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TUESDAY MAY 30
 

8:30 - 15:45

Global Regulators Summit

Closed Event. By Invitation Only

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16:00 - 19:00

Badge Pick Up & Onsite Registration

Delegates planning to attend 8:00am roundtables should pick up badges
before Wednesday, May 31 to guarantee timely entry into the venue.

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WEDNESDAY MAY 31
 

08:00 - 09:00
ROUNDTABLES
Debate. Deliberate. Drive Consensus

COGs & Business Models

  

Bioprocessing
& Manufacturing

Global Regulatory Perspectives

Regulation
& Reimbursement 

The Clinic
& The Lab.

 Mayo Clinic Enterprise: How Does the Center for Regenerative Biotherapeutics use Teamwork to Accelerate Technology to the Patient

 

  


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


(GRP) Twice the Challenge?  Gene Edited iPSC derived T-Cell and NK/NK-like Products for Cancer Therapy


Hospital Exemption: Can we Attain Consensus in the EU? (part I)


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

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09:15 - 10:15
ROUNDTABLES
Debate. Deliberate. Drive Consensus

Bioprocessing & Manufacturing

  

Manufacturing
Tools & Tech 

Bioprocessing
& Manufacturing

Global Regulatory Perspectives

Regulation
& Reimbursement 

The Clinic
& The Lab.

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

 

  

Overcoming Barriers to iPSC Market Readiness: Part I

 

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

(GRP) Models or Muddles: How Do Animal and In Vitro Models Stack Up?


Hospital Exemption: Can we Attain Consensus in the EU? (part II)


Exosome Therapeutics: Are MSCs now Redundant?

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10:15 - 10:45
 COFFEE BREAK

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10:45 - 11:45
ROUNDTABLES
Debate. Deliberate. Drive Consensus

COGs
& Business Models 

  

Manufacturing
Tools & Tech 

Bioprocessing
& Manufacturing

Global Regulatory Perspectives

Regulation
& Reimbursement 

The Clinic
& The Lab.

Overcoming Barriers to iPSC Market Readiness: Part II


 

  

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


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

(GRP) The What, Why and When in your Bioassay Development Strategy 

 


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


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

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11:45 - 13:00
LUNCH

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12:00 - 13:00
CORPORATE SESSIONS

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Strategies for managing factors affecting cell therapy efficacy

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Advancing patient experience and the importance of QA/QC for autologous CAR T-cell therapy
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13:00 - 14:00
ROUNDTABLES
Debate. Deliberate. Drive Consensus

COGs
& Business Models 

  

Manufacturing
Tools & Tech 

Regulation
& Reimbursement 

Regulation
& Reimbursement 

The Clinic
& The Lab.

Beyond the Lab: When Should you Spin Out your Innovation?

  

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

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

How will the EU SoHO Regulation Impact your Cell Collection?


Failure to Launch MSCs 10 years later: What's on the Horizon?

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14:15 - 15:15
ROUNDTABLES
Debate. Deliberate. Drive Consensus

COGs
& Business Models 

  

Manufacturing
Tools & Tech 

Bioprocessing
& Manufacturing

Regulation
& Reimbursement 

Regulation
& Reimbursement 

Manufacturing
Tools & Tech 

Point of Care Manufacturing: Disrupting and Decentralizing Autologous Delivery

  

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


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

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


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


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

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15:00-16:30

CORPORATE SESSION
15:15 - 15:45
 COFFEE BREAK
 

 Cutting-edge cell and gene therapy – overcoming obstacles from point-of-care to centralized manufacturing
   
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16:15 - 17:00
WELCOME ADDRESS & MAJOR AWARDS 
 
 
 

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18:30 - 20:30
WELCOME & POSTER RECEPTION 1

Mesenchymal Stromal/Stem Cells

Exosomes/EVs

Hematopoietic Stem/Progenitor Cells and Engineering

Tissue Engineering

Embryonic, Organ and Other Tissue Specific Stem Cells

Regulatory Affairs, Quality Systems, Policy, and Ethics

 

 

 

 

 

 

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19:00 - 20:00
ELEVATOR PITCH

Process Development & Manufacturing

Immunotherapy

Gene Editing/Gene Therapies

iPSC
 

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GLOBAL SHOWCASE

18:45 - 19:00


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19:00 - 19:30



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19:15-20:30
Salle Maillot
INNOVATION ZONE

