WEBINARS AND VIDEOS

• Driving Down COGS Audience Q&A

  Expert panelists provide detailed answers to questions submitted in real time by our registrants providing insightful responses regarding analytical challenges to automation, test automation, and more.

• Safety And Efficiency Of Source Material Collection

  Expert CTO's detail how automation improves safety and efficiency when collecting source material.

• Auto, Allo, And AI

  CTO experts debate autologous and allogeneic, and how automation improves the CAR-T cell process every step from collection to infusion. They also discuss the major ways AI optimizes automation.

• Pipeline Progress

  Experts working on robust pipelines that focus on various therapeutic areas explain how process automation looks different per therapeutic focus area.

• Mitigating Risk In Process Automation

  Two Chief Technical Officer's for therapeutic organizations cover the various ways in which automation helps to reduce risk and why closing systems and reducing the number of manual manipulations is so critical.

• Technology Needs For Automated Manufacturing

  Investigate the importance of technology as it relates to automation and standardization within cell therapy manufacturing. The panelists in this discussion cover solutions and services needed for process automation in CGT.

• Breaking Down Automated Manufacturing

  Experts explain the general benefits of automated manufacturing as well as the key areas that need improvement to scale up quality and to help reduce the costs of therapeutics.

• 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 provide detailed, insightful responses to our audience questions on everything from regulatory timelines to successful and unsuccessful strategies needed to convince the regulators that current regulation requirements are either inappropriate or alternatively excessively burdensome for cell and gene-based therapies.

• 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 Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, examine the regulatory requirements for safety and efficacy demonstration and identify the gaps in regulatory oversight that require clearer guidance.

• 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 the FDA and CBER to have the capacity to provide feedback on development and review submitted applications, among other critical activities. During our 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 break down how PDUFA VII, Fiscal Year 2023 Omnibus Appropriations Bill, and more will impact the cell and gene therapy field in the next few years.

• 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 Regulatory Affairs Officer at BridgeBio, by asking the experts to highlight the main opportunities where the cell and gene therapy industry is working to meet regulatory requirements. They cover accelerated and expedited designation of regenerative medicines, navigating the regulatory requirements around the root causes of genetic disease by repairing or replacing a patient’s genes, and much more.

• 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 with roadblocks with regulators and how they and their teams worked to overcome them.

• 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 demonstrating the prospect of direct benefit.  During this segment of Cell & Gene Live, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO discusses novel approaches to consider going forward.

• Accelerating mAb Development To Meet Increase In mAb Approvals

  To accelerate the delivery of life-saving therapeutics, it is essential to evaluate ways to maximize efficiencies, while minimizing risk, to stay up to speed with the growing demand.

• Enabling GMP Production with Enhanced Single-Use Fermentors

  As more products are moved into single use fermenters, there is greater need to improved oxygen delivery closer to or beyond the abilities of stainless-steel vessels.

• A Collaborative Path To Single-Use Supply Assurance

  Learn how leading biopharma companies such as Sanofi and single-use solutions provider Thermo Fisher Scientific are addressing supply challenges and developing collaborative processes. 

• Optimizing Cell & Gene Therapy Manufacturing Post-COVID

  Cell and gene therapy developers have felt the pressure to optimize processes and streamline activities in order to ensure clinical and commercial success of these critical therapies.

• Accelerating Progress: Key Considerations For CDMOs To Maximize Productivity And Scalability

  Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

• Single-Use Technologies In The Battle Against SARS-CoV-2

  The Single-Use Technologies (SUT) business at Thermo Fisher Scientific is helping our customers in their fight against SARS-CoV-2 by providing assurance of supply. This video discusses our escalation routes through the Coronavirus Command Centre, our SUT capacity expansions and contains a customer testimonial from AGC Biologics.