조 공정에 대한 규제 및 가이드라인 지원을 주도할 계획. NIH의 유전자 치료 관련 컨소시엄에서 각 희귀 질환에 대한 최대 6개의 새로운 임상 시험을 규제적 절차 간소화를 통해 지원할 계획 |
| 바이오경제 측정법과 기준 발전 (Advance measurements and standards for the bioeconomy) |
DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy. This support will catalyze development of capabilities for engineering biology, advance biomanufacturing processes and technologies, and help utilize artificial intelligence to analyze biological data. DOC에서 내년 1,400만 달러를 National Institute of Standards and Technology for biotechnology research 프로그램에 투자해 미국 바이오경제 측정기술과 기준 그리고 데이터에 대한 개발 진행 예정 |
| 바이오보안 혁신 투자 리스크 감소 (Reduce risk through investing in biosecurity innovations) |
DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development. DOE에서 2천만 달러를 투자해 생명공학 및 바이오의약품 생산 리스크 예측 및 평가 등 역량 향상과 바이 오보안 영역의 통합을 위한 프로그램 시작할 계획 |
| 바이오경제 발전을 위한 데이터 공유 구축 (Facilitate data sharing to advance the bioeconomy) |
Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials Cancer Moonshot 프로젝트를 통해 NIH에서 개인 맞춤 치료와 새로운 치료 발견을 위한 암 연구 데이터 구축 및 공유를 장려. NSF에서 2천만 달러를 투자해 생명과학 데이터 센터 구축 경쟁 발표 |
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