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Medical Research

  • Digital Therapeutics: Trends and Growth Opportunities
    Digital Therapeutics: Trends and Growth Opportunities Frost & Sullivan's Global Digital Health Team, Wolf Shlagman CEO - Care Angel, Amer Haider CEO - Doctella Jun 26 2018 5:00 pm UTC 75 mins
    Digital therapeutics presents a significant opportunity for traditional pharmaceutical therapeutics and information technology (IT) capabilities to influence a new approach to increase positive patient outcomes while reducing the overall cost of healthcare.

    Key Takeaways:
    · Gain expert insight into the accurate definition of digital therapeutics and market participants.
    · Learn about new solutions from mHealth companies that will combine apps, patient education, professional intervention and peer support to increase patient engagement and medication adherence by augmenting or replacing traditional drug therapeutics.
    · Hear opportunities to utilize digital therapeutics to improve medical workflow and patient communications.
    · Learn about some of the critical milestones related to digital therapeutics.
  • Modelling Piezoelectric Devices
    Modelling Piezoelectric Devices Paul Wilson, Knowledge Transfer Associate, Queen's University Belfast and Richard Chippendale, Technical Manager, COMSOL Jun 27 2018 1:00 pm UTC 60 mins
    In this webinar, learn about a multiphysics approach for modelling piezoelectric devices with couplings between electrostatics, acoustics and structural mechanics. Incorporating such models within the design process enables a better understanding of the interactions between structural materials, piezoelectric ceramics and fluid damping, which can reduce development time and prototyping costs.

    Piezoelectric transducers can be used, for example, in ultrasonic cleaning, sonochemistry and cell disruption or homogenisation. For such applications it is important to accurately design the ultrasonic horns (or sonotrodes) to increase the amplitude of piezoelectric vibrations and transfer energy to liquids through the production and disintegration of microscopic bubbles.

    In this presentation, Paul Wilson from Queen's University Belfast will discuss how to design such a horn to maximise power transfer to a liquid. An existing transducer will be modelled and the tuning of material parameters to match experimental results will be discussed. Parametric sweeps are then used to investigate the design space of the horn and predict the electrical and mechanical properties of the model. These results can then inform experimental procedure, where the simulated response shows strong agreement with laboratory measurements.

    The webinar will include a live demonstration in the COMSOL Multiphysics® software and conclude with a Q&A session.
  • Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX USA, Inc. Jun 28 2018 2:00 pm UTC 75 mins
    Title: Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Presenter: Dr. Ruth Daniels, Janssen
    This presentation will discuss:
    - Endotoxin hold time studies to identify LER
    - In silico assessment of interfering factors and associated LER mitigation strategies
    - Case study: optimization of product-specific LAL assay to overcome LER

    Title: : Addressing LER at the root, with ENDO-RS® sample preparation (demasking) prior to endotoxin assay of choice
    Presenter: Kevin L. Williams, Senior Scientist Endotoxin - BIOMÉRIEUX
    Scientific studies have demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants, are likely to change the aggregate state of endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin detection methods (LAL and rFC). The ENDO-RS® endotoxin recovery method developed by Hyglos - a bioMérieux company, is a unique toolbox of dedicated reagents for demasking (recovering) endotoxin prior to detection, also for conventional LAL. This presentation covers the mechanism of LER, regulatory requirements, work principle of ENDO-RS, the demasking services of bioMérieux, as well as method application data.
  • MilliporeSigma CRISPR Protein Products
    MilliporeSigma CRISPR Protein Products Yanfang Jiang, Ph. D. Jun 28 2018 3:00 pm UTC 75 mins
    MilliporeSigma is a pioneer in commercially offering targeted genome editing tools. With its 14-year experience in the first generation of genome editing tools such as TargeTron® and Zinc Finger Nuclease, MilliporeSigma has emerged as a prominent leader in the development of CRISPR systems, the most flexible and efficient genome editing technology thus far developed. CRISPR-based DNA integration patents have been granted to MilliporSigma in seven regions including Australia, Canada, the European Union, Singapore, Israel, South Korea, and most recently in China. The MilliporeSigma CRISPR portfolio consists of an array of CRISPR products, in both the plasmid, RNA, protein, and lentiviral formats. MilliporeSigma is also the first commercial provider to offer both pooled and arrayed whole human genome CRISPR libraries.

