Announcements

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) Community on January 15^th, 2026, 12 pm – 1 pm ET on the following topic:

 
Featured 2025 PharmSci 360 Biomarker Posters:  A Collection for Community Discussion

This OSD will showcase the following posters that caught our Biomarker Community's interest.

• Comparison of Exosome Isolation Methods for the Analysis of a Disease Biomarker in Serum and Urine by PCR Methodologies
• Comparison of Novel Whole Blood Preservation Methods as Alternative to Cryopreserved PBMC for Immunophenotyping in Multicenter Clinical Trials

Presenters:

• Jean Paul Ouedraogo (Charles River Laboratories)
• Thomas (TJ) Beadnell (Eurofins)

 
Organizers:  Carmen Fernández-Metzler (PharmaCadence) and Karen Quadrini (Prothena Biosciences)

 
We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

 
When: Thursday, Jan 15, 2026, 12 pm – 1 pm EST

Where: Please join from your computer, tablet or smartphone.

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Hello BPABC Community, 

I hope everyone is doing well.

This is an important update regarding restructuring of AAPS Communities. Briefly, there is a large number of Communities (34) currently in existence, which have a fair amount of overlap among them in terms of scope. In the interest of streamlining Communities' structure, and after comprehensive consultations and reviews, AAPS will be reducing this number to 8 core Communities, as shown in the snapshot below. 

The BPABC Community will be rolled under the new “Quality” Community and existing members will automatically migrate to the new structure. You're welcome to join more than one Community. The new Communities will become effective in March 2026. Regarding Community leadership, AAPS will call for volunteers to apply for Chair and Vice Chair roles as well as other positions.    

Warm regards, 

Mayank Patel

BPABC Community Chair

Join us for our upcoming webinar: A Solvatochromic Approach to Streamlining Protein Formulation: Mapping Electrostatic and Polarity Effects of Excipients by Dr. Valeria Briceida Tellez Gallego. 

The AAPS Journal just shared this #editorial from the AAPS Biomarker & Precision Medicine Community on the 2025 FDA BMVB Guidance with authors spanning 19 organizations.

AAPS Communities unite members with a common interest in a specific topic in a web-based, always-available, virtual environment. Join us in giving a round of applause to these Community leaders. 👏 👏

The phase behavior of excipients in multicomponent pharmaceutical systems during freeze-drying involves a complex interaction between formulation components and processing conditions. Successful drug product and process development depends on thoroughly characterizing the phase transitions of excipients in both the frozen and drying stages, understanding their tendency to crystallize during processing, and identifying the physicochemical stability needs and critical quality attributes of the final product.

Raj Suryanarayanan, Ph.D., of the University of Minnesota, explains how excipient phase behavior influences the stability of the API, the intricate relationship between formulation composition and processing conditions, and the strengths and limitations of analytical techniques used to monitor phase transitions in frozen and freeze-dried systems.

AAPS joins STEM organizations from across the breadth of the sciences in recognizing Peer Review Week, September 15-19, 2025. This week-long celebration highlights the value of peer review in ensuring credibility in research and this year's theme is "Rethinking Peer Review in the AI Era."

In recognition of Peer Review Week, AAPS will open the eLearning webinars, “Publish or Perish: Peer Review in the Pharmaceutical Sciences” and “Understanding the 'Dreaded' Manuscript Review Process” to non-members for a limited time, along with the opening plenary from the 2025 PharmSci 360. This session featured a panel discussion (starts at 48:00) with Ivan Oransky, M.D., Co-founder of Retraction Watch and Colby Vorland, Ph.D., Assistant Research Scientist at the Indiana University School of Public Health-Bloomington.

Through its four peer-reviewed journals (The AAPS Journal, AAPS PharmSciTech, Pharmaceutical Research, and AAPS Open), AAPS supports ethical, credible science with the help of hundreds of scientist-volunteers who share their time and expertise by participating in peer review. Independent peer reviewers for these publications are critical to assuring the quality of scientific research used in the development of products and therapies that improve global health.

We’ve seen a shift in how food and pharma approved colors are viewed in recent years. Alongside updated regulatory guidance, there’s also been an increase in misinformation, making it harder to separate facts from assumptions.

We are excited to share that Dave Schoneker, who has followed this topic during his 48 year career, will be presenting a 'recap and update on the current landscape and how we got here' at our September meeting. His talk will be followed by an open Q&A.

September 25th, Time: 12–1 pm (EST)

Experience cutting-edge scientific content at #PharmSci360, November 9-12, in San Antonio, along with #professionaldevelopment sessions and opportunities at #Careers360 in our Solution Center.

