AGENDA AT A GLANCE
8:00
Registration
9:00
IMAPAC & Chairmans Welcome Address
R&D Nordics Biologics Scale-Up Vision
9:05
Strategies for Designing High-Performing Processes - From Early Development to
Manufacturing
- Explore the economic and operational benefits of process intensification (PI) across bioprocessing stages
- Learn practical strategies to optimize upstream and downstream processes from early development to manufacturing
- Gain insights into accelerating scale-up while reducing costs and facility footprint
09:35
Panel Discussion: The First-in-Human Playbook: Integrating CMC, Clinical, and Regulatory Strategy
- Best practices for designing a "phase-appropriate" CMC package that satisfies regulators without over-investing.
- Navigating the specific regulatory pathways (e.g., ATMP) for novel cell and gene therapies.
- Aligning preclinical data, manufacturing readiness, and clinical trial design for a faster, successful IND/CTA submission.
10:20
Coffee & Networking Break
R&D Early Phase and Clinical Trial Design
11:20
Can We Utilise a Small Molecule Strategy When Developing Therapeutic Peptides?
- Industry landscape analysis: Cross-EFPIA working group findings on DDI packages for approved therapeutic peptides
- Size matters: DDI likelihood is low for larger peptides (>2 kDa), but specific mechanisms require deeper investigation
- Mechanism-specific considerations: Case examples where larger peptides cannot exclude clinical DDI risk without further study
11:50
From Design to Delivery: Executing Personalised Cell Therapy Trials in Sweden – A Small Biotech Perspective
- Developing robust frameworks for first in human studies involving autologous T-cell therapy
- Setting up a local trial in Sweden: considerations and actions
- Providing a small company perspective on cell therapy R&D, manufacturing, and trial execution
12:15
Lunch & Poster Exhibition
13:30
Case Study : Early-Phase Clinical Trial Design: Smarter Strategies for Dose-Finding and Rapid Efficacy Readouts
- Implementing adaptive and Bayesian trial designs to accelerate Phase 1/2 and find the right dose faster.
- Leveraging novel biomarkers and digital readouts (e.g., wearables) for earlier signals of efficacy.
- Dose-finding strategies for complex modalities (e.g., cell therapy, combination therapies) where traditional models fail.
Manufacturing - Innovations in Upstream Processing
14:00
Karolinska ATMP Centre: Accelerating Translational Research to Clinical Application
- Karolinska ATMP Center build on the collective strengths of Karolinska University Hospital and Karolinska Institutet to accelerate translational research into clinical applications.
- leading universities and hospitals have evolve from traditional centres of care, education, research and sporadic innovation into fully recognised Hubs for thriving innovation ecosystems.
- The potential of ATMPs to relieve and cure severe diseases has led to large investments in developing new advanced treatments.
- Collaboration and partnership within the ATMP ecosystem at the "glocal" level is necessary to succeed in bringing all the new research and therapies to patients.
14:30
Tea & Networking Break
15:00
Panel Discussion: Mastering Process Economics: Strategies to Slash Cost of Goods (COGs) in Downstream Operations
- The Cost Drivers: Analyzing the unit cost impact of resins, buffers, and membranes to pinpoint high-ROI optimization targets.
- Intensification Tactics: Leveraging continuous chromatography (MCC) and inline conditioning to reduce facility footprint and buffer consumption.
- Techno-Economic Analysis (TEA): Using predictive modeling to validate that process changes will deliver actual commercial profitability before implementation.
16:00
Cocktail Reception
17:30
End of Day 1
8:50
IMAPAC & Chairmans Welcome Address
AI in Drug Discovery / Digital Factory
9:00
Next-Generation Immunotherapies: Optimising Precision and Efficacy in TCR-T and Bispecific Pipelines
- Therapeutic Development: Advancing TCR-T, TILs, and CAR-T for targeted oncology treatment.
- Precision Characterisation: Monitoring immune response through advanced NGS and single-cell sequencing.
- Bispecific Engagers: Optimising T-cell and NK-cell antibodies for improved safety and efficacy.
- Translational Strategy: Bridging stem cell research and immunotherapy for personalised patient outcomes.
9:30
Solving the 'Translation' Problem: Advanced Preclinical Models & Biomarkers
- Bridging the gap between preclinical efficacy and clinical outcomes with physiologically relevant models
- Leveraging organoids, patient-derived xenografts, and humanised systems to improve predictive accuracy
- Identifying translatable biomarkers for patient stratification and early proof-of-mechanism readouts
10:00
Coffee & Networking Break
Future of Clinical Trials
10:30
Myeloid-Targeted Immunotherapies: Clinical Lessons from MDS and Solid Tumour Studies
- Targeting tumour-associated macrophages and myeloid-derived suppressor cells to overcome immunosuppression
- Clinical trial outcomes: efficacy signals, patient stratification strategies, and biomarker-driven selection in MDS
- Translating learnings from haematological malignancies to solid tumours: combination approaches and resistance mechanisms
11:00
Regulatory Intricacies to Successfully Guide a Product to the Market.
- Navigating FDA, EMA, and global approval pathways with divergent requirements
- Managing CMC comparability and process validation from Phase I to commercial scale
- Leveraging early agency engagement to de-risk timelines and avoid setbacks
11:30
CMO cooperation during CMC Development for the different clinical phases
- Outsourcing Framework: Strategic reliance on CMOs for clinical material production.
- Risk-Benefit Analysis: Evaluating the pros and cons of the external manufacturing model.
- CMC Roadmap: Overviewing critical development stages for non-manufacturing firms.
- Operational Excellence: Optimising clinical supply chains through effective CMO partnerships.
12:30
Lunch & Poster Exhibition
The Nordic Execution Playbook: Integrated R&D and Manufacturing Success Stories
14:00
Resilience on the Road to Innovation: Lessons from Diamyd Medical’s Journey
- Strategic frameworks for overcoming scientific and operational hurdles in complex drug development lifecycles.
- Managing critical partnerships with production vendors to maintain supply chain continuity during setbacks.
- Resilience strategies for transforming manufacturing and partnership challenges into opportunities for long-term growth.
- Analysing the "relentless drive" model and its impact on moving towards mainstream commercial success.
14:30
Case study: Recall of antibiotic capsules released on the Danish and Islandic market.
- Navigating a product recall: timeline, scope decisions, and stakeholder communication
- Root cause investigation: analytical methods, CAPA implementation, and regulatory reporting
- Managing EU authority actions: inspections, warning letters, and pathway to market re-entry
15:00
Patent Dispute Strategies in the Biologics Landscape
- Case studies of biosimilar launches and the resulting legal battles
- Navigating the Patent Cliff
- Dissecting the litigation strategy: When to challenge a patent vs. when to seek licensing
- Key lessons in FTO analysis and patent landscaping to de-risk development and avoid costly, multi-year legal battles
15:30
Chairman's Closing Remarks & End of Conference
15:45
End of Day 2
