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Medical Research

  • More Success in LC-MS: Tips and Tricks for Sample & Mobile Phase Preparation
    More Success in LC-MS: Tips and Tricks for Sample & Mobile Phase Preparation
    Vivek Joshi, PhD Recorded: Nov 15 2018 46 mins
    LC-MS is one of the most commonly used analytical techniques in various sectors for quantitation and identification of unknown from variety of complex samples. Use of LC-MS has expanded over the years as it offers both selectivity and specificity in analysis. With advances in both chromatography and mass spectrometry, sensitivity and accuracy of this technique has further increased, allowing for detection and identification of low-level analytes in complex sample matrices.

    The LC-MS workflow has three main components, which determine successful analyses: sample preparation, choice of mobile phase components and column selection. Not paying enough attention to one of these components can complicate data analysis, quantitation and identification.

    In this seminar, you will learn critical factors to consider when selecting the sample preparation methods, mobile phase components and HPLC columns.
  • Accelerating Discovery with In Situ Electron Microscopy
    Accelerating Discovery with In Situ Electron Microscopy
    Jordan Moering, Protochips and Ray Unocic, Oak Ridge National Lab Recorded: Nov 15 2018 54 mins
    As the imaging and analytical capabilities of the modern transmission electron microscope (TEM) have improved, it has become an increasingly vital tool to characterize and study nanoscale materials. With the advent of MEMS-based sample supports, researchers are now capable of easily heating and electrically characterizing their sample in situ, directly imaging the dynamic sample reactions occurring at the atomic scale.

    For semiconductor and electrical device applications, Protochips has developed focused ion beam (FIB) tools and sample preparation workflows that enable researchers to prepare FIB lamellae directly on MEMS-based sample supports, allowing pA-level electrical characterization of their sample at atomic resolution. With the growing interest surrounding graphene and other 2D materials, in situ TEM has become increasingly utilized to accelerate the discovery of these next-generation materials. At Oak Ridge National Laboratory, researchers Xiahan Sang and Ray Unocic used in situ heating to synthesize and characterize complex structural and chemical transformations of edge defects at atomic resolution. Their work pioneered new means by which 2D materials could be engineered directly in the TEM, opening new avenues for materials development and characterization. These and other novel results in the field of material science will be presented in this webinar.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Recorded: Nov 15 2018 42 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • MR/RT for precision radiation medicine: see what you treat with Elekta Unity
    MR/RT for precision radiation medicine: see what you treat with Elekta Unity
    Jihong Wang and Daniel Zips Recorded: Nov 14 2018 60 mins
    A new class of radiation devices is emerging, and it has the potential to transform how cancer is treated through more precise tumor targeting and adapting treatment at the time of delivery. High-field MR-linac technology integrates the power of state-of-the-art MR imaging with precision radiation technology. It can deliver precisely-targeted radiation doses while simultaneously capturing the highest-quality MR images. This will allow clinicians to visualize tumors and the surrounding healthy tissue at any time during radiation delivery, and then adapt the treatment accordingly.

    High-field MR-linac devices based on diagnostic-standard MRI technology will offer many avenues for exploring improvements in radiotherapy, such as shorter treatment regimens or targeted adaption of the treatment in real time. Also, by integrating precision radiation and MRI technologies, high-field MRI capabilities can be optimally explored to help bring personalized cancer care to radiation therapy.

    During this webinar, clinical experts will share their experience with Elekta Unity.
  • Research Metrics and Your Career
    Research Metrics and Your Career
    Dr. Charles Martinez, Client Consultant Research Management Recorded: Nov 12 2018 40 mins
    earn about Research Metrics and how to use them responsibly and effectively throughout your academic career.
  • Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D and Adam Kaletski, Business Leader, Bioprocess Recorded: Nov 9 2018 64 mins
    Clinical manufacturing facilities require the flexibility to configure the sequence of unit operations as well as equipment characteristics to fit diverse types of manufacturing processes.

    While stainless steel facilities remain as more traditional and suitable for large volume products, single-use facilities provide tremendous advantage for flexibility, infrastructure and capital costs, and start-up time. 

    Single-use equipment and single-use facilities are particularly suitable for clinical manufacturing due to smaller investment requirements, smaller footprint, reduced risk, and increased operational flexibility. 

    While single-use equipment are evolving and catching up to the functionality and reliability of stainless steel equipment, in some instances, stainless steel equipment may still be preferred. 

    We will be providing a description of a new clinical manufacturing facility where single-use and stainless steel equipment were combined in a strategic manner to meet the business objectives.

