Medical Research

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The medical research community on BrightTALK brings together medical and research professionals. Find relevant webinars on medical research, laboratory science, continuing medical education and more presented by recognized medical researchers. Join the conversation by participating in live webinars and round table discussions on the latest in medical devices, medical research practices and trends in the healthcare industry.
  • Biological terror agents are frequently spore-forming bacteria and hardy in the environment, intended to persist despite best efforts at disinfection. This webinar explores the field of UV-C disinfection and the power of pulsed-xenon UV disinfection systems to neutralize such threats. Full spectrum pulsed-xenon UV is lab-tested to deactivate bioterrorism agents in the environment, expanding the options for protecting first responders and armed forces from dangerous pathogens.
  • Visit this page to download our infographic:
    http://www.vitaminsinmotion.com/fileadmin/data/pdf/Infographics/The_Liver_FOR_DIGITAL_05.pdf

    Fatty liver – and the focus is on fatty liver caused by lifestyle, not by alcohol - is a growing issue worldwide. A non-alcoholic fatty liver is frequently associated with obesity, insulin resistance and diabetes type 2. Today, there are approximately 1.5 billion overweight or obese people worldwide, and more than 300 million have diabetes type 2. Non-alcoholic fatty liver is also observed in 16% to 20% of normal weight individuals, and often has no symptoms.

    In this informative webinar, independent expert Dr. Arun Sanyal – a leading scientist from Virginia Commonwealth University – joins DSM’s Dr. Manfred Eggersdorfer, Professor for Healthy Ageing at Groningen University, and Jacob Bauly to present the latest research on the role of vitamin E supplementation in limiting the negative health implications of fatty liver.

    The results of several human studies have demonstrated that vitamin E was found to be effective in reducing the onset and development of a non-alcoholic fatty liver, was safe in the applied dose and did not lead to side effects such as weight gain. Currently, there is no approved drug for the treatment of a non-alcoholic fatty liver. It has been shown that vitamin E directed at a defined daily dose improves the liver condition in non-diabetic adults with a non-alcoholic fatty liver.
  • Key insights on mHealth and Disruption in Pharma, presented by experts.

    •How do new technologies disrupt industries?
    •Why does the network always win?
    •What are some key trends in healthcare technologies?
    •How can pharma leverage these trends?
  • Visit this page to download our infographic:
    http://www.vitaminsinmotion.com/fileadmin/data/pdf/Infographics/The_Liver_FOR_DIGITAL_05.pdf

    Fatty liver – and the focus is on fatty liver caused by lifestyle, not by alcohol - is a growing issue worldwide. A non-alcoholic fatty liver is frequently associated with obesity, insulin resistance and diabetes type 2. Today, there are approximately 1.5 billion overweight or obese people worldwide, and more than 300 million have diabetes type 2. Non-alcoholic fatty liver is also observed in 16% to 20% of normal weight individuals, and often has no symptoms.

    In this informative webinar, independent expert Dr. Arun Sanyal – a leading scientist from Virginia Commonwealth University – joins DSM’s Dr. Manfred Eggersdorfer, Professor for Healthy Ageing at Groningen University, and Jacob Bauly to present the latest research on the role of vitamin E supplementation in limiting the negative health implications of fatty liver.

    The results of several human studies have demonstrated that vitamin E was found to be effective in reducing the onset and development of a non-alcoholic fatty liver, was safe in the applied dose and did not lead to side effects such as weight gain. Currently, there is no approved drug for the treatment of a non-alcoholic fatty liver. It has been shown that vitamin E directed at a defined daily dose improves the liver condition in non-diabetic adults with a non-alcoholic fatty liver.
  • Abstract:
    As a key determinant of drug pharmacokinetics, transporter mediated drug-drug interaction has garnered significant attention from the pharmaceutical industry and regulatory authorities. Corning offers a comprehensive list of tools to support drug transporter studies and recently introduced Corning® TransportoCells™ products to support in vitro assessment of drug interaction with SLC transporters. This new model provides a convenient “thaw and go” cell-based model with robust activity and consistent performance. In this webinar, we will provide an overview of Corning TransportoCells products along with applications for in vitro-to-in vivo correlation. Validation data will also be presented for the newly available TransportoCells products, including OATP1A2, OATP2B1, PEPT1, PEPT2, and NTCP.

