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X-WR-CALDESC:Events for The BioCalendar
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DTSTART;TZID=America/Los_Angeles:20260707T110000
DTEND;TZID=America/Los_Angeles:20260707T120000
DTSTAMP:20260624T203118Z
CREATED:20260623T180209Z
LAST-MODIFIED:20260624T203118Z
UID:10636-1783422000-1783425600@thebiocalendar.com
SUMMARY:Solving Vector Yield Challenges in In Vivo CGT
DESCRIPTION:What does it take to turn breakthrough biology into successful in vivo therapies? \nAs innovations in synthetic biology\, RNA editing\, and gene therapy continue to accelerate\, vector design and manufacturing remain the critical link between scientific discovery and patient impact. \nJoin Chief Editor Erin Harris for a special Cell & Gene Live discussion with Robert Bell\, Ph.D.\, CSO at Ascidian Therapeutics\, and Karen Kozarsky\, Ph.D.\, Founder of Vector BioPartners. Together\, they’ll explore how capsid engineering affects transduction efficiency\, the tradeoffs between tissue specificity and manufacturability\, and what manufacturing teams need to know about real-world in vivo performance. \nDon’t miss this expert conversation on the challenges and opportunities shaping the future of in vivo cell and gene therapies. \nRegistration is free.
URL:https://thebiocalendar.com/event/solving-vector-yield-challenges-in-in-vivo-cgt/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260709T110000
DTEND;TZID=America/Los_Angeles:20260709T120000
DTSTAMP:20260618T235644Z
CREATED:20260615T143351Z
LAST-MODIFIED:20260618T235644Z
UID:10598-1783594800-1783598400@thebiocalendar.com
SUMMARY:The mRNA Therapeutics Regulatory Paradigm: A Closer Look
DESCRIPTION:In some ways\, it has been a quiet(er) year on the regulatory front for mRNA; there have been no mRNA-specific guidances released since the MHRA personalized cancer immunotherapy guidance and the EMA’s mRNA vaccine quality guidance — both of which were released in the winter of 2025. However\, there has been a flurry of activity at the FDA\, including new leadership appointments and the release of several guidances impacting the advanced therapies/personalized medicines sector. \nIn this discussion\, Advancing RNA Live Chief Editor Anna Rose Welch will dig into current events and recent guidance to identify the impacts these developments will have on the mRNA sector overall.
URL:https://thebiocalendar.com/event/the-mrna-therapeutics-regulatory-paradigm-a-closer-look/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260710T110000
DTEND;TZID=America/Los_Angeles:20260710T120000
DTSTAMP:20260618T235602Z
CREATED:20260615T145422Z
LAST-MODIFIED:20260618T235602Z
UID:10612-1783681200-1783684800@thebiocalendar.com
SUMMARY:Modular vs Flexible Aseptic Filling Lines: Impacts on Speed\, Changeovers\, and Scale
DESCRIPTION:As biologics\, complex injectables\, and stricter regulatory requirements reshape sterile manufacturing\, facility design has become a critical factor in operational success. In this webinar\, learn how purpose-built modular aseptic filling facilities can improve contamination control\, manufacturing flexibility\, and scalability compared with retrofitted legacy sites. \nUsing real-world insights from Kindeva’s Bridgeton facility\, attendees will explore how modern facility design—from modular filling suites and independent environmental controls to warehousing\, cold storage\, and utilities—can accelerate operations\, support future growth\, and create a more resilient aseptic manufacturing ecosystem.