    Biopharmaceutical manufacturing facilities are designed and operated to meet business objectives at various stages of a product lifecycles. While large stainless-steel facilities are appropriate for large volume established products, smaller single-use facilities are more efficient for smaller volume manufacturing needs, particularly for clinical supplies. Stainless steel equipment can be combined with single-use equipment to create hybrid facilities to meet process needs and business objectives in a more efficient manner. Typical challenges with building and validating a biopharmaceutical manufacturing facility can be overcome by strategic planning, good execution and a high-performance team.
  • Cell Culture in 3D Systems; Moving from a 2D to 3D Environment
    Cell Culture in 3D Systems; Moving from a 2D to 3D Environment
    Seth Hanson, Academic Research Technology Specialist - Merck KGaA, Darmstadt, Germany Recorded: Nov 9 2018 64 mins
    Cell culture in 3D systems: moving from 2D to 3D cell culture?
    It’s now well accepted by the scientific community that the 3D cell culture condition better recapitulate the in vivo environment and behaviours of cells. But it’s not a trivial change to move from 2D cell culture conditions to 3D, and not always easy to choose the right system to use.

    An understanding of the key parameters for 2D and 3D cell culture will be reviewed, followed by an overview of the technologies available at Merck with features, benefits, and application data.
  • 2019 Healthcare Predictions – Growth Opportunities, Technology, and Trends
    2019 Healthcare Predictions – Growth Opportunities, Technology, and Trends
    Reenita Das, Partner and Senior Vice President, Kamaljit Behera, Industry Analyst, Transformational Healthcare Recorded: Nov 8 2018 72 mins
    In 2019, digital health will come of age. Favorable reimbursement policies for clinically relevant digital health applications will expand care delivery models beyond physical medicine. 2019 will be a reality check for two of the most hyped healthcare technologies of this decade—Artificial Intelligence (AI) and Blockchain.

    Globally, 2019 will be a year of value-based care as we expect the outcomes-based care focus to globalize. Access to affordable and quality care will be a key political agenda for upcoming elections in emerging markets such as Asia, Africa, and Central and Eastern European countries. Non-traditional players with digital technologies, such as Amazon, Ali Health, Microsoft and IBM, will provide the required impetus to public health systems to ensure accessibility and affordability of care.

    Key Takeaways:
    • Learn how many of our 2018 predictions came true
    • Gain insight into the critical issues affecting the healthcare industry globally
    • Identify new opportunities connected to the pharmaceutical, biotechnology, medical technologies, diagnostics, and healthcare IT sectors
  • Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River Recorded: Nov 8 2018 65 mins
    Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release
    Rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
    Followed by Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology Presented by Nicola Reid, Senior Product Manager at Charles River – Microbial Solutions
    The human element can never be completely eliminated in Bacterial Endotoxin Testing, but what can be done to mitigate the risk for human error and how does it relate to the data integrity problem?
    Reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
    We’ll apply those principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it’s utilized. The end result is the revolutionary cartridge technology.
  • Mendeley Advisor Briefing Nov 1, 2018
    Mendeley Advisor Briefing Nov 1, 2018
    Rachel Brennesholtz, Laura Thomson, Adrian Raudaschl Recorded: Nov 8 2018 65 mins
    An update on Mendeley for the Mendeley Advisor Community covering the Mendeley Advisor Events and the beta of the new Mendeley Reference Manager.
  • Protein Sample Prep Tips & Tricks
    Protein Sample Prep Tips & Tricks
    Natasha L. Pirman, Ph.D. Recorded: Nov 7 2018 35 mins
    E. coli is the most widely used recombinant expression system to overexpress protein given that it is inexpensive, easy to scale up, and relatively fast. Due to its wide-spread use, there are numerous molecular tools, products, and expression/purification protocols available. Determining which tools and products to use, such as plasmid, strain-type, affinity tag and resin system, or buffer exchange device can be daunting. Here, we present a workflow overview of the recombinant protein expression from E. coli and provide insight and various tips and tricks about how to optimize and improve protein yield and purity enabling you to make the best decisions for your protein of interest.
  • Beyond the Blame Game: Improving Patient, Physician, Pharma Relation
    Beyond the Blame Game: Improving Patient, Physician, Pharma Relation
    Andrew McConaghie Recorded: Nov 7 2018 59 mins
    We often hear patients report a lack of ‘connection’ with their physician, and where lifestyle plays a role in the development of a disease, such as obesity or type 2 diabetes, patients may even feel the doctor blames them for their condition.

