Theme 1: Applications for Predictive and Clinically Relevant In Vitro, Ex-Vivo and In Vivo Models
Testing in clinically relevant preclinical models are critical for design, optimization, rank-ordering, and selection of effective therapeutic candidates. Several considerations including mechanism of action, clinical relevance, time and resource needs, animal welfare, throughput, variability, and reproducibility impact the selection of preclinical models.
This theme focuses on challenges, opportunities, and innovations in applying predictive and clinically relevant in vitro, ex-vivo, and in vivo models for preclinical development. This includes (but is not limited to) innovations in applying patient-derived samples, organ-on-chip systems, and novel animal models capturing disease pathophysiology. This theme includes: designing of in vitro (MABEL and beyond) experiments that are clinically relevant for optimal clinical dose selection; development of metabolites in safety testing (MIST) guidance to inform the design of toxicology studies; and application of relevant preclinical models to characterize microbiome impact on drug ADME and therapeutic activity. In addition, preclinical models for selection of molecules and combination partners (e.g., cancer immunotherapy) will be covered.
Theme 2: Design and Preclinical Development of Novel Therapeutic Modalities, Molecules and Delivery Approaches
In recent years, there has been an explosion of new therapeutic modalities and novel molecular designs that has created new hope for the treatment of many hard-to-treat diseases. These approaches have enabled scientists to exploit novel mechanisms of action and modulate targets that were previously undruggable. However, these promising novel approaches also bring a new set of challenges during the discovery and preclinical development stage.
This theme focuses on opportunities, strategies, and lessons learned in the design and development of novel modalities such as oligonucleotides, peptides, gene and cell therapies, proteolysis targeting chimeras (PROTACs), targeted covalent inhibitors, and antibody-drug conjugates. Innovations in molecular design (both biomolecular and chemical entities) and drug delivery strategies for effective delivery to the target site, and to enhance therapeutic index, will be covered in this theme. Additional topics include tox strategies, ADME considerations, and regulatory perspectives on the preclinical packages needed for development of novel modalities and molecular constructs.
Theme 3: Model-Informed Preclinical and Translational Drug Development
The role of modeling and simulation in supporting the discovery and development of effective therapeutic agents has been well recognized by academia, industry, and regulatory agencies. The growth of precision and personalized medicine is driving the development of more fit-for-purpose, mechanism-based and quantitative systems pharmacology models (QSP) to support drug discovery and early development.
This theme focuses on quantitative modeling approaches (e.g., PBPK, mechanistic PKPD, QSP) for forward and reverse translation in drug development, and in the application of mechanism-based and systems pharmacology modeling in the early discovery and preclinical development space. This theme also covers opportunities and challenges for advanced-analytics and machine learning approaches in therapeutic development, and regulatory considerations and perspectives on the use of translational mathematical models for first-in-human (FIH) and prospective efficacious dose selection.
Theme 1: Bioanalysis – Beyond the Bench
Bioanalysis encompasses more than analyzing samples. This theme focuses on the non-sample analysis activities/collaborations that bioanalytical scientists deal with in the course of their work. Examples of topics falling under this theme include the bioanalytical/IT interface (e.g., next generation sequencing workflows, data integrity, system validation, cloud use, artificial intelligence, data analysis, verification of data calculations in commercial software), as well as operational and regulatory challenges (e.g., country specific requirements, environmental considerations, export/import logistics) that bioanalytical scientists encounter and navigate in the course of drug discovery and development.
Theme 2: The Evolving World of Bioanalysis
In recent years, bioanalysis has moved beyond the analysis of small molecules and mAbs in biofluid samples. The need to support vaccine development, biomarker analysis, point of care diagnostics, patient-centric sampling approaches, characterization of the pharmacokinetics and immunogenicity of new/novel therapeutic modalities (e.g. PROTACs), and to augment plasma analysis with quantitation of drug in tissues, has led to the development of new approaches as well as new and newly applied technologies and platforms that will be highlighted in presentations under this theme.
