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.
The increasing number of diagnoses of brain metastases in asymptomatic patients – as a result of screening MRIs – has created the need for both durable control and prevention of cognitive decline in patients who are expected to have increasing median survivals. Since the mainstay of their therapy is systemic management, “Radiosurgery Now” represents the idea of immediate radiosurgery with the intent of avoiding interruption of systemic management.
This webinar will discuss the impact of delay in radiosurgery on tumour growth and the benefits of repeat radiosurgery for the long-term preservation of cognitive function. The linear and robust rapid workflow of the Leksell Gamma Knife® Icon™ is ideally suited to this concept.
Vasilis Tsaousis, PhD., Medicon HellasRecorded: Apr 11 201947 mins
Latex enhanced immunoassay reagents can be adapted to automated biochemistry bio-analyzers ,equipment available in every modern biochemistry laboratory. Combining existing knowledge in the areas of antibody development and bead conjugation these reagents are suitable for the determination of proteins in patient samples. Their use can override the need for specific and expensive equipment necessary to perform these tests in the past. This talk will focus on the methods we could follow in the design of these reagents, the optimization of crucial factors in the development phase and the validation procedures to reach the expected analytical performance.
Erik Engwall and Erik KorevaarRecorded: Apr 11 201960 mins
The quality of a radiation treatment plan strongly depends on the ability to deal with uncertainties originating from setup and density interpretation errors, as well as from changes in patient anatomy. The creation of robust treatment plans and the evaluation of robustness prior to delivery is therefore one of the main challenges in radiation therapy. During the first part of this webinar, Erik Engwall, chief physicist at RaySearch, presents some versatile tools to address this challenge:
- Robust optimization with the inclusion of 4DCT images, and setup and density uncertainties;
- Robustness evaluation over multiple error scenarios.
In the second part, Erik Korevaar, a medical physicist at UMCG, will present how robust optimization is used in a clinical setting and discuss appropriate metrics for robustness evaluation based on previous clinical experience.
Did you know that the incidence of liver cancer has tripled since 1980? Have you wondered what current antibodies are being used to label liver carcinomas by IHC? Or are you curious what antibody grids are used in the differential diagnosis of primary liver carcinoma? In this presentation we will discuss the markers used in detecting liver carcinoma as well as other antibody grids that can be ran to aid in the identification of primary liver carcinoma.
Presented by Friedrich von Wintzingerode Global QC at Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA,Recorded: Apr 9 201962 mins
Full Title: New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process
Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans.
Monocyte Activation Test: a powerful tool to assess pyrogenic risk in pharmaceutical process
Microbial risk in pharmaceutical process is not limited to viable microorganisms. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. According to the European Pharmacopeia, chapter 5.1.10, a risk assessment has to be performed to justify the method to be used for pyrogen detection: bacterial endotoxin testing is not sufficient if the presence of non-endotoxin pyrogens in the production process cannot be excluded.The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay provides sensitive results based on the human immune reaction and can be a powerful
We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.
Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim BiotechRecorded: Mar 27 201958 mins
Full Title: From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?
The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase requires large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.
Janssen Vaccines has transitioned over the last 3 years from early stage process development to full late stage development programs. In this presentation, we present the implications of such a transition, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production at Janssen Vaccines.
Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West PharmaRecorded: Mar 25 201977 mins
Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
The terminologies of “Extractable” and “Leachable” have been used interchangeably to describe test data from a study which fall in between a grey zone of typical “Extractable” or “Simulation” and “Leachable” study. During this webinar, we will explore to better understand what are the key challenges with case study and survey this grey area to capture the view of all participants.”
