Overview: Many anti-cancer drugs are not tumor selective. 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 platform of first in class first in man compounds that demonstrate selective uptake into tumor cells. Safer more effective treatment has been demonstrated in xenograft models. This Webinar will discuss the present and future development challenges and strategies in the context of novel drugs with selective delivery properties entering the FDA process for consideration and evolution from clinical research to drug product development.
Why should you attend: To establish and contribute to an enhanced understanding of novel drugs targeting tumor metabolism, more specifically bioenergetics and FDA guidelines for new chemical entities. Unlike many cancer chemotherapeutics these new drugs are selectively taken up into cancer cells. This being of critical importance as the pharmaceutical being delivered, targets the intracellular organelle mitochondria. Such novel "smart drug" delivery features 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
Dr. Shorr obtained his PhD and DIC from the University of London Imperial college Department of Biochemistry, London England where he worked with Prof. Eric Barnard and Oliver Dolly. His thesis described the isolation and characterization of the acetylcholine receptor in mammalian skeletal muscle. His postdoctoral work was with Prof. Robert Lefkowitz and Marc Caron at the Howard Hughes Research Institute Duke University Medical Center, Durham North Carolina where he focused on the isolation and characterization of different beta adrenergic receptors. In addition, while at Duke Dr. Shorr worked with Dr. Jeffrey Stadel to develop an understanding of the interaction of beta adrenergic receptors with G protein subunits and the activation of adenylate cyclase.
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