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.
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
A primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity before entering into human clinical trials. Nonclinical testing is required to evaluate the potential efficacy of a new therapeutic and establish a safe starting dose for initial human clinical trials. Knowing when and where to invest your time and effort in preparing for these nonclinical studies is a critical component of a company’s drug development strategy. Many companies outsource their nonclinical testing to contract research organizations (CROs) and have little to no prior experience in working with a CRO. There are a number of technical challenges involved in the process of outsourcing, which if not taken under consideration, can cause delays and unexpected expenses in developing a compound. These challenges range from determining which species is appropriate for your project to basic formulation and dosing aspects. Being aware of and mitigating as many of these challenges early in the process as possible reduces the potential for delays and allows a company to proceed with increased confidence. This webinar will describe some common technical challenges that we have encountered while working with our Sponsors.
Childhood cancer and pediatric cancer are general terms used to describe a wide range of neoplasms found in children and teenagers. Occurring in approximately 1 in 300 people under the age of 20, compared to 1 in 6 adults, pediatric cancers are more rare than adult cancers. Because less is known about pediatric cancers, diagnosis can be quite challenging for pathologists.
This presentation covers the basic science, as well as facts and statistics about pediatric cancer. We will discuss how the utility of immunohistochemical testing along with the application of novel antibodies can contribute to accurate diagnosis and survival rates of pediatric cancer patients.
Watch this EMC webcast and learn how solutions and cloud technologies can help improve capital projects performance and simplify project document sharing and transmittals.
Managing capital projects requires addressing many complex challenges at the same time. At every phase of a project, documents need to be managed and shared across large project teams, inside and beyond the organization. During this webcast, we will explore how customers are leveraging solutions to manage documents and enable collaboration across distributed teams. We will highlight real-world examples of companies that are deploying cloud technologies to take control of their projects and simplify sharing project documents and transmittals.
Watch this EMC webcast and discover how Clinical Research Information Platform is a key aspect in making all patient information available to researchers and clinicians.
Learn how a resilient Clinical Research Information Platform is a key aspect in making all patient information available to researchers and clinicians. Better leveraging the insights coming from new data as genomics and through a wider use of big data and analytics, the platform helps improving clinical trials outcomes making personalized medicine affordable and effective at scale. IDC Health Insights EMEA Senior Research Manager Silvia Piai and Michael Graetz, VP of Healthcare Sales EMEA at EMC will discuss about a recent European study on the needs and opportunities of convergence between Healthcare institutions, Research Centers and life science organization.
Attend this EMC webcast and explore key strategies to managing and providing access to critical asset information during the Big Crew Change.
In today’s Energy industry, the workforce is undergoing tremendous change, as all sectors are facing the wave of employees retiring as part of the Big Crew Change. In the Oil & Gas industry, shakeups in the wake of lower oil prices have seen thousands of employees leaving companies. With the large exodus of subject matter expertise, managing and providing access to your asset information is more important than ever. During this webcast, we will explore the key strategies that ensure that you are able to survive without your most seasoned employees and are positioned to onboard new, less experienced employees in the future.
The ImageStream® and FlowSight® are multispectral imaging flow cytometers that generates high resolution images of cells at a rate of 1000’s of cells per second. This allows for the rapid acquisition of tens of thousands of images per sample. Using the IDEAS® image analysis software, the system calculates features based not only on fluorescence intensity but the morphology of that fluorescence as well. This novel approach is able to seamlessly combine the quantitative power of flow cytometry with the high content information associated with microscopy. The system can collect data on a wide range of applications including nuclear localization during a signal transduction cascade, measuring colocalization of two probes, or quantify features on the phagocytosed particles in macrophages.
Dr. Mikael Roussel from the University Hospital of Rennes, France, will lead a discussion around the organization of the cell morphology and flow cytometry core laboratory. Hear his tips using Beckman Coulter's hematology solutions to improve management of patients with lymphocytosis. P.A.C.E. credit is available for your participation.**
This presentation describes critical factors for selecting microcarriers, as well as starting protocols to help you optimize the attachment and expansion of cells in spinner flask and bioreactor environments.
In addition, you’ll learn about new dissolvable microcarrier technology, which provides unique advantages for cells that cannot be easily separated from standard microcarriers.
Jennifer Weber is a senior development scientist with Corning Life Sciences. She has helped develop a variety of products for culturing advanced cell types including Corning® Synthemax™, a synthetic, xeno-free surface, and Corning stemgro ® hMSC, a serum-free, chemically defined medium for hMSC culture.
She recently transitioned to microcarrier product development and customer support for bioprocess applications. As part of this role, she facilitates customer adoption of Corning products for specific applications through protocol development, on-site technical support, and in-house customer-driven projects.
Video content accounted for 64% of all the world’s internet traffic in 2014 and is expected to grow to 80% by 2019. As the way in which we connect and digest information evolves, high quality mobile video capture and advanced digital analysis offers ever more authentic, intimate and rich insights into the customers’ world. This webinar will focus on:
– How emerging technology can enable us to realise the true value of ‘video data’ in our analysis and beyond
– How mobile technology can be used to get you closer to your customers and their real world experiences right from the earliest stages in product development
– How real world video content can engage your key stakeholders and ensure customer insights drive action
Chris Dagdigian, co-founder and CTO of BioTeam, Inc., delivers a candid assessment of the best, the worthwhile, and the most overhyped information technologies (IT) for life sciences. He’ll cover what has changed (or not) in the last year regarding infrastructure, storage, computing, and networks. This presentation, designed for those responsible for information management and support in research institutes, will help you understand what technologies will help you build and support data intensive science.