    So how can patients and healthcare professionals move beyond the ‘blame game’? This webinar will explore:
    • How HCPs and patients can establish a better partnership
    • The role pharma can play in facilitating this change
    • Opportunities for intervention at key points in the patient journey

    Join Cello Health Insight and Pharmaceutical Market Europe (PME)’s webinar to hear an expert discussion of these issues and the consequences for the patient, the patient-physician relationship and for pharma.
  • Advances and Challenges in Vaccine Development and Manufacture
    Advances and Challenges in Vaccine Development and Manufacture
    Tony D’Amore, Sanofi Pasteur Recorded: Nov 2 2018 41 mins
    This webinar reviews the constraints and complexities of vaccine product development and manufacture.
    The evolution of bioprocess and analytics innovation and technologies to overcome these challenges are discussed.
    The strategy and leveraging of innovation and technology for rapid product development and accelerating timelines is described.
    Case studies to illustrate the advances in vaccine development and manufacture are illustrated.
    A look into the future with state of the art technologies.
  • Medical Marijuana Market Trends—Future Clinical Role of Medical Marijuana & CBD
    Medical Marijuana Market Trends—Future Clinical Role of Medical Marijuana & CBD
    Nitin Naik (Moderator) Barbara Gilmore, Senior Consultant, Frost & Sullivan, Dr. Joseph C. Maroon, University of Pittsburgh Recorded: Oct 30 2018 48 mins
    Medical cannabis use is driving industry revenues into the billions. Investments by pharmaceutical and Big Tobacco companies in the development of cannabis and CBD-based products and devices, along with healthcare-conscious consumers having access to these products, are spurring growth. Physicians, aware of increasingly widespread medical marijuana legalization, are interested in understanding the potential of these treatments. In US states where cannabis is approved, the use of prescription drugs, including the use of opioids, has decreased.

    Key Takeaways:
    • Learn about a variety of medical marijuana science and clinical uses/applications (patient experiences)
    • Discover health-related applications of medical marijuana based on interactions with the endocannabinoid system
    • Explore the latest clinical research in cancer, neurological, psychological, metabolic and pain disorders using medical marijuana
  • Get off Your Lazy NAS by Transforming Your Data Management Strategy
    Get off Your Lazy NAS by Transforming Your Data Management Strategy
    Stefaan Vervaet, Sr. Director, DCS Solutions & Alliances, Western Digital; Krishna Subramanian, COO, Komprise Recorded: Oct 30 2018 25 mins
    NAS is essential to your IT environment, but a lazy NAS can hurt performance, cause you extra work and bust your budget.

    Join experts from Western Digital and Komprise to learn how to transform your data management strategy by gaining visibility and an understanding of your data, automating the movement of inactive data to less expensive storage and optimizing your storage environment.

    In this webinar you’ll learn how to:
    •Increase NAS performance
    •Free up NAS capacity
    •Reduce costs by up to 50% or more
    •Reduce backup times by up to 60 percent or more

    A small investment of time can deliver BIG cost savings!
  • High Precision PCR utilizing ThermaGenix Reagents
    High Precision PCR utilizing ThermaGenix Reagents
    Professor Lawrence Wangh, Founder and CSO of ThermaGenix, Inc. Recorded: Oct 30 2018 47 mins
    The polymerase chain reaction (PCR) is a mainstay of molecular biology and genomics that provides an efficient and rapid in vitro method for enzymatic amplification of DNA or RNA sequences from various sources. There are three unique, easy-to-use PCR additives that act at different temperatures to improve sensitivity and product yield by preventing mis-priming:

    1. ThermaStop™: a novel reagent that acts like a universal hot-start for Type A and Type B DNA polymerases
    2. ThermaGo™: a unique reagent that enhances the specificity of these same enzymes during the course of amplification
    3. ThermaStop™-RT: a first-in-class reagent that acts like a hot-start for many reverse transcriptases.