    Presenter Biography:
    Dr. Na Li received her B.S degree in Biology from Fudan University, Shanghai, China, and her Ph.D. in Pharmacology from Dartmouth Medical School, Hanover, NH. Her major research focus is on drug transporters, including interspecies differences in hepatobiliary transporters, transporter quantification, and in vitro-to-in vivo extrapolation of drug pharmacokinetics. At Corning, Dr. Li contributes her expertise in in vitro drug transporter technology and its application in drug ADME.
  • As part of its launch year, 2D Materials is helping authors to go further in sharing their research. In the first of our dedicated webinar series for rising stars in the field of 2D materials research, Andres Castellanos-Gomez will present some of his recent work on 'Atomically thin black phosphorus nanodevices’. Andres Castellanos-Gomez, is a Marie Curie Fellow at Delft University and a Visiting Researcher at IMDEA Nanoscience (Madrid, Spain). His research is focused on the study of the mechanical, electrical and optical properties of two-dimensional atomically thin crystals fabricated by exfoliation of bulk-layered crystals.

    The webinar should be of interest to researchers of monolayer and bulk-layered 2D crystals, particularly phosphorene, and their optoelectronic properties.
  • Introduction on what are considered as acceptable extractable and leachable data for submissions. The talk will focus on extractable and leachable study design considerations with examples on single project level. Also, discuss how to evaluate and leverage supplier data if they are available to you. Close with discussion on how to simplify and reduce numbers of E&L studies on entire project or multiple products/lines/buildings level.
  • Interested in treatment adaption? Learn about deformable registration and how it is essential for adaptive therapy. We will bring up common cases where deformable registration can be used, discuss related challenges as well as necessary features for success. You will see RayStation's approach to deformable registration with functionalities like structure propagation, dose deformation, treatment evaluation for delivered fractions and various QA options.

    We have applied to CAMPEP for 1 MPCEC (Medical Physics Continuing Education Credit)
  • Thermal Analysis is often used to investigate pharmaceutical substances. Polymorphism, pseudo-polymorphism, phase diagrams, stability, and purity determination can all be measured by thermal analysis.

    
The four main techniques of thermal analysis, DSC, TGA, TMA, and DMA are ideal for characterizing such substances. The chief advantage is that properties can be measured as a function of the temperature or time over a wide temperature range, from –150 to 1600 °C.

    

In this Webinar, we will show how thermal analysis is used to investigate pharmaceutical substances. We will present some typical examples measured by DSC, TGA, TMA or DMA.
  • COPD is a widespread, costly and largely preventable condition which affects over 300 million people worldwide and is recognised as the ‘third-leading’ cause of death in most countries. Adherence rates among patients with the condition are seen to be low, despite evidence that shows appropriate use of medication and sensible lifestyle changes can reduce mortality by 60% and hospital admissions by as much as 42%.

    Given the proven increase in quality of life when adherence occurs, and yet the persistence of non-adherence globally, there is clearly a disconnect. So why is poor self-management so prevalent and what can we do about it?

    In conjunction with self-management and behavioural change specialists Atlantis Healthcare, we present a multi-stakeholder webinar and debate, which will combine real world patient needs with expertise from healthcare, pharma and patient advocates to look at the challenges to successful self-management/adherence and ascertain what the industry can do to better support patients in achieving optimum outcomes.

    The webinar is comprised of 15 minutes of presentation and 40 minutes of live debate - which you can participate in, sending questions to the panel.

    A live tweetchat (#rwCOPD) will follow the webinar, enabling full interaction across all stakeholders to further delve into this topic and explore some of the issues and solutions raised during the webcast.

    This is the second webinar within the Patient Insights Summarized series.

    Your panel for this event is:

    Ana-maria Arboleda, Managing Director, Atlantis Healthcare Spain
    Dr Joan Escarrabill, Director of the Master Plan for Respiratory Diseases, Ministry of Health (Catalonia)
    Prof. John Weinman, Head of Health Psychology, Atlantis Healthcare
    Rolf Taylor, ‎Senior Director, Corporate Development, COPD Foundation
    Paul Tunnah (Moderator), CEO, pharmaphorum
  • This session gives an overview of the support available from the NIHR Clinical Research Network life-sciences industry team at a local and National level and explains how the network works in partnership with you to ensure your study is set up rapidly and recruits to time and target.

    Guidance on communication routes and our query resolution pathway is included.

    The webinar will also look at up to date performance data, how we collect it and how this information is transformed to ensure studies and sites are actively managed to deliver.

    Who should view this session?

    "Getting the best from the Network" is a must see for any CRA, Start up manager, study manager or NHS R&D manager who is involved in setting up and managing commercial contract clinical research in the NHS.
  • Join us on January 28th for a special Corning-sponsored webinar presented by ATCC®.

    Abstract:
    The significance of 3D tissue modeling opens up new possibilities for the study of complex physiological processes in vitro. Advances in cell isolation, media development, substrates, and growth surfaces are leading to culture environments that provide better biological and functional properties than traditional 2D cell culture. These models may provide a more predictive analysis and result in a more streamlined process of drug discovery and development. In this webinar, we will discuss recent developments in 3D modeling using ATCC primary and hTERT immortalized cells with specialized Corning® permeable support culture systems in dermatologic and respiratory studies.

