One of the biggest challenges in dermatological research today remains the development of meaningful methodologies to determine the rate and extent to which topically or systemically applied drugs reaches its site of action and engages its target in the skin.
In this workshop learn how to make the most of early clinical development by integrating advances in techniques to quantitate dermal PK and PD measurements in model and patient settings and their role in dose finding.
Key topics to be discussed include:
Join us in this interactive session that will bring practical insights into the inclusion of PK and PD measurements and clinical models in early clinical development programs and how these can provide value and de-risk clinical development of dermatological drugs.
Betsy Hughes-Formella, Independent Consultant - Dermatology Drug Development
Robert Rissmann, Research Director Dermatology, Center for Human Drug Research
A key area of focus for drug developers working in dermatology is to ensure the optimization of drug delivery platforms and formulation approaches. In this workshop, you will have the opportunity to gain in-depth insights from leading experts in this space that will help you advance your topical development.
Key topics to be discussed include:
Phase specific method development to support early drug development through selection of a lead formulation. The typical approaches to method development vary for new chemical entities versus known molecules. For known molecules, compendia or literature searches generally provide starting point conditions and any known impurities/related substances are commonly established. New chemical entities present a unique set of challenges as the method development process is undefined, requiring studies to gain adequate knowledge and understanding of impurity profiles/degradation pathways. In addition to gaining understanding on API stability; drug excipient compatibility studies are utilized to identify incompatible excipients by combining the drug substance with penetration enhancers, viscosity modifiers, emollients, preservatives, oils, etc. in which the data generated can be used to assist in predicting product stability. To support product stability, suitable extraction procedures must be developed. Implementation of suitable “topical” extraction procedures present significant challenges as development is two-fold: ensuring that the solvent/technique used is sufficient to 1) penetrate the formulation matrix and 2) extract and solubilize the drug substance. Once the lead formulation has been selected, phase appropriate validation to support varying clinical development stages will be executed. A life-cycle approach to method validation is applied as differences exist in requirements between early development and late-stage development (Phase IIb and beyond). For technology transfer activities, streamlining the method transfer process is critical to avoid common pitfalls and challenges which could cause unnecessary and timeline-impacting delays.
In Vitro Release Test (IVRT) is a test to measure the release of active ingredient from a formulation matrix into an appropriate receiving medium. It is based on Fick’s laws on diffusion. Release of active ingredient is a complicated process, and it depends upon the properties of the drug, the formulation matrix and the barrier. Specifically, for IVRT, the barrier is an inert, synthetic membrane that acts as a holding surface for the dosage form in a diffusion apparatus, thereby limiting the dependence of release rate onto the properties of the dosage form and the active ingredient. Most commonly used apparatus for IVRT is the vertical Diffusion cell. USP chapter <1724> describes the apparatus and the use procedure in detail. IVRT has several applications during development of a topical dosage form. During early stage of development, it serves to characterize and understand the release properties of the active ingredient and the dosage form, allowing formulators to make appropriate changes in excipients/process to optimize a formulation prototype. When Quality by Design approach is used, as it should and desired by the agency, IVRT remains to be an important parameter to evaluate when changes are made in excipients, excipient supplier or grad and process of manufacturing.
Join this interactive and comprehensive session that will allow you to streamline and boost innovative delivery and formulation approaches that match the potential of your drug candidates.
Vijendra Nalamothu, CEO, Tergus Pharma
Jean-Philippe Therrien, Head, Skin Biology, Tergus Pharma
Tammy Payne, Head, Analytical R&D, Tergus Pharma
Kailas Thakker, (Co-Founder Emeritus), In Vitro Sciences, Tergus Pharma
Pharma/biotech companies in dermatology and medical esthetics will maximize the value of development programs and prevent multiple missteps with significant financial ramifications when genuine paradigm shift from product-centricity to patient-centricity finally occurs. The paradigm shift is already happening within regulatory agencies, among healthcare industry stakeholders, in scientific journals and at medical conferences.
Key topics being addressed include:
This interactive session, packed with relevant content and crisp-clear takeaways, will enable you to stimulate innovation in your organization, maximize the value of your development programs and see ROI for patient engagement.
Jasmina Jankicevic, Dermatologist, Clinical Development & Medical Affairs Consulting