The medical research community on BrightTALK brings together medical and research professionals. Find relevant webinars on medical research, laboratory science, continuing medical education and more presented by recognized medical researchers. Join the conversation by participating in live webinars and round table discussions on the latest in medical devices, medical research practices and trends in the healthcare industry.
Aaron Mack, Engineer at Biogen & Dave Kolwyck, Director at Biogen and David Gemmell Senior Process Engineer at MerckRecorded: Oct 17 201983 mins
Presented by Aaron Mack, Engineer at Biogen
This talk will focus on the risk based approach that Biogen used for determining which raw materials to initially include in its upstream raw material viral risk mitigation portfolio. High Temperature Short Time (HTST) at raw material suppliers is an integral part of this risk mitigation approach. The merits of a risk-based approach to upstream viral safety will be explored, highlighting the HTST pasteurization viral mitigation capability suppliers like Merck have introduced and expanded. Treatment parameters have been detailed in publically available peer reviewed literature and confirmed in specific raw material components prior to implementation in commercial manufacturing processes. Additionally, benefits of decoupling materials with high risk of viral contamination will be reviewed.
Followed by Implementation of a Robust Upstream Viral Mitigation Strategy for Cell Culture Feeds
Presented by David Gemmell Senior Process Engineer at Merck (Contact at email@example.com)
High temperature short time (HTST) pasteurization is a highly effective method to achieve virus inactivation. This technology has been typically used as an in-house pretreatment tool for high risk bioreactor feeds. The availability of HTST-pretreated feeds minimizes the need to install complex and costly systems in the bioproduction facility, which have significant capital expenditure costs and can become a process bottleneck. The availability and use of complementary virus mitigation strategies minimizes the risk of introducing adventitious agents into the bioreactor, which can impact manufacturing operations and ultimately affect drug supply to patients.
The webinar details the products and capabilities Merck have developed regarding viral removal utilizing viral filtration or viral inactivation via High Temperature Short Time pasteurization, of high-risk raw material feeds for the biopharmaceutical industries.
Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall BiotechRecorded: Oct 16 201983 mins
FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
Presented by Dr Lily Koo, Consumer Safety Officer at Food and Drug Administration
The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing.
Followed by Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production
Presented by Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech
Adeno-associated virus (AAV) vectors are potent gene therapy vectors, used to deliver therapeutic transgenes to target tissues. Gene therapy clinical trials often require high titer vector preparations to adequately deliver the therapeutic transgene, in great excess of research-level production utilized in many laboratories. To bring the virus into the pre-clinical and clinical phases, Pall Biotech simplified, optimized and scaled-up the current upstream and downstream process of viral vector production to industrial scales using the fully-closed, single-use Xpansion® multiplate seed train bioreactor and the production packed-bed iCELLis® 500 single-use bioreactor. In these processes, it is important to ensure that steps are built into the process to ensure adequate control of adventitious agents.
Jim Richardson, Sr Scientific Liaison at USP and Horst Ruppach, Ph.D. Scientific Director at Charles RiverRecorded: Oct 7 201980 mins
Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia
Dr. Richardson works in the standards pipeline development group within Global Biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics. Dr. Richardson earned his Ph.D. in Biomedical Sciences at the Mount Sinai School of Medicine.
Followed by Viral Safety Aspects of Raw Materials Used in the Production of Biologics Including Cellular Therapy Products
Presented by Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River's Biologics Testing Solutions
After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.
Narasimha Rao Nedunuri, CEO of CLONZ Biotech and Tania Pereira Chilima, Product Manager at UnivercellsRecorded: Oct 2 201963 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.
Followed by a presentation by Tania Pereira Chilima, Product Manager at Univercells
Tania Pereira Chilima is a Product Manager at Univercells, responsible for the NevoLine platform for cost-effective viral production. She completed her Bachelors’ degree in Biochemical engineering with focus on protein manufacture at the University College London. She was then awarded an Engineering doctorate, also at the University College London, looking at building and applying decisional tools to help guide the cell therapy industry in selecting commercialization strategies (process, facility design, reimbursement strategies etc.). Her post-doc was sponsored by the Bill & Melinda Gates Foundation, focused on identifying the optimal manufacturing strategies to deliver low cost vaccines.
