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Live Webinar

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Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing, Drug Delivery and Drug Products

Date & Time: Tuesday, June 12, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Dr. Robert Shorr

Location: Online

Price : $245.00

 

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Instructor Profile:

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 b e 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.

Dr. Robert Shorr Chief Executive Officer, Cornerstone Pharmaceuticals 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. At SmithKline and French Dr. Shorr was the associate Dir. for the Department of molecular pharmacology reporting to the president of worldwide R&D Dr. Stanley Crook. A focus on receptors and disease pathology continued. Dr. Shorr and his colleagues invented several new materials for electrophoretic separations of proteins and nucleic acids introducing the products to the market place through a newly formed company, AT biochem with the assistance of SmithKline and French and Beckman instruments. The company was later sold to Centocor and FMC. ...more

Areas Covered in the Session: Suggest a Topic l

Introduction into nanotechnology drug delivery and needs for

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improvement Review of relevant FDA regulation, guidelines and points to consider for manufacturing and drug product composition

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Clinical research to support clinical development and protocol preparation for human study working with the FDA

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Clinical development planning and path to approvals

Click here to register for this webinar Who Will Benefit: l l l

Formulation Scientists and Researchers Regulatory Affairs Managers, Directors and VPs Quality Managers, Directors and VPs

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Lipid Based Formulations and Targeting Tumors - FDA Considerationsof Nanotechnology  

Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemothe...

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