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.
Dino Eliopulos, Managing Director, EIS & Bryan Kohl, VP, Business Development, EISRecorded: Dec 13 201848 mins
Artificial Intelligence (AI) has the potential to completely revolutionize the B2B selling function. And depending on who you talk to, AI will either enable massive productivity gains from your employees or replace them entirely.
Hype aside, AI is coming, and B2B companies need to understand how to harness it. And despite the promise of ‘plug and play‘ technology, real AI requires varying degrees of knowledge engineering, product and content architecture, and high-quality data sources to be effective.
In this session, EIS's Bryan Kohl, VP, Business Development and Dino Eliopulos, Managing Director demystify AI for your B2B organization.
You will learn:
--How you can leverage best practices to re-think processes for the product content lifecycle, from initial onboarding to post-production syndication
--The infrastructure you’ll need to consider when planning for your AI initiative
--How AI enables new product associations and personalized experiences to drive deeper engagement with your customers
Heiko Schmidt, Integrated Multichannel Marketing and Sales, Bayer, Sari Ruth Carter, Head of Marketing, Anthill AgencyRecorded: Dec 6 201868 mins
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.
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.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, GermanyRecorded: Dec 4 201858 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.
Gabe Musso, CSO, BioSymetricsRecorded: Dec 3 201854 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.
Julie Glanville, Associate Director at York Health Economics ConsortiumRecorded: Dec 3 201851 mins
Please note: change of date!
In this webinar, Julie Glanville , Associate Director at York Health Economics Consortium, will discuss literature searching in Health Economics.
Health economics evidence is a key element in much health services research and particularly in health technology assessments. Health economic models are increasingly used to assist with health care decision making. Identifying economic evidence to inform such research can involve searches in a range of databases and using a variety of strategies.
This webinar will summarize the key resources which can be searched to identify health economics information including economic evaluations and economic models. We will also explore how to design search strategies to find economic evaluations including economic models. With the closure of key economic evaluation databases (NHS EED and HEED) we will be focusing on how to identify economic evaluations from major bibliographic databases.
Julie Glanville is Associate Director at York Health Economics Consortium, part of the University of York. Here, she manages systematic review and literature review projects. She also organizes the YHEC training programme.
YHEC provides a range of research services including literature searches and evidence identification to inform research projects in healthcare topics but also in other fields such as food safety and feed safety, social care, housing, criminal justice and education. YHEC contributes to the evidence base for information retrieval with a special focus on identifying economic evidence and search filters (strategies) for a range of research methods.
YHEC carries out systematic and non-systematic reviews for a range of clients to identify the effects of drugs, devices and other interventions. The training program also partners with Quantics Consulting to provide indirect treatment comparisons (ITCs) and mixed treatment comparisons (MTCs).
Mike Pace, Sr. Principal, Global Pricing & Market Access; Nathan White, Senior Vice President, Integrated Access & OutcomesRecorded: Nov 28 201863 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
Jem Rashbass, Health Data Insight, Chris Carrigan, use MY data, Adam Reich, IQVIA, Dominic Tyer, pharmaphorumRecorded: Nov 27 201868 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.
Jessie Parker @ PatSnapRecorded: Nov 21 201835 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.
Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe)Recorded: Nov 21 201855 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)
Yuyi Shen, Associate Director at Bolt Bio, John Cyganowski, Director of Manufacturing Sciences for MilliporeSigmaRecorded: Nov 19 201877 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.
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.
Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, IndiaRecorded: Nov 15 201842 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.
Leonardo Carissimi, Security Solutions Director, Unisys Latin AmericaRecorded: Nov 14 201862 mins
Unisys Security Index es una importante encuesta regular de las preocupaciones de seguridad llevada a cabo en todo el mundo. Lanzada a nivel mundial desde 2007, proporciona una medida regular y estadísticamente sólida de las preocupaciones que tienen los consumidores de 13 países con respecto a los principales aspectos de la seguridad, incluyendo seguridad nacional, financiera, personal y ciber seguridad.
Únase a este webinar para escuchar a Leonardo Carissimi, director de Ciberseguridad para Unisys América Latina, compartir los resultados y realidades de la encuesta sobre de las preocupaciones de seguridad de los consumidores en Argentina, Colombia y México.
Leonardo usará los resultados de este año, yuxtapuestos con más de una década de historial de encuestas realizadas para proporcionar un informe convincente sobre el estado de la seguridad desde la perspectiva que más importa: la del usuario.
Leonardo Carissimi, Security Solutions Director, Unisys Latin AmericaRecorded: Nov 14 201863 mins
Unisys Security Index é uma importante pesquisa sobre preocupações de segurança realizadas em todo o mundo. Lançado globalmente em 2007, fornece uma medida regular e estatisticamente sólida das preocupações que os consumidores em 13 países têm sobre os principais aspectos da segurança, incluindo segurança nacional, financeira, pessoal e cibernética.
