Aktuella utlysningar, vecka 38, 2023

Europeiska utlysningar

HORIZON-HLTH-2024-DISEASE-08-20: Pandemic preparedness and response: Host-pathogen interactions of infectious diseases with epidemic potential

Call details: Research and Innovation Action, €7-8 million per project, 5 projects will be funded

Scope:
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is expected to accelerate due to among other factors, climate change, and thus a proactive approach to the development of vaccines and inhibitors for the cellular uptake of viruses in preparedness for future infectious disease outbreaks is needed. The availability of vaccines and candidates that inhibit cellular uptake of viruses would provide a critical preparedness measure against future health threats, in particular against pathogens with high pandemic potential meeting the criteria identified by the Health Emergency Preparedness and Response Authority (HERA)^[1].

More information can be found on the call page.

Closing date: 11 April 2024

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HORIZON-HLTH-2024-TOOL-11-02: Bio-printing of living cells for regenerative medicine

Call details: Research and Innovation Action, €6-8 million per project, 4 projects will be funded

Scope:
Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the "process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function". 3D-printing in general is considered an advanced manufacturing technique and 3D-printing of non-viable biomaterials to serve e.g. as scaffold for cell growth or as structure for medical devices is already broadly used.

However, bio-printing technology involving living cells is still in early stages of development, but has a huge potential for tissue engineering, drug testing and other biomedical applications. Tissue-specific functional 3D bio-printing is a new approach for transplantation applications in regenerative medicine, relying on the fabrication of tissues and organs with respect to the desired shape and function and their delivery and application in vivo. “In-situ bio-printing” known as printing cells and biomaterials directly onto or in a patient, or 4D bio-printing, which introduces a “time” variable that allows 3D printed materials to change shape or function when external stimulus is applied, are recent developments facing multiple additional challenges.

More information can be found on the call page.

Closing date: 11 April 2024

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HORIZON-HLTH-2024-IND-06-08: Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)

Call details: Research and Innovation Action, €8-10 million per project, 1 project will be funded,

Scope:
The Medical Device Regulation (MDR) and in vitro diagnostic medical device Regulation (IVDR) provides a new regulatory framework where reinforcement of clinical/performance evaluation of medical devices and IVDs, and in particular high-risk medical devices, is a key element. The confirmation of conformity with the relevant general safety and performance requirements set out in the MDR and IVDR^[2] is based on clinical data and its assessment (clinical/performance evaluation), including the evaluation of the acceptability of the benefit-risk- ratio. Within this new framework, the clinical/performance evaluation should follow a defined and methodologically sound procedure based on the critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations/performance studies, as well as consideration of currently available alternative treatment options for the device under evaluation. Clinical/performance evaluation has to be updated throughout the life cycle of the device. Hence, clinical/performance evaluation can draw on multiple types of data including data from initial clinical investigations/performance studies and data gathered by the manufacturer's post-market surveillance system. To operationalise this new requirement, research is needed to help regulators develop common methodological frameworks (including common specifications^[3]) on the clinical evidence needed to demonstrate safety, performance and clinical benefit all along the life cycle of devices taking into account the type of device and clinical intended purpose.

More information can be found on the call page.

Closing date: 11 April 2024

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HORIZON-HLTH-2024-IND-06-09:
Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for EU regulators

Call details: Coordination and Support Action, €2 million  per project, 1 project will be funded.

Scope:
There is increasing scientific evidence pointing to the limitations of animal testing for safety and efficacy assessment of chemicals and pharmaceuticals. Europe is also experiencing a strong societal demand to move away from animal testing. Scientific progress of the past two decades has produced a number of animal-free New Approach Methodologies (NAMs) that have the potential to be used instead of the animal models that are currently employed for such testing. However, knowledge, experience and confidence on how results from the NAM assays could be used is still lacking among regulators, which could limit the industry’s use of NAMs because of lack of legal certainty when generating safety and health data requested by EU legislation.

More information can be found on the call page.

Closing date: 11 April 2024

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Amerikanska utlysningar

Federal Funding

NIH - HEAL Initiative: Developing an Evidence Base for Co-Occurring OUD-AUD Interventions (R01 Clinical Trial Optional)

Funding Opportunity ID: RFA-AA-23-005

Upcoming deadlines: Full application - 14^th December, 2023

Abstract: This notice of funding opportunity (NOFO) seeks to support studies that will inform safe and effective medication-assisted, psychosocial, and complementary interventions for people with co-occurring Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD). Alcohol increases lethal opioid overdose risk. As a result, treatment providers may under-prescribe or be reluctant to provide opioid agonist therapies (OATs) such as methadone and buprenorphine to people with OUD who also have AUD or misuse alcohol. There is also scant research on non-pharmacological therapies for people with OUD-AUD. Reciprocal relationships between opioid use and alcohol use has been observed for OUD-AUD patients such that reduced opioid intake may result in increased drinking which heightens opioid relapse and overdose risk and suggests an urgent need for targeted therapies in this population. Research projects dedicated to OUD treatment and prevention, while not excluding subjects who drink, seldom explicitly recruit subjects with AUD. The purpose of this NOFO is to support secondary analysis of data from relevant clinical projects and archives, and to support new hypothesis-clarifying studies to identify how people with OUD-AUD are being treated and associated treatment outcomes, identify challenges for treating people with OUD-AUD, and formulating best treatment practices for this population.

