ISCT 2022 Roundtables


When a lecture just doesn't cut it, JOIN THE CONVERSATION and be PART OF THE SOLUTION

NEW FOR 2022, ISCT will feature 30+ roundtable sessions dedicated to addressing barriers and milestones in innovation, clinical translation, product launch and patient access.  Attendees can expect to immerse themselves in highly interactive focus group discussions to tackle controversial topics, issues and find solutions for the biggest challenges facing the translation of cell and gene therapies.


Roundtable Topics

Curated to confront the most topical issues facing the CGT sector today  

The ISCT 2022 Roundtables are organized and hosted by our 40+ standing committees as well as our corporate partners, representing a global network of experts spanning the entire cell and gene therapy translation chain.    

Potency Assays: Why, When and What If?

How to bridge clinical data and remove variability, assess alternate applications of potency assays during development and manufacturing

Of interest to: Investigators, lab staff, quality and regulatory personnel

Expanded Access and Hospital Exemption: Understanding Investigational Treatment Pathways

What’s the purpose of investigational treatment pathways? What are the limitations of these pathways? What are the considerations for risk vs. benefit assessments?

Of interest to: Developers, Regulatory, Clinicians, Ethicists

Let’s Talk Particulates: Risk Assessment and Mitigation Practices for CGT Product Development

Is there a need to reexamine the effects of particulates in product development? Can the industry establish a standardized approach to current regulatory guidance interpretation or are new cell therapy standards required? Are the current standards applicable to therapies beyond auto/allo products?

Of interest to: Developers, Regulatory, Clinicians, Manufacturers

CAR T Infrastructure Expansion Beyond BMT Centers: How do we get there?

Preparing for the next wave of CAR T. Debating the need, feasibility and benefit of administering these therapies outside of BMT facilities. The session addresses social and physical infrastructural requirements for community oncologists and hematologists to administer CAR T-cell therapies

Of interest to: Developers, Regulatory, Clinicians, Enablers

Starting Materials for Cell Therapies: Where Are We and Where Are We Headed

Building consensus on standardization of donor materials (eligibility and testing).

Of interest to: Labs, Regulatory, Clinicians, Manufacturers, CDMOs, Developers

COVID-19 Effects on Critical Supply Shortages: Strategies to Adapt

The methods used to mitigate delays work as a short term solution, but are they sustainable in the long-term? What lessons were learned during the first wave? How are manufacturers proving equivalence to satisfy regulations? How have suppliers and manufacturers dealt with these shortages and what challenges remain?

Of interest to: Labs, Clinicians, Suppliers, Manufacturers 

Navigating in the Dark: Off-Target Effects of Gene Editing

How to evaluate risk without sufficient regulatory guidance? 

Of interest to: Investigators, Clinicians, Developers, Regulatory

Strategies to Attract Capital for CGT Tools and Technologies Businesses

How to support manufacturing capabilities to keep up with clinical advancements?

Of interest to: Tool Developers, CDMOs, Manufacturers, Logistics, Investors

Linking Patient Biology to MSC Responsiveness

Overcoming the roadblocks for MSC therapies – discussing new approaches to link patient endotypes and MSC attributes to expected clinical outcomes

Of interest to: Investigators, Clinicians, Developers, Enablers, Regulatory

CGT Workforce Development: Managing the Revolving Door – Recruitment and Retention Strategies

Addressing challenges associated with maintaining competent, skilled personnel for cell and gene therapy.

Of interest to: Industry biotechs, labs, academic institutions

Optimizing CAR T Therapies: Mitigating Toxicity While Improving Patient Outcomes

Addressing the factors that impact relapse and toxicity outcomes of CAR T therapies and strategies to develop optimal CAR T package therapy.

Of interest to: Clinicians, developers, regulatory

Tackling Challenges in your Stability Program

Discuss and debate challenges with stability programs for cryopreserved HCTPs.

Of interest to: Lab, enablers, supply chain, logistics

Sterility testing: What and When to Test, and How to Manage Positive Results

Discuss how/when/what to test for sterility during IND product manufacturing, and how to mitigate and report contamination occurrences.

Of interest to: Quality Personnel, Regulatory, CDMOs, Manufacturers

Debating the Acceptable Risk of AAV- Based Genomic Integration

Explore how to measure, characterize genome integration. Discuss how to assess the risk associated with genome integration.

Of interest to: Regulatory, manufacturers, preclinical, clinical

Discussing the Complexity of Cold Chain Management

Part 7 of PPD Cold Chain Series – Summarizing the challenges mentioned along the pipeline and what we can do to address.

