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.
Heather Van Epps, Editor-in-Chief The Lancet RheumatologyRecorded: Dec 12 201971 mins
Join Heather Van Epps, Editor-in-Chief of The Lancet Rheumatology, to learn about techniques and strategies for preparing your paper to submit to high-impact journals.
Heather will share her experiences working with researchers and authors throughout the research publishing cycle. You will learn how to develop papers for submission to publications like the Lancet family of journals.
Do not miss this engaging webinar―you are invited to join and ask any questions that you feel will benefit your research.
Don't forget to download your manuscript checklist from the resources section.
Faris Omary and Leah HartmanRecorded: Dec 11 201940 mins
Have you ever found yourself wondering which clone of Napsin A to use? What about PAX-8? Or the ongoing dilemma of ordering a mouse monoclonal vs rabbit polyclonal? Then this webinar is for you!
In this presentation we will explore how antibody's are produced in their corresponding hosts. From there we will identify the main differences between the most popular types of antibodies, including mouse and rabbit monoclonals, and rabbit polyclonals. We will then compare the performance of specific clones that are backed by NordiQC data. We hope this will aid in choosing the best clone for your IHC tests.
Debra Rodensky and Chip Wolfe, Embry-Riddle Aeronautical UniversityRecorded: Dec 11 201939 mins
At Embry-Riddle Aeronautical University, world-class experts conduct cutting-edge air and space research, and the Library works diligently to capture and share all the unique work through their institutional repository. When the Chief Information Officer asked library staff for help creating a Promotion and Tenure tool to better serve faculty looking to advance, librarians Debra Rodensky and Chip Wolfe knew they had the technology, all the content of the IR and the strong campus relationships to make it happen. Join Debra and Chip on December 11 for a webinar on the Library's collaboration with IT and the library’s relationships with faculty through the tenure and promotion process. Topics will include:
- The historical relationship between the Library, its IR and the IT department at Embry-Riddle
- The changing culture of promotion and tenure on campus
- Challenges and successes of building a tool to meet the needs of both IT and faculty.
Debra has a BA in Legal Studies from Quinnipiac University and a MLS from the University of South Florida. She has worked as a librarian at the Museum of Science & Industry in Tampa, the Veterinary Library at Disney’s Animal Kingdom, and the Horticulture Library at Walt Disney World before joining the Research Department at ERAU’s Hunt Library in 2001. She now works as a Scholarly Communication Librarian who assists faculty, students, and staff with adding their research works to the institutional repository.
Chip has been at ERAU’s Hunt Library since 2005 and serves as the Scholarly Commons Administrator. He was instrumental in bringing up and developing the repository that began in 2013. Previous careers include US Naval Security Group, Digital Imaging Service Director, and owner of East Coast Archiving.
Jürgen Swienty-Busch, Elsevier and Ye Li, PhD, MLIS Chemistry and Chemical Engineering Librarian, MITRecorded: Dec 10 201958 mins
This webinar will examine how index databases can help navigate chemical information efficiently, and how the structured chemical data may enable innovative discoveries. Attendees will be able to:
•Understand the intellectual value of chemical data and literature indexing
•Explore functionalities based on indexing and taxonomy in databases
•Recognize innovative and computational trends of using structured chemical data
Audrey Bergeron, Applications Scientist & Ann E. Rossi, Ph.D, Senior Bioprocess Applications Scientist, Corning Life SciencesRecorded: Dec 5 201931 mins
Advanced cell culture techniques and scale-up offer exciting research opportunities; however, they also come with complex challenges and questions. Corning Life Sciences knows cells – you might even say it’s in our DNA with over 100 years of experience in the field.
In this webinar, Corning scientists put their expertise in the areas of 3D cell culture and bioprocess to work as they answered submitted questions from the audience.
•Our lab is new to working with spheroids. What are some options for spheroid formation? (2:02 - 4:10)
•How do you perform media changes in the 96-well Corning spheroid microplate without losing spheroids? (4:11 - 5:49)
•How do you dissociate single cells from a spheroid for analysis? (5:50 - 6:51)
•How do you transfer spheroids? (6:54 - 7:30)
•What is the surface area of the Corning® CellSTACK® 10-layer vessels? (7:56 - 10:02)
•Is there an easier way to fill Corning CellSTACK 10-layer vessels? (10:03 - 11:33)
•What is the maximum culture volume for the 5L expansion bag? (11:34 - 13:25)
•What cell types can I culture in the 5L Erlenmeyer flask? (13:26 - 15:25)
Live Q&A session with audience (16:10 - 29:30)
•How do you prevent organoids from sticking to collection tubes?
