The medical research community on BrightTALK brings together medical and research professionals. Find relevant webinars on medical research, laboratory science, continuing medical education and more presented by recognized medical researchers. Join the conversation by participating in live webinars and round table discussions on the latest in medical devices, medical research practices and trends in the healthcare industry.
Join us as we share some exciting new initiatives and discuss what’s to come in the remainder of 2016 and in 2017. We’ll also be giving updates on content coverage and content curation programs, as a lot has happened since we last presented on Scopus content in February. Tune in to stay current on all there is to know about Scopus - the Gold Standard multidisciplinary abstract and citation database.
Join expert medical librarian Amanda Horsman and Doug Felder from Mendeley for an exclusive webinar focused on how librarians like you use Mendeley Institutional Edition to support students and researchers. Amanda will demonstrate the power of facilitating inter-professional collaboration between research group members.
Extreme Light Infrastructure – Nuclear Physics (ELI-NP) is the most powerful laser system dedicated to laser-matter interaction and nuclear physics studies. With a recent investment in creating a new cutting-edge research facility ELI-NP is now seeking the very best minds to join their crew in Romania.
Join Nicolae Victor Zamfir, Project Manager at ELI-NP, to discuss the incredible work being done in understanding the fundamental processes involved in light-matter interaction. You'll find out about the new opportunities available as well as:
- what ELI-NP is looking for in your application
- the benefits of working for ELI-NP
- how to apply
Discover how to promote your research, receive practical tips for working with the media and learn more about boosting your own research profile.
In this webinar you’ll receive the practical advice you need to ensure you work effectively with your institution or publisher to promote your research. Hear why you should get involved in Standing up for Science throughout your career and understand how to responsibly communicate with the media.
Hear from experts at Wiley and Sense About Science on:
•How to make your research have an impact
•Assessing how newsworthy your research is – finding the ‘hook’
•Understand how the media works and receive practical advice on working with journalists
•Your role as a scientist in society and the importance of sharing your research
•Responsible communication of your research
In this webinar, Dr. Barbara Zimmer will discuss the mechanisms of antibiotic resistance that are most concerning to the Centers for Disease Control (CDC). Attendees will receive an in-depth review of the classes of beta-lactamase resistance found in Enterobacteriaceae and the challenges associated with detection in the laboratory. P.A.C.E. credit is available for your participation.*
This briefing will answer the following key questions:
· How are technology trends, such as new sequencers on the high end (Illumina HiSeq X Ten) and low end (Illumina MiniSeq, Oxford Nanopore MinION), impacting NGS services providers?
· How will the market change in accordance with the declining cost of sequencing, which hit the $1,000 genome mark?
· When will the $100 genome be realized, and how will that achievement occur?
· What are “answer-based services,” and why should NGS service providers be concerned about an impending paradigm shift in the way research questions are answered?
· How should NGS service providers be positioning now in order to take advantage of the various changes expected in the marketplace over the next 10 years, as well as the growth opportunities available from these changes?
Prostate cancer is the most common cancer among men. Fortunately, it can be detected early by monitoring PSA levels. However, PSA tests have limited specificity for cancer, resulting in numerous unnecessary biopsies each year, which creates the need for a more precise test to help with prostate cancer detection. In this webinar, Dr. Vernon Mustoe will discuss how a simple blood test can help provide more accurate information on what an elevated PSA level might mean and the probability of finding prostate cancer on biopsy. P.A.C.E. credit is available for your participation.*
Dr. Vernon Mustoe is one of Beckman Coulter’s medical affairs managers, supporting customers with advanced clinical and technical issues. Having obtained his undergraduate and graduate degrees from New York University, he spent over 23 years in the clinical laboratory. Most recently, he was the Director of Clinical Chemistry and Assistant Director of Laboratory Services at Sisters of Charity Medical Center in Staten Island, N.Y. He has also taught Clinical Pathology at the Bayley Seton Physician Assistant School, as well as Clinical and Anatomic Pathology at the College of Staten Island Campus of the City University of New York. Dr. Mustoe has been with Beckman Coulter since 2001.
