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

img
Robinson
0 0 Reviews
Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Robert Shorr

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

SPEAKER PROFILE:
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. Dr. Shorr also became vice president for research and development at Enzon, Piscataway New Jersey. A drug delivery company focused on the attachment of polyethylene glycol strands to proteins, peptides and small molecule drugs for the treatment of human disease wherein the polyethylene glycol attachment would enhance circulating life time and often improve safety and efficacy. Polyethylene glycol conjugated hemoglobin, polyethylene glycol conjugated glucocerebrosidase, polyethylene glycol conjugated camptothecin, polyethylene glycol conjugated adenosine deaminase, polyethylene glycol conjugated arginine deiminase and polyethylene glycol conjugated alpha interferon were studied in human clinical trials. The approval of polyethylene glycol conjugated alpha interferon in partnership with Schering Plough, NJ, establishing the technology and company as a leader in drug delivery. Dr. Shorr served as vice president for technology and chief scientist for United Therapeutics where he was responsible with others for the invention of longer acting prostacyclin analogs for the treatment of pulmonary hypertension. In addition Dr. Shorr served as Dir. for business development for the State University of New York at Stony Brook biotechnology center and as associate professor in the department of biomolecular engineering. Dr. Shorr and his partner Robert Rodriguez established Altira capital and consulting and worked with Chris Prior PhD to establish Principia a company using human serum albumin conjugates for drug delivery and which was later sold to Human Genome Sciences. Altira capital worked with other groups to establish Cornerstone Pharmaceuticals a company focused on developing cancer metabolism-based drugs and drug delivery systems. The proprietary work described here emerges from Cornerstone Pharmaceuticals where Dr. Shorr is currently CEO and chief scientist. The company's bioenergetics metabolism targeting drugs are in clinical trials. The drug delivery technology described herein is in preparation for clinical study.

After your payment, we will contact you with instructions about how to access the webinar.
Delivery in 7 day(s)
0.0
0