    Each reagent is a chemically modified oligonucleotide produced under GMP conditions and sold as a dry powder. Stable at room temperature, each reagent can simply be added to the enzyme of your choice prior to adding that enzyme/reagent complex to the master mix. These improvements are observed for both inexpensive Type A Taq polymerases and very expensive HiFi Type B DNA polymerases in applications such as qPCR, multiplexing, and preparation of DNA amplicons prior to next-generation sequencing (NGS).
  • Safety First Throughout the Histology Workflow
    Safety First Throughout the Histology Workflow
    Shalmica Jackson, PhD Recorded: Oct 25 2018 49 mins
    From tissue processing to slide coverslipping, the histology workflow is laden with hazardous steps. Chemical sensitizers, strong acids, alkaline substances, and oxidizing agents are routinely used during histological workflows. These classes of chemicals are known to damage and even destroy living tissues. Ensuring the safety of laboratory workers is of the utmost importance. This workshop will present new approaches to help make the histopathology laboratory a safer environment with the use of formalin-free fixatives, phenol-free stains, DBP-free mounting media, IVD-certified ready-to-use reagents, and more.
  • Emerging Quantum Dot Materials: Synthesis and Application
    Emerging Quantum Dot Materials: Synthesis and Application
    Osman M. Bakr, PhD Recorded: Oct 25 2018 40 mins
    Quantum Dots (QDs) undoubtedly attracted lots of interest with their superior luminescent properties. What is distinct about their luminescent properties is that the wavelengths of emitted light can be precisely tuned by changing of nanoparticle size or composition. Quantum dots possess narrow full width at half maximum (FWHM), high photoluminescence quantum yield (PLQY), emission wavelength tunability through the entire visible and near IR range. In this webinar, we talk about synthesis and application of emerging quantum dots materials: Perovskite and PbS QDs. Perovskite QDs emit light within the visible range, have high PLQY (up to 100 %), narrow FWHM (below 20-25 nm), and are considered as the best alternatives for CdSe and InP QDs for display application. PbS QDs emit light in near IR region with narrow FWHM of absorption and emission, making them ideal in NIR photodetectors and solar cells.
  • Making new connections – An overview of new TLC-MS Applications Session 2
    Making new connections – An overview of new TLC-MS Applications Session 2
    Michaela Oberle Recorded: Oct 23 2018 48 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • Making new connections – An overview of new TLC-MS Applications Session 1
    Making new connections – An overview of new TLC-MS Applications Session 1
    Michaela Oberle Recorded: Oct 23 2018 51 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • 3D Organ-on-a-chip Applications Using the AIM Biotech Chip
    3D Organ-on-a-chip Applications Using the AIM Biotech Chip
    Kuan Chee Mun and Mahama Aziz Traore Recorded: Oct 22 2018 31 mins
    In vitro 3D cell culture models have emerged as a bridge between conventional 2D cell culture models and the complex & expensive in vivo animal models. By analyzing and comparing the biological behavior of tissues embedded in 3 dimensional hydrogels, results are significantly different from classic 2D cell culture in terms of proliferation, morphology, drug response and gene expression. These differences have been attributed to the topographically complex 3D environment surrounding the cells, where cell adhesion, structure, effector transport and mechanotransduction are substantially altered. A carefully designed 3D model can provide more physiologically relevant information using experimental designs unachievable by conventional 2D assays at a fraction of the cost of in vivo models.
    Current 3D cell culture assays like hanging drop culture often lack the capability to organize different co-cultured cell types in a meaningful way. The application of chemical gradients or flow is usually not possible.
    We are now able to address this issue with a modular microfluidic platform that can co-culture multiple cell types in discrete 3D and 2D channels. Organotypic assays with animal model-like complexities using human cells have been developed for research, drug discovery & diagnostics. These include models for immune checkpoint, T-cell killing efficiency, angiogenesis, metastasis, cell migration, microvascular networks and the blood-brain barrier. Additional applications that focus on a liver model will also be discussed. Drug Induced Liver Injuries (DILI) contributes to drug failures, drug withdrawals and acute liver failures. The liver strongly interacts with other organ systems and in some instances the metabolites secreted by the liver are responsible for other organs' injury. Engineered 3D liver models may increase the physiological relevance of drug toxicity by maintaining the expression levels of key cytochrome P450 enzymes and metabolic activity in liver cells.
  • Extractables and leachables testing using a Quality Risk Management approach
    Extractables and leachables testing using a Quality Risk Management approach
    Dhaval Tapiawala, Pfizer and Satish Kumar Mohanvelu Life Sciences Management Professional at MilliporeSigma Recorded: Oct 17 2018 79 mins
    • Understanding extractables and leachables for better adoption of single use systems
    • Ensuring safety of drug through determining the level of leachables throughout product life cycle
    • Case Study of implementation of standardized testing protocol
  • Digital therapeutics and healthcare innovation
    Digital therapeutics and healthcare innovation
    Roberto Ascione, Healthware International, Megan Coder, Digital Therapeutics Alliance, Pierre Leurent, Voluntis Recorded: Oct 12 2018 70 mins
    Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care.

    The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

    At the same time as digital therapeutics are breaking new ground there’s a whole ecosystem of digital health innovations that are also tackling healthcare issues in new and imaginative ways.

    From doctor-patient communication to managing healthcare costs, from healthcare monitoring to clinician workflow, the range of digital health tools and services available is rapidly expanding.