Interaction between antigen-specific T cells and antigen presenting cells (APC) cognate ligand involve reorganization of the cytoskeleton and recruitment of adhesive and signaling molecules to the site of intercellular contact. Sustained adhesion of T cells to APCs and formation of the immunological synapse after T cell receptor stimulation are required for the antigen-specific response. One way to measure an immunological synapse is by fluorescently labeling the molecules that have been recruited to the synapse and imaging by fluorescence microscopy. However, immunological synapses are rare and therefore difficult to analyze objectively and statistically by traditional microscopy methods. To overcome these problems, we employed the Amnis brand imaging flow cytometers to objectively collect imagery of large numbers of cells. We report the percentage of T cells involved in an organized immunological synapse, the recruitment of adhesion molecule LFA-1 and signaling molecule Lck to the synaptic complex and subsequent translocation of NFkB from the cytoplasm to the nucleus in the T cell. In this study, Raji B cells loaded with Staphylococcal enterotoxin B (SEB) were incubated with human T cells to create T cell-APC conjugates. Cells were stained in various combinations for CD3, CD19, Actin, LFA-1, Lck and NFkB. Results from the FlowSight and the ImageStream imaging flow cytometers are compared. Using the FlowSight imaging flow cytometer we demonstrate image-based parameters that were used to assess the frequency of conjugates with an organized immunological synapse in an objective and statistically significant manner. Employing the ImageStream imaging flow cytometer we further evaluate the specific location of the adhesion and signaling molecules LFA-1 and Lck within the immunological synapse complex in T cells and measure the nuclear localization of NFkB in the T cell.
Corning was pleased to have recently sponsored a GEN webinar highlighting the latest techniques for 3D cell culture in cancer research.
The use of 3D cell cultures has been rising sharply in recent years from its initial introduction, over two decades ago. Because 3D cultures more accurately mimic the cellular environment, they can be used to study various forms of cancer by fostering the growth of organoids that replicate key properties of in vivo organ systems or the original tumors from which they were derived.
In addition, many 3D cultures are amenable to large-scale drug screens for rapid detection of phenotypic or genetic changes associated with therapeutic compounds—an approach that opens the door for the use of 3D culture as an integral part of personalized medicine.
In this GEN webinar, panelists discussed how the latest 3D cell culture methods have facilitated breakthroughs in their research projects.
Marshall Kosovsky, Ph.D., Global Scientific Support Manager for Corning Life Sciences, will give a brief introduction into advances in Corning’s 3D culturing solutions.
Ömer H. Yilmaz, M.D., Ph.D., Assistant Professor of Biology at the Massachusetts Institute of Technology, will describe his work on how adult stem cells and their microenvironment adapt to diverse conditions within the context of tissue regeneration and cancer initiation through the use of ex vivo intestinal organoid assays.
Wojciech Senkowski, Doctoral candidate in the Department of Medical Sciences at Uppsala University in Sweden, will discuss his current work, which looks for applications of various tumor spheroid models in high-throughput drug screening for ways to identify novel compounds that target these cell populations
Traditional models of cognitive behaviour remain meaningful, but they can fail to deliver strong links between ‘smart’, cognitive-based factors of judgement and the decision-making associated with actual behaviour change.
In contrast, behavioural economics accounts for the ‘lazy’ judgments and thoughts that occur at an automatic level, but can over-weight the prevalence of such behaviour.
On October 4 Cello Health Insight, in association with PMGroup, will host a free webinar on applying adaptive and integrated behavioural models to qualitative enquiry.
It will look at how to achieve a better understanding of what drives therapeutic decision-making and how medical marketing, digital and PR initiatives can change future behaviours in favour of achieving target sales.
Childhood cancer and pediatric cancer are general terms used to describe a wide range of neoplasms found in children and teenagers. Occurring in approximately 1 in 300 people under the age of 20, compared to 1 in 6 adults, pediatric cancers are more rare than adult cancers. Because less is known about pediatric cancers, diagnosis can be quite challenging for pathologists.
This presentation covers the basic science, as well as facts and statistics about pediatric cancer. We will discuss how the utility of immunohistochemical testing along with the application of novel antibodies can contribute to accurate diagnosis and survival rates of pediatric cancer patients.