    Presenter Biography:
    Dr. Yukari Tokuyama is a Field Application Scientist at ATCC. Prior to this role, she led the Stem Cell Product Development group and focused on products for human induced pluripotent stem cells and lineage specific differentiation. She earned her Ph.D. in Cell and Molecular Biology from the College of Medicine at the University of Cincinnati, where she studied the mechanism of genomic instability in cancer. She completed her post-doctoral training at the Oregon Health & Science University, Oregon National Primate Research Center, with a research focus on human and non-human primate stem cell biology.
  • The healthcare industry is entangled in a transitory phase where therapeutics, products and services are sold into traditional care settings that are saturated and exhausted. Yet, the opportunities for new services and care, like ambulatory, mobile, and home care, lack the appropriate level of maturity to provide robust revenue streams.

    As a result, Frost & Sullivan’s experts are predicting a year full of big disruptions, transformations and innovations. What’s in store for pharmaceuticals, biotechnology, medical devices, medical imaging, mobile health, healthcare IT, etc.? This briefing will provide an in-depth discussion examining at what degree we can expect the impact to take hold and transpire over the upcoming year.

    Attend this webinar to discover:
    •Insightful analyst predictions and probative analysis of the global healthcare industry in 2015.
    •Key strategies and initiatives executed by companies and organizations to capture opportunities for solutions in health, wellness, and prevention.
    •Track the progress of key macro level industry trends and their projected milestones for 2015.
    •An interactive Q&A session with Frost & Sullivan’s senior industry thought leaders.
  • The truth about delivering clinical research in the UK

    - Are you looking to deliver your research within Europe?
    - Need multiple, reliable sites?
    - Do you want to know why you should come to the UK?

    In the past the UK’s reputation for delivering clinical research was questionable. But that’s all changed. Over the last six years the research landscape here has changed dramatically allowing us to make great strides in delivering research for the life-sciences industry. So whether you’re a small CRO, a medium med tech, or a pharma giant - we can help you.

    The National Institute for Health Research (NIHR) Clinical Research Network* (see below) is hosting a live webinar which will explode common myths around the UK’s ability to deliver commercial clinical research. This session will be hosted by Matt Cooper, Life-sciences Development Director. It will include performance data that will demonstrate why the UK should be your first choice for clinical research. You can find out:

    - How much the UK’s market volume of commercial contract research (supported by the NIHR CRN) has changed
    - What percentage of the UK’s National Health Service (NHS) is actively delivering commercial contract research studies (with support from the NIHR CRN)
    - On average how many days it takes for NHS sites to get regulatory approval for research to take place (with NIHR CRN support)
    - What percentage of commercial contract studies (supported by the NIHR CRN) are delivered to time and target
    - How we are keeping clinical research in the public eye
    - How the UK is sharpening its competitive edge by achieving more and more key first global patient milestones
  • With the advent of NGS and existing molecular approaches, why is IHC unique and relevant for companion diagnostics? January 22, 2015 to learn more from Dr. Mary Padilla, Pathologist, Senior Medical Director, Companion Diagnostics, Ventana Medical Systems Inc. If you provide companion diagnostic services, develop targeted therapies, or prescribe targeted therapies, then this is the webinar for you!
  • In this webinar we explain how Public Sector organisations are using predictive analytics to make sense of their data to improve outcomes, allocate resources more effectively and reduce costs.

    See how your peers in Local and Central government and Healthcare are moving beyond spreadsheets to find hidden patterns and trends in their data to help them..

    Improve services, programs and outcomes
    Allocate resources effectively and reduce costs
    Understand causes of satisfaction and dissatisfaction
    You will see a demonstration of SPSS in action and have the chance to put your questions to Hannah Bauling. SPSS Technical Expert.

    If you cannot find the answers you need from your data or find you are getting frustrated with the limitations of a spreadsheet, then take a look at SPSS and discover a better way.
  • Public and private sector initiatives continue to transform the Healthcare industry in the Asia-Pacific - and their impact is likely to be seen in the coming months. For example, improving access to quality and affordable healthcare is a major goal of governments across the region, and a focus for reform efforts in many countries.

    Frost & Sullivan provides in-depth insights on how impending regulations, ethics and compliance reforms, emerging business and service models and industry partnerships will impact healthcare in the region

    Join us as we examine key trends for 2015 and beyond and discuss their impact on pharmaceuticals, medical devices, health technology, insurance, healthcare delivery and wellness across Asia-Pacific.
  • Why is IHC a useful and essential tool for companion diagnostics? Listen to the perspective of Dr. Peter Banks, an international recognized diagnostic pathologist, the former President Society for Hematopathology, and a founding member International Lymphoma Study Group.
  • Join us for a special Corning sponsored webinar presented by Promega Corporation.

