Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.
3D culture is gaining pivotal importance for attaining in vivo-like conditions in a dish to study developmental cues as well as therapeutic possibilities. Organoid development promises to be one of the most important research tools in the near future. This presentation will cover:
• Methodologies used in organoid culture
• Matrices for growing organoids
• Recovery of organoids for downstream applications
Dr. Nitin Kulkarni is a member of the Scientific Support team at Corning Life Sciences. He has a Ph.D. in Biology and has worked on engineering transgenic mouse models for autoimmune diseases during his post-doctoral research at the Beth Israel Deaconess Medical Center in Boston, MA.
In his current role, he supports researchers with applications related to cell culture including advanced surfaces and extracellular matrices, genomics, drug discovery and bioprocesses.
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
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.
According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist. This requires the pathologist to have a have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system. However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system. Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns.
Three-dimensional cell cultures, and multicellular tumor spheroids in (MCTS) in particular, have recently become a widely used tool for preclinical anticancer drug testing in high-throughput screening (HTS) setup. However, even though MCTS have been applied for HTS, their use has been limited to simple assays, such as assessing cell viability or inhibition of growth.
This webinar will cover new approaches to MCTS-based HTS. It will present a new, robust viability assay, well-suited for HTS and based on green fluorescent protein (GFP) used as a surrogate marker of spheroid viability. It will also review a first-ever approach to obtain information-rich transcriptomic data from drug-treated MCTS on a large scale. In addition, the presenter will demonstrate how this novel platform resulted in the identification of previously unrecognized, context-dependent drug responses of cancer cells and in findings with potential clinical relevance.
In summary, this webinar will demonstrate new ways of how MCTS-based HTS can be used to provide unique insights into context-dependent biology and cellular drug responses.
About the Presenter:
Wojciech Senkowski will soon complete his Ph.D. in Medical Sciences at Uppsala University, Sweden. In his work, he looks for applications of various tumor spheroid models in high throughput drug screening. For his work, Wojciech has received the AACR Scholar-in-Training Award. He was also a presenter and expert panelist at the Genetic Engineering & Biotechnology News webinar on 3D cell cultures, sponsored by Corning in February of 2016.
Join us as we discuss CiteScore metrics - the free, transparent, comprehensive, and current metrics now available as part of the Scopus basket of metrics.
Here are some of the topics you can expect to learn about:
-The Scopus basket of metrics
-Why have CiteScore metrics been added to the basket?
-What are CiteScore metrics?
-How can CiteScore metrics be accessed?
-How you can get involved in defining the basket of metrics
In this webinar, Dr. Michael Samoszuk will discuss the correlation between images of urine sediment particles captured on the iRICELL3000 and images viewed manually under the microscope using actual patient samples. Attendees will learn how these images compare and how automated microscopy helps to reduce user subjectivity in microscopy by standardizing the process.
In this webinar, Dr. Guido Vranken and product manager Lobke Tremmerie discuss how to implement Bulls XB algorithm, which uses RBC indices to create a weighted moving average of patient sample results, to statistically monitor hematology results. This unique algorithm, offered on Beckman Coulter hematology instruments, allows users to monitor result quality with no additional reagents, software licenses or costs. Laboratories worldwide can implement this simple, powerful tool to enhance results and improve compliance. P.A.C.E. credit is available for your participation.*
Dr. Guido Vranken has been working with customers for over 30 years across different disciplines, including protein chemistry, immunoassay and hematology. He specializes in conducting internal and external validation studies. Dr. Vranken spent three years as a lecturer on statistics at the University of Ghent.
Lobke Tremmerie earned her environmental engineering degree from the University of Ghent in 2002. She first became an electrophoresis and nephelometry sales engineer at Analis, Beckman Coulter’s exclusive Belgian distributor. Following her true passion, she transferred into the hematology division in 2004. Ms. Tremmerie currently serves as Analis’ cellular biology product marketing manager.
Preclinical laboratories face several challenges when conducting animal studies requiring Biosafety Level (BSL) 2 level containment. Some of these challenges include informed study design (including knowledge of associated regulatory guidelines), proper preparation of the vivarium, species isolation, traffic control between containment areas, training of personnel, veterinarian care, and proper decontamination of equipment/waste/bedding prior to disposal. In addition, proper post-life handling of animals and samples, with focused attention on tissue sampling and specialized evaluation is a vital element in ensuring personnel safety and high scientific quality. Overcoming these hurdles will generate high quality data and allow for a safe and productive environment.
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
In this webinar, Dr. Michael Samoszuk discusses the correlative relationships between urine chemistry analytes and the particles noted under the microscope. Attendees will learn how using the knowledge of these correlations can optimize parameter setting for improved laboratory workflow.
Join us and PHOENIX group as we delve into the concept of current launch excellence and the role of patient insights in overcoming the multiple challenges the industry currently faces.