    We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

    This free webinar will also see our expert panel:
    •Consider the current state of play with digital therapeutics and what the future holds for them
    •Discuss how to harness healthcare innovations to involve and engage patients
  • Engaging with patient communities – tailoring approaches
    Engaging with patient communities – tailoring approaches
    Jamie Bearse, Thomas Farrington, Chuck Strand and Jenny Kite Recorded: Oct 11 2018 62 mins
    Change Together will be presenting a live webinar with leading figures from the patient advocacy community, who will discuss communication and engagement as well as the different approaches advocacy groups can take to address the unique challenges of their communities. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
  • Lighten Up!  Long-term imaging with ultra-bright, organic AIE cell trackers
    Lighten Up! Long-term imaging with ultra-bright, organic AIE cell trackers
    Liu Bin, PhD,Department Head - Department of Chemical and Biomolecular Engineering, National University of Singapore Recorded: Oct 10 2018 33 mins
    With the recent discovery of a special class of organic compounds with aggregation-induced emission (AIE) characteristics, new opportunities have opened for in vitro and in vivo imaging. In combination with advanced polymer encapsulation technologies, AIE compounds are now available as LuminiCell ultra-bright, organic nanoparticles that enable long-term cell tracking and imaging for applications such as cancer research and stem cell biology.
  • Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Yuyi Shen, Associate Director at Bolt Bio, John Cyganowski, Director of Manufacturing Sciences for MilliporeSigma Nov 19 2018 5:00 pm UTC 75 mins
    The desire for innovative technology that can eventually cause disruptive changes remains high in the biotech pharmaceutical industry. The road between pursuing and developing that technology to genuine implementing is not a smooth ride. In this webinar, the presenter identifies key challenges of implementing innovative technologies and the major drive for implementing innovative technologies and process upgrades. The presenter will share some case studies of implementing successful innovation tools and provide comparative economic analysis based on the understanding the true value of innovation driven process design. The webinar also provide the insight of the balance needs for quality, cost and speed.
  • How to get published in Austria
    How to get published in Austria
    Jane Hesling, Associate Editor, IOP Publishing Nov 20 2018 9:30 am UTC 60 mins
    The webinar, aimed at early career researchers, will cover a range of topics including how to choose the right journal, peer-review and publication ethics, and your open access publishing options thanks to funding agreements in Austria.
  • How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe) Nov 21 2018 3:00 pm UTC 60 mins
    The 2018 Digital Trends report released by Adobe & Econsultancy found that only 5% of healthcare and pharma organizations reported being digital-first. Yet in today’s digital world, there has never been a better time for the Pharma industry to innovate and improve health outcomes whilst driving business performance. Technology has sparked a revolution across all functions, from research and development to sales and operations. However, meeting these demands is not without its challenges. The unique nature of the pharma and life sciences industry means that it faces issues that other businesses do not have to grapple with. There are complex supplier networks, growing regulatory requirements and increasing pressure to reduce costs – so what can digital leaders do to effect change quickly?

    Join Econsultancy & Adobe in this webinar to learn:
    • The reality of the digital first challenge and the trends causing complexity.
    • How technology is shaping the future and the opportunities for digital agility & efficiency.
    • How Merck transformed time consuming business processes though digital workflows – accelerating business, and improving the employee & customer experience.
    • How electronic signatures can digitally transform your documents and workflows, accelerating an organisations digital transformation journey.
    • How to ensure you stay compliant with regulations including a live demonstration the BioPharma module (covering Title 21 CFR Part 11)
  • How to accelerate FTO searches on sequences by 70%
    How to accelerate FTO searches on sequences by 70%
    Jessie Parker @ PatSnap Nov 21 2018 4:00 pm UTC 60 mins
    Scientists in the biotech and pharma industries spend a large amount of time and resources on researching sequences. However, often as researches progress to the later stages of R&D, they become blocked by competitors and products that are already on the market.

    Using a sequence searching tool which links to patent data can help you identify obstacles and freedom to operate much earlier on. Having access to a full data set sooner, can help you save time, money and enhance your R&D.

    Join this webinar to find out how you can accelerate FTO searches on your sequences.
  • Can simulated datasets unlock the potential of patient data?
    Can simulated datasets unlock the potential of patient data?
    Jem Rashbass, Health Data Insight, Chris Carrigan, use MY data, Adam Reich, IQVIA, Dominic Tyer, pharmaphorum Nov 27 2018 2:00 pm UTC 75 mins
    Patient level data offers the promise of insights which can craft new and better pathways, enable development of innovative therapies and treatments, and of course identify and prevent diseases much earlier in their lifecycle.

    One area of particular interest is cancer. However, in trying to realise the potential, the health sector is faced with the conundrum of protecting patients’ identities, while at the same time allowing doctors access to their data and enabling industry to benefit from vital insights into the disease.

