Speakers: Mirjam Trame (Certara), Ophelia Yin (Iteos Therapeutics), Ravi S. Singh (Pfizer), Kosalaram Goteti (EMD Serono),Youwei Bi (FDA)
Organizers: Jayaprakasam (Prakash) Bolleddula, PhD
Date: 2023-09-01
Time: 8:30-16:05 Eastern Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Between Jobs: $125; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $995; Lunch Sponsorship: $1250; On-site Registration: $500. Lunch included.
Location: AstraZeneca Waltham
Major Sponsor:
Vendor show vendors registered to date: (1)Veloxity Labs, Inc.
Registration: http://www.PBSS.org
Registration deadline:2023-10-31  (it will close sooner if the seating cap is reached)

About the Topic

Variability in intrinsic (e.g., age, gender, organ function, disease, etc.) and extrinsic (e.g., diet, concomitant medication use, smoking habits, etc.) factors have the potential to influence exposure and response in patient population.  Population pharmacokinetic (pop-PK) models describe the time course of drug concentrations and investigate sources of variability in drug exposure.  Exposure-response (E-R) analyses delineate the relationship between drug exposure and treatment emergent clinical endpoints of efficacy and safety.  Pop-PK modeling together with E-R analyses guide and justify selection of doses with optimal benefit-risk profile. In addition, both Pop-PK and E-R analyses are integral part of clinical development and regulatory submissions. The objective of the workshop is to provide fundamentals and applications of pop-PK modeling and E-R analyses.  

• Population PK modeling: model development, validation, covariate analysis, and applications
• Exposure-Response Analyses: Basics and Applications
• Regulatory guidelines of population PK modeling and Exposure-Response analysis