Transdermal & Intradermal Drug Delivery Systems 2017 1 : 55 Sustained Delivery of an HIV Subunit Vaccine

Coming Soon 10:15 Networking Coffee Break Critical Issues—The Pharmacokinetics of Transdermal Delivery 10:40 Minimization of CYP2D6 Polymorphic Differences and Improved Bioavailability via Transdermal Administration Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer Transdermal delivery has the potential to offer improved bioavailability by circumventing first-pass gut and hepatic metabolism. This presentation will describe pharmacokinetic differences between transdermal and oral delivery of latrepirdine in extensive and poor CYP2D6 metabolizers (EM/PM). Dose-normalized latrepirdine total exposures were approximately 11-fold and 1.5fold higher in EMs and PMs, respectively following administration of transdermal relative to oral. Differences between EM and PM latrepirdine exposures were decreased, with PMs having 1.9and 2.7-fold higher peak and total exposures, respectively, following transdermal administration compared to 11and 20-fold higher exposures, respectively, following oral administration. Transdermal delivery can potentially mitigate the large intersubject differences observed with compounds metabolized primarily by CYP2D6. Transdermal delivery was readily accomplished in this early clinic evaluation using an extemporaneously prepared solution. Spotlight on Microneedle Arrays— The Present & (Near) Future of Microneedle Drug Delivery 11:20 How Microneedle Arrays Can Overcome the Challenges Facing Transdermal Drug Delivery Dr. Ryan F. Donnelly, Chair in Pharmaceutical Technology, Queen’s University Belfast Transdermal delivery using conventional passive patches has perhaps passed its peak. Second generation physical enhancement techniques, such as ultrasound and iontophoresis have not progressed as once hoped. Research based upon microneedle arrays has intensified recently. While the initial focus was on biomolecules, the field has expanded to include delivery of conventional small molecule drugs. Much success has been achieved, particularly in the vaccines field. Recent innovations have focused on enhanced formulation design, allowing delivery of clinically relevant doses of small molecule Thursday, September 28, 2017 7:45 Complimentary Breakfast & Chairperson’s Welcome and Opening Remarks The Transdermal & Intradermal Landscape—Key Challenges and Opportunities 8:15 How Challenges Evolve for Delivery into Skin as we Transition from Passive Diffusion to Delivery Technologies Dr. Ajay Banga, Chair & Professor of Pharmaceutical Sciences, Mercer University Moderately lipophilic drugs can passively diffuse into skin but even these simple patches are considered to be drug-device combinations and face challenges such as drug crystallization, cold flow, or failure of adhesive. Hydrophilic molecules and macromolecules do not normally pass through the skin unless enabling technologies are used, and these offer different types of challenges. For example, iontophoresis is limited to deliver molecules up to around 13kDa and may potentially induce skin burns if skin contact is not uniform. Sonophoresis and laser-based devices may face challenges to miniaturize the device for home use by patients. Innovations and challenges in these technologies, especially for iontophoresis, ablative and non-ablative fractional laser, and microneedle-based devices, will be presented. • Learn about challenges facing passive patch development, e.g., drug crystallization and how these challenges change as we move into delivery technologies, e.g., potential burns with an iontophoretic patch. • Learn how new technologies are expanding the scope of transdermal delivery to include hydrophilic macromolecules • Learn the success and failures of novel skin delivery technologies developed and marketed over the years. 8:55 Keynote: Recent Advancements in Intradermal Delivery of Biopharmaceuticals Lisa Dick, Ph.D., Lab Manager & Technology Leader, 3M Drug Delivery Systems As population demographics shift and new medicines become available, patient preferences and new technologies remain top of mind at 3M. In recent years, 3M has been developing a patient-friendly and easy-to-use microstructured transdermal system drug delivery platform that includes solid and hollow microneedle options along with associated applicators. These devices are well suited for dermal skin targets or systemic distribution for drugs that enter the lymphatic system. This talk will include recently generated data and examples that support intradermal delivery as a method to meet the evolving needs of pharmaceutical companies, regulators, providers, and patients. KEY NOTE