Presented by Ken Wong, Deputy Director at Sanofi Pasteur
Followed by Building a Bridge to Leachable Assessment
Extractable data is a practical guide to support selection of components used in drug product container closure systems and to understand potential for leachables. Standardization of extractables testing is a topic of interest in the pharmaceutical industry and debate in the scientific community, however; the challenge for standardized tests is to verify the extent of data and type of extractions needed to drive the best decisions. As a starting point, comparative extractable data can indicate differences, but this may not be relevant to end use application. According to USP informational chapter on extractables assessment, the design of an extraction study is dictated by the purpose of the extractables assessment. This presentation will put into practice the overarching principles of USP for developing extractable study designs. Three case studies will be given representing risk of leachables across product lifecycle. Data will be shown related to the selection process, post approval changes, and considerations for biologic product quality.
Presented by Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
Helen Parfitt, Head of Therapy Watch, Research Partnership, Mariel Metcalfe and Mark Hollis, Research PartnershipRecorded: Mar 21 201952 mins
Rheumatoid arthritis (RA) has been a major growth driver for the pharmaceutical industry over the last 15 years, led by AbbVie’s blockbuster anti-TNF inhibitor treatment Humira (adalimumab).
The emergence of low-cost biosimilar versions of Humira and the new janus kinase (JAK) inhibitors, are shaking up a once-stable market.
Although there are only two drugs in this class available in the region – Eli Lilly’s Olumiant (baricitinib) and Pfizer’s Xeljanz (tofacitinib) – this is not likely to be the case for much longer, as several other candidates reach late-stage development.
Analysis of Therapy Watch data, a real-time' syndicated market tracking tool from Research Partnership, shows that JAK inhibitors have already made a strong impression in the European RA market, where their convenient oral administration advantage may override cost considerations that would otherwise favour biosimilar uptake.
This pharmaphorum webinar, held in conjunction with Research Partnership, will use the latest intelligence from both physicians and patients to look at emerging trends in the RA market, how these will shape the RA market of tomorrow and how companies can best position themselves for future success.
This webinar will provide an opportunity to interact with the panel about how companies can best harness the potential of this increasingly complex, but highly rewarding, market.
Topics to be covered include:
The European RA market
Current status and market situation of JAK inhibitors (key EU5 countries)
Uptake curve of JAKs compared to other new entrants and biosimilars
Profile of physicians prescribing JAKS
The future of new classes of JAK inhibitors
Tami Freeman, Anna Demming and Susan CurtisRecorded: Mar 21 201927 mins
Thank you for your interest in becoming a student contributor for Physics World. This webinar will provide you with an overview of Physics World and IOP Publishing, plus we will also explain how you will be able to contribute your own content to the site.
Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SARecorded: Mar 19 201935 mins
TRANSFORMATIONAL SCIENCE: MOVING FROM CHALLENGES OF HIGH CONCENTRATION PROTEIN FORMULATIONS DEVELOPMENT TO MEET THE NEEDS OF HIGH POTENT BISPECIFICS
Monoclonal antibodies (mAbs) have significantly contributed in the treatment of oncological and immunological disorders over last two decades. Next advancement in this line is the introduction of bispecific antibodies – molecules which can bind to two different receptors at the same time. Engaging T-cells to target tumor cells and eventually killing tumor cells have been clinically demonstrated by such bispecific antibody. Traditionally one of the key challenge for developing mAbs is to administer high quantities of mAbs, on the other hand bispecific antibodies are extremely specific and more efficient, which makes them highly potent – leading to a reduced dose. This turns the focus from developing high concentration formulations for mAbs to the development of low concentration formulations. Scientific challenges are of very different nature with surface adsorption being the key challenge; during drug product manufacturing as well as during clinical dosing a protein molecules encounters various different surfaces and preventing/controlling adsorption on any of these surfaces is important. Analytical methods are also required to be adapted for reliable low concentration measurement for the drug product as well as the diluted preparation for infusion in clinic.
Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USARecorded: Mar 18 201940 mins
Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs. LC-MS/MS complements next-generation sequencing (NGS) of product cDNA and amino acid analysis (AAA) of cell culture medium during clone selection and process optimization in providing sensitive, comprehensive screening to strategically prevent/minimize SVs and ensure high product quality.