•How do I check the cell confluence in a HYPERFlask?
•And many more questions
Franziska Wienholz and Philip WagstaffRecorded: Dec 5 201950 mins
Three-dimensional Models: Organoid Study and Co-culture for Oncology
Three-dimensional (3D) cell culture environments provide structural and biochemical clues for cellular differentiation and functionality. For specialized cell types such as primary cells and stem cells, a two-dimensional (2D) growth substrate may not be sufficient to support complex cellular behaviors such as cell polarity, morphology, spheroid formation, signal transduction, and tissue-specific gene expression. This seminar will introduce the newest tools developed to help researchers: Corning® Matrigel® matrix for organoid culture and Corning Elplasia® plates for bulk production of spheroids. We will also present advanced case studies using spheroids and organoids.
Franziska Wienholz is a Scientific Support Specialist at Corning Life Sciences.
Retinal Organoids: Developing Disease Models to Better Understand Glaucoma Pathogenesis
Glaucoma refers to a group of complex genetic diseases that affect the retinal ganglion cells that relay visual input along the optic nerve to the visual cortex. In glaucoma, these cells are damaged and degenerate, resulting in permanent progressive visual field loss and ultimately, blindness. Retinal organoids are routinely used to model glaucoma in vitro; however, a drawback is the lengthy culture times to generate retinal ganglion cells, which can be 2 months or longer. This can be reduced by using a 3D Corning Matrigel matrix culture, which has been used to generate retinal ganglion cells in just 28 days. With advances in gene editing, retinal organoids can be used to model genetic mutations that lead to the development of glaucoma and provide clues to future therapies to halt the loss of vision.
Philip Wagstaff is currently a Ph.D. researcher studying the genetics of glaucoma at University of Amsterdam, Netherlands.
Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.
Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.
Join solution marketing manager Dr. Marnix Wieffer for this webinar, where he will discuss how to leverage extracted pharmacokinetic data from literature and FDA/EMA Drug Approval documents to make better-informed decisions on which drugs have the most potential to succeed in clinical development.
Using PharmaPendium we will
•Retrieve detailed information on PK parameters on approved drugs
•Retrieve all data on PK parameter of interest (for example Cmax) on drug acting on the same target I am working on
•Investigate what is the best translational model to assess Serum protein binding
•And much more
Alison Tran, Client Partner, EIS; Chantal Schweizer, Principal Consultant, EISRecorded: Dec 4 201953 mins
As your business and product data complexity grows, so too may your need for an enhanced PIM system that accounts for numerous operating units, separate companies, global operations, and more.
How do you judge whether you are ready to jump from your homegrown solution? And if you’re ready to make the jump, what is the best path to ensure that you transition from one system to another successfully?
In this session you will learn:
* The milestones that signal your readiness to take on a commercial PIM
* Best practices when making the transition to a commercial PIM
* How to align your PIM strategy to a logical data model
Alison Tran, EIS, Client Partner, brings over 14 years of business and technology consulting experience in technology adoption, software implementation, organizational redesign, change management and process reengineering.
Chantal Schweizer, EIS, Principal Consultant, a senior information organization professional with over 10 years experience in product information and taxonomy design.
Eva Thalmann, Janssen, Jean-Yves Douillard, ESMO, Katie Koziol and Andrew Moore, Ashfield Meetings & EventsRecorded: Dec 3 201970 mins
Research from Ashfield Meetings & Events clearly demonstrates that face-to-face meetings and events form a major part of continuing medical education (CME). National and international congresses have been identified as the primary event to attend by HCPs.
But what makes congresses such a valuable education channel for time-restricted physicians? This pharmaphorum webinar, in association with Ashfield Meetings & Events, will dive into a unique study of HCP educational and behavioural preferences towards attendance at medical congresses.
Ashfield Meetings & Events’ The Science of Healthcare Congresses study, involved over 200 HCPs, drawn from a range of therapy areas, from both Europe and the US to ask what really matters to them and share some intriguing insights.
These encompassed how HCPs value this type of activity, how they apportion their time on-site and engage with the healthcare industry, and how they evaluate a congress once its doors have closed for another year.