    Cells cultured in 3D model systems often acquire relatively large in vivo-like structures compared to the thickness of a 2D monolayer of cells grown on standard plastic plates. Multicellular 3D culture systems containing more than one cell type and exhibiting formation of a complex extracellular matrix represent a more physiologically relevant environment, yet provide a challenge for assay chemistries originally designed for measuring events from monolayers of cells. There is an unmet need for guidelines for design and verification of convenient and effective assays useful for larger 3D microtissues. Critical factors to consider for each model system and cell type include effective penetration of detection reagents and/or complete lysis of microtissue structures using combinations of detergent and physical disruption. We will present the approach used to verify performance of a bioluminescent ATP detection assay for measuring cell viability, a caspase assay for detecting apoptosis, and cell stress reporter assays to detect mechanisms leading to cytotoxicity. Recommendations for factors to consider when verifying performance of cell health assays on 3D culture models will be presented.

    Speaker Bio:

    Dr. Terry Riss started the Cell Biology program at Promega Corporation in 1990 and has since held several R&D and Project Management positions. Dr. Riss managed development of cell viability, cytotoxicity, apoptosis, and protease assay systems and also led efforts to identify and promote multiplexing of cell-based assays to determine the mechanism of cell death. Dr. Riss now serves as Senior Product Specialist, Cell Health involved in outreach educational training activities including validating assay systems applied to 3D cell culture models.
  • The application of Rapid Microbiological Methods (RMM) in a topic that has gained interest over the past few years as pharmaceutical manufacturers investigate and look to gain improved efficiencies across all areas of their businesses – including the microbiology laboratory. This presentation will show how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.

    *** Presented by Yongqiang Zhang, Senior Scientist, BD Diagnostics:

    Examination of the microbiological quality of water used for manufacturing pharmaceuticals is integral to current Good Manufacturing Practices (GMP) and ensuring product safety. Membrane filtration, the conventional method for assessing microbial burden in water, takes three to seven days to complete. Valuable opportunities for intervention could be missed due to a delay in obtaining test results. In this study, we assessed the effectiveness of flow cytometry as a rapid microbiology method for water analysis. The data with four representative bacteria [Burkholderia cepacia, Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus] indicate that a low level bacterial presence in water can be rapidly detected and enumerated. These results highlight the potential of flow cytometry for real time monitoring of the microbiological quality of water in pharmaceutical manufacturing.

    *** Presented by Scott Sutton Ph.D. – President of Pharmaceutical Microbiology Forum & Owner of The Microbiology Network

    There has been excitement about the potential of RMM in QC microbiology since the ATP bioluminescence method was commercialised in the early 1970s. After 45 years however, pharma microbiology is notable for its lack of adoption of these methods. This presentation will examine this situation and offer some potential explanations, as well as recommendations for better microbiology service to the pharmaceutical industry.
  • Respiratory gated delivery holds the promise of improved dose conformality by allowing for tighter margins and/or increasing the geometric separation between the treatment volume and sensitive structures. Elekta linear accelerators can be gated in an automated manner making use of Elekta's Response gating kit. This talk will review our experience delivering gated treatments with an Elekta linac.
    Topics will include:
    (1) how to minimize the impact of beam on latency;
    (2) a review of gating strategies such as assisted breath-hold, coached breath-hold, and free breathing based gating; and
    (3) advancements in gated beam delivery such as the use of flattening filter free (FFF) beam delivery.
  • Peer review is a great opportunity for early career researchers to play a greater role in the research community and gain valuable experience to help improve your own research writing. If you’d like to get involved in peer review, or are looking for tips on how to deliver a great review, join our webinar for top advice from our team of experts.

    We will cover the following:

    - Why peer review matters: Why peer review is important, your responsibilities as a peer reviewer, and why you should get involved.

    - The Editors’ perspective: Find out how editors choose reviewers, what editors expect from peer review, and how your review is used to inform editorial decisions.

    - How to write a great peer review: Learn how to provide a top quality evaluation that is useful for the authors in improving their manuscript, and editors in making their decisions.

    - The ethics of peer review: We’ll guide you through your ethical obligations as a reviewer, and the main pitfalls to watch out for.