    This presents a paradox, as the UK has some of the best healthcare data in the world, however, accessing the data can be challenging and time consuming due to patient confidentiality checks.

    So, what is the solution?

    IQVIA brings a unique perspective to this event, having partnered with Health Data Insight to develop an innovative solution to this seemingly intractable problem: Simulacrum, a database comprised of only artificial data that is modelled on real patient data collected by the National Cancer Registration and Analysis Service (NCRAS) in England.

    Simulacrum has already produced identical results to the real data when predicting incidence of tumours in the population, whilst simultaneously removing any risk of breaching patient confidentiality.

    In this webinar, IQVIA and pharmaphorum will also provide advice to industry, patient advocacy groups and healthcare professionals on how to leverage Simulacrum, and utilise this simulated dataset to facilitate access to England’s world-leading healthcare data, while complying with regulations designed to protect and maintain individual confidentiality.
  • Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Gabe Musso, CSO, BioSymetrics Nov 28 2018 4:00 pm UTC 75 mins
    Despite tremendous achievements in the fields of Artificial Intelligence (AI) and Machine Learning (ML), there remain several areas in healthcare and drug discovery where AI/ML has seen limited success. This includes, notably, improving the high attrition rates associated with discovery of new drugs. As genomic data becomes more widely available and clinical data continue to become digitized, there is an opportunity to use this data to understand and predict drug activity at a more personalized level than ever before. So what limits the application of AI/ML in the precision medicine & drug discovery space? Here we discuss the practical advantages and limitations of AI/ML as it relates to precision medicine and drug discovery, focusing on challenges that need to be addressed before the promise of AI-based approaches can be realized.
  • Expert Tips for Publishing in JACC Journals and Cardiovascular Health Promotion
    Expert Tips for Publishing in JACC Journals and Cardiovascular Health Promotion
    Dr. Valentin Fuster, M.D., Ph.D. Nov 29 2018 2:30 pm UTC 105 mins
    Join Valentin Fuster, MD, PhD, MACC, editor-in-chief of the Journal of the American College of Cardiology (JACC) to learn techniques and strategies for publishing in high-impact journals. During this engaging webinar intended for new and experienced researchers, Dr. Fuster will share his expertise in working with researchers and authors throughout the research publishing cycle; uncover strategies for developing papers for premium publications; and discuss the opportunities journals present to broadly disseminate findings. Evidence of the potential reach and impact of published research, Dr. Fuster will also present on the recent JACC Cardiovascular Health Promotion Series and how preventing cardiovascular disease is as important as treating it. Don’t miss this engaging webinar and how it can benefit your authoring process and the impact of your research.
  • New Preparation Approach for Improved Pesticide Analysis of Challenging Samples
    New Preparation Approach for Improved Pesticide Analysis of Challenging Samples
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Dec 4 2018 6:00 am UTC 75 mins
    For Pesticide Analysis in food and feed QuEChERS is an established Sample Preparation technique. Nonetheless there are some challenging sample matrices that require variations of the classical QuEChERS methodology. These are fat-rich matrices, intensively coloured matrices and dry, complex matrices such as teas, spices or herbs.

    As even the variations in the official methods AOAC 2007.01 and EN 15662:2008 cannot fully remove all matrix interferences, this talk will introduce new sample preparation approaches leading to improved clean-up and recovery of pesticides in these challenging matrices.
  • Next Generation IHC
    Next Generation IHC
    Jeff Gordon Dec 5 2018 4:00 pm UTC 75 mins
    Immunohistochemistry has now been a staple in diagnostic pathology for decades. This is partially due to pathologist utilization of antibodies in the realm of specialty panels. As the science evolves, the panels evolve, creating demand for the next generation of antibodies to improve diagnostic capabilities. This talk will give an overview of some of these novel diagnostic markers and how they fit into the specialty panels with the traditional antibodies to provide the best diagnostic capabilities to the pathologist, therefore giving the patient the best care available.
  • The devil’s in the e-detail: what HCPs really want from you
    The devil’s in the e-detail: what HCPs really want from you
    Heiko Schmidt, Integrated Multichannel Marketing and Sales, Bayer, Sari Ruth Carter, Head of Marketing, Anthill Agency Dec 6 2018 10:00 am UTC 75 mins
    Overview:
    Communication; we all do it, it is a critical part of effective business practice and in this pharma is no exception.

    It is no secret that for pharma companies, face time with healthcare professionals (HCPs) has reduced drastically over the last 10 years while the cost of in person engagements has increased significantly.

    Like any customer their expectations for the content they receive have changed, with a focus on useful, succinct and easy to consume materials rather than the sales materials of old.

