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Grants to USA, Canada, and International Research Laboratories for Pathogen Studies Involving Animals

Preclinical Network Expansion for Model Development and Testing Innovations


GrantWatch ID# 207076
Agency: Foundation

Funding Source
Coalition for Epidemic Preparedness Innovations (CEPI)
Array ( [0] => American Samoa (USA); [1] => Guam (USA); [2] => Puerto Rico (USA); [3] => Virgin Islands (USA); [4] => Northern Mariana Islands (USA); )

Geographic Focus
All USA
USA Territories: American Samoa (USA);   Guam (USA);   Puerto Rico (USA);   Virgin Islands (USA);   Northern Mariana Islands (USA);
USA Compact Free Associations:The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)
Canada:Alberta;   British Columbia;   Manitoba;   New Brunswick;   Newfoundland and Labrador;   Northwest Territories;   Nova Scotia;   Nunavut;   Ontario;   Prince Edward Island;   Quebec;   Saskatchewan;   Yukon;
International, Israel and Canada.

Important Dates
LOI Date: 02/20/23
Deadline: 03/03/23 11:59 PM Central European Time (CET) Save

Grant Description
Grants to USA, Canada, and International research laboratories for pathogen studies involving animals. Applicants are required to submit an LOI prior to a full grant application. Eligible expenses include individual training courses addressing proper animal handling and welfare, equipment, and appropriate cages.

The Coalition for Epidemic Preparedness Innovations (CEPI) has a portfolio of vaccines at various stages of development targeting pathogens selected from the WHO Blueprint list of priority diseases. Due to the sporadic and unpredictable nature of outbreaks these pathogens cause and the typically limited numbers of cases, obtaining field efficacy data for these vaccines will be very challenging; therefore, licensure may rely heavily on high quality, well-controlled animal efficacy studies. 

To meet these research needs CEPI is launching a Call for Proposals (CfP) to identify and select potential partners to expand their preclinical laboratory network. The CfP is open to any laboratory worldwide that is able perform model discovery/development research and proof of concept studies; and/or advanced product testing/IND-enabling preclinical studies; and/or toxicology and biodistribution studies; and/or in vitro or ex vivo tissue modeling studies. These four areas are presented as Parts A, B, C and D, respectively, in the CfP and interested laboratories are invited to apply to any or all Parts. CEPI is interested in partnering with a broad range of laboratory types, ranging from infectious diseases research labs in low to middle income countries to advanced development biocontainment labs in higher resource countries.

In performance of these types of studies and where required depending on the category of application, successful applicants will demonstrate three pillars of capabilities: animal welfare and ethics compliance, performance of studies at high biocontainment, and performance of studies under a high-quality data collection system. 

CEPI also seeks additional partners who can perform studies under a spectrum of research quality levels. CEPI seeks partners

  1. Who can perform studies under research conditions where a robust quality system is not required; and
  2. Partners who possess existing data quality systems that ensure collection of data with high integrity in line with Good Laboratory Practice (GLP) requirements (OECD, FDA 21 CFR 58)

Partners with capabilities in either or both of these areas will be considered for flexible placement of early discovery (studies in the precompetitive space) and advanced product development studies (studies in the competitive space). 

This Call for Proposals is divided into four subsections (Parts A-D) as follows:

  • Part A: Model discovery/development research and proof of concept studies
  • Part B: Advanced product testing/IND-enabling preclinical studies
  • Part C: Toxicology and biodistribution studies
  • Part D: In vitro and ex vivo tissue modeling studies 

For additional information regarding these parts, see page 2 of the RFP, in Supporting Documents, below. 

Estimated budgets will be evaluated during review and if a proposal is invited for consideration, the CEPI Budget Template will be supplied to the applicant during the Due Diligence phase. At that time, CEPI will want to review itemized proposed costs, such as personnel, travel, consultants, equipment, other direct and indirect costs and subawards. Travel costs must be in accordance with CEPI's travel policy.



Recipient

Eligibility
  • Others (see text field entitled "Additional Eligibility Criteria" for clarification)

Additional Eligibility Criteria
The CfP is open to any laboratory worldwide.

Applicants for Part A must meet the following minimum eligibility criteria:
- Applicants must have the ability to house one or more animal species, as referenced in Objectives above, under appropriate biocontainment.
- Applicants must demonstrate how they are already meeting NC3Rs guidelines for these species or propose how they could use CEPI funding to move towards compliance.
- Where applicable, applicants must have the ability to work with human and/or zoonotic viruses in families such as those listed previously for CEPI’s Disease X initiative, including handling of agent(s) in BSL-3 or BSL-4 containment as appropriate.
- Applicants must be willing to publish research findings in a peer-reviewed open-access journal.
- Applicants must be willing to collaborate with CEPI and its partners to design each study and develop a study plan, including methods for data presentation and provision.
- Applicants must be willing to provide a brief report summarizing the research and associated data using a format to be provided by CEPI and must be willing and able to share with CEPI how the integrity of the scientific data collected is assured and maintained.
- Applicants must be willing to work with CEPI and CEPI partners to tech transfer the animal model(s) as needed and if required for pre-licensure and licensure studies.

