Webinars

Join us throughout the year for a steady stream of educational and scientific webinars on topics related to the drug, device, crop and chemical development process.

  • Join this informative webinar where presenters will discuss how integrating data sources and reporting on metrics and KPIs in a thoughtful and clear way can enable study teams to quickly ascertain the health of a study or group of studies in crisis circumstances. A case study demonstrating the tracking of metrics important to COVID-19 will also be presented. In this webinar, attendees will learn about:

    • Creating flexible metrics to meet critical sponsor and CRO needs in a time of crisis
    • Gauging the impact of external events on KPIs
    • Comparing milestone performance

     

    Jun. 04, 2020
  • Digital devices are helping researchers forge new paths to better understand and treat neurological disorders. Join this webinar to learn about the types of digital devices that are currently available as well as the key clinical insights that can be gained from their use.

    Join this webinar to learn about:

    • An overview of current devices supporting monitoring and treatment of neurodegenerative disorders
    • Newly available digital devices
    • Clinical insights gleaned from digital device data
    • Insights into regulatory authority acceptance of digital biomarker data
    • Examples of digital biomarkers data usage and implications in clinical endpoints
    Jun. 11, 2020
  • Join this informative webinar on static & PBPK modelling to assess potential DDIs. We will also share our interpretations, as regulatory agencies recommend different approaches for calculation of the DDI potentials including static and PBPK models.

     

    In this webinar, attendees will learn about:

    • Assessment of potential DDIs by in vitro studies
    • Application of the FDA guidance to DDI study design, data interpretation and modelling
    • Understanding of fundamental theories and development strategies of PBPK models
    • Benefits and applications of PBPK models to preclinical drug development and design of first clinical trials
    Jun. 16, 2020
  • In this webinar, presenters will discuss aspects of an adoptive cell therapy preclinical program that are central to an IND/IMPD submission – namely, in vitro and in vivo pharmacology, toxicology and pharmacokinetics (PK) assessments using the appropriate models & test systems. Together, these studies help to guide determination of clinically safe and biologically relevant dose levels, establish safety endpoints for clinical study monitoring and elucidate the biological disposition of administered cell product.

    In this webinar, attendees will learn about and understand:

    • In vitro verification of product function
    • Animal model selection in preclinical studies
    • Pharmacology and toxicity studies to guide determination of biologically relevant and clinically safe dose levels
    • The biological disposition of product including tumor cell infiltration, persistence and viral shedding
    Jun. 18, 2020
  • Bioanalysis of protein therapeutics by LC-MS/MS continues to gain popularity as a complementary approach to ligand-binding assays (LBA). LC-MS/MS offers multiple advantages over LBA including higher specificity, multiplexing capability and reduced development time. Immunoaffinity enrichment can be coupled to LC-MS/MS to produce a hybrid method that increases sensitivity and selectivity.

     

    This webinar will highlight the systematic optimization of a flexible, hybrid IA-LC-MS/MS workflow that uses streptavidin-coupled magnetic beads, ’rapid’ trypsin digestion and surrogate peptide quantification:

    • The selection of streptavidin-coupled magnetic beads as the platform for the immunoaffinity enrichment system due to their amenability to use in combination with analyte-specific biotinylated capture reagents
    • A workflow case study for a humanized antibody therapeutic in preclinical serum using generic conserved surrogate peptides for quantification that, when optimized, ultimately requires only ~3 hours with minimal direct handling
    • Additional applications for the optimized workflow, such as highly selective and sensitive analysis of humanized antibody in preclinical samples and protein therapeutics using analyte-specific biotinylated capture reagents
    Jun. 25, 2020
  • Potency is an important critical quality attribute of any large molecule drug product and a precise and accurate assay is required for the release of drug product under Good Manufacturing Practice (GMP). Potency assays are technically difficult to develop and transfer but are also an essential part of the analytical strategy in any drug development pathway.. Developing a suitable potency assay is fraught with challenges and so a well thought-out plan and an understanding of what is important at each stage can help enormously.

     

    Specifically, the webinar will cover:

    • An introduction to relative potency assays including regulatory requirements, why a dose range is used and how to assess similarity to a reference standard.
    • Specific considerations for development and optimization of the assay for GMP environment.
    • Differentiating and understanding the differences between system suitability criteria and sample criteria
    • Strategies used to evaluate the performance of the potency assay prior to the validation phase including useful tips on monitoring the performance of the assay and what to track once the assay is developed
    Jun. 30, 2020