2020 PharmSci 360Workshops
AAPS is hosting six workshops and short courses taking place the week of November 9th. Each event will consist of four 90-min sessions over a two-day period. Please visit our event website for a detailed agenda and speaker details.
Monday, November 9 – Tuesday, November 10, 2020
10:30 am - 12:00 pm & 2:00 pm - 3:30 pm daily
Workshop: Drug Transporters 2020: Old Challenges and New Opportunities
The goals of this workshop are 1) to bring together experts in the transporter field from academia, industry and regulatory agencies, 2) to enhance interaction and communication between these three entities, and 3) to inform the audience about existing challenges and new opportunities in the transporter field. Session topics will include: transporter animal models, predicting human PK/IVIVE, transporters as drug targets, and an update on DDI guidances. The workshop will consist of interactive lecture-based sessions, one dialogue and debate session, one podium discussion, and one session focused on regulatory perspectives by FDA representatives.
Workshop: Excipients Complexities That Are Relevant to Analytical and Manufacturing
With the increasing growth of new and generic drugs entering the market, more and more excipients are being used in specialized drug delivery systems such as biologics, injectables, and modified released dosage forms. As a result, there is a growing need to control critical excipient material properties that contribute to excipient variability in dosage forms. As not all the critical physical and chemical properties may be identified in excipient monographs via compendial tests and specifications, a USP information chapter Excipient Performance was developed to provide an overview of the key functional categories of excipients and tests or procedures that can be used by both the user and maker of the excipient to identify, monitor and control critical material attributes or properties of the excipient that may impact the dosage form. Further, excipient complexity continues to increase in terms of composition and impurities that create challenges in the selection of excipients that are fit for purpose. Additionally, FDA GMP requirements are limited to finished pharmaceuticals (see 21 CFR 210 & 211). USP is developing a chapter to provide guidance on how best to ensure and maintain product quality through the supply chain over a product’s lifecycle through a toolbox approach used to identify and mitigate risks. This presentation aims to highlight both challenges and opportunities for USP in collaboration with key stakeholders to provide up-to-date USP-NF monograph standards and chapters helpful in qualifying an excipient for its intended pharmaceutical use, provide a better understanding of excipient composition and impurities that may help in the selection of excipients for pharmaceutical use and a toolbox approach to supplier qualification to help mitigate associated risks.
Workshop: Introduction to Vaccine Clinical Development
The Introduction to Vaccine Clinical Development workshop/short course will provide a general introduction to key concepts in vaccine process development and vaccine clinical development. Case study examples will be used to illustrate key concepts across vaccine process development, clinical development, and regulatory strategy for vaccine licensure. The lectures will set the foundation for a COVID-19 roundtable discussion. Participants will have multiple opportunities to engage the expert panel across hot topic areas to deepen understanding of what is needed to develop and license a novel vaccine and how we may adapt the traditional development process during a pandemic to meet the global need.
Wednesday, November 11 – Thursday, November 12, 2020
10:30 am - 12:00 pm & 2:00 pm - 3:30 pm daily
Workshop: Be Specific – Biomarker Assay Validation in Context
Although the concept of Context of Use (COU) has gained significant traction in the past 2 years, bringing this concept into day-to-day practice for implementation of biomarkers throughout all stages of drug development has been challenging, with ongoing confusion regarding what exactly constitutes a COU. This presentation will provide foundational concepts including clarification on what differentiates a biomarker category from a biomarker endpoint from the biomarker’s COU. Furthermore, since the majority of biomarkers are deployed for exploratory purposes, or to support internal decision making during early clinical development, how to craft specific COU statements to address these scenarios will be discussed. Lastly, the content will highlight how to manage situations where COU is not forthcoming, but an assay is being requested (or demanded). By providing an analytical characterization of the assay along with clear communication of assay performance characteristics and limitations, the analytical biomarker scientist can deliver an assay against which suitability for different COUs can be evaluated. This latter step will then determine whether the assay is valid for a given context or not. Examples of COUs with attendant validation considerations/requirements and/or assay characterizations and the COUs they may support (or not) will be discussed.
Workshop: Gene Therapy: Inserting Old Genes into a New Modality!
This proposed workshop intends to provide a more comprehensive look at the discovery and development of gene therapy. Some of the aspects that will be presented include basic transgene and gene editing target selection, delivery mechanisms, quality testing, immunogenicity, clinical pharmacology and biomarker responses. The intended target for this workshop is for new CGT scientists and cross-discipline scientists, such as, Molecular Biologists, Drug Delivery, CMC Manufacturing, Regulatory Sciences, and Clinical Teams. Specific topic consideration will be given to dose projections, gene delivery, and manufacturing challenges.
Workshop: Strategic Approaches to Develop Phase-Appropriate Organic Impurity Control Strategies
This program will describe best practices for development of early phase control strategies for organic impurities and extractable/leachables in small molecule drug products. In the current landscape of drug development, the design and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety. While there currently exist well-established guidelines for commercial control of organic impurities in drug substances and drug products there is limited guidance on how to apply these principles throughout the various stages of development, especially in the early phases. Mutagenic impurities are an area of specific interest for which new guidances exist but application of these guidances in an early phase environment represents unique risk-based challenges. One example, nitrosamine impurities, is a current area of fervent interest, with many companies struggling to understand how to set up risk based approaches to assess, detect, control, and monitor these impurities, especially considering the strict regulatory guidances. This program will also include a discussion of robust and phase-appropriate extractables/leachables strategies to ensure that packaging supports the quality and efficacy of the drug products throughout their shelf life. This program will serve to provide pharmaceutical scientists with case studies and real-world examples of how appropriate control strategies can be successfully applied throughout the drug development for all of these impurity topics. It will also provide a forum to discuss new and innovative technologies that can be applied to the detection, isolation, identification, control, and monitoring of impurities throughout a product lifecycle.
To register for any workshop or short course, please visit our registration page for PharmSci 360. You may add this to your existing registration for PharmSci 360 or select the “workshop only” fee type to only attend and pay for one of the above events.
All cancellation and substitution policies for PharmSci 360 apply.
Please contact Experient:
800.611.2720 Toll free
240.439.2922 International registrants