Join ASCPT for Two Online Satellite Sessions
Register for two upcoming online learning opportunities with ASCPT: Small but Mighty: Innovative Clinical Trial Design for Pediatric Drug Development and Practical Aspects of Using PBPK Modeling to Support Model-Informed Dosing in Pregnant Women and Children: A Hands-on Workshop for Non-Modelers.
Thursday, May 12 and Friday, May 13, 2022
8:00 AM – 12:00 PM ET
Small but Mighty: Innovative Clinical Trial Design for Pediatric Drug Development
Theis pediatric trial design program is a two-half-day offering that will include a highly interactive hands-on activity on Day 2 where teams will be given a “drug” with appropriate adult data and be tasked with drafting a pediatric development plan using these novel strategies. Teams will present to the “Governance Board,” which will be comprised of regulatory and industry experts who represent the key functions in Development, i.e., Statistics, Clinical Pharmacology, Medical and Regulatory Affairs. The Board will grant a decision on each team’s plan with appropriate feedback. Case studies and current thinking on innovative clinical trial designs using Bayesian methodology, real-world evidence, novel clinical endpoints and biomarkers, and the use of artificial intelligence/machine learning in patient selection and diagnosis will also be presented.
Friday, September 16, 2022
10:00 AM – 4:00 PM ET
Practical Aspects of Using PBPK Modeling to Support Model-Informed Dosing in Pregnant Women and Children: A Hands-on Workshop for Non-Modelers.
Because drug dosing information in pediatrics and pregnant women is often insufficient or scarce, sub-optimal use of medicines is common in investigator driven trials and in clinical practice. Physiologically-based pharmacokinetic (PBPK) models of medicines verified using data from adult and non-pregnant subjects, coupled with virtual physiology models representing children and pregnant women have the potential to enhance dose selection in these situations through simulations. While PBPK modeling has gained momentum to support pediatric dose selection in commercial drug development, the opportunity for PBPK to support dose selection in investigator-initiated research or clinical care in both children and pregnant women has not been fully embraced. The underusage of PBPK is more pronounced in global health drug development.
A major roadblock to the use of PBPK in these settings is the perceptions of the complexity of the approach that require special modeling expertise, and the lack of confidence in application of PBPK by many healthcare providers who are in need of optimal dosing for children and pregnant women in real-life situations. The workshop intends to fill the translational gap between the modeling and simulation community and decision makers at the forefront of global drug development and clinical care.
The objectives of this workshop are to:
- Understand basics of PBPK modeling, its utility and impact in drug development, and key considerations when applying these models to evaluate drug dosing in children and pregnant women.
- Use PBPK models, through hands-on simulations to evaluate the impact of physiological changes on a drug’s disposition, and the implication of dose modification in these populations.
- Discuss the necessary framework for implementing of model-informed dosing paradigm in drug development and clinical care.
See the full programs online at www.eventscribe.net/2022/ASCPT
. Questions may be sent to firstname.lastname@example.org