Roundtable Program

DEBATE, DELIBERATE and DRIVE CONSENSUS

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

Following its success at ISCT 2022 San Francisco, ISCT has curated an enhanced and expanded Roundtable Program for ISCT 2023. ISCT will feature 50+ 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 2023 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. Roundtable sessions are 60-minute pragmatic, participatory, deliberative, and constructive sessions that address practical issues and bottlenecks in CGT translation.

Introducing Confirmed ISCT 2023 Roundtable Sessions

This page will be updated as new topics are introduced

1 Hospital Exemption: Can we Attain Consensus in the EU?

How do we ensure Hospital Exemption serves the interest of individual patients without impeding product development for the broader patient population?

Of interest to: Developers, regulators, clinicians, industry, government

2 Point of Care Manufacturing: Disrupting and Decentralizing Autologous Delivery

Assess capital requirements and the feasibility of establishing point of care manufacturing.

Of interest to: Developers, enablers, regulators, clinicians

3
Regulating MSC Clinics: Are we Doing Enough to Protect Patients?

How do we balance patient access to novel MSC therapies while ensuring they meet sufficient levels of efficacy?

Of interest to: Regulators, clinicians, researchers, manufacturing and processing centers, patient advocates

4
Overcoming Barriers to iPSC Market Readiness: Part I

What game changing technologies can overcome the barriers to iPSC scalability and manufacturing?

Of interest to: Developers, CDMOs, CROs

5
Missing the Cut: Does Prime Editing Advance the Field?

Debate advantages and disadvantages of the two dominant gene-editing technologies. Is one better than the other?

Of interest to: Regulators, clinicians, developers, investors, pharmaceuticals, patient advocates

6
Industry Site Qualification and Surveillance Audits: Is Standardization the Answer?

Can these audits be standardized to optimize human and financial resources without reducing their quality?

Of interest to: Lab managers and technologists, regulators, developers

7
The Threat of Supply Chain Disruptions: Developing Contingency Plans for Cell Processing Labs

How can we establish backup critical materials and supplies by referencing lessons learned from COVID-19?

Of interest to: Lab professionals (technologists, managers, directors), manufacturers, clinicians

8
Automation and Digitalization in Manufacturing: Why is Adoption so Slow?

Identify barriers to the adoption of automation and digitization in manufacturing and explore potential solutions.

Of interest to: CDMOs, manufacturers, upper management

9
COVID-19 Hangover: How do we Regain Trust in Research?

Public trust in science and medicine has decreased during the pandemic. Identify strategies to reverse this trend.

Of interest to: Clinicians, ethicists, researchers, policy makers

10
Raising Capital in the EU Versus the US: Are You Attracting the Right Investor?

Explore similarities and differences between US and EU investors and implications for raising capital.

Of interest to: Academic innovators, biotechs, investors

11
Failure to Launch MSCs 10 Years Later: What's on the Horizon?

Is there a future for MSCs? What is the path forward for these therapies?

Of interest to: Clinicians, developers, regulatory

12
Overcoming Barriers to iPSC Market Readiness: Part II

How to harmonize Quality Control requirements without impacting safety?

Of interest to: Manufacturers, biotechs, regulators, academic researchers

13
The Case of Darvadstrocel: What are the Lessons for Clinical Adoption of MSCs?

With the slow adoption of Darvadstrocel for perianal Crohn's disease, what can the clinic teach us?

Of interest to: Clinicians, gastroenterologists, regulators, developers

14
Exosome Therapeutics: Are MSCs now Redundant?

Debate manufacturing and regulatory advantages of MSC-Exosomes versus MSCs.

Of interest to: Researchers, clinicians, manufacturers, regulators

15
How Emerging US and EU Regulations Impact your Product Development Strategy?

How will new regulatory directives, guidance, programs and clinical trial regulations impact product development in the EU, UK, and US?

Of interest to: Developers, regulators, policists

16
Bypassing the Trial: Where do we Draw the Line for US Expanded Access?

Assess the use of Expanded Access in terms of ethics, regulation, risk, and reimbursement.

Of interest to: Ethicists, researchers, developers, regulators, clinicians, patient advocacy

17
How will the EU SoHo Regulation Impact your Cell Collection?

What are the implications for cell collection based on the European Commission's proposal to combine directives for blood, tissue, and cells?

