Roundtable Program

Understand how MSCs interact with other cell types to capitalize on their therapeutic potential.

Of Interest to:
Researchers, Principal Investigators, Investors, Developers, Regulatory Professionals

Improve workflows for handling commercial CGTs from the sponsor's manufacturing facility through to delivery in the hospital setting.

Of Interest to:
Physicians, Pharmacy Professionals, Advanced Practice Professionals, Laboratory Professionals, Hospital Administrators and Managers, Commercial CGT Manufacturers, Regulatory Professionals

Apply lessons from the oncology field to structure successful clinical development strategies for autoimmune diseases.

Of Interest to:
Therapeutic Developers, Clinicians, Medical Directors, Regulatory Professionals, and Investors

Overcome challenges to designing a large-scale clinical trial for patients requiring immediate care, including patient selection, harmonization of outcome measures, patient monitoring and de-risking.

Of Interest to:
PIs, Product Developers, Clinicians, Regulatory Professionals

Develop strategies to increase the active components in these products and generate value for investors and regulators.

Of Interest to:
Researchers, Therapeutic Developers, Regulatory Professionals, Investors

The failure to gain regulatory approvals in spite of promising pre-clinical data holds lessons for the field. Understand how clinical trial heterogeneity and commercial manufacturing in the MSC space can inform future CGT development.

Of Interest to:
Therapeutic Developers, Manufacturers, Clinicians, Researchers, Regulatory Professionals, Investors

Assess ongoing MSC clinical trials to understand how clinical trial design, disease indication, MSC potency, dose, MSC fatigue and lack of enhancement impact outcomes

Of Interest to:
Academic Researchers, PIs, Therapeutic Developers, Investors, Regulatory Professionals

While Post-Transplant Cyclophosphamide is emerging as standard of care in GVHD prophylaxis, debate whether novel T-cell depletion strategies and techniques should be implemented instead.

Of Interest to:
Clinicians, Laboratory Professionals

Identify key emerging areas in scientific publishing that will shape the future of CGT translation.

Of Interest to:
Academic Researchers, Clinicians, R&D Staff, Students, Laboratory Professionals, Authors, Readers

Optimize strategies to reduce risks across shipment to and cryostorage at clinical sites, and the thawing process prior to administration.

Of Interest to:
Cold Chain Professionals, Therapeutic Developers, Cold Chain Service Providers, QA/QC, Regulatory Professionals

Bridge differences in processes, practices, and strategies across collection sites and sponsors to enable consistency and scalability.

Of Interest to:
Manufacturers, Lab Professionals, Cold Chain Professionals, Industry, Developers, Quality Personnel, Regulatory Professionals

Integrate technologies for the large-scale manufacturing of iPSCs that do not elicit immune responses.

Of Interest to:
Manufacturers, CDMOs, iPSC Product Developers, Academic Researchers, Regulatory Professionals, Investors

Supported by:

Featuring representation from US FDA

Debate the merits and disadvantages of centralized manufacturing, regional processing, and point of care manufacturing.

Of Interest to:
Researchers, Clinicians, Developers, Manufacturers, Regulatory Professionals, Lab Professionals, Operations Management

Leverage key takeaways from ISCT's survey of developers and biomanufacturers to establish effective particulate management strategies.

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

Supported by:

Outline the automated, rapid, and complex QC tests whose integration will enable Point-of-Care deployment.

Of Interest to:
Regulatory Professionals, QA/QC, Laboratory Personnel, Clinicians, PIs, Manufacturers

Debate pros and cons of each vector type in terms of technical barriers and innovation, CMC, applications, and regulatory challenges.

Of Interest to:
Therapeutic Developers, Academic Researchers, Regulators, Enablers

Supported by:

Leverage key takeaways from ISCT's survey of CGT manufacturers to identify opportunities to leverage PATs to improve CGT processes and products.

Of Interest to:
CDMOs, Product Developers, Laboratory Professionals, Tool Providers

Supported by:

Develop an operational plan for designing a large CGT manufacturing lab and managing your transition into the new expanded facilities.

Of Interest to:
Laboratory Professionals, CDMOs, Product Manufacturers

Supported by:

Identify challenges and benefits of implementating post-thaw viability testing programs in clinical cell therapy laboratories.

Of Interest to:
Laboratory Professionals, Clinicians

Learn techniques to de-risk the utilization of cellular starting and raw materials in the manufacture of advanced therapies.

Of Interest to:
Biomanufacturers, Cold Chain Professionals, Sourcing Director, Quality Personnel, Senior Scientist, Operations Manager

Explore Mayo Clinic's collaborative endeavors with industry, academia, and startups to accelerate the adoption of innovative healthcare technologies, gaining valuable insights into their collaboration strategies and their impact on patient-centered cures.

Of Interest to:
Biomanufacturers, CDMOs, Enablers, Start-Ups, Business Development Professionals, Investors

Understand the potential impact of AI tools on the future of drug discovery and development, biomarker discovery, and large-scale clinical -omics data sets.

Of Interest to:
Basic Researchers, Clinicians, Data Scientists, Lab Technologists, Lab Directors, R&D Staff, Therapeutics Developers

Recognize high-potential technologies that will increase product manufacturability and scalability, reduce cost of goods, and improve quality in the CGT sector.

Of Interest to:
Product Developers, Manufacturers, CDMOs

Leverage digital transformation to increase biomanufacturing efficiencies and reduce product costs.

