The Ultimate Directory on Pharmaceutical Webinars

Enhancing adeno-associated virus (AAV) viral vector quality can significantly impact product efficacy and is essential to ensure patient safety. We invite you to join our team of experts for a deep dive into our AAV viral vector development expertise and showcase our recent breakthroughs.In this webinar, our speakers will delve into how the characterisation of the contents and surface of AAV capsids has helped identify factors influencing charge heterogeneity, and, consequently, the potency of AAV products:We will first present how VP1 deamidation, which has been associated with a decrease in potency, is also connected to hydrophobicityWe will investigate how production time within the bioreactor and AAV location inside or outside the cell affects capsid post-translational modifications and surface chargeWe will finally demonstrate the importance of reducing and controlling the level of intermediate (partially full) and empty capsids, which can impact product efficacy and have potential implications for patient safetyAfter the webinar, we will host a live Q&A session, providing attendees with the opportunity to ask questions directly to the presenters. We look forward to your participation.Who Should Attend?This webinar will appeal to professionals in the following fields or those having the following job titles:Biotechnology and pharmaceutical professionalsProject Managers/Technical ExpertsResearch & DevelopmentCell and Gene Therapy Program LeadersBusiness DevelopmentAcademicsWhat You Will LearnAttendees will learn about:Negative charge due to deamidation and hydrophobicity are related and impact capsids separationProduction duration and location of capsids at harvest affect AAV charge and potencyHow although intermediate capsids contribute to overall titer and are infectious, their payloads are not efficacious and thus considered a process-related impuritySpeakers: Sarah Laughlin-Toth - Senior Scientist II Analytical Development, Oxford Biomedica; Thomas Thiers - Scientist II Purification Sciences, Oxford Biomedica; Alex Meola - Associate Director, AAV Downstream Process Development, Oxford Biomedica.

Manufacturing cell and gene therapy products is complex and involves multiple challenges, including a unique combination of expensive cell culture solutions and experience. It is crucial to keep the end product in mind from the beginning in order to expedite processes and ensure a seamless scale-up, while reducing costs. Optimizing cell culture media and buffers to fit your process allows you to enhance experimental conditions, improve cell performance, and achieve more reliable and reproducible results in your studies.  In this webinar, our experts will discuss the importance of optimized cell media and buffers using the design of classical media formulations to demonstrate the importance of component selection in the formulation process. Our collaborators at University of Pennsylvania and SK pharmteco will explain how media and buffer design has optimized their processes and improved outcomes. You will learn how cell media and buffers can impact cell growth, viability, and therapeutic efficacy as well as strategies to simplify custom media and buffer design and optimization for all stages of development and manufacturing.  Key Takeaways: • Understand how customized media and buffers can optimize CQAs in C&GT. • Explore real-world case studies demonstrating the impact of customized solutions. • Gain practical insights into improving bioprocess development and consistency. Speakers: Asma Ayari, Ph.D., Director of Research and Development, Nucleus Biologics; John Bowen, Ph.D., Senior Director of Nucleic Acids and Plasmid Operations, SK pharmteco; Roddy O’Connor, Ph.D., Research Assistant Professor, Center for Cellular Immunotherapies, University of Pennsylvania Perelman School of Medicine.

The viral vector market, which is crucial for vaccines and gene therapies, is experiencing rapid growth. Essential factors to produce viral vectors needed for clinical trials and commercial manufacturing include scalability in transitioning from process development to commercial production and the simplicity of operating the culture device. Thermo Fisher Scientific's ThermoScientific DynaDrive Single-Use Bioreactor (S.U.B.) is a versatile bioreactor that can cultivate cells used for AAV production across a wide range of volumes, from 50 L to 5,000 L.In this seminar, representatives from both Takara Bio and Thermo Fisher Scientific, key players invigorating the gene therapy market, will explain the features of single-use bioreactors that enable mass manufacturing of AAV vectors. Additionally, they will present case studies with data that highlight the successful viral vector manufacturing process.Speakers: Hideto Chono, Ph.D. serves as the Deputy Head of CDM Business Development Division and General Manager at Takara Bio Inc. He holds a Ph.D. in Agriculture from Kyoto University and has been with Takara since 1992. He specializes in the research, development, and manufacturing of viral vectors, mRNAs, and engineered T-cells.Hiroshi Nagasaki, Ph.D. is a Field Application Scientist at Thermo Fisher Scientific K.K. in Japan. With 13 years of experience at the company, Hiroshi leads a team of Field Application Scientists specializing in BioProduction. He holds a Ph.D. in agriculture from Nagoya University. Hiroshi's expertise and leadership have been instrumental in providing support to customers.

Watch our webinar with Nyrada, featuring CEO James Bonnar.The webinar will commence with a presentation, followed by a live Q&A with the audience, providing you the opportunity to ask James any questions about NYR that you may have.Key topics:• Nyrada's brain injury program and its core technology• Non-dilutive funding opportunities• Success in the Phase I trial• Upcoming plans in the next 12-18 months• Near-term catalysts for the company----------------- Nyrada is a drug development company specialising in novel treatments for diseases where there is an unmet clinical need, or where current treatments are suboptimal. US incorporated, ASX listed, Australia headquartered, Nyrada is pioneering a family of small molecule drugs that target Transient Receptor Potential Cation (TRPC) channels. Its lead program is a first in class neuroprotection therapy for both traumatic brain injury (TBI) and stroke.