Join our expert panel on Tuesday 3rd December to find out more on:
• Why physicians attend congresses
• How to ensure medical education provides value to attendees
• How pharma can enhance industry symposia
In addition, our panel will also share the results of an ongoing association and multi-pharmaceutical company research project, designed to standardise and benchmark the evaluation process of all congress medical education activities.
Biomedical literature is an important source of adverse event reporting. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies and CROs are facing significant challenges around costs, efficiencies, oversight and regulations.
During this webinar, Dr Jean Dominique Pierret, Customer Consultant Pharmacovigilance at Elsevier, will discuss how, through query design, prioritization technology and outsourcing we can significantly improve efficiency and compliance of literature screening.
We will explore:
1.The optimization of queries in literature databases
2.The benefits if literature workflow management
3.Efficiency gains through prioritization
4.How outsourcing can support efficiency gains
Christian Poinsot, Président Groupe Icare, Sabine Bessières Recasens Field Marketing Manager Environnemental Monitoring LifeRecorded: Dec 3 201976 mins
Il s’agit d’un webinar visant la stratégie de maîtrise de la qualité des dispositifs médicaux stériles avec un renforcement de leur réglementation et l’intérêt croissant de la surveillance environnementale de leurs zones à risque de fabrication donc à atmosphère maitrisée
Rappel des bases de la surveillance de la biocontamination environnementale -Air Surface Personnel - des zones à atmosphère contrôlée des DM et informations sur le nouveau projet de norme européen EN 17141 sur le contrôle de la biocontamination des salles propres en préparation avec une annexe dédiée.
Massimiliano Siciliano, Grunenthal, Kasper Jerlang, LEO Pharma, Alejandra Betancourt, Anthill Agency, Dom Tyer, pharmaphorumRecorded: Nov 28 201962 mins
Pharmaceutical companies spend a huge amount of time and resources on creating valuable brand strategies, but when they come to life there’s often a disconnect.
Strategy and execution can easily drift apart when tactics come to life, making it harder for them to drive business and deliver on the long-term action plans to engage with healthcare professionals.
This is as true for eDetailing or closed-loop marketing initiatives as it is for multichannel marketing strategies that encompass the latest chatbot technology or innovative digital content platforms.
To remedy this, those working in pharma on multichannel marketing, brand planning and digital need to apply the human factor to their global brand strategies to achieve the kind of tactics that deliver on strategic goals.
Join Anthill on Thursday 28th November from 13:00 GMT / 14:00 CET for a live expert panel discussion on multichannel marketing, brand planning and how to apply global brand strategies in pharma to every customer interaction for greater HCP reach and return-on-investment.
In addition to looking at brand planning across pharma, common frustrations for the industry and whether or not brand planning is set up to deliver good multichannel marketing, the webinar will also cover:
• The most common challenges in the brand planning process
• How to build executional and strategic understanding across an entire brand plan
• How to activate your existing channels and create the best channel mix for customers
• How insight-based multichannel marketing can drive strategy and build new insights for the future
The pharmaceutical industry has been making great progress in its digital transformation, but boundaries are there to be pushed if companies want to continue to innovate their marketing practices and processes.
Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia Recorded: Nov 26 201960 mins
The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates. This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.
Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia
Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
In this webinar, Dr. Konnick will discuss the biology, background and
rationale for targeting TRK fusions. You will learn about the clinical
evidence for TRK inhibitors and issues implementing pan-tumor assays,
specifically pan-TRK assays.
Ann Connolly, Director of ProductRecorded: Nov 20 201942 mins
Thanks to some sharp questions from vigilant customers, the Digital Commons Product team recently completed a stringent review of IR content discoverability on the two most popular search engines, Google and Google Scholar. The results, and what we learned along the way, create a great opportunity to share more about open web discoverability and what you can do to maximize the reach of your IR’s content. On November 20, join Digital Commons Director of Product Ann Connolly for “The art & science of your IR’s discoverability: an update on Google & Google Scholar,” a tour of discoverability and current best practices. Topics will include:
•Demystifying the difference between discoverability and SEO
•Unexpected findings from recent data analysis on Google and Google Scholar
•Why a hosted platform benefits your institution’s discoverability
•The best use of resources for maximizing downloads of IR content
Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall BiotechRecorded: Nov 20 201964 mins
Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd
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
Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech
Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, GermanyRecorded: Nov 19 201961 mins
Interest in chromatography using hydrophilic interaction liquid chromatography (HILIC) has continued to build in recent years. Although HILIC chromatography is known to provide valuable retention and selectivity of polar compounds and provide highly compatible conditions for coupling with mass spectrometry, it is sometimes avoided due to issues surrounding robustness and repeatability. In this webinar stationary and mobile phase selection will be discussed in detail together with the impact of sample solvent and equilibration procedures on retention times. Based on this HILIC method development practices can be improve and better understanding of HILIC is gained.
Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive EngineeringRecorded: Nov 15 201967 mins
Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective
Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen
Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).
Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
Dr Lan-Lan Smith, Editor-in-Chief of The Lancet HaematologyRecorded: Nov 14 201972 mins
Gender equity is not only a matter of justice and rights, it is crucial for producing the best research and providing the best care to patients. If the fields of science, medicine, and global health are to improve human lives, they must be representative of the societies they serve. The fight for gender equity is everyone’s responsibility: men and women, researchers, clinicians, funders, institutional leaders, and, yes, even medical journals.
Join Dr Lan-Lan Smith, Editor-in-Chief of The Lancet Haematology, to learn about:
• Why is gender equity important in research
• What do statistics say about diversity and inclusion in publishing
• What initiatives have been started at The Lancet to bridge the gap
Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieuxRecorded: Nov 11 201977 mins
Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene
The views and opinions expressed during the Webinar are those of the presenter.
Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.
Followed by an Industry Perspective presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control. She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.
Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGSRecorded: Nov 11 201967 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.
Rebecca Harris, Adobe; Steve Walker, AdobeRecorded: Nov 6 201931 mins
Universities across the globe are facing new challenges, the digital world is transforming the way we interact with students, staff and suppliers. Adobe Sign is helping Universities to adopt new ways of working that eliminates the need for manual form filling and wet signatures across both back office & front office processes.
Join our webinar to find out how integrating with existing technology investments such as Adobe Acrobat & Microsoft solutions can help you to reduce your IT costs by 30%, increase staff efficiencies and deliver fantastic digital experiences for staff and students. You’ll learn:
• The immediate value of implementing electronic signatures with Adobe Sign
• How to save staff time by creating powerful workflows for regularly used processes
• Create an all-digital onboarding process for suppliers, students and staff. Get contracts signed up to 21x faster
• Utilise your existing investments in Adobe Acrobat and Microsoft to drive value and adoption
• Deliver a great digital experience for all staff and students
• Automate workflows. Reduce mistakes, improve compliance, deliver the right documents to the right people
Nextleaf Solutions & PatSnapJan 15 20204:00 pmUTC60 mins
We take a look at how changes in legislation, such as in Canada, opens up huge potential in both market opportunities and the emergence of disruptive technology. We will join experts in this space, Nextleaf, which pioneers the development and delivery of market-validated, patented cannabis processing solutions
Nextleaf pioneers the development and delivery of market-validated, patented cannabis processing solutions. We maximize the return on every harvest, through innovative processes and value-added products.
Maura Kibbey Director, Science & Standards at USP and Martin Wisher, Global Head of Regulatory Affairs at MerckJan 16 20203:00 pmUTC90 mins
The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.
Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia
Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards. Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
Adverse drug reactions (ADRs) are a serious problem worldwide. One reason for the increase in ADRs is the growth in prescription use—especially among aging populations where drug–drug interactions (DDIs) are more likely. Currently, 9 percent of Americans over age 55 take 10 or more prescription drugs, which greatly increases the likelihood of DDIs and ADRs.
Identifying potential drug-drug interaction risk is a key priority for pharmaceutical manufacturers and regulatory authorities. To minimize health risks to clinical trial subjects and patients, assessments should be performed as early as possible in development.
Join solution marketing manager Dr Marnix Wieffer for this webinar where he will discuss outstanding issues with predicting Drug-drug interaction risk and possible solutions. We run through a couple of live examples that show how PharmaPendium is supporting Drug-drug interaction risk prediction.
Using PharmaPendium we will investigate
•What enzymes and transporters act on my drug of interest?
•What is the DDI risk for drugs that are substrates CYP2D6?
•What is the DDI risk of my drug under development with Antiarrhythmic drugs?
Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher ScientificJan 30 20203:00 pmUTC90 mins
Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?
Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
Jason Creasey, Analytical Chemist at GSKFeb 3 20203:00 pmUTC90 mins
Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?
The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.