    In this webinar, we will give an introduction to our current CRISPR protein products, including SpCas9 (CAS9PROT), Cas9-D10A nickase (CAS9D10APR), high fidelity eSpCas9 (ESPCAS9POR), catalytically inactive dCas9-FLAG-biotin (DCAS9PROT), and FnCas9 (FNCAS9PROT), focusing on specific enzyme characteristics of each protein and their potential applications for the research community.
  • Multiplexed immunofluorescence and digital image analysis for clinical use
    Multiplexed immunofluorescence and digital image analysis for clinical use Mehrnoush Khojasteh, PhD & Lei Tang, PhD Jun 28 2018 3:30 pm UTC 75 mins
    There is an ever increasing need to understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy. In this webinar, Drs. Lei Tang, PhD and Mehrnoush Khojasteh,PhD of Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), present their work on multiplex immunofluorescence staining and digital pathology analysis in a CAP/CLIA certified laboratory. Multiplexed immunohistochemistry (IHC) enables the spatial characterization of TME immune cells and tumor cells by detecting multiple biomarkers while preserving tissue morphology. Co-expression of multiple biomarkers and relative spatial relationships requires whole slide digital pathology image analysis algorithms that are tailored to individual assays and their intended uses. The process described in this presentation demonstrates how multiplexing and digital pathology enable biotech and pharmaceutical research and development teams to explore the potential medical value of specific biomarkers,
  • Soft Tissue Cancer & IHC
    Soft Tissue Cancer & IHC Jeff Gordon Jun 29 2018 3:00 pm UTC 75 mins
    Soft tissue tumors are a broad group of neoplasms that involve the connective tissue of the body. Each year, over 13,000 people in the US are diagnosed with soft tissue sarcomas and over 5,000 people succumb to the malignancy. Because soft tissue sarcomas are very ambiguous and amorphous, many time sarcomas are classified as an uncertain type. Advances in immunohistochemistry as well as the utility of novel markers such as TFE3, TLE1, MyoD1, and MUC4 have aided pathologists in classifying these soft tissue tumors. This discussion will cover the key facts and statistics about soft tissue tumors and what role IHC plays in these difficult diagnoses.
  • Changing Landscape: How Life Sciences Companies can Respond to the Latest Brexit
    Changing Landscape: How Life Sciences Companies can Respond to the Latest Brexit Andrew McConaghie Jul 5 2018 1:00 pm UTC 60 mins
    Brexit means Life Science companies operating in the UK and Europe are having to rapidly respond to a changing but still uncertain landscape. The lack of clarity in trade and regulation for the sector means life science companies need to make multiple risk assessments and plans for a number of scenarios.
  • Object Storage. What it Solves & Why it’s Better for Your Data at Scale.
    Object Storage. What it Solves & Why it’s Better for Your Data at Scale. Mike McWhorter, Senior Technologist, Western Digital Jul 10 2018 4:30 pm UTC 30 mins
    Most have heard about object storage, but what problem is it solving, and how does it compare to other storage solutions like SAN or NAS? If these are questions you’ve asked yourself this webinar is for you! (Hint: The problem Object Storage solves is scalability.)

    Join Senior Technologist Mike McWhorter as he explains how Object Storage differs from SAN, NAS and distributed file systems, the unique technological features which make object storage ideal for archiving, accessing or protecting data (especially unstructured data), and how different industries are using Object Storage today.

