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.
Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USARecorded: Mar 18 201940 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.
Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher ScientiRecorded: Mar 14 201961 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 Claire Irvine (HGF Ltd), Sarah Morgan (Life Sciences IP Review)Recorded: Mar 12 201965 mins
CRISPR gene-editing continues to hit the headlines regularly as a ground-breaking technology with many millions now flowing into companies seeking to exploit the technology in both the therapeutic and agricultural fields. Unfortunately, the IP landscape continues to lack clarity with possibility of divergence between Europe and the US.
This webinar is aimed at those wishing to hear about the latest developments in the CRISPR IP landscape whether in the commercial, academic, legal or patent world. With the CRISPR IP saga seemingly not close to the final chapter, it will also provide an opportunity to raise questions which may arise from the on–going lack of clarity.
Keith Davis, Principle Scientist at PfizerRecorded: Mar 12 201921 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.
Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch CenterRecorded: Mar 11 201939 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 (
Thomas French, Industry Consultant, SAS & Vince Tocce, Host, Vince in the Bay PodcastRecorded: Mar 7 201923 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
Nicole Cannon, CEO, Cannon Quality Group & Miguel Tam, VP Marketing, PropelRecorded: Mar 7 201961 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?
Recorded live in March 2019, Nicolle Cannon, CEO of the Cannon Quality Group hosted. Nicolle provided guidance and best practices to quality systems implementation and answer your questions.
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.
John Jolliffe (Strategic Engagement, Adobe Document Cloud) & Viky Manaila (CEO, Trans Sped)Recorded: Mar 7 201937 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.
Volker Zeinar - B Braun, Grant Hodgkins - Smith & Nephew, Geraldine Lissalde-Bonnet - GS1, Jenny James - Innovit,Recorded: Mar 6 201959 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?…
Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigmaRecorded: Mar 5 201976 mins
BPOG 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.
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.
Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEARecorded: Feb 26 201981 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.
Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter,Project Line Lead at RepligenRecorded: Feb 25 201976 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.
Seth Earley, CEO, Earley Information Science & Enid Martinez, Senior Director of Engineering and Automation, ADPRecorded: Feb 21 201933 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
Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe)Recorded: Feb 21 201954 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)
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?
In January 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 led a panel discussion of the new digital health software regulations. and answered questions in this webinar recorded in February 2019. Learn the following:
- Is my company eligible for the program?
- What is the timeline for the new regulations?
- What does it mean to be pre-certified?
- What are the risks of non-participation?
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.
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.
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."
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.
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
Seth Earley, Founder and CEO, Earley Information Science, Tom Davenport, author of The AI AdvantageMar 21 20196:00 pmUTC60 mins
Artificial Intelligence (AI) for organizations of all sizes is becoming more practical every day. Many successful implementations are having subtle, but far reaching implications for companies across industries. In this roundtable we will discuss:
1. Where to begin looking for practical opportunities to leverage AI in your organization
2. How market forces are driving this evolution
3. Prioritizing incremental wins over big hit projects
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 Don DeCou, Extractable and Leachable Technology 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 Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
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.
Miguel Tam, Propel and Joe Dunne, OnshapeMar 28 20193:00 pmUTC60 mins
Companies have been integrating CAD and PLM for decades, so is there anything really different that cloud technologies can do? For over 20 years, integrating CAD systems like SolidWorks and Creo to PLM systems has helped mechanical engineers be more efficient. But what about everyone else who needs to see the latest product updates? That’s where the cloud comes in. With their brand new cloud CAD connector, Onshape and Propel are changing how companies can design, launch and sell. The newly launched Onshape and Propel connector not only helps mechanical engineers be more productive, it also allows everyone inside and outside a company to securely share product designs and data.
In this webinar, Joe Dunne, Head of Developer Relations at Onshape, Jayson Kadlecek, Product Manager at Propel, and Miguel Tam, VP of Marketing at Propel, will explain the benefits of an integrated cloud CAD and PLM solution. Joe and Miguel will walk through specific use cases that customers are exploring, and Jayson will do a live demonstration of how Onshape and Propel work for everyone to deliver amazing products.
They will show how Propel and Onshape can:
- Streamline creation of parts and assemblies from Onshape to Propel
- Synchronize product updates across CAD and PLM
- Better support business models like Engineer to Order
Note: Contact information from this webinar will be shared with Onshape.
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.
Seth Earley, CEO, EIS & Carla Pealer, Taxonomy Consultant, EISApr 3 20195:00 pmUTC52 mins
Business agility rests upon a well-architected environment of business processes, workflows, and communications.
So how does taxonomy fit in? It’s everywhere - taxonomy is the foundational building block that improves efficiencies, collaboration, and cost reductions across the enterprise. And the more agile you are, the better opportunity you have to compete and win.
In this webcat you will learn:
• Industry-agnostic best practices to boost your bottom line and beat your competition through taxonomy design and semantic integration
• How taxonomy design enables customer acquisition, search relevancy, structured data, faster time to market, asset reuse, and more.
