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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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How Model-based Approaches Can Improve Precision Dosing in Clinical Care

In this webinar, Dr. Adam Darwich, Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester, presented several case studies that illustrate how PBPK models have been used to predict drug-drug interactions, extrapolate to special populations, and optimize clinical study design.

Speaker(s): Adam Darwich
Solution: Biosimulation, PBPK Modeling & Simulation
Therapeutic Area: Central Nervous System, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics
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Early Development and Translational/Quantitative Pharmacology Strategies in Pediatric Drug Development

This seminar described the application of early development strategies to enable development in children, in cases where limited adult data are available. Extensive use of translational science and quantitative modeling and simulation methods are key underpinnings to facilitate the successful execution of these programs.

Speaker(s): Patrick Smith, Craig Rayner
Solution: Biosimulation, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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Leveraging Phoenix for Dissolution Testing to Meet Regulatory Guidelines

During this presentation, Jean-Michel Cardot, professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Auvergne University in France, discussed the tools available to formulation scientists performing dissolution testing and what regulatory guidelines must be considered when performing these tests.

Speaker(s): Jean-Michel Cardot
Solution: Biosimulation, Drug Development & Regulatory Strategy, PK/PD Modeling & Simulation
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Get Ready for CDISC SEND

In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance.

Speaker(s): Chris Lovejoy
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Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?

Speaker(s): Leon Bax
Solution: Biosimulation, Model-based Meta-analysis, PK/PD Modeling & Simulation
Therapeutic Area: Cardiovascular, Endocrinology, Other
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A Streamlined Approach to Policy 70

David Cornwell, Founder and CEO of PleaseTech and Lora Killian, Synchrogenix Director of Transparency and Disclosure, provided an in-depth review of the full streamlined process created as a result of the partnership between Synchrogenix and PleaseTech.

Speaker(s): David Cornwell, Lora Killian
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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