Dr Joe X Zhou CEO Walvax Bio Group & Sarah Wang Head of Segment Marketing Biosimilars and Bioconjugations at Sarotrius ChinaFeb 10 20208:00 amUTC90 mins
Presented by Dr Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group
Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
1. Landscape changes of mAb therapeutics
2. New targets and process/manufacturing innovation
3. Key consideration of mAb industry in China
4. Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
Followed by Biosimilar development—how to deal with the similarity challenge
Presented by Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech
Globally we have more than 1000 biosimilars in the pipeline till the beginning of 2019, Sales of mAb biosimilars is also taking up as popular targets being approved both in Europe and US. With the 3rd wave of the biosimilar coming the challenges is still ahead---how to keep the similarity from the beginning of the development to the manufacturing stage and cover the whole lifecycle? With the evolving cell line development platform, good analytical strategy and QbD implementation better similarity will be achieved step by step.
Eric Munson, Professor and Head at Purdue UniversityFeb 11 20203:00 pmUTC90 mins
Full Title: High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products
The local interactions between a drug and its surrounding environment is critical in both small and large molecule formulations. For small molecules, the drug-polymer interaction is needed to ensure that the drug does not crystallize in an amorphous solid dispersion. For proteins, phase separation in lyophilized formulations will lead to reduced stability and the potential for aggregation. In this presentation, the ability to probe these local structures and interactions in both small and large molecule systems will be shown. Case studies will be presented that demonstrate how structural properties (e.g. degrees of interaction, changes in conformation) can impact functional properties such as crystallization and aggregation.
Eric Munson of Purdue University
Eric Munson, Ph.D., is currently Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become Professor and Head of the department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on three patents and has published more than 100 research, review, and book chapters.
Sachin Bhandari, GM, Head IT CSV at Sun PharmaFeb 18 20209:30 amUTC90 mins
Full Title: MES –Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.
Defining the role of MES in using technology to achieve compliance.
Addressing challenges in implementation of MES in current scenario with focus on Indian companies.
Technology taking the compliance and quality framework to the next level.
Organizational strategies to leverage the Power of technology by implementing MES.
Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at SanofiFeb 19 20203:00 pmUTC90 mins
Full Title: Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development
Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi
Process optimization through the use of modeling is a key objective to accelerate and de-risk process development. A critical step to improve our process development, process monitoring and process control is to understand the strength and limitations of each types of modeling approaches. Using the most relevant empirical approaches - from DoE to Multivariate Analysis - and the mechanistic understanding we have about our processes – Kinetics, thermodynamics – we are rethinking the way we conduct process development.
Dr. Umesh Nandal, Principal NLP Scientist, ElsevierFeb 19 20203:00 pmUTC60 mins
By combining content with cutting-edge technology in Artificial intelligence (AI), Machine learning (ML) and Natural language processing (NLP), we enable professionals to find the precise information they need to advance their research and make decisions that affect the lives of patients and whole societies. In pharmacovigilance, post-market surveillance is critical to the protection of public health and monitoring the diverse sources of information for cases of Adverse Drug Reactions (ADRs) is a critically important and time-consuming task. Automatic extraction of ADRs from both highly regularized and variably structured content could play an important role in augmenting the information about ADRs that is obtained during short-term clinical trials.
In this webinar, Dr. Umesh Nandal, the Principal NLP Scientist at Elsevier will talk about
- the challenges of literature mining using AI
- the Biomedical Named Entity Recognition (BNER) and its advantages for information extraction tasks
- how to create a quality training set for machine learning
- the experiment outcome and further applications
Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen PharmaceuticalsMar 2 20203:00 pmUTC90 mins
Full Title: The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry
Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals
The presentation shares the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization’s performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time. Improving these metrics require a comprehensive technology strategy that addresses all the metrics together. Janssen’ s strategy has three pillars. 1: process intensification, 2: modular and flexible designs, and 3: process digitalization and advanced process control. Each pillar contributes differently to the key metrics but in aggregate make it possible to reach our goals.
APC is a critical component of the technology strategy. It is an enabler for process intensification and modular and flexible designs. As a stand-alone tool APC can bring significant reductions in deviations and impact right first-time performance. Additionally, it is possible to improve cost and cycle time modestly in exciting processes. We will highlight areas where APC is being used in open loop control. In these applications there is much value to a manufacturing organization in enabling smoother operations and helping operators making sense of complex data.
Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVIMar 3 20202:00 pmUTC90 mins
Presented by Anders Sparén, Associate Principal Scientist at AstraZeneca
The use of process analytical technology (PAT) in the pharmaceutical industry has significantly increased as an effect of regulatory guidelines and the transition towards continuous manufacturing of oral solid dosage forms. In the direct compression process, the most common way to assess homogeneity of powder blends is after the final mixing operation, followed by end-point testing of tablets. However, focusing on the homogeneity of powder blends does not consider the potential of segregation during material storage and powder transport and also faces severe sampling issues.
In this study, NIR spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested, in order to improve the quality of the NIR measurements. These were made in laboratory settings that simulated in-line measurements in a vertical tube between the two blenders and in the feed frame of the tablet press. A model formulation consisting of powder mixtures of a drug substance, mannitol, microcrystalline cellulose (MCC), croscarmellose sodium (NaCMC) and sodium stearyl fumarate (NaSF) was used for the experiments. A design of experiments, where the API was varied at five levels while MCC, NaCMC and NaSF were varied at two levels, was used for the calibration powder blends.
Orthogonal partial least squares (OPLS) calibration models for the NIR measurements in the two positions were developed and validated with independent test sets. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.
Followed by an Industry Perspective Presented by Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Solutions
John-David McElderry, Scientist at BiogenMar 4 20203:00 pmUTC90 mins
Presented by John-David McElderry, Scientist at Biogen
John-David McElderry graduated from University of Michigan with his PhD in 2012 and has been an analytical scientist and PAT expert in the Pharma/Biotech industry for seven years. He started his career at Vertex Pharmaceuticals creating PAT applications for the first continuous DP manufacturing rig and helped develop the first real-time release strategy in the industry. He is currently at Biogen where he has developed PAT-based control strategies for continuous flow chemistry of small-molecule drugs and continuous synthesis of oligonucleotide drugs. He is interested in enabling real-time control of quality attributes in pharmaceutical manufacturing through the application of smart sensors and machine learning.
Santosh Whatkar, Senior Manager, Automation and Digital Technology at PfizerMar 5 20208:00 amUTC90 mins
Full Title: Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Manufacturing
Presented by Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer
At Pfizer Singapore, significance of Data Analytics was realized after a period of 1 and half years when we were able to successfully implement the pilot use cases enabling us with Digital capabilities.
It would be a sharing with the audience about the Pfizer, Singapore journey of Digital Transformation and the various learnings along the way; which enabled several attributes from teamwork, persistence, believing the vision and doing things differently. Data Analytics significance was realized after passing through this journey and we were enlightened with the amazing capabilities existing data can have. Although our problem statements existed for several years, the change in perspective of using Digital technologies and existing data enabled us to find robust solutions.
Below case studies would elaborate more on the enhancing Pfizer’s manufacturing robustness leveraging on Digital Transformation capabilities –
• Model based real time estimation of loss of drying
• Model based predictive ability of failure for automated valves
• Virtual sensors for energy monitoring in manufacturing environment
• Process condition monitoring using Machine Learning
Patrick Wray, Senior Research Investigator at Bristol-Myers SquibbMar 10 202010:00 amUTC90 mins
Full Title: In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from Rapidly Disintegrating Tablets
Presented by Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb
Spectroscopic imaging is a powerful chemically specific and spatially resolved approach which can be used to effectively monitor tablet dissolution. This work employs Raman mapping and Near Infrared (NIR) chemical imaging to examine drug release from model tablet formulations as complementary technologies. Modern pushbroom type NIR imaging systems allow extremely fast acquisition of chemical images. Consequently this allows us to study the chemical and physical changes which occur during drug release from rapidly disintegrating formulations.
A custom designed flow through cell is used to carry out the tablet dissolutions in such a way that the sample is presented to the optics of the chemical imaging system being used. The cell is compatible for use with NIR, Raman and Mid IR spectrometers.
Two types or formulations will be presented: Rapidly disintegrating formulations with varying amounts of super disintegrant and tablets containing a model drug exhibiting fast onset of disproportionation in pH neutral conditions.
The fast NIR imaging system is seen to be capable of monitoring ingress of water into the tablet and the subsequent disintegration of the formulation. Data from the disproportionating formulations has shown the benefit of chemical imaging to improve our understanding of form change in real time.
