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Medical Research

  • 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 Recorded: Dec 6 2018 68 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.
  • Next Generation IHC
    Next Generation IHC
    Jeff Gordon Recorded: Dec 5 2018 57 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.
  • Research Metrics and Your Career
    Research Metrics and Your Career
    Dr. Charles Martinez, Client Consultant Research Management, SciVal Fairy Recorded: Dec 4 2018 39 mins
    Learn about Research Metrics and how to use them responsibly and effectively throughout your academic career. In this session you will learn about ORCID, the H-index and journal metrics including CiteScore and Impact Factor. Our speaker discusses how research metrics can help you chose a publication for your research and how you can use them to help promote your own 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 Recorded: Dec 4 2018 58 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.
  • Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Machine Learning, Personalized Medicine, and the Future of Drug Discovery
    Gabe Musso, CSO, BioSymetrics Recorded: Dec 3 2018 54 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.
  • 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 30 2018 59 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.
  • 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. Recorded: Nov 29 2018 59 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.
  • Industry Perceptions and Expectations - The Role of ICER as an Independent HTA
    Industry Perceptions and Expectations - The Role of ICER as an Independent HTA
    Mike Pace, Sr. Principal, Global Pricing & Market Access; Nathan White, Senior Vice President, Integrated Access & Outcomes Recorded: Nov 28 2018 63 mins
    This webinar explores:

    - The evolution of health technology assessment in the US and possibilities for the future
    - Opinions of manufacturers and US payer stakeholders on the role of - - ICER in the US healthcare system, as learned through a primary research study of more than 50 participants
    ICER methodologies and approaches to evaluation of clinical and health economic evidence
    - Ways manufacturers can begin to more proactively prepare for an ICER assessment
  • 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 Recorded: Nov 27 2018 68 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.
  • How to accelerate FTO searches on sequences by 70%
    How to accelerate FTO searches on sequences by 70%
    Jessie Parker @ PatSnap Recorded: Nov 21 2018 35 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.
  • 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) Recorded: Nov 21 2018 55 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 get published in Austria
    How to get published in Austria
    Jane Hesling, Associate Editor, IOP Publishing Recorded: Nov 20 2018 42 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.
  • 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 Recorded: Nov 19 2018 77 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.
  • 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.
  • 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.
  • The Template for a Successful Digital Trial
    The Template for a Successful Digital Trial
    Marie McCarthy, Sr. Director, Product Innovation; Chen Admati, Director, Intel Pharma Analytics Recorded: Nov 8 2018 61 mins
    Despite the increasing availability of mHealth technologies that can successfully capture physiological data, and digital platforms that can ingest and analyze the data to date, the adoption of these technologies is only cautiously embraced in clinical research.

    This webinar discuss the main challenges in the areas of:

    - Patient Engagement and Burden
    - Device Suitability
    - Data Complexity and Insight Generation
    - Operationalization
    - Privacy and Security Issues
    - Regulatory Acceptance
  • 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.
  • 6-AM and BUP:  New Useful Assays in the Opiate Crisis
    6-AM and BUP: New Useful Assays in the Opiate Crisis
    Dr. Mary Mayo Dec 12 2018 7:00 pm UTC 120 mins
    The opiate crisis has reached epidemic proportions, evidenced by more than 17,000 deaths a year and $504 billion in economic costs in the U.S. alone¹. Healthcare providers and laboratories need highly specific tests that accurately detect drugs of abuse in patient-care, employment, athletic and prescription drug monitoring settings.

    In this webinar, Dr. Mary Mayo discusses two highly sensitive assays—the Syva® EMIT® II Plus 6-Acetylmorphine (6-AM) and Buprenorphine (BUP)—that expand available options for drugs-of-abuse testing.

    After attending this webinar, you will be able to describe the:
    • Differences in opioid drugs
    • Magnitude of the opioid epidemic
    • Reasons to use specific drug tests related to opioids
    • Performance characteristics of the Syva EMIT II Plus 6-AM and BUP assays

    P.A.C.E. credit is available for your participation.*

    Presenter: Mary Mayo, Ph.D.

    Dr. Mary Mayo is a medical affairs manager with Beckman Coulter Diagnostics, with more than 25 years’ experience in the clinical laboratory. This includes twelve years as a laboratory director, nine years as director of clinical chemistry at a tertiary-care academic hospital and three years as the laboratory director of a commercial laboratory.

    References:

    ¹ CDC. “Opioid Overdoses Treated in Emergency Departments.” https://www.cdc.gov/vitalsigns/opioid-overdoses/. Accessed 6 Mar 2018.