Are you new to publishing your research? Struggling to select a journal or understand Peer Review? In this webinar you’ll hear practical tips from top journal editors who’ll guide you through the publishing process and help you discover all you need to know to successfully publish your next article.
You’ll learn more about:
•Where to start if you’re thinking of publishing your research
•Selecting the right journal
•Writing and submitting your article
•Tools to help you through publication and beyond
Plus you’ll have the chance to ask the editors your questions and connect with fellow researchers attending from across the globe. Sign up today to reserve your place!
Across all industries, people are changing the ways they engage with products, services, and brands. Meanwhile, the digital revolution is blurring the lines between personal and professional spaces. To stay relevant, pharmaceutical companies must re-evaluate their traditional commercial models and address the changing expectations of their customers—at scale. In this podcast, we’ll explore opportunities pharma marketers have to create engaging experiences that will deliver new types of value to meet their targets’ evolving expectations.
During this webinar we will discuss the development of the Caltech High-Speed Multi-Color Camera (CHIMERA), using two Andor iXon Ultra 888 EMCCDs, for ground-based searches for occultations of sub-kilometre-sized KBOs, which it achieves through monitoring thousands of stars simultaneously.
CHIMERA has completed 20 nights of observing in 2015 and 2016, with an additional 50 nights observing to be completed by July 2018, yielding a final data set likely to have more than 100 occultation events.
For several years, professional astronomers have been looking to Andor as a source of extreme performance, exceptionally robust off-the-shelf detector solutions, utilized across many of the key observation sites worldwide. We will provide an overview of the key high-sensitivity, high-temporal-resolution detector technology types, used in diverse applications such as adaptive optics wavefront sensing, solar exploration, high-time-resolution astrophysics, transit exoplanet discovery, gravitational lensing and even customized guide cameras.
The ImageStream® and FlowSight® are multispectral imaging flow cytometers that generates high resolution images of cells at a rate of 1000’s of cells per second. This allows for the rapid acquisition of tens of thousands of images per sample. Using the IDEAS® image analysis software, the system calculates features based not only on fluorescence intensity but the morphology of that fluorescence as well. This novel approach is able to seamlessly combine the quantitative power of flow cytometry with the high content information associated with microscopy. The system can collect data on a wide range of applications including nuclear localization during a signal transduction cascade, measuring colocalization of two probes, or quantify features on the phagocytosed particles in macrophages.
Dr. Mikael Roussel from the University Hospital of Rennes, France, will lead a discussion around the organization of the cell morphology and flow cytometry core laboratory. Hear his tips using Beckman Coulter's hematology solutions to improve management of patients with lymphocytosis. P.A.C.E. credit is available for your participation.**
Hear from experts at Wiley, Publons and ORCID about how to get recognition for review, why it’s important and how it can benefit your research profile.
Peer Review Week is back! The theme this year is ‘Recognition for Review’ and to celebrate, we’re exploring why recognition matters and how to get it.
This webinar will explore:
The researcher’s view of why recognition for reviewing is important – why should you care, and what types of recognition are the most beneficial
How journals recognize reviewer activity – find out what journals are doing to help support their reviews and recognize their contribution
How organizations are helping to facilitate review recognition - hear from two organizations (Publons and ORCID) about their approaches to public recognition for review activity, and how this can benefit your research profile.
During radiation therapy, the patient’s anatomical state is not static. Many different factors contribute to a shifting picture, and it is essential to account for uncertainties in order to ensure the quality of the treatment plan.
In the first half of this webinar, Niek Scheuder, Chief Medical Physicist, will share his experience from implementing an adaptive planning workflow with RayStation at the Provision Center for Proton Therapy.
In the second half, Cameron Ditty, Senior Physicist, will explain the concept of robustness in RayStation, illustrating with practical examples.
Robust optimization handles possible variations that are not sufficiently accounted for by PTV. The resulting plan maintains target coverage while reducing dose to critical structures, even if anatomical changes or positional errors occur.
Demystify the process of writing and submitting your research with practical tips on selecting the right journal, handling feedback, bouncing back from rejection and streamlining the writing process.
