PDA Advanced Therapy Medicinal Products Conference 2026

Topics we are looking for:

• 1. Cell and Gene Products

  • Gene Modified Stem Cells 

  • Gene Edited Products 

  • CAR T-Cells and other Lymphocytes 

  • Tumor-Infiltrating Lymphocytes (TILs) 

  • Natural Killer Cells 

  • In Vivo Gene Therapy (AAV) 

  • Viral Vectors (GRV, Lentiviral) 

  • Dendritic Cells 

  • mRNA-based Products 

  • Autologous and Allogeneic Products

  • iPSC 

• 2. Regulatory and Policy Updates

  • EU GMP Part IV & Annex 1 Revisions 

  • PIC/S Annex 2A/2B Updates 

  • SoHO Regulation 

  • Harmonization in GMO Regulation 

  • Regulatory Requirements for Process Validation 

  • European Health Technology Assessment Regulation 

  • ICH Q5A and Comparability Guidance 

  • Global Regulatory Alignment and Mutual Recognition Agreements 

  • New Pharma Legislation in the EU

• 3. Raw and Starting Materials and Equipment

  • Cell Lines, Buffers, Proteins, and Complex Raw Materials 

  • Characterization and Life Cycle Management 

  • Application and Delivery Devices 

  • Single-use and Digitalized Equipment 

  • Transition to GMP-grade Materials 

  • Scaffolds, iPSCs, and Media 

  • Packaging Requirements

• 4. Manufacturing

  • Process Development and Unit Operations 

  • Facility Design, Closed/Open Systems 

  • Viral Vector and mRNA Manufacturing 

  • CMC Strategies and Cost of Goods 

  • Automation and Robotics 

  • Data Management, Digital Twins and AI 

  • Sterility Assurance and Contamination Control 

  • Validation Strategies 

  • Comparability Strategy 

  • Risk Management and Visual Inspection 

  • Emerging Technologies: CRISPR, Exosomes, Lipid Nanoparticles 

  • Technology Transfer 

  • Operator Training and Qualification 

  • Particles 

  • Visual Inspection for ATMPs 

  • Donor Screening

• 5. Logistics and Supply Chain

  • Chain of Custody/Identity 

  • Cryopreservation and Cold Chain 

  • Shipping Validation and Hold Studies 

  • Supply Chain Labelling and CDMO Management 

  • Operator Qualification and Paperless Systems 

  • Turnaround Time and Site Localization

• 6. Analytical Development and Testing

  • Bioassays and Potency Testing 

  • Quality Control and Method Validation 

  • Viral Vector Characterization 

  • NGS and Contamination Testing 

  • Comparability and Conditional Release 

  • Alternative and Platform Methods 

  • Automation and Speed in QC 

  • Rapid Methods 

  • Inline Monitoring 

• 7. Clinical Aspects

  • Clinical Trial Design and Immuno-Profiling 

  • Measuring Treatment Response and Potency 

  • Drug Delivery Devices and Companion Diagnostics 

  • Apheresis and Point-of-Care Standards 

  • Correlation Between Manufacturing and Outcome 

  • Novel Oncology Applications

• 8. From Lab to Market

  • Academic and Commercial Partnerships 

  • Technology Transfer and Scalability 

  • Intellectual Property and Market Frameworks 

  • Innovative Financing and Reimbursement Models 

  • Commercialization Pathways and Risk-Based Strategies 

  • Hospital Exemption vs. Centralized Approval 

  • Phase Appropriateness 

• 9. Sustainability

  • Cost of Goods Reduction 

  • Ecological and Carbon Footprint 

  • Energy and Waste Management 

  • Biosafety and PFAS Alternatives 

  • Sustainability Tools and Culture 

  • Environmental and Occupational Safety