From Click to Connection: Accelerate Nordic ATMP Translation Through Collaboration
The Nordic ecosystem leads in discovery and process innovation, supported by a public that embraces medical advances. Yet too many programs slow at the handoff from lab to clinic to market.
This in-person session focused on what organizers can do now: align universities, hospitals, industry, and payers across borders to reduce friction, grow capacity, and deliver ATMPs sooner.
18 Sep 2025
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Ashley Alderson
Captured live at Advanced Therapies Europe, this session distills how Nordic stakeholders can turn discovery strengths into faster trials, scalable manufacturing, and real patient access.
TL;DR
In a hurry? Here are the essentials at a glance:
Treat cross-Nordic collaboration as essential, not optional.
Tie workforce pipelines to universities and hospitals to retain skills in-region.
Use investigator-led trials and public grants to de-risk early clinical work.
Engage payers early on alternative costs and long-term outcomes.
Leverage health data and registries to speed study setup and real-world evidence.
Standardize core CMC practices to create repeatable development paths.
Build the services layer: analytics, QC, and regulatory support.
Sustain public awareness to support trial participation.
The Nordics excel in discovery and process innovation. Treat that advantage as a platform, not a destination. Prioritize clean handoffs from university labs to translational teams and into clinical operations with clear ownership for CMC, QA, and trial readiness.
“We have an opportunity to collaborate across the region, but we also have an obligation to do it… it is a must if we want to be world leading.” - Thomas Carlsen, CEO, Novo Nordisk Foundation Cellerator
Use existing hubs rather than recreating capacity. Several university settings already support preclinical to early clinical steps and are closely tied to industry facilities. Where a site has proven capability in stem cell–based therapies or analytics, route programs there and standardize SOPs around that strength.
Map your pipeline against current Nordic sites and assign lead hubs per modality.
Define handoff criteria at each stage so projects do not stall between discovery and clinic.
Build public–private partnerships
Pre-GMP and small GMP units are expanding across the region. Pair them with industry infrastructure to create a continuous path from proof of concept to first-in-human. Consortia work where each party contributes a defined asset: academic IP and models, hospital access and investigators, industry for CMC scale-up and regulatory.
Start with one joint program and make the model repeatable. Share equipment schedules, qualified staff, and templates for protocols, validation plans, and quality agreements. The goal is throughput: more programs moving faster with less reinvention.
Develop and retain the workforce
Talent is the limiting reagent. Anchor training inside technical universities and teaching hospitals, then create roles that keep people in the region. Build a shared curriculum that covers CMC fundamentals, assay development, cleanroom behavior, documentation, and deviation management. Rotate early-career hires through process, analytics, manufacturing, and QC so they understand the full chain.
“There are major gaps in workforce development. Maturing an ecosystem together is how we attract and retain talent.” - Thomas Carlsen, CEO, Novo Nordisk Foundation Cellerator
Tie training to real programs. Offer joint fellowships sponsored by two sites, with a commitment to place graduates into open roles. Publish a transparent skills matrix and salary bands across participating hubs to reduce attrition to other regions.
Use smart funding and trials
Investigator-led trials and national grants unlock budgets that single entities cannot access alone and often shorten setup timelines. Structure consortia so hospitals hold the protocol with industry supporting CMC and supply. This approach reduces bureaucracy and can accelerate first-in-human, especially in rare and niche indications.
“We do a lot with very little money. Investigator-led clinical trials and public funding let companies move faster and cut bureaucracy.” - Lindsay Davies, Chief Scientific Officer, NextCell Pharma
Prioritize indications with strong registry depth and experienced sites.
Convert promising projects into multi-site Nordic protocols to reach enrollment targets and share data capture standards early.
Engage payers on value
State healthcare heightens scrutiny, so move the discussion from price per dose to avoided lifetime costs and functional outcomes. Model alternative costs compared with current care, including clinic time, admissions, and productivity. Prepare for the next wave of ATMPs beyond oncology, such as Parkinson’s or diabetes, and use today’s evaluations to build repeatable pathways for tomorrow.
“It is not only the cost of a pill. These therapies involve the healthcare organization itself… we really need to collaborate around this.” - Magdalena Bengtsson Levin, Regional Policy Specialist, J&J Innovative Medicine
Bring payers in before pivotal design. Share proposed endpoints, follow-up plans, and how real-world evidence will be generated post-approval. Align on what “good enough” looks like for coverage decisions.
Standardize CMC and services
Not every step must sit in-region, but a common spine of methods will cut cost and speed transfer. Identify golden-standard unit operations per modality and lock them into shared SOPs. Centralize analytics, release testing, and regulatory writing where it increases velocity, and document tech transfer packages that any Nordic site can execute.
“We need to identify the golden standard within cell therapy development to make development efficient.” - Thomas Carlsen, CEO, Novo Nordisk Foundation Cellerator
Maintain a validated toolbox of assays and reference materials.
Track cycle time from engineering run to clinical lot and remove bottlenecks quarterly.
Harness data and registries
Nordic health records and disease registries are strategic assets. Use them to target recruitment, define endpoints, and generate real-world evidence that supports access decisions. Align EHR extracts and registry fields with trial CRFs so post-market follow-up is baked in from day one.
Create shared readiness dashboards across sites: eligible patients by indication, time to first patient in, screen-fail reasons, and protocol deviations. Use these to focus training and fix site-level issues quickly.
Coordinate hubs across borders
Clusters like Copenhagen–Skåne and Stockholm–Uppsala should operate as a network, not isolated nodes. Sign cross-border MOUs for referrals, material logistics, and shared SOPs. Run a rotating leadership forum that sets quarterly priorities, unblocks resourcing issues, and engages policymakers with a single voice.
“Each country is too small to solve this alone. We need to operate on a Nordic level, with the EU framework playing a key role.” - Magdalena Bengtsson Levin, Regional Policy Specialist, J&J Innovative Medicine
Measure collaboration, not just science. Track the number of programs handed from one hub to another without rework, shared staff utilization, and time saved through common templates. The region wins when the network moves faster than any single site.
Final word
The Nordic region stands at a pivotal moment in advanced therapies: strong academic foundations, a culture of collaboration, and growing manufacturing infrastructure are in place. Turning this edge into global leadership requires clearing translation bottlenecks, scaling multi-site trials, and building a durable talent pipeline that links universities, hospitals, and industry. Standardize core CMC methods, expand investigator-led studies across borders, align payers on outcomes and alternative costs, and use national registries to power smarter recruitment and real-world evidence. Unite hubs with shared SOPs and data standards so programs move cleanly from discovery to patient access. Do this well and the region moves from pilots to scalable care, delivering life-changing therapies worldwide.
The Nordic region benefits from world-class research institutions, a collaborative culture, and a population receptive to clinical trials, making it a fertile ground for advanced therapies innovation.
Key challenges include translating innovations into clinical products, workforce shortages, limited manufacturing infrastructure, and reimbursement complexities within state healthcare systems.
Cross-border and public-private partnerships enable resource sharing, harmonized regulatory approaches, and pooled funding, which accelerate clinical trials and commercialization efforts.
Developing and retaining skilled personnel ensures high-quality manufacturing, regulatory compliance, and efficient clinical development, all crucial for sustaining growth in ATMPs.
Demonstrating long-term value and cost-effectiveness to payers, along with increasing public awareness and engagement, helps integrate ATMPs into standard care despite reimbursement challenges.
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