REGULATORY GUIDANCE AND ENABLING COMPLIANCE
A Successful Journey To Cell Therapy Manufacturing
Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.
Leveraging Rapid Sterility Testing To Advance Cell Therapy Production
Explore the crucial role of rapid sterility testing in cell therapy manufacturing. This presentation delves into the benefits of swift, accurate detection for product quality and patient safety.
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...
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.
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.
Microbial Identification Via DNA-Seq
Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.
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.
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...
Challenge #1: The Changing Regulatory Landscape
By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for...
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.
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.
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...
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.
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.
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.
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.
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.
Key Considerations For Rapid Microbial Methods For Mycoplasma Detection
Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.
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...
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.
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.
Leveraging dPCR r Techniques To Quantitate Lentivirus Particles
Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.
Other CGT Regulatory Challenges
During this segment of Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio detail their own experiences ...
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.
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...
How Past Gene Therapy Approvals Are Shaping the Future with Dr. Peter Marks
In this segment of Cell & Gene Live, Dr. Peter Marks shared what he and his team have learned from current gene therapy approvals to accelerate future approvals.
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.
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.
Advancing Vaccine Development With Novel Chromatography Solutions & Quality Testing
Learn more on novel chromatography solutions that can help improve the downstream processes of different vaccine types such as mRNA, recombinant proteins, and Virus-Like Particles (VLPs).