Past Webinars
Spring 2012
Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases
Apr 24, 2012
This webinar addressed advances in the development of drugs to treat respiratory diseases with a focus on new technologies that enrich data collected early in clinical research. Prof. Stuart Elborn, Queen’s University, Belfast is a leading researcher in pulmonary function assessments and biomarkers for chronic infections that impact patients with respiratory diseases such as cystic fibrosis, COPD and asthma. Complementing Prof. Elborn’s insights, Dr Stephen Smith addressed the logistical considerations in conducting these complex but data rich early clinical studies with new therapeutic agents.
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Challenges in Early Comparability Assessment of Biosimilars
Mar 20, 2012
The success of biologically-derived drug products has driven the demand for “biosimilar” versions of these products to increase competition and reduce costs to patients and providers. However, these products are complex to manufacture. Once an apparent source of drug substance has been established it is critical to understand whether its safety, immunogenicity, pharmacokinetics and pharmacodynamics are comparable to the innovator product before proceeding to expensive multi-center patient studies.
This webinar addressed the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety.
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Spring 2011 Webinar Series: Optimizing Early Clinical Research to Accelerate Drug Development Timelines
Microtracer Studies
Jun 8, 2011
Micro-radiotracer studies in humans that take advantage of the very high sensitivity of Accelerator Mass Spectrometry (AMS) provide new approaches to answering important questions in early clinical drug development.
This webinar reviewed the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays were reviewed. The audience had the opportunity to question experts involved in both parametric release of drug product and AMS analyses.
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Adaptive Study Design
May 17, 2011
Study designs for clinical pharmacology studies have become increasingly innovative. In this webinar, Celerion’s clinical pharmacology scientists described recent trends in adaptive designs, highlight areas where innovative approaches resulted in more robust clinical study results and discuss the challenges sometimes faced with these designs. Through case studies, the audience learned key advantages for using adaptive study designs in early clinical research, understand challenges for this approach and how to maximize the amount of information gained from data in the least amount of time.
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Value of Early Safety Assessments
Apr 28, 2011
In this webinar, Celerion’s experienced physicians described their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the speakers discussed changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric and cardiovascular adverse effects, as well as assessing risk for ocular toxicity in humans.
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Fall 2010 Webinar Series: The Need for Speed
Employing Real-Time Strategies in the Bioanalysis Workspace
Nov 11, 2010
In this webinar, Celerion Bioanalytical Services scientists discussed how a couple of innovative approaches to bioanalytical science improved workflow and data delivery.
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Science and Innovation Driving Efficient, Cost Effective QT Assessment
Oct 26, 2010
This webinar presented information on cost effective study designs and the evolution of cost effective ECG analysis strategies, including the increased use of Holters, greater automation in ECG process, QT interval measurement, and integration of Phase I and ECG Core Lab functions.
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Enriching Early Clinical Studies for Better Data, Faster
Oct 7, 2010
In this webinar, Celerion partnered with Xceleron to discuss how Accelerator Mass Spectrometry (AMS) through measurement of ultra low levels of drug-associated radioactivity, can enrich the information gathered from early clinical studies.
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