Wiley Author Services presents Publishing Secrets for Early Career Researchers in Nursing. If you’re new to research or want to know more about the process, this webinar will give you practical guidance on:
•Selecting the RIGHT Journal
•Preparing your article – How to follow author guidelines
•Peer Review/Rejection – How to address reviewers comments
•Post publication and SEO – How to promote your work
With expert advice from top editors in the nursing research community you’ll discover all you need to help you successfully publish your next article.
Susan Gennaro, RN, PhD, FAAN
Dean and Professor, Boston College
Editor-in-Chief of Journal of Nursing Scholarship
Bernadette Mazurek Melnyk, PhD, RN, CPNP/PMHNP, FAANP, FNAP, FAAN
Dean, Associate Vice President for Health Promotion, Chief Wellness Officer, Ohio State University
Editor-in-Chief of Worldviews on Evidence-Based Nursing
Charon A. Pierson, PhD, GNP, FAANP, FAAN
Journal of the American Association of Nurse Practitioners
Professor Roger Watson,University of Hull
Faculty of Health and Social Care
BSc, PhD, RN, FRSB, FFNMRCSI, FRSA, FHEA, FEANS, FRCP Edin, FRCN, FAAN
Editor-in-Chief of Journal of Advanced Nursing
This presentation describes critical factors for selecting microcarriers, as well as starting protocols to help you optimize the attachment and expansion of cells in spinner flask and bioreactor environments.
In addition, you’ll learn about new dissolvable microcarrier technology, which provides unique advantages for cells that cannot be easily separated from standard microcarriers.
Jennifer Weber is a senior development scientist with Corning Life Sciences. She has helped develop a variety of products for culturing advanced cell types including Corning® Synthemax™, a synthetic, xeno-free surface, and Corning stemgro ® hMSC, a serum-free, chemically defined medium for hMSC culture.
She recently transitioned to microcarrier product development and customer support for bioprocess applications. As part of this role, she facilitates customer adoption of Corning products for specific applications through protocol development, on-site technical support, and in-house customer-driven projects.
Video content accounted for 64% of all the world’s internet traffic in 2014 and is expected to grow to 80% by 2019. As the way in which we connect and digest information evolves, high quality mobile video capture and advanced digital analysis offers ever more authentic, intimate and rich insights into the customers’ world. This webinar will focus on:
– How emerging technology can enable us to realise the true value of ‘video data’ in our analysis and beyond
– How mobile technology can be used to get you closer to your customers and their real world experiences right from the earliest stages in product development
– How real world video content can engage your key stakeholders and ensure customer insights drive action
In the first in a series of webinars showcasing presentations from the PMB 60th Anniversary Symposium, Steven Meikle will examine the progression of medical physics over the last 60 years. He will discuss key developments in radiation therapy, cancer diagnosis and surgery, and describe some of the underlying technologies that enabled this medical physics revolution.
Medical doctor Dheerandra Prasad talks about clinical prospects and his clinical experience of the Leksell Gamma Knife® Icon™ for precise, frameless and frame-based stereotactic radiosurgery of the brain.
Leksell Gamma Knife Icon combines the unprecedented accuracy of Gamma Knife with integrated immobilization, workflow and imaging technologies to provide even greater clinical flexibility for brain radiosurgery. This is due to a number of advancements, including on-board cone beam computer tomography, a thermoplastic mask system and an infrared-based high-definition motion-management system for patient tracking during treatment, which provide the opportunity to perform frameless and fractionated radiosurgery, as well as frame-based and single-session treatments, and to perform online adaptive planning.
Based on his experience as a radiation oncologist and a neurosurgeon, Dr Prasad discusses how these novel features of Gamma Knife Icon have opened up the possibility of extending Gamma Knife treatment to more patients and new indications. He will explain how the on-board CBCT imaging capabilities of Gamma Knife Icon have improved imaging workflows for both frame-based and frameless treatments at his clinic, and how the thermoplastic mask system has enabled him to treat targets outside the range of frame fixation. He also will describe how the ability to fractionate treatments has allowed him to expand his case mix, for example to patients with tumours that are situated close to critical structures, allowing such patients to benefit from the superior dosimetry of Gamma Knife.