The occurrence of genetic SVs was evaluated using Sanger sequencing and LC/MS. In this work, mAbs with known high and low-level genetic SVs were studied at various cell culture conditions including scale, process and cell age. While scale and process had no significant impact on genetic SV levels, low-level SVs were found to decrease with cell age whereas high level SVs remained constant.
Multiple cell culture process options and the final process conditions are analyzed via LC-MS/MS prior to lock-down of the manufacturing process. Additionally, the cell culture medium (days in culture) for all small scale, pilot and clinical batches are analyzed by AAA to ascertain amino acid nutrient levels, which provides indirect monitoring of possible misincorporation situations. For mAbs with confirmed misincorporations, AAA and LC-MS/MS-peptide mapping results primarily correlated with amino acid nutrient depletion.
Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher ScientiRecorded: Mar 14 201961 mins
Single Use technologies are more and more used close to final product leading to increase concern related to integrity. In this article we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in process no sterile filtration is possible.
Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration. Finally, we will also present data analyzing the effect of such a strategy on lowering defect occurrence .
Keith Davis, Principle Scientist at PfizerRecorded: Mar 12 201921 mins
Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch CenterRecorded: Mar 11 201939 mins
Title: Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors
A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer (kLa) studies, computational simulation and scale-down model experiments were used within this newly developed work-flow. Utilizing this approach, scale-up was successfully accelerated (
Introducing the Mendeley Data datasets API on SSRN! Learn more about early stage research and the integration of Mendeley Data datasets on SSRN encourages authors to upload the research data associated with their papers, allowing for greater transparency and reproducibility. SSRN authors get the credit for their research outputs, attract more citations, compliance with funder mandates data sharing, and more. SSRN readers easily access the data, can evaluate and follow the data connections, and use the data to create individual research.
John Jolliffe (Strategic Engagement, Adobe Document Cloud) & Viky Manaila (CEO, Trans Sped)Recorded: Mar 7 201937 mins
Pharmaceutical and Life Sciences companies are subject to unique legal and regulatory requirements that fundamentally impact the way they create and manage content and data. What role can digital signatures play in helping companies manage risk and comply with regulations for the management of clinical trials, securing patient informed consent, and the control of good manufacturing practices?
Join our live webinar to learn how:
• Life Sciences companies can achieve digital transformation in this highly regulated sector
• To comply with ICH E6(R2) guidelines on data integrity to avoid rejection of clinical trial data.
• To secure legally valid Informed Consent and comply with the new EU Regulations on clinical trials data.
• To work alongside signature solutions in non-regulated areas of life sciences companies.
• To achieve compliance with SAFE-BioPharma standards.
Divyaa Ravishankar, Industry Principal,Frost & Sullivan, Kyle Fetter, Executive Vice President, XIFINRecorded: Mar 5 201964 mins
What are the winning strategies for a laboratory to be successful? This webinar will focus on the state of the clinical laboratories market in the US, Canada, and Europe. Given the reimbursement cuts, it is essential to understand how this can impact the revenue-generating abilities of clinical laboratories and what strategies they can take now to keep the business profitable.
Frost & Sullivan invites you to join Divyaa Ravishankar, Industry Principal, Frost & Sullivan and Kyle Fetter, Executive Vice President & General Manager of Diagnostic Services, XIFIN, for the webinar: Future of Clinical Laboratories—Winning Strategies & Emerging Growth Opportunities. The event will provide an overview of the current state of clinical laboratories and recommendations for future success followed by an interactive, live question-and-answer session.
