Theme: Novel Therapeutic Modalities — Clinical Pharmacology Considerations
These symposia will focus on clinical pharmacology considerations related to the development of novel therapeutic modalities. The symposia will cover case studies and discuss challenges and issues in dose selection, therapeutic individualization and overall drug development of novel therapeutic modalities. Examples of relevant new therapeutic modalities include oncolytic viruses, fusion proteins, nanobodies, immunocytokines, bi or tri-specifics, oligonucleotides, CAR-T or other cell and/or gene therapies.
Theme: Novel Approaches Informing Understudied Populations
Patient subpopulations that may be relevant to an intended indication are often excluded from clinical trials during drug development. These subpopulations can include women who are pregnant or lactating, those with advanced degrees of renal or hepatic impairment, pediatrics, adolescents, racial or ethnic subpopulations in support of global registrational plans. Furthermore, patients with rare genetic makeup or comorbidities such as HCV, HBV or AIDS could also be either excluded from trials or enrolled in insufficient numbers for adequate characterization of the benefit-risk profile in these subpopulations. Underrepresentation of these subpopulations presents a challenge in extrapolating findings from the general population to these patient subgroups. This symposium will focus on strategies, experiences and results from studying these subpopulations of patients, and their impact on the drug’s approval and use in these populations.
Theme: Model Informed Drug Development: 2020 and Beyond
The crucial role of model-informed drug development (MIDD) in effective delivery of novel treatments has been recognized by regulatory authorities, pharmaceutical industry, and academia. MIDD is currently an integral component in drug development. MIDD increases the confidence in decision making across drug development stages, reduces development cost, and/or enables accelerated development for drugs serving unmet medical needs.
These symposia will discuss current and future applications in MIDD methodologies including, but not limited to, population pharmacokinetics, physiologically based pharmacokinetic models and quantitative systems pharmacology, in evaluating the probability of technical success at different drug development stages, optimizing combination regimens, benefit-risk assessments, dose optimization, health economics, cost-effectiveness, alternative approaches to evidence generation, novel clinical trial designs, and drug approvals.
Register for PharmSci 360 today!
2020 AAPS PharmSci 360 – Now accepting Late Breaking Abstracts
Submission Deadline August 12 at 5pm ET
ADDENDUM to the Call for Poster Abstracts
The purpose of PharmSci 360 is to bring scientists together to exchange research and insights. The AAPS Board of Directors believes that it is especially important for AAPS to make this conversation possible in 2020, when the ability of our members to continue developing cures and therapies is hampered by the impacts of COVID-19 around the world.
AAPS recognizes that researchers have been especially affected by the pandemic, which has closed labs and forced the abandonment of projects. The Board wants you to present whatever research and insights you are able to share at the 2020 PharmSci 360. Therefore: AAPS will accept abstract submissions that have no data: The board is relaxing the data requirement for poster abstracts for 2020, and welcomes promising research that may not be complete by the submission deadline.
AAPS is developing contingency plans for PharmSci 360 that will give scientists from around the world the ability to participate in the event even if they cannot travel. The board will announce those plans in the near future. In the meantime, we urge you to submit an abstract and give yourself the option of presenting a poster at PharmSci 360.
2020 AAPS PharmSci 360 – Call for Volunteer Abstract Screeners
Deadline to complete online sign-up is August 12 at 5pm ET
AAPS seeks volunteer poster abstract screeners to review late breaking abstracts for the 2020 PharmSci 360.
To be a screener you must agree to:
• Review and select the Review Groups in which you are experienced. The Review Groups correspond to PharmSci 360’s tracks and topics.
• Review Screener Training webinars before screening begins.
• Spend a few minutes familiarizing yourself with the applicable literature in your area of expertise.
• Spend a few minutes reading each abstract assigned to you and answering a few questions about it.
• Review assigned abstracts August 14–August 31, 2020.
Ready to apply?