
Welcome to Cell & Gene Live – An interactive forum to discuss some of the most important technologies and trends impacting cell and gene therapies.
Throughout the year, our Chief Editor, Erin Harris, sits down with industry experts to discuss how biotechs can tackle some of today’s biggest challenges they may face in driving progress in the cell and gene therapy field. Even better, the audience gets ask questions during the presentation. Each Cell & Gene Live session is archived and can be accessed at any time by registered site users.
ARE WE THERE YET? ROADMAP(S) TO HIGHER QUALITY AAV
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Are We There Yet? Roadmap(s) To Higher Quality AAV
Current limitations in AAV gene therapy manufacturing platforms often leave us making difficult tradeoffs. To learn how companies are evaluating and striving to overcome these tradeoffs in their technology and outsourcing partner selections, facility designs, and regulatory preparations, tune into this archived episode of Cell & Gene Live.
- What’s Keeping The AAV Space Up At Night?
- AAV Critical Quality Attributes: Advances In Analytical Characterization
- For The Love Of Mass Photometry: The Most Notable AAV Analytical Technology Advancements
- Beyond Full-Empty Capsids: Additional AAV Quality Concerns & Questions To Address
- "Space Invaders," Expression Systems, & Producer Cell Lines: AAV Upstream Process Development Innovations
- Greatest Advances & Unmet Needs In AAV Downstream Process Development
- AAV Outsourcing: Identifying A “High-Quality” CDMO Partner
- Where Are The Greatest Innovations Yet To Come For The AAV Field?
OPTIMIZING YOUR COLD CHAIN FOR CELL THERAPIES
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Optimizing Your Cold Chain For Cell Therapies
Cell & Gene’s Chief Editor Erin Harris and expert panelists discuss practical ways to improve shipping systems, tracking, product monitoring, and more for both just-in-time delivery and cryogenic preservation.
- An Inside Look At Umoja Biopharma And Bristol Myers Squibb's Cold Chains
- Overcoming Cryopreservation Challenges
- Risk Mitigation Strategies
- Regulatory Considerations For An Optimized Cold Chain
- Inventory Management, Staff Training, And Timeline Optimization
- Courier Optimization
- Breaking Down Shipping
- Optimizing Your Cold Chain For Cell Therapies | Audience Questions
STABILITY TO SCALABILITY: THE FUTURE OF VIRAL VECTOR THERAPIES
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Stability To Scalability: The Future Of Viral Vector Therapies
Despite advances that have contributed to improvements in viral vector yields, innovation is still needed in the CGT sector to impact product quality and accelerate scale for viral vector production.
REGULATING THE CGT WORKFLOW TO IMPROVE PATIENT SAFETY
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Regulating The CGT Workflow To Improve Patient Safety
As regulatory guidelines evolve, and the need to meet accelerated timelines increases, so too does the need for an efficient manufacturing workflow.
- Regulatory Considerations For Scale Up
- Late-Stage Comparability Of The Manufacturing Process
- Partnerships With CDMOs
- Policy Development
- Real-World Evidence And Registries
- COAs And DHTs And Post-Approval Monitoring
- Class-Specific Considerations
- Regulating The CGT Workflow To Improve Patient Safety: Audience Q&A
DRIVING DOWN COGS: AUTOMATION'S ROLE IN CELL THERAPY MANUFACTURING
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Driving Down COGS: Automation's Role In Cell Therapy Manufacturing
Process automation, task automation, and test automation have become crucial components of cell therapy manufacturing. Improve your cell therapy manufacturing costs and scalability via standardization and automation.
MAJOR TRENDS IN NEXT-GEN RNA ENGINEERING
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Major Trends In Next-Gen RNA Engineering
From tissue specificity to potency and durability, major trends in RNA are developing as the space continues to evolve at record-breaking speed. In June 2023, Cell & Gene Live welcomed Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics for a deep dive into how RNA can accelerate drug development and how the evolution in the scale-up production of novel engineering technologies impacts near- and long-term deployment of new therapies.
BUILDING AN IN-HOUSE CELL & GENE MANUFACTURING FACILITY BEST PRACTICES LESSONS LEARNED
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Building An In-House Cell & Gene Manufacturing Facility: Best Practices & Lessons Learned
Listen in on a panel discussion where cell and gene therapy experts share their experiences in building state-of-the-art manufacturing facilities and offering detailed advice on how your company can do the same.
SCALING CELL THERAPIES PART 2: ESTABLISHING COMPARABILITY IN MANUFACTURING
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Scaling Cell Therapies Part 2: Establishing Comparability In Manufacturing
Michael Blackton, SVP, Cell Therapy Manufacturing, DeTIL Development at Nurix Therapeutics and John Lee, SVP, Cell Therapy Manufacturing at Center for Breakthrough Medicines are back with Cell & Gene Live host Erin Harris for Part 2 of our Scaling Cell Therapies series. Check out the conversation as these experts focused on comparability - how establishing manufacturing, characterization, and controls can positively affect scalability. Available on-demand thanks to the support of Corning Life Sciences.
TACKLING CELL & GENE THERAPIES’ TOP 3 REGULATORY IMPEDIMENTS
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Tackling Cell And Gene Therapies’ Top 3 Regulatory Impediments
Listen in to this expert discussion on problems in the cell and gene therapy industry, specific FDA initiatives to overcome these, broader regulatory trends, and more.
