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8:30 - 15:30
Global Regulators SummitClosed 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.
08:00 - 09:00ROUNDTABLESDebate. Deliberate. Drive Consensus
COGs & Business Models
Manufacturing Tools & Tech
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
Pain Points in CGT Cryopreservation: How to Bridge the Gap?
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 - 10:15ROUNDTABLESDebate. Deliberate. Drive Consensus
Bioprocessing & Manufacturing
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?
10:45 - 11:45ROUNDTABLESDebate. Deliberate. Drive Consensus
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?
12:00 - 13:00CORPORATE SESSIONS
13:00 - 14:00ROUNDTABLESDebate. Deliberate. Drive Consensus
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?
14:15 - 15:15ROUNDTABLESDebate. Deliberate. Drive Consensus
Point of Care Manufacturing: Disrupting and Decentralizing Autologous Delivery
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?
Missing the Cut: Does Prime Editing Advance the Field?
15:00-16:30
CORPORATE SESSION
Cutting-edge cell and gene therapy – overcoming obstacles from point-of-care to centralized manufacturing
18:30 - 20:30WELCOME & 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
19:00 - 20:00ELEVATOR PITCH
Process Development & Manufacturing
Immunotherapy
Gene Editing/Gene Therapies
iPSC
GLOBAL SHOWCASE
18:45 - 19:00
19:00 - 19:30
19:45 - 20:30INNOVATION ZONE
ROUNDTABLE
COGs and Business Models
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?
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
iPSCs
10:15 - 10:45
Global Showcase Presentation
Wuxi
12:15 - 13:45
LUNCH
12:45 - 13:45
Streamlining process optimization from process development to commercial with automated solutions
GLOBAL SHOWCASE PRESENTATIONS
12:15 - 12:30
12:30-12:45
12:45-13:00
13:00-13:15
13:15-13:30
13:30-13:45
15:15-15:30
15:15- 15:30
15:30-15:45
Regulation and Reimbursement
Advancing iPSCs for Clinical Use
Extracellular Vesicles are Getting Hotter than Ever
Manufacturing Gene-Modified Cells: How Do we Get the Process Right?
Chief Scientific Officer Abstract Showcase
Progress and Challenges with Gene Editing
New Frontiers in CGT for Cardiovascular Diseases
Next-Generation MSC Therapies
Thinking Outside the Box: How Can we Redefine Manufacturing?
Late Breaking Abstracts
18:30 - 19:00
ELEVATOR PITCH
18:00 - 19:30
Accelerating the path to new cell and gene therapies
POSTER RECEPTION 2
18:15 - 19:15
18:15-18:45
18:45-19:00Forge
19:00-19:15
19:30 - 21:00
INDUSTRY NETWORKING RECEPTION
By Invitation Only
EARLY-STAGE PROFESSIONAL NETWORKING RECEPTION
Regulation& Reimbursement
Improve Your Starting Material and the Patient Experience with Data and Partnering
Roundtable
Tackling Challenges in Cell Therapy for Solid Tumors
Quality, process development, process optimization
Investor accelerator, what’s of interest during clinical acceleration
Gene Editing/Gene Therapy
GLOBAL SHOWCASE PRESENTATION
10:45 - 12:15FIRST IN HUMAN TO CLINICAL ACCELERATION PLENARY
Next Generation Biotherapeutics: Mapping Roads to Future Healthcare
12:15 - 12:45
AGM
12:15 -13:45
12:15-12:45
15:00 -15:30
15:00-15:15
15:15-15:30GenScript ProBio
LAUNCH & PATIENT ACCESS
Mapping the landscape of public and patient access and engagement
Required infrastructure for manufacturing advanced therapy products at mass scale
Bioprocessing & Biomanufacturing
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
Overlooking Particulate Generation: Challenging the Status Quo
09:00 - 10:00
ROUNDTABLES
Debate. Deliberate. Drive Consensus
10:15 - 11:15
Asia Pacific (APAC)
The Clinic & The Lab
Market Access and Reimbursement: Same Problem, Different Region
Pediatric Patients – How to Measure the Risk/Benefit?
11:45 - 12:45
The Clinic & the Lab
Crossing the Border for a Therapy – What’s the Risk?
Tissue Engineering and 3D Bioprinting: Is it still science fiction?
09:00 -14:30
Exosomes/ EV Workshop
10:00 - 13:00
Cytotherapy Manuscript Writing Workshop for Early Stage Professionals