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Life Sciences

  • Multicellular Tumor Spheroids in HTS: New Assays Multicellular Tumor Spheroids in HTS: New Assays Wojciech Senkowski Jan 25 2017 3:00 pm UTC 60 mins
    Three-dimensional cell cultures, and multicellular tumor spheroids in (MCTS) in particular, have recently become a widely used tool for preclinical anticancer drug testing in high-throughput screening (HTS) setup. However, even though MCTS have been applied for HTS, their use has been limited to simple assays, such as assessing cell viability or inhibition of growth.

    This webinar will cover new approaches to MCTS-based HTS. It will present a new, robust viability assay, well-suited for HTS and based on green fluorescent protein (GFP) used as a surrogate marker of spheroid viability. It will also review a first-ever approach to obtain information-rich transcriptomic data from drug-treated MCTS on a large scale. In addition, the presenter will demonstrate how this novel platform resulted in the identification of previously unrecognized, context-dependent drug responses of cancer cells and in findings with potential clinical relevance.

    In summary, this webinar will demonstrate new ways of how MCTS-based HTS can be used to provide unique insights into context-dependent biology and cellular drug responses.

    About the Presenter:

    Wojciech Senkowski will soon complete his Ph.D. in Medical Sciences at Uppsala University, Sweden. In his work, he looks for applications of various tumor spheroid models in high throughput drug screening. For his work, Wojciech has received the AACR Scholar-in-Training Award. He was also a presenter and expert panelist at the Genetic Engineering & Biotechnology News webinar on 3D cell cultures, sponsored by Corning in February of 2016.
  • Common Challenges in Evaluating the Reproductive System Common Challenges in Evaluating the Reproductive System Justin Vidal, PhD, DVM, DACVP Feb 9 2017 3:00 pm UTC 60 mins
    According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist. This requires the pathologist to have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system. However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system. Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns. This webinar will highlight some of the commonly encountered challenges using case examples and provide potential solutions and/or ways to minimize the impact of these variables in studies.
  • Challenges and Successes in Externalization of the ADC Supply Chain Challenges and Successes in Externalization of the ADC Supply Chain Firelli Alonso, Ph.D. Feb 14 2017 3:00 pm UTC 75 mins
    Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks. ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload. Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently. This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product. Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
  • How do you Decide Whom to Biopsy for Prostate Cancer? How do you Decide Whom to Biopsy for Prostate Cancer? Dr. E. David Crawford Feb 17 2017 12:00 am UTC 60 mins
    In our webinar, Identifying Men with Significant Prostate Cancer—The Role of phi and Other Biomarkers, Dr. E. David Crawford will discuss key issues that challenge a physician's ability to make informed decisions regarding whom to biopsy for prostate cancer. After the webinar, you will be able to:

    • Understand the historical perspective and controversy regarding prostate-specific antigen (PSA) screening

    • Improve your interpretation of a PSA result

    • Use biomarkers, such as Prostate Health Index (phi), to reduce negative biopsies and have more confidence in the decision to biopsy

    • Understand how the phi score, combined with family and patient history, can determine patient management decisions

    Dr. Crawford is an internationally renowned urologist and distinguished endowed professor of surgery, urology and radiation oncology. He also serves as the head of the section of urologic oncology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. Dr. Crawford received his medical degree from the University of Cincinnati. His postgraduate training included an internship and residency in urology at the Good Samaritan Hospital in Cincinnati. He subsequently completed a genitourinary cancer fellowship at the University of California Medical Center in Los Angeles.
  • Subvisible Particle Identification & Characterisation by Multi-Technique Methods Subvisible Particle Identification & Characterisation by Multi-Technique Methods Dr Jonas Hoeg Thygesen Feb 23 2017 2:00 pm UTC 75 mins
    Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:

    1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and

    2. United States Pharmacopia Chapter 2
  • Analytical Strategies for Comparability in Bioprocess Development Analytical Strategies for Comparability in Bioprocess Development Christine P. Chan, Ph.D Mar 28 2017 2:00 pm UTC 75 mins
    Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.
  • Single Use Systems in Biologics Manufacturing & their Impact on Operational Tech Single Use Systems in Biologics Manufacturing & their Impact on Operational Tech Gloria Gadea-Lopez & John Maguire Apr 4 2017 1:00 pm UTC 75 mins
    The increased interest and adoption of single use systems (SUS) or disposables require that organizations rethink their operational business processes and the design and configuration of manufacturing execution systems (MES). Drawing from their previous experience implementing MES and SUS for biologics manufacturing, the authors discuss the key areas of impact of SUS on operational technology, outline new user requirements, and propose practical solutions for successful MES implementation.