This webinar is sponsored by Avere Systems and is being presented in cooperation with AIRI (airi.org).
We'll also highlight exciting content to be unveiled at the 2nd Annual Converged IT Summit coming to San Diego in October. You won't want to miss it!
Diabetes is one of the most prevalent and most costly conditions worldwide – with a prevalence equating to 8.5% of the global population. Due to the complex nature of diabetes, with numerous co-morbidities and its asymptomatic nature, accurately modelling and therefore discerning which interventions are most effective, in terms of cost and patient impact is an equally complicated process.
This webinar will explore the patient pathway and how effective modelling – when pharma works together with healthcare stakeholders – can improve outcomes for both patients and the healthcare system as a whole.
Fully integrated with Salesforce, DocuSign helps users close more deals, faster. Your customers can sign contracts within minutes from anywhere, anytime and on any device. Sending a contract for electronic signature from Salesforce is simple: just click “Send with DocuSign” from any object. You can even generate and send contracts synced with data from Salesforce. When you automate time-consuming manual workflows, you eliminate rekeying of data and increase your productivity.
Join DocuSign and Outbrain, the global leader in content marketing, for a compelling webinar presentation and discussion.
This webinar will feature guest speaker Harel Shaked, Technical Project Manager at Outbrain. He will review how Outbrain:
- Improved sales productivity “with the click of a button” to send and sign contracts and agreements
- Began closing deals within minutes from the time an order is sent
- Lowered contract processing time by several hours
Register now to learn how Outbrain utilized DocuSign to improve the efficiency and effectiveness of their sales operations.
The need to securely share your files quickly and easily while knowing what's going on with your business is extremely important. DocuSign's integration with Box allows you to select documents from Box you want to sign or send for signature and prepare it in just a few clicks. Completed documents automatically save back to Box and can be accessed from anywhere, on any device.
Join this webinar to learn:
- How to securely share files quickly
- How to be more productive regardless of what device or application you're using.
- How Salesforce automatically creates a workflow process with Box and DocuSign
See how the DocuSign and Box integration can help you improve contract processes, keep all documents digital and help you get business done in 2016.
Predictive assays are a key element of personalized healthcare because these assays aid physicians in selecting individuals who are most likely or least likely to benefit from specific therapies. In addition to analytical validation, predictive assays require clinical validation to establish their clinical utility. Krista Acosta, Manager, CDx Pharma Services Assay Development, Nicole Schechter, PSM, PMP, CDx Director, Project Leader and Alton Yates PhD, Senior Manager, Clinical Sciences Management, will address the development and performance differences between predictive assays developed under in vitro diagnostic regulations and laboratory developed tests.
Are you prepared for the 2017 open enrollment season? Health plans and health exchanges expect member rates to increase upwards of 60 percent this year alone. Balancing this increase along with unexpected events like staff reductions, strikes, unforeseen or special projects can add additional complexity during your busiest season. We want to help you be prepared.
Register for this live webinar hosted by Dell Services and discover how to take control of the member experience, increase organizational flexibility, and reduce your costs by leveraging innovative staffing services. Our panel of industry-leading experts will review the state of the marketplace, share real-life success stories, and provide tips on ensuring your full-time and/or temporary staff is ready to handle this season’s surge in demand.
By attending this webinar, you will learn:
• Tips to prepare for open enrollment and other special projects
• When and when not to outsource
• Common pitfalls to avoid related to staffing
• Secrets to ensure claims staff productivity
• David Buchanan, Health Plan Innovation & Consulting, Dell Services
• Donna Reed, Managing Director, Health Plans, Dell Services
• Anna Mathy, Healthcare Staffing Services Sr. Leader, Dell Services
Cancer cells are found to fuse with macrophages giving rise to a hybrid cell that retains genotypes and phenotypes of both parental cells, the cancer cell and the macrophage. Dr. Wong’s intriguing data suggests that cell fusion is one mechanism for how cancer cells gain metastatic behaviors.
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.
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.
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.
You will learn:
- 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 BioCoat products.
Currently he provides applications support for invasion, migration, permeability, transport, differentiation, metabolism, assays.
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"
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.
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
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
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.
As you clear the nonclinical hurdle in support of your IND submission, you are ready to embark on the exciting, yet demanding journey of clinical development. The journey begins with drafting your IND, followed by entering three, or more, phases of clinical trials with nonclinical support required at each step in the process. The goal is submitting your New Drug Application (NDA)/Biologics License Application (BLA) and regulatory approval to market your product. While many of the considerations from the previous topic “How Do I Get My Compound Into Phase I?” will be applicable when designing subsequent nonclinical support of Phase II, III, and registration, additional considerations will need to be taken into account for these post-IND activities.
During this webinar, our presenters will outline the early clinical trial design as well as the necessary nonclinical studies required to advance a therapeutic through post-IND drug development. We will cover general considerations in the design of the nonclinical studies, and variations of early clinical trials.
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.