ISCT 2022 Roundtables

1
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

2
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

3
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

4
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

5
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

6
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 

7
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

8
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

9
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

10
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

11
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

12
Tackling Challenges in your Stability Program

Discuss and debate challenges with stability programs for cryopreserved HCTPs.

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

13
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

14
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

15
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

16
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

17
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

18
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

19
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

20
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

21
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

22
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

23
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