Please join the AAPS WIPS community on Tuesday, May 21 st , 12:00 - 1: 00PM (EST) for a panel discussion on Women in Regulatory Science with Lina Aljuburi , Head, Regulatory Science Policy North America, Sanofi, Nimi Chhina , Executive Director, Head of Global R&D and Regulatory Policy, BioMarin Pharmaceutical Inc., and Yogita Bahl , Senior Director, Regulatory CMC, Bristol Myers Squibb. Meeting Link: https://meet.goto.com/AAPSWIPSAll-Communitybi-monthlymeeting
In 2019 USP created an Expert Panel (New Advancements in Product Performance Testing) to do a gap analysis on the need for and possible creation of tests/standards for measuring the performance of drug products. The results of Working Groups within the Expert Panel have been presented in a series of articles in Pharmacopeal Forum and Dissolution Technology. The purpose of this webinar is to present to stake holders and interested members of the pharmacy community, the findings of the Working Group dealing with inhalation and nasal products and allow for questions and suggestion from participants for improvement/modifications for the Working Group’s findings. Learning Objectives: • Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP). • Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing. • Evaluate the findings of the Working Group addressing inhalation and nasal products as presented in the stimuli article. • Question and provide input to the findings of the Inhalation and Nasal Working Group.
Register for this webinar!! Four great experts in the field will be together for an interesting webinar on the development of inhaled biologics. John Patton, Keith Ung, Andy Clark and Jeff Weers will make us travel in the current and future trends, opportunities and considerations for the development of inhaled biologics.
The Biomarkers and Precision Medicine (BPM) Community is hosting a series of Open Scientific Discussions (OSDs) on Multi-omics in Drug Development . Please join us for the first OSD in the series hosted on May 30 th , 12 - 1 pm ET : Part 1: Multi-omics in Precision Medicine · What are the factors that influence novel biomarker identification and characterization using multi-omic approaches? · What are key considerations when choosing between the various multi-omic technologies? · Case studies on the use of multi-omics to support precision medicine will be presented. Discussion Leaders: Matt Blatnik (AbbVie) and Christina Ebert (BMS) Organized by: Jurre Kamphorst (Olaris), Iris Qiu (Novartis), Ayuko Ota-Selik and Jianing Zeng (BMS) We start at 12:00 ET sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. (Please remain on mute unless asking questions) When : Thurs, May 30, 2024, 12 pm – 1 pm ET Where : Please join from your computer, tablet or smartphone. https://global.gotomeeting.com/join/305789893 You can also dial in using your phone. United States: +1 (872) 240-3412 Access Code: 305-789-893 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 305 789 893 Or dial directly: [email protected] or 67.217.95.2##305789893 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://global.gotomeeting.com/install/305789893 Please feel free to share with colleagues who may be interested in this topic. Thank you, The AAPS BPM Community Leadership Team
Monthly meeting for AAPS Global Health Community Leadership All members of the Global Health Community welcome to attend to learn more, volunteer for specific items, influence the direction of activities! Please join meeting from your computer, tablet or smartphone. https://meet.goto.com/471580205 You can also dial in using your phone. Access Code: 471-580-205 United States: +1 (872) 240-3311 Join from a video-conferencing room or system. Meeting ID: 471-580-205 Dial in or type: 67.217.95.2 or inroomlink.goto.com Or dial directly: [email protected] or 67.217.95.2##471580205 Get the app now and be ready when your first meeting starts: https://meet.goto.com/install
JULY 22-25 KANSAS CITY, MO The AAPS Summer Scientific Forum makes AAPS the premier scientific convener of the pharmaceutical industry: breadth, depth, and quality science. Attend this meeting for depth in the latest bioanalysis or pharmaceutical analysis science and seize the opportunity to cross-connect with other scientists in shared high-level sessions focused on key regulatory issues facing these scientific areas.
Antibody drug conjugates (ADCs) are revolutionizing the pharmaceutical industry. This emerging modality comes with the promise of targeted therapy with increased precision and selectivity therefore enhancing the overall therapeutic index. ADCs, by nature, have characteristics of both antibody therapeutics and small molecules, posing a unique challenge for the field of PK/PD and clinical pharmacology. In this webinar, we bring top scientists of the field to introduce how the concepts of PK/PD and clinical pharmacology are being applied to support discovery and development of ADCs. Specific focus will be given to model-informed drug discovery and development. The first part of the webinar will cover how the different pieces of PK/PD data can be brought together with quantitative systems pharmacology (QSP) modeling to aid the preclinical to clinical translation of ADCs. It will showcase how the complexity of the ADC modality can be characterized for its PK/PD and how the different data can be integrated with the approach of QSP modeling and simulations. The second part of the webinar will focus on clinical development of ADCs. Industry examples will be presented on dose selection and justification during clinical development that were supported by population pharmacokinetic modeling and exposure-response analysis. It will demonstrate how the complex challenges associated with unique characteristics of ADCs were tackled using the concepts of clinical pharmacology. Learning Objectives: How the PK/PD principles are applied to the ADC modality Clinical pharmacology considerations of ADCs Application of MIDD concepts for ADCs Speaker Information Eshita Khera, Novartis Claire Li, Daiichi Sankyo
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