Participe deste webinar para ouvir Leonardo Carissimi, diretor de Segurança Cibernética da Unisys América Latina, compartilhar os resultados e fatos da pesquisa sobre as preocupações de segurança dos consumidores do Brasil.
Leonardo usará os resultados deste ano, justapostos com mais de uma década de histórico de pesquisas para fornecer um relatório convincente sobre o estado de segurança da perspectiva que mais importa: o usuário.
Teletech Holdings, Booz Allen Hamilton, Opus ResearchRecorded: Nov 9 201861 mins
Provided with access to the right information chatbots can help facilitate a new transaction or provide account support to an existing customer. Many vendors are claiming to use machine learning and artificial intelligence in their virtual assistant applications. However, the reality is, curated, structured content needs to be developed for these applications, rather than having the system ingest large amounts of unstructured content.
What makes content appropriate for training? How should organizations prepare for these types of systems? How do the underlying processes that support the customer need to evolve to operationalize AI applications for customer service?
In this panel, we discuss:
--The different types of automated virtual assistants used for support
--How artificial intelligence powers these tools
--The role of knowledge engineering
--Practical steps toward deployment
Join our experts for an in depth discussion of “the next big thing” in customer experience.
Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D and Adam Kaletski, Business Leader, BioprocessRecorded: Nov 9 201864 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.
Seth Hanson, Academic Research Technology Specialist - Merck KGaA, Darmstadt, GermanyRecorded: Nov 9 201864 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.
John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles RiverRecorded: Nov 8 201865 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.
Marie McCarthy, Sr. Director, Product Innovation; Chen Admati, Director, Intel Pharma AnalyticsRecorded: Nov 8 201861 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
- Privacy and Security Issues
- Regulatory Acceptance
Joan McGowan, Senior Analyst at Celent and Steve Migliore, Head, Cybersecurity at UnisysRecorded: Nov 7 201846 mins
A recent warning issued to banks by the FBI reads like the script for a Hollywood movie: cybercriminals are plotting a sophisticated, global “ATM cash-out” using cloned credit cards to fraudulently withdraw millions of dollars in just a few hours. A few days later, reports of a $13.5 million heist of 25 ATMs across the globe confirmed the reality that ATMs are a prime target for hackers.
Are you prepared for when an ATM breach occurs, or more importantly, when a hacker gains access to your network and confidential customer information through your ATM networks?
Join Unisys and Celent for this very critical, time sensitive topic that will help you understand this increasing threat and how to respond.
In this webinar we will cover:
•How global trends, such as open banking, will increase these threats
•How ATM security fits in your end to end security and risk posture
•We will be discussing Unisys Stealth®, which is a flexible software suite that leverages microsegmentation to secure critical assets
•And so much more!
Seth Earley, CEO, EIS; Andy Hoar, CEO, Paradigm B2B, Minal Parker, Senior Product Mgr, HD SupplyRecorded: Nov 7 201831 mins
Join Seth Earley, CEO of Earley Information Science, and special guests Andy Hoar, CEO of Paradigm B2B and Minal Bhargava Parker, Senior Product Manager eBusiness at HD Supply, as they consider the digital trends making the news these days, and identify those that are critical to success in 2019, and those that might just be hype.
We’ve all heard it – digital transformation is coming for us. From how our customers engage with us, to how our partners leverage us, and how our business operations scale, digital transformation is the ultimate goal for successful eCommerce companies in 2019.
Yet to be truly strategic and exacting in your digital transformation initiatives, we must first decide which trends are ‘in,’ and which ones are ‘out.’
Natasha L. Pirman, Ph.D.Recorded: Nov 7 201835 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.
Wysdom.AI, Aspect Software, VerizonRecorded: Nov 7 201861 mins
When training an AI-driven virtual assistant, harvesting and reusing knowledge assets is critical to success.
A good digital experience is about facilitating information flows between the organization and its customers. Whether answering questions on community bulletin boards, self service through FAQ’s, email communications, interactions with call center agents or text exchanges with bots, the objective is to give customers the information they need to use a product, make a selection, solve a problem and achieve their overall goal.
At the heart of this is knowledge in various formats. In the AI world, it is referred to as “training content” – the knowledge assets that support customers directly or indirectly. Whether training a support engineer or training an AI-driven virtual assistant, harvesting and reusing these assets is key. However in most large organizations training platforms, knowledge bases and support applications have evolved organically with different architectures, changing ownership, fragmented taxonomies and disparate approaches.
