Roundtable Program

Address gaps in industry expertise and regulatory uncertainty to assess potential value of employing uncommon starting materials.

Of Interest To:
CMC & Quality Professionals, Developers, Clinicians, Biotech, Researchers, Regulatory Professionals

Debate whether newly established consensus criteria constrain scientific innovation.

Of Interest To:
Researchers, Manufacturers, Clinicians

Address operational requirements, including upskilling of staff, that will enable smaller, local clinical sites to deliver complex CGT products to their patients.

Of Interest To:
Therapy Developers, Clinicians, Medical Directors, Regulatory Professionals, and Patient Advocates

Discuss lessons from the US FDA approval process for RYONCIL®, and how these impact development considerations for other cell therapy products for GvHD.

Of Interest To:
Therapy Developers, Clinicians, Medical Directors, Regulatory Professionals, Researchers, Investors, Business Development

Identify major hurdles in the way of manufacturing iPSCs at scale, and develop consensus on priority strategies for the sector to overcome these challenges.

Of Interest To:
Clinical and Biomedical Researchers, Regulatory and Compliance Professionals, Healthcare Policy Makers, Patient Advocates

Debate whether variability in starting materials impacts manufacturing and clinical outcomes of cell therapy products.

Of Interest To:
Researchers, Clinical Researchers, QC Professionals, Industry Leaders, Regulatory Professionals

Address strategies to reduce MSC-EV inter-donor and batch-to-batch heterogeneity, and debate whether these products can succeed where MSCs failed.

Of Interest To:
Researchers, Clinicians, Investors, Regulators, Therapy Developers

Compare innovative approaches to overcome immunogenic barriers and enhance the effectiveness of allogeneic iPSCs.

Of Interest To:
Researchers, Clinicians, Regulatory Professionals, Industry Leaders, Manufacturers

DIscuss whether long-term follow-up study plans can enable accelerated approvals for CGTs, and identify solutions to challenges with long-term data collection and reporting.

Of Interest To:
Clinicians, Business and Industry Leaders, Patient Advocacy

Evaluate how MSC tissue origin, culture conditions, and post-culture processing influence the reproducibility, consistency, and efficacy of MSC-EV therapies, to develop strategies to standardize manufacturing and improve their viability.

Of Interest To:
Process Development Professionals, Manufacturers, Therapy Developers, Biotech, Researchers

Address whether national registries can standardize starting materials, and identify the resources required to successfully launch and maintain one.

Of Interest To:
Therapy developers, Regulatory Professionals, Researchers, CMC & Quality professionals, Clinicians

Discuss key challenges that limit patient access to CGTs and debate how healthcare decisions should frame these challenges given quality-of-life considerations that are specific to CGTs

Of Interest To:
Developers, Regulators, Policy-Makers, CDMOs, Investors, Researchers, Quality Professionals, Manufacturers, Lab Professionals, Industry, Business Development Professionals, Regulatory Professionals, Therapy Developers

More information forthcoming

Of Interest To:
TBD

Discuss novel practices and technologies that enable consistent and reproducible manufacturing of iPSCs.

Of Interest To:
Therapy Developers, Manufacturers, CDO/ CDMO, Preclinical CRO

Evaluate innovative Quality Control strategies that maintain rigorous quality standards while enabling rapid deployment of cell and gene therapies at scale.

Of Interest To:
Quality Control Specialists, Manufacturer, Process Development Professionals, Regulatory Professionals, Researchers

Compare advantages and disadvantages of various unique facility designs, and develop recommendations to expand manufacturing capabilities.

Of Interest To:
Therapy Developers, Manufacturers, CDO/ CDMO, Regulators

Overcome obstacles to decentralized and distributed manufacturing to enable access to approved CGTs.

Of Interest To:
CMC & Quality Professionals, Process Development Professionals, Clinicians

Debate the optimal use of controlled-rate freezers.

Of Interest To:
Cold Chain Professionals, Therapy Developers, Cold Chain Service Provider, QA/QC, Regulators

Address strategies to realize the full potential of PATs, and evaluate the impact of AI, including Computer Vision, on these technologies.

Of Interest To:
Therapy Developers, Process Development Professionals, CDO/ CDMO, Tool and Technology Developers, Academic Translation Centers

More information forthcoming

Of Interest To:
TBD

Evaluate opportunities to integrate AI into manufacturing processes, and establish robust data governance frameworks that address data verification, validation, and monitoring.

Of Interest To:
Biotech, Pharmaceuticals, Manufacturers, CDO/ CDMO, Process Development Professionals, QA/ QC, Regulatory Professionals, Lab Technologists

How can adopting data-driven manufacturing and advanced analytics optimize cell health data, build predictive models, and ensure quality control, to ultimately making these therapies more accessible and cost-effective?