⏰ Today is the final day for Early Bird Pricing! Register today and save. ⏰

AAPS is pleased to announce that our members have elected new leaders to the AAPS Board of Directors.

Congratulations to President-elect @Otilia Koo, PhD, FAAPS, Novo Nordisk, and Members-at-Large @Carl Allenspach, Ph.D., Bristol Myers Squibb and @Kevin Litwiler, Ph.D., OnKure Therapeutics.

👏👏 AAPS is pleased to announce that eight members have been selected for elevation to Fellow status in recognition of their professional excellence and sustained superior impact in fields relevant to AAPS’ mission: advancing the capacity of pharmaceutical scientists to develop products and therapies that improve global health.

The new Fellows will be formally inducted at #PharmSci360.

Congratulations to all! 🎉

Join industry experts at the Bioprocessing Summit, taking place August 18-21, 2025, at the Omni Boston Hotel at the Seaport, a new venue in the heart of Boston’s trendy Seaport District.

Recognized as the premier event for innovation in bioprocess R&D, scale-up, quality, analytics, and the growing role of AI and machine learning, the Summit brings together the brightest minds from pharma, biotech, and academia.

This year’s program features over 250 expert speakers and cutting-edge sessions that span the full bioprocessing spectrum, offering opportunities to connect, collaborate, and advance strategy from early discovery to commercial manufacturing.

Explore the sessions, training seminars, and networking opportunities, plan your experience, and see how you can get involved at BioprocessingSummit.com.

Join industry experts at the Bioprocessing Summit, taking place August 18-21, 2025, at the Omni Boston Hotel at the Seaport, a new venue in the heart of Boston’s trendy Seaport District.

Recognized as the premier event for innovation in bioprocess R&D, scale-up, quality, analytics, and the growing role of AI and machine learning, the Summit brings together the brightest minds from pharma, biotech, and academia.

This year’s program features over 250 expert speakers and cutting-edge sessions that span the full bioprocessing spectrum, offering opportunities to connect, collaborate, and advance strategy from early discovery to commercial manufacturing.

Explore the sessions, training seminars, and networking opportunities, plan your experience, and see how you can get involved at BioprocessingSummit.com.

👏 AAPS is pleased to announce that the impact factors for the peer-reviewed journals AAPS PharmSciTech and Pharmaceutical Research increased in 2024. 👏

📚 AAPS members have free, unlimited, electronic access to articles in AAPS’ four peer-reviewed #journals.

AAPS fosters the #science you practice by advancing scientific discovery, exchange, and learning. AAPS members receive a discount on AAPS books. 📚

Don't miss "Bioequivalence Requirements in Various Global Jurisdictions", a part of the AAPS Advances in the Pharmaceutical Sciences Series, from editor Isadore Kanfer. This book 📖 :

📗 Combines BE, #bioequivalence, standards from across the world into a single reference source-harmonize standards
📘 Provides updated information on #regulatory guidances for the market approval of generic products
📙 Describes and explains the various procedures, protocols, and statistical requirements for bioequivalence studies

Please join us for an Open Scientific Discussion (OSD) hosted by the Biomarkers and Precision Medicine (BPM) Community on July 9, from 1-2 PM ET on the following topic:

Multi-Parametric Biomarker Signatures

·         How do we go from identifying a potential biomarker with omics tools to an assay that is used in clinical trials?

·         Examples of biomarker panel assay use:  Renal safety biomarkers, Alzheimer’s disease, pharmacodynamic signatures

·         Challenges in establishing and translating multi-parameter biomarker assays to the clinic

Discussion Leaders:

Tom Lanz (Pfizer)

Tim West (C2N Diagnostics)

Chris Whelan (formerly Johnson & Johnson)

Organized by:  

Joel Matthews (Ionis Pharmaceuticals)

Jurre Kamphorst (AstraZeneca)

Carmen Fernández-Metzler (PharmaCadence Analytical Services)

Karen Quadrini (Prothena Biosciences)

We start at 1:00 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: Wednesday July 9, 2025, 1 pm – 2 pm ET

Where: Please join from your computer, tablet or smartphone.

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The AAPS BPM Community Leadership Team

Tune in 🔊 to the latest BioTalk Unzipped #podcast episode, filmed live during the #NBC2025 in Boston, that features AAPS President @Russell Weiner.

