AGENDA AT A GLANCE
Biologics Manufacturing
8:00
Registration
8:50
IMAPAC & Chairmans Welcome Address
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.
10:15
Accelerating Drug Discovery through Multimodal Data Integration
- Integrating omics, imaging, and clinical data to create unified AI models for drug discovery.
- Strengthening target identification, drug efficacy predictions, and patient stratification.
- Overcoming data silos to enable a more efficient and predictive discovery pipeline.
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
Innovations in Upstream Processing
11:05
The CDMO Hand-Off: A "Right-First-Time" Tech Transfer Playbook
- Best practices for creating a robust tech transfer package (data, process, analytics) for your CDMO.
- The CDMO perspective: Top 3 reasons tech transfers fail and how to prevent them.
- Managing the human element: communication, project management, and aligning cross-functional teams.
11:30
Reserved for Solution Provider
BSP Pharmaceuticals
11:55
Optimizing the Upstream Workflow: Intensification, Perfusion, and High-Density Cell Culture
- Implementing intensified fed-batch and N-1 perfusion strategies to multiply yield without increasing facility footprint.
- Addressing the specific metabolic challenges and media optimization required for high-cell-density processes.
- Real-time monitoring: Integrating PAT (Process Analytical Technology) to maintain critical quality attributes (CQAs) during long-duration runs.
12:20
Lunch & Poster Exhibition
Innovations in Downstream Processing
13:50
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.
14:15
Reserved for Solution Provider
14:40
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.
15:25
Tea & Networking Break
15:55
Roundtables
- Staffing the €6.8B Expansion: A Strategy Session for Competing with the "Novo Talent Vacuum"
- The 2.5-Year ATMP Gap: "Tech Transfer or Build?" Interim Strategies Before CCRM Nordic Opens
- The "Build vs. Outsource" Dilemma: A Frank Discussion on Nordic Costs, Talent, and Global Competition (vs. Ireland/Asia)
- The +101% Energy Price Shock: OPEX Mitigation Strategies for Danish Manufacturing Sites
- The €6.8B Facility "Land Grab": De-Risking Your Equipment Procurement & Supply Chain for 2025-2027
16:40
Awards Ceremony & End of Conference Day 1
17:30
End of Day 1
8:50
IMAPAC & Chairmans Welcome Address
The Digital Factory
9:00
The Digital Shop Floor: Implementing MES and Electronic Batch Records (EBR) to Eradicate Human Error
- Strategies for the transition from paper-based logs to fully digital Manufacturing Execution Systems (MES) without disrupting production.
- Ensuring "Data Integrity by Design": How digitization automatically solves common GMP compliance headaches and speeds up batch release.
- Change management: Getting shop-floor operators to embrace digital tools and reducing the "review by exception" timeline.
9:50
Reserved for Solution Provider
10:15
Data Integrity & Advanced Process Control (APC): The Pillars of the Digital Factory
- Best practices for ensuring 21 CFR Part 11 and GxP compliance for all digital systems.
- A look at the next generation of PAT and process analytical sensors (e.g., Raman, smart probes).
- Integrating sensor data into a centralized APC system for automated process monitoring and control.
10:40
Coffee & Networking Break
Future of Quality & Formulation
11:10
Formulation & Delivery: Strategies for High-Concentration, Stable, and Patient-Centric Biologics
- Overcoming the challenges of high-concentration formulations (e.g., viscosity, stability).
- Formulation strategies for next-gen modalities (e.g., LNPs for RNA, ADCs).
- A look at innovative drug delivery devices (e.g., auto-injectors) that improve patient compliance.
11:35
Reserved for Solution Provider
12:00
Panel Discussion: The Future of Quality: A Roadmap to Predictive Analytics, Digital QMS, and Real-Time Release
- How to move from a "quality control" (testing) to a "quality assurance" (predictive) mindset.
- Implementing a fully digital, cloud-based Quality Management System (QMS).
- The regulatory and technical roadmap to achieving "Real-Time Release Testing" (RTRT).
12:30
Lunch & Poster Exhibition
The Nordic Execution Playbook: Integrated R&D and Manufacturing Success Stories
13:40
Case Study: A Successful Digital Twin Implementation at a Nordic Biomanufacturing Facility
- A step-by-step walkthrough of the project: from initial concept to full implementation.
- The "lessons learned": What went right, what went wrong, and what they would do differently.
- Quantifiable results: A clear presentation of the project's impact on yield, cost, and compliance.
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