Drawing from individual case studies and his personal experience, Dr Prasad will illustrate how Leksell Gamma Knife Icon is a valuable and flexible tool for brain radiosurgery and its role alongside linac-based stereotactic radiotherapy in today’s radiation oncology centres.
Commercial analytic solutions are becoming more and more common within the Pharma industry. Companies are spending millions implementing tools which are aimed at helping users identify opportunities to improve the bottom line, segment customers, track multichannel campaign success and meet a myriad of other objectives. Despite all the 'perceived' value these tools can add, they remain largely unused. Excuses for the lack of adoption are varied but can generally be classified into one of three areas - they are either too complex, it isn't convenient to use or it just doesn't deliver on the value promised. These issues are compounded by the fact that they are generally only identified when the solution has been deployed and expected to be used. By ensuring that these issues are addressed at all stages during the development and not just when adoption targets are not being met, commercial analytic solutions can be exploited to attain the anticipated value and more.
Cancer cells are found to fuse with macrophages giving rise to a hybrid cell that retains genotypes and phenotypes of both parental cells, the cancer cell and the macrophage. Dr. Wong’s intriguing data suggests that cell fusion is one mechanism for how cancer cells gain metastatic behaviors.
If you're publishing scientific work, applying for grants, or just want to better convey your research to a wider audience you need to join us for this special webinar with authors Sam Illingworth and Grant Allen on their book Effective Science Communication: A practical guide to surviving as a scientist.
Sam and Grant will talk us through the research behind their book, why they feel there is a need for this, and provide advice on not only how to survive, but to prosper in the process.
There will be a live Q&A session at the end of the webinar.
In research areas such as academic, biofuel, food and pharmaceutical industries the determination of algal viability, lipid content, and cell concentration is important in the selection, monitoring, and maintenance of algal cultures. Flow cytometry has been shown to be an ideal method to assess health and lipid content of cultures but has been challenging to adopt due to high complexity and cost of traditional technologies. In this webinar, we present novel simplified methods for algal characterization using microcapillary cytometry on either a simple touch screen based cytometer, the Muse® Cell Analyzer, or a higher throughput cytometric platform, the compact Guava® easyCyte platforms. The MilliporeSigma algae kits utilize simple mix and read protocols, dedicated software modules, and provide quick results for the of count and viability measurements or relative lipid content on algae strains. The optimized and dedicated algae kits allow for high precision and comparable results to predicate methods. Data from applications to multiple common algal strains such as Chlorella vulgaris and Chlamydomonas reinhardti under different culture conditions will be presented. Availability of dedicated kits for algae research on simple and easy to use cytometric platforms will empower and enable algae researchers to rapidly select optimal culture conditions and strains for downstream experiments.
Continuing our series of webinars showcasing presentations from the PMB 60th Anniversary Symposium, Brian Pogue discusses the evolution of diagnostic imaging over the last 60 years. He will present examples of successful medical imaging technologies, explain how the use of contrast agents can improve delineation and function assessment, and present some fundamentally new physical imaging systems.
Most life sciences companies know they need to move their multichannel marketing forward, but that requires managing a greater volume of tactics that need to be developed, approved, implemented, and measured.
And of course, those tactics must reflect how their target audiences engage in content – such as the 65% of healthcare professionals who say they prefer clinical summaries.
To truly transform the commercial model, companies must have a strategic blueprint that combines business objectives with brand goals to determine the appropriate resource levels and channel attribution.
On November 9 Aptus Health, in association with PMGroup, will explore three essential ingredients for transforming the commercial model and driving success:
• Learn how to deploy multichannel marketing at scale through integrated campaigns that reach millions of HCPs across specialties, languages, and markets
• Gain insights into your target HCPs’ behaviours - and how to leverage those insights to make your campaigns more effective
• Explore results from a recent survey of European HCPs revealing their preferences for the types of online medical education, as well as the resources they find most helpful in their daily practice
H&E is the most frequently used stain in histology and is the basis for diagnostics and further selected methods. Thus it is important to have brilliant staining. We will show which minor factors can give a negative effect or spoil the result completely. Tips will be given on improving the sensitivity of the stain. For PAS, we will give advice on how to avoid common errors and always get colourful results.