• Understand what is driving business for clinical laboratories and what will change in the future
• Learn how are clinical laboratories adjusting to the declining reimbursement situation
• Gain insight on ways a data-driven approach can help laboratories increase efficiency
• Better understand how blockchain applies in the world of clinical laboratory services testing
Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigmaRecorded: Mar 5 201976 mins
BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities
Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
Prof Dr EMD (Ed) Schuuring & Prof Dr HJM (Harry) GroenRecorded: Feb 28 201956 mins
Join Dr. Ed Schuuring and Dr. Harry Groen, University Medical Center Groningen, The Netherlands, to explore the role of immunohistochemistry (IHC) in the assessment of ALK rearrangements in non-small cell lung cancer (NSCLC), with a focus on the binary algorithm and comparison with fluorescence in situ hybridization (FISH). Clinical implications for ALK IHC vs. FISH and treatment options for ALK inhibitors will be discussed including side effects and overall as well as intracranial efficacy.
Come one, come all to the troubleshooting gallery as we learn sure-fire techniques to troubleshoot IHC stains. Inappropriate stains impact patient care, slow your lab down, and waste reagents, all of which cost your lab money, time, and peace of mind. This workshop will cover common histology and immunohistochemistry protocols, paying close attention to how each step influences stain quality. We’ll take aim at the root cause for most stain issues and set our sights on the red flags to look for when troubleshooting. We’ve got you covered from specimen collection to cover slipping. Too Light, Too Dark, Background, No Stain and the rest of the outlaws won’t stand a chance. You’ll mosey out of this workshop with a thorough understanding of how histology and immunohistochemistry work to produce a quality stain and the tools you will need to efficiently troubleshoot the most common stain issues. Giddy up and count yourself among the ranks of ‘Sharp Troubleshooter’ for your lab.
Dr Diana Stanley, Deputy Editor of The Lancet Respiratory MedicineRecorded: Feb 26 201944 mins
Join Dr Diana Stanley, Deputy Editor of The Lancet Respiratory Medicine, to learn about:
• The Lancet family of journals’ peer review process
• What Lancet editors are looking for in a submission
• Strategies for preparing your manuscript for submission to a premium publication
Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEARecorded: Feb 26 201981 mins
Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product life cycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.
If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.
Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.
This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
Denise Biderman (Mary's List), Lisa Snyder (Tokeativity), Adelia Carrillo (Direct Cannabis Network)Apr 24 20193:00 pmUTC55 mins
Wondering how to get into the cannabis industry? Join Mary's List along with Adelia Carrillo and Lisa Snyder as they discuss start-up life, career transitions and being entrepreneurs.
Adelia Carrillo - Founder & CEO of Direct Cannabis Network. DCN is the leading digital B2B news network covering the latest tech, entrepreneurs and innovative companies in the cannabis industry. With her roots in the corporate and consumer electronics industry, her passion for technology, startups and innovation has been a key strength in her transition into the cannabis space. Becoming a voice for the upcoming startups, uniting the cannabis business community, Adelia is building an inspiring yet prominent voice in the world on the topic of cannabis entrepreneurship.
Lisa Snyder - Founder & CEO of Tokeativity, The Global Cannabis Community for Women. Lisa is a cannabis and women’s rights activist, a web developer and online strategist. She has designed and launched over three hundred websites and digital campaigns, including ecommerce & membership platforms, and has extensive background in Google SEO leading back to 2004. Her work has been recognized in Forbes, Rolling Stone, The Guardian, MJ Lifestyle, Travel Portland, CannabisTours.com, Dope Magazine, Civilized, Willamette Week and Time Out New York among others.
Denise Biderman (Mary's List), Mary Pryor (Cannaclusive), Cynthia Salarizadeh (AxisWire)Apr 24 20194:00 pmUTC55 mins
Wondering how to get into the cannabis industry? Join Mary's List along with Mary Pryor and Cynthia Salarizadeh as they discuss the world of cannabis marketing, their own career transitions, and the future of cannabis advertising and media.
Mary Pryor is the Co-Founder and CEO of Cannaclusive. She is a passionate and vocal media expert currently based in Los Angeles and New York. Raised in Detroit, Michigan, Mary received exposure to automotive design, electrical engineering, music, digital arts and marketing at an early age. Today, Mary is a powerful and accomplished Digital and Marketing Specialist who has worked for major brands such as Sony Music Group, Viacom, Attention PR, City Parks Foundation, Mirrorball, Uptown Magazine, Black Enterprise, CBS News, Ebony Magazine, The Rolling Stones, VaynerMedia, Mindshare, McGarryBowen, McCann, SheKnows, and MusicWorld.
