Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on July 30,2024, 12 pm- 1 pm EDT on the following topic: “ Will you lose your job to AI? Landscape and applications in natural language processing (NLP) and Machine Learning (ML) for bioanalytical assays, and CMC applications ” Overview of AI in early drug development and manufacturing including regulatory requirements. The role of the pharmaceutical scientist in the age of AI. Landscape and application of AI/ML in regulatory, bioassay, and CMC: Regulatory applications of AI/ML Bioanalytical Assay monitoring and statistics computations Expert advice on bioanalytical assay development and challenges Drawing insights from rich CMC data for cellular therapies Discussion Leaders: Stephanie Pasas-Farmer, BioData Solutions, LLC Rob Dodge, Biopharmaceutical Consultant Rashed Harun, Genentech Dale Miles, Genentech Organized by: Dale Miles (Genentech) We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. Please remain on mute unless asking questions) Please feel free to share with colleagues who may be interested in this topic. Login Details Below: When: Tuesday, July 30, 2024: 12 pm to 1 pm EDT Where : Please join from your computer, tablet or smartphone. https://meet.goto.com/505947717 You can also dial in using your phone. United States: +1 (646) 749-3122 Access Code: 505-947-717 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 505-947-717 Or dial directly: [email protected] or 67.217.95.2##505947717 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://meet.goto.com/install Thank you, The Leadership Teams of the AAPS Communities
Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on July 30,2024, 12 pm- 1 pm EDT on the following topic: “ Will you lose your job to AI? Landscape and applications in natural language processing (NLP) and Machine Learning (ML) for bioanalytical assays, and CMC applications ” Overview of AI in early drug development and manufacturing including regulatory requirements. The role of the pharmaceutical scientist in the age of AI. Landscape and application of AI/ML in regulatory, bioassay, and CMC: Regulatory applications of AI/ML Bioanalytical Assay monitoring and statistics computations Expert advice on bioanalytical assay development and challenges Drawing insights from rich CMC data for cellular therapies Discussion Leaders: Stephanie Pasas-Farmer, BioData Solutions, LLC Rob Dodge, Biopharmaceutical Consultant Rashed Harun, Genentech Dale Miles, Genentech Organized by: Dale Miles (Genentech) We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. Please remain on mute unless asking questions) Please feel free to share with colleagues who may be interested in this topic. Login Details Below: When: Tuesday, July 30, 2024: 12 pm to 1 pm EDT Where : Please join from your computer, tablet or smartphone. https://meet.goto.com/505947717 You can also dial in using your phone. United States: +1 (646) 749-3122 Access Code: 505-947-717 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 505-947-717 Or dial directly: [email protected] or 67.217.95.2##505947717 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://meet.goto.com/install
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
Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on Aug 8, 2024, 12 pm- 1 pm EDT on the following topic: “ Quantitative modeling approaches for LNP-mRNA therapeutics ” Why are quantitative approaches important for LNP-mRNA product development during preclinical and clinical stages? What are the key features and challenges when applying quantitative approaches for LNP-mRNA therapeutics? How to build and implement quantitative approaches for LNP-mRNA therapeutics? Discussion Leaders: Saroja Ramanujan, previous Executive Director, Translational Sciences & Pharmacology, Head of QSP, Genentech Hojjat Bazzazi, Director, Quantitative System Pharmacology, Moderna Min Liang, Associate Director, Pharmacometrics, Moderna Organized by: Dale Miles (Genentech), Yun Liu (Moderna), Yan Ni (Passage Bio), Yanmei Lu (Sangamo Therapeutics) We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. (Please remain on mute unless asking questions) Please feel free to share with colleagues who may be interested in this topic. Login Details Below: When: Thursday, Aug 8, 2024: 12 pm to 1 pm EDT Where : Please join from your computer, tablet or smartphone. https://meet.goto.com/505947717 You can also dial in using your phone. United States: +1 (646) 749-3122 Access Code: 505-947-717 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 505-947-717 Or dial directly: [email protected] or 67.217.95.2##505947717 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://meet.goto.com/install Please feel free to share with colleagues who may be interested in this topic. Thank you, The Leadership Team of the AAPS GCTP Community
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
October 20-23, 2024 Salt Palace Convention Center Salt Lake City, UT From discovery to delivery, PharmSci 360 covers everything in pharmaceutical sciences, with a focus on: Discovery and Basic Research. Preclinical and Translational Sciences. Bioanalytics. Manufacturing and Analytical Characterization.
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