Of Interest to:
Developers, Regulators, Policy-Makers, Biomanufacturers, CDMOs, Investors, Researchers, Data Scientists, Quality Professionals, Manufacturers, Lab Professionals, Cold Chain Professionals, Industry, Quality Personnel, Enablers, Start-Ups, Business Development Professionals, Manufacturing & Processing Centers, Lab Directors, PIs, Operations Upper-Management

A takeaway from ISCT 2024 Vancouver was that several APAC countries apply PIC/S GMP standards differently. This year, approaches to bridge these differences will be identified.

Of Interest To:
CMC & Quality Professionals, Manufacturers, Regulators, Regulatory Professionals, Therapy Developers

Discuss scientific, ethical and legal considerations of germline gene editing.

Of Interest To:
Researchers, Policy-Makers, Regulators, Developers, Patient Advocacy Groups

Leverage lessons from the Viral Specific Cytotoxic T Lymphocytes (VSTs) field to identify critical factors in the design of successful cell therapy clinical trials.

Of Interest To:
Biotech, Regulatory Professionals, Industry Leaders, Clinical Researchers, Researchers, Clinicians

Develop viable solutions that Health Authorities can implement.

Of Interest To:
Biotech, Regulatory Professionals, Industry Leaders, Clinical Researchers

Outline regulatory challenges in decentralizing manufacturing, including quality control and comparibility across sites, and debate whether it will be necessary to adapt regulation.

Of Interest To:
Manufacturers, Therapy Developers, Regulatory Professionals

Debate whether the administration of genetically-modified IECs increases secondary malignancy risks.

Of Interest To:
Researchers, Clinicians

Integrate operational constraints into trial design to enable informative CGT studies in sites with varying infrastructures and expertise.

Of Interest To:
Researchers, CRO, Regulatory Professionals, Clinicians, Patient Advocates, Clinical Operations Staffs

Five years since its inception, debate how the implementation of Project Orbis can inform an ambitious global approval regulatory pathway.

Of Interest To:
Regulatory Professionals, Regulator, Therapy Developer

Address how recent regulatory developments regarding Lab Developed Tests, including Companion Diagnostics, can impact your lab.

Of Interest To:
QA Professional, Regulatory Professionals, Program Director, Lab Technologist

Define the major manufacturing challenges for RNA-based therapies and develop recommendations for the sector.

Of Interest To:
Therapy Developer, Researchers, Manufacturers, Regulatory Professionals

Identify key opportunities and challenges across the sector globally as political administrations implement new policies.

Of Interest To:
Researchers, Biotech, Pharma, Investors, Clinicians, Regulatory Professionals, Manufacturers

Address when pursuing RCTs might be unfeasible or unethical, and approaches to strengthen clinical data obtained through other trial designs to secure reimbursement.

Of Interest to:
Market Access Teams, Industry Leader, Clinical Researchers, Clinicians, Start-Ups, Regulators, Researchers, Regulatory Professionals

Discuss the impact of regional regulatory differences on ancillary materials for cell and gene therapy and their effects on manufacturers and therapy developers.

Of Interest To:
Developers, Regulators, Biomanufacturers, CDMOs, Researchers, Quality Professionals, Manufacturers, Industry, Quality Personnel, Manufacturing & Processing Centers, Lab Directors, PIs

Debate the impact on the market of new CAR T products being made available at reduced costs.

Of Interest To:
Clinicians, Therapy Developers, Regulators, Reimbursement Agencies, Patient Advocacy Groups

As Japan's ASRM legislation gains traction in other Asian regulatory frameworks, debate the risks and benefits of this innovative approach and explore potential challenges to its implementation.

Of Interest To:
Therapeutic Developers, Clinicians, Regulators, Policy Makers, Academic Researchers

What can we learn from CAR T products being manufactured at significantly reduced costs, and will this drive the costs of these therapies down globally?

Of Interest To:
Manufacturers, Therapy Developers, Regulatory Professionals, Researchers

Assess how incubators can support early-stage ventures and debate whether these organizations can evolve at the pace of the sector.

Of Interest To:
Academic Spin-outs, Start-ups, Business Development

Deconstruct the capital market to understand whom to raise from and when.

Of Interest To:
Academic Spin-outs, Start-ups, Investors, Business Development, Therapy Developers

Analyze recent trends in pharmaceutical licensing and acquisitions to assess their viability as a funding source for your product.

Of Interest To:
Tools and Technologies Developers, Therapy Developers, Biotech, Investors

Using Sickle Cell Anemia as a case study, debate key challenges in making gene therapies viable globally.

Of Interest To:
Market Access Teams, Senior Business Leaders, Clinicians, Industry, Researchers

Optimize a strategy to secure reimbursement across multiple systems by evaluating novel creative reimbursement models and key differences between payer frameworks.

Of Interest To:
Therapeutic Developers, Policy-Makers, Business Development, C-Suites

Debate the current and future workforce gaps, and identify critical training needs that organizations such as ISCT can address.

Of Interest To:
Biotech, Trainees, Educators, Manufacturing Professionals, Training-Focused Non-Profits, QC/QA