Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.
Preclinical laboratories face several challenges when conducting animal studies requiring Biosafety Level (BSL) 2 level containment. Some of these challenges include informed study design (including knowledge of associated regulatory guidelines), proper preparation of the vivarium, species isolation, traffic control between containment areas, training of personnel, veterinarian care, and proper decontamination of equipment/waste/bedding prior to disposal. In addition, proper post-life handling of animals and samples, with focused attention on tissue sampling and specialized evaluation is a vital element in ensuring personnel safety and high scientific quality. Overcoming these hurdles will generate high quality data and allow for a safe and productive environment.
With rising healthcare costs, more informed and engaged patients, and advancing technology, health wearables have seen a significant uptake in recent years. However, the full potential of health wearables has yet to be recognised and there are still challenges to be resolved. What needs to be done on the regulatory, technical and healthcare side to take health wearables to the next level?
In this webinar, experts from the life sciences and technology industries discuss their views on the current state and future developments of health wearables, including:
– The user perspective: perception, adoption and expectations today and tomorrow
– The technology perspective: biggest successes and most room for improvements
– The societal and regulatory perspective: cost and risks versus benefits and opportunities
In this webinar, Dr. Michael Samoszuk will discuss the correlative relationships between urine chemistry analytes and the particles noted under the microscope. Attendees will learn how using the knowledge of these correlations can optimize parameter setting for improved laboratory workflow.
Join us and PHOENIX group as we delve into the concept of current launch excellence and the role of patient insights in overcoming the multiple challenges the industry currently faces.
Key topics to be discussed include:
– The challenges of launching a product in Europe
– How pharma can improve its understanding of the process through the use of business intelligence
– How insights from new data can be applied to the process of launch excellence
– The role of real-world data in launch strategy
– The downstream effect of applying real-world data to product launch on patient outcomes.
Working with QuintilesIMS, we present a digital debate which will offer modellling-based insights into the future of hepatitis C treatment.
Key topics to be discussed include:
– The burden of HCV
– The current market landscape
– The current patient access model and its impact on budget
– Cost efficiencies shown by modelling
– Cure versus lifetime treatment costs
Watch this Dell EMC and IDC Webcast, and explore integrated care readiness and how to sustain better decision making on care pathways as IDC shares results from its recent Health insights research.
Learn more about the readiness of integrated care, the priorities of clinical and IT executives, the barriers still preventing having care truly centered around the patient. IDC health insights reports on the details of a research conducted in the UK and Nordics, measuring the maturity of adoption of strategies, governance and architectures able to sustain better decision making on care pathways. The webinar also includes a zoom into mental health integrated practices and directions, and addresses some of the most common mistakes and misconceptions on improving patient information management, including analyst's guidance for hospital, primary care and secondary care executives.
Watch this Dell EMC Webcast and explore the true meaning of digital transformation.
With all the talk about “digital transformation,” some are left to wonder: what does digital transformation really mean? As organizations strive to become digital enterprises, it is important to understand what this encompasses in order to implement the appropriate strategies to become a truly digital organization.
In this webinar, Dr. Michael Samoszuk will discuss how red blood cell data reported from urine chemistry test strip analysis can correlate to red blood cell data gathered from the microscope, even when the data appears to be conflicting. Attendees will discover some of the underlying factors that could cause this to occur and learn how to minimize reporting inconclusive or inaccurate results.
The CRISPR/Cas genome editing system has revolutionized almost every aspect of the life science industry. Until recently, the most used formats for this technology have been plasmids, mRNA, or lentivirus. Each reagent has been successful in its own right, however, each approach has limitations. SygRNATM, the two-part synthetic crRNA and tracrRNA, increases the pace of research, decreases costs, and can be used with Cas9 protein, Cas9 mRNA and Cas9 expressing cells/models.
This webinar discusses the development of the SygRNATM system, protocol optimization, and proposes workflows that enable scientists to quickly incorporate CRISPR technologies into their research.
Over the past 20 years, behavioural economics has identified factors that influence and determine how people behave, including alternative decision-making pathways and many cognitive biases and heuristics. Taking account of these helps to build a clear view of how healthcare customers think and behave in relation to your product in the real world.
This short masterclass explores ‘quantitative demand assessment research’ – what it is and how insights from behavioural economics can improve the application of this important tool in pharmaceutical market research.
The masterclass will:
•Introduce demand assessment research and why it is important to healthcare market research
•Discuss how insights from behavioural economics can improve quantitative demand assessment market research
•Highlight a range of techniques using behavioural economics that help you build a more accurate picture of your customers and market.
H&E is the most frequently used stain in histology and is the basis for diagnostics and further selected methods. Thus it is important to have brilliant staining. We will show which minor factors can give a negative effect or spoil the result completely. Tips will be given on improving the sensitivity of the stain. For PAS, we will give advice on how to avoid common errors and always get colourful results.
