Funds will not be awarded to the applicant.
Accurate CRO/CMO quotes must be provided with the preclinical application. If accurate CRO/CMO quotes are not provided, the application will be noted as "unresponsive" and will not go out for peer review.
The Catalyze Coordinating Center (RTI) will manage the services and work with the investigators to ensure that tasks are being completed correctly at the CROs/CMOs. The Catalyze Coordinating Center (RTI) will select CROs/CMOs that will provide preclinical services.
Additional commercialization milestones will be required of the investigator.
List of potential studies/information to share with Vendors in the Preclinical Phase
Investigators are not expected to have all this information.
Drug substance information
- Starting material quality (quality e.g. USP, endotoxin-free)
- Route of synthesis/manufacture
- In-process controls
- Procedures (precursor to SOPs)
- Analysis Methods (also used for Stability Testing)
- Purity
- Stability Data
- Stability Plan
Drug Product
- Formulation (solubility, pH, osmolality, etc.)
- Stability
- Stability Plans
- Test Methods
- Sterility
- Quantitative Assay
- Potency Assay
Pharmacology assays
- Primary pharmacology
- Formulation used
- Secondary pharmacology
ADME including in vitro studies
- Safety/Tox studies in vitro and in vivo
- Dose range finding on early formulations
- Therapeutic index (narrow or broad)
- Formulation, route of administration