URL:https://thebiocalendar.com/event/modular-vs-flexible-aseptic-filling-lines-impacts-on-speed-changeovers-and-scale/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-10-26-Kindeva-eBlast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260714T110000
DTEND;TZID=America/Los_Angeles:20260714T120000
DTSTAMP:20260624T203130Z
CREATED:20260623T180356Z
LAST-MODIFIED:20260624T203130Z
UID:10640-1784026800-1784030400@thebiocalendar.com
SUMMARY:The Risk And Reality Of 3D Printed Parts In Single-Use Workflows
DESCRIPTION:The trend toward 3D printing in process development is driven by early-stage benefit: engineers can create custom equipment for scale-up and scale-down initiatives and mitigation of process integration challenges. When sourcing unique or bespoke single-use parts is the bottleneck\, 3D printing offers a rapid way to keep development moving. However\, it comes with inherent risks. \n3D printing puts validation on the shoulders of the sponsor company. Issues like extractables and leachables\, integrity\, and regulatory scrutiny warrant serious consideration for anyone working toward GMP compliance. Building processes using components that may not exist\, now or ever\, outside your process lab could upend a pipeline before Phase 2. \nBioprocess Online Live’s expert panel\, including James Dean Vogel of The BioProcess Institute\, Vikash Kumar at Merck\, and Robert Dream\, an independent consultant and former biopharmaceutical executive\, will explore where and why 3D printing is being incorporated into process development workflows. They’ll also dig into some of the show-stopping hazards of “DIYing” your way to GMP.
URL:https://thebiocalendar.com/event/the-risk-and-reality-of-3d-printed-parts-in-single-use-workflows/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260716T110000
DTEND;TZID=America/Los_Angeles:20260716T120000
DTSTAMP:20260618T235534Z
CREATED:20260612T113815Z
LAST-MODIFIED:20260618T235534Z
UID:10594-1784199600-1784203200@thebiocalendar.com
SUMMARY:The Site AI Playbook: Vendor Tools\, Homegrown Solutions & What's Working
DESCRIPTION:This webinar gives clinical research sites a practical look at how AI is being used today across source documentation\, regulatory compliance\, finance\, eSource\, and other site operations. CRIO’s Mike Wenger will join a panel of clinical site operators to discuss what’s working\, what’s overhyped\, and how sites can evaluate AI opportunities with more confidence. \nAttendees will walk away with the ability to:\n• Decide when to build\, configure\, or buy AI solutions\n• Identify high-impact AI use cases for site operations\n• Evaluate vendor claims and spot potential red flags\n• Apply real examples from eSource\, document review\, compliance\, and financial workflows\n• Use AI to improve speed\, quality\, and compliance across clinical trials
URL:https://thebiocalendar.com/event/the-site-ai-playbook-vendor-tools-homegrown-solutions-whats-working/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260721T110000
DTEND;TZID=America/Los_Angeles:20260721T120000
DTSTAMP:20260618T235502Z
CREATED:20260615T145655Z
LAST-MODIFIED:20260618T235502Z
UID:10616-1784631600-1784635200@thebiocalendar.com
SUMMARY:When High-Stakes ADC Decisions Can't Wait for More Material or Better Data
DESCRIPTION:Early ADC development often requires critical decisions to be made with limited data and scarce material. In this webinar\, discover a streamlined analytical approach that enables accurate measurement of antibody-drug conjugate (ADC) concentration and drug-to-antibody ratio (DAR) without resource-intensive calibration assays. \nAttendees will learn how combining LC-MRM with a single UV280 measurement can generate reliable concentration data\, establish reusable linker-payload extinction coefficients\, and accelerate candidate evaluation. The session will provide practical insights into improving developability assessments and making more confident ADC decisions earlier in the development process.
