AAPS PharmSci 360 2025: what can conference attendees look forward to?

Written by Emma Hall (Contributing Editor)
Conference reports

AAPS has released the program for the 2025 PharmSci 360 event taking place on November 9–12, at the Henry B. Gonzales Convention Center (San Antonio, TX, USA).

Symposia, keynotes, speaker spotlights, poster sessions, hot topic presentations, and rapid-fire talks taking place at PharmaSci 360 will examine the current trends in pharmaceutical sciences. With five main tracks, topics include regulatory guidance for AI in bioanalysis, techniques for novel therapeutic modalities such as ADCs and peptide-based treatments, navigating the complexities of delivery systems, and predictive tools in the drug manufacturing and quality space.

Richard T Thakor from the University of Minnesota (MN, USA) will deliver the opening plenary on Sunday, November 9, and Daniel G Anderson, who is a Professor at the Koch Institute for Integrative Cancer Research at MIT (MA, USA) and a leader in the nanotherapeutics field, will deliver the closing plenary on Wednesday, November 12.

Here are some of the presentations and plenaries our Editors are looking forward to:

1. Bioanalytics of new drug modalities and cell/gene therapies

When: Monday, November 10, 2:30 PM–3:00 PM CT
What: This presentation aims to address the growing complexity of bioanalytics in characterizing advanced biotherapeutics, including gene and cell therapies, which often require integrated assay strategies to account for intracellular targets and post-translational modifications. It will also emphasize the importance of navigating diverse regulatory frameworks to ensure compliant and effective bioanalysis for next-generation drug development.

2. Hot topic: Rise of machines and biosensors in drug delivery

When: Monday, November 10, 9:30 AM–10:30 AM CT
What: The talk of the town these days, this presentation explores how machines and biosensors, enhanced by AI, are switching up biomedical applications such as diagnosis, treatment and personalized drug delivery. Some of the highlights include key design and translational challenges in developing these technologies and how to advance their clinical adoption through interdisciplinary collaboration.

3. Rapid fires: Shaping biologics: from molecules to manufacturing excellence

When: Tuesday, November 11, 3:00 PM–4:00 PM CT
What: With individual sessions covering improving oligonucleotide mass spectrometry data through ion source optimization, analytical methods used to measure aggregation and fragmentation of large molecules, and how to predict and prioritize critical quality attributes during early and late-stage drug development, this series of presentations is set to be extremely interesting.

4. Hot topic: 2025 FDA guidance BMV for biomarkers: impact and path forward

When: Tuesday, November 11, 10:30 AM–11:30 AM CT
What: This discussion will explore the FDA’s 2025 guidance on biomarker assay validation, which builds on the 2018 framework but emphasizes a fit-for-purpose approach tailored to each biomarker’s context of use (COU). Speakers will highlight key differences between PK and biomarker assays, stressing the need for flexible validation strategies that reflect biological and analytical variability across platforms.

5. Symposium: Using mass spec to support PD/PK

When: Tuesday, November 11, 09:00 AM–11:00 AM CT
What: This symposium will gather experts to discuss a range of topics, including what analytical tools and platforms can be used to develop receptor occupancy assays, how mass spectrometry imaging can be used for spatially resolved analysis of biological tissues, and innovative mass spectrometry strategies for clinical bioanalysis.

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About AAPS

The American Association of Pharmaceutical Scientists (AAPS) is a 501(c)(3) non-profit association of more than 7,000 scientists and professionals employed in academia, industry, regulatory and other research related to the pharmaceutical sciences worldwide. Its mission is to advance the capacity of pharmaceutical scientists to develop products and therapies that improve global health, which members pursue through four peer-reviewed journals and a variety of events in person and online. www.aaps.org

AAPS journals publish articles covering the breadth of pharmaceutical science, including complementary disciplines like chemistry, biology, and engineering. AAPS publishes four peer-reviewed journals: The AAPS Journal, AAPS PharmSciTech, Pharmaceutical Research, and AAPS Open. The latter is AAPS’ first fully open-access journal. It is freely available worldwide, and authors retain copyright. All four are available with AAPS membership or through institutional access. www.aaps.org/journals