Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing, Drug Delivery and Drug Products
Overview:
Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting.
Preventing a therapeutic level to be achieved in a patient. An extensive list of unwanted toxicities, some of which may be permanent and serious adverse events that may be fatal are well known. We have been developing a non-phospholipid lipid nanoemulsion nanotechnology for the solubilization of anticancer drugs and selective uptake into tumor cells. Lower safer more effective dosing has been demonstrated in xenograft models. This Webinar will discuss the present and future development challenges and strategies in the context of a novel drug delivery technology with known or new pharmaceutical active, entering the FDA process for consideration of nanotechnology in drug product manufacturing, drug delivery, clinical research and drug product development.
Why should you attend:
To establish and contribute to an enhanced understanding of drug solubilizing tumor targeting technology that differentiates between selective uptake into a tumor mass versus uptake into tumor cells. The former often based on drug encapsulation or conjugation (as prodrugs) relying on diffusion to enter cells. The latter being of critical importance if the pharmaceutical being delivered, targets an intracellular organelle or function where a more active recognition and cell uptake can more evenly and extensively deliver drug. Such novel “smart nanotechnology” delivery methods also requiring discussion and consideration of preclinical approaches that would support clinical development in man with the potential need for a clinical research period wherein during clinical studies, how current disease progression measurement methods (CT/PET and RECIST) might be used along with the potential identification of biomarkers and companion diagnostics that could be validated in retrospective studies. The latter possibly being linked to delivery technology or active pharmaceutical mechanism of action or to disease progression markers.
Areas Covered in the Session:
- Introduction into nanotechnology drug delivery and needs for improvement
- Review of relevant FDA regulation, guidelines and points to consider for manufacturing and drug product composition
- Clinical research to support clinical development and protocol preparation for human study working with the FDA
- Clinical development planning and path to approvals
Who Will Benefit:
- Formulation Scientists and Researchers
- Regulatory Affairs Managers, Directors and VPs
- Quality Managers, Directors and VPs
- Manufacturing Managers, Directors and VPs
- Strategic Planning Managers, Directors and VPs