What services does this resource provide?
The Malaria Vaccine Production and Support Services program provides preclinical and nonclinical services in support of malaria vaccine development, including
- Development, characterization, and production of limited quantities of clinical grade material for lead candidates for malaria vaccines
- Development of processes to identify optimal production and purification strategies for clinical-grade immunogens or other vaccine components
- Development of assays and reagents for product evaluation
- Formulation and production of pilot lots of clinical trial material
- Regulatory support for compiling documentation necessary for submission of an Investigational New Drug (IND) application and/or Master Files to the Food and Drug Administration (FDA).
As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice).
Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.
Where are services provided?
Services are provided by Science Applications International Corporation (SAIC) and subcontractors.
Access
Who is eligible and what preliminary data are required?
You may request services if you are an investigator in academia, a not-for-profit organization, industry, or government worldwide. You need not be a grantee of NIAID or another National Institutes of Health Institute or Center. However, you must have appropriate preliminary data to support advancing a product you wish to have studied to the requested stage of the product development pathway.
Please get in touch with the Division of Microbiology and Infectious Diseases Program Officer listed under Contact Info to learn of preliminary data required in order to derive meaningful data from the studies you propose.
What assurances are provided to users?
Users may request appropriate assurances regarding confidentiality, transfer of materials, and intellectual property.
What is the application and approval process?
Step 1 – Discuss the potential request with the Program Officer.
Contact the Program Officer listed under Contact Info to discuss your preliminary data and the suitability of your proposed studies for support vis a vis the following standard criteria:
- Proposed studies within the DMID/NIAID mission
- Proposed studies within the scope of and/or technology provided by awarded contracts
- Sufficient quality and/or quantity of product available
- Proposed studies in compliance with animal welfare regulations
- Proposed work not supported by other funding sources/available from other sources
- Previous use of DMID resources for assessment of the same or similar product (Repeat use of DMID resources may be undertaken with strong justification.)
- Preliminary data adequate to support the request to advance the product to the next step in the product development pipeline
- Likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality
- Purported public health impact
- Improvements in health benefits offered beyond current measure(s)
- Availability of a plan for advancing the product beyond completion of the services requested
Step 2 – Submit a concept to the Program Officer
Investigators with adequate preliminary who propose promising studies will be invited to submit concepts to the Program Officer. The request must include
- A description of the overall product development plan, including, for example, how data obtained via these contract resources fit into the overall development plan of the product, information/plans regarding intellectual property rights and licensure.
- Background and significance including, for example, a concise scientific justification for use of this product, discussion of proposed mechanism of action, and supporting references and documents.
- Preliminary data that supports the request to advance the product through provision of contract services, including, for example, in vivo or in vitro experimental results, toxicity and efficacy data.
- A list of other governmental and non-governmental funded and pending support and a brief description of activities relevant to the request
- Description of the overall plan for advancing the product beyond completion of the services requested.
Requests are also initiated by DMID staff members based on identification of gaps in the research portfolio.
Step 3 – Concept approval by the Program Officer
The Program Officer reviews and approves concepts that propose to fill a gap in malaria vaccine development. Investigators who put forward approved concepts then work with SAIC to produce an overall product development or project plan for submission by SAIC to the Program Officer.
Step 4 – Development and approval of product development plan
The Program Officer evaluates product development or project plans submitted by SAIC, arranging for review by subject matter experts for complex product develop plans. The Program Officer then prioritizes and approves product development plans based on recommendations of subject matter experts; strategic advice provided to the contractor by malaria vaccine consultants who periodically evaluate contractor-performed projects in the context of the NIAID malaria research agenda; and input from DMID program staff and/or senior DMID management.
All are guided by the criteria listed above as well as scientific and technical merit and competing priorities/availability of contract resources.
What requirements must users fulfill?
Users are required to acknowledge the contribution of NIAD contract support in any publications or presentations resulting from use of this service. They are required to submit manuscripts, scientific meeting abstracts, or presentations containing data generated under this contract to the NIAID Project Officer for review and approval before submission for public presentation or publication.