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.
Rick Altinger, Medical Devices Consultant ; Bradley Thompson, Epstein Becker & Green, Scott.Thiel, NavigantRecorded: Feb 19 201962 mins
Is your company developing or planning to develop a software product that meets the definition of a medical device?
On January 7, 2019, FDA published its draft working model for a new precertification program, to supplement its medical device approval process for software which functions as a medical device. The FDA recognized that the traditional regulatory methodology is not well suited for the fast-paced, iterative-design development used for digital health software products.
Medical device expert and executive Rick Altinger will outline the new digital health software regulations and answer your questions in this live webinar, such as:
- Is my company eligible for the program?
- What does it mean to be pre-certified?
- What are the risks of non-participation?
Literature is one of the essential sources to identify high quality adverse drug reaction (ADR) reports. Regulatory authorities require companies to monitor major international publications through databases, as well as local, non-English content sources in each of the countries where the drugs are marketed. In November, 2018, Embase introduced the first non-English content – French Local Language Module, which is designed to screen, review and monitor French literature for pharmacovigilance.
In this webinar, Embase product manager Iveta Petrova will discuss:
-The challenges in Local Literature Monitoring process for pharmacovigilance
-The concepts of Embase French Local Literature Module
-How to use this module in Embase.com to build effective searches to identify the mention of drugs and ADRs in French journals
About the speaker:
Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. She joined the Embase team at Elsevier as part of the Content quality department. For 2 years she was responsible for writing and updating the indexing guidelines, as well as monitoring the quality of indexing. One year ago she joined the Product management team of Embase. Currently her tasks include continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities, specifically the enhancement of evidence-based medicine, pharmacovigilance and medical device clinical evaluation and safety.
Sune Klint Andersen, Janssen Pharmaceutica & João Vicente Senior Scientist - Particle Engineering Team Leader at HovioneRecorded: Feb 19 201977 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.
Gregor Kolk (Business Development Lead, Adobe) & Ulrich Isenmeyer (Senior Business Development Manager, Adobe)Recorded: Feb 15 201961 mins
Digitale Transformation und Wettbewerbsfähigkeit gehen für viele Unternehmen Hand in Hand – vor allem in Branchen wie dem Finanz- und Versicherungswesen, in denen Vertragsabschlüsse zentral sind, ist eine gute Customer Experience differenzierend.
Die Grundlage dafür bilden oft die Geschäftsprozesse innerhalb eines Unternehmens. Denn wenn es intern schnell und reibungslos läuft, kann das nach außen weitergegeben werden.
Im ersten Teil unserer Webinar-Serie „Sign-Up 2019“ verraten Ihnen Experten, wie Sie Ihre Geschäftsprozesse mit den richtigen Tools digitalisieren und die Weichen für das bestmögliche Kundenerlebnis stellen. Erfahren Sie mehr zu smartem Dokumentenhandling und E-Signaturen im Webinar:
• Dokumente digitalisieren und Verarbeitungszeiten um bis zu 83% reduzieren.
• Wichtige Prozesse erneuern und mittels KI automatisieren.
• Mit digitalen Berührungspunkten mehr Komfort für Kunden schaffen.
Erik Nordkamp, GM UK, Pfizer, Dr Keri Torney, Deputy Director Life Sciences, NHS England, Angela McFarlane, IQVIARecorded: Feb 7 201973 mins
Brexit uncertainty isn’t going away any time soon – but it’s important to remember that the UK government has already set out two plans for the future shape of the country’s healthcare industry: the second Life Sciences Sector Deal and the long-term plan for the NHS.
With these two plans in place there are plenty of opportunities for the industry and the government to work together to keep the UK at the top of the international life sciences sector – and perhaps reach even greater heights.
This pharmaphorum webinar, held in partnership with IQVIA, will analyse the current and future landscape for UK life sciences as well as what steps have been taken so far to boost the sector.
Panellists from across the industry will look at the challenges presented by the current situation with Brexit and how the 10-Year Plan and the Sector Deal 2 (or 2018) play into this. They will discuss the positive steps taken by the government to prepare NHS innovation for a radically different future and make sure the UK remains an attractive location for ongoing inward investment from global pharma.