    The Speakers
    • Chair: Verity Warne, Author Marketing, Wiley
    • Michael Willis, Senior Manager Peer Review, Wiley and ISMTE president Elect
    • J. Matthias Starck, Editor, Journal of Morphology
    • Paul Trevorrow, Executive Journals Editor, Wiley
    • Dr John Langley, University of Southampton
    • Emily Jesper, Sense About Science
  • With challenges to highly priced rare disease medicines and the Cancer Drug Fund evolving again – what is next, what are the ramifications for high priced/innovative treatments delivering beneficial outcomes to defined patient populations in the UK and how can pharma navigate seemingly choppy waters of access for rare disease treatments and orphan drugs?

    Working in partnership with IMS Health, pharmaphorum has assembled an expert panel including NHS England’s Malcolm Qualie, Alan Kane of Shire Pharmaceuticals, Angela McFarlane of IMS Health, the Cystic Fibrosis Trust's Nick Medhurst and pharmaphorum’s own Paul Tunnah to present and debate around these issues in a free to attend one hour webinar.

    This event will cover:
    • Access, in the UK, to higher priced drugs/innovative treatments
    • Rare Disease/Orphan Drug access in the UK
    • The evolution of the Cancer Drugs Fund - what does this look like, what could it mean for pharma/healthcare

    It will also enable frank discussion around the new NHS England processes.
  • Continuing concerns exist in the clinical laboratory community about the appropriate methodologies for satisfying requirements for calibration verification and linearity testing.

    During his presentation, Dr. Jack Zakowski will discuss issues associated with these regulatory requirements and will outline approaches to satisfy them.
  • Recent advances in genome editing have opened new potential for a wide variety of specific genomic modifications in virtually any cell type. In this 30-minute seminar, we will discuss the process of genome editing, address factors affecting the design of a genome editing project, and explore the application of modified cell lines for target discovery and validation.
  • Combining the process of tableting with a multiple unit pellet system requires the protection of the drug release controlling coating as well as the limitation of segregation of the tableting mixture in order to provide mass and content uniformity. Limiting pellet size and fraction (ideally 50 – 60 % w/w), using concave tooling and of course applying flexible coatings at high layer thickness are best precaution to prevent damage of the drug release controlling coating.
  • Visualization of protein-protein interactions at endogenous levels of expression is a powerful advancement in Life Science. Duolink® is a versatile tool for detection, quantification and localization of cytoplasmic signaling events. PLA® provides the ability to see and quantitate protein posttranslational modifications, define complex interactions, illuminate complex protein clusters or amplify low abundant single events.
  • Visualization of protein-protein interactions at endogenous levels of expression is a powerful advancement in Life Science. Duolink® is a versatile tool for detection, quantification and localization of cytoplasmic signaling events. PLA® provides the ability to see and quantitate protein posttranslational modifications, define complex interactions, illuminate complex protein clusters or amplify low abundant single events.
  • Key insights on Marketing Automation in Pharma, presented by experts of Across Health.

    - What is Marketing Automation?
    - How are other markets using this technology?
    - Benchmarking Life Science against other markets
    - Our observations and learnings in the Life Science industry.
    - Identifying the challenges of implementing Marketing Automation for your organisation.
  • The proximity ligation assay (PLA) is a powerful technique for performing in situ analysis of antibody targets in cells or tissues. This antibody-based application is very robust, and will provide unique data on localization and/or interaction of proteins. The webinar will outline the development of PLA, using an approach that is designed to help all researchers—regardless of their level of experience with this application. Topics addressed will include the following: guidelines for getting started, tips on the crucial bioinformatics investigations involved with the planning phase, specific details on the bench-work associated with performing the assay, and troubleshooting suggestions to allow investigators to refine the assay and successfully integrate it into their research program.
  • Visit this page to download our infographic:
    http://www.vitaminsinmotion.com/fileadmin/data/images/infographics/Eat_right_for_your_sight_Digital_06.pdf

    The global market for eye health ingredients is increasing fast with a projected compound growth rate of 5.9% until 2019 [1]. The innovation is no longer focusing only on age-related macular degeneration. Supplementation can be beneficial to healthy people of all ages to achieve optimized visual performance and comfort.

    DSM, Kemin and the University of Georgia have recently published a new study to show how lutein and zeaxanthin supplementation can help younger, healthy people improve their vision, such as the ability to see objects under glare conditions.

    Join our webinar and hear lead author Professor Billy R. Hammond Jr. and DSM’s Jens Birrer and Wolfgang Schalch present the latest findings and explain what the new science means to the market.

