Past Event
Date
September 10-13, 2023
Location
Boston, Massachusetts
Booth #207
25th North American ISSX Meeting
Sunday, September 10, 2023 | 1:00 pm - 4:00 pm
Short Course 3: Strategies That Enable Successful FIH and Beyond – Pharmacology and Translational Aspects
Mirjam Trame, PharmD, PhD
|Vice President, Pharmacometrics
This short course is aimed at scientists desiring to gain experience in successful IND submissions that enable first-in-human (FIH) studies with clear line of sight to successful approvals. The course is broken into three parts with three experienced lecturers across industry and FDA. The first section will cover translational aspects, modeling approaches, and FIH exposure/dose predictions in the context of the desired therapeutic benefit. The next section will focus on the work needed in the preclinical toxicology package (e.g. expected mechanism-based toxicity, off-target toxicity, species selection, target exposure/dose justifications and metabolites). The last section will focus on the understanding the absorption, distribution, metabolism, and excretion (ADME) of the investigational drug with a particular emphasis on drug-drug interactions and inclusion/exclusion criteria in the initial FIH studies and the long range view towards drug approval.
Monday, September 11, 2023 | 10:00 am
Symposium 1: Quantitative LC-MS Proteomics
Co-Chair: Amin Rostami
|Chief Scientific Officer & Senior Vice President of R&D
Monday, September 11, 2023 | 3:00 pm
Symposium 3: Pediatrics – Story of Maturation – Modelers vs Models in the Paediatric Space
Amin Rostami
|Symposium Session Co-Chair, Chief Scientific Officer & Senior Vice President of R&D