Roundtable Program

DEBATE, DELIBERATE AND DRIVE SOLUTIONS

50+ Roundtable Sessions meticulously designed to tackle barriers and milestones in innovation, clinical translation, manufacturing, regulatory approval, product launch and patient access for cell and gene therapies.

DISCOVER OUR 8 ROUNDTABLE TRACKS


ENGAGE IN IMMERSIVE, HIGHLY INTERACTIVE FOCUS GROUP DISCUSSIONS TO DRIVE IMPACTFUL ADVANCEMENTS IN THE FIELD


Basic & Discovery Research

Novel science with potential implications.

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

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


The Clinic & Therapeutic Development

From bedside to bench and back again.  The critical role of clinical centers in innovating new therapies and insights into how new therapies are progressing.

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


Bioprocessing & Manufacturing

Developing and implementing an efficient and scalable manufacturing process.

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

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

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


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

Of Interest to:
Laboratory Professionals, Clinicians


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


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 how Mayo Clinic Physicians are redefining patient care by developing cutting edge technologies on innovative immunotherapy, tissue engineering, and 3D Bioprinting.

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


Tools & Tech

Emerging trends in enabling manufacturing and analytical tools.

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 scalibility, 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


Regulation & Policy

Understanding the legislative underpinnings of regulatory authorities and how they impact critical regulatory policies and approaches.

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

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

Discuss how the program will be implemented and participate in the standards development process.



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

Understand challenges associated with commercializing products that are 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

GLOBAL REGULATORY PERSPECTIVES 

The Global Regulatory Perspectives (GRP) is a flagship ISCT program first established in 2007. These roundtables have been crafted using the expertise of the ISCT Global Regulatory Task force to bring together regulators and ISCT delegates from across the globe to work through complex case studies that offer practical insights into timely regulatory challenges.

Integrating shared clinical data into product development can offer significant reductions in resources and time, a model that has been employed in the rare disease space. While clinical data sharing poses challenges, panelists will address whether this might be a feasible model for securing regulatory approval for products derived from the same platform outside the rare disease space.

Of Interest to:
Product Developer, Researcher, Industry, Regulatory Professionals

While a shared-platform approach can simplify and accelerate product development, demonstrating comparability across CGT products remains challenging. This session addresses key design considerations for studies assessing the comparability of CGT products manufactured using the same platform.


Of Interest to:
Product Developer, Researcher, Industry, Regulatory Professionals

Develop pre-clinical studies that pre-empt regulatory challenges for platform-developed products.







Of Interest to:
Product Developer, Researcher, Industry, Regulatory Professionals


Global CGT Markets

Establishing sustainable business models and cost structures to assure development, manufacturing and adoption of advanced therapies.

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

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


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


Established 10 years ago, understand key takeaways from the Japanese experience using the ASRM pathway to regulate clinical access to research-stage unproven therapies for patients in need.

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


COGs & Business Models

Addressing the challenges of developing, manufacturing, and deploying advanced therapies in emerging CGT markets.

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


Workforce Development

Assuring our industry has a skilled and engaged workforce for years to come.

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

MORE ROUNDTABLE TOPICS COMING SOON