Cynthia Salarizadeh is the Founder of AxisWire, as well as the Founder of House of Saka, which houses the world’s first cannabis infused still and sparkling rosé out of Napa Valley. In addition, Cynthia is the Co-founder of Green Market Media, most recognized for its cannabis finance news publication, Green Market Report, as well as Co-founder of Industry Power Women. As an entrepreneur, Cynthia has either founded or co-founded multiple companies that have successfully exited through acquisition within the cannabis industry. In 2018, Cynthia was nominated as Entrepreneur of the Year and CEO of the Year by Cashinbis; she was named by High Times as one of the 100 Women in High Places, and she was featured by Dope Magazine as one of the “Outstanding Women in Cannabis."
Wondering how to get into the cannabis industry? Join Mary's List along with Solonje Burnett, Sasha Perelman & Ashley Kingsley as they discuss community & the importance of creating events of impact.
Solonje Burnett is a cannavist & Co-Founder of Humble Bloom. As a culture consultant, she creates innovative workplace conferences, designs & implements D&I plans & forges agency partnerships. Her clients include Databricks, Working Mother Media, BetterCloud, & Koya Leadership Partners. Solonje produces events & festivals for conscious companies, hosts nightlife parties & programs music at membership clubs. She has worked with Afropunk, Summit Series, Le Bain at the Standard Hotel, Transgender Legal Defense & Education Fund & Soho House, among others.
Sasha Perelman is the CEO of Revolver Productions. With 17+ years of global brand event curation, her portfolio includes Yves Saint Laurent, Giorgio Armani, 23&Me, & Lenscrafters. Sasha’s event 'Immersion' was featured in Rolling Stone as the “Best Pot Party in California.” In 2017, Revolver worked with the Grammy Award Winning Artist & Activist Common’s Non-Profit, Imagine Justice, for the Hope & Redemption Tour - a 30,000 person concert in Sacramento, & two prison shows raising awareness around mass incarceration. In 2018, Revolver Productions, partnered with MARY Magazine to launched Mary Talks - discussions around cannabis as a wellness & lifestyle tool.
Ashley Kingsley is the Co-Founder of Ellementa. She is a strategic, multidisciplinary marketing executive who partners with CEOs & entrepreneurs - multi-million dollar brands and start-ups alike - to grow companies, brands, & profits. Noted as 'Top 50 People to Watch in Social Media' by Arrea Agency in 2017, she built & launched Daily Deals for Moms that expanded into 27 markets before it sold. She has been featured in the Wall Street Journal, Fox, CNN, CNBC, MSNBC, Mashable for Daily Deals for Mom, HERB, Techcrunch, Women's Day Magazine, Westword, & Fox31.
Professor Antonio Bertoletti, M.D. Program in Emerging Infectious Diseases, Duke-NUS Medical School, SingaporeApr 25 20192:00 amUTC75 mins
Adoptive transfer of lymphocytes expressing engineered T cell receptors (TCRs) is a promising immunotherapeutic option which specifically targets antigens from viral-infected cells and tumors. Prof. Bertoletti and his team engineered a library of TCRs specific for different Hepatitis B Virus (HBV) antigens to generate a pool of HBV-specific TCR-T cells. These TCR-T cells have been shown to recognize HBV epitopes presented on infected hepatocytes and hepatocellular carcinoma (HCC) cells with HBV-DNA integration in both experimental models and selected patients with HBV-related HCC relapses. However, safety concerns on possible irreversible structural and functional liver damage by cytotoxic TCR-T cells have limited the clinical usage of this immunotherapeutic approach. To overcome this limitation, they selected patients with HCC relapses after liver transplantation for immunotherapy since TCR-T cells only target HBV epitopes presented on HCC-relapses. Moreover, they also modified TCR-T cell production methods to reduce cytotoxicity and life span of TCR-T cell. These strategies that lead to the successful production of safe TCR-T cell effectors for immunotherapy of HBV infection and HBV-related cancers will be discussed in this webinar.
