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Requests to utilize contract resources administered by DAIDS should be accompanied by detailed preclinical or clinical data to allow evaluation of the request. Summarized below are topics which should be addressed in the submission of a data package. Although responses to all of the items are not mandatory, and indeed may not be possible, the completeness of the provided information will be particularly important during the decision-making process and in the prioritization and implementation of approved projects.

The requests and any accompanying data, chemical structures, and developmental plans are treated by DAIDS as proprietary and confidential. A Disclosure Agreement can be signed at the sponsor's request prior to submission of written materials.

Requests for In Vitro Testing against Lentiviruses, OIs, and TB

• What specific assistance is being requested (e.g., pathogen strains, cell types, endpoint parameters) and how will it further the preclinical development plan of the compound?
• Chemical structure and molecular weight
• Recommended storage conditions
• Solubility profile in aqueous solutions
• Proposed mechanism of action
• Demonstrated efficacy in another test system for the pathogen in question, a closely related microorganism, or a relevant biochemical or cell based screen, and an assessment of cytotoxicity in uninfected cells (provide methodology and results)

Requests for In Vivo Testing against Lentiviruses, OIs, and TB

• What specific assistance is being requested (e.g., pathogen strains, animal species, endpoint parameters) and how will it further the preclinical development plan of the compound?
• Chemical structure and molecular weight
• Recommended storage conditions
• Solubility profile in aqueous solutions
• Amount of drug available for these studies
• Potential formulation issues
• Drug stability and potential metabolite formation in vivo
• Summary of data from previous animal efficacy, toxicology, or pharmacokinetic studies (e.g., species, doses, routes and duration of administration, outcome parameters)

Requests for Compound Synthesis

• What specific assistance is being requested (e.g., chemical structure, quantities) and how will it further the preclinical development plan of the compound?
• Full synthetic and purification procedures and likely yields at each step
• Potential sources and purity of non-standard reagents
• Mass, UV, IR, and/or fluorescence spectral data and boiling/melting point values to confirm identity of synthesized compounds and intermediates
• Discussion of patent and/or licensing position for GMP-compliant work

Requests for Analytical Chemistry and Methods Development

• What specific assistance is being requested (e.g., source of samples to be analyzed, type of assay needed, detection limits of assay) and how will it further the preclinical development plan of the compound?
• Chemical structure and molecular weight
• Recommended storage conditions
• Solubility profile in aqueous and non-aqueous solvents
• Amount of drug available for these studies
• Mass, UV, IR, and/or fluorescence spectral data to confirm identity of parent compounds and metabolites
• Previous analytical assay methodologies used for the compound or any analogous structures, including literature references
• Discussion of patent and/or licensing position for GLP-compliant work

Requests for Formulation Development

• What specific assistance is being requested (e.g., formulation type) and how will it further the preclinical development plan of the compound?
• What is the proposed animal model or clinical use of the formulation (e.g., target blood levels, treatment regimens)?
• Chemical structure and molecular weight
• Recommended storage conditions
• Solubility profile in aqueous and non-aqueous solvents
• Amount of drug available for these studies
• Mass, UV, IR, and/or fluorescence spectral data and boiling/melting point values to confirm identity of parent compounds and metabolites
• Stability of undissolved material and of compound in solution
• Results of any previous attempts to formulate the compound
• Previous analytical assay methodologies used for the compound or any analogous structures, including literature references
• pKa and pI values
• Discussion of patent and/or licensing position for GLP-compliant work

Requests for Manufacturing of Specific Dosage Forms

• What specific assistance is being requested (e.g., what dosage form, quantities) and how will it further the preclinical and/or clinical development plan of the compound?
• What are the compositional specifications of the dosage form (e.g., sources, purity, and quantities of active ingredients, preservatives, flowing agents, binders, fillers, and other excipients)?
• What are the physical specifications of the dosage form (e.g., size, color, capsule vs injectable vs other) and any recommended manufacturing procedures?
• Are matching placebos needed?
• Packaging requirements (e.g., material, size, color, closure)
• Labeling requirements, including IND labeling statement
• Shipping requirements, including investigator and site address
• Plans for conducting stability, release-defining, and other Quality Control testing of the final product
• Material Safety Data Sheet; personnel protection instructions
• Evidence of IND submission and likely approval

Requests for Toxicology/Pharmacokinetic Testing

• What specific assistance is being requested (e.g., determination of minimum toxic dose, oral bioavailability) and how will it further the preclinical development plan of the compound?
• Proposed clinical use, including target blood levels and Phase I/II treatment schedules
• Chemical structure and molecular weight
• Recommended storage conditions
• Solubility profile in aqueous and non-aqueous solvents, including recommended vehicle for administration
• Amount of drug available for these studies and whether material was synthesized in compliance with FDA’s current GMP recommendations
• Stability of undissolved material and of compound in solution; stability and potential metabolite formation in vivo; Expiration date of lot to be tested
• Mass, UV, IR, and/or fluorescence spectral data to confirm identity of parent compounds and metabolites
• Previous analytical assay methodologies used for the compound or any analogous structures, including literature references, particularly those validated for use in animal fluids (e.g., plasma, urine)
• Summary of data from previous animal efficacy, toxicology, or pharmacokinetic studies (e.g., species, doses, routes and duration of administration, outcome parameters)
• Discussion of patent and/or licensing position
• Material Safety Data Sheet