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  • Modified Release Community Webinar - Jan 24, 12-1 pm, EST

    The AAPS Modified Release Community is excited to share our first webinar of 2025! This will be co-hosted by the Nanotechnology community. Please don’t miss the opportunity to learn about the preclinical and clinical applications of nanocarriers for targeted and controlled drug delivery.

    Date and time: Friday, Jan 24, 2025, 12-1:00 PM, EST

    Topic: Engineering Nanocrystals: Advancing Controlled and Targeted Therapies

    Speaker: Dr. Alejandro J. Paredes, School of Pharmacy, Queen’s University, Belfast, UK

    Free registration link: https://pitt.zoom.us/meeting/register/8R47AN1cTYm9uS5cxRYvbA

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  • Upcoming ELISPOT Webinar hosting by AAPS ELISPOT Working Group

    Please join for a live virtual webinar on Jan 28, 2025, from 12:30 pm - 2 pm hosted by the AAPS ELISpot Working Group, a newly formed sub-team of the Biomarkers and Precision Medicine Community. The topic is as follows:

    Enhancing Drug Development with ELISpot/FluoroSpot Assays: Foundational Insights and Recent Advancements

    Presenters:

    Sylvia Janetzki (ZellNet Consulting)

    Xinyan (Nemo) Li (Johnson & Johnson)

    Madhan Masilamani (Bristol Myers Squibb)

    Moderators:

    Karen J. Quadrini (Prothena Biosciences)

    Sofie Pattyn (IQVIA Laboratories)

    Register for the webinar through the link here

    There is a short survey upon registration to best understand registrant proficiency with ELISpot/FluoroSpot assays.

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  • Stability Community Monthly Meeting - Thursday, Jan 09 12PM PT / 3PM ET

    A reminder that our next Stability community meeting is this Thursday, Jan 09 at 12PM PT / 3PM ET.  Hope you can join us!

    Topic

    Subtopic

    Lead

    Meeting Notes (check box indicates action is required)

    Introductions

    First time attendees / new members

    Community

    Community Updates

    Publications

    Community

    Book

    ·        

    Papers

    ·        

    Regulatory Guidelines

    Community

    ICH Guidance Updates (Lori)

    • Public draft availability?

    Others

    • USP Chapter on Biologics Stability (Stephanie/Camilla)
      • Addendum to 1049.1.  Commenting target

    Conferences

    Kim / Lori

    Upcoming Conferences

    • CMC Strategy/WCBP (Jan’25)
    • KENX Laboratory University (May’25): Call for speakers!
    • IABS Stats (Nov’25)
    • FDA – Jan 29, 2025.  Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA

    https://www.fda.gov/drugs/news-events-human-drugs/knowledge-management-and-modernization-regulatory-quality-assessment-and-submissions-fda-01282025

    Webinars / Community Collaborations

    Community

    Stats/Stability Joint Meeting

    • Upcoming Meetings
      • Q1: Reference Standards (Stephanie/Helen)
      • Q2: Impact of ICH Q1 Revisions on Statistical analysis of Stability data (Lori M./ Laura P.)
      • Q3: Stability Specification Setting (Nick P. / TBD)
      • Q4: Recap

    Webinars

    ·         Discuss topics for future webinars

    Knowledge Sharing

    PFS Stability Studies: BLGF

    Community

    Companies approach to “device” stability testing for biologics

    Part A: Do other companies routinely incorporate BLFG (Break Loose, Glide Force) in their stability program?

    1.      Frequency of testing

    2.      Clinical/Commercial or both

    3.      Success in eliminating this testing during commercial

    Part B: Enrollment of assembled device (PFS + Needle safety device) on stability

    1.      Success in justifying testing just PFS without assembly

    2.      Frequency of testing

    3.      Clinical/Commercial or both

    Topics for Future Meetings

    Community

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  • Get your questions answered this month!

    🤔 Do you have questions? We have answers! Start your 2025 off by getting your questions answered by AAPS leaders and experts during one of our upcoming #AskTheExpert sessions.

    ➡️ A panel of AAPS leaders will host, “Ask Me Anything About the Latest AAPS Salary Survey,” on January 13 from 11 am–12 noon ET on the AAPS Community platform. 

    The AAPS Salary Survey is the only survey that exclusively tracks compensation data within the pharmaceutical science sector. Each year, AAPS surveys its members about salary and compensation information along with demographic data.

    ➡️ A panel of experts will host an exclusive Ask Me Anything (AMA) session on the Characterization of Nanoparticles, on January 27, 11am ET. 

    This is a unique opportunity to chat with experts in the field and get answers to your most pressing questions about nanoparticle characterization.

    Join us and get your questions answered!

    #AMAs #Community

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