REGULATIONS AND COMPLIANCE
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...
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.
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...
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...
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?
Lower Variability For Viral Titer Determination
Learn about the benefits of ddPCR for ensuring precise and reproducible viral titers in the development of effective adeno-associated virus AAV-based gene therapies.
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...
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...
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 ...
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...
Master The 2-Point Calibration Process To Maintain Data Integrity
Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.
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...
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.
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.
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...
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.
Prioritizing Quality, Fit, And Supplier Reliability In CGT Materials
In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," 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 & Gen...
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.
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...
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.
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...
Executive Roundtable: Cell Therapy Predictions For 2025 And Beyond
In this executive roundtable discussion, Bioprocess Online editor Tyler Menichiello is joined by CEO, co-founder, and president of Ossium Health, Kevin Caldwell, CSO of FibroBiologics, Hamid Khoja, Ph.D., and president and acting CEO of Triumvira Immunologics, Ro...
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.
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 ...
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...
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 ...
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?
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 #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...
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...