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.
Miguel Tam, VP AlliancesRecorded: Jun 26 201946 mins
View the Future of PLM today! See a live and interactive demonstration of Propel’s game-changing cloud PLM solution Join us on Wednesday, June 26 to see why Propel is the fastest growing PLM solution in the market.
Weston Morris, Global Leader for Unisys Digital Workplace ServicesRecorded: Jun 26 201961 mins
Today’s enterprises need capabilities that go beyond the “Service Desk” and “Desktop Support.” Enterprises need capabilities that:
•Start with how users devices are provisioned and configured so they are ready to ‘phone home’ when a problem is detected.
•Include Artificial Intelligence and machine learning as inherent components of the digital workplace ecosystem.
•Go beyond the visualization of device data to proactive resolution response.
•Use intelligent analytics to infer how the end-users feel about their service without the hassle of a formal survey.
Please join us as we profile seven clients’ use of our Digital Support innovations to accelerate digital transformation.
Biomedical literature has a critical role in post-market surveillance and vigilance to ensure the safety and effectiveness of drugs and medical devices. In the meantime, data extracted from the literature is being more used in different stages of drug discovery and development to achieve different goals. Understanding the relationship between drug-disease, drug-drug, device-disease and device-device can provide important insights for drug development and re-positioning.
In this webinar, Quality Control Scientist Dr. Erin van Buel will discuss
•Indexing principles and relationships identified with in-depth indexing in Embase
•How to use advanced search filters and features to identify semantic relationships between drugs and diseases, such as drugs used to treat a disease, drug-drug combination, drug-drug interaction, etc.
•How the semantic relationships identified with in-depth indexing can be used to inform drug development, re-positioning and safety
Chris Chen PhD, CEO of WuXi Biologics and Dr. Sébastien Ribault, Senior Director for Global Delivery and Sales at MerckRecorded: Jun 20 201972 mins
Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also require other logistics models. Chris will explain WuXi Biologics' approach to biological facilities of the future.
Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher ScientificRecorded: Jun 14 201977 mins
by Ravi Kalyanaraman, Director at BMS
Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics.This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.
Followed by Why Use Raman Microscopy for Pharmaceutical Forensics?
by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific
Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials. All of these aspects of Raman microscopy make it an indispensable tool for pharmaceutical forensics.
Peter Meeus, European Orphan Medicines, Sarah Rickwood, IQVIA, Angela McFarlane, IQVIA, Paul Tunnah, pharmaphorumRecorded: Jun 13 201972 mins
Launching orphan medicines excellently will become even more important over the next five years as more patients with rare diseases have pharmacotherapies available.
There are also a growing number of disease-focussed registries, increasing public and policy maker awareness, and significant R&D investment in orphan drugs, as well as in digital technologies to support trials and treatment.
But a new frontier of challenge faces orphan medicines companies as the gap between orphan medicines and mainstream specialty products narrows.
To understand how to succeed in launching an orphan medicine in the coming years, companies must learn from past launches and apply an orphan medicines-focused launch excellence framework for success.
This internationally relevant webinar will provide US and European examples to illustrate the ways in which the pharmaceutical market for orphan medicines is changing and how, consequently, launch strategies must evolve.
This pharmaphorum debate, held in partnership with IQIVA, will also look at how pharmaceutical companies can optimise all the activities needed to take orphan medicines from clinical development to commercialisation, including:
•Identifying the three fundamental challenges for orphan medicine launch excellence
•Discussing the ways in which companies launching orphan medicines can learn from excellence in mainstream launches
•Examining, in-depth, the specific areas of focus which are crucial for orphan medicines excellence.
Alexia Lafarge and Adele GisselmanRecorded: Jun 13 201951 mins
Evolutions des référentiels qualité et crises sanitaires, comment le nettoyage et la désinfection apportent des réponses aux changements majeurs.
Nous présenterons les solutions de contrôle rapide du nettoyage allant des méthodes conventionnelles microbiologiques aux méthodes rapides en passant par le contrôle de l’air.
Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering at University of GreenwichRecorded: Jun 11 201943 mins
Hot Melt Extrusion (HME) is an established processing technology that can be used for the development of paediatric formulations. The processing of lipids via HME has been proved ideal for high drug loaded dosage forms with sustained release of drugs. The study investigates the effect of the lipid type and the food grade on the dissolution rates of extruded pellets or extemporaneous formulations. The stability of lipidic formulations is a very important aspect especially for paediatric applications. Here the stability of various formulations comprising of GRAS excipients is also examined.
Margaret Phillips, Purdue University and Eleonora Presani, ElsevierRecorded: Jun 6 201959 mins
Join us for a webinar on Thursday, June 6th as we discuss how Scopus can assist librarians in addressing researchers’ top priorities and questions, such as:
•Where do I publish?
•How can I make sure my research is novel?
•How can I easily maintain my researcher profile and showcase my impact?
Co-presenting the webinar will be:
Margaret Phillips, Purdue University
Margaret is an Assistant Professor of Library Science and Engineering Information Specialist at Purdue University Libraries and School of Information Studies. She is the Libraries liaison to the Schools of Engineering Technology, Industrial Engineering, Mechanical Engineering, and Nuclear Engineering.
Eleonora Presani, Elsevier
Before Dr. Eleonora Presani (@elepre17) joined Elsevier in 2012, she was a particle physicist at CERN. At Elsevier, her first role was as a publisher, managing 14 academic journals in Nuclear and High Energy Physics. In 2016 she joined the Scopus team as Product Manager, working on research data linking and author assessment.
Biomagnetic separation has proven to be a quick, efficient and clean process in Life Sciences. However, most researchers and developers focus only on the magnetic beads or particles to optimize their separation process. The effectivity of the biomagnetic separation depending on the magnetic carrier is only half of the story. To have the complete picture we also need to pay attention to the role of the applied magnetic field on the play. Not understanding or controlling the parameters linked to the magnetic separator will result in failure when developing new applications, and also in industrializing lab-scale developments. The webinar will review the basic concepts of magnetic separation and help the attendees understand how advanced systems may enlight key aspects of the process. These concepts will be applied to parameterize, monitor and validate the magnetic beads behavior in controlled conditions. Afterwards, the discussion will focus on how to transfer the correctly characterized biomagnetic separation process from laboratory to production scale. Finally, the webinar will address how to use this knowledge to assure the quality of the magnetic-carriers based products.
Giustino Di Pretoro, of Johnson and Johnson and Dr. Robin Meier of L.B. Bohle MaschinenRecorded: May 28 201974 mins
- What is Drug Product Continuous Manufacturing?
- Is Continuous Manufacturing really worth the effort? "without data, you are just another person with an opinion"
- What are the challenges implementing CM?
- Development and tech transfer considerations for CM.
Demonstrate finacial and operational benefits of Continuous Manufacturing
Explain the key challenges in the implementation of CM in R&D
Explore key strategies in drug product development of CM
Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGSRecorded: May 24 201968 mins
Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C>) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
Chemiluminescent immunoassays (CLIAs) offer one of the best solutions for the quantification of low concentrations of specific analytes from a complex mixture for in vitro diagnostic industry. The assay format is similar to enzyme-linked immunoassays, usually based on heterogeneous assays where antibodies or antigens are immobilized on a solid phase but one of the components is conjugated with a chemiluminescent label.
The benefits of CLIAs can be enhanced using magnetic beads as a solid platform which improves the separation of the un-bound reagents and reduces the interferences using a magnetic field.
The CLIA assays based on magnetic beads together with chemiluminescent tagging of immunoreagents are widely used in high throughput automated platforms obtaining an amplified signal and decreasing the matrix interferences. The complexity of these type of immunoassays rely on the optimization of several components and parameters. The critical points are highly related to the type of immunoassay format that best suits the desired specifications, magnetic beads selection and conjugation conditions for magnetic particles and chemiluminescent labelling parameters.
Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieuxRecorded: May 23 201975 mins
Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
This webinar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.
Audrey Bergeron, Applications ScientistRecorded: May 22 201923 mins
In recent years, three-dimensional (3D) cell culture models have been emerging as the preferred in vitro cancer model as they better mimic the in vivo tumor microenvironment. For instance, 3D cultures develop hypoxic cores and demonstrate gradients of soluble factors and a diffusion profile for drugs similar to solid tumors. Understanding the interactions between cancer cells and other cell types in the tumor microenvironment is also critical to predicting therapeutic efficacy.
