Pharmaceutical Webinars

While synthetic biology has considerably advanced in the past decade, cost continues to be a major factor in commercial viability. Saccharomyces cerevisiae is a commonly used microbial host in synthetic biology. These cultures can be grown to very high densities with high expression levels of target molecules, making S. cerevisiae a preferred candidate for cost-effective natural product synthesis.In this webinar, the expert speakers demonstrate the seamless scale-up of a high-yield fermentation process from 250 mL to 5 L, enabled by extensive vessel characterization using cloud-connected bioreactors. The speakers will share insights into how utilizing S. cerevisiae provided an efficient and cost-effective scale-up method.They will also present case studies that illustrate the steps taken to reduce costs and mitigate risks during the scale-up process. The attendees will also gain a comprehensive understanding of how cloud-connected bioreactors can dramatically accelerate the scale-up process in biomanufacturing. The speakers will then delve into practical troubleshooting methods, designed to address and overcome common challenges encountered during scale-up.Moreover, the session will explore effective strategies for reducing costs and de-risking the scale-up process, equipping attendees with tools and knowledge needed to optimize production efficiency and ensure successful outcomes in their biomanufacturing projects.Register for this webinar to discover how cloud-connected bioreactors are revolutionizing the scale-up process for biomanufacturing.What You Will LearnAttendees will learn about:• How cloud-connected bioreactors can accelerate scale-up• Troubleshooting methods to overcome scale-up challenges• Strategies for reducing costs and de-risking scale-upWho Should Attend?This webinar will appeal to:• Small-Mid-Large Biotech/Pharma• Emerging biotechs and startups/Agricultural biotechnology firms• Food Technology and fermentation-based food companies• Biofuel and renewable chemical companies• Research institutions and academia• Bioprocess Engineers• Head of Process Development/Innovation• Upstream Process Development Scientists• Formulation Scientists• Product Development• Consultants/R&D/Scientists/FormulatorsSpeakers: Andrew Horwitz, PhD, Vice President Research and Development, Inscripta; Kris Tyner, Senior Director, Bioprocess Sciences, Culture Biosciences.

ISAM is pleased to announce the next Webinar presented by Clair Brooks, Applications Specialist at Copley Scientific, Nottingham, England, UK. She will explore the latest advancements in nasal drug delivery, focusing on in-vitro testing methods and innovative tools for improved nasal deposition.Key points:• Utilising the intranasal route for systemic and nose-to brain drug delivery • Compendial in vitro testing requirements of nasal drug products • Challenges and developments in nasal testing• Studying nasal deposition with the Alberta Idealised Nasal Inlet and the Kiel Nasal InletNasal drug delivery presents a promising avenue for therapeutic administration, offering a non-invasive route that bypasses the gastrointestinal tract and hepatic first-pass metabolism. This method has become increasingly attractive for systemic drug administration, particularly for drugs that are poorly absorbed orally, as it utilises the highly vascularised and large surface area of the nasal mucosa for rapid absorption. Additionally, the permeability of the nasal mucosa and its nerve pathways are being utilised to achieve targeted drug delivery to the brain, effectively overcoming the blood-brain barrier. Rigorous testing is vital to ensure the safety, efficacy and quality of these products, and compendial in-vitro testing methods play a key role in evaluating product performance and ensuring compliance with regulatory standards. However, challenges remain in replicating physiological conditions and addressing patient-to-patient variability. Ongoing research and technological advancements continue to drive progress in this area, including the development of realistic nasal models to improve in vitro-in vivo correlations and automated device actuation to standardise dose delivery when evaluating bioequivalence. This webinar explores the advancements in in-vitro nasal testing and presents recent studies using two novel tools to look at nasal deposition.