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THURSDAY JUNE 1
 
08:00 - 09:00
SCIENCE & INNOVATION SCIENCE & INNOVATION

CORPORATE SESSION

ROUNDTABLE

COGs and Business Models

 ORAL ABSTRACT

Scaffolding and Extracellular Matrix

Promise and obstacles of cell-derived nanovesicular therapeutics

Scaling Standardized Cell Therapies from Process Development to Clinical Manufacturing

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

Process Development & Manufacturing

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09:15 - 10:15
SCIENCE & INNOVATION SCIENCE & INNOVATION SCIENCE & INNOVATION

ROUNDTABLE

COGs and Business Models

 ROUNDTABLE
Manufacturing
Tools & Tech 		 ORAL ABSTRACT

The Rise of Mitochondrial Transfer Technology in Regenerative Medicine

Novel genome editors and their application in human disease

Organs-on-chips: Advanced culture systems to shape future therapies

 Raising Capital in the EU versus US: Are You Attracting the Right Investor? CDMO Selection: Critical Considerations That Can Make or Break your CGT Development

iPSCs

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10:15 - 10:45
 COFFEE BREAK 
 
 
 

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10:15 - 10:45

Global Showcase Presentation

Takara Bio


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TFBS Bioscience


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12:15 - 13:45

LUNCH

 

 

 

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12:45 - 13:45

CORPORATE SESSION

 


  Overcoming cell therapy manufacturing challenges with automation, scalability, and process flexibility

 

 Streamlining process optimization from process development to commercial with automated solutions

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12:15 - 13:45

GLOBAL SHOWCASE PRESENTATIONS

12:15 - 12:30

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12:30-12:45

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12:45-13:00


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13:00-13:15

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13:15-13:30

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13:30-13:45

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15:15 - 15:45
 COFFEE BREAK
 

15:15-15:30

GLOBAL SHOWCASE PRESENTATIONS

15:15- 15:30


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15:30-15:45



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15:45 - 16:45
TRANSLATION TO CLINIC TRANSLATION TO CLINIC

ROUNDTABLE

Bioprocessing
& Manufacturing

The Clinic
& The Lab

 ORAL ABSTRACT

Advancing iPSCs for Clinical Use

Extracellular Vesicles are Getting Hotter than Ever

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


How does Genome Editing Advance the Field?

Chief Scientific Officer Abstract Showcase

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17:00 - 18:00
TRANSLATION TO CLINIC TRANSLATION TO CLINIC TRANSLATION TO CLINIC

ROUNDTABLE

Manufacturing Tools & Tech

 ORAL ABSTRACT

Progress and Challenges with Gene Editing

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New Frontiers in CGT for Cardiovascular Diseases

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Next-Generation MSC Therapies

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Thinking Outside the Box: How Can we Redefine Manufacturing?

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Late Breaking Abstracts

         

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18:30 - 19:00

ELEVATOR PITCH

Mesenchymal Stromal/Stem Cells

Exosomes/EVs

Hematopoietic Stem/Progenitor Cells and Engineering

Tissue Engineering

Embryonic, Organ and Other Tissue Specific Stem Cells

Regulatory Affairs, Quality Systems, Policy, and Ethics

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18:00 - 19:30

CORPORATE SESSION

Accelerating the path to new cell and gene therapies

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18:00 - 19:30

POSTER RECEPTION 2

Process Development & Manufacturing

Immunotherapy

Gene Editing/Gene Therapies

iPSC

 

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18:15 - 19:15

GLOBAL SHOWCASE PRESENTATIONS

18:15-18:45



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18:45-19:00

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19:00-19:15


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19:30 - 21:00

INDUSTRY NETWORKING RECEPTION

By Invitation Only

19:30 - 21:00

EARLY-STAGE PROFESSIONAL NETWORKING RECEPTION

By Invitation Only
 
FRIDAY JUNE 2
 
08:00 - 09:00
FIRST IN HUMAN TO CLINICAL ACCELERATION FIRST IN HUMAN TO CLINICAL ACCELERATION

CORPORATE SESSION

ROUNDTABLE

Regulation
& Reimbursement 

 ORAL ABSTRACT
Implementing the first mile of big data early to deliver smarter, scalable manufacturing Allogeneic vs Autologous Debate: Developing Cell Therapies with an Eye to Patient Access