    [1] Frost&Sullivan (2013). “Strategic Analysis of the Global Eye Health Ingredients Market”.
  • The proximity ligation assay (PLA) is a powerful technique for performing in situ analysis of antibody targets in cells or tissues. This antibody-based application is very robust, and will provide unique data on localization and/or interaction of proteins. The webinar will outline the development of PLA, using an approach that is designed to help all researchers—regardless of their level of experience with this application. Topics addressed will include the following: guidelines for getting started, tips on the crucial bioinformatics investigations involved with the planning phase, specific details on the bench-work associated with performing the assay, and troubleshooting suggestions to allow investigators to refine the assay and successfully integrate it into their research program.
  • Visit this page to download our infographic:
    http://www.vitaminsinmotion.com/fileadmin/data/images/infographics/Eat_right_for_your_sight_Digital_06.pdf

    The global market for eye health ingredients is increasing fast with a projected compound growth rate of 5.9% until 2019 [1]. The innovation is no longer focusing only on age-related macular degeneration. Supplementation can be beneficial to healthy people of all ages to achieve optimized visual performance and comfort.

    DSM, Kemin and the University of Georgia have recently published a new study to show how lutein and zeaxanthin supplementation can help younger, healthy people improve their vision, such as the ability to see objects under glare conditions.

    Join our webinar and hear lead author Professor Billy R. Hammond Jr. and DSM’s Jens Birrer and Wolfgang Schalch present the latest findings and explain what the new science means to the market.

