REGULATORY GUIDANCE AND ENABLING COMPLIANCE
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.
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...
Interview With Pharma Analytics Field Application Specialist - Sandi True
Hear Sandi True, a Field Applications Specialist discuss helping customers navigate challenges often encountered when evaluating and implementing Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.
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...
Simple In-House Mycoplasma Testing Method For Regulatory Expectations And Rapid, Confident, And Actionable Results
In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities.
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.
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.
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.
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.
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.
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.
Innovative Contamination Control: Enabling Integrity And Efficiency
An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.
ResDNASEQ Workflow Solution
Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.
Interview With Nico Chow And Sandi True, Field Applications Specialists
Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.
Cell And Gene Therapy Innovations
This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.
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.
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.
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...
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.
A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation
Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.
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.
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?
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...
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...
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.
Microbial Identification Via DNA-Seq
Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.
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.
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.
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.
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.