Speaker: Carla Pealer, Consultant, Earley Information Science
Adopt a Customer-Centric Approach to Reduce Risk with Post-Market Surveillance and Product Complaints:
Being customer-centric in the medical device industry isn’t just about personalized healthcare or integrating IoT feedback into your next generation of devices. Customer centricity has a major role in reducing risk with your post-market surveillance and product complaints process. By having a much more streamlined process to gather customer feedback - both positive and negative - medical device companies can lower risk, improve regulatory compliance, reduce errors and increase customer responsiveness.
In this webinar, Miguel Tam of Propel will focus on the importance of putting your customers first and integrating customer feedback directly into your product quality processes and design reviews.
Hear more about the following:
=> How medical device companies can reduce risk by tying CRM, QMS and PLM (Product Lifecycle Management)
=> Real-world examples of companies who have streamlined customer complaints, CAPAs and engineering changes
=> A live demonstration of how Propel helps with customer complaints and post-market surveillance
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.
Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro BiosystemsApr 8 20198:00 amUTC75 mins
Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
- RMM are not accepted by regulation authorities,
- RMM will never replace classical microbial methods,
- RMM will not offer return on investment (ROI),
- Data generated from RMMs will exceed current specifications and limits involving increase in batch rejections.
Nevertheless a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:
- Time to results in days to weeks,
- Results vary with microbial population, media, culture conditions,
- Lack of reactivity in case of exceeding limit results,
- Sensitivity could be insufficient giving underestimations in the contamination risk,
- Existence of confluent growth.
This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
Presented by Friedrich von Wintzingerode Global QC bei Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA,Apr 9 20198:00 amUTC75 mins
Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The CCAB approach described here enables a comprehensive assessment of these risks.
Monocyte Activation Test: a powerful tool to assess pyrogenic risk in pharmaceutical process
Microbial risk in pharmaceutical process is not limited to viable microorganisms. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. According to the European Pharmacopeia, chapter 5.1.10, a risk assessment has to be performed to justify the method to be used for pyrogen detection: bacterial endotoxin testing is not sufficient if the presence of non-endotoxin pyrogens in the production process cannot be excluded.The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay provides sensitive results based on the human immune reaction and can be a powerful
Sergio Barberan-Soler, Ph.D., Director of Sequencing Technologies, SomaGenics, Inc.Apr 9 20193:00 pmUTC60 mins
The ability to accurately quantify all microRNAs (miRNAs) in a sample is not only important for understanding miRNA biology, but for the development of new biomarkers and therapeutic targets. SomaGenics has developed the RealSeq®-AC library preparation kit – a new method for preparing miRNA sequencing libraries that involves ligating the miRNAs with a single adapter and circularizing the ligation products. When compared to other methods, the RealSeq®-AC kit provides greatly reduced miRNA sequencing bias and allows the identification of the largest variety of miRNAs in biological samples. This reduced bias also allows robust quantification of miRNAs present in samples across a wide range of RNA input levels.
Andrew Reiser, Mountain Point; Miguel Tam, PropelApr 9 20196:00 pmUTC60 mins
How the Cloud Helps Sales, Engineering and Operations to Create Winning Quotes
Changing customer expectations, new types of competitors, and more complex products are endangering the entire business model of engineer-to-order (ETO) companies. ETO companies need to change now because the old game of throwing information back-and-forth between engineering, sales and operations is no longer good enough.
Customers are no longer satisfied with mediocre response times, lack of project visibility and disjointed communication across sales, engineering, and operations. Blaming other teams for lower margins from poorly coordinated quotes doesn’t help with lost business to more nimble competitors.
In this webinar, Andrew Reiser of Mountain Point, a Salesforce and manufacturing consulting firm, and Miguel Tam of Propel, a Salesforce manufacturing software provider, will share how best-in-class companies are embracing the cloud to work better together, with internal teams and customers, and win more business.
This live webcast will cover how cloud applications like Propel and the Salesforce Sales Cloud can create an integrated business process from initial customer request to design discussions to winning customer quotes.
Join this webinar to see:
- How a unified cloud platform can tie sales, engineering and operations processes
- Real-world customer examples that have seen product throughput grow by 500%
- A live demonstration of how Mountain Point, Propel and Salesforce uniquely support modern Engineer to Order business processes
Hossein Sahraei, Data Scientist, Sanofi PasteurApr 10 20192:00 pmUTC75 mins
The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.
Information found in the biomedical literature is a significant source for every stage of the medical device life cycle, from concept and design through clinical trials to release and reimbursement, as well as post-market surveillance.
In June 2016, the updated Medical Device Clinical Evaluation Report (CER) guidelines came into effect (Revision 4 of MEDDEV 2.7/1), detailing where and how to search for literature and how to record the process of collecting, appraising and analyzing the items found.