    So what is it that HCPs want and through this lens, what is it that pharma should be doing?

    The evidence points towards creating meaningful two-way conversations through multiple channels, connecting otherwise siloed touchpoints with and for HCPs in the process.

    For the past 40 years detailing has been the backbone of pharma/HCP communication – but what about e-Detailing? Is it just detailing on an ipad or is it supposed to be something more? How does this fit and what is possible, and more importantly desirable?

    To analyse the current situation and present practical insights, pharmaphorum presents a new free to attend digital debate. Working with our partner Anthill agency we have put together a panel of leading experts from Bayer and Anthill.

    This debate will cover:

    •What is the current landscape for optimal HCP communication?
    •What is the future in terms of HCP channel preference?
    •New technologies in pharma marketing that help you to better engage with HCPs and extend HCP reach – AI, chatbots, self-detailing
    •How to reach more HCPs, when, where and how they want
    •How to overcome low content usage by HCPs
    •The most common challenges for traditional eDetailing effectiveness
    •How to achieve better communication without having to reinvent the wheel
    •How to activate your existing content and reach all customers willing to engage with your brand, regardless of their preference.
  • Metrics to meaning: demonstrating the value of medical communications
    Metrics to meaning: demonstrating the value of medical communications
    Lynda Chang, Scientific Director, Complete HealthVizion, David Pearce, Commercial Director, Complete HealthVizion Dec 6 2018 3:00 pm UTC 75 mins
    Medical affairs and publications teams are under increasing pressure to demonstrate effectively the success of the medical communications activities they undertake.

    Naturally, there are a huge number of metrics that could be used to measure and demonstrate medical communications value. The challenge is to identify, and track, those metrics that really matter, and ensure this information is interpreted effectively.

    This pharmaphorum webinar, which will be held in partnership with Complete HealthVizion, will look at how to measure medical communications activities, how to continue with what is successful and how to change what isn’t working.

    This means identifying what can be measured, both in terms of reach and engagement as well as behavioural impact, deciding what ‘great’ looks like and how best to define success.

    The expert panel will also look at how behavioural science can provide a framework to develop smarter communications and, ultimately, drive better patient outcomes.

    This Metrics to Meaning webinar will take place on Thursday, 6 December, at 15:00 pm GMT (10:00 EST) and will teach you how to measure the effectiveness of different types of medical communications programmes.

    Interacting with the panel will also allow you to learn about a range of practical approaches to implementing metrics, including:

    • Innovative ways to measure medical communications value and success
    • How to help medical affairs and publications teams demonstrate greater value
    • How to optimise tactical outputs year on year
    • The importance of demonstrating and measuring behavioural change

    In doing so they will also discuss the role of behaviour and the implications of this for measuring success.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials
    Ingrid Hayenga, PhD & Markus Obkircher, PhD Dec 12 2018 7:00 am UTC 75 mins
    his webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials
    Ingrid Hayenga, PhD & Markus Obkircher, PhD Dec 12 2018 3:00 pm UTC 75 mins
    This webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Don Singer, GlaxoSmithKline R&D Jan 9 2019 3:15 pm UTC 75 mins
    The pharmaceutical industry paradigm change is occurring and industry has taken an important leap towards formality of quality improvement using quality tools. Recent industry and regulatory support of ‘risk-based’ concepts and principles are leading to a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety and efficacy.
    Microbiologists’ role as active partners in the pharmaceutical environment is to help transform industry to a routine Quality by Design paradigm. With the help of quality tools and using the concepts and principles of Quality by Design, a better understanding of how and where to implement microbiological control of processes can be developed, and microbiological purity can be built into products for all patient populations.
  • Challenges Faced by the End Users During the Qualification of Single Use System
    Challenges Faced by the End Users During the Qualification of Single Use System
    Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead, Sanofi, Swiftwater Jan 14 2019 2:45 pm UTC 75 mins
    Pharmaceutical industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics
    mAb Industry in China: Biosimilars vs. Innovative Biologics
    Dr. Joe X Zhou is the CEO Walvax Bio Group & Floris D Smet, Director of Field Marketing, Sarotrius China Jan 15 2019 8:00 am UTC 75 mins
    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
  • Overcoming Downstream Bottlenecks In The Upscaling Process
    Overcoming Downstream Bottlenecks In The Upscaling Process
    Dr. Dakshesh Mehta, Associate Vice President and Head of Bioprocess Group at Biotech & Genomics division Jan 17 2019 9:30 am UTC 75 mins
    In recent years, due to major advances in upstream process, therapeutic proteins can be produced at higher concentrations than ever before. For, these high-titer, high-cell density production, chromatography operations may be as perceived bottlenecks. Column size limitations, low dynamic capacity and buffer volume requirements are generally considered as contributing factors, apart from high resin costs.