We will discuss:
•How to prevent "critical situations"
Across the globe, omega-3 intake is lower than recommended. This means a large proportion of the population is missing out on the wide range of health benefits offered by omega-3s. Omega-3s have been linked to the reduction of the risk of cardiovascular disease, which is responsible for more deaths worldwide than any other condition.
Join us for the next in our webinar digest series to hear Prof. Philip Calder, DSM’s Prof. Manfred Eggersdorfer and Brent MacDonald, discuss how omega-3s can help reduce the risk of cardiovascular disease.
Webinar: The Impact of Soluble Factors and Substrate on Cell Culture: Media Additives, Growth Factors, and Surface
From basal media with feeder layers or serum to highly defined recombinant growth factors, cytokine, and extracellular matrix, there are many ways to grow the same cell type. The choice is dependent on scale, cost, control, skill, and regulatory factors.
This webinar will cover:
- Different ways to grow the same cell type
- The actual material costs of various methods
- Methods used to optimize formulations
Kevin Kelly graduated from Hawaii Pacific University and for 15 years worked on process scale-up and optimization for extracellular matrix proteins, growth factors, cytokines, antibodies, ELISA kits, and Corning® BioCoat™ products.
Currently he provides applications support for invasion, migration, permeability, transport, differentiation, and metabolism assays.
Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclinical testing is required to establish a safe starting dose for the initial human clinical trials. In partnering with our pharmaceutical and biotechnology Sponsors, our goal is to improve the odds of selecting the right lead candidates, and to conduct the right studies in the right way, taking all factors into consideration to ensure a successful IND submission.
As part of this webinar we will outline the nonclinical studies needed to progress a therapeutic into a Phase I clinical trial. We will cover small molecules to vaccines to biopharmaceuticals as well as standard indications to life-threatening and rare/orphan indications.
In research areas such as academic, biofuel, food and pharmaceutical industries the determination of algal viability, lipid content, and cell concentration is important in the selection, monitoring, and maintenance of algal cultures. Flow cytometry has been shown to be an ideal method to assess health and lipid content of cultures but has been challenging to adopt due to high complexity and cost of traditional technologies. In this webinar, we present novel simplified methods for algal characterization using microcapillary cytometry on either a simple touch screen based cytometer, the Muse® Cell Analyzer, or a higher throughput cytometric platform, the compact Guava® easyCyte platforms. The MilliporeSigma algae kits utilize simple mix and read protocols, dedicated software modules, and provide quick results for the of count and viability measurements or relative lipid content on algae strains. The optimized and dedicated algae kits allow for high precision and comparable results to predicate methods. Data from applications to multiple common algal strains such as Chlorella vulgaris and Chlamydomonas reinhardti under different culture conditions will be presented. Availability of dedicated kits for algae research on simple and easy to use cytometric platforms will empower and enable algae researchers to rapidly select optimal culture conditions and strains for downstream experiments.
Join us as we share some exciting new initiatives and discuss what’s to come in the remainder of 2016 and in 2017. We’ll also be giving updates on content coverage and content curation programs, as a lot has happened since we last presented on Scopus content in February. Tune in to stay current on all there is to know about Scopus - the Gold Standard multidisciplinary abstract and citation database.
Join expert medical librarian Amanda Horsman and Doug Felder from Mendeley for an exclusive webinar focused on how librarians like you use Mendeley Institutional Edition to support students and researchers. Amanda will demonstrate the power of facilitating inter-professional collaboration between research group members.
Watch and discover how Documentum Electronic Trial Master File (eTMF) can help navigate the complex clinical trial path and provide more granular eTMF plannin, better quality and actionable insight.
Watch this webcast and hear Adam Kelch, Senior Product Manager, Documentum Clinical Solutions, provide an overview of the key enhancements of Documentum eTMF announced at EMC World in Las Vegas in May. He’ll also discuss how our latest release (4.2) delivers more granular eTMF planning, better quality and actionable insight.
The Inova Translational Medicine Institute (ITMI) applies genomic and clinical information from individuals to develop personalized healthcare for patients. It is a division of Inova Center for Personalized Health (ICPH), which connects researchers, clinicians and consumers to integrate genomic research for patient care, prevention and wellness.
ITMI’s Informatics team saw the potential risk of rapid data set growth causing slowed research and increased demand for compute and storage resources. In this webinar, Aaron Black, Director of Informatics for ITMI, will share his innovative hybrid cloud solution that uses a high performance caching layer to couple existing on-premises compute and storage with cost-efficient cloud-based resources.
Jeff Tabor, Senior Director of Product Management and Marketing for Avere Systems, and Mark Johnston, Director of Business Development for Amazon Web Services, also discuss how ITMI supports large genomic and clinical data sets within their companies.