John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and James Carriere, Product Line Manager at CoherentApr 26 20192:00 pmUTC75 mins
Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region, provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential. Whether during process development or production, low frequency Raman bands provide greater sensitivity for detecting the onset of crystallization and has allowed differentiation of crystal types when multiple forms are possible. Applying this to Quality by Design (QbD) studies brings an increase in process understanding leading to developing optimal control strategy and avoid the many pitfalls that can occur when scaled-up to the production environment. A recent applications of in-line crystallization processes provided insight into establishing the ideal crystallization control parameters. The parameters evaluated include temperature, mixing rate, seed levels and solvent variable. In-line and off-line QbD studies demonstrated both ideal and non-ideal conditions, ultimately yielding critical process knowledge. As a results of our studies, low frequency Raman has proven to be a valuable tool for at-line and on-line monitoring of active pharmaceutical ingredient crystallization and paves the way for robust production in a large scale facility.
Dr Marc Chaigneau - AFM/Raman Product ManagerApr 29 20192:00 pmUTC60 mins
Two-dimensional semiconductors, specifically the broad class of transition metal dichalcogenides (TMDs), have attracted significant attention in the research community in recent years due to the wealth of interesting and potentially applicable phenomena observed in these materials. In order to control the performance of devices based on TMDs, it is important to characterize their properties at the scale relevant to the corresponding application, which in most cases today corresponds to a few tens of nanometres.
Conventional far-field photoluminescence (PL) and Raman imaging provide highly averaged information with spectral congestion. In contrast, the TEPL and TERS methods (tip-enhanced photoluminescence and tip-enhanced Raman spectroscopy) performed with an AFM–Raman system, not limited by diffraction, provide substantial information related to the nanoscale optical properties of 2D materials with resolution down to a few nanometres.
In this webinar, we report on the application of scanning-probe microscopy (SPM) cross-correlated with TERS and TEPL measurements. The techniques are used to image various TMD (MoS2, WS2, MoSe2, WSe2) alloys and heterostructures, revealing detailed nanoscale features and unexpected heterogeneities. These variations in the nanoscale optical and chemical properties, correlated with the structural information obtained with SPM, can provide a better understanding of 2D TMD materials for the future development of highly efficient, flexible, lightweight optoelectronic devices.
Advances in gene editing technologies have generated a great amount of interest within the scientific community over the past few years. In addition to the ability to make precise double stranded DNA cuts virtually anywhere in the human genome, new variations of these tools show promise in the ability to activate or repress the expression of individual genes. Besides the obvious interest in clinical applications for these tools, there are practical uses of these tools for modifying and improving in vitro cell-based assays in areas such as preclinical ADME/Tox. This webinar will highlight these recent advances in gene editing technology and provide several examples of how this technology has been applied to ADME/Tox assays, including intestinal, hepatic and renal proximal tubule cell lines.
Within this 45m webinar, you will gain insights from Natalie Cain, Senior Scientific Editor from Cell Press, on the publishing topics Ethics and Copyright. Learn about authoring responsibilities, post-publication issues, and strategies for publishing in high-standard and high-impact journals. Dr. Cain will also introduce you to Cell Press Mentor, a new service for scientists. Through the Egyptian Knowledge Bank (EKB,) all Egypt-based researchers and students have access to the Cell Press portfolio of scientific journals. Join us and discover the resources of Cell Press.
Mike Tobyn, Research Fellow at Bristol-Myers SquibbMay 2 20199:00 amUTC75 mins
The Pharmaceutical Industry has a strong need to develop knowledge from data. Although the latter is not at a premium in the Pharmaceutical Industry the former is, as always, at a premium. Multivariate data analysis (MVA) is a set of statistical data analytical methods which has been widely adopted within the Pharmaceutical Industry, and it has pre-eminence within the discipline.