    Register today to watch live or for the on-demand recording.
  • Raman spectroscopy measurements during Bioprocessing
    Raman spectroscopy measurements during Bioprocessing Nobel Vale, Research Scientist II, Bristol-Myers Squibb Jul 11 2018 2:00 pm UTC 75 mins
    Raman spectroscopy has been seen as spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman’s insensitivity to water and ability to analyze samples without manipulation. However there are certain challenges for Raman when analyzing a complex and dynamic sample such as a cell culture. This article will describe the different challenges in analyzing in-line Raman data and how to mitigate changes in samples that include changes in fluorescence background, presence of cells/debris in samples, and spectral interference.
  • Development and Manufacturing of Recombinant Nanoparticle Vaccines
    Development and Manufacturing of Recombinant Nanoparticle Vaccines Atin Tomar, CPL Biologicals Jul 12 2018 9:30 am UTC 75 mins
    A recombinant vaccine technology platform based on highly purified, properly-folded protein antigens in stable well-defined Nanoparticles, enabling efficient and safe manufacture of vaccines against highly pathogenic targets. Nanoparticles are intrinsically immunogenic, producing both durable neutralizing antibodies and cellular immunity. The platform can be utilized for rapid response to potential pandemics as the time from identification of relevant viral gene sequence to final GMP drug product ready for human studies has been demonstrated to take less than 4 months for multiple vaccines.
    The GMP drug substance manufacturing process for the platform largely utilizes single-use technologies. Single-use-technologies and recombinant platform enables the utilization of same manufacturing facility for multiple products with rapid change-over.
  • Key components of a comprehensive program for the management of single use techn
    Key components of a comprehensive program for the management of single use techn John Maguire, Shire Jul 18 2018 2:00 pm UTC 75 mins
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • Introducing the CellStream® System, A Highly-Sensitive, 7-Laser Flow Cytometer
    Introducing the CellStream® System, A Highly-Sensitive, 7-Laser Flow Cytometer Robert Smith-Mccollum and Christine Probst Jul 18 2018 3:00 pm UTC 75 mins
    MilliporeSigma is excited to launch the new CellStream® benchtop flow cytometry system, a highly-customizable, highly-sensitive 7-laser flow cytometer. Its unique optics system and design provides researchers with unparalleled sensitivity and flexibility when analyzing cells and submicron particles. Within the CellStream® system, the Amnis® time delay integration (TDI) and camera technology rapidly captures low resolution cell images and transforms them into high-throughput intensity data. Researchers acquire the intensity data they are accustomed to from traditional flow cytometers, but with greater fluorescence sensitivity. Join us in this webinar to take a deeper look inside the instrument design, system performance and software of this exciting new system.
  • HPLC Method Development in One and a Half Days Using the Selectivity Concept
    HPLC Method Development in One and a Half Days Using the Selectivity Concept Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Jul 24 2018 6:00 am UTC 75 mins
    Modern HPLC technologies such as UHPLC, monolithic silica or Fused-Core™ particles provide superior separation efficiency and resolution of peaks. But in general resolution is more strongly impacted by selectivity which in turn can be affected by different stationary bonded phases. This presentation will discuss the choice of RP HPLC column chemistries such as RP-Amide, Phenyl, Pentafluorophenyl (F5) or Cyano which can provide alternative selectivities to traditional C18. It will compare their different retention mechanisms and highlight an approach to develop HPLC method within one and a half days.
  • High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models
    High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models Henriëtte Lanz, Ph.D. Jul 24 2018 5:00 pm UTC 75 mins
    Drug toxicity remains a major issue in drug discovery and stresses the need for better predictive models. Here, we describe the development of a perfused renal proximal tubule cell (RPTC) model in Mimetas’ OrganoPlates®[1] to predict kidney toxicity. The OrganoPlate® is a microfluidic platform, which enables high-throughput culture of boundary tissues in miniaturized organ models. In OrganoPlates®, extracellular matrix (ECM) gels can be freely patterned in microchambers through the use of PhaseGuide technology. PhaseGuides (capillary pressure barriers) define channels within microchambers that can be used for ECM deposition or medium perfusion. The microfluidic channel dimensions not only allow solid tissue and barrier formation, but also perfused tubular epithelial vessel structures can be grown. The goal of developing a perfused RPTC model is to reconstruct viable and leak-tight boundaries for performing cytotoxicity, as well as transport and efficacy studies. Human RPTC (SA7K clone, Sigma) were grown against an ECM in a 3channel OrganoPlate®, yielding access to both the apical and basal side. Confocal imaging revealed that the cells formed a tubular structure. Staining showed tight junction formations (ZO-1), cilia pointing into the lumen (acetylated tubulin) and correct polarization with microvilli on the apical side of the tubule (ezrin). Tightness of the boundary over several days was shown by diffusion of a dextran dye added to the lumen of the tubule. Addition of toxic compounds resulted in disruption of the barrier which could be monitored in time. The time point of loss of integrity corresponds with the concentration and the toxic effect of the compound.