📅 Date: Monday, June 16, 2025

🕛 Time: 12:00 PM – 1:00 PM Eastern Time

📍 Location: Virtual Seminar @ https://global.gotomeeting.com/join/271724949

🧪 OSD Overview

Join us for an engaging 1-hour discussion featuring:

Dr. Gabriela Hernandez Hoyos (BMS) and Dr. Ilayaraja Muthuramu (J&J)
Experts in genomic risk analysis and safety assessments of CAR T platforms

They will explore:

●        Genomic risks in lentiviral vs. gene-edited CAR T products

●        Key molecular and functional assays used in risk assessment

●        Preclinical safety challenges in autologous vs. allogeneic approaches

●        Insights from published case studies and FDA-approved testing strategies

🧠 Who Should Attend?

Scientists, researchers, and professionals working in:
- Gene and cell therapy
- Regulatory science
- Oncology R&D
- Translational medicine

🔗 Why Attend?

- Hear from leaders in the field
- Participate in an open discussion on safety assessment strategies
- Gain insights into regulatory and translational approaches for CAR T therapies

15th May 12-1pm EST

_______________________________________________________________________________

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The landscape of GLP-1 therapeutics is rapidly evolving. Staying ahead of the curve is crucial for research teams. 🌐
Join AAPS on May 13-14, for Beyond GLP-1s: Where the Science Will Take Business Next. This workshop brings business leaders and scientists together to explore the latest innovations in the field and how science is driving the future of diabetes therapeutics. 💡
With discounted pricing for AAPS members and a great lineup of speakers, this is an opportunity you won’t want to miss!

#DYK Allergic asthma is primarily driven by abnormal T helper (Th2) cells, where interleukin receptors and STAT6, a crucial transcription factor, play central roles in inflammation and disease progression. A major hurdle in asthma treatment is the lack of biocompatible vectors for efficient siRNA delivery to target cells. Join AAPS tomorrow as Mahavir Bhupal Chougule, Ph.D., of Mercer University, presents a study using receptor-guided STAT6 siRNA-loaded gelatin #nanocarriers conjugated with a targeting peptide to selectively deliver siRNA to T cells.

All AAPS members receive access to numerous archived AAPS #webinars similar to this along with many other high-value benefits. 

#DYK Allergic asthma is primarily driven by abnormal T helper (Th2) cells, where interleukin receptors and STAT6, a crucial transcription factor, play central roles in inflammation and disease progression. A major hurdle in asthma treatment is the lack of biocompatible vectors for efficient siRNA delivery to target cells. Join AAPS tomorrow as Mahavir Bhupal Chougule, Ph.D., of Mercer University, presents a study using receptor-guided STAT6 siRNA-loaded gelatin #nanocarriers conjugated with a targeting peptide to selectively deliver siRNA to T cells.

All AAPS members receive access to numerous archived AAPS #webinars similar to this along with many other high-value benefits. 

See the latest science and make new connections this November. AAPS just opened registration for the 2025 #PharmSci360 in San Antonio, TX, November 9-12! Register today!

This is your final opportunity to submit a session proposal for the 2025 PharmSci 360. The submission deadline is today, April 8, at 5 PM ET.

See you tomorrow! 👉 In recognition of #WorldHeathDay, Ana Jaklenec, Ph.D., of Massachusetts Institute of Technology, will present #research aimed at enhancing #vaccine efficacy and availability for worldwide health initiatives.

See you tomorrow! 👉 In recognition of #WorldHeathDay, Ana Jaklenec, Ph.D., of Massachusetts Institute of Technology, will present #research aimed at enhancing #vaccine efficacy and availability for worldwide health initiatives.

Here's the link for the MSE Community Meeting at 12:30pm on Thursday Sept. 4th. Meet the MSE Leadership Team.  We'll share our 2025 goals and we welcome any feedbaack.

Topic: MSE Community Meeting
Time: Sept 4, 2025 12:30 PM Eastern Time (US and Canada)
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+1 346-413-5633,,855424035# United States, Spring

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Dear all,

A reminder that our next Stability community meeting is this Thursday, Mar 13 at 12PM PT / 3PM ET.  Hope you can join us!

🌟 Join Us for an Insightful Discussion with Dr. Nigel Langley! 🌟

With over 35 years of experience in the excipient industry, Dr. Nigel Langley is a name many in pharmaceutical product development are familiar with. Are you curious about his insights on the 'Importance of Excipient Grade'? I know I am! 😊

The AAPS Excipient Community invites you to our March monthly discussion session with Dr. Langley. This is an excellent opportunity to learn about the ‘Importance of excipient grade in the pharmaceutical industry’ - a key topic for IPEC-Americas, and ask any questions you may have.

📅 Date: 27-March-2025

🕛 Time: 12-1pm EST

🌐 Format: Virtual

Don't miss out on this chance to gain valuable knowledge from an industry expert!

AAPS Excipient Community Leadership Team