Mark Jules, Global VP, Hitachi Vantara | Sameer Sharma, Global GM, IntelRecorded: Sep 27 201959 mins
Video data has long supported safety and security efforts. But thanks to improvements in vision technology, machine learning (ML) and artificial intelligence (AI), and the ability to run analysis at the edge, there are innovative new uses for video data that improve safety, operations and customer experience.
Join us in this live webinar where we’ll discuss:
•The evolution of video technology and how it drives insights that improve the way we do business.
•How video data and vision technology are used across various industries to drive ROI.
•The technologies that drive these innovations and outcomes.
About our speakers
Mark Jules: Global Vice President, Smart Spaces and Lumada Video Insights, Hitachi Vantara
Mark Jules leads Hitachi Vantara’s Smart Spaces business which provides solutions incorporating video technologies, internet of things (IoT) sensors and analytics to help organizations create smarter spaces that operate more efficiently. Mark served as CEO of Avrio RMS Group for more than a decade and was also the President and Founder of Protean Solutions, a provider of mobile platforms for battlefield and emergency communications.
Sameer Sharma: Global GM (New Markets/Smart Cities), Intel
Sameer Sharma is the Global GM (New Markets/Smart Cities) for IoT Solutions at Intel and a thought-leader in the IoT/mobile ecosystem, having driven multiple strategic initiatives over the past 19 years. He leads a global team that incubates and scales new growth categories and business models in IoT and Smart Cities. These solutions include intelligent transportation, AI and video, air quality monitoring and smart lighting in cities.
Sameer has an MBA from The Wharton School at UPenn, and a Master’s in Computer Engineering from Rutgers University. He holds 11 patents in the areas of IoT and Mobile.
The prognosis of patients with glioblastoma (GBM) remains dismal with a median survival of approximately 15 months. Current preclinical GBM models are limited by the lack of a “normal” human microenvironment and the inability of many tumor cell lines to accurately reproduce GBM biology. To address these limitations, our guest presenter and her team have established a unique model system whereby they can retro-engineer patient-specific GBMs using patient-derived glioma stem cells (GSCs) and human embryonic stem cell (hESC)-derived cerebral organoids. Their cerebral organoid glioma (GLICO) model shows that GSCs home toward the human cerebral organoid, and deeply invade and proliferate within the host tissue forming tumors that closely phenocopy patient GBMs. Furthermore, cerebral organoid tumors form rapidly and are supported by an interconnected network of tumor microtubes that aids in the invasion of normal host tissue. This GLICO model provides a new system for modeling primary human GBM ex vivo and for high throughput drug screening.
Guest Presenter Bio:
Dr. Amanda Linkous previously served as the Director of the Starr Foundation Cerebral Organoid Translational Core at Weill Cornell Medicine (New York, NY). She completed her postdoctoral training in the Neuro-Oncology Branch at the National Cancer Institute (Bethesda, MD). Dr. Linkous is currently the Scientific Center Manager for the NCI's Center for Systems Biology of Small Cell Lung Cancer (SCLC) at Vanderbilt University, where she is developing similar 3D model systems to study the biology and refractory nature of SCLC (Nashville, TN)
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.
Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher ScientificRecorded: Sep 24 201976 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.
Elizabeth Palavecino, M.D.Recorded: Sep 23 201965 mins
Antimicrobial resistance is rising, prompting clinical laboratories to find effective solutions for fast, accurate microorganism identification. MALDI-TOF mass spectrometry has emerged as a rapid, cost-efficient and clinically effective tool for identifying pathogens.(1,2)
In this webinar, Dr. Elizabeth Palavecino shares her laboratory’s clinical experience with MALDI-TOF mass spectrometry. This discussion explores the clinical effectiveness of this technology in patient management as well as the challenges of antimicrobial susceptibility reporting.
P.A.C.E. credit is available for your participation.*
(1)Tan, KE et. al. “Prospective Evaluation of a Matrix-assisted Laser Desorption Ionization—Time of Flight Mass Spectrometry System in a Hospital Clinical Microbiology Laboratory for Identification of Bacteria and Yeasts: A Bench-by-bench Study for Assessing the Impact on Time to Identification and Cost-effectiveness. “J Clin Microbiol, 2012;50(10):3301–8.