In this webinar, Audrey Bergeron will review:
•An introduction to 3D cell culture
•Assay techniques in spheroid microplates
•Several 3D cancer models and technology tools used to better capture the complexity of the tumor microenvironment in assay-compatible formats.
About the Presenter:
Audrey Bergeron is an applications scientist for Corning Life Sciences. She evaluates new products and develops protocols and technical documents using Corning cell culture products. She also provides product training to Corning employees and customers, and assists technical services with customer support by helping to troubleshoot customer experiments.
Routine and special stains are usually selected to demonstrate a special structure, chemical or molecular characteristic of the tissue. They are the first tool in a pathologist’s arsenal in detecting cancer in a patient's tissue. If there still are questions, a pathologist will request more advanced staining. This workshop will look at the more commonly requested special stains, and we will review the methods, application and results of these stains. We will also look at the complimentary IHC stains and how they compare.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt GermanyRecorded: May 22 201959 mins
Solid Phase Microextraction (SPME) is an invaluable tool for sample preparation in Environmental Analysis, because it is a trace analysis technology that is easy to fully automate. SPME is method of choice in many official analytical methods In Environmental Testing. This webinar provides an introduction into SPME and showcases how SPME facilitates different environmental applications for water testing.
Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein SimpleRecorded: May 21 201953 mins
Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.
Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging
Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple
Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
Rachel Brennesholtz, Community Marketing ManagerRecorded: May 16 201945 mins
Mendeley is a free reference manager and academic social network that can help you organize your research, easily create a bibliography, collaborate with others online, and discover the latest research. We will be having an introductory session covering Mendeley's main features. This online presentation is free to register and will run for approximately forty-five minutes.
Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt GermanyRecorded: May 8 201948 mins
Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech
Extractables and their perceived impact on product and patients continue to be a challenge. The challenge is augmented by the lack of standardized extractable data from suppliers. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements. This paper will discuss case studies where data from a supplier using the BPOG protocol significantly reduced the time for implementation.
Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective
Presented by Dr. Saskia Haehn, Laboratory Manager for E & L at Central Analytics of Merck KGaA, Darmstadt Germany
The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
Natalie Cain, PhD., Scientific Editor, Cell ReportsRecorded: May 8 201939 mins
Within this 30m webinar, you will gain insights from Natalie Cain, Senior Scientific Editor from Cell Press, on the publishing topics Ethics and Copyright. Learn about authoring responsibilities, post-publication issues, and strategies for publishing in high-standard and high-impact journals. Dr. Cain will also introduce you to Cell Press Mentor, a new service for scientists. All researchers and students are welcome to attend. For our Egypt-based attendees, through the Egyptian Knowledge Bank (EKB,) all Egypt-based researchers and students have access to the Cell Press portfolio of scientific journals. Join us and discover the resources of Cell Press.
About the presenter: Natalie Cain received her Ph.D. in Biology from MIT, where she studied nutrient regulation of intracellular trafficking of amino acid transporters in yeast, under the mentorship of Chris Kaiser. She was an American Cancer Society postdoctoral fellow in the lab of Daniel Starr at the University of California, Davis, studying mechanisms of nuclear positioning in C. elegans. During her postdoc, she served as an editorial fellow at the AAAS journal Science Translational Medicine. She joined the Cell Reports team as a Scientific Editor in 2017.
Tony Kratovil, Salesforce; Miguel Tam, PropelRecorded: May 7 201955 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
Dennis Douroumis, of University of Greenwich and Dr.-Ing Margarethe Richter, Pharma Application Specialist at Thermo FisherRecorded: May 7 201959 mins
Full Title: Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s
• Identifying the appropriate excipients for HME processing of water insoluble drugs
• Using novel excipients to achieve increased dissolution rates (Granulation)
• Extrusion with polymeric carriers for the development of solid dispersions
• Co-crystallisation of water insoluble drugs
In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.
As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e. to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The presentation gives an introduction into HME technology as an alternative to spray drying. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms hot melt extrusion (HME) can be used for novel delivery methods. The presentation gives an overview on possible applications including examples and case studies.
Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei RoRecorded: May 3 201971 mins
Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
John Wasylyk, Sr Principal Scientist at BMS and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems IncJul 1 20192:00 pmUTC75 mins
During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for monitoring both chemical and physical transformations. They can be used to monitor the progress of the chemical reaction leading to the desired product, the slurry-to-slurry form transformation leading to the desired crystalline form, and the instability of API leading to undesired degradant. When used in-line, they can also be used to study the kinetics of a chemical reaction as well as the rate of crystalline form conversion...
Followed by Utility of Raman spectroscopy in continuous processing of liquids and solids
An important consideration in successful continuous manufacturing is integrating analytical tools into the flow. In batch reaction monitoring, on-line and at-line analyses enable Quality by Design (QbD) and ensure stable operations. Intense reaction conditions, non-traditional chemistries, high throughput and speeds, and miniaturized reactors are challenging environments for analytical tools originally developed for batch reaction monitoring. We present process Raman technologies adapted for continuous manufacturing processes in liquids and solids. Over the last 20 years, Raman spectroscopy has become an established technique for process monitoring and control, with applications in continuous manufacturing of liquids and solids...
Seth Maislin, Principal Consultant, Earley Information Science & Seth Earley, CEO, Earley Information ScienceJul 10 20195:00 pmUTC60 mins
Let’s face it - no one likes the ‘G’ word. It’s too often a sour antidote to excitement and nimbleness: Triple checks, security barriers, privacy forms, council reviews. It’s as awful as pulling teeth and paying taxes, right?
Thankfully it doesn’t have to be, and many organizations have found an effective rhythm for long-term, sustainable data stewardship.
Join us on Tuesday, August 28th, at 11:00 AM ET as we discuss ‘Data Governance: Achieving Sustainability Among Whiners,’ where we’ll explore how you can implement this necessary rhythm, even if you’re surrounded by governance resistors.
You will learn:
1.Good governance is empowering, not (only) a “necessarily evil”
2.The Effective As: Automation, Assignment, Attitude
3.Analytics for achieving fast failure (and recovery)
Seth Maislin is a Principal Consultant with Earley Information Science. For more than 20 years he has demonstrated strengths in classification and taxonomy, indexing and content modeling, information architecture, search, and usability. He has dedicated the last 10+ years to providing sustaining information management solutions to clients facing real and complex findability challenges.
Seth Earley is the Founder and CEO of Earley Information Science. An expert with 20+ years experience in Knowledge Strategy, Data and Information Architecture, Search-based Applications and Information Findability solutions. Seth has worked with a diverse roster of Fortune 1000 companies helping them to achieve higher levels of operating performance by making information more findable, usable and valuable through integrated enterprise architectures supporting analytics, e-commerce and customer experience applications.
Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE LtdJul 15 20192:00 pmUTC75 mins
Full Title: Use of Computational Modelling in Specification Setting and Establishing Control Strategy
The proportion of scientific evidence supporting medical product regulatory applications derived from modeling and simulation studies is expected to continue to grow into the future. In the Quality by Design framework, mathematical models can and have be utilized at every stage of product development and manufacturing. Thus, the regulatory assessment of product quality models is not unprecedented but the frequency, types of models, and applications are evolving. This evolution is being driven in part by the adoption of advanced manufacturing such continuous pharmaceutical manufacturing.
The ICH Quality Implementation Working Group points to consider document categorizes models based on the model’s contribution in assuring the quality of the product. Models utilized as part of the control strategy are typically categorized as either high or medium impact depending on the role of the model. Minimal guidance though is provided on model validation. A recent standard (ASME V&V 40) outlines a process for making risk-informed determinations as to whether a model is credible for decision-making for a specified context of use. The presentation will discuss how the framework could be used to develop model validation plans and support regulatory assessment using case studies from both drug substance and drug product manufacturing.
Robb DeFilippis, Managing Director, Life Sciences, Tag, Steve Pitts, Business Director, Tag, Dominic Tyer, pharmaphorumJul 23 20193:00 pmUTC75 mins
Customer journeys in pharma are changing, with important implications for the marketing supply chain. How can pharmaceutical marketers capitalise on this trend and free up budget to invest in additional marketing channels?