- Discover the objectives of ITMI clinical research programs and how they collaborate with other organizations for studies and to leverage predictive analytics that can guide patient care
- Learn how ITMI developed and executed a hybrid cloud infrastructure to manage massive research data growth and improve scalability to optimize cost effectiveness and deliver on its mission
- Discover how ITMI has eliminated redundancies of storing petabyte scale research data between cloud and on-premises storage while managing access to that data for research compute using both cloud and owned resources.
- Gain insight into technologies and services essential to the topology design and delivery with discussion among supporting panelists
Watch and learn how Documentum Research and Development (R&D) and Documentum Submission, Store and View (SSV) ensures alignment with global regulatory guidance to speed submissions.
Listen as Lena Shafir, Product Manager, Life Sciences Regulatory Solutions, provides an overview of recent enhancements to Documentum Research and Development (R&D) and Documentum Store and View (SSV). She’ll also cover how our latest release (4.2) delivers lifecycle support for medical device documentation and ensures alignment with global regulatory guidance to speed submissions.
Join the Webcast and learn how the latest enhancements of Documentum Q&M can deliver lifecycle support for medical device documentation - from design to production manufacturing, while ensuring compliance.
Hear Jessica Kelley, Quality Product Manager, provide an overview of the key enhancements and integrations with Documentum Q&M announced at EMC World in Las Vegas in May. She’ll also explain how our latest release (4.2) delivers lifecycle support for medical device documentation from design to production manufacturing and provides flexible print controls to maximize efficiency while ensuring compliance.
Interaction between antigen-specific T cells and antigen presenting cells (APC) cognate ligand involve reorganization of the cytoskeleton and recruitment of adhesive and signaling molecules to the site of intercellular contact. Sustained adhesion of T cells to APCs and formation of the immunological synapse after T cell receptor stimulation are required for the antigen-specific response. One way to measure an immunological synapse is by fluorescently labeling the molecules that have been recruited to the synapse and imaging by fluorescence microscopy. However, immunological synapses are rare and therefore difficult to analyze objectively and statistically by traditional microscopy methods. To overcome these problems, we employed the Amnis brand imaging flow cytometers to objectively collect imagery of large numbers of cells. We report the percentage of T cells involved in an organized immunological synapse, the recruitment of adhesion molecule LFA-1 and signaling molecule Lck to the synaptic complex and subsequent translocation of NFkB from the cytoplasm to the nucleus in the T cell. In this study, Raji B cells loaded with Staphylococcal enterotoxin B (SEB) were incubated with human T cells to create T cell-APC conjugates. Cells were stained in various combinations for CD3, CD19, Actin, LFA-1, Lck and NFkB. Results from the FlowSight and the ImageStream imaging flow cytometers are compared. Using the FlowSight imaging flow cytometer we demonstrate image-based parameters that were used to assess the frequency of conjugates with an organized immunological synapse in an objective and statistically significant manner. Employing the ImageStream imaging flow cytometer we further evaluate the specific location of the adhesion and signaling molecules LFA-1 and Lck within the immunological synapse complex in T cells and measure the nuclear localization of NFkB in the T cell.
Corning was pleased to have recently sponsored a GEN webinar highlighting the latest techniques for 3D cell culture in cancer research.
The use of 3D cell cultures has been rising sharply in recent years from its initial introduction, over two decades ago. Because 3D cultures more accurately mimic the cellular environment, they can be used to study various forms of cancer by fostering the growth of organoids that replicate key properties of in vivo organ systems or the original tumors from which they were derived.
In addition, many 3D cultures are amenable to large-scale drug screens for rapid detection of phenotypic or genetic changes associated with therapeutic compounds—an approach that opens the door for the use of 3D culture as an integral part of personalized medicine.
In this GEN webinar, panelists discussed how the latest 3D cell culture methods have facilitated breakthroughs in their research projects.
Marshall Kosovsky, Ph.D., Global Scientific Support Manager for Corning Life Sciences, will give a brief introduction into advances in Corning’s 3D culturing solutions.
Ömer H. Yilmaz, M.D., Ph.D., Assistant Professor of Biology at the Massachusetts Institute of Technology, will describe his work on how adult stem cells and their microenvironment adapt to diverse conditions within the context of tissue regeneration and cancer initiation through the use of ex vivo intestinal organoid assays.
Wojciech Senkowski, Doctoral candidate in the Department of Medical Sciences at Uppsala University in Sweden, will discuss his current work, which looks for applications of various tumor spheroid models in high-throughput drug screening for ways to identify novel compounds that target these cell populations
In this webinar, Dr. Michael Samoszuk will discuss the correlation between images of urine sediment particles captured on the iRICELL3000 and images viewed manually under the microscope using actual patient samples. Attendees will learn how these images compare and how automated microscopy helps to reduce user subjectivity in microscopy by standardizing the process.
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.
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
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.
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.