Improve Your Starting Material and the Patient Experience with Data and Partnering

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

Exosomes/EVs 
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09:15 - 10:15
FIRST IN HUMAN TO CLINICAL ACCELERATION FIRST IN HUMAN TO CLINICAL ACCELERATION FIRST IN HUMAN TO CLINICAL ACCELERATION

Roundtable

Regulation & Reimbursement

 ORAL ABSTRACT

Tackling Challenges in Cell Therapy for Solid Tumors

Quality, process development, process optimization

Investor accelerator, what’s of interest during clinical acceleration

Global Perspectives: Understanding Challenges to Clinical Adoption

Gene Editing/Gene Therapy 
Learn More Learn More Learn More Learn More
         

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10:15 - 10:45
COFFEE BREAK

10:15 - 10:45

GLOBAL SHOWCASE PRESENTATION

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12:15 - 13:45
LUNCH
 
 
 

 

 

12:15 - 12:45

AGM

 

 

 

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12:45 - 13:45

CORPORATE SESSION

12:45 - 13:45

CORPORATE SESSION



Multivalent RNA CAR-T fro high grade glioma

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Overcoming the inertia; in-house abbreviated qualification of commercial mycoplasma detection kits for your CGT products
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12:15 -13:45

GLOBAL SHOWCASE PRESENTATIONS

12:15-12:45


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12:45-13:00

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13:00-13:15


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13:15-13:30


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13:30-13:45


Learn More

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15:15 - 15:45
COFFEE BREAK
 
 

15:15 -15:45

GLOBAL SHOWCASE PRESENTATIONS

15:15-15:30

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15:30-15:45
GenScript ProBio


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15:45 - 16:45

LAUNCH & PATIENT ACCESS

 LAUNCH & PATIENT ACCESS The Clinic & the Lab ORAL ABSTRACT

Mapping the landscape of public and patient access and engagement

Required infrastructure  for manufacturing advanced therapy products at mass scale


Sustainability of CAR Growth – Streamlining Efforts around the World

Mesenchymal Stromal/Stem Cells

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17:00 - 18:00
LAUNCH & PATIENT ACCESS   LAUNCH & PATIENT ACCESS  LAUNCH & PATIENT ACCESS ORAL ABSTRACT  

The required changes for broad and early accessible cellular therapies: the role of clinical centers

CGT investing basics: Don’t step on the commercial landmine

Regulatory revolution: global harmonization for safe personalized medicines

Immunotherapy

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19:30 -23:30

GALA DINNER

Separate Ticket Required

 

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SATURDAY JUNE 3
 

09:00 - 10:00

ROUNDTABLES

Debate. Deliberate. Drive Consensus
Asia Pacific (APAC) Workforce Development JSRM

The Way of Japan: Japan's Efforts to Promote Science and Industry in the Field of Regenerative Medicine
 Maximizing CGT product value: Why you shouldn’t overlook APAC

Leveling Up: Expanding the Ranks of CGT Lab Leadership and Management Professionals
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10:15 - 11:15

ROUNDTABLES

Debate. Deliberate. Drive Consensus

Asia Pacific (APAC)

 Workforce Development ARM

Closing the CGT Workforce Gap and the Role of Best Practices in Workforce Education 

The Clinic & The Lab

 Market Access and Reimbursement: Same Problem, Different Region

Elevating the CGT Workforce in Europe - Challenges, Opportunities, and Educational Approaches

Pediatric Patients – How to Measure the Risk/Benefit?
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11:15 - 11:45
COFFEE BREAK
 
 

11:45 - 12:45

ROUNDTABLES

Debate. Deliberate. Drive Consensus
Asia Pacific (APAC)  Workforce Development

Regulation & Reimbursement

The Clinic & the Lab
Regulating biological ancillary materials, who's doing it right?

Retaining the CGT Workforce: How NOT to Lose a Technician in 10 Days

Implementation Strategies for a Standardized Chain of Identity Identifier

Tissue Engineering and 3D Bioprinting: Is it still science fiction?
Learn More Learn More Learn More Learn More
 

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09:00 -14:30

Exosomes/ EV Workshop

(Additional registration required)

 

 

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10:00 - 13:00

Cytotherapy Manuscript Writing Workshop for Early Stage Professionals

 

 

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