New developments in data and digital are changing traditional customer journeys and forcing pharmaceutical companies to evolve in order to keep up.
Companies like Apple and Amazon have elevated customer expectations for personalised content and interactions across multiple channels, in the process setting new standards for marketing. But, as they push the envelope, what are the implications for pharma’s work in customer engagement?
This pharmaphorum webinar, in association with Tag, will examine the challenges that pharma marketing faces to stay ahead of the evolving customer journey and offer expert insight from both the pharma and FMCG sectors on how to convert these challenges into opportunities .
The expert panel will consider exclusive research carried out by Tag and pharmaphorum across the US, Europe and Asia-Pacific among senior decision-makers in pharma and FMCG marketing.
The webinar, which takes place on Tuesday 23rd July at 16:00 BST , will also look at:
•How pharma currently allocates its marketing budgets
•Where marketers would like to have more money to invest
•How much time is spent directing creative ideation and managing marketing production
For more information, please visit:
Geoffry Hodge, Chief Technical Officer at Unum Therapeutics and Gary Pigeau, Ph.D., Director at GE HealthcareJul 30 20192:00 pmUTC75 mins
Presented by Geoffry Hodge, Chief Technical Officer at Unum Therapeutic
Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.
Followed by Gary M. Pigeau, Ph.D., Director – Centre for Advanced Therapeutic Cell Technologies at GE Healthcare
Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined GE Healthcare and the Centre for Advanced Therapeutic Cell Technologies (CATCT) @ CCRM in 2016 and led the pluripotent stem cell process development, scale-up and manufacturing efforts. Today, Gary is the GEHC Director of the CATCT delivering on customer-focused fee for service process, media and assay development projects, development of new products for GE Healthcare and internal technology development projects to continue to develop and grow capabilities within the group.
Francis Verhoeye, Director Single Use Technologies, GSK VaccinesAug 5 201912:00 pmUTC75 mins
Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.
EarleyInfoSci, Mouser Electronics, Brock WhiteAug 7 20195:00 pmUTC59 mins
The B2B technical buyer is a unique persona with specialized needs. In order to get and keep this valuable customer on your site you must speak directly to their needs. So, how are the needs of technical buyers defined and translated into an engaging experience? The B2B and B2C ecommerce experiences have many similarities. Some lessons learned from B2C can be valuable to B2B. However, the two markets also have important differences, and the customer journey needs to reflect them.
In this panel you will learn specifics about:
--The archetypes of B2B buyer
--Motivators and demotivators for making purchases
--How to identify, structure and present content and assets that move the sale forward
--The critical role of personalization
--How merchandizing, cross-sell and up-sell leverage organizational knowledge about customer challenges
This roundtable delivers valuable insights for CMOs, VPs of Digital, and Senior Marketing executives in organizations that operate as manufacturers, suppliers, and/or distributors in the industrial, high-tech, aerospace, life-sciences, and MRO spaces.
Dr Udayanath Aich, Associate Director at Bristol-Myers SquibbAug 9 20192:00 pmUTC75 mins
Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.
Dr. Udayanath Aich is an Associate Director at Bristol-Myers Squibb. He previously was a Principal Scientist at Sanofi-Genzyme. He has extensive experience and management skills in analytical chemistry, high throughput technologies and process analytical technologies (PAT). Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. In 2011, Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Before Sanofi-Genzyme, Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics and structure-function study.
This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
It’s no secret that we live in a celebrity centric culture hungry for the latest news about our favorite famous faces. This lecture will employ the fascinating world of celebrities to introduce the immunohistochemical grid approach to cancer disease states. We will specifically use cancer stories from past and present entertainers, athletes, and politicians to examine the histological characteristics and statistics that define various tumor types. These cases will also be our launching pad as we take a deep dive into the intricate world of tumor immunophenotyping by highlighting recent antibody additions and their impact on modern detection. Attendees will learn the utility of these new antibodies and gain a better overall understating of how diagnostic grids are used by pathologists to provide thorough and accurate patient care.