Topics to be covered include:
•Highlights of the 10-Year Plan and the second Sector Deal
•Progress with the current Life Sciences Industrial Strategy, the Sector Deal and plans for 2019
•The NHS innovation uptake agenda
•Maintaining UK attractiveness for inward global pharma and biotech investment
Dr Xin Bu, Principal Scientist, Bristol-Myers SquibbRecorded: Feb 5 201943 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).
Seth Earley, CEO, Earley Information Science & Jennifer St. Hill, COO, Earley Information ScienceRecorded: Jan 30 201932 mins
How far along are we when it comes to digital transformation? EIS set out to discover the answer by launching an industry-wide ‘State of Digital Business’ Survey which asked respondents to share their data readiness, planned digital projects, future goals, and more.
This month, we’re ready to share these results with you. Join Seth Earley, Founder and CEO, Earley Information Science, and Jennifer St. Hill, COO, as they present results from our December 2018 ‘State of Digital Transformation Survey.’
You will learn:
**The trends your peers are experiencing that are driving digital business initiatives within your organization.
**The challenges your peers are facing when implementing a digital business strategy, as well as the tactics they’re using to overcome those challenges.
**Common (and not so common) digital business initiatives that are underway within your peer companies.
We hope you'll join us on January 30th at 1:00PM ET to find out "The Real State of Digital Business for 2019."
Danyi Wen, Shanghai LIDE Biotech, Stefan Jellbauer, Mitra Biotech, Lakshmi Santhosh Maithel, RepositiRecorded: Jan 29 201961 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?
Franziska Wienholz, Scientific Support Specialist, Corning Life SciencesRecorded: Jan 28 201944 mins
Cell Culture Masterclass: A 10-Point Plan to Prevent Contamination
All cell culture laboratories have experienced it: cell culture contamination and its inevitable loss of material. Contaminants may be biological or chemical, visible or invisible, destructive or seemingly benign, but in all cases, they adversely affect both the use of your cell cultures and the quality of your research.
Identification and, even better, prevention of contamination are crucial for ensuring high-quality research. This expert webinar will present an overview on how to prevent, recognize and tackle contamination by introducing good lab practices and targeted interventions.
If you work with cell culture daily or are interested in setting up prevention strategies to minimize contamination, then join SelectScience and Franziska Wienholz, scientific support specialist of Corning Life Sciences, for this educational masterclass. Franziska will share a 10-point plan to prevent contamination and provide a comprehensive refresher on all aspects of cell culture.
Key learning objectives:
Understand the basic rules of cell culture
Know how to properly manage cell lines to prevent cross-contamination
Be able to implement a 10-point plan to contamination prevention in your laboratory
Who should attend:
Scientists working with cell culture on a daily basis
Cell culture managers who are interested in setting up programs to prevent contamination and determine authentication of cells
Researchers that struggle with contamination issues
Dr. Richard E. Eglen, Vice President and General Manager, Corning Life Sciences.Recorded: Jan 28 201962 mins
Advances in three-dimensional Cell Culture in Drug Research, Discovery and Biologic Manufacture.
Cellular research is optimal when using physiologically relevant cell phenotypes and genotypes of human origin. This assertion has accelerated the adoption of primary cells, stem cells, and, increasingly, patient-specific cells in drug discovery. Over the past five years, technological improvements in 3D cell culture technology, to better mimic in vivo physiology, have also advanced. This is true not only in the areas of cancer and neurological research, but also in the assessment of clinical candidates for metabolic and toxicological liabilities. Furthermore, 3D cell culture is facilitating novel approaches to both the scale-up and manufacture of biologics, including those used in immuno- and stem cell-based therapies.
Are you a scientist interested in 3D cell culture? Join this expert webinar, in which Dr. Richard Eglen will discuss the importance of 3D cell culture in drug discovery and manufacture and how technological improvements are causing significant advancements in this field.
- The existing and future impacts of 3D cell culture technology on fundamental research
- The impacts of 3D cell culture on drug discovery and manufacture, particularly in the context of using phenotypically relevant cells?
