Game changing drugs and the fda

Live Webinar on Game Changing Drugs and the FDA Date & Time: Thursday, August 23, 2012 10:00 AM PDT | 01:00 PM EDT Register Now Duration: 60 Minutes Instructor: Dr. Robert Shorr Location: Online Price : $245.00 (for one participant) Instructor Profile: Overview: Dr. Robert Shorr Many anticancer drugs are not tumor selective. For chemotherapy Chief Executive Officer, the lack of drug and disease specificity and need for higher dosing Cornerstone Pharmaceuticals leads to adverse and serious adverse events that may be dose limiting. Preventing a therapeutic level to be achieved in a patient. Dr. Shorr obtained his PhD and DIC from the University of London An extensive list of unwanted toxicities, some of which may be Imperial college Department of permanent and serious adverse events that may be fatal are well Biochemistry, London England where he worked with Prof. Eric Barnard known. We have been developing a platform of first in class first in and Oliver Dolly. His thesis described man compounds that demonstrate selective uptake into tumor cells. the isolation and characterization of Safer more effective treatment has been demonstrated in xenograft the acetylcholine receptor in models. This Webinar will discuss the present and future mammalian skeletal muscle. His development challenges and strategies in the context of novel drugs postdoctoral work was with Prof. with selective delivery properties entering the FDA process for Robert Lefkowitz and Marc Caron at consideration and evolution from clinical research to drug product the Howard Hughes Research development. Institute Duke University Medical Center, Durham North Carolina where he focused on the isolation Why Should You Attend: and characterization of different beta adrenergic receptors. In addition, To establish and contribute to an enhanced understanding of novel while at Duke Dr. Shorr worked with drugs targeting tumor metabolism, more specifically bioenergetics Dr. Jeffrey Stadel to develop an and FDA guidelines for new chemical entities. Unlike many cancer understanding of the interaction of chemotherapeutics these new drugs are selectively taken up into beta adrenergic receptors with G cancer cells. This being of critical importance as the pharmaceutical protein subunits and the activation of being delivered, targets the intracellular organelle mitochondria. adenylate cyclase. At SmithKline and French Dr. Shorr was the associate Such novel “smart drug” delivery features also requiring discussion and consideration of preclinical approaches that would support Dir. for the Department of molecular pharmacology reporting to the clinical development in man with the potential need for a clinical president of worldwide R&D Dr. research period wherein during clinical studies, how current disease Stanley Crook. A focus on receptors progression measurement methods (CT/PET and RECIST) might be and disease pathology continued. Dr. used along with the potential identification of biomarkers and Shorr and his colleagues invented companion diagnostics that could be validated in retrospective several new materials for studies. The latter possibly being linked to delivery technology or electrophoretic separations of active pharmaceutical mechanism of action or to disease progression proteins and nucleic acids markers. introducing the products to the market place through a newly formed company, AT biochem with Areas Covered in the Session: the assistance of SmithKline and French and Beckman instruments. The company was later sold to l Introduction into nanotechnology drug delivery and needs for Centocor and FMC. ...more improvement l Review of relevant FDA regulation, guidelines and points to consider for manufacturing and drug product composition Suggest a Topic More Webinars l Clinical research to support clinical development and protocol preparation for human study working with the FDA Your Necessity is our Priority l Clinical development planning and path to approvals Click here to register for this webinar Who Will Benefit: l Formulation Scientists and Researchers l Regulatory Affairs Managers, Directors and VPs l Quality Managers, Directors and VPs l Manufacturing Managers, Directors and VPs l Strategic Planning Managers, Directors and VPsIt would be really nice if you can circulate this mail to all your deserving colleagues who can immenselybenefit from this program.For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,Event-coordinatorGlobalCompliancePanelAbout GlobalCompliancePanelGlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for onlinecompliance training by creating a single window of learning opportunities for compliance professionals & providing aforum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Ourcommitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment trainingsessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learningand development on/through our website. Keep track of all webinars arranged for your industry through notifications &event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities forprofessionals.GlobalCompliancePanelwww.globalcompliancepanel.com1000 N West Street Suite,1200 Wilmington DE 19801Phone: 800-447-9407 orFax your PO to: 302-288-6884If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Game changing drugs and the fda

by John Robinson on Jul 25, 2012

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