Of interest to: Regulators, lab personnel, clinicians

18
Ensuring Broad Access to Advanced Therapeutics: The Price is Right?

Recognizing the significant cost associated with the development of advanced therapies, how do we ensure pricing does not impede access?

Of interest to: Policists, patient advocacy, ethicists, clinicians, payers, developers, manufacturers, hospital management

19
Beyond the Lab: When Should You Spin-Out your Innovation?

When should academics spin-out their innovation and how to assess partnering opportunities?

Of interest to: Academic innovators, biotechs, pharmaceuticals

20
Thinking Outside the Box: How Can we Redefine Manufacturing?

How do we turn manufacturing from a cost centre into a key capability enabling innovation?

Of interest to: Manufacturers, upper management

21
Manual Data Collection: Is Digital Capture the Key to Success?

How significant can the impact of early digital capture be on successful product development?

Of interest to: CDMOs, manufacturers, upper management, researchers

22
Pain Points in CGT Cryopreservation: How to Bridge the Gap?

How to develop effective cryo solutions and bring them into the clinical manufacturing paradigm?

Of interest to: Developers, manufacturers, cryobiologists, cold chain suppliers

23
Ditching the Virus: Is This the Future of Gene Therapy Delivery?

What are the technology and regulatory challenges for adoption of non-viral gene therapy?

Of interest to: Academic researchers, clinicians, developers, regulators

24
Manufacturing Gene-Modified Cells: How Do we Get the Process Right?

What are the innovative process development strategies that will improve the manufacturing space?

Of interest to: CDMOs, manufacturers, upper management

25
The Risk of Introducing a New Product into a GMP Facility: Aligning on Critical Parameters

What strategies should be deployed to mitigate risks when introducing new products in GMP facilities?

Of interest to: Lab personnel, manufacturers

26
Lack of Harmonization in CGT: Can we Achieve Global Convergence?

Should convergence on CGT names, regulation and manufacturing be an objective for the field?

Of interest to: Regulators, developers, policists, researchers, manufacturers, clinicians

27 Overlooking Particulate Generation: Challenging the Status Quo

How do we minimize unintended particulate generation in product development?

Of interest to: Clinicians, quality personnel, therapy process developers, tools and enablers

.

28 Investigator to Investor (I to I) Workshop: Where is the Capital?

How do investors approach the CGT field in 2023, and what funding opportunities does this create for investigators?

Of interest to: Researchers, Developers, Investors

29

Global Perspectives: Understanding Challenges to Clinical Adoption.

How do we ensure advanced therapies will reach patients globally, and who will be responsible for it?

Of interest to: Clinicians, upper management, investors, biotechs, pharma, hospitals, policy-makers

30 Asia-Pacific (APAC) Track:

Global Market Strategy: Why is APAC so important in your CGT product value?

How to navigate the complex APAC market to create a sound global commercialization strategy

Of interest to: Business Development, Upper Management, Developers, Biotechs, Pharmaceuticals

31 Asia-Pacific (APAC) Track:

Substantial Challenges for Market Access and Reimbursement in the APAC Region

What are market access challenges in a high density region?

Of interest to: Policy Makers, Investors, Upper Management, Payers, Developers, Hospitals

32 Asia-Pacific (APAC) Track:

Regulation of Biological Ancillary Materials

Compare approaches in APAC, the US, and the EU on risk assessment of ancillary materials

Of interest to: Enablers, Regulators, Developers, Quality Personnel

36
Global Regulatory Perspectives Track:

Twice the Challenge? Gene-Edited iPSC Derived T-Cell and NK/NK-like Products for Cancer Therapy

Are T-cell and NK-like lines multiplying the regulatory and safety challenges in this new dawn of human therapy?

Of interest to: Researchers, Clinicians, Regulators, Biotechs, Investors

37 Global Regulatory Perspectives Track:

Models or Muddles: How do Animal and In Vitro Models Stack Up?

Are T-cell and NK-like lines multiplying the regulatory and safety challenges in this new dawn of human therapy?

