REGULATORY GUIDANCE AND ENABLING COMPLIANCE
Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry
Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.
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...
CGT's Main Opportunities To Meet Regulatory Requirements
Host and Moderator, Erin Harris, Chief Editor of Cell & Gene, began this Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, featuring Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regul...
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...
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.
Successful Microbial Testing And Identification
In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.
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.
Rapid Micro Methods In QC Micro Testing: A NIBRT Perspective
Learn about some of the advanced Rapid Micro Method systems that are being adopted by biopharma companies worldwide, and how they are changing the face of QC Microbiological testing.
Maximize Quality Assurance Through Rapid Sterility Testing
This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.
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.
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...
Explore The Analytics Knowledge Hub
Discover smarter solutions with the new Analytics Knowledge Hub that provides articles, webinars, e-books, and infographics designed to enhance and streamline your bioprocess workflow.
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.
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.
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...
mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A
During our Cell & Gene Live, mRNA For Cancer Immunotherapy 2024 Outlook, our expert panelists answered audience questions regarding patient safety, foreseeable challenges in mRNA cancer immunotherapy for solid tumors, and much more.
Implementing Rapid Microbial Identification In Biotherapy Manufacutring
Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.
Validation Of A qPCR Assay For Host Cell DNA Quantitation
Here, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of host cell DNA to help meet regulatory requirements.
CAR-T Innovation: Balancing Allogeneic And Autologous Cell Therapy
Join experts as they discuss strategies for optimizing allogeneic and autologous therapies, aiming for balanced development and wider patient accessibility by 2030.
Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials
Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.
What's New for 2024: Dr. Nicole Verdun Offers a Look Inside The Office Of Therapeutic Products
What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024?
Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies
Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.
Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A
During each Cell & Gene Live, our audience has the opportunity to submit real-time questions for our expert panelists. Watch and listen as Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio p...
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.
Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data
There are more than 7,000 unique, rare diseases recognized in the United States, and 300 million people worldwide living with a rare disease; patients often experience a long journey to receive their diagnosis. Our expert panelists, Nina Hunter, Ph.D., VP Corporate Strate...
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.
An All-In-One Solution For Residual DNA Quantitation
Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.
Microbial Identification Via DNA-Seq
Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.
Challenge #3: Lack Of Animal Models
Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial. In the absence of good animal models, there may be challenges demon...
Innovations In Mycoplasma And Sterility Testing For Biopharma
In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.