Meeting on the Med: a pulse check on CGT
The Alliance for Regenerative Medicine’s Meeting on the Med brought therapeutic developers, regulators, investors, manufacturers and technology vendors together for three intense days of debate and deal‑making in Rome. From main‑stage keynotes by EMA Executive Director Emer Cooke to packed break‑outs on automation and payment models, the conference offered a clear signal: 2025 is the year CGT moves from pilot phase to industrial scale.
Below are five high‑level themes that dominated the agenda, paired with practical ways Lonrú Consulting can help stakeholders translate talk into traction.
Dr Caoimhe Nic An tSaoir, PhD MBA representing Lonrú Consulting at its first ARM Meeting on the Med—illuminating innovation in Rome.
Industrialisation & Cost‑of‑Goods: from artisan to assembly line
Conference focus
Speakers from Cellares, ScaleReady and SmartCella touted up to 10× productivity gains with closed, automated systems, while plenary panels urged “robotics, AI and digitalisation” to improve labour hours.
Why timing matters – Conference veterans warned: “Don’t bolt robots onto a sub-optimal process.” The smart sequence is:
Close & automate the core workflow to drive consistency.
Iterate and optimise based on fresh, high-fidelity data.
Roboticise only when the process is lean enough to justify the CapEx.
Where Lonrú helps
VantagePoint™ Scale models the true economics of automated vs. manual workflows—integrating batch size, labour inputs and capital depreciation—so equipment vendors and therapy developers can make evidence‑based CapEx decisions.
2. Regulatory Convergence: alignment gives way to harmonisation
Conference focus
EMA, MHRA, AIFA and other agencies previewed a joint dossier framework for ATMPs, signalling a shift from bilateral “alignment” to multilateral convergence in 2025‑26. Under this model, one core CMC/clinical package could be reviewed simultaneously by several regulators, trimming duplicate studies and bringing therapies to multiple markets months sooner.
Where Lonrú helps
VantagePoint™ Insights offers a policy tracker that maps emerging common modules, review timelines and regional inflection dates —allowing CGT technology suppliers to support submissions and market launches with confidence.
3. Financing Climate: capital comes with a data‑driven thesis
Conference focus
Investors are showing signs of optimism that deal flow will rebound in H2 2025, but before cheques are written they want proof of differentiated tech, clear ROI and capital‑efficient scale‑up paths. Capital will flow first to platforms able to quantify near-term revenue and manufacturing economics.
Where Lonrú helps
VantagePoint™ Accelerate packages market sizing, NPV/DCF modelling and competitive white‑space analysis into investor‑ready narratives—helping technology providers translate ground-breaking science into a thoroughly de‑risked business case.
4. Ethics, Access & Novel Payment Models: transparency is non‑negotiable
Conference focus
Panels on ethics urged more openness around cost of goods, while payers showcased staged‑payment and subscription pilots to manage six‑figure therapy costs. A shared takeaway emerged: sustained access depends on communicating with transparency and demonstrating tangible value—tailored to regulators, payers, clinicians, and patient communities alike.
Where Lonrú helps
VantagePoint™ Illuminate distils complex value propositions and pricing strategies into clear, stakeholder‑specific messaging—supporting technology firms as they negotiate value‑based contracts and build public trust.
5. Emerging Geographies: the Gulf states step onto the CGT stage
Conference focus
A dedicated session spotlighted UAE and KSA initiatives to build GMP capacity and local innovation hubs, with regional investors actively scouting technology partners. Speakers emphasised the opportunity; whoever locks in early reference sites now will shape standards for a market that is forecast to treat tens of thousands of regional patients by 2030.
Where Lonrú helps
VantagePoint™ Connect maps innovation clusters, stakeholder networks and funding programmes in any target geography, then brokers introductions for enabling-technology providers to regulators, hospital networks, strategic investors and channel partners—giving first movers the inside track on commercial pilots and policy dialogues.
The takeaway
The ARM meeting in Rome confirmed that scale, regulatory convergence, and credible economics are now the gating factors for progress in CGT—and it is the enabling-technology companies who can unlock every one of those gates. Lonrú’s mission to Accelerate Growth of Cell and Gene Therapy Technology Companies — exists precisely to drive momentum at this inflection point.
Whether you’re rolling out an automated manufacturing platform, launching next-gen analytical tooling, or scaling a digital batch-record system, Lonrú turns fresh industry insights into practical roadmaps—combining market intelligence, stakeholder alignment, and financial modelling so breakthrough technologies reach industrial impact sooner. Ready to view your CGT strategy from a higher vantage point? Let’s talk.