    [1] S. J. Trietsch, G. D. Israëls, J. Joore, T. Hankemeier, and P. Vulto, “Microfluidic titer plate for stratified 3D cell culture.,” Lab Chip, vol. 13, no. 18, pp. 3548–54, Sep. 2013.
  • Lifecycle management of single use technologies
    Lifecycle management of single use technologies Francis Verhoeye, Director Single Use Technologies, GSK Vaccines Jul 25 2018 12:00 pm UTC 75 mins
    Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production Sune Klint Andersen, Janssen Pharmaceutica & Filipe Gaspar, Hovione FarmaCiência Jul 25 2018 2:00 pm UTC 75 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • Subvisible Particles Matter, Developments in Regulations and Low Volume Methods
    Subvisible Particles Matter, Developments in Regulations and Low Volume Methods Dr Satish K Singh, Lonza Jul 26 2018 2:00 pm UTC 75 mins
    The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP is a new chapter that addresses the limitations of USP for therapeutic proteins in measurement of subvisible particles. USP is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.
  • Next generation processes: What model works the best in Asia?
    Next generation processes: What model works the best in Asia? Ravishankar Kasturi, Reliance Life Sciences Aug 9 2018 5:00 am UTC 75 mins
    Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Aug 13 2018 9:30 am UTC 75 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • Is India Anywhere Closer to Implementing Continuous Bioprocessing
    Is India Anywhere Closer to Implementing Continuous Bioprocessing Narasimha Rao Nedunuri, CEO of CLONZ Biotech, and José Castillo, PhD, CTo and co-founder of Univercells Aug 16 2018 9:30 am UTC 75 mins
    Continuous processing has been widely employed in many biological manufacturing processes. In recent years it gained the momentum in the field of Biosimilar manufacturing due to an ever-increasing pressure for reduction in manufacturing costs.
    Potentially, the continuous processing offers Lower Cost of Goods, ease of scalability, and lower manufacturing footprint and hence became a topic of interest to many biosimilar players. Ongoing research on various new technologies for continuous operation, both in upstream and downstream processing may potentially be a game changer. Top on the wish list being, integration of all the multiple unit operations into a single continuous process with real time analytical tools.
    Though there are several challenges to develop and adapt continuous bioprocess, the magnitude of potential benefits are currently driving the research programs worldwide. India , being a significant global player in the biosimilar domain, currently making efforts to adapt these novel processes to make the drugs more cost effective.
  • Implementing CMC Strategies for scale-up operations in biologics manufacturing
    Implementing CMC Strategies for scale-up operations in biologics manufacturing Dr Anita Krishnan, Lupin Aug 20 2018 9:30 am UTC 75 mins
    Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with best product quality, is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is remnant quality difference beyond the capability of process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to successful licensure of biotherapeutics.
  • Material Understanding for Continuous Manufacturing of Solid Dosage Forms
    Material Understanding for Continuous Manufacturing of Solid Dosage Forms Dr Yifan Wang, regulatory research scientist, FDA CDER Aug 23 2018 2:00 pm UTC 75 mins
    In continuous manufacturing of solid dosage forms, continued assurance of process performance and product quality is based on accurate and consistent flow of solid materials. Acknowledging the multidimensionality of material flow properties is often the first step to explore the material knowledge space. In addition, modular operations such as feeding and continuous blending often requires additional material testing for better understanding of process dynamics. As a key element of control strategy, tolerance of incoming material variations needs to be considered. The FDA’s Division of Pharmaceutical Quality Research is working to understand the impact of material properties and explore the material knowledge space for continuous manufacturing of solid dosage forms.
  • Project and Portfolio Management as a key tool to manage continuous improvement
    Project and Portfolio Management as a key tool to manage continuous improvement Gloria Gadea-Lopez, Ph.D.and Melvin Santos Sep 6 2018 2:00 pm UTC 75 mins
    Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
  • Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D Sep 12 2018 2:00 pm UTC 75 mins
    Salient facility design aspects to achieve manufacturing efficiency
    Combining single use and stainless steel strategically creating a hybrid
    Risk-based approach to CQV- Reducing cost and tme