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 then register. Questions may be sent to meetings@ascpt.org.

 

Network/Community Affiliations
Are you looking to get more involved with ASCPT’s Networks and Communities?

You can affiliate with them directly from your Member Dashboard. Once you are logged in, select “Update My Profile.” Scroll down to the bottom of the page to find the section listing all Networks and Communities with clickable checkboxes. There you’ll find the Networks and Communities you have already joined and can add any new ones by clicking on the box next to them.

To receive communication about your Networks or Communities, scroll back up and confirm that you’ve selected “Yes” under “Network/Community Updates” in the “Notifications and Alerts” section. Scroll down again, click “Update Profile” at the bottom right, and you will now be affiliated with those Networks or Communities you selected.

You can always contact us at members@ascpt.org, and we will be happy to connect you with a Network or Community.

 

New Guest Blogs for Translational Bytes

Be sure to check out two new guest posts on Translational Bytes, the official blog of Clinical and Translational Science (CTS)!

Dr. Tal Burt contributed a blog titled, “Phase 0 Is Big in Drug Development,” which highlights his recent CTS publication and digs into the feasibility, economic, and cultural aspects of Phase 0 approaches, including topics such as the regulatory framework, analytical tools, and ethical considerations. You’ll also find a great post by Dr. Jeff Barrett discussing, “Can We Help Address Anti-Vaccination Campaigns?” Dr. Barrett explores the importance of open communication with anti-vaccination groups and the necessity of engaging the next generation of clinical and translational scientists to tackle this issue. You can read the paper upon which this post is based here.

Translational Bytes is regularly updated, so check back frequently to make sure you don’t miss a post!