One of the biggest challenges the pharma industry continues to face today is the failure of drug candidates due to unexpected adverse reactions. Late-stage clinical attrition for safety reasons represents a high risk in terms of patient safety and cost. Early anticipation of safety issues enables informed decisions.In this session we will present how OFF-X's analytic tools and curated data from a broad range of sources can help de-risk drug development.Agenda:Challenges the pharma industry continues to face today How the safety intelligence tool OFF-X can help de-risk drug developmentDrug - SemagacestatTarget – BTK inhibitorsTarget- 4-1BB activatorsSummaryQ&ASpeaker: Kinsi Oberoi, Senior Solution Consultant​

Join the IFIC Scotland webinar to learn about optimizing polypharmacy and adherence. This webinar will cover the importance of managing multiple medications and strategies for improving medication adherence. Don't miss this opportunity to enhance your knowledge on this important topic.

Get a comprehensive overview of the current AI landscape in the pharmaceutical industry with regulatory affairs leaders highlighting key trends, use cases, challenges, and opportunities.Experts in the field will share insights on how AI is changing the remit of regulatory affairs professionals and transforming regulatory processes.Attendees will gain a deeper understanding of AI applications in these areas and learn strategies to effectively adopt and leverage AI technologies for enhanced decision-making and efficiency in their roles.

The field of biosimilars, which seeks to offer cost-effective alternatives to biologic drugs, has garnered significant attention in recent years. This report aims to provide an in-depth analysis of the biosimilar industry, tracing its evolution, examining its current market status over the past three years, and exploring future opportunities. Omnitrope's launch in 2006 was a pivotal moment for biosimilars, introducing them as viable options in healthcare. Initial regulatory hurdles were substantial, as biosimilar guidelines were nascent. The industry saw a turning point with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) establishing a comprehensive approval pathway, which has since facilitated the entry of numerous biosimilars into the market. This report details the biosimilars approved up to the present, segmented by therapeutic application—such as treatments for growth hormone deficiency, anaemia, and autoimmune diseases. We highlight the first biosimilar moieties launched between 2021 and 2023, including their regulatory approvals and market impact on their reference drugs. The current regulatory environment and market dynamics for biosimilars are evaluated to understand their position in the healthcare landscape. We will analyze the upcoming biosimilars anticipated for launch in the upcoming years and their respective focused indications. The webinar offers a comprehensive analysis of the biosimilar landscape, from its inception to its future prospects. The increasing focus on research and development, combined with regulatory advancements, underscores the significant role biosimilars will play in enhancing patient access to affordable, effective treatments.

Oestrogen receptor 1 (ER/ESR1) mutations have arisen as crucial biomarkers for endocrine therapy resistance in ER positive metastatic breast cancer. Detecting these mutations is key for understanding acquired resistance during treatment.APIS will be joined by SensID GmbH to deliver this FREE educational webinar on ESR1 mutations and the importance of their accurate and sensitive detection.Gain insights into: - ESR1 mutations significance in breast cancer and their role in endocrine therapy resistance - APIS ESR1 Mutations Kit, an accessible method to detect ESR1 mutations - SensID ESR1 reference set to ensure accurate detection of mutations in cell-free DNA (cfDNA)Have your questions answered by experts in gene mutation assay development and validation!

Ensuring prescription drug affordability continues to be a top concern for consumers, caregivers, and policymakers. To address these concerns, state and federal legislators have taken action by enacting a variety of laws that would set limits on certain prescription drug costs. At the state level, this legislation frequently takes the form of Prescription Drug Affordability Boards, also known as PDABs. Currently, seven states have passed PDAB legislation, with several more states proposing PDAB legislation in 2023 and 2024. Unfortunately, for advocates, there is not one approach to PDABs. For example, some PDABs are only empowered to review drug prices, report on pricing trends, and offer policy recommendations to improve consumer affordability. Meanwhile, other PDABs have authority to implement price controls based on the Inflation Reduction Act (IRA) Medicare negotiations, international reference pricing, or upper payment limits. This diverse landscape of PDAB functions has created challenges for consumers to actively engage with these entities and ensure that the patient voice and lived experience are integral to these processes. To empower advocates in engaging with PDABs, Aimed Alliance is thrilled to host an upcoming webinar: Prescription Drug Affordability Boards 101: Everything You Need to Know. This webinar will provide a comprehensive overview of the diverse approaches employed by different state PDABs, shedding light on the mechanisms these boards utilize to tackle the challenge of rising drug costs. By incorporating insights from policy advocates and patient perspectives, attendees will gain valuable insights into the multifaceted strategies employed by PDABs. The discussion will delve into potential problems and uncertainties associated with PDAB implementation, addressing concerns such as the lack of patient representation, reduced innovation, and considerations about the data and methodologies used. With an interactive Q&A session, attendees will have the opportunity to explore the challenges and ambiguities inherent in the functionality of these boards. Attendees can expect to leave with an increased understanding of PDABs, their impact on drug affordability, how advocates can engage PDABs in 2024 and beyond; and key considerations for legislators proposing or considering to propose these bills. Ultimately, this free, one-hour webinar serves as a comprehensive guide to navigating the evolving landscape of prescription drug affordability, empowering advocacy organizations, patients, and providers to better engage these entities.