Theme 3: Best Practices in Bioanalysis
How do scientists ensure that bioanalytical data generated in the lab are “fit for purpose”? Are there times when working in specific geographies requires taking a region-specific approach, that is, applying a region-specific best practice? This theme will present answers to these questions. Best practices refer to those developed either through cross company/regulatory agency collaborations or through internal discussions among multiple stake holders dealing with topics such as immunogenicity, assay validation, sample handling/management, and biomarker analysis. This theme will provide an opportunity to share such discussions/collaborations to a wide audience.
Look for the New Poster Formats Returning at PharmSci 360
AAPS introduced new poster formats at the 2020 PharmSci 360, and many authors loved the new options! Those options have been incorporated into all AAPS events that offer posters, including the National Biotechnology Conference (NBC) and PharmSci 360.
AAPS requires all authors to include: the title; authors; the complete, unedited abstract that was submitted for approval; purpose; methods; results; conclusion—and the data!
Now authors have more options for how they display this information.
Learn more about submitting a poster abstract for PharmSci 360, or submit now! www.aaps.org/posters
AAPS PharmSci 360 Poster Abstracts
Now accepting Late-Breaking Poster Abstracts (LBPA)—The 2021 PharmSci 360 LBPA submission deadline is July 21 at 5 pm ET!
Make the most of a unique experience—find research collaborators at PharmSci 360!
Poster floors are a hotbed of research at any scientific meeting. A poster presentation provides a unique opportunity to convey important research findings while interacting with a targeted audience and expanding one’s professional network. By the end of an active Poster Forum at AAPS PharmSci 360, both poster presenters and attendees will have learned from each other. This exchange can be especially important to presenters who intend to continue their work in future presentations and submissions to journals.
Posters must be explained quickly and clearly so your audience understands why a project is important and what your findings mean. Effective communication is a vital skill every scientist uses day to day! Presenters at PharmSci 360 grow their ability to network and collaborate.
Posters are a hybrid form of learning. They are more detailed than a general lecture, but less demanding than a full research paper. Most important, they are more interactive than either and thus are unique. In a lecture, for example, the presenter determines the goal and the focus of the presentation. But in a poster session, the audience drives the conversation with their questions. A poster presenter at a conference will be approached by a number of people—all with different expertise and knowledge levels—who will ask about different facets of the research.
This provides an unparalleled opportunity for presenters to collaborate and promote their research. So, be prepared to capitalize on this experience. Here are six tips to make the most of your poster time.
A GOOD POSTER MUST:
- Be written with the audience in mind—As you design your poster, provide enough background on both the topic and the methods to convey the purpose, findings, and implications of your research to the expected range of readers/audience.
- Tell a simple, clear story—Providing a clear take-home message that can be grasped in a few minutes is key!
- Explain statistical methods and results—Present statistical significance that keeps the focus on the results, not on the arithmetic needed to conduct inferential statistical tests.
- Use graphs and charts—Let your figures do the talking! Reduce the need for long text descriptions or complex tables with tiny numbers that are cumbersome to read.
- Have a short, specific title—This is the first glimpse of your poster, so make a good impression. Make it inviting and easy to read from a distance.
- Be ready with your story—Keep it short! Prepare a few sentences that highlight what you are studying, present a couple of key findings, and explain why they are important to capture attendees’ attention.
The poster abstract submission site for the 2021 AAPS PharmSci 360 is now open.
Visit Abstracts and Posters to review the Call for Poster Abstracts
Submit your abstract now!
What are Rapid Fires?
Rapid Fires are quick, 10-min presentations with 3-min of Q&A on the latest scientific topics. Have research or ideas that are novel and exciting? Share them on the Rapid Fire stage!
AAPS is still accepting Rapid Fire programming ideas for the 2021 PharmSci 360. Submit your presentation idea by June 15, 2021 to be considered.
Your program ideas are vital to the success of PharmSci 360. Contribute to the body of science and the exchange of knowledge—submit a proposal! PharmSci 360’s programming covers every aspect of the pharmaceutical sciences in a 6-track format.
Visit the 2021 PharmSci 360 submission instruction page to learn more about this year’s programming—including the tracks, topics, and themes it will cover—as well as how to submit your proposal.
Learn More!