Applicants for Part B must meet the following minimum eligibility criteria:
- Applicants must have the ability to house one or more animal species, as referenced above in Objectives, under appropriate biocontainment.
- Applicants must demonstrate how they are already meeting NC3Rs guidelines for these species or propose how they could use CEPI funding to move towards compliance.
- Applicants must have the ability to work with human and/or zoonotic viruses in families such as those listed previously for CEPI’s Disease X initiative (see Objectives).
- Applicants should be able to perform studies under OECD Principles of GLP or US FDA 21 CFR Part 58 or under a robust quality system that assures data quality and integrity. Applicants should reference experience with SEND datasets, or partnership with organizations that can provide data in such formats (CDISC). In the absence of this, the applicant should describe existing quality compliance gaps and propose how CEPI funding could be used to move towards filling these gaps and implementing a quality system.
- For laboratories with an established quality system, demonstration of experience with animal model use during advanced product development testing should be described.
- Applicants must be willing to collaborate with CEPI and CEPI product development partners to design each study and prepare a study protocol that defines all aspects of study execution, data quality and integrity, reporting, and archiving.

Applicants for Part C must meet the following minimum eligibility criteria:
- Applicants must have the ability to house one or more animal species as referenced above.
- Applicants must demonstrate how they are already meeting NC3Rs guidelines for these species.
- Applicants must be able to demonstrate a successful history of toxicology and/or biodistribution studies executed under GLP compliance, including regulatory inspections. Applicants should reference experience with SEND datasets, or partnership with organizations that can provide data in such formats (CDISC).
- Applicants must be able to demonstrate integrated project management capabilities for preclinical toxicology programs.
- Applicants must be willing to collaborate with CEPI and CEPI product development partners to design each study and prepare a study protocol that defines all aspects of study execution, data quality and integrity, reporting, and archiving.

Applicants for Part D must meet the following minimum eligibility criteria:
- Applicants must have a proven track record in the development of in vitro and ex vivo tissue modeling systems.
- Where applicable, applicants must have the ability to work with human and/or zoonotic viruses in families such as those listed previously for CEPI’s Disease X initiative, including handling of agent(s) in BSL-3 or BSL-4 containment as appropriate. When not possible, applicants must be willing to collaborate with or transfer the technology system to a partner BSL-3 and/or BSL-4 laboratory.
- Where applicable, for example if ex vivo experiments incorporate the use of tissues from nonhuman primates housed by the laboratory, applicants must demonstrate how they are already meeting NC3Rs guidelines or how they will procure tissues from a fully compliant source.
- Applicants must be willing to publish research findings in a peer-reviewed open-access journal.
- Applicants must be willing to collaborate with CEPI and its partners to design each study and develop a study plan, including methods for data presentation and provision.
- Applicants must be willing to provide a brief report summarizing the research and associated data using a format to be provided by CEPI and must be willing and able to share with CEPI how the integrity of the scientific data collected is assured and maintained.

Pre-Application Information
Please submit your application before 23:59 Central European Time (CET) on March 03, 2023.

- If you are considering submitting a proposal, please send an email to the contact, below, by 20th Feb 2023 in order for CEPI to best plan for the subsequent review process.
- Questions posed to CEPI by February 15th 2023, and CEPI’s responses will be published anonymized as FAQs on the website (https://cepi.net/tenders/) on February 16th, 2023.
- Submission must be completed by 03rd March 2023 11:59 pm CEST. Applicants are encouraged to submit well in advance of the deadline.
- CEPI will contact successful applicants once all submitted proposals have been reviewed, a process, which is estimated to be completed by July 2023.

Term of Contract
All funds should be spent within 6 months of any funding payment from CEPI unless there is specific justification warranting a modified timeline.

Contact Information
Please submit your questions and application to preclinicalstudies@cepi.net

CEPI
Oslo, Norway (HQ)
Postal: Postbox 1030 Hoff, 0218 Oslo

Visiting: Skøyen Atrium, Askekroken 11, 0277 Oslo

London, UK
Gibbs building, 215 Euston Rd, Bloomsbury, London NW1 2BE, UK

Washington, USA
1901 Pennsylvania Ave, NW; Suite 1003; Washington, DC 20006; USA

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