(2)Cherkaoui, A et. al. "Comparison of Two Matrix-Assisted Laser Desorption Ionization—Time of Flight Mass Spectrometry Methods with Conventional Phenotypic Identification for Routine Identification of Bacteria to the Species Level.” J Clin Microbiol, 2010;48:1169–75.
Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZenecaRecorded: Sep 19 201944 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.
Jincai Li, Vice President of WuXi Biologics Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher ScientificRecorded: Sep 18 201979 mins
Presented by Dr. Jincai Li, Vice President of WuXi Biologics
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 continuous bioprocessing concept and share WuXi’s efforts on this area.
Followed by a presentation by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC and Heidi Hagen, Co-founder and CSO for Vineti IncRecorded: Sep 17 201976 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.
Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro BiosystemsRecorded: Sep 12 201977 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.
Per Sikora, Co-Chair, Technology and Infrastructure, Genomics Medicine SwedenRecorded: Sep 11 201933 mins
GMS is a national genomics project that strives to redefine how cancer and rare disease diagnostics is performed within Swedish healthcare, by moving towards precision medicine. A core component of our mission is to organise, structure and share genomics data on a national level, which, in turn, will enable faster and more efficient diagnostics and harmonisation of healthcare in Sweden.
Dr. Lara Dick,Dr. Lukasz Porwol and Virginia Ballance. Moderated by Rachel BrennesholtzRecorded: Sep 10 201947 mins
For a researcher, building knowledge is a complex and time-consuming process: finding and evaluating the relevance of information is only the first step; then comes the need to properly collect, organize, retrieve and use literature and data to create a true knowledgebase.
Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGSRecorded: Sep 10 201989 mins
Full Title: Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol
Presented by Ken Wong, Deputy Director at Sanofi Pasteur
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.
Followed by Case Study and Experience in Extractables and Leachable Studies of Plastic Process Materials – a CRO perspective
Presented by Dujuan Lu, Manager/Global Lead Extractables & Leachables at SGS Life Sciences
Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products.
The USP risk assessment model will be briefly reviewed. Challenges regarding design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.
Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at RocheRecorded: Sep 4 201943 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.
Smita Sealey and Barry Farimond, ZS Associates, Malcolm Qualie, NHS England, Alain Boulanger, Filippo DragoRecorded: Sep 2 201964 mins
With pricing of drugs at the centre of political and social debate, the market access and pricing environment in Europe has become increasingly challenging over the years. Innovative contracting has since become a common route to overcome these challenges and ensure timely access for patients.
Join us on Monday 2nd September from 15:00-16:00 BST as we discuss the future of innovative contracting with our panel of European payers. Key topics to be covered include:
To what extent and how contracting helps improve patient access?
What prior successes and failures can teach us about designing contracts that deliver true value to the health systems?
Can we avoid contracting and what would be the alternative?
In the past decade, we have moved from simple discounting and traditional volume-based agreements to more complex value-based models involving measurement of health outcomes, risk-sharing and cost containment guarantees. The feasibility of these contracts tends to vary by EU market, dependent mainly on the available healthcare system infrastructure to collect and process data as well as other regulatory and philosophical differences.
Ultimately, the question remains as to whether these agreements are a move towards better healthcare provision and more connected healthcare infrastructures, or are they slowing down access and creating administrative burden due to their complexity?
Moritz von Stosch of GlaxoSmithKline Vaccines Followed by Klaus Mauch and Shilpa Nargund of Insilico Biotechnology AGRecorded: Sep 2 201984 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.
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.
Various SRS treatment platforms are available, and there has been an increasing number of platform-comparison studies in recent years, but most of these are limited to single-centre studies. The recently published NHS England study, a national commissioning programme benchmarking different planning cases to evaluate current practices across clinical centres treating SRS cases for benign brain tumours and metastases, will be reviewed in detail during the webinar. Bias is common, due to various study flaws, including comparison of non-contemporary equipment, unequal expertise and comparison of plans created in a clinical versus study environment.
However, this NHS study, arguably the "study to end all studies", provides a unique dataset of current practice across a large number of providers and equipment platforms.