URL:https://thebiocalendar.com/event/when-high-stakes-adc-decisions-cant-wait-for-more-material-or-better-data/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260722T100000
DTEND;TZID=America/Los_Angeles:20260722T120000
DTSTAMP:20260618T235449Z
CREATED:20260611T145828Z
LAST-MODIFIED:20260618T235449Z
UID:10578-1784714400-1784721600@thebiocalendar.com
SUMMARY:Smart Sourcing: Patient Recruitment & Retention Showcase
DESCRIPTION:This 2-hour virtual showcase gives clinical teams a faster\, easier way to evaluate patient recruitment and retention partners. Attendees will hear short capability presentations\, compare providers side by side\, and ask questions directly during live Q&A. \nAttendees will gain: \n• A clearer view of available recruitment and engagement solutions\n• A more efficient way to compare potential partners without conference travel\n• Practical ideas to support enrollment timelines\, diversity goals\, and site experience\n• Direct access to provider insights during live Q&A\n• A stronger shortlist of partners to consider for upcoming studies\n• Takeaways to help reduce patient drop-off and improve recruitment planning
URL:https://thebiocalendar.com/event/smart-sourcing-patient-recruitment-retention-showcase/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-2026-CLSE-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260723T110000
DTEND;TZID=America/Los_Angeles:20260723T120000
DTSTAMP:20260630T200748Z
CREATED:20260630T141331Z
LAST-MODIFIED:20260630T200748Z
UID:10678-1784804400-1784808000@thebiocalendar.com
SUMMARY:Enhancing AAV Manufacturing Yield Through a Promoter-Optimized Mini-Helper Plasmid
DESCRIPTION:Discover how a simple redesign of the AAV helper plasmid could make gene therapy manufacturing more efficient and cost-effective. \nIn this webinar\, Samsung Biologics shares how its promoter-optimized mini-helper plasmid delivers up to a 6.5-fold increase in AAV yield\, reduces DNA synthesis costs\, and maintains high particle quality from lab scale to bioreactor production. \nYou’ll gain practical insights into the platform’s design\, transfection optimization\, and its potential to enable next-generation AAV manufacturing strategies.
URL:https://thebiocalendar.com/event/enhancing-aav-manufacturing-yield-through-a-promoter-optimized-mini-helper-plasmid/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-23-26-Samsung-eblast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260724T110000
DTEND;TZID=America/Los_Angeles:20260724T120000
DTSTAMP:20260630T200730Z
CREATED:20260630T174022Z
LAST-MODIFIED:20260630T200730Z
UID:10698-1784890800-1784894400@thebiocalendar.com
SUMMARY:The Hidden Cost of CRO Change Orders and How Sponsors Can Best Manage Them
DESCRIPTION:CRO change orders can quickly become difficult to manage once a study is underway\, especially when budget revisions\, approvals\, comments\, and financial projections are spread across emails\, spreadsheets\, and disconnected systems. Join Clin.AI Founder and President Kalyan Obalampalli and clinical operations executive Leticia Tarilonte for a discussion on how sponsors can improve visibility into change order status\, track projections versus actual spend\, streamline approvals\, and maintain a complete audit trail throughout study execution. \nThis webinar will explore practical approaches for managing CRO change orders more efficiently\, reducing budget surprises\, and improving collaboration with vendors. \nRegister for the webinar on July 24\, 2026\, at 12:00 PM ET.
URL:https://thebiocalendar.com/event/the-hidden-cost-of-cro-change-orders-and-how-sponsors-can-best-manage-them/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260729T110000
DTEND;TZID=America/Los_Angeles:20260729T120000
DTSTAMP:20260630T200707Z
CREATED:20260626T155658Z
LAST-MODIFIED:20260630T200707Z
UID:10653-1785322800-1785326400@thebiocalendar.com
SUMMARY:Building Inspection-Ready Systems with Digital Documentation
DESCRIPTION:This expert panel will discuss how digital documentation is reshaping inspection readiness. Panelists will explore the role of electronic batch records\, integrated quality systems\, and automated workflows in supporting compliance with ALCOA+ principles\, while enabling real-time visibility and faster audit response.
URL:https://thebiocalendar.com/event/building-inspection-ready-systems-with-digital-documentation/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/26_07-POL-Internal-1280x720-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260729T110000
DTEND;TZID=America/Los_Angeles:20260729T120000
DTSTAMP:20260630T200643Z
CREATED:20260630T142341Z
LAST-MODIFIED:20260630T200643Z
UID:10688-1785322800-1785326400@thebiocalendar.com
SUMMARY:Outsourced Pharma Capabilities Update July 2026: Fill/Finish
DESCRIPTION:Looking for fill-finish manufacturing capacity? This webinar brings together leading CDMOs to showcase their latest sterile filling\, lyophilization\, and advanced packaging capabilities\, along with current facility availability and timelines. \nGain valuable insights into quality\, regulatory compliance\, and manufacturing options to help identify the right partner for your biopharmaceutical development and commercialization needs.
