REGULATIONS AND COMPLIANCE
Inside The Phased, Risk-Based Approach For CGT Materials
In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss the efforts that are underw...
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...
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...
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.
Regulatory Challenges And Future Outlook For iPSC Therapies
In this part of our discussion during the Cell & Gene Live, Unlocking the Potential of iPSC Therapies in Regenerative Medicine, Julie Allickson, Ph.D., Chief Technology Officer at Mayo Clinic's Center for Regenerative Biotherapeutics and Erin Kimbrel, Ph.D., Head ...
Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process
Help shape the future of medicine by building better, safer cell therapies. See how expertise in scalable, GMP-compliant cell engineering can effectively mitigate clinical development risks.
Bridging Analytical Gaps To Ensure CGT Material Quality
In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Cell & Gene Chief Editor Erin Harris was joined by Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Sen...
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...
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...
Strategies To Reduce Regulatory Risks In Gene Therapy
Learn how to mitigate regulatory risk for your gene therapy process.
A CDMO Perspective: Bioprocess Automation And Data Management
Watch this video to understand data management and process automation challenges across single-use bioprocessing applications from a CDMO leader, Paul Jorjorian, VP and GM of Pharma Services at Thermo Fisher Scientific.
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 ...
Ensuring Consistent Removal Of Residual Impurities
In this Cell & Gene Live segment, Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and Kate Rochlin, Ph.D., COO at IN8bio discuss validating impurity r...
MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing
Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.
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.
Regulatory And Biosafety Testing Expertise
Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.
Assessing Residuals In Processing And Fill/Finish For iPSCs
In this segment of Cell & Gene Live, Optimizing Storage Solutions for iPSCs, our expert panelists, Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and...
Simplifying Bioprocess Data Collection
Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.
A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems
In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.
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.
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...
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?
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.
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...
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.
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.
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...
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.
Making USP Guidance Actionable For CGT Materials
In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss USP’s Cell & Gene...
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...