    [1] Frost&Sullivan (2013). “Strategic Analysis of the Global Eye Health Ingredients Market”.
  • Within the development of rapid screening methods to secure the global supply chain, the FDA’s Division of Pharmaceutical Analysis (DPA) has been building Raman spectral libraries for verification of pharmaceutical materials, in conjunction with handheld instruments in the field. Focusing on finished products, we evaluate the spectral library for method specificity, showing high specificity for drugs containing different active ingredients.
  • Today use of the term “single use technologies” can be considered as being synonymous with the modern biotech industries. Based on the proliferation of companies now specialising in providing solutions to pretty much anyone anywhere, along with the intensive level of marketing and industry discussion, it is clear to see that the sector has progressed significantly over the years. The ability to purchase systems and technologies off the shelf as a consumable, rather than invest in significant capital infrastructure, better facilitates small enterprises to perform small and pilot GMP scale manufacture in-house. Organisations are able to leverage the experience of the manufacturers in the development of these products. The concept of single use technologies has been proven to produce solutions which are compliant and work. However, there still are questions around regulatory guidance for single use technologies.
  • Mass spectrometry and other methods such as yeast two-hybrid can now accurately discern protein complexes or larger protein interactomes in diseases such as cancer, yet it is difficult to forward translate this knowledge into human samples. To overcome this hurdle, we began experiments using proximity ligation assays (PLA) to directly translate protein complexes into human tumor materials. Our assay reflects protein complexes between EGFR and GRB2 protein, a key adaptor protein necessary for EGFR pathway activation and coupling to downstream MAPK signaling. We annotated nearly 300 primary xenograft models (PDX) of cancer and show tumor subtype enrichment of EGFR:GRB2 signaling-associated complexes. Furthermore, tumors with abundant levels of EGFR:GRB2 signaling-associated complexes are more likely to respond to anti-EGFR antibody-based therapy. Finally, in 350 lung cancer tissues, across three distinct cohorts of patients, we demonstrate the ability of EGFR:GRB2 protein complexes to segregate tumors and show benefit to EGFR tyrosine kinase inhibitor therapy in patients whose tumors harbor high levels of EGFR:GRB2 signaling-associated complexes. This suggests that annotation of signaling-associated protein complexes in cancer tissues can not only molecularly annotate disease types but may also have predictive capacity for cancer therapeutics. This work opens up the human protein interactome as a new class of molecular markers for disease in a more practical manner. Proteins, encoded by DNA, do not work in isolation but instead function as part of multi-protein complexes that drive both normal and disease physiology. While we demonstrate the utility of this approach in cancer, receptor tyrosine kinase signaling and tyrosine kinase inhibitor therapeutics, our approach described here could have utility across a wide spectrum of both signaling-associated complexes and different types of disease, and thus would be attractive to a large audience.
  • This webinar will discuss the evolving role of Cell Lines and Cell Culture and their usefulness as models of physiological function and disease. The webinar will review the depth, breadth and best use of currently available Cell Lines. The role played by Cell Lines in ensuring that the output of future research continues to be valid and credible will also be evaluated. This is the first of a three part webinar series focused on delivering a broad picture of the role of cell lines as models in scientific research, the various strategies and approaches available.
  • Mass spectrometry and other methods such as yeast two-hybrid can now accurately discern protein complexes or larger protein interactomes in diseases such as cancer, yet it is difficult to forward translate this knowledge into human samples. To overcome this hurdle, we began experiments using proximity ligation assays (PLA) to directly translate protein complexes into human tumor materials. Our assay reflects protein complexes between EGFR and GRB2 protein, a key adaptor protein necessary for EGFR pathway activation and coupling to downstream MAPK signaling. We annotated nearly 300 primary xenograft models (PDX) of cancer and show tumor subtype enrichment of EGFR:GRB2 signaling-associated complexes. Furthermore, tumors with abundant levels of EGFR:GRB2 signaling-associated complexes are more likely to respond to anti-EGFR antibody-based therapy. Finally, in 350 lung cancer tissues, across three distinct cohorts of patients, we demonstrate the ability of EGFR:GRB2 protein complexes to segregate tumors and show benefit to EGFR tyrosine kinase inhibitor therapy in patients whose tumors harbor high levels of EGFR:GRB2 signaling-associated complexes. This suggests that annotation of signaling-associated protein complexes in cancer tissues can not only molecularly annotate disease types but may also have predictive capacity for cancer therapeutics. This work opens up the human protein interactome as a new class of molecular markers for disease in a more practical manner. Proteins, encoded by DNA, do not work in isolation but instead function as part of multi-protein complexes that drive both normal and disease physiology. While we demonstrate the utility of this approach in cancer, receptor tyrosine kinase signaling and tyrosine kinase inhibitor therapeutics, our approach described here could have utility across a wide spectrum of both signaling-associated complexes and different types of disease, and thus would be attractive to a large audience.
  • C-H functionalization is a powerful addition to the toolbox of the medicinal chemist. Modern C-H functionalization techniques hold the potential to enable the rapid exploration of structure activity relationships (SAR), the generation of oxidized metabolites, the blocking of metabolic hot spots and the preparation of biological probes. This presentation will describe a variety of high-value C-H functionalization chemistries, developed in house and in collaboration with academic groups, and give examples of how these technologies have been deployed successfully to impact drug discovery programs.
  • C-H functionalization is a powerful addition to the toolbox of the medicinal chemist. Modern C-H functionalization techniques hold the potential to enable the rapid exploration of structure activity relationships (SAR), the generation of oxidized metabolites, the blocking of metabolic hot spots and the preparation of biological probes. This presentation will describe a variety of high-value C-H functionalization chemistries, developed in house and in collaboration with academic groups, and give examples of how these technologies have been deployed successfully to impact drug discovery programs.
  • How do ischemia and fixation impact the quality of your assay results and information transfer? Garbage in! Garbage out! Join Geoffrey Baird MD, PhD and David Chafin, PhD at 9 AM Mountain Time, March 31, 2015, who will discuss the impact of ischemia and fixation on assay results, information transfer and some novel approaches to address these important factors. Dr. Baird is an Assistant Professor of Laboratory Medicine and an Adjunct Assistant Professor of Pathology at the University of Washington. Dr. Chafin is a Principle Scientist, Technology and Applied Research at Ventana Medical Systems Inc.