Of Interest to:
CDMOs, Manufacturing & Processing Centers, Developers, Lab Directors, Operations Upper-Management

As immune reconstitution drives all outcomes post-allogeneic transplantation, discuss the innovative strategies and engineering techniques that maximize this reconstitution.

Of Interest to:
Clinicians, Therapeutic Developers

In the wake of the COVID pandemic, debate whether recent innovations in manufacturing and in vivo delivery have made mRNA the most promising therapeutic platform in the sector.

Of Interest to:
Academic Researchers, Clinicians, Therapeutic Developers, Investors, Patient Advocates, Regulatory Professionals

Featuring representation from CAT-EMA (EU)

Understand how regulation can enable or restrict the transformative potential of AI for biomanufacturing.

Of Interest to:
Developers, Regulatory Professionals, Policy-Makers, Biomanufacturers, CDMOs, Investors, Researchers, Data Scientists, Quality Professionals, Lab Professionals

Assess existing and potential standards and accreditation requirements for centers supplying cell therapies across diverse medical specialties.

Of Interest to:
Quality Specialists, Regulatory Affairs Professionals, Laboratory Directors and Managers, Clinicians, Therapeutic Developers

Featuring representation from US FDA, PMDA (Japan), and CAT-EMA (EU)

Develop evidence-based guidelines for the therapeutic development of iPSC-based therapeutics globally.

Of Interest to:
Lab Professionals, Regulatory Professionals, Regulatory Specialists, Clinicians, Manufacturers, Researchers, Therapeutic Developers

Improve on existing models to circumvent risks associated with decentralized manufacturing.

Of Interest to:
Regulatory Professionals, Clinicians, CGT Manufacturers, Policy-Makers, Patient Advocacy Groups, Hospital Administrators

Bridge regulatory and reimbursement requirements so market authorization does not become synonymous with withdrawn CGT products.

Of Interest to:
Therapeutic Developers, Regulatory Professionals, Policy-Makers, Business Development, C-Suites

Better understand malignancy risks associated with CAR-Ts and how these compare to alternative treatments.

Of Interest to:
Clinicians, Regulatory Professionals, Investors, Developers, Researchers

Featuring representation from US FDA, SCB (USA), and NIST (USA)

In this session, panelists from FDA, SCB and NIST will discuss how the Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT) will be implemented and participate in the standards development process.

Of Interest to:
Therapeutic Developers, Academic Researchers, Regulators, Enablers

Featuring representation from US FDA

Understand the challenges associated with commercializing products developed for ultra-rare diseases and debate whether providing these products through perpetual INDs can be a sustainable strategy.

Of Interest to:
Regulators, Policy-Makers, Product Developers

Identify emerging trends in the marketing of unproven products and tactics employed by bad actors to circumvent regulation.

Of Interest to:
Bioethicists, Policy Makers, Regulatory Professionals, Clinicians, Patient Advocates

Adapt your CGT manufacture, infrastructure, and process to anticipate new sustainability-related policies and regulations, and to minimize environmental impacts.

Of Interest to:
Policy-makers, Regulatory Professionals, Academic Researchers, CDMOs, Manufacturers, Product Developers

Supported by:

C-suites from companies in Asia Pacific share their success stories, lessons learned, and future predictions for this emerging leader in CGT.

Of Interest to:
Regulatory Professionals, Developers, PIs, Investors, Researchers, Manufacturers, Multinational Organizations, Upper Management, Business Development

Understand how CAR-Ts are being implemented in emerging markets and debate whether novel therapeutic approaches such as allogeneic NK cells, in vivo gene editing, and combination therapies will enable broader patient access globally.

Of Interest to:
Clinicians, Therapeutic Developers, Pharmaceuticals, Policy-Makers

Featuring representation from PMDA (Japan)

Established 10 years ago, understand key learnings from the Japanese experience using the ASRM pathway to regulate clinical access to research-stage unproven therapies for patients in need and how this differs from the PMDA process.

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

Hear about the dynamics of CGT stakeholder responsibilities and uncover strategies to supercharge collaboration, drive program acceleration, and streamline market entry while reducing costs and minimizing risks.

Of Interest to:
Developers, Biomanufacturers, CDMOs, Investors, Researchers, Manufacturers, Quality Personnel, Enablers, Start-Ups, Business Development Professionals, Manufacturing & Processing Centers, Operations Upper-Management

Understand factors influencing the current capital environment and how CGT companies can creatively generate value.

Of Interest to:
Developers, Enablers, Start-Ups, Business Development

Identify the products and technologies that attract capital, and predict how current behaviors may evolve in upcoming years.

Of Interest to:
Therapeutic Developers, Tools and Service Providers, Academic Spin-Outs, Start-Ups, Investors, Business Development

Expand your company's operations effectively by understanding the value of a good partner and how to set-up a framework for a successful collaboration.

Of Interest to:
Early Stage Developers, Investors, Academic Researchers, Pharmaceuticals Business Development, Large Biotech Business Development

Develop an IP and commercialization strategy that promotes product exclusivity across multiple markets without preventing access for patients in healthcare systems with fewer resources.

Of Interest to:
Product developers, Academic Researchers, Regulatory Professionals, Policy-Makers

Address how training programs can enable cell therapy clinical trials outside large established hospitals, in spite of knowledge gaps and key financial, facility, regulatory, and personnel challenges.

Of Interest to:
Therapeutic Developers, Healthcare Providers, Regulatory Professionals, Patient Advocates, Policy-Makers

Address ongoing efforts by ISCT to establish a comprehensive training curriculum for laboratory technologists.

Of Interest to:
Laboratory Technologists