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The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. An ACT can provide independent and objective advice to industry and academia, on a real-life therapeutic pathway of drug development programmes. An ACT review can help an applicant to position a candidate compound along a realistic and well-informed pathway to clinical trial and eventual
registration.

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Information to principal investigators

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AdviceTranslational Research

The aim of the mentoring is to increase the impact and patient benefit of the excellent science funded in ERDERA. With this mentoring support, applicants will receive project-specific feedback from a panel of drug development, biomarker validation, methodological and regulatory experts tasked with optimizing the translational feasibility of the study. There are no costs or obligations to you.

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Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

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Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to enhance predoctoral research training of individuals seeking a PhD or an equivalent research health professional degree and help ensure a heterogenous pool of clinical and translational scientist trainees who are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications aimed at improving health.

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Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25 – Clinical Trial Not Allowed)

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Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.

To accomplish the stated overarching goal, this FOA will provide support to recipients of Clinical and Translational Science Awards (CTSA) for creative educational activities with a primary focus on research experiences designed to ensure that the participants receive exposure to the scientific and operational principles underlying each step of the translational process so that they can apply these principles to clinical and translational science research areas such as: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and 4) public health.

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