Upcoming Events


  • Wednesday
    29
    May

    eChalkTalk: MAY 29 - AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

    Gene therapy has already demonstrated its potential of bringing life‐changing therapies to patients with devastating diseases and a growing number of clinical trials have been approved in recent years. One of the requirements in clinical development is to monitor vector shedding to control the potential environmental risk associated with the therapy. The assay read‐out is qualitative, providing the sponsor and investigator with the relevant information about vector‐shedding clearance after therapy. A sensitive and reliable method is needed in several different matrices, typically including blood, plasma, faeces, semen, urine and saliva. Viral shedding assays involve the extraction of viral DNA from patient secretions and excreta, the presence of which is then measured by selective and sensitive molecular methods (qPCR or ddPCR). Here we present the development of a shedding method for the detection of a AAV8 vector in several matrices, including whole blood, plasma, faeces, semen, urine and saliva. The method development is split into 3 distinct phases: primer/probe design, PCR optimization and extraction. In first part of method development, we designed 5 sets or primers/probes. In the second phase we optimised the best qPCR conditions by comparing the five primers/probe sets and four master mixes to identify the combination, showing the best amplification efficiency and linearity and the lowest limit of quantification (LLOQ), limit of detection (LOD), and background noise. In the third phase, we compared seven commercially available DNA extraction kits and evaluated them based on the viral DNA recovery efficiency and, most importantly, the sensitivity, measured in genome copies per μl (or mg) of starting material. While we chose a single combination of primer/probe set and master mix, we observed that different DNA extraction kits have to be used depending on the matrix of interest in order to achieve the best sensitivity which ranged from 0.6 to 7.4 GC/μl (mg) obtained from 50‐200 μl (mg) of starting material. In this presentation, we share the unique requirements and challenges in developing vector shedding assays, based on the results of a streamlined AAV8 shedding assay method development. We are sharing an extensive comparison of most commercially available extraction kits. We conclude with our recommendation for validation parameters, acceptance criteria and results reporting to support clinical and preclinical gene therapy studies. Learning objectives: Understand the critical role of vector shedding assays in assessing the environmental safety of gene therapies, highlighting the importance of monitoring AAV8 vector shedding in clinical and preclinical settings. Gain insights into the methodological advancements in primer/probe design, PCR optimization, and DNA extraction techniques that enhance the sensitivity and reliability of detecting viral DNA across various biological matrices. Learn to evaluate and select the most effective DNA extraction kits based on matrix‐specific performance, contributing to the development of standardized protocols for vector shedding assays in gene therapy research.

  • Thursday
    30
    May

    Multi-omics in Precision Medicine (Part 1)

    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

  • Friday
    14
    June

    Free Webinar - U.S. Visa and Immigration Options and Outlook - June 2024

    oin us for a groundbreaking webinar, designed specifically to support international students and professionals in navigating the complexities of U.S. visa situations. 📅 Date: June 14, 2024 🕛 Time: 12:00 pm ET 🎤 Speaker: Robert Webber , Immigration Attorney at Webber Arredondo Oja, LLC. Join Zoom Meeting: https://ucsd.zoom.us/j/7202320247 With the ever-changing landscape of U.S. immigration policies, it's crucial to stay informed and prepared. Robert Webber brings his wealth of expertise to the table, offering insights and guidance on various visa and immigration options available, along with an outlook for the future. Whether you're a student planning your educational journey or a professional seeking opportunities in the U.S., this webinar promises invaluable information to help you make informed decisions and navigate the visa process. Don't miss out on this opportunity!

  • Friday
    14
    June

    AAPS Global Health Community Leadership Meeting Jun 2024

    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

  • Wednesday
    26
    June

    WIPS PANEL DISCUSSION ON LEADERSHIP WITHIN AAPS

    Please join Women in Pharmaceutical Science Community (WIPS) on Wednesday 26th June, 12:00-1:00 PM, for a panel discussion on "Leadership Within AAPS" with Lakshmi Amaravadi, Yan Ni, Maiara Montanha, Amanda Hays and Robin Walsh. Meeting Link: https://meet.goto.com/AAPSWIPSAll-Communitybi-monthlymeeting #AAPS #AAPS #3DTechnology #Leadership #womeninpharmaceuticalsciences

  • Friday
    12
    July

    AAPS Global Health Community Leadership Meeting Jul 2024

    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

  • Monday
    22
    July

    2024 Summer Scientific Forum

    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.

    Kansas City, MO, United States

  • Tuesday
    30
    July

    Webinar: PK/PD and Clinical Pharmacology of ADCs

    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

  • Tuesday
    30
    July

    Webinar: PK/PD and Clinical Pharmacology of ADCs

    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

  • Friday
    9
    August

    AAPS Global Health Community Leadership Meeting Aug 2024

    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

  • Friday
    13
    September

    AAPS Global Health Community Leadership Meeting Sep 2024

    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

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