Modeling PK/PD Systems with Distributed Delays

Speaker(s): Wojciech Krzyzanski
Date: May 16, 2017
Time: 11 am EST
Duration: 1 hour

Systems with distributed delays are extensions of systems with discrete delays where a single lag time is represented by a distribution of lag times. Distributed absorption times for orally administered drugs serve as an example of a pharmacokinetic (PK) system with distributed delays. Another example is a hematopoietic cell population with distributed lifespans.

The topic of this webinar is to introduce mathematical tools to model pharmacokinetic/pharmacodynamic (PK/PD) systems with distributed delays. These models will be implemented in Phoenix NLME by means of the delay() operator. A distributed delay version of the transit compartment model for oral drug absorption will be provided. A distributed lifespan PD model of RBC production will be also discussed.

About Our Speaker

Dr. Wojciech Krzyzanski is an Associate Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York (UB). Dr. Krzyzanski holds a PhD in applied mathematics and a MA in pharmacology. His PK/PD modeling interests and capabilities include the modeling of pharmacokinetics and pharmacodynamics of hematopoietic growth factors, the model-based development of optimal dosing regimens for chemotherapy induced cytotoxicities, particularly myelosuppression, the pharmacometric analysis of properties of various types of indirect response models, and the evolution of target-mediated PK/PD models.

Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

Speaker(s): Tatyana Wanderer, Behtash Bahador
Date: May 24, 2017
Time: 11 am ET
Duration: 1 hr.

In recent years, pharmaceutical companies have become increasingly aware of the regulatory and ethical mandates to develop and disseminate plain language summaries of clinical trial results. However, awareness alone doesn’t confer the ability to develop scientifically accurate, non-promotional, and easy to understand plain language summaries.

When the results of your clinical trials become available, will you be ready to communicate them to patients in a timely manner? Do you have the experience and expertise needed to comply with the latest guidance from regulatory bodies and plain language standards?

CISCRP and Synchrogenix have partnered to offer a program to meet upcoming reporting requirements, increase public transparency and trust, and engage patient communities. In this webinar, Tatyana Wanderer and Behtash Bahador will provide insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results. Whether you’re just starting program planning or simply need help developing compliant and patient-friendly summaries of clinical trial results, by attending this webinar, you’ll gain keys insights on what it takes to develop a plain language summary program that meets all your needs.

About Our Speakers

Tatyana Wanderer, PhD, is the Director of Strategic Partnerships and Alliances at Synchrogenix, a Certara company. She has experience in clinical writing and project management of a variety of ICH-compliant documents, with expertise in documentation related to rare disease indications.

Behtash Bahador is a Senior Project Manager for the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). With a background in health communication, Behtash leads global implementation of programs for communicating clinical trial results in plain language for a wide range of industry sponsors. He works directly with sponsors to align best practices in patient education and health communication with regulatory and industry guidelines.

Obeticholic Acid – From PK Model to Drug Label

Speaker(s): Jeffrey Edwards
Date: June 1, 2017
Time: 11 am ET
Duration: 1 hr.

Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cholangitis/cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), and other liver diseases. OCA is the 6α-ethyl derivative of chenodeoxycholic acid (CDCA) and has similar pharmacokinetic (PK) properties.

The results from a hepatic impairment clinical study revealed that systemic OCA concentrations increased with moderate and severe hepatic impairment. These results are consistent with previously reported studies wherein plasma endogenous bile acids were elevated in patients with hepatic impairment, but liver concentrations were only modestly increased. Accordingly, an alternate dosing regimen was developed for OCA based on modeling and simulations for patients with moderate and severe hepatic impairment to mitigate tolerability concerns with high systemic exposures.

Join this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By attending this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

About Our Speaker

Dr. Jeffrey E. Edwards has over ten years of industrial experience in clinical and preclinical pharmacokinetics and pharmacology. He received a BS in Chemistry from James Madison University and then earned his Doctorate in Toxicology at University of Kentucky in the lab of Patrick J. McNamara. After completing his post-doctoral work at North Carolina State University, Dr. Edwards began his industrial career in pharmacokinetics and pharmacology at Arena Pharmaceuticals, Inc. followed by Amylin Pharmaceuticals, LLC. Most recently, Dr. Edwards serves as the Senior Director of Clinical and Preclinical Pharmacology and DMPK at Intercept Pharmaceuticals, Inc.

Using Modeling and Simulation to Combat Tuberculosis: A Global Health Priority

Speaker(s): Klaus Romero
Date: June 22, 2017
Time: 11 am ET
Duration: 1 hour


Tuberculosis (TB) is a deadly disease, a principal cause of death by infectious disease, and the leading cause of mortality for HIV+ patients. Most available TB drugs are more than 40 years old, have significant side effects and drug interactions, and require a long treatment period. Furthermore, these drugs are becoming less effective as TB strains grow increasingly drug resistant. New tools are desperately needed to help TB drug developers combat this deadly disease.

The Critical Path to T Drug Regimens (CPTR) Initiative, in partnership with Certara, developed a TB-specific set of lung and granuloma models, together with a library of drug and metabolite files. These models and library files are implemented in Certara’s Simcyp Simulator physiologically-based pharmacokinetic (PBPK) platform, which helps optimize the design of clinical studies for multiple indications and has been widely adopted by industry and regulators.

Attend this webinar with C-Path’s Dr. Klaus Romero to learn how they integrated these components into the latest version of the Simcyp Simulator to establish a robust resource that will help development teams and regulators evaluate the safety and efficacy of novel anti-TB drug regimens.

About Our Speaker

Dr. Klaus Romero is a clinical pharmacologist and epidemiologist by training, with 12 years of experience in clinical research. He is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics and the International Society for Pharmacoepidemiology. He has conducted research on endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglycemia, drug-induced QT prolongation, pharmacoepidemiology, and patient education. Dr. Romero has been with C-Path since January 1, 2008, where he has led clinical pharmacology, pharmacoepidemiology, and modeling and simulation projects for the Coalition Against Major Diseases, the Polycystic Kidney Disease Outcomes Consortium, and the Critical Path to TB Drug Regimens Consortium, achieving major milestones such as the first regulatory endorsement by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of a clinical trial simulation tool for mild and moderate Alzheimer’s Disease. He is fluent in English, Spanish, German, and Portuguese, and has published in the areas of clinical pharmacology, pharmacometrics, cardiovascular drug safety, and pharmacoepidemiology.


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