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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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Agile Access to Drug Discovery Data with D360

D360 makes it easy for all project team members to access standard discovery project data views or perform exploratory analyses. This webinar focuses on utilizing D360 to get the most out of drug discovery data by utilizing simple query-building with integrated chemistry tools and analysis tools, dynamically linked data visualizations and easy to use annotations. […]

Speaker(s): Dennis Powell
Solution: Scientific Informatics
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A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners

Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the Sponsor or research center after the last study visit, leaving many volunteers wondering if their participation was valued or appreciated. Over the past five years, the nonprofit Center […]

Speaker(s): Tatyana Wanderer
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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