Key topics to be discussed include:
– The challenges of launching a product in Europe
– How pharma can improve its understanding of the process through the use of business intelligence
– How insights from new data can be applied to the process of launch excellence
– The role of real-world data in launch strategy
– The downstream effect of applying real-world data to product launch on patient outcomes.
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
Watch this Dell EMC and IDC Webcast, and explore integrated care readiness and how to sustain better decision making on care pathways as IDC shares results from its recent Health insights research.
Learn more about the readiness of integrated care, the priorities of clinical and IT executives, the barriers still preventing having care truly centered around the patient. IDC health insights reports on the details of a research conducted in the UK and Nordics, measuring the maturity of adoption of strategies, governance and architectures able to sustain better decision making on care pathways. The webinar also includes a zoom into mental health integrated practices and directions, and addresses some of the most common mistakes and misconceptions on improving patient information management, including analyst's guidance for hospital, primary care and secondary care executives.
Watch this Dell EMC Webcast and explore the true meaning of digital transformation.
With all the talk about “digital transformation,” some are left to wonder: what does digital transformation really mean? As organizations strive to become digital enterprises, it is important to understand what this encompasses in order to implement the appropriate strategies to become a truly digital organization.
In this webinar, Dr. Michael Samoszuk will discuss how red blood cell data reported from urine chemistry test strip analysis can correlate to red blood cell data gathered from the microscope, even when the data appears to be conflicting. Attendees will discover some of the underlying factors that could cause this to occur and learn how to minimize reporting inconclusive or inaccurate results.
The CRISPR/Cas genome editing system has revolutionized almost every aspect of the life science industry. Until recently, the most used formats for this technology have been plasmids, mRNA, or lentivirus. Each reagent has been successful in its own right, however, each approach has limitations. SygRNATM, the two-part synthetic crRNA and tracrRNA, increases the pace of research, decreases costs, and can be used with Cas9 protein, Cas9 mRNA and Cas9 expressing cells/models.
This webinar discusses the development of the SygRNATM system, protocol optimization, and proposes workflows that enable scientists to quickly incorporate CRISPR technologies into their research.
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.
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"
Across the globe, omega-3 intake is lower than recommended. This means a large proportion of the population is missing out on the wide range of health benefits offered by omega-3s. Omega-3s have been linked to the reduction of the risk of cardiovascular disease, which is responsible for more deaths worldwide than any other condition.
Join us for the next in our webinar digest series to hear Prof. Philip Calder, DSM’s Prof. Manfred Eggersdorfer and Brent MacDonald, discuss how omega-3s can help reduce the risk of cardiovascular disease.
Webinar: The Impact of Soluble Factors and Substrate on Cell Culture: Media Additives, Growth Factors, and Surface
From basal media with feeder layers or serum to highly defined recombinant growth factors, cytokine, and extracellular matrix, there are many ways to grow the same cell type. The choice is dependent on scale, cost, control, skill, and regulatory factors.
This webinar will cover:
- Different ways to grow the same cell type
- The actual material costs of various methods
- Methods used to optimize formulations
Kevin Kelly graduated from Hawaii Pacific University and for 15 years worked on process scale-up and optimization for extracellular matrix proteins, growth factors, cytokines, antibodies, ELISA kits, and Corning® BioCoat™ products.
Currently he provides applications support for invasion, migration, permeability, transport, differentiation, and metabolism assays.
Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclinical testing is required to establish a safe starting dose for the initial human clinical trials. In partnering with our pharmaceutical and biotechnology Sponsors, our goal is to improve the odds of selecting the right lead candidates, and to conduct the right studies in the right way, taking all factors into consideration to ensure a successful IND submission.
As part of this webinar we will outline the nonclinical studies needed to progress a therapeutic into a Phase I clinical trial. We will cover small molecules to vaccines to biopharmaceuticals as well as standard indications to life-threatening and rare/orphan indications.
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.
2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers. We also see member states working to understand the process of enabling cost-effective patient access to personalised and high-cost treatments, such as new oncology combination therapies, antibiotics and stem cell therapies, which offer the promise of efficacy in key disease areas.
With market access being referred to as the “fourth hurdle” in drug development (beyond efficacy, safety and quality), it is vital that the requirements for both approval and access are addressed early in the process. Parallel scientific advice from HTA bodies and regulators is increasing to deliver tangible and successful strategies, but is the process smooth enough to overcome the challenges from both sides?
pharmaphorum in partnership with DIA will be hosting an expert panel debating the best way forward for life sciences companies, payers and providers in this emerging European market access paradigm.
Join our webinar to hear from experts in industry and healthcare discussing the challenges and solutions of access in the changing European market.