- The potential for spheroids, organoids, scaffolds, and hydrogels in cellular research and compound identification, screening, and development?
Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSATRecorded: Jan 25 201934 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.
Scott McGregor, Allergan, Lynda Chang, Complete HealthVizion, David Pearce, Complete HealthVizion, Dominic Tyer, pharmaphorumRecorded: Jan 23 201962 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.
Yasser Nashed-Samuel, Principal Scientist at Amgen Donald Young, Sr. Product Manager at Thermo Fisher ScientificRecorded: Jan 22 201964 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.
Researcher Academy (https://researcheracademy.elsevier.com/) provides free access to countless e-learning resources designed to support researchers on every step of their research journey. Browse our extensive module catalogue to uncover a world of knowledge, and earn certificates and rewards as you progress.
Both PLM and ERP vendors tout capabilities for managing bills of materials (BOMs), changes, versions, files and other information related to your products. This makes some people wonder why you need both. The truth is PLM focuses on planning, while ERP focuses on execution.
What makes Propel different? Because we're built on the Salesforce platform, it's easy to tie customer, sales, engineering and operations together to improve the Engineer to Order process - and deliver products that customers will love.
Lance Marquardt, Bristol-Myers Squibb & Sara Bell, MerckRecorded: Jan 17 201966 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.
Dr. Dakshesh Mehta, Associate Vice President and Head of Bioprocess Group at Biotech & Genomics divisionRecorded: Jan 17 201935 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?
Tom Patterson, Chief Trust Officer, UnisysRecorded: Jan 16 201944 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.
Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS GroupRecorded: Jan 14 2019129 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.
Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe)Feb 21 20192:00 pmUTC54 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)
Seth Earley, CEO, Earley Information Science & Enid Martinez, Senior Director of Engineering and Automation, ADPFeb 21 20196:00 pmUTC60 mins
ADP shares their successes in harnessing AI to drive engagement and information sharing with customers.
The age of customer-driven, Artificial Intelligence (AI)-powered enterprises is here, and B2B/B2C companies are beginning to harness its value. Yet, while many companies are considering AI initiatives, few are provided with a clear roadmap and best practices to evaluate, develop, implement, and measure the impact of their efforts.
Join Seth Earley, Founder and CEO, Earley Information Science and special guest Enid Martinez, Senior Director of Engineering and Automation, ADP, for "Why AI? A Case Study with ADP."
Topics they will cover include:
**The business drivers considered when evaluating AI for ADP
**Best practices in building the initial project plan
**Tips to overcome roadblocks and pitfalls to avoid
**Lessons learned when implementing a large-scale AI initiative
Ru Zang, Associate Director at Mersana Therapeutics 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 20193:00 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.
Come one, come all to the troubleshooting gallery as we learn sure-fire techniques to troubleshoot IHC stains. Inappropriate stains impact patient care, slow your lab down, and waste reagents, all of which cost your lab money, time, and peace of mind. This workshop will cover common histology and immunohistochemistry protocols, paying close attention to how each step influences stain quality. We’ll take aim at the root cause for most stain issues and set our sights on the red flags to look for when troubleshooting. We’ve got you covered from specimen collection to cover slipping. Too Light, Too Dark, Background, No Stain and the rest of the outlaws won’t stand a chance. You’ll mosey out of this workshop with a thorough understanding of how histology and immunohistochemistry work to produce a quality stain and the tools you will need to efficiently troubleshoot the most common stain issues. Giddy up and count yourself among the ranks of ‘Sharp Troubleshooter’ for your lab.
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
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.
Volker Zeinar - B Braun, Grant Hodgkins - Smith & Nephew,Jenny James - Innovit,Mar 6 20196:00 pmUTC60 mins
Seven years ago when the Federal Drug Administration (FDA) announced its Unique Device Identification (UDI) regulations, there were no off-the-shelf solutions for submitting regulatory data to the Global UDI Database (GUDID).
Now these options exist, so how will this influence your approach to Medical Device Regulations (MDR)? How would you do things differently for MDR and UDI, specifically European Databank on Medical Devices (EUDAMED)? Our panel of experts will weigh‑in on:
- How this is a key priority for global medical device manufacturers.