We will discuss:
•How to prevent "critical situations"
This webinar aims to highlight the benefits of correlative Raman imaging for the analysis of chemical composition, crystallinity, stress and optoelectronic properties of materials such as semiconductors, 2D materials and electrodes. Used in combination with either atomic force microscopy or scanning electron microscopy, Raman correlative microscopy provides deep insight into the relation between molecular and structural features of materials – even in 3D.
The principles of state-of-the-art confocal Raman imaging will first be introduced, then its power as an ideal tool for investigating the chemical and molecular characteristics of a sample will be demonstrated with examples of 2D materials, semiconductors and battery electrodes. The webinar will describe clearly the advantages and ease- of- use offered by Raman imaging systems integrated with other microscopy technologies.
Over the past 20 years, behavioural economics has identified factors that influence and determine how people behave, including alternative decision-making pathways and many cognitive biases and heuristics. Taking account of these helps to build a clear view of how healthcare customers think and behave in relation to your product in the real world.
This short masterclass explores ‘quantitative demand assessment research’ – what it is and how insights from behavioural economics can improve the application of this important tool in pharmaceutical market research.
The masterclass will:
•Introduce demand assessment research and why it is important to healthcare market research
•Discuss how insights from behavioural economics can improve quantitative demand assessment market research
•Highlight a range of techniques using behavioural economics that help you build a more accurate picture of your customers and market.
Immuno-oncology therapies that harness the body’s own defences to fight tumours are widely acknowledged as the new frontier in cancer treatment, but until recently only a few products had reached the market for a limited number of indications.
Over the past 12 months several new products have been approved for a wider range of tumour types and with pipelines boasting numerous other products in the area, competition looks set to hot up.
On November 17 Research Partnership, in association with PMGroup, will host a free webinar which will explore the key features of the immuno-oncology market and the critical success factors for remaining competitive.
I would like to invite you to register for the webinar - either to watch it live on the day or for access to a recorded version.
To celebrate the 30th anniversary of the Nobel prize in scanning tunnelling microscopy (STM) and the 30th anniversary since the first paper in atomic force microscopy (AFM), Nanotechnology™ has been organising a focus collection with guest editors Franz Giessibl, Rodolfo Miranda and Johannes Barthes to collate some of the latest cutting-edge progress developing and exploiting these scanning probe techniques.
In this webinar, we invite one of the guest editors of the collection, members of our editorial board and authors of contributions in the collection itself to join our panel to look at some of the highlights in STM and AFM over the past 30 years and some of the most exciting research developments in the field today.
Working with QuintilesIMS, we present a digital debate which will offer modellling-based insights into the future of hepatitis C treatment.
Key topics to be discussed include:
– The burden of HCV
– The current market landscape
– The current patient access model and its impact on budget
– Cost efficiencies shown by modelling
– Cure versus lifetime treatment costs
With rising healthcare costs, more informed and engaged patients, and advancing technology, health wearables have seen a significant uptake in recent years. However, the full potential of health wearables has yet to be recognised and there are still challenges to be resolved. What needs to be done on the regulatory, technical and healthcare side to take health wearables to the next level?
In this webinar, experts from the life sciences and technology industries discuss their views on the current state and future developments of health wearables, including:
– The user perspective: perception, adoption and expectations today and tomorrow
– The technology perspective: biggest successes and most room for improvements
– The societal and regulatory perspective: cost and risks versus benefits and opportunities
Single-Use Process Analytical Technologies (PAT) tools have a great potential to not only increase process understanding at the seed stage but also simplify cell culture operations. By utilizing PAT, the risk from bioburden or contamination can be significantly reduced and the overall operating efficiency increased. In fact, PAT also provides a data-driven platform to integrate Process Development and Manufacturing Operations that can mitigate risks associated with technology/process transfer.
Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a range of opportunity and challenges, including the use of Process Analytical Technology (PAT) for process characterization, process control, and process robustness, in support of a Rapid Product Release (RPR) strategy.
Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks. ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload. Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently. This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product. Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:
1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and
Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.