    *Beckman Coulter Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. These credits are recognized by the State of California. Most programs also provide State of Florida credits (with valid license number). At this time, we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
  • Authoring in The Lancet — Learn from the Editors!
    Authoring in The Lancet — Learn from the Editors!
    John McConnell, Editor-in-Chief of The Lancet Infectious Diseases Dec 18 2018 9:30 am UTC 75 mins
    Join John McConnell, Editor-in-Chief of The Lancet Infectious Diseases to learn about techniques and strategies for authoring in high-impact journals. Mr. McConnell will present his experience working with researchers and authors throughout the research publishing cycle. You will learn how to develop papers for premium publications, and how to broadly disseminate findings. Do not miss this engaging webinar, join and ask any questions that you feel will benefit your research!
  • Introduction to writing research articles
    Introduction to writing research articles
    Dr Trevor Lane Dec 18 2018 2:00 pm UTC 60 mins
    Join Dr Trevor Lane as he hosts a webinar covering an introduction to writing research articles. In this webinar, you will learn how to write original research articles clearly and concisely and use an appropriate writing style for journals. You will also gain valuable insight into making strategic publication decisions that will help increase your chances of publication success.

    During this webinar you will hear how to:

    1. Make strategic decisions on how and where to publish your work
    2. Identify the features of effective research articles
    3. Devise some strategies to improve your research writing
  • The Modern Management of Brain Metastases
    The Modern Management of Brain Metastases
    Arjun Sahgal MD, FRCPC, Deputy Chief of Radiation Oncology at Sunnybrook Health Sciences Odette Cancer Center Jan 8 2019 3:00 pm UTC 60 mins
    During the webinar, Dr Arjun Sahgal will share his perspective on the latest trends for treating brain metastases. Dr Sahgal will examine the most recent published clinical data comparing the benefits of SRS with previous treatment techniques, and the use of the most recent technologies available. The session will explore traditional treatments with WBRT and compare some of the latest SRS techniques used to treat specific targets and their clinical outcomes. Discussion is focused on precision radiation medicine, improving outcomes and quality of life for patients.
  • 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, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS Group Jan 14 2019 2:45 pm UTC 90 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
  • Growth Opportunities in the Healthcare Technology and Biosciences Sector
    Growth Opportunities in the Healthcare Technology and Biosciences Sector
    Charlie Whelan, Vice President of Consulting, Transformational Health, Americas, Frost & Sullivan Jan 16 2019 4:00 pm UTC 75 mins
    For most cities and states, the healthcare technology and biosciences sector is one of the most attractive industries of the future that can grow their communities. However, that attention attracts significant competition among players seeking to expand in a field that is highly complex. How should your community address this industry, and what is the best path to nurturing start-ups, retaining existing employers, attracting new companies and encouraging workforce development?

    Key Takeaways:

    • The healthcare technology and biosciences market is large and complex. Learn how the industry is structured and which segments might align best with your community.
    • Cities and states across the country are all competing to grow their own biosciences economies. Find out what types of programs and strategies are the most effective.
    • Come away with a simple model for assessing your own community’s strength relative to the healthcare technology and biosciences 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.
  • Researcher Academy: An introduction to e-learning resources for researchers
    Researcher Academy: An introduction to e-learning resources for researchers
    Priyanka Kalra Jan 22 2019 9:30 am UTC 60 mins
    Researcher Academy (https://researcheracademy.elsevier.com/) provides free access to countless e-learning resources designed to support researchers on every step of their research journey. Browse our extensive module catalogue to uncover a world of knowledge, and earn certificates and rewards as you progress.
  • 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.
  • Metrics to meaning: demonstrating the value of medical communications
    Metrics to meaning: demonstrating the value of medical communications
    Scott McGregor, Allergan, Lynda Chang, Complete HealthVizion, David Pearce, Complete HealthVizion, Dominic Tyer, pharmaphorum Jan 23 2019 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 Wednesday, 23rd January, 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.
  • 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.
  • Cancer, genomics and personalised medicine: Modelling the future of oncology
    Cancer, genomics and personalised medicine: Modelling the future of oncology
    Danyi Wen, Shanghai LIDE Biotech, Stefan Jellbauer, Mitra Biotech, Lakshmi Santhosh Maithel, Repositi Jan 29 2019 4:00 pm UTC 75 mins
    The prevalence of cancer is currently predicted to be higher than ever. Current statistics show 1 in 2 people in the UK and 1 in 2 men/1 in 3 women in the US will experience it at some stage in their lives. And yet the picture for patients is an improving one.

    The move towards immunotherapies heralds much promise and this is potentially just the beginning. As cancer is understood increasingly not by type, or even tumour type but specific mutation the era of personalised oncological therapies is visible.
    To delve further into this pharmaphorum is pleased to present an exclusive online discussion.