The ability of MVA to provide validatable solutions within a Regulated Pharmaceutical environment has arisen because of its transparency and reproducibility, across a wide field of data sources. An ecosystem of software providers, allied with hardware solutions, means that the techniques are becoming widely understood and applied.
Key to this adoption has been the ability of MVA techniques to meet not only direct Regulatory Guidance, but also Industry Standards such as ICH Q8 and initiatives such as Quality by Design.
A wide body of literature is now available which explains how to use the technique appropriately, so that these Guidances can be met, leading to robust solutions
Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei RoMay 3 20198:00 amUTC75 mins
Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
Dennis Douroumis, of University of Greenwich and Dr.-Ing Margarethe Richter, Pharma Application Specialist at Thermo FisherMay 7 20191:00 pmUTC75 mins
Full Title: Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s
• Identifying the appropriate excipients for HME processing of water insoluble drugs
• Using novel excipients to achieve increased dissolution rates (Granulation)
• Extrusion with polymeric carriers for the development of solid dispersions
• Co-crystallisation of water insoluble drugs
In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.
As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e. to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The presentation gives an introduction into HME technology as an alternative to spray drying. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms hot melt extrusion (HME) can be used for novel delivery methods. The presentation gives an overview on possible applications including examples and case studies.
Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt GermanyMay 8 20192:00 pmUTC75 mins
Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech
Extractables and their perceived impact on product and patients continue to be a challenge. The challenge is augmented by the lack of standardized extractable data from suppliers. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements. This paper will discuss case studies where data from a supplier using the BPOG protocol significantly reduced the time for implementation.
Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective
Presented by Dr. Saskia Haehn, Laboratory Manager for E & L at Central Analytics of Merck KGaA, Darmstadt Germany
The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
Curious about Cannabis? Join Mary's List along with Amanda Ostrowitz (RegsTechnology) & Cristina Buccola (CB Counsel) to learn about the current state of the industry.
Cristina Buccola, Esq. is an attorney, advisor, & advocate who helps her clients build & sustain viable cannabis & hemp enterprises. She advises on transactional matters & investment opportunities, designs brand/IP protection & licensing programs & develops strategic ventures. Cristina is admitted to practice law in New York, New Jersey, Massachusetts, Oregon, & Illinois (retired). Cristina dedicates a portion of her practice to public interest/policy work related to medical cannabis & economic & social justice issues, has testified in front of the New York State & New Jersey Legislatures about cannabis regulatory programs, & has worked with elected officials on developing cannabis legalization positions. She is a member of the New York Cannabis Bar Association & the National Cannabis Bar Association. Before dedicating herself exclusively to the full-spectrum law practice that is CB Counsel, Cristina served as the General Counsel of High Times & was a partner in an adult-use cultivation concern.
Amanda Ostrowitz, Esq. is a regulatory attorney & entrepreneur who’s identified a need for a user- friendly, scalable platform to research regulations & laws in the cannabis industry. Amanda founded RegsTechnology & its current product, CannaRegs, as a tool to aid attorneys, business people, & governments with localized tracking of regulatory issues. Although RegsTechnology has its origins in covering the dynamics of cannabis regulation, Amanda has created an innovative framework that can be applied more broadly to other emerging, hyper-localized regulatory issues. Prior to conceiving, developing & founding RegsTechnology, Amanda worked as a bank examiner in the Denver branch of the Federal Reserve Bank of Kansas City.
Charlie Whelan, Vice President of Consulting, Transformational Health, Americas, Frost & SullivanMay 14 20193:00 pmUTC75 mins
For most cities and states, the healthcare technology and biosciences sector is one of the most attractive industries of the future that can grow their communities. However, that attention attracts significant competition among players seeking to expand in a field that is highly complex. How should your community address this industry, and what is the best path to nurturing start-ups, retaining existing employers, attracting new companies and encouraging workforce development?
