AGENDA AT A GLANCE
R&D and Clinical Trials
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
Early-Phase 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
11:55
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.
12:20
Lunch & Poster Exhibition
From Discovery to Operations
13:50
Translational Oncology in Practice: Bridging the Gap from Discovery to Clinical Validation
- A real-world case study of a successful translational program in oncology, from target to patient.
- Strategies for "back-translation": using clinical data and patient samples to inform and improve discovery.
- Managing the cross-functional R&D, clinical, and operational teams for a successful program.
14:15
Reserved for Solution Provider
14:40
Panel Discussion: Slashing Timelines: How to Integrate R&D, Process Development, and Clinical Operations
- Identifying and eliminating the key operational bottlenecks between R&D, PD, and clinical supply teams.
- Building integrated data systems and project management workflows that actually accelerate, not hinder, progress.
- Case studies from pharma leaders who have successfully cut their development timelines from discovery to IND
15:25
Tea & Networking Break
15:55
Roundtables:
- From 109 Days to 14 Days": A Peer-to-Peer Workshop on Eliminating the Multi-Nordic CTIS Penalty
- The Jan 2025 HTA Cliff (Post-Mortem): Sharing "In-the-Trenches" JNHB Submission Strategies
- Solving the Nordic Data Paradox: Practical Tools for Slashing the €2,000/Patient Harmonization Cost
- Reversing the "Spain Leakage": A Strategic Playbook for Making the Multi-Nordic Region the #1 EU Trial Destination
- The "Denmark-Only" vs. "Multi-Nordic" Debate: A Practical Cost-Benefit Analysis for Clinical Operations
16:40
Awards Ceremony & End of Conference Day 1
17:30
End of Day 1
8:50
IMAPAC & Chairmans Welcome Address
AI in Drug Discovery
9:00
Opening Crossover 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
Beyond the Trial: Using RWD and Biobanks to Build Smarter, Faster Clinical Studies
- Case studies on using Nordic biobank and real-world data (RWD) for better patient stratification and recruitment.
- Leveraging RWE to create "synthetic" or "hybrid" control arms to reduce trial costs and timelines.
- The operational and regulatory challenges of integrating diverse, non-standardized RWD into a clinical submission.
10:40
Coffee & Networking Break
Future of Clinical Trials
11:10
The Biosimilar Battlefield: Navigating the Complex Scientific, Regulatory, and IP Landscape
- Strategies for demonstrating "totality of the evidence" to the EMA and FDA for complex biologics.
- The intellectual property (IP) "patent dance": Freedom-to-operate, litigation, and market-entry strategies.
- Scientific challenges in analytical and clinical comparability for next-gen biosimilars (e.g., ADCs).
11:35
Reserved for Solution Provider
12:00
Panel Discussion: The 'Patient-Centric' Trial: Integrating Digital Tools and Decentralized (DCT) Models
- How digital health tools (wearables, sensors, ePRO) are generating higher-quality data and new endpoints.
- Operational best practices for running a successful decentralized or hybrid trial in the Nordic region.
- Meeting the formidable regulatory, logistical, and data privacy challenges of new digital trial models.
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
