Quantifying Age-related Brain Volume Changes to Support Neurodegenerative Disease Drug Development

Speaker(s): Cesar Pichardo
Date: November 15, 2018
Time: 11 am EST
Duration: 1 hour

Incomplete understanding of the pathophysiology of neurodegenerative chronic diseases (eg, Alzheimer’s) has hindered the development of effective drug treatments. In particular, considering the impact of aging is important when analyzing clinical data derived from a geriatric population.

Physiological modeling and simulation including brain physiology (and/or pharmacology) have typically assumed that the brain has a constant volume. However, several studies have shown that the volume of the brain varies with age. It increases in volume during development with a peak around age 20 and then shows a slow and steady decrease over time. Quantifying the changes in brain volume with age is important for estimating the concentration of biomarkers in the brain, eg, amyloid beta, cholesterol, etc.

Quantitative systems pharmacology (QSP) models combine computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP may also be able to take advantage of the enormous amounts of information we now have access to, including genomics and proteomic data.

QSP models predict how drugs modify cellular networks in space and time and how they impact and are impacted by human pathophysiology. Additionally, QSP facilitates evaluating complex, heterogeneous diseases such as cancer, immunological, metabolic, and CNS diseases that will probably require combination therapies to fully control them.

In this webinar, Dr. Cesar Pichardo will explain how he:

  • Leveraged QSP to assess the impact of brain volume changes on estimating biomarker concentrations
  • Compared the results of a model with variable brain volume with a model using constant brain volume
  • Evaluated the effect of variability in brain volume changes in a given population on estimates of biomarker concentrations

Attend this webinar to learn why many major pharma organizations are investing in QSP for its potential to improve pharma R&D productivity.

About Our Speaker

Cesar Pichardo is currently a Principal Scientist at Certara, creating quantitative systems pharmacology (QSP) models and solutions for drug discovery. He earned his first degree in Chemical Engineering (MEng) and a MSc in Systems Engineering (Control Theory) from Simon Bolivar University (Venezuela) and got his PhD in Applied Mathematics from Ecole Centrale de Lille (France). He has spent the last 15 years developing biological, physiological and medical models for lifestyle interventions, drug development, mortality risk, and actuarial science.

He has worked as a senior researcher in both academia (eg, University College London, University of Sheffield, INSA de Lyon) and industry (Pfizer, XenologiQ).

Using Realistic Covariates with New Trial Simulator to Optimize Meropenem Dosing in Renally-impaired Children

Speaker(s): Mark Lovern, Edward Nehus
Date: November 27, 2018
Time: 11 am EST
Duration: 1 hour

In this webinar, see the new Trial Simulator v2.3 in action as Dr. Edward Nehus of Cincinnati Children’s Hospital and Dr. Mark Lovern, VP of Integrated Drug Development at Certara, evaluate target attainment of meropenem in various age groups and fluid overload in children receiving continuous renal replacement therapy (CRRT), reconstructing a previously published Trial Simulator model.  Meropenem is often prescribed in children receiving CRRT, but fluid overload can be present in ill children, affecting drug disposition.

Trial Simulator provides a powerful and efficient approach to computer-assisted trial design, balancing ease-of-use with robust tools for defining study design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an intuitive user interface to help new users learn trial simulation, Trial Simulator also has the flexibility and versatility to be applied to the most complex trial situations and now connects directly with R and ggplot for custom plotting capabilities.

Join this webinar to learn how to use trial simulation to anticipate risks and preview the range of expected results before millions in R&D dollars are spent, and subjects are exposed to experimental therapies.

About Our Speakers

Mark Lovern  |  Dr. Mark Lovern joined Certara (then Quantitative Solutions) in 2012 with 14 years of experience in applying modeling and simulation tools and techniques toward optimally informing drug development decision-making. Since joining Certara, Dr Lovern has led and contributed to numerous consultancy projects involving population PK, PK/PD, and model-based meta-analysis. In June 2014, Dr Lovern assumed leadership of the Eastern US division of Quantitative Solutions, and continues in this capacity within Certara Strategic Consulting (CSC). His previous work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Pharsight). In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.

Edward Nehus  |  Dr. Edward Nehus is a Pediatric Nephrologist in the Division of Nephrology at the Cincinnati Children’s Hospital Medical Center and an Assistant Professor at the University of Cincinnati, Department of Pediatrics. Edward conducted and published a cross-sectional study which investigated the association of serum resistin with cardiovascular risk factors in children with chronic kidney disease. In addition, he recently published a study evaluating the outcomes steroid-avoidance protocols in pediatric kidney transplant recipients. He continues to be the primary investigator for ongoing studies that explore pharmacokinetic alterations in critically ill children receiving continuous renal replacement therapy. (Photo courtesy of Cincinnati Children’s Hospital Medical Center: www.cincinnatichildrens.org)

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