Collaborate with CNDD
At UNC-Chapel Hill, the CNDD offers the following capabilities to facilitate a seamless transition from drug discovery to clinical investigation:
1. Facilitating Drug Discovery:
The CNDD partners with UNC drug discovery scientists to increase the rate at which leads are identified and to reduce the rate at which leads are not found due to poor physical/chemical properties (i.e., solubility, stability, membrane permeability, cell localization, etc.). Delivery approaches including, for examples, micellular solubilization and nano-entrapment methodologies that can rapidly and efficiently be incorporated into high-throughput in-vitro screens will greatly benefit drug discovery efforts.
2. Characterizing the Identified Lead:
The CNDD assesses the physical-chemical properties (i.e., pH-solubility profile, pH-stability profile, partition coefficients, membrane permeability, etc.) of the leads and advises drug discovery chemists on rationale drug delivery and formulation approaches to address possible limitations of the identified lead. In some cases, CNDD will recommend chemical modifications to the identified lead.
3. Formulating the Identified Lead:
initial acute and subchronic toxicity tests. Oral and parenteral formulations utilizing GRAS excipients are most often developed; however, alternative routes of administration have also been developed. These formulations are developed with the clinical trial objectives and endpoints in mind so that a more seamless transition from preclinical testing through GLP safety/toxicity testing and human clinical testing is obtained. CNDD will develop initial quantitative stability indicating assays for the identified lead that will be used to conduct initial informal stability studies on the formulation lead.
4. Manufacturing the Lead Formulation:
The CNDD takes the lead role as “Head, CMC consultant” and facilitates scale-up and product development efforts at partner pharmaceutical manufacturing facilities to ensure the product is manufactured under cGMP compliance to conduct GLP safety/toxicity studies and human clinical studies. CNDD also writes the CMC section for the IND submission.