CELL AND GENE ONLINE SHORTS
Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene share that future proofing ...
Streamlining Tech Transfer And Advancing Next Generation CAR T Therapies
In this final segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman emphasizes tha...
Balancing Innovation And Flexibility In Early Cell Therapy Manufacturing Technologies
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman explains that introd...
The Importance Of Early Manufacturing Choices And Simple Flexible Process Design
In this first segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene explore how early man...
Why Academic Centers Reach The Clinic Faster
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman explains that academ...
Early Development Choices Define Scalability And Product Quality In CGT
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene stress that early-stage pro...
Building Strong Data Foundations And Smart Logistics For Scalable CGT Development
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene emphasize that early invest...
2025 CGT Regulatory Outlook | Audience Q&A
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
How The New Administration Could Shape FDA Oversight, Compliance, And Guidance In 2025
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
How The FDA Strengthens Industry Collaboration
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Key Regulatory Challenges, Innovations, And Opportunities For CGT In 2025
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Congruence And Divergence In Global Regulatory Approvals
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Unlocking The Future Of Allogeneic Cell Therapy For Oncology | Audience Q&A
Expert panelists in this Cell & Gene Therapy Live presentation provided detailed responses to questions about the potential risks of CAR-T therapy, screening criteria for donor material, comparability, and more.
Autoimmune Disease Research's Impact On The Development Of Cell Therapies For Oncology
Recently, many cell therapy companies have been pivoting to autoimmune diseases. Expert panelists discuss whether they think there are any learnings or potential headwinds these pivots could provide to cell therapies for oncology.
Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies
During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.
Improvements In Scaling And Sequencing For Allogeneic Cell Therapies For Oncology
During this segment, Nguyen and Wagner agree that scalability will be a top concern for most CGT companies.
Best Practices For Effective Donor Management
Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.
Major Trends Impacting Allogeneic Cell Therapies For Oncology
We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.
2024 Regulatory Outlook With Dr. Peter Marks And Dr. Nicole Verdun | Audience Q&A
Experts on the Cell & Gene Live event, 2024 Regulatory Outlook, answer questions about topics including pediatric development in rare diseases, diversity planning for ultra-rare disease, anticipated approvals by 2025, and more.
Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs
In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.
Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun
During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.
The Need for Speed: Dr. Peter Marks and Dr. Nicole Verdun Explain Meeting Unmet Need for Pediatric Patients
How can sponsor companies accelerate development in pediatric patients for genetic diseases that affect both children and adults, but where gene therapy holds the greatest promise to address unmet needs in pediatric patients?
Dr. Peter Marks on the Adoption of Novel Precision Analytics
Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.
CMC Comparability: Transitioning to Commercial Manufacturing with Dr. Nicole Verdun
In this segment, Dr. Nicole Verdun shares some of the challenges demonstrating CMC comparability during late-stage product development (i.e., pivotal or Phase 3 clinical trial) that occur while transitioning to commercial manufacturing.
Patient Data's Impact On CMC Robustness
When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.
Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing
In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.
Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways
Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.
Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies
Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?