Optimize manufacturing and commercialization strategies

Of Interest To: Manufacturers, Therapy developers, Industry leader 

Evaluate how MHRA guidelines frame current opportunities and challenges for successful broad implementation of POC manufacturing.

Of Interest To: Manufacturers, Therapy developers, CDO/ CDMO, Tools and Technologies Developers, Clinicians, CMC & Quality professionals 

Prioritize opportunities to implement AI to accelerate iPSC development.

Of Interest To: Manufacturers, QA/QC, Regulatory Professionals, Therapy developers 

Evaluate the risks and benefits of novel regulatory frameworks that support patient access to safe but unapproved and unproven investigational therapies. 

Of Interest To: Clinicians, Researchers, Regulatory Professionals, Regulators, Market Access Teams

Compare advantages and disadvantages of expedited access pathways across major regulatory jurisdictions

Of Interest To: Academic Translation Centers, Therapy developers, CDO/ CDMO, Regulators

Tailor a multifaceted strategy to counteract misinformation campaigns from tech bros and other rogue actors

Of Interest To: Regulators, Industry leader, Researchers, Clinicians

Compare strategies for sourcing and managing raw materials when manufacturing CGT products across multiple jurisdictions

Of Interest To: Regulators, Regulatory Professionals, Manufacturers, Therapy developers, CDO/ CDMO

Establish key opportunities to collect and leverage real world data to inform CGT decision-making

Off Interest To: Researchers, Regulators, Preclinical CRO, Clinicians, Academic Translation Centers

Debate whether regulatory frameworks can evolve fast enough to keep pace with technological innovation in CGT

Of Interest To: Therapy developers, Regulators, Clinicians

Establish a roadmap for implementing New Approach Methodologies to reduce animal use and improve decision-making while meeting regulatory requirements

Of Interest To: Developers, Tools and Technologies Developers, Process Development professionals, Senior Business Leaders

Define the operational, training, and infrastructure strategies needed to safely deliver CGTs in community settings.

Of Interest To: Clinicians, Manufacturers, Therapy developers, CDO/ CDMO

Integrate patient signatures and biomarkers into trial design to maximize patient-specific clinical responsiveness

Of Interest To: Clinicians, Researchers, Investors, Regulators, Senior Business Leaders, Industry leader 

Define strategies to overcome mobilization barriers, personalize protocols, and expand access for gene therapy in sickle cell disease and β-thalassemia.

Of Interest To: Clinical Researchers, Clinicians, Researchers, Regulatory Professionals

Debate whether MSC-sEVs should be classified as a single drug entity or as a batch-specific therapeutic, and outline the implications of each approach

Of Interest To: Regulatory Professionals, Industry leader, Researchers, Clinical Researchers, CMC & Quality professionals 

Define actionable steps for establishing standardized immunomonitoring pipelines and shared data infrastructures

Of Interest To: Clinicians, Researchers, Industry leader, QA/QC, CMC & Quality professionals, 

Explore the safety and long-term follow-up needs, logistical and patient-navigation challenges, and financial and reimbursement considerations for accessing legitimate CGT via cross-border pathways

Of Interest To: Regulatory Professionals, Regulators, Clinicians, Therapy developer, Market Access Teams, Industry leader, Payer

Explore early development strategies to generate commercial viability beyond clinical success.

Of Interest To: Start-ups, Investors, Business development, Manufacturers

Evaluate innovative business approaches to maximize long-term success

Of Interest To: Developers, Researchers, Investors

Determine how the global CGT development pathway will evolve in response to the Most-Favored-Nation prescription drug pricing executive order

Of Interest To: Investors, Industry leader, Regulatory Professionals, Researchers