Alzheimer's-focused Celdara Medical High-Potential Entrepreneurial Fellowship Program (A-CHEF)

专注于阿尔茨海默病的 Celdara 医疗高潜力创业奖学金计划 (A-CHEF)

• 批准号: 10675010
• 负责人: Julie H Coleman
• 金额: $ 16.2万
• 依托单位: CELDARA MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675010
• 关键词: Academia; Active Learning; Aducanumab; Advisory Committees; Alzheimer' s Disease; Alzheimer' s disease therapeutic; Award; Biological; Biotechnology; COVID-19 pandemic; Clinic; Clinical; Collaborations; Communication; Development; Development Plans; Diagnosis; Disease; Doctor of Philosophy; Education; Educational Curriculum; Entrepreneurship; Evaluation; Feedback; Fellowship; Fellowship Program; Funding; Grant; Immersion; Individual; Intellectual Property; Intelligence; Laboratories; Leadership; Learning; Maine; Medical; Medical center; Mentors; Mentorship; Names; National Institute of General Medical Sciences; Outcome; Patients; Persons; Phase; Pilot Projects; Preparation; Process; Research; Running; Scientist; Small Business Innovation Research Grant; Structure; Therapeutic; Training; Training Programs; Universities; Writing; apprenticeship; biomedical scientist; career; career development; cognitive function; college; coronavirus disease; drug development; effective therapy; flexibility; improved; innovation; lens; next generation; novel; operation; pre-clinical; preclinical development; programs; recruit; responsible research conduct; success; therapeutic development

While the majority of biomedical scientists end up in professions outside of academia, most receive little-to-no training in preparation for this transition. Here, we seek to establish a comprehensive training program to prepare scientists for their actual careers: to meet the nation’s greatest biomedical and clinical needs. This program includes a core curriculum covering key aspects of drug development (e.g., due diligence, preclinical development, clinical unmet need, intellectual property management, regulatory path, financing, competitive intelligence, and scientific communication), experiential learning, regular, structured collaboration with biotech professionals, training in SBIR grant mechanisms and writing, engagement with multiple early-stage biotech companies, a complementary online training platform, and a formal mentoring program. This program will be focused on one of the most critical disease-challenges of the 21st century: Alzheimer’s Disease (AD) and is named the Alzheimer’s-focused Celdara Medical High-Potential Entrepreneurs’ Fellowship (A-CHEF). Celdara Medical (CM) is an entrepreneurial biotech company that builds academic innovations into high-potential therapeutics. A-CHEF will be run by CM in collaboration with eight universities: Brown, Dartmouth, Maine Medical Center, MDI Biological Laboratory, UDel, UNH, URI, and UVM. CM currently collaborates with each of these universities through its leadership of the NIGMS-funded Regional Accelerator Hub, the DRIVEN Accelerator Hub. CM has previously run a fellowship program (Celdara fellowship) in collaboration with Dartmouth College that acts as a pilot study for A-CHEF. The Celdara fellowship provides evidence of success, as well as a basic training structure to formalize, expand, and improve upon. A-CHEF Annual Milestones: 1) Train ≥ 5 diverse scientists from the Northeast IDeA states each year in biomedical entrepreneurship / drug development; each Fellow will (annually): a) Complete A-CHEF didactic training b) Complete due diligence on ≥ 30 AD-relevant therapeutics; c) Prepare at least one AD therapeutic pitch and present to the CM and DRIVEN teams; d) Create and iterate upon an adaptive individual development plan (IDP). 2) Create a complete funding and development plan (preclinical to clinical) for ≥1 AD therapeutic. Successful completion of the aims and milestones outlined in this application will provide invaluable immersive training and career development for biomedical scientists while also expanding the AD research workforce and advancing AD therapeutic development.

虽然大多数生物医学科学家最终从事学术界以外的职业，但大多数人几乎没有接受过为这种转变做准备的培训。在这里，我们寻求建立一个全面的培训计划，以准备科学家为他们的实际职业生涯：以满足国家最大的生物医学和临床需求。该计划包括一个核心课程，涵盖药物开发的关键方面（例如，尽职调查、临床前开发、临床未满足的需求、知识产权管理、监管路径、融资、竞争情报和科学交流）、体验式学习、与生物技术专业人员的定期结构化合作、SBIR资助机制和写作培训、与多家早期生物技术公司的合作、补充性在线培训平台和正式的指导计划。该计划将重点关注21世纪最关键的疾病挑战之一：阿尔茨海默病（AD），并且是 名为阿尔茨海默氏症为重点的塞尔达拉医疗高潜力企业家奖学金（A-CHEF）。Celdara Medical（CM）是一家创业型生物技术公司，致力于将学术创新融入高潜力疗法。A-CHEF将由CM与八所大学合作运营：布朗大学、达特茅斯大学、缅因州医学中心、MDI生物实验室、Udel大学、UNH大学、URI大学和UVM大学。CM目前通过领导NIGMS资助的区域加速器中心（DRIVEN加速器中心）与这些大学合作。CM以前曾与达特茅斯学院合作开办过一个奖学金项目（Celdara奖学金），作为A-CHEF的试点研究。塞尔达拉奖学金提供了成功的证据，以及一个基本的培训结构，以正规化，扩大和改进。A-CHEF年度里程碑：1）每年培训来自东北部IDEA州的≥ 5名不同科学家进行生物医学创业/药物开发;每位研究员将（每年）：a）完成A-CHEF教学培训B）完成对≥ 30种AD相关疗法的尽职调查; c）准备至少一种AD治疗方案，并提交给CM和DRIVEN团队; d）创建并验证适应性个人发展计划（IDP）。2)为≥1种AD治疗药物制定完整的资助和开发计划（临床前至临床）。成功完成本申请中概述的目标和里程碑将为生物医学科学家提供宝贵的沉浸式培训和职业发展，同时还将扩大AD研究人员队伍并推进AD治疗开发。