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Development of Anticancer Agents

Description:

 

The short term goal of this SBIR contract topic is to support small businesses that are developing novel candidate 
therapeutic agents of interest. The scope of work may include structure activity relationships (SAR), medicinal 
chemistry and formulation, animal efficacy testing, pharmacokinetic, pharmacodynamic, and toxicological studies, 
as well as production of GMP bulk drug and clinical product. These data will establish the rationale for continued 
development of the experimental therapeutic agent to the point of filing an investigational new drug application 
(IND) (http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm). Successful projects may be eligible for 
further development at NCI, through participation in the NCI Experimental Therapeutics (NExT) Program 
(http://next.cancer.gov/). For this, companies should submit proposals for the development of agents that are in 
mid to late pre-clinical development (expected time to clinic 1-3 years). The development plan, targeted to 
oncologic indications, will be reviewed by NCI. Agents for rare cancers are of particular interest to the NCI.
 
Project goals:
 
The goal of the NCI SBIR program is to accelerate the development of products that benefit cancer patients. The 
long term goal of this contract is to enable a small business to bring a fully developed cancer therapeutic agent to 
the clinic and eventually to the market. 
 
Phase I Activities and Expected Deliverables: 
 
• Specific activities will range from SAR and medicinal chemistry to animal toxicology and pharmacology, 
depending on the agent selected for development. 
• Development plan that details the experiments necessary to file an IND or an exploratory IND. 
• Demonstrate ability to deliver results for the initial set of experiments (project-specific, according to the 
development plan above). 
 
Phase II Activities and Expected Deliverables: 
 
• Complete all experiments (e.g. pharmacokinetics, preclinical efficacy, GMP manufacturing) according to 
the development plan (can be re-evaluated if needed). 
• If warranted, provide sufficient data to file an IND or an exploratory IND for the candidate therapeutic 
agent in question (oncologic indications). 
• Demonstrate the ability to produce a sufficient amount of clinical grade materials suitable for an early 
clinical trial (according to FDA’s Exploratory IND guidance)
(http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/InvestigationalNewDrugIND
orDeviceExemptionIDEProcess/). For additional guidance refer to the following guidance. 
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm0789
33.pdf).
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