URL:https://thebiocalendar.com/event/outsourced-pharma-capabilities-update-july-2026-fill-finish/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/Outsourced-Pharma-Capabilities-Update-July-2026-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260729T130000
DTEND;TZID=America/Los_Angeles:20260729T140000
DTSTAMP:20260630T200627Z
CREATED:20260630T142856Z
LAST-MODIFIED:20260630T200627Z
UID:10693-1785330000-1785333600@thebiocalendar.com
SUMMARY:Outsourced Pharma Capabilities Update July 2026: Large Molecule
DESCRIPTION:Explore the latest large molecule manufacturing capabilities from leading CDMOs in this informative webinar. \nLearn about advances in cell line development\, fermentation\, purification\, process optimization\, and scale-up\, while gaining insight into available capacity\, facility locations\, and timelines. \nWhether you’re evaluating manufacturing partners or planning future biologics production\, this session offers a practical overview to help you identify the right CDMO for your program.
URL:https://thebiocalendar.com/event/outsourced-pharma-capabilities-update-july-2026-large-molecule/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260730T110000
DTEND;TZID=America/Los_Angeles:20260730T120000
DTSTAMP:20260630T200611Z
CREATED:20260629T174444Z
LAST-MODIFIED:20260630T200611Z
UID:10673-1785409200-1785412800@thebiocalendar.com
SUMMARY:Breaking the Bottleneck: How Modular Workflows Are Redefining CAR T Manufacturing Performance\, Flexibility\, and Scalability
DESCRIPTION:As cell therapies advance toward commercial-scale manufacturing\, developers can face increasing pressure to balance performance\, scalability\, and process flexibility. Flexible modular workflows are emerging as a powerful approach for scalable cell therapy manufacturing\, enabling enhanced process control\, workflow adaptability\, and operational efficiency while maintaining consistency across the manufacturing pipeline. These advantages can be particularly valuable in environments where evolving process requirements may challenge more fixed manufacturing approaches. \nIn this webinar\, we will explore how modular Gibco™ CTS™ workflows compare to an integrated system across critical CAR T manufacturing quality attributes\, including transduction efficiency\, T cell activation\, expansion\, and phenotype preservation. Data demonstrate that modular workflows can achieve high transduction efficiency (up to ~80% by day 8)\, increased CAR+ T cell yields\, and enhanced enrichment of stem cell–like memory (TSCM) populations\, which can be key factors associated with improved therapeutic potential. \nWe will also highlight how flexibility in workflow design enables parallel processing\, reduced instrument lock times\, and improved operational efficiency\, without compromising cell quality metrics such as purity and isolation efficiency. Attendees will gain practical insights into how modular strategies can future-proof manufacturing processes and support both early development and commercial-scale production. \nKey Learning Objectives \nUnderstand how modular workflows impact critical CAR T manufacturing attributes\, including transduction efficiency\, expansion\, and T cell phenotype\nEvaluate the trade-offs between integrated and modular systems in terms of scalability\, flexibility\, and operational efficiency\nLearn how flexible workflow design can enable parallel processing\, reduce bottlenecks\, and support evolving process requirements
URL:https://thebiocalendar.com/event/breaking-the-bottleneck-how-modular-workflows-are-redefining-car-t-manufacturing-performance-flexibility-and-scalability/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260811T100000
DTEND;TZID=America/Los_Angeles:20260811T120000
DTSTAMP:20260630T200555Z
CREATED:20260629T131816Z
LAST-MODIFIED:20260630T200555Z
UID:10658-1786442400-1786449600@thebiocalendar.com
SUMMARY:Cell Therapy Solutions
DESCRIPTION:Cell & Gene Tech Expo offers a live virtual experience designed to empower industry professionals in sourcing best-fit solutions for their cell and gene therapy manufacturing needs. Through this series of digital sessions\, attendees will have the chance to explore the newest equipment and solutions offered by our presenters\, aimed at addressing the current challenges within the cell and gene therapy manufacturing process. This interactive online experience ensures convenience and accessibility\, fostering an environment of learning and innovation for all participants. \nThe attendees of the Cell Therapy Solutions session will have the chance to explore the newest equipment and solutions offered by our presenting suppliers. \nWhat can you expect? Short\, digital presentations with live interaction. You will have the opportunity to ask questions to better understand if suppliers can meet your needs – all from the convenience of your computer!