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NIH - Computational Models of Influenza Immunity (U01 Clinical Trial Not Allowed)

Funding Opportunity ID: RFA-AI-23-056

Upcoming deadlines: Full application - 26^th January, 2024

Abstract: This Notice of Funding Opportunity (NOFO) invites applications for the Computational Models of Influenza Immunity (CMII) Cooperative Agreement Program. The program will employ computational modeling and immunologic studies to advance our understanding of the requirements for improving anti-influenza immunity, including inducing broad immune protection and enhancing immune durability. This program will help inform design of universal or improved seasonal flu vaccines. Projects may lead to a better understanding of how pre-existing immunity and repeat exposures (natural infection and/or vaccines) shape an individual’s immune “landscape.” Predictive modeling of adjuvants/vaccine formulations and experimental validation supported by this program should lead to enhanced host immune responses and universal or improved seasonal influenza vaccine efficacy.

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Foundation

Parkinson's Foundation, US - Launch and Postdoctoral Fellowship Grants

Upcoming deadlines: LOI - 27^th October 2023; Full Application - 22^nd February 2024

Amount: Launch award: $400,000 maximum, up to 4 years in duration. Postdoctoral fellowship award: $124,000 maximum, 2 years in duration. Indirect costs are not supported in the Postdoctoral Fellowship and first two years of the Launch award, however 10% indirect costs will be provided during the final two years of the Launch award.

Eligibility: Launch award: Applicant must possess a PhD, MD, or equivalent degree and be within 18 months to 6 years of completing that degree or clinical training at the time of application, including resubmission. Applicant must currently be in a postdoctoral or other mentored position and must name and provide a letter of support from an established investigator who will serve as the mentor and supervisor. Applicants requiring less than 12 months of mentored research training and career development are not eligible for this award. Applicants may not have their own lab or equivalent. Postdoctoral: The Basic Scientists applicants must be within five years of receiving their PhD at the time the award starts. The Clinical Neurologists must possess an MD or equivalent and be within three years of having completed a residency in neurology at the time the award starts. If awarded, a Postdoctoral Fellow must commit 80 percent of their effort to the Parkinson's Foundation-funded project.

Abstract: The Parkinson's Foundation offers several types of grants to encourage young scientists, clinicians and students to devote their talents to the study of Parkinson's disease (PD):

• Launch Award: four-year, two-stage award for outstanding postdoctoral researchers that will enable them to complete needed mentored training and transition promptly to independent research careers in PD.
• Postdoctoral Fellowships: two-year fellowships for young scientists fresh from their PhD training or neurology residencies.

Website

Gateway for Cancer Research, US - Research Grants

Upcoming deadlines: LOI - 15^th December 2023; Full Application - by invitation (deadline typically 4-5 weeks after notification)

Amount: $200,000 to $1.5 million for between 2-5 years. Indirect costs are not covered.

Eligibility: Any investigator who is ready to conduct a novel clinical trial in cancer research—one which will have an immediate impact on cancer patients—may apply for funding. The principal investigator will be required to submit a bio-sketch illustrating their work as a clinician and/or researcher.

Abstract: Gateway is focused on funding integrative oncology research that pairs conventional therapies with evidence-based integrative therapies to manage symptoms and side effects from treatment. This also aims to increase quality of life, especially post-treatment. We advance our mission by funding Phase I and II patient-centered clinical trials focusing on the following priority research areas: Biomarkers/Molecular Markers (genomic or proteomic); Gene Therapy; Histology Agnostic/Basket Trial; Immunotherapy; and Targeted Therapies. Our focus is on the following therapeutic areas: New Investigational Therapies; Novel Use or Approach; Precision Medicine; and Integrative Medicine. We seek to bring urgency to the process of cancer research for those patients who are looking for treatments today and are faced with difficult decisions without innovative live-saving options. Gateway will place increasing emphasis on the funding patient centered and novel research that includes approaches with a high potential for success.

Website

CHDI Foundation, US - Research Grants

Upcoming deadlines: applications accepted on a continuous basis.

Amount: Negotiable. Indirect costs are capped at 15%.

Eligibility: Open to all independent researchers.

Abstract: CHDI Foundation is exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of individuals with HD. We have organized our preclinical research programs into three interconnected units that focus on what we consider the most promising therapeutic areas; namely lowering huntingtin, handling and repair mechanisms related to recently identified modifier genes, and the chemistry capability to fully explore potential therapeutic approaches. CHDI are receptive to novel ideas and will explore new areas of biology that have relevance to HD, particularly when there is either robust human data evidence or the therapeutic approach has disease-modifying potential. Initial proposals are reviewed on a rolling basis by unit team members. If we are interested in your proposal, then a science director will invite you to submit a full proposal and budget for further review and consideration. If we are interested in funding your research proposal then typically CHDI and your research institution will enter into a research agreement that defines a detailed project description, milestones with deliverables, and a specific budget.

Website

American Sleep Medicine Foundation (ASMF), US - Strategic Research Award

Upcoming deadlines: LOI - 23^rd October, 2023; Full application - 29^th January, 2024

Amount: Up to $250,000. Indirect costs are capped at 8%.

Eligibility: Individuals may apply for multiple AASM Foundation grants, however, the same proposal (i.e., projects with budgetary and scientific overlap) may not be submitted for multiple requests for applications in a given cycle. Individuals who are the Principal Investigator on an open AASM Foundation research grant at the time of the application deadline are eligible to apply if they can demonstrate that there is no budgetary or scientific overlap between their open grant and the new project they are applying for funding. If there is budgetary and/or scientific overlap between projects, the applicant must indicate their plan to close their open grant in the event their new application is selected for funding (e.g., relinquish the current grant or complete the current grant to start the new grant).

Abstract: The AASM Foundation is committed to improving patient-centered diagnosis and care for all people with sleep disorders. To ensure that there is a continued advancement in effective diagnosis and care of people with sleep disorders, the AASM Foundation provides research funding through the Strategic Research Grant. This grant is investigator-initiated and supports high-impact research projects aimed at addressing gaps in knowledge that impact the ability to provide optimal, patient-centered, cost-effective diagnosis and care for people with sleep disorders.

Website