In this session, Elsevier's solution manager Xuanyan Xu will demonstrate how Embase is especially suited to help Medical Device manufacturers prepare CER, including:
- How to design effective literature searches for Clinical Evaluation reports using the PICO search form in Embase;
- How to build a more comprehensive search using Emtree terms and synonyms;
- How trade name and manufacturer name indexing supports analyses of devices already on the market;
- How to find mentions of adverse device reactions in the literature for effective post-market surveillance (PMS) reporting
Did you know that the incidence of liver cancer has tripled since 1980? Have you wondered what current antibodies are being used to label liver carcinomas by IHC? Or are you curious what antibody grids are used in the differential diagnosis of primary liver carcinoma? In this presentation we will discuss the markers used in detecting liver carcinoma as well as other antibody grids that can be ran to aid in the identification of primary liver carcinoma.
Vasilis Tsaousis, PhD., Medicon HellasApr 11 20194:00 pmUTC75 mins
Latex enhanced immunoassay reagents can be adapted to automated biochemistry bio-analyzers ,equipment available in every modern biochemistry laboratory. Combining existing knowledge in the areas of antibody development and bead conjugation these reagents are suitable for the determination of proteins in patient samples. Their use can override the need for specific and expensive equipment necessary to perform these tests in the past. This talk will focus on the methods we could follow in the design of these reagents, the optimization of crucial factors in the development phase and the validation procedures to reach the expected analytical performance.
View the Future of PLM today! See a live and interactive demonstration of Propel’s game-changing cloud PLM solution Join us on Thursday April 11, 2019 at 10am PT / 1pm ET to: See how easy it is to use and customize
Daniel Christe, Innovation Advisor, ElsevierApr 17 201910:00 amUTC60 mins
When we think of Mendeley, we tend to think of the Reference Manager, but did you know that Mendeley can help you track research metrics like h-index and the number of times your papers are shared? Mendeley can also help you search for your next job or your next research grant.
Tony Kratovil, Salesforce; Miguel Tam, PropelApr 23 20196:00 pmUTC60 mins
As the world’s #1 customer success platform, Salesforce has helped thousands of manufacturers transform sales, service and marketing. But there’s more ways the Salesforce cloud platform can help manufacturing companies with their digital transformation.
For the highly customer-focused Engineer to Order business, the Salesforce platform can uniquely help sales, engineering and operations work better together on changing customer requirements, product designs, tooling estimates and supplier updates to deliver more winning and profitable bids.
Join this webinar with Salesforce and Propel, a Salesforce manufacturing software provider, to learn how companies are already improving their Engineer to Order processes and increasing product throughput by 500%.
Tony Kratovil, VP Manufacturing Solutions at Salesforce, and Miguel Tam, VP Alliances at Propel, will share how Salesforce and Propel are helping different teams collaborate directly with customers on everything from due dates, bills of materials, manufacturer parts and more.
In this live webcast learn the following and more:
=> How Salesforce solutions help Engineer to Order manufacturers track customer requests, product designs, files, and cost estimates
=> Real-world manufacturing examples that have increased customer retention, engineering throughput and operational efficiency
=> A live demonstration of how Propel and Salesforce uniquely support modern Engineer to Order business processes
John Jolliffe, Strategic Engagement, Adobe Document Cloud.Apr 25 20191:00 pmUTC45 mins
When it comes to conducting business with paperless documents, organisations have embraced electronic and digital signatures. The Electronic Identification and Trust Services Regulation (eIDAS) clarifies and simplifies the legal framework for e-signatures across Europe, but how should organisations decide which type of e-signature is appropriate to their needs? And how are new technologies helping to make electronic signatures relevant for the multi-device, highly mobile workspace of today?
Join our webinar, to learn:
• Why e-signatures are essential to your company's success now and in the future.
• Which three signature types are legal under eIDAS.
• How to select the right approach for your business.
• Next-gen e-Signatures and The Cloud Signature Consortium.
John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and James Carriere, Product Line Manager at CoherentApr 26 20192:00 pmUTC75 mins
Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region, provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential. Whether during process development or production, low frequency Raman bands provide greater sensitivity for detecting the onset of crystallization and has allowed differentiation of crystal types when multiple forms are possible. Applying this to Quality by Design (QbD) studies brings an increase in process understanding leading to developing optimal control strategy and avoid the many pitfalls that can occur when scaled-up to the production environment. A recent applications of in-line crystallization processes provided insight into establishing the ideal crystallization control parameters. The parameters evaluated include temperature, mixing rate, seed levels and solvent variable. In-line and off-line QbD studies demonstrated both ideal and non-ideal conditions, ultimately yielding critical process knowledge. As a results of our studies, low frequency Raman has proven to be a valuable tool for at-line and on-line monitoring of active pharmaceutical ingredient crystallization and paves the way for robust production in a large scale facility.
Advances in gene editing technologies have generated a great amount of interest within the scientific community over the past few years. In addition to the ability to make precise double stranded DNA cuts virtually anywhere in the human genome, new variations of these tools show promise in the ability to activate or repress the expression of individual genes. Besides the obvious interest in clinical applications for these tools, there are practical uses of these tools for modifying and improving in vitro cell-based assays in areas such as preclinical ADME/Tox. This webinar will highlight these recent advances in gene editing technology and provide several examples of how this technology has been applied to ADME/Tox assays, including intestinal, hepatic and renal proximal tubule cell lines.