    The talk will cover how flexible manufacturing systems could help establish efficient downstream processes to overcome capacity bottleneck. Also how downstream footprint can be reduced whilst speeding up purification process. Is there anyway, one could eliminate chromatography operations with other technologies that may require less space and buffers and also may be more cost effective?
  • Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network
    Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network
    Lance Marquardt, Bristol-Myers Squibb & Sara Bell, Merck Jan 17 2019 3:00 pm UTC 75 mins
    By Lance Marquardt, Associate Director – Upstream Processing for Hopewell Clinical Manufacturing at Bristol-Myers Squibb and Sara Bell, Senior Marketing Manager for Mercks’s single-use product portfolio.
    An overview of the current use of single use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state. The challenges in implementing single use manufacturing for commercial production will be discussed. Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.
  • Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance
    Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance
    Yasser Nashed-Samuel, Principal Scientist at Amgen Donald Young, Sr. Product Manager at Thermo Fisher Scientific Jan 22 2019 3:00 pm UTC 75 mins
    Attribute Sciences, Process Development, Amgen Biopharmaceuticals are drugs manufactured bygrowing genetically engineered cells in bioreactors to produce a therapeutic protein. Plastic single-use bioreactors are of interest to biopharmaceutical drug manufacturers due to their significant environmental and cost benefits and flexibility over stainless steel bioreactors. Effect of plastics on the biomanufacturing process is not yet completely understood. A case study on extractables from single-use bioreactors and impact on cell culture performance will be presented.
  • Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT Jan 25 2019 10:00 am UTC 75 mins
    Downstream processing of Biosimilar Monoclonal Antibody utilises variety of raw materials that a critical for achieving the desired product quality. In this webinar, we would like to discuss the data from three cases of lot to lot variability namely Depth filtration, Chromatographic resin and buffer component used in downstream chromatography unit operations. Changes in lots of depth filter resulted in significant clogging and differences in Host cell impurity clearance. Similarly, changes in resin lots resulted in increased back pressure during processing and variability in buffer raw material lots resulted in undesirable colouring of resin upon contact. In each case, we will present the root cause investigation, impact on product quality profile and associated CAPAs to control the effects of variability to ensure manufacturing continuity.
  • Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Dr Xin Bu, Principal Scientist, Bristol-Myers Squibb Feb 5 2019 3:00 pm UTC 75 mins
    Dissolution is one of the critical quality attributes for solid oral dosage forms, typically tablets and capsules. In addition as a quality control (QC) test to release commercial products, dissolution is often used as a comparative test to 1) apply biowaiver for lower strength(s) when multiple strengths of one product with the same or similar formulation are marketed, or 2) support post approval changes. In these cases, in-vitro dissolution test is used in place of in-vivo bioequivalence study to establish equivalency between products of different strengths or pre- and post-change. Guidances provided by major regulatory agencies, the United States Food & Drug Administration (US FDA) and European Medicines Evaluation Agency (EU EMEA) are often followed by many countries around the world. However some countries/ regions, such as Australia, Japan, China, Taiwan and Korea have their own country specific guidances. The dissolution requirements by the FDA and EMEA are generally similar, and depend on the type and level of changes as outlined in the relevant guidances. The requirements from other mentioned countries are often significantly different from that of US and EU, and different from each other. For products marketed globally, it’s prudent to understand the differences amongst the different country requirements when applying post approval changes using dissolution to demonstrate equivalency. Several sets of comparative dissolution studies may have to be conducted in order to satisfy all regulatory agencies. This presentation compares differences in dissolution testing requirements among the listed countries and provide examples to illustrate how for conduct studies to comply with the relevant guidance(s).
  • Extractables and Leachables have been used interchangeablely for too long. Are w
    Extractables and Leachables have been used interchangeablely for too long. Are w
    Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma Feb 6 2019 3:00 pm UTC 75 mins
    Title: Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
    Presenters: Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma

    Description:TBA
  • Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist, Bioprocessing Technology Institute, A*STAR  Feb 19 2019 8:00 am UTC 75 mins
    Adding Mass Spectrometry as part of the host cell protein workflow
    Analytical Strategies in HCP identification and purification process
    Developing Quantitative MS/MS method to determine HCP Levels
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Sune Klint Andersen, Janssen Pharmaceutica & Filipe Gaspar, Hovione FarmaCiência Feb 19 2019 3:00 pm UTC 75 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry
    Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro Feb 21 2019 9:00 am UTC 75 mins
    Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.