Advanced Therapy Medicinal Products Conference

Key Themes for the ATMP Conference 2025

• Gene & Cell Therapy Development: Advances in ex vivo/in vivo gene editing, CAR-T, TCR-T, and stem cell technologies.
• Manufacturing & Scale-Up: Next-gen GMP manufacturing platforms, automation, and decentralized models.
• Clinical Trials & Translational Science: Innovative trial design, biomarkers, and patient-centered approaches.
• Regulatory Frameworks & Approvals: Navigating EMA, FDA, and HTA pathways for faster, safer ATMP access.
• Access, Reimbursement & Health Economics: From pricing models to value-based outcomes and market entry strategies.
• Hospital Exemption & Academic Innovation: Non-commercial ATMPs and public-sector pathways for treatment innovation.

Who Should Attend

• Scientists & Clinicians: Researchers in gene/cell therapy, regenerative medicine, immunology, oncology
• Biotech & Pharma Executives: Leaders in R&D, clinical development, manufacturing, regulatory affairs, CMC
• Investors & Venture Capitalists: Focused on emerging biotech, platform technologies, and cell/gene therapy startups
• Regulators & Policymakers: From EMA, FDA, and national health agencies working on ATMP frameworks and policy
• Academic & Hospital GMP Units: Public and university-based developers of non-commercial/hospital exemption ATMPs
• Patient Advocates & HTA: Professionals Driving equitable access, patient-centered design, and health technology assessment

Industries Represented

• Cell & Gene Therapy: R&D, vector engineering, CAR-T, genome editing, regenerative platforms
• Biomanufacturing & GMP Facilities: Scale-up, aseptic processing, automation, closed systems, QA/QC
• Regulatory Affairs & Policy: EMA, FDA, HTA bodies, regulatory strategy, market access experts
• Clinical Trials & Translational Medicine: Trial design, biomarker development, investigator sites, CROs
• Investment & Venture Capital: Biotech VCs, institutional investors, innovation accelerators, licensing leads
• Academic Medical Centers& Hospitals: Hospital-exempt ATMP developers, university GMP units, translational consortia
• Global Health & Rare Disease Advocacy: Foundations, NGOs, and public–private partnerships driving equitable access

Key Themes

• Gene & Cell Therapy Frontiers; Ex vivo and in vivo gene editing (CRISPR, base editing)
• GMP Manufacturing & Platform Technologies; Decentralized, hospital-based, and modular production
• Regulatory Innovation & Global Harmonization; EMA’s new guidance on ATMPs and PRIME designation
• Clinical Trials & Translational Strategy; Adaptive trial designs and decentralized trials
• Reimbursement & Health Technology Assessment; Early access schemes and outcomes-based pricing
• From Innovation to Patient; Long-term safety tracking and patient registries