AGENDA AT A GLANCE
8:00
Registration
8:50
IMAPAC & Chairmans Welcome Address
R&D Nordics Biologics Scale-Up Vision
9:00
Future-Proofing Production: Designing a Resilient, Long-Term Manufacturing Network
- The "Build vs. Buy" decision: When to invest in-house vs. outsourcing to strategic CDMO partners.
- Designing a flexible network that can handle multiple modalities (mAbs, CGT, mRNA).
- Geopolitical strategy: How to build a "sovereign" and resilient supply chain for critical medicines.
9:25
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
09:50
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.
10:35
Coffee & Networking Break
R&D Early Phase and Clinical Trial Design
11:05
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.
11:30
Reserved for solution provider (Or Ralph Knoll, Chief Scientist, AstraZeneca)
11:55
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
12:20
Lunch & Poster Exhibition
Manufacturing - Innovations in Upstream Processing
13:50
The Clinical-to-GMP Hurdle: Tech Transfer & QbD Best Practices for Emerging Biotechs
- Implementing Quality-by-Design (QbD) principles early in R&D to prevent late-stage manufacturing failures.
- Creating a robust tech transfer package to ensure a seamless, "right-first-time" move to a CDMO.
- Common pitfalls for startups when scaling up from the research bench to a 2000L GMP bioreactor.
14:15
Reserved for Solution Provider
14:40
Bridging the Manufacturing Gap: Accelerating Translation through Strategic Value Chain Partnerships
- Identifying critical manufacturing bottlenecks that delay clinical translation and commercialisation
- Leveraging CDMO partnerships and tech transfer strategies to de-risk scale-up from Phase I to Phase III
- Building integrated value chains: aligning CMC development, regulatory strategy, and commercial manufacturing early
15:25
Tea & Networking Break
Manufacturing - Innovations in Downstream Processing
15:55
Solving the Downstream Bottleneck: Purification Strategies for Next-Gen Biologics
- New technologies (e.g., multi-column chromatography, membrane adsorbers) to handle high-titer upstream processes.
- Purification challenges for non-mAbs: strategies for AAV, mRNA, and bispecifics.
- How continuous downstream processing can eliminate bottlenecks and reduce resin costs.
16:20
Reserved for Solution Provider
16:45
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 by 50%.
- Techno-Economic Analysis (TEA): Using predictive modeling to validate that process changes will deliver actual commercial profitability before implementation.
17:30
Cocktail Reception
18:30
End of Day 1
8:50
IMAPAC & Chairmans Welcome Address
AI in Drug Discovery / Digital Factory
9:00
Opening Panel: From R&D Data to GMP 4.0: Integrating AI, Data, and Automation
- How a high-quality R&D data foundation (ELN/LIMS) is the essential prerequisite for manufacturing AI.
- Case studies of implementing AI and automation in a GxP-compliant bioprocessing environment.
- Solving the data integrity and validation challenges of a fully digital, "lights-out" factory.
9:50
Reserved for Solution Provider
10:15
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
10:40
Coffee & Networking Break
Future of Clinical Trials
11:10
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
11:35
Reserved for Solution Provider
12:00
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
12:30
Lunch & Poster Exhibition
The Nordic Execution Playbook: Integrated R&D and Manufacturing Success Stories
13:40
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
14:00
Reserved for Solution Provider
14:20
Patent Dispute Case Study
- A real-world (anonymized) case study of a biosimilar "at-risk" launch and the resulting legal battle.
- Dissecting the litigation strategy: When to challenge a patent (inter partes review) vs. when to settle or seek licensing.
- Key lessons in FTO analysis and patent landscaping to de-risk development and avoid costly, multi-year legal battles.
14:40
Case Study: Overcoming Scale-Up Hurdles: A Real-World Roadmap to Commercial Manufacturing
- Identifying and mitigating the "hidden" process variables that only appear when scaling from pilot (200L) to commercial (2000L) scale.
- Crisis management strategies: Real-world examples of handling unexpected deviations and root-cause analysis during a critical validation run.
- The impact of rigorous "Quality by Design" (QbD) implementation on reducing batch failure rates and ensuring supply security.
15:00
Tea & Networking Break
The Future of the Nordics Biopharma
15:30
Closing Keynote: The Investor Outlook: Funding the Full Nordic Value Chain, from R&D to Factory
- A data-driven analysis of VC and private equity trends in Nordic biotech and biomanufacturing.
- What investors are looking for: breakthrough science & novel platforms (R&D) vs. scalable capacity & tech platforms (Mfg).
- Predicting the next wave of M&A and strategic partnerships across the entire ecosystem.
16:00
The Great Debate: Where Should Nordic Biopharma Invest its Next Billion Dollars - R&D or Manufacturing?
- A dynamic, provocative debate between a top R&D leader and a top Manufacturing/Ops leader.
- The case for "R&D First": Funding groundbreaking science and novel platforms to build a world-class pipeline.
- The case for "Manufacturing First": Building sovereign capacity and digital factories to secure future production and reduce COGs.
16:50
Chairman's Closing Remarks & End of Conference
17:00
End of Day 2