- CGT’s Main Opportunities To Meet Regulatory Requirements
- Challenge #1: The Changing Regulatory Landscape
- Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data
- Challenge #3: Lack Of Animal Models
- Other CGT Regulatory Challenges
- Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A
EVALUATING TRANSLATIONAL RESEARCH TOOLS FOR CGTS
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Evaluating Translational Research Tools For CGTs
Translational research tools, including biological assays (bioassays) and biological markers (biomarkers), are needed to bridge the gap from understanding the disease process to identifying therapeutic targets and testing potential therapies in preparation for clinical research in humans.
On November 15, 2022 Gregory Opiteck, Ph.D., VP Head of Translational Sciences at Allogene Therapeutics and Douglas Sanders, Ph.D., VP Head of Translational Medicine at AVROBIO joined Cell & Gene Chief Editor Erin Harris to cover assay and vendor selection in support of allogenic CAR T therapy as well as the various modalities of AAV gene therapy.
SCALING CELL THERAPIES: AUTO VS. ALLO
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Scaling Cell Therapies: Auto vs. Allo
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy.
ADVANCEMENTS IN TARGETED MRNA DELIVERY
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Advancements In Targeted mRNA Delivery
mRNA has broad potential as a therapeutic. The clinical translation of mRNA therapeutics has been made possible through advances in the design of mRNA manufacturing and intracellular delivery methods. However, broad application of mRNA is still limited by the need for improved delivery systems.
WIN THE CGT TALENT FIGHT: HOW TO FIND AND RETAIN EXPERTS
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Win The CGT Talent Fight: How To Find And Retain Experts
The cell and gene therapy (CGT) market is expected to be worth $5.5 Billion by 2026. Yet, the sector struggles with recruiting and retaining enough experienced candidates needed to bring life-saving treatments to market. Why is that, and what can you do now to overcome the talent crunch and keep skilled professionals in highly sought-after roles? Now available On-Demand, Rosie Walker, Director of ARM’s GROW RegenMed Internship Program, Dr. Andrew M. Scharenberg, co-founder and CEO of Umoja Biopharma, Juliette Hilliard, Director of Talent Acquisition at Novartis Gene Therapies, and Dr. Ray Tabibiazar, Chairman and CEO at SalioGen Therapeutics joined Cell and Gene Live host Erin Harris to share their experiences as well as the specific takeaways that you, too, can use to source and retain the skilled experts you need to reach commercialization.
KITE PHARMA'S ULTIMATE SUPPLY CHAIN TEST
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Kite Pharma's Ultimate Supply Chain Test - A Q&A With Their 4-Exec Panel On Overcoming The Pandemic's Disruption
Throughout the pandemic, Kite Pharma overcame constantly disrupted supply chains, including limited flights and border closings, all while ensuring that daily shipments of live cells remained on schedule and that the critical needs of people with cancer were met. Four of Kite's supply chain executives share their lessons learned and how those learnings will continue to evolve and shape their supply chain operations going forward.
THE THERAPEUTIC POTENTIAL OF EXOSOMES
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The Therapeutic Potential Of Exosomes
In this Cell & Gene Live, Dr. Maria Mitrani, Co-Founder and Chief Scientific Officer at Organicell; Benny Sorensen, Scientific Advisory Board member at Codiak BioScience; and Nicolas Rousseau, Co-Founder and COO at EVerZom talk to Chief Editor Erin Harris about the sector’s understanding of extracellular vesicles (EV). Specifically, they cover the regulatory landscape for exosomes as well as appropriate characterization models and advancements in manufacturing needed to ensure scalability. The expert panelists also provided detailed responses to audience questions submitted during the live event.
TACKLING THE CELL & GENE MANUFACTURING TALENT CRUNCH
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Tackling The Cell & Gene Manufacturing Talent Crunch
Join Project Farma and Precision ADVANCE leaders Anshul Mangal and John Khoury for a discussion with BioProcess Online Chief Editor Matt Pillar to address solutions to the biotherapeutic and cell and gene therapy process and manufacturing talent gap.
CAN INNOVATION DRIVE DOWN CELL THERAPY MANUFACTURING COSTS?
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Can Innovation Drive Down Cell Therapy Manufacturing Costs?
The high cost of producing new cell and gene therapies is one of the largest issues facing the industry. After launching Kymriah and Yescarta, Novartis’ price tags were $475,000 and $375,000, respectively. Advancements in manufacturing are driving costs down, but not at the required pace.
THE FUTURE OF CRISPR-ENGINEERED STEM CELL THERAPIES
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The Future of CRISPR-Engineered Stem Cell Therapies
To learn more about CRISPR gene editing, Cell and Gene Chief Editor, Erin Harris, sat down with Sadik Kassim, Chief Technical Officer at Vor Biopharma to discuss the benefits of CRISPR-engineered stem cell therapies, the challenges and feasible solutions, what’s next, and more.
- The History of CRISPR Gene Edited Therapies
- The Future of CRISPR-Engineered Stem Cell Therapies: 3 Clinical Trial Examples
- The Ethical Implications Of Editing A Genome
- The Challenges Associated With CRISPR Gene Editing
- The Patient Perspective Of CRISPR-Engineered Stem Cell Therapies
- The Future of CRISPR-Engineered Stem Cell Therapies: Adverse Effects In Clinical Trials
- The Future of CRISPR-Engineered Stem Cell Therapies: Technology & Platforms
- The Permanency Of Gene Therapy
- The Future of CRISPR-Engineered Stem Cell Therapies: Digestive Disease Studies
- The Misconceptions Of CRISPR Gene Edited Stem Cell Therapies
- Will CRISPR Change Modern Medicine?
- The Future of CRISPR-Engineered Stem Cell Therapies: Outsourcing vs. In-House
- What The Gene Therapy Sector Doesn't Understand About CRISPR?
- The Future of CRISPR-Engineered Stem Cell Therapies: Virtual Event Audience Q&A