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Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

In this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.

Speaker(s): Angela Colbers, Rick Greupink
Solution: PBPK Modeling & Simulation
Therapeutic Area: Infectious Disease
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Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).

Speaker(s): Jean-Francois Marier, Barry Mangum
Solution: Drug Development & Regulatory Strategy
Therapeutic Area: Pediatrics
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Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

In this webinar, Dr. Tom Snowden demonstrated: why reduction methods are a potent and necessary tool in the modeler’s arsenal; how reduction methods can be applied to QSP models; and, how model reduction can be used to extract scientific and business insights from complex models.

Speaker(s): Tom Snowden
Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
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Obeticholic Acid – From PK Model to Drug Label

Watch 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 watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

Speaker(s): Jeffrey Edwards
Solution: PK/PD Modeling & Simulation
Therapeutic Area: Rare/Orphan Disease
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

In this webinar, Tatyana Wanderer and Behtash Bahador provided 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.

Speaker(s): Tatyana Wanderer, Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Mechanistic Modeling of Genome Scale Molecular Interaction Networks

The scope of Physiologically-based Pharmacokinetic (PBPK) modeling can be expanded by assimilating mechanistic models of intracellular processes from the Systems Biology field. Genome Scale Metabolic Networks (GSMNs) represent whole sets of metabolic enzymes expressed in human tissues. Dynamic models of the gene regulation of key drug metabolism enzymes are also available. Here, we introduce GSMNs and review ongoing work on integrating PBPK, GSMNs and metabolic gene regulation. We demonstrate example models.

Speaker(s): Andrzej Kierzek
Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Speaking into the Ether: Challenges of the Virtual Pharma Workplace

In this webinar, Drs. Peter Bonate and Stacey Tannenbaum discuss what kind of technology tools can facilitate a connection with your audience and address the difficulties of speaking into the ether. They offer practical solutions that you can use to strengthen your collaboration in the virtual workplace.

Speaker(s): Peter Bonate, Stacey Tannenbaum
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