Topics up for discussion include:
•Integrating HTA and regulatory strategy – the best way forward
•Regional variation and implication – how to efficiently and effectively navigate EU market access
•Proving value – how to leverage real world evidence to meet increasing demands for observational data
•Future proofing market access – how to improve upon evidence generation and use technology effectively and competitively
The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGAa Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Mr. Johnson will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.
In this webinar, Elena Lazarova, M.D., esteemed clinical biology specialist, researcher and speaker, will discuss the value of precise cell volume measurement in differentiating for blood disorders and its importance in effective patient care. Gaining information about cell volume at different stages in the maturation process provides important insight into a patient’s underlying pathology and may have added value in the diagnosis of blood disorders. Beckman Coulter offers precise cell volume measurement* through the advanced technology and sophisticated algorithms of its uniquely designed DxH 800 hematology systems.
After the webinar, you will be able to:
• Cite the challenges laboratories face in differentiating for rare types of anemia
• Outline the benefits of flow cytometric reticulocyte analysis, available on the DxH 800 platform
• Understand the value of precise cellular volume measurement* to aid in the differential diagnosis of anemia
*For research use only and not cleared by the FDA for clinical diagnosis
**P.A.C.E. credit is available for your participation.
Dr. Elena Lazarova earned her M.D. degree from the Medical University of Varna, Bulgaria, in 2002. With over 10 years of experience in clinical and laboratory hematology, immunohematology and transfusion medicine, Dr. Lazarova is a highly sought-after teacher and lecturer. She has authored/co-authored seven medical journal articles and has served as primary author on 17 poster and oral presentations at congresses throughout the world. Dr. Lazarova continues her work in laboratory medicine, focusing on hemoglobinopathies and red blood cell pathologies (hereditary spherocytosis and autoimmune hemolytic anemia) in laboratories at Hôpital Erasme in Brussels.
CRISPR Cas9 nucleases have revolutionized the field of gene editing and high-throughput lentiviral screens continue to hold ever-increasing promise for both basic research and development of future therapies to benefit human health. Even with such powerful technologies at hand, researchers new to the field may find the screening of multiple targets to be challenging and time-consuming. This webinar discusses the Evotec partnership with Life Science Business of Merck KGaA, Darmstadt, Germany and the screening services for drug discovery.
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.
Pharmacists are highly trained healthcare professionals who have a deep understanding of medicines and daily contact with patients and consumers. This puts them in a unique position in terms of being able to maximise the benefits that patients get from their medicines – however, healthcare systems and pharmaceutical companies frequently overlook this potential.
Pharmacists are especially well placed to help patients with multiple long-term conditions manage their health and medications, and pharmacist-led interventions have been shown to have a very significant impact on compliance and disease management in the community.
We present a webinar debate in which our expert panel will discuss how pharmaceutical companies can work in collaboration with pharmacists in Europe to help patients make the most of their medicines, help generate data to prove the value of these interventions, and above all get the right medicine to the right patients and consumers.
Join us and the PHOENIX group as we look at the practical steps needed to make this a reality. Key topics to be discussed include:
•The challenges of identifying the right patient population across European markets
•Understanding how pharmacists can play a greater role in patient care, e.g. improved adherence and outcomes
•How optimum use of pharmacy level information can contribute to providing ‘real world’ evidence of treatments
The use of calibrators in an analytical method is important to ensure measurement accuracy and traceability and instrument reliability. The major challenges with testosterone testing by LC-MS/MS typically involve achieving consistency in performance and accuracy of results at low levels found in women and children across different laboratories. This lecture presents the new CE marked testosterone serum calibrator kit for in-vitro diagnostic (IVD) from Merck KGaA, Darmstadt, Germany . It is for use in LC-MS/MS testosterone testing methods. Dr. Hardt will highlight the unique features and benefits of this regulatory cleared Certified Reference Material as a calibrant for standardization of laboratory LC-MS/MS testosterone methods.
Next-generation sequencing (NGS) technology has brought an influx of large-scale data and ever-growing demands for compute, resulting in a challenge for those in science informatics. To overcome these issues, laboratories need to be able to support researchers while managing data and the infrastructure needed to deliver mission-critical results and ultimately, positive patient outcomes.
At the NGS Data Analysis and Informatics Conference in February, attendees spoke about these challenges at length. This webinar, built from content shared at the event, will review potential approaches to cost-effective data growth using cloud compute and storage. Moving genomics workloads to the cloud can provide scale and affordability, while optimizing investments in existing resources. Adding that ability to allow researchers to easily collaborate while reducing latencies to these resources is pertinent to usability.
In this webinar, you’ll learn how to:
- Increase computation potential
- Optimize your physical infrastructure
- Diagram common use cases to meet specific research goals
- Increase flexibility by limiting data gravity
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.
Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implementation of Good Manufacturing Practice (GMP) regulations with current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.