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Conference: Accelerating Drug Product Development and Approval: A Critical Need in Response to National Emergencies

Conference: Accelerating Drug Product Development and Approval: A Critical Need in Response to National Emergencies
会议:加速药品开发和审批:应对国家紧急情况的迫切需要
批准号:
2232197
负责人:
Gintaras Reklaitis
金额:
$8.5万
依托单位国家:
美国
项目类别:
Standard Grant
财政年份:
2023
资助国家:
美国
项目状态:
已结题
起止时间:
2023-02-15 至 2024-01-31

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中文摘要
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英文摘要
The drug discovery, development, and regulatory evaluation process, from the point where a molecule is identified as a potential therapeutic agent to when it is approved for commercialization as a drug product, can take up to 15 years. This lengthy process involves many stages, including the determination of efficacy, safety, toxicity, and therapeutic regime, identification of target populations, side effects, and interactions, selection of a feasible synthetic pathway, and development of a product formulation and a reliable manufacturing process. This lengthy time frame makes it hard to respond to emergencies requiring new therapies, deprives patients of faster access to life-saving medicines, decreases the profitability period of pharmaceutical companies, and contributes to the high cost of new medicines. Moreover, the COVID-19 pandemic has made clear the need for faster drug development and regulatory evaluation process. To address these issues, a workshop is proposed to bring together a focused group of thought leaders from academia, industry, and regulatory agencies to discuss the critical elements needed to accelerate drug discovery, development, and regulatory evaluation based on recent scientific and technical advances in medicine, biology, materials science, biostatistics, and advanced manufacturing technologies. Acceleration mechanisms will be examined from multiple perspectives, including the strength of the underlying science, technical feasibility, and regulatory acceptability. The systemic brainstorming and analysis with the participation of experts across the relevant disciplines will enable significant outcomes, including the production of a strategic plan to implement the workshop findings.The project leadership team propose to organize and conduct a structured workshop that will bring together a focused group of thought leaders from academia, industry, and regulatory agencies, to discuss the critical elements needed to accelerate drug discovery, development, and regulatory evaluation based on recent scientific and technical advances in medicine, biology, materials science, biostatistics, and advanced manufacturing technologies. These discussions will be led by pre-selected panelists with established track records in their respective fields. Acceleration mechanisms will be examined from multiple perspectives, including the strength of the underlying science, technical feasibility, and regulatory acceptability. The systemic brainstorming and analysis with the participation of experts across the relevant disciplines will generate significant outcomes, which would not be achieved in any existing scientific communication forum or conferences. Acceleration mechanisms deemed to be potentially effective will be selected for further analysis by a focused multidisciplinary team of workshop participants, which will be tasked to integrate these mechanisms into a strategic plan and an implementation pathway. These documents, which will be the main output of the workshop, will serve as a blueprint for the Federal Government, industry, and academia to direct efforts in this field. The workshop will be held in the Washington, DC area 24-26 January 2023 and will be attended by leaders from industry, academia, and government organizations such as NSF, NIH, NIST, and FDA. The proposed workshop will achieve two goals, to: 1) identify Scientific, Technological, and Regulatory mechanisms capable of significantly reducing the drug discovery, development, and commercializing time frame with improved efficiency and reduced risks to patients; and 2) integrate these mechanisms into a coherent strategy and integrated implementation plan.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
期刊论文(3)
专著(0)
科研奖励(0)
会议论文
WANTED DEAD OR ALIVE: New Thinking to Incentivize Drug Development
生死攸关:激励药物开发的新思维
DOI: 10.1007/s11095-024-03666-6
发表时间: 2024
期刊: Pharmaceutical Research
影响因子: 3.7
作者: [Kinch, Michael S.]
通讯作者: Kinch, Michael S.
DOI: 10.1007/s11095-023-03566-1
发表时间: 2024
期刊: Pharmaceutical Research
影响因子: 3.7
作者: [Bak, Annette, Burlage, Rubi, Greene, Nigel, Nambiar, Prabu, Lu, Xiuling, Templeton, Allen]
通讯作者: Templeton, Allen
I-Corps: Transforming Personalized Medicine With Printed Medicine
  • 批准号:
    1644609
  • 项目类别:
    Standard Grant
  • 资助金额:
    $5.0万
  • 财政年份:
    2016
  • 负责人:
    Gintaras Reklaitis
  • 依托单位:
CDI-Type II: Cyber-enabled engineering of pharmaceutical products
  • 批准号:
    0941302
  • 项目类别:
    Standard Grant
  • 资助金额:
    $193.28万
  • 财政年份:
    2009
  • 负责人:
    Gintaras Reklaitis
  • 依托单位:
Engineering Virtual Organization for Pharmaceutical Engineering and Science
  • 批准号:
    0742760
  • 项目类别:
    Continuing Grant
  • 资助金额:
    $19.0万
  • 财政年份:
    2007
  • 负责人:
    Gintaras Reklaitis
  • 依托单位:
International Travel Grant for Participants in Process Systems; January 5-10, 2004; Kunming, China
  • 批准号:
    0403304
  • 项目类别:
    Standard Grant
  • 资助金额:
    $2.58万
  • 财政年份:
    2003
  • 负责人:
    Gintaras Reklaitis
  • 依托单位:
海外基金