Theme 1: Clinical Pharmacology Challenges and Opportunities in Rare and Neglected Diseases and Special Populations
The drug development programs for rare, ultra-rare, and orphan diseases, as well as for special populations such as pregnant and lactating women, the elderly, and pediatrics, are generally atypical in comparison to conventional programs. They have unique considerations and challenges such as limited understanding of disease progression and pathophysiology, disease heterogeneity, recruitment hurdles due to small patient populations, safety risks and anticipated differences in PK/ PD (in comparison to the general population). In addition, designing clinical trials with the dilemma of placebo arms, global regulatory requirements, and reimbursement questions create more complexity.
This theme will cover these challenges and the role of clinical pharmacology and model-in- formed drug development in overcoming some of these barriers. Applications of exposure-response analysis, Population PK/PD and PBPK modeling, adaptive trial designs, use and design of real-world evidence, and the role of caregivers and advocates in the drug development for such diseases and patient populations will be discussed. Case studies and specific examples are also encouraged.
Theme 2: Clinical Pharmacology and Immunogenicity Considerations of Novel Modalities
As new drug modalities continue to evolve, drug discovery and development is transitioning from traditional small molecules to immunogenicity.
This theme will cover challenges in the development of novel modalities, and the role of clinical pharmacology in determining dose; considerations of cellular kinetics; exposure-response relationships; drug interactions; and managing immunogenicity. Specific regulatory challenges will be discussed and debated as well.
Theme 3A: Recent Developments in Physiologically- Based Pharmacokinetic (PBPK) Modeling of Transporter-monoclonal antibodies, engineered proteins, oligonucleotides, cell therapies, and gene-based therapies.
Approaches to define dose, pharmacokinetics, drug interactions, and their relevance to clinical activities vary from conventional drug therapies and pose new challenges in developing these modalities. The new modalities mainly interact with elements of the immune system that can cause immunogenicity. With discovery of these new modalities, clinical pharmacologists need to establish innovative approaches to support drug development and manage PD and PBK modeling.
Mediated Drug Dispositions
Transporters may play a significant role in drugs disposition affecting their efficacy and safety. Depending on the transporters function (e.g., efflux or influx), location (e.g., basolateral or apical) and organ (e.g., gut, liver, kidney, brain, muscle) their impact may vary. Similar to metabolizing effects on drug pharmacokinetics, pharmacodynamics, safety, and tolerability. Therefore, PBPK modeling of transporters can help clinical pharmacologists better understand drugs mechanism of action, design clinical studies, and determine covariates affecting drugs PK and PD.
This theme provides an opportunity to present, learn about, and discuss recent advancements in clinical pharmacology applications of PBPK transporter modeling for study design, dose selection, personalized dosing, regulatory interactions, and informing drug labels.
Theme 3B: Clinical Pharmacology Challenges of Special Delivery Routes
Drugs can be given through various special delivery routes including subcutaneous, inhalation, intraviterial, intrathecal, and long-acting injectable. Depending on the therapeutic area and patients’ need, one or several of these routes may be selected. Running clinical studies using such routes can be challenging and requires specific considerations. For example, the bioavailability and release rate of the drug, disposition from the administration sites, biological and physiological factors affecting these parameters, and the role of devices used are not or less known.
This theme will provide an opportunity to discuss clinical pharmacology considerations when special routes of administrations are selected. In addition, the role of model-informed drug development in designing such studies and related regulatory considerations and challenges are highlighted using case studies.
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!