Speakers: Yaning Wang (FDA), Neil Benson (Certara), Mark Peterson (Pfizer, Inc), John Burke (AppliedBioMath), Jay Mettetal (AstraZenecka), and others (tbd)
Organizers: Pratap Singh (Alexion) and Jing-Tao Wu (Takeda)
Date: 9/29/2017
Time: 8:30-16:00
Registration fee (USD): Regular: $175; For Academic / Unemployed: $125;
Location: Boston/Cambridge Area: Marriott Kendall Square, 50 Broadway, Cambridge MA 02142
Major Sponsor: (1)Applied BioMath, LLC
Vendor show vendors registered to date: (8)Absorption Systems; Cambridge Biomedical; Certara; IVAL; Lonza / TRL Biosciences; Nuventra Pharma Sciences; QPS LLC; Simulations Plus, Inc.
Registration: https://www.PBSS.org
Registration deadline:9/28/2017  (it will close sooner if the seating cap is reached)

About the Topic

Quantitative systems pharmacology (QSP) modeling is increasingly being utilized by the pharmaceutical and biotech industry to accelerate drug discovery and development, and facilitate rational decision making. The QSP modeling enables early selection/validation of novel targets, identification of ideal drug properties, preclinical to clinical translation, and prediction of biomarker response and efficacy in clinic. It is essentially an extension of standard pharmacokinetic/pharmacodynamic (PK/PD) modeling approaches, and incorporates mechanistic details of drug interaction with its target in physiological context, subsequent pharmacological modulation and effect on disease biomarkers and progression. In this workshop, pharmaceutical/biotech industry’s recent experience in applying QSP techniques for decision making will be highlight using real world case studies from the fields of inflammation, oncology, immuno-oncology, and cardiovascular diseases. Additionally, fresh perspectives on regulatory acceptance and hurdles for QSP modeling will be highlighted by the speakers.

Tentative list of talks and case studies:

• Overview and evolution of QSP modeling in pharmaceutical drug discovery and development;
• Perspective on QSP model building and right-sizing of models using bone calcium homeostasis model as a case study;
• Case study examples from oncology, immunology and cardiovascular areas highlighting impact on target and biomarker selection, and projections of pharmacological response in humans.
• Regulatory perspective on QSP model application and acceptance.