Moritz von Stosch of GlaxoSmithKline Vaccines Followed by Klaus Mauch and Shilpa Nargund of Insilico Biotechnology AGSep 2 20198:00 amUTC75 mins
Title: Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development
Knowledge from first principles is freely available and generally valid, and when integrated along with Artificial Intelligence (data-driven) methods, it can greatly improve the understanding and applicability. The applications of such an approach, referred to as hybrid modelling, to a fermentation and controlled drug release case are presented and the learnings from the development of these models are shared.
Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at RocheSep 4 20199:00 amUTC75 mins
Adoption of strategic and systematic use of lean principles to improve operational efficiencies and cost competitiveness
Systematic reduction of waste, complexity and variability,
Reduction of order lead time,
Higher employee satisfaction and engagement tackling the cultural challenges
Achieving speed and reliability in the manufacturing value chain.
Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
Uwe Voelker is currently the Site Head (GM) at Roche in Mannheim, leading Pharma Operations (Biologics DP site). He was previously in VP-roles in both Quality and Techn. Operations, local and global roles, a.o. Head of Global Quality Small Molecules, Site Head in a Biologics DP site in Switzerland.
Uwe is well versed in all aspects of Quality Management; Lean, Operational Excellence and Change management.
Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGSSep 10 20192:00 pmUTC75 mins
Title: Case Study and Experience on Sanofi's Implementation of BPOG's Leachable Risk Assessment Model
Brief review of the BPOG's Leachable Risk Ranking model. A case study of the leachable risk model implementation into Sanofi will be presented. All changes to specific risk factors and weights changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.
Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro BiosystemsSep 12 20192:00 pmUTC75 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.
Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec LtdSep 13 20199:30 amUTC75 mins
Current trends and regulation affecting Biopharmaceutical Industry
Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
QbD-Bringing Improvements in Biologics development and Manufacturing Space
Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC and Heidi Hagen, Co-founder and CSO for Vineti IncSep 17 20192:00 pmUTC75 mins
The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.
Jincai Li, Vice President of WuXi BiologicsSep 18 20197:00 amUTC75 mins
With the rapid growth of the biotherapeutics industry, the need and challenge for high quality, cost efficient production has been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that vary greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with multi-purpose facility and smaller, modular facility being favored by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the somewhat unique challenge of transitioning from clinical manufacturing to commercial manufacturing and maintaining both clinical and commercial manufacturing in the same facility.
Presented by Dr. Jincai Li, Vice President of WuXi Biologics
Dr. Li has over 17 years’ experience in Biologics process development, scale-up and cGMP manufacturing. His group contributed to over 40 IND submissions, both in and outside of China, as well as BLA submission works. Dr. Li joined WuXi Biologics in 2011, helped built and led the Cell Culture Process Development & pilot plant production group, and then managed the cGMP Drug Substance manufacturing facility. Before joining WuXi Biologics, Dr. Li was a cell culture process development Group Leader at Genentech Inc. Before that, Dr. Li also worked at Tanox, Inc, where he led the manufacturing sciences group supporting PhIII production of a mAb product, and at Diversa Corporation (now BASF), in charge of process development for multiple recombinant enzyme projects.
Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZenecaSep 19 20192:00 pmUTC75 mins
Full Title: How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality
Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and adoption of these high-throughput chromatography methods with the data generated being of comparable quality to that from longer lot release methods.
Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
Jeremy Springall has worked in the Analytical Sciences group, part of R&D Biopharmaceutical Development, at AstraZeneca for the past five years. His responsibilities include assess new technologies and work processes to support early and late stage development assets as well as being a CMC analytical team lead on several non-mAb projects currently in the AstraZeneca development pipeline. Previous roles include In-process analytical development scientist at UCB and analytical development scientist at Patheon, both in the UK. He holds a Ph.D. in bioorganic and medicinal chemistry and a BSc in chemistry from the University of Bath, UK.
Pearl Fong, VP at Mycenax Biotech Inc.and Gerben Zijlstra, Global Technology Consultant at Sartorius Stedim BiotechSep 24 20198:00 amUTC75 mins
As the development process of monoclonal antibodies has come to a steady, it is assumed the automatic flow can be adopted and it is the beginning test ground for continuous manufacturing, to link the upstream cultivation to downstream purification in a continuous mode. We will show some preliminary results for this new era, Biomanufacturing 4.0.
