Xtalks

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.

This webinar will explore the latest trends in the clinical trial industry, emphasizing direct-to-patient trial strategies and their impact on diversity, equity and inclusion (DEI). Reaching marginalized communities is a critical component for fulfilling study enrollment, yet these communities often face unique challenges.One significant hurdle is the financial burden placed on patients due to the leveraging of patient insurance, which can hinder study enrollment and impact efforts to improve clinical trial diversity in the United States. Current industry trends are centered on patient-centric approaches such as DEI, accelerated start-up timelines and decentralized clinical trials.Prioritizing patient-centricity can significantly enhance patient experience and enrollment, leading to more successful clinical trials. In addition, as clinical trial sites manage numerous studies simultaneously, it is essential to develop supply strategies that simplify the management of investigational medicinal products (IMPs) and non-IMPs (NIMPs).This webinar will dive into how patient-centric supply strategies can address these complexities, improve trial efficiency and support clinical trial diversity. Through case studies, the featured speakers will examine various sourcing options for sponsors, highlighting their benefits and drawbacks for sponsors, patients and sites. Additionally, the discussion will cover how comparator drug supply vendors handle complex trial designs and access to specialty drugs, ensuring that patient needs are met efficiently.Register for this webinar to learn about innovative, on-demand local sourcing solutions, methods to minimize cost and waste in clinical trials and how clinical trial diversity can benefit both sites and patients.Who Should Attend?This webinar will appeal to professionals in the following fields:Vendor Managers/Clinical Vendors ManagerClinical Trial Operations/Supplies Management/Supply ConsultantClinical Trial Comparator Managers/Clinical Trial Sourcing ManagersClinical Supply PlanningStrategy Lead Comparator ManagersClinical Trial ManagersClinical research organisationsWhat You Will LearnAttendees will gain insights into:How direct-to-patient strategies and patient-centric supply chain solutions can enhance clinical trial diversityHow patient centricity can significantly enhance patient experience and enrollmentThe challenges of leveraging patient insurance and how innovative approaches can alleviate financial burdensSpeakers: Samit Bhatt - Vice President, Clinical Trial Patient Solutions, Myonex; Todd Luckritz - Associate Director, Clinical Trial Patient Solutions, Myonex.

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

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

As more and more clinical trials are conducted internationally, with a higher level of protocol complexity, and with increased competition to get medical products to market faster globally, the need for efficient and streamlined clinical product development is greater than ever.Many clinical teams have experienced delays or bottlenecks in their programs as a result of not getting accurate local-language documentation to sites quickly enough. With companies working to bring innovative therapies to market faster, the effective localization of clinical documentation has never been more critical for success and staying competitive in a constantly evolving landscape.This webinar will bring together industry leaders to explore the critical role of centralized localization in accelerating clinical timelines for global studies. During this webinar, the expert speakers will discuss how centralizing localization of documentation for global studies with the aid of new technologies, including artificial intelligence (AI), can significantly accelerate clinical and product launch timelines.In this webinar, they will also discuss practical ways of leveraging technology automation and AI to streamline the localization process, and how these innovative tools have transformed the way clinical documentation is created and managed, offering unprecedented speed, accuracy and scalability. Through real-world application and case studies, the attendees will discover how leading companies have leveraged these approaches to overcome some of the greatest challenges in clinical product development across multiple languages and regions. One such case study will be a close examination of the clinical programs for vaccines and other treatments for COVID-19, and an analysis of the tactics used to meet unprecedented timelines in those studies that can bring similar time efficiencies to all programs.Register for this webinar today to gain insights into actionable strategies to reduce clinical timelines on a global scale, and to gain great clarity on how a centralized approach to localization can drive efficiency, enhance compliance and ultimately help in clinical product development.Who Should Attend?This webinar will appeal to professionals in the following fields:Clinical operationsRegulatory affairsMedical writingClinical researchPatient recruitmentMedical communicationsWhat You Will LearnAttendees will learn about: How centralizing localization of clinical documentation can drastically reduce timelines for global studiesPractical methods for leveraging technology automation and AI to streamline the localization processInsights from real-world case studies on overcoming challenges in clinical product developmentSpeakers: Kathleen Ruddy - Process & Standards Lead, Global Site & Study Operations, Pfizer; Kristofer Carilli - Senior Manager, Study Startup Management, AbbVie; Quantes Randle - Associate Director, Clinical Operations, Alexion.Moderator: Alexandra Farrell - Regional Director, TransPerfect Life Sciences