Robert Gronke, Ph.D., Senior Principal Scientist, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaConMar 10 20202:00 pmUTC90 mins
Full Title: Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up
Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen
Recently, our first full scale GMP batch for an antisense oligonucleotide was manufactured in the newly built synthesis suite at Biogen. A four-step purification process was then carried out in the existing flexible volume manufacturing facility that, up until this point, has been used for manufacturing Biogen’s protein-based parenterals. This was our first test case to demonstrate that Biogen can manufacture ASOs safely, at scale, and achieve high purity and yield. Results are presented on the scalability of the ASO process from bench to GMP scale, highlighting successes and challenges faced with scale-up of the downstream ASO process.
Followed by an industry perspective presented by Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and CompanyMar 13 20202:00 pmUTC90 mins
Full Title: Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization of Biological and Chemical Threats and Accelerated Development of Pharmaceutical Countermeasures for Unanticipated Medical Needs
Presented by Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and Company
Potentially catastrophic chemical and biological threats represent deliberate or unintentional actions placing civilian and military personnel at considerable risk. Rapid response requires novel approaches for detection and characterization of chemical and pathogenic biological impurities and effective deployment of life-saving countermeasures with acceptable benefit/risk ratio. Challenges include the development of robust, portable technologies for rapid and reliable threat identification, processes for development, manufacture, review/approval and deployment of countermeasures, and supply chain integrity.
Jun Huang, Director/Team Leader, Automation&Control at Pfizer and Amos Dor, Pharma General Manager & CTO at Applied MaterialsMar 17 20202:00 pmUTC90 mins
Full Title: IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From Hype to Reality
Presented by Jun Huang, Director/Team Leader, Process Monitoring, Automation & Control at Pfizer
Driven by increased connectivity enabled by Industrial Internet of Things (IIoT) and more sophisticated data gathering and analytics/AI capabilities, manufacturing is ushering in a new era of production, where information technology (IT) and operation technology (OT) are converging to form so-called cyber-physical systems. IIoT and analytics are key complementary driving forces behind digitalization, enabling a securely connected plant and a streamlined flow of data and information between physical production and digital worlds, as well as prescription of data-driven actions pervasively across manufacturing and quality operations. Use case examples will be given to demonstrate how IIoT and analytics are implemented in practice to drive continual improvement in manufacturing visibility, quality and productivity.
Followed by an Industry Perspective Presented by Amos Dor, Pharma General Manager & CTO at Applied Materials Automation Product Group
Bastiaan Leewis of MeiraGTx and Ankita Desai of EppendorfMar 18 20202:00 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.
Ping Wang, Director at Johnson & Johnson and Donald DeCou, E&L Technology Manager at West Pharmaceutical ServicesMar 23 20202:00 pmUTC75 mins
Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production
Presented by Ping Wang, Director at Johnson & Johnson
• Safety assessment of extractables and leachables is often based on assumption that E&L are highly toxic
• Most common extractables from about 40 sets of study data indicates that none of them is part of “cohort of concern” per ICH M7 guideline.
• Safety profiles of common extractables from common single use systems can be used to design a risk-based approach for future materials.
Followed by Current Trends in Extractables and Leachables Testing from Manufacturing Equipment to Single Use Manufacturing Components
Presented by Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services
There are many types of components that a drug formulation may contact during a typical manufacturing process. This can range from large volume mixing vessels to filters, tubing and other smaller components. More recently the use of Single Use Systems (SUS) have been steadily increasing during the manufacture, handling and storage of biologics. Each contact component has the potential to introduce leachable compounds to the drug formulation. The BioPhorum Operations Group (BPOG) has developed standardized extractables testing protocol for SUS. This talk will review some of the central concepts of the BPOG protocol as well as current trends in performing extractable, leachable and simulation studies on manufacturing components and single use systems.
Dan Hill, Manufacturing Scientist at BiogenApr 2 20202:00 pmUTC90 mins
Full Title:Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes
Presented by Dan Hill, Manufacturing Scientist at Biogen
The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology’s long-term success and sustainability.
This presentation will describe Biogen’s past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.
Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte LtdApr 7 20206:00 amUTC90 mins
Full Title: New Technologies for Improving and Controlling Product Quality, Expression, Timelines and Yield in Upstream Process Development
Presented by Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd
Increasing product demands at competitive pricing drive the need for accelerated product approval timelines, with reduced manufacturing risks and costs. New technologies which can debottleneck upstream process development or improve manufacturability success in early phase process development, translate into cell culture processes with high yield and desired product quality. An overview of different strategies and recent perspectives in upstream process development will be presented.