This webinar will explore the applications of Dynamic Light Scattering (DLS) and Electrophoretic Light Scattering (ELS) in the pharmaceutical industry. The experts will also discuss how these techniques enhance drug formulation, stability, delivery, and improve the quality and efficacy of pharmaceutical products.Key Takeaways• Understanding the fundamentals of Dynamic Light Scattering (DLS) and Electrophoretic Light Scattering (ELS)• How particle size distribution and zeta potential impact pharmaceutical formulations and stability• Utilizing DLS and ELS to enhance drug delivery systems and improve pharmaceutical quality• Comprehensive understanding of BeNano’s advanced measurement capabilities for pharmaceutical applications.• Real-world case studies demonstrating BeNano’s applications in LNP, proteins, micelles, microemulsions, drug carriers, and Ag nanoparticles.Who Should Attend?This webinar will benefit beginners and professionals in research, development, processing or quality control who acquire understanding of comprehensive pharma characterization or who want to refresh and expand existing knowledge. Furthermore, those who are looking for suggestions for further possible uses of particle size characterization as well as stability of pharmaceutical suspensions should attend this webinar.Speakers: John F. Miller, PhD - Inventor of PALS; Zhibin Guo, MS - Senior Application Scientist.Register now to secure your spot!

The Inflation Reduction Act and the resulting Medicare Part D price negotiations are shaping up to be the most far reaching of any event impacting pharma manufacturing in recent history.Although the first set of negotiated prices for selected drugs will not take effect until January 1, 2026, the immediate impact has been fast and furious — more than a dozen lawsuits have been filed by pharmaceutical companies, advocacy groups and the US Chamber of Commerce. Industry media is ablaze with discussions on how price negotiations will impact the pricing of non-selected same-class drugs and biosimilars, as well as future drug development in general.With the first-round negotiated prices for selected drugs to be made public on September 1, 2024, companies are preparing themselves for the second round of selections. This timely webinar will provide an update on:To-date information on the legal actions, existing price negotiations, and market reactionsDrugs likely to be selected for the second round and their same-class competitors who will be impactedThe changes and impact of out-of-pocket costs on enrolleesPrice negotiation benchmarking on selected drugs compared to net pricing on competitorsHow manufacturers should prepare for the overall impact to the industryPart D plan utilization managementRegister for this webinar today to understand the profound impact of the Inflation Reduction Act and Medicare Part D price negotiations on the pharmaceutical industry.Speakers: Mark McCoy, RPh, MBA - Director, Client Engagement Pricing Market Access and Reimbursement, ICON; Amith Shetty, PharmD, RPh - Senior Clinical & Market Access Specialist, ICON; Dr. Xin Zhao - Principal, Global Market Access, ICON.Who Should Attend?This webinar will benefit pharmaceutical and biotech professionals in the following areas:Market access/Marketing/Managed markets/Market researchReal world evidenceRegulatory affairsChannel marketingClinical researchCompetitive intelligenceGovernment affairsHealth economics and outcomes researchWhat You Will LearnAttendees will learn about:The ongoing legal challenges initiated by pharmaceutical companies and other stakeholders against the Inflation Reduction Act’s price negotiation provisionsDrugs likely to be targeted in the upcoming rounds of Medicare Part D price negotiationsThe impact of changes to enrollees and drug manufacturers around reductions in patient out-of-pocket costsThe future impact on Part D plan utilization management

Join us for an informative webinar tailored for healthcare providers interested in understanding and recommending serum tears to their patients. Serum tears, derived from a patient’s own blood, offer a natural and personalized treatment option for chronic dry eye and other ocular surface diseases.Our featured presenter, Dr. Matthew Ward, a leading expert in the industry, will guide you through the science behind serum tears, their therapeutic benefits, and the process of preparing and prescribing them.Dr. Ward will cover:• The benefits of serum tears and the compounding process• The cost-effectiveness of serum tears as a treatment option for patients• The safety of serum tears as opposed to traditional eye drops and solutions• And so much more!This session will equip you with the knowledge and tools to confidently recommend serum tears, offering your patients a cutting-edge solution to manage their eye health.Who Should Attend:• Ophthalmologists• Optometrists• Primary care physicians• Healthcare providers involved in ocular care

