Upcoming Events


  • Wednesday
    10
    July

    eChalkTalk: JULY 10 - How Good Does Your Medicine Taste: Overcoming Bitterness Challenges in Drug Pr

    Over 60% of Active Pharmaceutical Ingredients on the market are considered bitter, and the demand for innovative, patient friendly dosage forms that increase patient compliance is rising. Galenic forms such as orally disintegrating tablets, orodispersible films, and oral liquids require a more careful taste design, due to the inherent contact of all the formulation components with the tongue and taste receptors prior to ingestion. Flavor tonalities, taste modulators such as maskers, blockers, sensates, and sweetness enhancers are examples of technologies available to create the ultimate flavor perception. A combination of several technologies is usually the best solution for a given formulation, and varies depending on the form, use level and type of ingredients, preparation process, regional regulatory compliance, and patient group (age, country of origin, potential taste distortions). Often, the regulatory landscape is the most concerning aspect to drug product formulators, as there is an increased scrutiny from regulatory bodies on the role of flavoring agents in drugs, and the documentation requirements for their approval. Innovations such as receptor-based discovery of new flavor molecules that bind and block specific receptors on the tongue are state-of-the-art technologies that enable the creation of targeted taste modulators for specific challenges common to the pharmaceutical industry, such as bitterness. Understanding how APls with off-tastes interact with taste receptors and how we can modulate these taste receptor activities, with targeted novel flavors and flavor modifiers, will allow the development of novel formulations truly unlocking the full potential of an innovative drug product. Speaker Information Guy Servant, Ph.D. Guy Servant was trained in receptor pharmacology in Canada and then conducted post-doctoral work at UCSF in molecular pharmacology and signalling. He joined dsm-firmenich in 2000 to functionalize taste receptors and established the high throughput screening operations for taste receptor assays. Since then, he has taken on increasing responsibilities, including leading the biology team and managing overall R&D activities at our San Diego research and development site. Lyzandra Passarella-Dutour, MSc. Global Taste Technical Director, dsm-firmenich, Switzerland More than 20 years of experience within the Flavor Industry MSc in Flavouring Expertise Formulation & Applications from ISIPCA Versailles –France Leading various teams from applications, flavor creations and analytical on Sweet Goods, Beverages and healthier products Experience in building innovative taste and flavors solutions in different food segments Creating and optimizing flavor portfolio’s following consumer trends and customer needs #eChalkTalk #onlinelearning

  • Thursday
    18
    July

    OSD on Part 3: Multi-omics Integration into Clinical Decision Making

    The Biomarkers and Precision Medicine (BPM) and Bioanalytical (BA) Communities are hosting a series of Open Scientific Discussions (OSDs) on Multi-omics in Drug Development . Please join us for the third OSD in the series on July 18 th , 12 - 1 pm ET : Part 3: Multi-omics Integration into Clinical Decision Making · What does the present regulatory environment look like for the application of multi-omics in clinical decision-making? · What challenges and considerations does multi-omics testing face, especially for adoption of MS-based proteomics, in clinical studies? · Case studies where multi-omics approaches have impacted clinical decision makings will be presented. Discussion Leaders: Robert Schuck (FDA) & Yuehan Feng (Biognosys) Organized by: Jurre Kamphorst (Olaris), Iris Qiu (Novartis), Ayuko Ota-Selik (Regeneron) 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 : Tuesday, July 18, 2024, 12 pm – 1 pm ET Where : Please join from your computer, tablet or smartphone. https://global.gotomeeting.com/join/305789893

  • 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

    OSD: Will you lose your job to AI? Landscape and applications in natural language processing (NLP)

    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

  • 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

  • Thursday
    8
    August

    OSD: Quantitative modeling approaches for LNP-mRNA therapeutics

    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

  • 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

  • Sunday
    20
    October

    AAPS' 2024 PharmSci 360

    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.

    Salt Lake City, UT, United States

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