• The healthcare technology and biosciences market is large and complex. Learn how the industry is structured and which segments might align best with your community.
• Cities and states across the country are all competing to grow their own biosciences economies. Find out what types of programs and strategies are the most effective.
• Come away with a simple model for assessing your own community’s strength relative to the healthcare technology and biosciences market.
Marc-André Renaud, medical physicist, PhDMay 17 20192:00 pmUTC60 mins
In radiation therapy, quality assurance is not only necessary and mandatory in many countries, but crucial for the treatment of patients. As treatment plans become more complex, a higher degree of accuracy in dose delivery is essential. The Monte Carlo QA technology in clinical settings provides an independent and fast calculation.
This webinar deals with the rationale for using a Monte Carlo-based QA software in the radiation therapy clinic. In this presentation we will discuss the types of treatment plans that a Monte Carlo-based QA system would be best utilized for.
Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein SimpleMay 21 20192:00 pmUTC75 mins
Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.
Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging
Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple
Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt GermanyMay 22 20196:00 amUTC75 mins
Solid Phase Microextraction (SPME) is an invaluable tool for sample preparation in Environmental Analysis, because it is a trace analysis technology that is easy to fully automate. SPME is method of choice in many official analytical methods In Environmental Testing. This webinar provides an introduction into SPME and showcases how SPME facilitates different environmental applications for water testing.
Dr Udayanath Aich, Associate Director at Bristol-Myers SquibbMay 22 20192:00 pmUTC75 mins
Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.
Dr. Udayanath Aich is an Associate Director at Bristol-Myers Squibb. He previously was a Principal Scientist at Sanofi-Genzyme. He has extensive experience and management skills in analytical chemistry, high throughput technologies and process analytical technologies (PAT). Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. In 2011, Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Before Sanofi-Genzyme, Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics and structure-function study.
Routine and special stains are usually selected to demonstrate a special structure, chemical or molecular characteristic of the tissue. They are the first tool in a pathologist’s arsenal in detecting cancer in a patient's tissue. If there still are questions, a pathologist will request more advanced staining. This workshop will look at the more commonly requested special stains, and we will review the methods, application and results of these stains. We will also look at the complimentary IHC stains and how they compare.
Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieuxMay 23 20192:00 pmUTC75 mins
Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
This webinar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.
Chemiluminescent immunoassays (CLIAs) offer one of the best solutions for the quantification of low concentrations of specific analytes from a complex mixture for in vitro diagnostic industry. The assay format is similar to enzyme-linked immunoassays, usually based on heterogeneous assays where antibodies or antigens are immobilized on a solid phase but one of the components is conjugated with a chemiluminescent label.
The benefits of CLIAs can be enhanced using magnetic beads as a solid platform which improves the separation of the un-bound reagents and reduces the interferences using a magnetic field.
The CLIA assays based on magnetic beads together with chemiluminescent tagging of immunoreagents are widely used in high throughput automated platforms obtaining an amplified signal and decreasing the matrix interferences. The complexity of these type of immunoassays rely on the optimization of several components and parameters. The critical points are highly related to the type of immunoassay format that best suits the desired specifications, magnetic beads selection and conjugation conditions for magnetic particles and chemiluminescent labelling parameters.
Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGSMay 24 20192:00 pmUTC75 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.
Giustino Di Pretoro, of Johnson and Johnson and Dr. Robin Meier of L.B. Bohle MaschinenMay 28 20198:00 amUTC75 mins
- What is Drug Product Continuous Manufacturing?
- Is Continuous Manufacturing really worth the effort? "without data, you are just another person with an opinion"
- What are the challenges implementing CM?
- Development and tech transfer considerations for CM.
Demonstrate finacial and operational benefits of Continuous Manufacturing
Explain the key challenges in the implementation of CM in R&D
Explore key strategies in drug product development of CM