QSP modeling has been demonstrated to accelerate clinical development, and we anticipate that we can contribute to accelerating the clinical development of effective treatments for new diseases and conditions of interest to our clients.  We employ the QSP modeling practices of combining predictions of compound exposure with the pharmacodynamic characteristics of a compound and how they can produce efficacy across a range of patients with pathophysiologic variability.  All of our platform development and use is guided by the best and most reliable data available.

DILIsym Services, Inc. has significant expertise in the areas of liver, kidney, immunology, the vasculature system, the hematopoietic system, toxicology, fibrosis, metabolic diseases, pulmonary diseases, and heart conditions, amongst others.  We are always looking to apply our present subject-matter expertise to new diseases and conditions as well.  We apply our QSP, pathophysiology, and pharmacology knowledge to assist with clinical development in collaborative partnerships and offers access to the software via corporate software licenses and/or joint IP arrangements.

We can also help with your application questions.  Full-scale QSP consulting projects are customized to each drug development application based on your goals and can include:

  • optimization of clinical trial protocols by determining favorable dosing paradigms and outcome (e.g. measurement frequency);
  • evaluation of efficacy and safety potential for targets and/or specific compounds utilizing key laboratory and/or clinical data describing DMPK and pharmacodynamic characteristics;
  • interpretation of preclinical and clinical data to provide improved mechanistic understanding of observed responses to compounds;
  • prioritization of compounds and targets;
  • determination of responsive and non-responsive patient subsets to support clinical trial patient recruitment;
  • predictions of efficacy for novel combinations of treatments;
  • and much more!

The heterogeneity of many etiologies is a major challenge in the quest for new treatments.  To this end, DILIsym Services includes an appropriate and mutually agreed upon number of simulated patients with varying stages of the applicable disease area or condition.  The simulated patients, or SimPops®, can be used to optimize clinical trial protocols by determining favorable measurement frequencies and dosing levels, evaluating targets using key internal laboratory or mechanistic clinical data, testing combination treatment approaches across varying patient backgrounds, and comparing efficacy in different patient groups (e.g. stratification by key metrics, etc.).  The SimPops are validated against a large backdrop of key data sets, which are chosen based on discussions between your organization and our team.

02. WHAT & HOW
Novel Approaches

We will work with your organization to develop a thorough plan for development and validation of a custom disease platform or fit-for-purpose mechanistic model.  We are flexible with respect to the software environment for development.  The platform will be available to your organization at the conclusion of the development and validation process.

After development of a platform designed to address your key questions, we can also assist with analyses through consulting services.  QSP consulting projects are customized to each drug development application based on your goals and can include:

  • optimization of clinical trial protocols;
  • evaluation of efficacy and safety potential for targets and/or specific compounds;
  • interpretation of preclinical and clinical data to provide improved mechanistic understanding ;
  • prioritization of compounds and targets;
  • determination of responsive and non-responsive patient subsets to support clinical trial patient recruitment;
  • predictions of efficacy for novel combinations of treatments;
  • and much more!

Depending on the scope of your goals and questions, custom QSP platforms or models can be developed within 2 months.  More complex development projects can take more than 1 year to complete, with on-going development, validation, and updates after the initial phase.

Get started with us today and make better use of  your platform over the life of your development efforts in a particular disease area!

03. Experts
Meet the Experts

How do I move forward from here?

Join your peers around the world and begin using QSP to generate the insight you can’t measure to make better decisions.

04. PUBLICATIONS
Peer-reviewed Publications