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FDA’s Office of Orphan Product Development (OOPD) has opened grant opportunity to support efficient and innovative natural history studies that advance medical product development in rare diseases with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.

The application deadline is February 15, 2022.

Key dates:

Posted Date	February 17, 2021
Open Date (Earliest Submission Date)	December 17, 2021; December 15, 2023
Letter of Intent Due Date(s)	January 14, 2022; January 12, 2024
Application Due Date(s)	February 15, 2022

Learn more: RFA-FD-22-001: Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required (nih.gov)

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2021 – FY 2022 to support innovative and efficient clinical trials for rare diseases and conditions. These studies are intended to provide acceptable data to the FDA that will substantially contribute to the approval of new products, or new indications for already marketed products. In the FDA OOPD Orphan Products Grants Program, products for rare diseases and conditions (orphan products) are defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the United States.  

Apply here: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1)

• Receipt Date: October 5, 2021
• FOA Number: RFA-FD-21-001

•    Purpose: To fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. 

•    Focus: Efficiency, innovation, impact, and added focus on leveraging patient input, infrastructure and financial resources

•    Innovation: Inclusion of a new optional innovative demonstration project

•    Contact: Katherine Needleman, Director, Orphan Products Grants Program

    E-mail: katherine.needleman@fda.hhs.gov

More information here

June 23rd 2020

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2021 – FY 2022 to support innovative and efficient clinical trials for rare diseases and conditions. 
These studies are intended to provide acceptable data to the FDA that will substantially contribute to the approval of new products, or new indications for already marketed products.
In the FDA OOPD Orphan Products Grants Program, products for rare diseases and conditions (orphan products) are defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the United States.  

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1) 

• Receipt Dates: October 6, 2020, October 5, 2021
• FOA Number: RFA-FD-21-001

Additional info and links:

• Purpose: To fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. 
• Focus: Efficiency, innovation, impact, and added focus on leveraging patient input, infrastructure and financial resources
• Innovation: Inclusion of a new optional innovative demonstration project
• Contact: Katherine Needleman, Director, Orphan Products Grants Program
  E-mail: katherine.needleman(at)fda.hhs.gov
• Additional Information: OOPD Website

As one of the joint undertakings under Horizon Europe, a draft Strategic Research & Innovation Agenda (SRIA) for the Innovative Health Initiative (IHI) has been published on the European Commission (EC) website.

IHI will build on the successes of and lessons learnt from the Innovative Medicines Initiative (IMI). The goal of IHI is to help create an EU-wide health research and innovation ecosystem that facilitates the translation of scientific knowledge into tangible innovations, with a total proposed budget of €2.4 billion.

The Commission welcomes feedback on the draft SRIA from members of the rare disease community. The draft SRIA will become a binding document of the IHI upon formal establishment and adoption by the Governing Board. Interested parties can send feedback by email: RTD-IHI [at] ec.europa.eu.

More information here: https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/european-partnerships-horizon-europe/candidates-european-partnerships-health_en (section titled “European Partnership for Innovative Health”)

August 25th 2020

GEnome Medical alliance Japan (GEM Japan), a Driver Project of the Global Alliance for Genomics and Health (GA4GH), has released  GEM Japan Whole Genome Aggregation (GEM-J WGA) — a first-of-its-kind open-access variant frequency panel of 7,609 Japanese whole genome sequences. Researchers at GEM Japan detected  >76M autosomal single nucleotide variations（SNV) and >10M autosomal insertion and deletion (INDEL) sequences in the dataset. They detected another >2M SNVs and >400K INDELs on the X chromosome. 

The Japan Agency for Medical Research and Development (AMED) established GEM Japan in 2018 to facilitate genomic and health data sharing among research and medical laboratory communities, both domestically and internationally. GEM Japan aggregates genotypic and associated phenotypic information from various Japanese disease-specific and population genetic studies into publicly available resources based on a standardized format.

“GEM-J WGA has been much encouraged by GA4GH to share Japanese allele frequency data, including rare variants of 0.01%, as a global reference to the Asian ethnic specificity,” said Hidewaki Nakagawa, M.D., Ph.D., Program Officer at AMED and the GEM Japan Driver Project Champion at GA4GH. “Our participation in GA4GH has motivated us to pursue this work through its focus on the value of ethnically diverse genomic data.” 

“In the GA4GH community, GEM Japan has become well recognized as the global leader in sharing Asian-specific data to facilitate the interpretation of human diseases and improve medical practice — not only in Japan but also around the world,” said Ewan Birney, Ph.D., Director of EMBL’s European Bioinformatics Institute and Chair of the GA4GH Steering Committee. “This selfless gift from Japan to the world will ensure that people of Japanese descent around the globe will benefit from genomic research.”

AMED is an IRDiRC member organization and it is part of the Funders Constituent Committee focused on “facilitating high-level coordination of funding initiatives to maximize the impact of rare diseases research projects by aligning strategies, avoiding unnecessary duplication, and identifying research funding gaps”.

For more info click here.