Of interest to: CROs, Regulators, Biotechs, Researchers

38 Global Regulatory Perspectives Track:

The What, Why and When in your Bioassay Development Strategy

Are T-cell and NK-like lines multiplying the regulatory and safety challenges in this new dawn of human therapy?

Of interest to: Researchers, Regulators, Biotechs, Pharmaceuticals, CDMOs, Enablers

33-36
Workforce Development Track
(3 sessions)

Understand issues affecting employers and employees in the CGT workspace and how they can be overcome (topics to announced shortly).

SPONSORED ROUNDTABLES

Industry 4.0 and Cell Therapies: Balancing the Tried and True with the Need for New Technologies to Address Bottlenecks in Patient Access

How can smart automation and AI be integrated effectively into ATMP development, manufacturing, and patient delivery?

Of interest to: Upper Management, Enablers, Developers, Manufacturers, Regulators

The Sources of Variability in Apheresis and Standardizing Collections for Improved Starting Material and Patient Experiences

What can biotechs, hospitals, and manufacturers do to improve the quality of starting material?

Of interest to: Manufacturers, Enablers, Developers, Hospitals

Roundtable Program

DEBATE, DELIBERATE and DRIVE CONSENSUS

Roundtable Topics

Introducing Confirmed ISCT 2023 Roundtable Sessions

This page will be updated as new topics are introduced

Hospital Exemption: Can we Attain Consensus in the EU?

Of interest to: Developers, regulators, clinicians, industry, government

Point of Care Manufacturing: Disrupting and Decentralizing Autologous Delivery

Of interest to: Developers, enablers, regulators, clinicians

3Regulating MSC Clinics: Are we Doing Enough to Protect Patients?

Of interest to: Regulators, clinicians, researchers, manufacturing and processing centers, patient advocates

4Overcoming Barriers to iPSC Market Readiness: Part I

Of interest to: Developers, CDMOs, CROs

5Missing the Cut: Does Prime Editing Advance the Field?

Of interest to: Regulators, clinicians, developers, investors, pharmaceuticals, patient advocates

6Industry Site Qualification and Surveillance Audits: Is Standardization the Answer?

Of interest to: Lab managers and technologists, regulators, developers

7The Threat of Supply Chain Disruptions: Developing Contingency Plans for Cell Processing Labs

Of interest to: Lab professionals (technologists, managers, directors), manufacturers, clinicians

8Automation and Digitalization in Manufacturing: Why is Adoption so Slow?

Of interest to: CDMOs, manufacturers, upper management

9COVID-19 Hangover: How do we Regain Trust in Research?

Of interest to: Clinicians, ethicists, researchers, policy makers

10Raising Capital in the EU Versus the US: Are You Attracting the Right Investor?

Of interest to: Academic innovators, biotechs, investors

11Failure to Launch MSCs 10 Years Later: What's on the Horizon?

Of interest to: Clinicians, developers, regulatory

12Overcoming Barriers to iPSC Market Readiness: Part II

Of interest to: Manufacturers, biotechs, regulators, academic researchers

13The Case of Darvadstrocel: What are the Lessons for Clinical Adoption of MSCs?

Of interest to: Clinicians, gastroenterologists, regulators, developers

14Exosome Therapeutics: Are MSCs now Redundant?

Of interest to: Researchers, clinicians, manufacturers, regulators

15How Emerging US and EU Regulations Impact your Product Development Strategy?

Of interest to: Developers, regulators, policists

16Bypassing the Trial: Where do we Draw the Line for US Expanded Access?

Of interest to: Ethicists, researchers, developers, regulators, clinicians, patient advocacy

17How will the EU SoHo Regulation Impact your Cell Collection?

Of interest to: Regulators, lab personnel, clinicians

18Ensuring Broad Access to Advanced Therapeutics: The Price is Right?

Of interest to: Policists, patient advocacy, ethicists, clinicians, payers, developers, manufacturers, hospital management

19Beyond the Lab: When Should You Spin-Out your Innovation?

Of interest to: Academic innovators, biotechs, pharmaceuticals

20Thinking Outside the Box: How Can we Redefine Manufacturing?

Of interest to: Manufacturers, upper management

21Manual Data Collection: Is Digital Capture the Key to Success?