Over the past century, life sciences has exploded with innovation and it continues to promise excellent commercial opportunities for those with scientific and academic research in this area. However, research on its own is not enough for these discoveries and inventions to reach their commercial potential. With over thirty years' experience in the biotechnology sector, expert Pete Hotten provides a framework for commercialisation, what to look out for in market research and how evaluating the competition can help determine next best steps.
Dr. Markus Suta, Utrecht UniversityOct 24 20191:00 pmUTC60 mins
Join Reaxys Prize Club member Dr. Markus Suta for fascinating insights into luminescence thermometry. In this webinar, he describes the development and validation of remote lanthanide-based luminescent thermometers with applications in bio-imaging. Discover why a combination of in silico modelling and wet-lab experiments were essential to the success of the project. Dr. Suta also talks about the importance of efficient literature research to his work.
In addition, Dr Marta da Pian will give an overview on tips and tricks for using Reaxys.
This 30 minute webinar will discuss how Elsevier supports researchers by providing tools to effectively showcase their research profile and increase their visibility, a skill that is vital in the research world.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, GermanyOct 30 20197:00 amUTC75 mins
Fatty acids are important analytes for nutritional value, product taste/texture, shelf-life and place of origin studies. They are not only relevant in food, but also in clinical, biochemical, industrial, agriculture testing.
In this talk we will give the background of fatty acid analysis and describe some current techniques and new developments for the GC analysis of fatty acids in a variety of applications. A special focus of the webinar is the separation of cis and trans isomers by either a sample prep approach using SPE or by improved GC approaches.
Marcia Palmer, Allen W. Becker, Anthony Chiefari, Howard Deutsch, Nicolle Hamilton, ZS AssociatesOct 30 20192:00 pmUTC90 mins
Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies).
Payers are in a difficult spot regarding the cost and management of these regimens. Traditional utilization management tools are still difficult to apply in oncology, given no payer wants to be on the front page of a major newspaper for denying treatment. Pathways have not held up to their promise for containing cost.
Personalized medicine approaches such as biomarkers serve an important role in targeting therapy to the most appropriate patients, thereby reigning in cost. However, there are limitations in the breadth and utility of these tools. For example, PD-1/PDL-1 drugs have shown conflicting outcomes associated with receptor expression – and these drugs are the backbone for many combo regimen programs in clinical development.
Environment/perception shifts, new approaches to management, indication-based pricing or other novel pricing approaches, and innovative payment models may hold promise for controlling cost in this new era of combination therapy.
Join ZS Associates for a live expert payer panel discussion on the challenges and potential solutions for managing the cost of combo oncology regimens. Topics will include:
•Perspectives on oncology drug management and combination regimen pricing today
•Potential payer-driven and pharma-driven solutions to price and cost management for oncology combo regimens
•What oncology manufacturers should consider in engaging payers in the future
The live payer webinar, co-moderated by Nicolle Hamilton, ZS Associates and Dominic Tyer, pharmaphorum, will take place on Wednesday, October 30 2019 from 14:00-15:15 GMT/10:00-11:15 ET.
Bernard McGarvey, PhD Chemical EngineeringNov 5 20193:00 pmUTC90 mins
Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.
Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher ScientificNov 6 20196:00 amUTC76 mins
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.
Followed by Pharmaceutical Forensics for Safe Manufacturing and Supply
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.
Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGSNov 11 20192:00 amUTC67 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.
Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieuxNov 11 20193:00 pmUTC90 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 a presentation presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive EngineeringNov 15 20193:00 pmUTC90 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
Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec LtdNov 20 20199:30 amUTC90 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
Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher ScientificNov 21 20193:00 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
Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia Nov 26 20193:00 pmUTC90 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.
Faris Omary and Leah HartmanDec 11 20194:00 pmUTC75 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.
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.
Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States PharmacopeiaJun 23 20202:00 pmUTC90 mins
Full Title:Utility of Generating Data: Drug Manufacture’s Perspective: Will USP permit such format?
Presented by Ken Wong, Deputy Director at Sanofi Pasteur
This talk will focus on an overall application of USP starting from risk assessment to qualification of disposable manufacturing systems based on USP data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.
Followed by a presentation by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA
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.
Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte LtdFeb 18 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.
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.
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
Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, BiogenMar 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.
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.