URL:https://thebiocalendar.com/event/cell-therapy-solutions/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260812T100000
DTEND;TZID=America/Los_Angeles:20260812T120000
DTSTAMP:20260630T200536Z
CREATED:20260629T132028Z
LAST-MODIFIED:20260630T200536Z
UID:10663-1786528800-1786536000@thebiocalendar.com
SUMMARY:Gene Therapy Solutions
DESCRIPTION:Cell & Gene Tech Expo offers a live virtual experience designed to empower industry professionals in sourcing best-fit solutions for their cell and gene therapy manufacturing needs. Through this series of digital sessions\, attendees will have the chance to explore the newest equipment and solutions offered by our presenters\, aimed at addressing the current challenges within the cell and gene therapy manufacturing process. This interactive online experience ensures convenience and accessibility\, fostering an environment of learning and innovation for all participants. \nThe attendees of the Cell Therapy Solutions session will have the chance to explore the newest equipment and solutions offered by our presenting suppliers. \nWhat can you expect? Short\, digital presentations with live interaction. You will have the opportunity to ask questions to better understand if suppliers can meet your needs – all from the convenience of your computer!
URL:https://thebiocalendar.com/event/gene-therapy-solutions/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260813T100000
DTEND;TZID=America/Los_Angeles:20260813T120000
DTSTAMP:20260630T200519Z
CREATED:20260629T132259Z
LAST-MODIFIED:20260630T200519Z
UID:10668-1786615200-1786622400@thebiocalendar.com
SUMMARY:Commercial Readiness Solutions
DESCRIPTION:The journey from a successful lab result to a reliable\, GMP-compliant product is rarely a straight line. It’s a transition filled with technical hurdles\, regulatory pressure\, and the constant challenge of scaling without compromise. \nWe created the Commercial Readiness Solutions session to help you navigate this transition. This virtual event is designed to be highly practical – moving past high-level theory to focus on the specific tools and partnerships needed to solve the real-world bottlenecks in your production lifecycle. \nJoin us to evaluate the solutions and technologies essential for a sustainable commercial platform\, including: \nGMP Execution & Inspection Readiness: Building the protocols and confidence to meet global regulatory standards.\nManufacturing Scale-up: Leveraging closed-system automation to reduce manual risk and variability.\nContamination Control: Implementing advanced strategies to ensure sterility and product safety at scale.\nQC & Release Testing: Optimizing testing strategies to accelerate the path from the facility to the patient.\nValidation & Data Integrity: Ensuring your process documentation is robust\, transparent\, and compliant.\nDigital Infrastructure: Integrating eQMS\, MES\, and LIMS for a seamless\, paperless manufacturing environment. \nPractical Insights\, Not Just Presentations. Through solution-focused sessions and real-world case studies\, this event will highlight the supplier capabilities and technologies that reduce risk and accelerate your timelines. Our goal is to show you how to strengthen your operational resilience – maintaining the highest quality standards without sacrificing the throughput you need to stay competitive. \nMove Forward with Confidence. Whether you are preparing for your next inspection\, refining your control strategy\, or building a repeatable platform for the global market\, we are here to connect you with the right expertise. Join us to find the tools and insights you need to move confidently from development to commercial success – bringing life-changing therapies to more patients\, faster.
URL:https://thebiocalendar.com/event/commercial-readiness-solutions/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
END:VCALENDAR