Some believe that AI and machine learning will solve this problem but while these technologies are promising, not every support application and knowledge source is amenable to a fully automated approach. Even when that is possible, certain elements have to be in place.
In this edition of the Earley Executive Roundtable, our panel of experts tackle such questions as:
--What does the changing technology landscape mean to support organizations, call centers, and customer service functions?
--Can knowledge be captured and structured for reuse in a sustainable, economically viable way?
--How can the customer be supported throughout their journey by knowledge that originates in different parts of the organization?
--How do processes need to evolve to provide an end to end seamless, positive experience?
Don Singer, GlaxoSmithKline R&DJan 9 20193:15 pmUTC75 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.
Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS GroupJan 14 20192:45 pmUTC90 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.
Dr. Joe X Zhou is the CEO Walvax Bio Group & Floris D Smet, Director of Field Marketing, Sarotrius ChinaJan 15 20198:00 amUTC75 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
Tom Patterson, Chief Trust Officer, UnisysJan 16 20194:00 pmUTC75 mins
Despite spending billions of dollars every year on security, companies and governments – as well as the products and services they use – often lose sight of their ultimate goal: protecting the user. Please join this webinar to hear Tom Patterson, the Chief Trust Officer for Unisys, share results and realities from the only recurring snapshot of consumer security concerns conducted globally. This year’s global Unisys Security Index survey brings to light key areas of consumer concern that are vital to understand, if society and the security sector are to be successful in achieving their goals.
Major findings affecting government services, entire business sectors and fast evolving technologies are all illuminated through the lens of the user, as opposed to the more typical providers. Learn what’s most important to the consumer in each region of the world, and across key demographic categories. This clarity of vision, brought by thousands of statistically significant consumers from around the world, is a voice that needs to be heard.
Tom will use this year’s results, juxtaposed with over a decade of survey history and informed by global events and leaders from both government and industry, to provide a cogent report on the state of global security from the perspective that matters most—the user.
Dr. Dakshesh Mehta, Associate Vice President and Head of Bioprocess Group at Biotech & Genomics divisionJan 17 20199:30 amUTC75 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?
Lance Marquardt, Bristol-Myers Squibb & Sara Bell, MerckJan 17 20193:00 pmUTC75 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.
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Yasser Nashed-Samuel, Principal Scientist at Amgen Donald Young, Sr. Product Manager at Thermo Fisher ScientificJan 22 20193:00 pmUTC75 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.
Scott McGregor, Allergan, Lynda Chang, Complete HealthVizion, David Pearce, Complete HealthVizion, Dominic Tyer, pharmaphorumJan 23 20193:00 pmUTC75 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.
Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSATJan 25 201910:00 amUTC75 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.
Danyi Wen, Shanghai LIDE Biotech, Stefan Jellbauer, Mitra Biotech, Lakshmi Santhosh Maithel, RepositiJan 29 20194:00 pmUTC75 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?
Dr Xin Bu, Principal Scientist, Bristol-Myers SquibbFeb 5 20193:00 pmUTC75 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).
Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West PharmaFeb 6 20193:00 pmUTC75 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
Sune Klint Andersen, Janssen Pharmaceutica & Filipe Gaspar, Hovione FarmaCiênciaFeb 19 20193:00 pmUTC75 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.
Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei RoFeb 21 20199:00 amUTC75 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.
Ru Zang, Senior Process Engineer at Momenta Pharmaceuticals and John Bonham Carter, Director of Upstream Sales at RepligenFeb 25 20194:00 pmUTC75 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.
Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEAFeb 26 20194:00 pmUTC75 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.
Dr. Gang Xue, Scientific Director at Amgen IncFeb 28 20193:00 pmUTC75 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
Danny Vellom, Senior Director, Global Technology and Innovation at Sanofi Pasteur Biologics, Inc.Mar 4 20194:00 pmUTC75 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.
Francis Verhoeye, Director Single Use Technologies, GSK VaccinesMar 5 20191:00 pmUTC75 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.
Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigmaMar 5 20193:00 pmUTC90 mins
Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities
Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim BiotechMar 7 20193:00 pmUTC75 mins
FROM EARLY STAGE TO LATE STAGE DEVELOPMENT: HOW TO CHARACTERIZE A PERFUSION-BASED VACCINE PRODUCTION PROCESS USING QBD?
The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase requires large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.
Janssen Vaccines has transitioned over the last 3 years from early stage process development to full late stage development programs. In this presentation, we present the implications of such a transition, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production at Janssen Vaccines.
Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch CenterMar 11 20193:00 pmUTC75 mins
Title: Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors
A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer (kLa) studies, computational simulation and scale-down model experiments were used within this newly developed work-flow. Utilizing this approach, scale-up was successfully accelerated (