- Whether this is it just the structured master data or more?
- What about forms and documents like: post-market vigilance and surveillance, clinical investigations and performance studies, actor registration, notified bodies & certificates?…
John Jolliffe (Strategic Engagement, Adobe Document Cloud) & Viky Manaila (CEO, Trans Sped)Mar 7 20192:00 pmUTC60 mins
Pharmaceutical and Life Sciences companies are subject to unique legal and regulatory requirements that fundamentally impact the way they create and manage content and data. What role can digital signatures play in helping companies manage risk and comply with regulations for the management of clinical trials, securing patient informed consent, and the control of good manufacturing practices?
Join our live webinar to learn how:
• Life Sciences companies can achieve digital transformation in this highly regulated sector
• To comply with ICH E6(R2) guidelines on data integrity to avoid rejection of clinical trial data.
• To secure legally valid Informed Consent and comply with the new EU Regulations on clinical trials data.
• To work alongside signature solutions in non-regulated areas of life sciences companies.
• To achieve compliance with SAFE-BioPharma standards.
Introducing the Mendeley Data datasets API on SSRN! Learn more about early stage research and the integration of Mendeley Data datasets on SSRN encourages authors to upload the research data associated with their papers, allowing for greater transparency and reproducibility. SSRN authors get the credit for their research outputs, attract more citations, compliance with funder mandates data sharing, and more. SSRN readers easily access the data, can evaluate and follow the data connections, and use the data to create individual research.
Nicole Cannon, CEO, Cannon Quality Group & Miguel Tam, VP Marketing, PropelMar 7 20196:00 pmUTC60 mins
Starting up a medical device company takes a lot of time, money and effort. In addition to the research, fundraising, product development, clinical trials, etc., the FDA and other regulatory agencies require a quality system to be defined and maintained. But when is the best time to implement a quality system in your medical device startup?
Join us on March 7 when Nicolle Cannon, CEO of the Cannon Quality Group will host a live webinar. Nicolle will provide guidance and best practices to quality systems implementation and answer your questions.
Thomas French, Industry Consultant, SASMar 7 201911:00 pmUTC30 mins
Join Thomas French, Industry Consultant, SAS for a live Q&A interview at RSA Conference 2019 to learn more about the key trends in digital identity and authentication, specifically in the Financial Services industry.
Discussion topics will include:
- Tends in payments fraud
- Ways this data is being monetized today
- Emerging cybersecurity and fraud trends that have resulted from the adoption of faster payments
- How financial institutions manage their risk postures with increasing security and fraud challenges
- How the concept of digital identity is changing in financial institutions
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 (
Keith Davis, Principle Scientist at PfizerMar 12 20193:00 pmUTC75 mins
Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher ScientiMar 14 20199:00 amUTC75 mins
Single Use technologies are more and more used close to final product leading to increase concern related to integrity. In this article we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in process no sterile filtration is possible.
Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration. Finally, we will also present data analyzing the effect of such a strategy on lowering defect occurrence .
Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USAMar 18 20193:00 pmUTC75 mins
Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs. LC-MS/MS complements next-generation sequencing (NGS) of product cDNA and amino acid analysis (AAA) of cell culture medium during clone selection and process optimization in providing sensitive, comprehensive screening to strategically prevent/minimize SVs and ensure high product quality.
The occurrence of genetic SVs was evaluated using Sanger sequencing and LC/MS. In this work, mAbs with known high and low-level genetic SVs were studied at various cell culture conditions including scale, process and cell age. While scale and process had no significant impact on genetic SV levels, low-level SVs were found to decrease with cell age whereas high level SVs remained constant.
Multiple cell culture process options and the final process conditions are analyzed via LC-MS/MS prior to lock-down of the manufacturing process. Additionally, the cell culture medium (days in culture) for all small scale, pilot and clinical batches are analyzed by AAA to ascertain amino acid nutrient levels, which provides indirect monitoring of possible misincorporation situations. For mAbs with confirmed misincorporations, AAA and LC-MS/MS-peptide mapping results primarily correlated with amino acid nutrient depletion.
Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SAMar 19 20193:00 pmUTC75 mins
TRANSFORMATIONAL SCIENCE: MOVING FROM CHALLENGES OF HIGH CONCENTRATION PROTEIN FORMULATIONS DEVELOPMENT TO MEET THE NEEDS OF HIGH POTENT BISPECIFICS
Monoclonal antibodies (mAbs) have significantly contributed in the treatment of oncological and immunological disorders over last two decades. Next advancement in this line is the introduction of bispecific antibodies – molecules which can bind to two different receptors at the same time. Engaging T-cells to target tumor cells and eventually killing tumor cells have been clinically demonstrated by such bispecific antibody. Traditionally one of the key challenge for developing mAbs is to administer high quantities of mAbs, on the other hand bispecific antibodies are extremely specific and more efficient, which makes them highly potent – leading to a reduced dose. This turns the focus from developing high concentration formulations for mAbs to the development of low concentration formulations. Scientific challenges are of very different nature with surface adsorption being the key challenge; during drug product manufacturing as well as during clinical dosing a protein molecules encounters various different surfaces and preventing/controlling adsorption on any of these surfaces is important. Analytical methods are also required to be adapted for reliable low concentration measurement for the drug product as well as the diluted preparation for infusion in clinic.
Dr. Joe X Zhou is the CEO Walvax Bio Group & Floris D Smet, Director of Field Marketing, Sarotrius ChinaMar 21 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
Helen Parfitt, Head of Therapy Watch, Research Partnership, Mariel Metcalfe and Mark Hollis, Research PartnershipMar 21 20193:00 pmUTC75 mins
Rheumatoid arthritis (RA) has been a major growth driver for the pharmaceutical industry over the last 15 years, led by AbbVie’s blockbuster anti-TNF inhibitor treatment Humira (adalimumab).
The emergence of low-cost biosimilar versions of Humira and the new janus kinase (JAK) inhibitors, are shaking up a once-stable market.
Although there are only two drugs in this class available in the region – Eli Lilly’s Olumiant (baricitinib) and Pfizer’s Xeljanz (tofacitinib) – this is not likely to be the case for much longer, as several other candidates reach late-stage development.
Analysis of Therapy Watch data, a real-time' syndicated market tracking tool from Research Partnership, shows that JAK inhibitors have already made a strong impression in the European RA market, where their convenient oral administration advantage may override cost considerations that would otherwise favour biosimilar uptake.
This pharmaphorum webinar, held in conjunction with Research Partnership, will use the latest intelligence from both physicians and patients to look at emerging trends in the RA market, how these will shape the RA market of tomorrow and how companies can best position themselves for future success.
This webinar will provide an opportunity to interact with the panel about how companies can best harness the potential of this increasingly complex, but highly rewarding, market.
Topics to be covered include:
The European RA market
Current status and market situation of JAK inhibitors (key EU5 countries)
Uptake curve of JAKs compared to other new entrants and biosimilars
Profile of physicians prescribing JAKS
The future of new classes of JAK inhibitors
Brad Hinke, Director of Quality Services & Validation at PropelMar 21 20196:00 pmUTC60 mins
If your company is thinking about buying software to help with product development and manufacturing, validation is a critical step for complying with FDA 21 CFR Part 11 and Part 820. But many firms often lack detailed expertise and experience to make sure their non-product software is validated. With lack of resources and direction, how can you make sure your software is validated at a reasonable cost.
Brad Hinke, Director of Quality Services & Validation at Propel will host a live webinar and provide guidance and best practices from real-life lessons on validation. Brad has worked with both small and large medical device firms in all aspects of validation and implementation.
In this webinar, learn the following:
- what software needs to be validated and lessons learned from past validation efforts
- frameworks for approaching validation
- steps you must do to be compliant with the FDA.
Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West PharmaMar 25 20192:00 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
Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim BiotechMar 27 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.
Mark Christiani, Miguel TamMar 28 20196:00 pmUTC45 mins
View the Future of QMS today! Join us for a live and interactive demonstration of Propel’s game-changing cloud QMS solution. See how quality and complaint management can ease the burden of regulatory compliance for medical device and other regulated industries.
We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.