Of interest to: CDMOs, manufacturers, upper management, researchers

22Pain Points in CGT Cryopreservation: How to Bridge the Gap?

Of interest to: Developers, manufacturers, cryobiologists, cold chain suppliers

23Ditching the Virus: Is This the Future of Gene Therapy Delivery?

Of interest to: Academic researchers, clinicians, developers, regulators

24Manufacturing Gene-Modified Cells: How Do we Get the Process Right?

Of interest to: CDMOs, manufacturers, upper management

25The Risk of Introducing a New Product into a GMP Facility: Aligning on Critical Parameters

Of interest to: Lab personnel, manufacturers

26Lack of Harmonization in CGT: Can we Achieve Global Convergence?

Of interest to: Regulators, developers, policists, researchers, manufacturers, clinicians

Overlooking Particulate Generation: Challenging the Status Quo

Of interest to: Clinicians, quality personnel, therapy process developers, tools and enablers

.

Investigator to Investor (I to I) Workshop: Where is the Capital?

Global Perspectives: Understanding Challenges to Clinical Adoption.

Of interest to: Clinicians, upper management, investors, biotechs, pharma, hospitals, policy-makers

Asia-Pacific (APAC) Track:

Global Market Strategy: Why is APAC so important in your CGT product value?

Of interest to: Business Development, Upper Management, Developers, Biotechs, Pharmaceuticals

Asia-Pacific (APAC) Track:

Substantial Challenges for Market Access and Reimbursement in the APAC Region

Of interest to: Policy Makers, Investors, Upper Management, Payers, Developers, Hospitals

Asia-Pacific (APAC) Track:

Regulation of Biological Ancillary Materials

Of interest to: Enablers, Regulators, Developers, Quality Personnel

36Global Regulatory Perspectives Track:

Twice the Challenge? Gene-Edited iPSC Derived T-Cell and NK/NK-like Products for Cancer Therapy

Of interest to: Researchers, Clinicians, Regulators, Biotechs, Investors

Global Regulatory Perspectives Track:

Models or Muddles: How do Animal and In Vitro Models Stack Up?

Of interest to: CROs, Regulators, Biotechs, Researchers

Global Regulatory Perspectives Track:

The What, Why and When in your Bioassay Development Strategy

3
Regulating MSC Clinics: Are we Doing Enough to Protect Patients?

4
Overcoming Barriers to iPSC Market Readiness: Part I

5
Missing the Cut: Does Prime Editing Advance the Field?

6
Industry Site Qualification and Surveillance Audits: Is Standardization the Answer?

7
The Threat of Supply Chain Disruptions: Developing Contingency Plans for Cell Processing Labs

8
Automation and Digitalization in Manufacturing: Why is Adoption so Slow?

9
COVID-19 Hangover: How do we Regain Trust in Research?

10
Raising Capital in the EU Versus the US: Are You Attracting the Right Investor?

11
Failure to Launch MSCs 10 Years Later: What's on the Horizon?

12
Overcoming Barriers to iPSC Market Readiness: Part II

13
The Case of Darvadstrocel: What are the Lessons for Clinical Adoption of MSCs?

14
Exosome Therapeutics: Are MSCs now Redundant?

15
How Emerging US and EU Regulations Impact your Product Development Strategy?

16
Bypassing the Trial: Where do we Draw the Line for US Expanded Access?

17
How will the EU SoHo Regulation Impact your Cell Collection?

18
Ensuring Broad Access to Advanced Therapeutics: The Price is Right?

19
Beyond the Lab: When Should You Spin-Out your Innovation?

20
Thinking Outside the Box: How Can we Redefine Manufacturing?

21
Manual Data Collection: Is Digital Capture the Key to Success?

22
Pain Points in CGT Cryopreservation: How to Bridge the Gap?

23
Ditching the Virus: Is This the Future of Gene Therapy Delivery?

24
Manufacturing Gene-Modified Cells: How Do we Get the Process Right?

25
The Risk of Introducing a New Product into a GMP Facility: Aligning on Critical Parameters

26
Lack of Harmonization in CGT: Can we Achieve Global Convergence?

36
Global Regulatory Perspectives Track:

33-36
Workforce Development Track
(3 sessions)