Presented by Pearl Fong, MSc., Vice president, Division of Business Development at Mycenax Biotech Inc.
Pearl has worked over 15 years in the biotechnology industries to serve both operating and consulting roles for more than 30 biomedical projects. As Director of Project development, she operates in CMC, project management, project oversight, regulatory consulting and business development fields. Pearl’s educational credentials include a Bachelor of Nutrition and Health Science and a Master in Molecular Biology and Biotechnology. She has brought the very first biological medicinal product from preclinical to NDA approval in Taiwan.
Followed by Gerben Zijlstra, Global Technology Consultant at Sartorius Stedim Biotech
Gerben is a regular speaker on process intensification and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen, NL, in the field of process integration in cell culture.
He has worked for more than 20 years at CMO DSM Biologics and has been involved in the development of several Bio-therapeutics. He was one of the early adopters of single-use bioreactors and is the first inventor of the Concentrated Fed-Batch – XD® technology. Gerben was deeply involved in the tech transfer of XD® technology to the Brisbane, AU site, which received the 2014 ISPE facility of the year award for process innovations. As a consultant at Xendo, Gerben has been working on Continuous BioManufacturing and Gene Therapy projects. Since 2016 he has joined the Sartorius Team, where he currently holds a position as Global Tech Expert for Intensified BioManufacturing.
Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher ScientificSep 24 20192:00 pmUTC75 mins
By Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia
Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.
Followed by Charge Variant Separation Coupled to High Resolution Mass Spectrometry for Routine mAb Analysis
By Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific
Biotherapeutics such as monoclonal antibodies are a heterogeneous mixture of structurally similar molecules that differ in mass and charge, referred to as charge variants. Charge variants result from sequence variations and post-translational modifications such as e.g. deamidation and sialylation resulting in species that are more basic or acidic than the main mAb monomer. The heterogeneity can be revealed by charge-sensitive separation methods, such as ion exchange chromatography. The use of MS-compatible buffers allows for online hyphenation to a mass spectrometer. This hyphenated setup provides the chromatographic resolution of ion exchange chromatography coupled to the identification of the separated variants by mass spectrometry.
In this webinar we will discuss a charge variant analysis (CVA) workflow that entails ion exchange chromatography using pH gradients for protein elution with online mass detection on a high resolution Orbitrap-based mass spectrometer. This workflow enables routine application to a wide range of antibody samples for comprehensive analysis based on a single injection without the need for sample preparation.
Bastiaan Leewis of MeiraGTx and Ankita Desai of EppendorfSep 25 20192:00 pmUTC75 mins
Full Title: Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx
As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.
Followed by Bioprocess solutions for upstream bioprocess development and scale-up
Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf
Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
Narasimha Rao Nedunuri, CEO of CLONZ Biotech and José Castillo, PhD, CTo and co-founder of UnivercellsOct 2 20199:30 amUTC75 mins
Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production.
Evaluating cost of production per gram conventional fed batch vs continuous process.
Key considerations for adapting continuous process for the production of Biosimilar MAbs.
Presented by Narasimha Rao Nedunuri, CEO of CLONZ Biotech
Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India.
He is currently serving the company as the Managing Director & CEO .
Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing a business division for its Indian subsidiary.
At CLONZ , a 7 year old start-up, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.
Seth Earley, CEO, EIS & Carla Pealer, Taxonomy Consultant, EISOct 2 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
Fouad Atouf, Ph.D., Director at USP and Horst Ruppach, Ph.D. Scientific Director at Charles RiverOct 7 20192:00 pmUTC75 mins
Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize the critical components of a manufacturing process. In addition to cell culture supplements, excipients and other formulation’s components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products. This presentation will discuss the critical challenges facing the development of cell therapies, and the type of qualification programs to help ensure consistency in the manufacturing of cell and gene therapies.
Presented by Fouad Atouf, Ph.D., Director at US Pharmacopeia
Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. His department supports the work of the associated USP Expert Committees. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Dr. Atouf has strong background and experience in the development and regulation of cellular and tissue-based products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the in vitro generation of cell-based therapies for diabetes. Dr. Atouf is the author of numerous publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences. Dr. Atouf earned his Master’s degree in Biochemistry and his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.