Of interest to: Quality personnel, industry, CDMOs, regulatory

Debating the MSC paracrine MoA: EVs vs Efferocytosis

The field is divided between two explanatory models: EVs and Efferocytosis. Discuss and debate both models.

Of interest to: Preclinical, Industry, Regulatory

CGT Workforce Development: Digging into the Problems and Root Causes of the Workforce Shortage Crisis

Exploring the problems and cross-sector impact faced by a shortage of a competent, trained, and skilled workforce as the CGT field tries to keep up with its exponential growth.

Of interest to: Industry biotechs, labs, academic institutions

Come to us First – Facilitating Product Development between Academia and Industry

Addressing the need for developers to consult with hospitals/academic centers throughout product development.

Of interest to: Industry Biotechs, Labs, Academic Institutions

Chain of Custody/Identity: Are there Broken Links to Fix that Ensure Patient Safety?

Discuss what are the fundamental critical control points that assure both collectors and distributors of product identity, and tackling the barriers and hurdles of adopting an international labeling standards (ISBT 128).

Of interest to: Quality Personnel, Lab Techs, CDMOs, Regulatory, Manufacturers

Current Approaches to Advanced Cell and Gene Therapies: How Much Risk is Too Much Risk?

Analyzing risk-benefit of cell and gene therapies in the context of immediate life threatening disorders vs. disorders that are devastating on the long term.

Of interest to: Clinicians, Regulatory, Developers

Expectations and Challenges for iPSC-based Cell Therapies

15 years since the inception of iPSCs, discuss the translational successes, challenges, and future horizons for the field.

Of interest to: Developers, Preclinical, Clinical, Academic Institutions

CGT Workforce Development: The Role of ISCT in the Creation of a Sustainable and Skilled Workforce

How can ISCT help overcome the CGT workforce bottlenecks identified in the first two installments of the series? Learn about current CGT workforce training initiatives and help shape ISCT strategies to build a sustainable, skilled workforce.

Of interest to: Industry Biotechs, Labs, Academic Institutions

CAR T Cell Therapy 10 Years Out: Are we at a Cure?

Ten years after remission of two patients treated with CAR T cells, can we talk about a cure for certain cancers?

Of interest to: Developers, Labs, Clinical Preclinical, Academic Institutions

Check back regularly as more roundtable sessions are confirmed


Innovative Cell and Gene Therapy Clinical Trial Design and Development Strategies to Enhance Inclusivity and Diversity

Description TBC

Of interest to: Industry Biotechs, Academic Institutions


Defining the Future of Cell Therapy Automation

  • When to automate, considerations based on your organizational goals and phase
  • The role of robotics in automation, what we can learn from other industries
  • The impact of automation on the workforce, endemic considerations
  • Lessons learned and impact of automation in cell therapies from biopharma

Of interest to: Industry Biotechs, Academic Institutions, Developers

SciBite and L7 Informatics Partner to Deliver Data Ontology Search Through  L7|ESP™

Digitalization of Cell Therapy Laboratories

There is a growing demand for digital solutions in cell therapy laboratories due to increasingly complex processing, shortening timelines, and ever-present shortages of trained personnel.  What are some of the key factors to consider as cell therapy laboratories map out their digitalization strategy?

Of interest to: Industry Biotechs, Labs, Academic Institutions

Importance of Utilizing Multiparametric Selection in Isolating More Persistent T-cell Population to Enable Better CAR-T Therapy Success

The session will include perspectives from multiple participants that speak to the importance of utilizing multiparametric selection in isolating more persistent T cell population to ensure better patient prognosis after CAR-T Therapy. The goal is to discuss the importance of process automation, targeted immune cell subtype selection, importance of purity and viability in a typical CAR-T manufacturing workflow

Of interest to: Academia, Labs, Regulatory, Developers, Enablers, Manufacturers


Mayo Clinic Building the Ecosystem in Regenerative Biotherapeutics

The session will include discussion on building an innovative, national ecosystem for Regenerative Biotherapeutics. What are the roadblocks from discovery to commercialization? How can we share innovative technology with industry for successful incubation and newco acceleration? What is different about the Mayo Clinic pathway from treatment to cures? How (and when) will patients benefit from these novel biotherapeutics?

Of interest to: Academia, Labs, Regulatory, Developers, Enablers, Manufacturers

cellicon valley

Creating an Academic-Industry Ecosystem for Advanced Therapies:  The Cellicon Valley Story and Lessons Learned

Of interest to: Academia, Labs, Regulatory, Developers, Enablers, Manufacturers


Optimizing the Vein to Vein Pathway: Part 2

Of interest to: Academia, Labs, Regulatory, Enablers, Manufacturers