    Bringing together experts at the cutting edge of this field it aims to interrogate where we are in terms of this shift towards personalised oncology, what this means in terms of the development pathway and looks at the approaches which could (and will) fully evolve the way that cancer treatments are developed in terms of efficacy, approach and outcome.

    this free to attend event will cover a number of topics critical to the future of oncology including:
    •The changing face of cancer: how do we define it now?
    •Personalised medicine in practice – where are we now in cancer?
    •What are the implications from these changes for clinical trials?
    •How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run
    •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development?
    •Modelling for the future of cancer – can this be done for personalised therapies?
  • 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.
  • Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Ru Zang, Senior Process Engineer at Momenta Pharmaceuticals and John Bonham Carter, Director of Upstream Sales at Repligen Feb 25 2019 4:00 pm UTC 75 mins
    EFFECT OF CELL CULTURE PROCESS CHANGE FROM FED-BATCH TO CONTINUOUS ON PRODUCTIVITY AND PRODUCT QUALITY

    Integrated continuous bioprocessing has attracted a growing interest due to its potential to improve agility and flexibility in the manufacture of therapeutic proteins. To convert an existing fed-batch cell culture process to continuous, or perfusion, the major technical hurdles include maintaining steady state cell culture performance and generating product with comparable product quality attributes. In this presentation, we evaluated three molecules including a fusion protein, an aglycosylated monoclonal antibody (mAb), and a glycosylated mAb. Steady state culture at high cell density was achieved for all three molecules, which allows the delivery of products with consistent product quality and adequate productivity. However, as compared to fed-batch processes, product quality and cell specific productivity differences were observed in perfusion cultures. Further studies indicated that it was feasible to modulate product quality in perfusion process by adding process levers in culture medium. It was also feasible to increase cell specific productivity through medium and process optimization. This presentation provides an insight into the product quality and productivity differences between traditional fed-batch and perfusion cell culture processes and potential approaches to addressing these differences.
  • Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Feb 26 2019 4:00 pm UTC 75 mins
    Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product life cycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.

    If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.

    Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.

    This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
  • Real Time Online Chromatography Monitoring of Product Quality Attributes for Bio
    Real Time Online Chromatography Monitoring of Product Quality Attributes for Bio
    Dr. Gang Xue, Scientific Director at Amgen Inc Feb 28 2019 3:00 pm UTC 75 mins
    REAL TIME ONLINE CHROMATOGRAPHY MONITORING OF PRODUCT QUALITY ATTRIBUTES FOR BIOLOGICS CONTINUOUS MANUFACTURING PROCESS

    The ever diversifying therapeutic modalities drive for modular and flexible bio-manufacturing, which transformed biologics process from traditional Fed-batch to Single Use BioReactor (SUB), then to Continuous Manufacturing (CM). Process Analytics evolve as critical enabling element of the CM process. It allows to move the release testing from the end of process to real time in the process, which not only eliminates weeks of material disposition delay, but also provides the process scientists product quality insight during the run to make process decisions. However, due to the structural complexity of the bio-molecules, spectroscopic sensors or probes nowadays lack the sensitivity and specificity to illustrate the product quality attributes (PQA) such as protein post translational modifications (PTM). We report here for the first time, we leverage a multi-functional automation system to directly take samples from the different stage of bio-process, purify, denature, derivatize and digest the samples before injecting onto the UHPLC and UHPLC/MS systems, one for online intact protein analysis, the other for Multiple Attribute Method (MAM) analysis for critical PTM PQAs. Benefiting from the high resolution chromatography and mass spectrometry, automated real time bio-molecule product quality monitoring is achieved for both SUB and CM process.

    Dr. Gang Xue is a Scientific Director at Amgen Inc. located in Cambridge, MA. With B.S. degree in Chemistry and B.E. in Computer Science from Tsinghua University and Ph.D in Analytical Chemistry from the Iowa State University, Gang is currently leading the Process Analytics group within Amgen Process Development organization. One of his group’s focuses is the cross modality PAT strategy for the biologics and synthetic continous manufacturing with the goal of process control and real time release testing
  • Challenges in the Development of Continuous Processes for Vaccines
    Challenges in the Development of Continuous Processes for Vaccines
    Danny Vellom, Senior Director, Global Technology and Innovation at Sanofi Pasteur Biologics, Inc. Mar 4 2019 4:00 pm UTC 75 mins
    The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.
  • Lifecycle management of single use technologies
    Lifecycle management of single use technologies
    Francis Verhoeye, Director Single Use Technologies, GSK Vaccines Mar 5 2019 1:00 pm UTC 75 mins
    Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.