Day 2 :
Sitara Pharmaceutical Group, USA
Time : 09:00-09:25
Irach B. Taraporewala has over 30 years’ experiece in drug discovery/drug development R&D. He currently is President of the Sitara Pharmaceutical Consulting Group. He previously served as founder, CEO, President and Chief Technology Officer, and on the Board of Directors of OHR Pharmaceutical, Inc. an ophthalmology drug development company, and as a Drug Development consultant at PAREXEL Consulting. Dr. Taraporewala has published papers in drug development and delivery in reputed journals and has lectured extensively. He received a Ph.D. in Medicinal Chemistry from the Philadelpjhia College of Pharmacy and Science, and has been Principal Investigator on several NIH/DoD biomedical research grants.
With the aging population and the global increase in the incidence of diabetes, chronic diseases of the posterior segment of the eye are becoming increasingly prevalent. Treatment of disorders such as age-related macular degeneration (AMD), diabetic retinopathy, macular edema and uveitis require the effective and reliable delivery of a drug molecule into the choroid and retinal tissue layers in the eye’s posterior segment. Because of the numerous natural barriers to a drug molecule’s entry into the interior of the eye, this is often a challeging proposoition. A number of drug substance classes with vastly different physicochemical properties are being developed to treat such disorders, including small molecule, polypeptides, monoclonal antibodies and oligonucleotide aptamers. With these advances comes the need to develop new drug delivery technologies to achieve sustained therapeutic levels of drug in the target ocular tissues. The presentation will review the current state of drug delivery and recent advances in this area. Both approaches of novel drug formulation methodologies and medical device development are being utilized for the purpose. Use of formulation additives, nanoparticle, microparticle and liposomal approaches are being increasingly developed, as are new types of implantable and injected medical devices that provide for successful elution of therapeutic levels of drug substances into the choroid and retina. These advances are likely to impact the future of drug development for the effective management of ocular diseases of the posterior segment.
NOBLE , USA
Time : 09:25-09:50
Joe Jensen is the director of marketing for Noble, an award-winning multisensory product development company for the world’s leading pharmaceutical brands. Noble develops educational and training solutions to improve the lives of patients who self-administer drug delivery device therapies, such as auto injectors, prefilled syringes, or metered dose inhalers.rnrnJensen has a BSBA in Marketing from the University of Florida, and an MBA from Nova Southeastern University. In addition to Noble, Jensen has had the privilege to teach up-and-coming business professionals at two universities, Nova Southeastern University and Lake Sumter State College.
Pharmaceutical companies can combat inconsistent patient training, non-compliance and low adherence is by offering device training and onboarding tools to their patients. Training devices can assist in minimizing common issues seen in patients, such as needle anxiety, injection angle and injection depth among others. To determine the link between device training and patient compliance a survey was conducted consisting of 721 patients. The study investigated whether or not compliance differed between patients who trained with a needleless training device versus those who did not train with a needleless training devices results from the survey found that 61 percent of patients do not thoroughly read the IFU; this is alarming as more than half of patients are simply not reading all of the instructions and are instead relying on demonstrations by HCPs which can be inconsistent or easily forgotten once the patient is in the everyday home environment. Building better tools requires a deeper knowledge of how patients learn, combined with an improved understanding of patients emotional and behavior patterns that occur after the point of diagnosis. Device training can help decrease user error, increase on-boarding confidence, and reduce HCP training times. Proper device training and educational products can help teach patients in the absence of HCPs. Injection training devices and even available to incorporate based on the needs of the brand and needs of patients. Incorporating these types of methods can increase the retention and recall of messages.
University of Tennessee Health Science Center, USA
Time : 09:50-10:15
Chauhan has completed his PhD at the age of 27 years from Central Drug Research Institute (CDRI), Lucknow, India and recieved postdoctoral training from University of Nebraska Medical Center (UNMC), Omaha, NE.. Currently he is serving as a Professor of Pharmaceutical sciences at Yniversity of Tennessee Health Science Center (UTHSC), Memphis, TN, a premier educational institution. He has published more than 85 papers in reputed journals and has been serving as an editorial board member for sevral journals of international repute.
Pancreatic cancer (PanCa), is the fourth leading cause of cancer related deaths in the United States due to the lack of early diagnosis and poor response to available therapeutics. Thus, identification of newer therapeutic approaches that can aid current therapeutics is highly desirable. We have defined multidimensional roles of MUC13 mucin in the pathogenesis and therapeutics/imaging of PanCa. We have reported that MUC13 is highly expressed in human pancreatic tumors but not in normal pancreas and its expression progressively increases with disease stage and metastasis. MUC13 enhances tumorigenesis through modulation of multiple oncogenes (HER2, PAK1, ERK, metastasin/S100A4, TERT, sonic hedgehog (SHH), GATA-1) associated with tumorigenesis/metastasis and desmoplasia. We have also observed a functional interaction of MUC13 and HER2 in PanCa cells and identified miR-145 as a tumor suppressor and a novel regulator of MUC13 in PanCa. Additionally, we have identified drugs that inhibit tumor desmoplasia (targets SHH pathway) and enhances therapeutic response of gemcitabine, thus, can be of therapeutic benefit for PanCa. Moreover, we have generated unique anti-MUC13 mouse monoclonal (MAb) and recombinant humanized (HuAb) antibodies that can efficiently target pancreatic tumors. Furthermore, we have successfully generated multiple patented nanoparticle formulations for antibody guided tumor specific targeted drug delivery and imaging. Taken together, our data suggest a crucial role of MUC13 in PanCa pathogenesis. Utilization of a novel anti-MUC13 monoclonal antibody can be used for the targeted tumor specific delivery of novel nanoparticle formulations in pancreatic tumors. This research will establish the multifaceted role of MUC13 in pathogenesis of PanCa and advance diagnosis and therapy of PanCa to reduce the morbidity and mortality caused by this devastating disease.