  • Although there are many techniques to study epigenetic marks such as DNA- and histone-methylation, on a genomic scale, there exists a need in the field to visualize these epigenetic marks at a single genomic locus in individual cells. Such an application requires a highly sensitive detection method. With this aim, a protocol was developed to perform in-situ hybridization followed by proximity ligation assay (a.k.a. Duolink®) and cell imaging to visualize DNA-methylation (5meC) on the SEPTIN9 promoter. SEPTIN9 promoter methylation is a known biomarker for colon cancer. After optimizing cross-linking, cell permeabilization and chromatin accessibility, the genomic specificity was ascertained by hybridizing with a pool of biotinylated-oligo probes that target the CpG islands in the human SEPTIN9 promoter. The Duolink assay was performed using anti-biotin and anti-5meC antibodies, corresponding proximity ligation assay probes, and Far Red detection reagents.
    Imaging by fluorescent microscopy revealed two red punctate spots in metastatic prostate cancer DU145 cells (diploid for chromosome 17 – location of SEPTIN9 gene) and three red spots in colon cancer SW480 cells (triploid for Chr17). No signal was observed in normal cells (BJ) or with non-specific oligo probes (LacZ). A decrease in Duolink signal was observed when the DU145 cells were treated with 5-AzaC, a drug known to block DNA-methylation. This proof of concept study will be extended to frozen and formalin fixed paraffin embedded human cancer tissue samples.
    Fluorescent imaging data will also be presented from a Duolink assay to monitor the interaction of EZH2 histone methyltransferase with the H3K27me3 epigenetic mark in prostate cancer (DU145) cells. Reduction in the Duolink signal demonstrated inhibition of EZH2 activity by the small molecule inhibitors SAHA and GSK343.
  • Although there are many techniques to study epigenetic marks such as DNA- and histone-methylation, on a genomic scale, there exists a need in the field to visualize these epigenetic marks at a single genomic locus in individual cells. Such an application requires a highly sensitive detection method. With this aim, a protocol was developed to perform in-situ hybridization followed by proximity ligation assay (a.k.a. Duolink®) and cell imaging to visualize DNA-methylation (5meC) on the SEPTIN9 promoter. SEPTIN9 promoter methylation is a known biomarker for colon cancer. After optimizing cross-linking, cell permeabilization and chromatin accessibility, the genomic specificity was ascertained by hybridizing with a pool of biotinylated-oligo probes that target the CpG islands in the human SEPTIN9 promoter. The Duolink assay was performed using anti-biotin and anti-5meC antibodies, corresponding proximity ligation assay probes, and Far Red detection reagents.
    Imaging by fluorescent microscopy revealed two red punctate spots in metastatic prostate cancer DU145 cells (diploid for chromosome 17 – location of SEPTIN9 gene) and three red spots in colon cancer SW480 cells (triploid for Chr17). No signal was observed in normal cells (BJ) or with non-specific oligo probes (LacZ). A decrease in Duolink signal was observed when the DU145 cells were treated with 5-AzaC, a drug known to block DNA-methylation. This proof of concept study will be extended to frozen and formalin fixed paraffin embedded human cancer tissue samples.
    Fluorescent imaging data will also be presented from a Duolink assay to monitor the interaction of EZH2 histone methyltransferase with the H3K27me3 epigenetic mark in prostate cancer (DU145) cells. Reduction in the Duolink signal demonstrated inhibition of EZH2 activity by the small molecule inhibitors SAHA and GSK343.
  • The article considers the opportunities for risk based change in facility design through quality by design (QbD) and advances in PAT. It suggests that the inclusion of a mix of biopharmaceutical products alongside oral solid dose products could work based on a manufacturing dancefloor concept. Further that both upstream and downstream may be considered in a new light with the potential for in-process real-time testing and approval significantly reducing or withdrawing entirely the need for work-in-progress (WIP) inventory and quarantine storage needs as supply chain management processes integrate.
  • The webinar will give an overview about general drug delivery requirements for paediatric drug products and current discussions concerning the EU and US regulations.
    In-depth Case Studies featuring Patient-centric Paediatric formulations, will also be presented.
  • Gap junctions (GJs) are large aggregates of intercellular channels that facilitate the diffusion of small molecules and ions between two interacting cells. GJ intercellular channels are formed through the interaction of two half-channels, called hemichannels, composed of oligomerized connexin protein subunits. Both GJs and hemichannels have numerous important physiological and pathological roles in tissue functions including propagation of the action potential in the heart, tumor growth and metastasis, the inflammatory response and adaptive immunity, wound healing, and electrical synaptic transmission in the central nervous system. The most widely expressed connexin isoform is Cx43, and its regulation in the abovementioned processes has been a major focus of GJ research. Over the past two decades protein-protein interaction with the cytoplasmic carboxyl terminus of Cx43 has come to the fore as an endogenous mechanism for controlling the GJ life cycle, channel gating, and channel-independent functions. We have used the Duolink proximity ligation assay (PLA) as a technique to study protein interactions with Cx43 in cultured cells. Two unique aspects of the technology – specifically, subcellular localization and the binary nature of the labeling – in combination with standard immunofluorescent confocal imaging techniques have yielded unexpected insights into GJ ultrastructure, action potential conduction, and the mechanistic regulation of Cx43 trafficking and hemichannel accretion to GJ plaques. In this context, the practical application of, appropriate controls for, and interpretation of Duolink PLAs will be explicated.
  • Gap junctions (GJs) are large aggregates of intercellular channels that facilitate the diffusion of small molecules and ions between two interacting cells. GJ intercellular channels are formed through the interaction of two half-channels, called hemichannels, composed of oligomerized connexin protein subunits. Both GJs and hemichannels have numerous important physiological and pathological roles in tissue functions including propagation of the action potential in the heart, tumor growth and metastasis, the inflammatory response and adaptive immunity, wound healing, and electrical synaptic transmission in the central nervous system. The most widely expressed connexin isoform is Cx43, and its regulation in the abovementioned processes has been a major focus of GJ research. Over the past two decades protein-protein interaction with the cytoplasmic carboxyl terminus of Cx43 has come to the fore as an endogenous mechanism for controlling the GJ life cycle, channel gating, and channel-independent functions. We have used the Duolink proximity ligation assay (PLA) as a technique to study protein interactions with Cx43 in cultured cells. Two unique aspects of the technology – specifically, subcellular localization and the binary nature of the labeling – in combination with standard immunofluorescent confocal imaging techniques have yielded unexpected insights into GJ ultrastructure, action potential conduction, and the mechanistic regulation of Cx43 trafficking and hemichannel accretion to GJ plaques. In this context, the practical application of, appropriate controls for, and interpretation of Duolink PLAs will be explicated.