There has never been a more exciting and promising time in pharmacological research related to obesity drugs. It is now broadly accepted that obesity is not just a lack of willpower but a complex chronic disease with increased morbidity and mortality that can be managed with the right treatment.Over the past decade or so, gut hormone-based drug development targeting obesity and type 2 diabetes indications and combinations of glucagon-like peptide 1 (GLP1) with other gut hormones (glucose-dependent insulinotropic polypeptide (GIP), glucagon and amylin) as dual or triple agonists or other complementary mode of action have increased rapidly.Semaglutide and, most recently, tirzepatide have demonstrated that a two-digit weight loss at one year is achievable and the Phase II data with retatrutide suggest that 100 percent of patients can now achieve the 5 percent weight loss that was targeted in the past. The next stage in obesity research needs to bring affordable and accessible drugs that can lead to selective fat loss, preservation of lean body mass and long-term weight maintenance. As with many other chronic diseases, combination therapies with complementary modes of action will be required to successfully treat patients with obesity.The objective of this webinar is to discuss the potential next steps in pharmacotherapy targeting obesity. The expert speakers will initially focus on the size of the health burden, the history of drug development and the current pipeline in this indication. They will also focus on the current methodologies to assess body composition. They will discuss the potential additional targets, beyond energy intake, to complement and improve the quality of weight loss and its maintenance, as well as present the methodologies that can be used to assess different components of energy expenditure (EE) and explain the concept of metabolic adaptation and the potential physio-pathological mechanisms involved.Moreover, they will discuss the implications of the changes in EE and metabolic adaptation in long-term weight maintenance. Finally, they will focus on brain imaging and how it can help to understand eating behavior and neurocognitive measures in obesity. The webinar will conclude with the current challenges and mitigation strategies for future clinical trials in obesity.Register for this webinar today to understand the latest advancements related to obesity pharmacotherapy.Speakers: Dr. Eric Ravussin, PhD - Boyd Professor, Douglas L. Gordon Chair in Diabetes and Metabolism, Pennington Biomedical Research Center-LSU System, Baton Rouge, Louisiana; Dr. Claudia Filozof - Vice President and Therapeutic Area Head in Obesity, MASH and Liver Indications, Fortrea; Dr. Peter Alfinito, PhD - Executive Director, Operational Strategy & Planning, Fortrea.Who Should Attend?This webinar is designed for drug developers, healthcare professionals, patient advocacy groups and anyone interested in the advancement of obesity drug development.What You Will LearnAttendees will learn about:Understanding obesity’s health burden and the evolution of drug development in obesityMethodologies used to evaluate body composition in the context of obesity researchPotential additional targets beyond energy intake to enhance weight loss quality and maintenanceCurrent challenges in obesity clinical trials and strategies to mitigate these challenges for future research efforts

Join NACDS President & CEO Steve Anderson and national political analyst Charlie Cook in an exciting virtual NACDS RxIMPACT Votes event to learn more about the 2024 elections and what that might mean for the future of pharmacy.Register to attend this virtual event taking place at 1:00pm ET on September 17 – the celebrated National Voter Registration Day inspiring thousands across the nation to register to vote and participate in the 2024 General Election set for November 5, 2024. You won’t want to miss this insightful election forecast and discussion about the 2024 elections and what this might mean in 2025!Can’t make the event? Register for the event and we will share with you a link to the recording!Elected leaders construct not only the laws by which you live, but the laws by which you are able to serve your patients. They introduce bills, pitch resolutions, and offer amendments. The pharmacy community has seen concrete examples over the years of how Governors, state leaders, and members of the U.S. Congress have played a critical role in the future – and fate – of pro-patient and pro-pharmacy policies and whether they are enacted into law. Those elected in November are key to our community’s policy priorities.Register to Attend this Complementary Zoom Event featuring Charlie CookDate: Tuesday, September 17, 2024, Time: 1:00 PM ETNote: Registering for this event will also subscribe attendees to receive NACDS RxIMPACT emails. Contact Hecker@nacds.org with questions.

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.