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8:00 AM
1 Session
9:00 AM
1 Session
9:15 AM
1 Session
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- Investment Summit
Theatre 1&2 (Rubi & Zafir)Story-driven investing is over, what does evidence driven investing actually demand from founders? From narrative to proof: why scientific promise alone no longer closes rounds, and what constitutes a complete investment case today Data, manufacturing, regulatory strategy and commercial pathways – the non-negotiables of an investable company in 2026 How recent market downturns have reshaped investor expectations, risk tolerance and capital deployment strategiesSpeakers
9:55 AM
1 Session
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- Investment Summit
Theatre 1&2 (Rubi & Zafir)Traditional venture capital is growing more selective and early-stage biotech are sourcing other routes of funding to progress their pipelines. Explore how alternative funding models are evolving to support early-stage innovation, and what it takes to successfully navigate a more fragmented and competitive funding landscape. Why traditional VC is pulling back from early-stage CGT and what this means for company creation Beyond venture capital – the growing role of grants, venture philanthropy, angel investors, family offices and strategic partnerships in early-stage funding How founders can combine multiple capital sources to build a blended funding strategySpeakers
10:35 AM
1 Session
11:05 AM
1 Session
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- Investment Summit
Theatre 1&2 (Rubi & Zafir)As the cell and gene therapy industry becomes increasingly crowded, differentiation has become a non-negotiable for securing investment. With multiple companies pursuing similar approaches, investors are placing greater emphasis on identifying technologies that demonstrate a clear and defensible advantage. Why companies struggle to articulate what makes them different – and why this costs them deals Investor frameworks for distinguishing true breakthrough from incremental improvement – what they look for and what falls flat How founders can cut through a saturated market and make investors pay attentionSpeakers
11:45 AM
1 Session
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- Investment Summit
Theatre 1&2 (Rubi & Zafir)Bringing together investor and founder who have successfully navigated the process to share practical insights on what it takes to secure capital in today’s environment. The 2026 investment checklist: team credibility, regulatory strategy, clear commercial pathways How to reach meaningful milestones with limited capital – and how investors evaluate this What does it take to close a round in this environment – candid reflections on what worked, what didn’t and what both sides would approach differently
12:15 PM
1 Session
1:15 PM
1 Session
1:20 PM
1 Session
1:40 PM
1 Session
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- Women in Advanced Therapies Congress
Workshop Room (Rossini 1&2)After years of discussion around bias, barriers, and representation, the question remains: what is actually changing and what isn’t? This candid opening session sets the tone for WiAT by shifting the focus from awareness to action. Hear from leaders across advanced therapies as they challenge conventional narratives, share unfiltered perspectives on where responsibility lies, and outline what must happen next, at both an individual and system level. You’ll gain:• A clear view of what progress really looks like today• A reframed perspective on responsibility and agency• A practical lens for the sessions that followSpeakers
2:10 PM
1 Session
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- Women in Advanced Therapies Congress
Workshop Room (Rossini 1&2)What does success actually look like and how do you get there? In this session, leaders share honest, experience-based insights into building careers, securing investment, and navigating pivotal transitions. This is not about inspiration, it’s about specifics. From critical turning points to missed opportunities, speakers will unpack what worked, what didn’t, and the networks that made the difference. You’ll gain:• Practical insights from real career and funding journeys• A clearer understanding of key decision points• Lessons you can directly apply to your own pathSpeakers
2:45 PM
1 Session
3:15 PM
17 Sessions
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- Women in Advanced Therapies Congress
- Roundtable
In Partnership with Advantera -
- Women in Advanced Therapies Congress
- Roundtable
Focus: progression into senior roles in pharma, biotech, and startups -
- Women in Advanced Therapies Congress
- Roundtable
Focus: the operational reality of building companies and careers in CGT/biotech -
- Women in Advanced Therapies Congress
- Roundtable
Focus: refine how you present your experience, expertise, and ambition -
- Women in Advanced Therapies Congress
- Roundtable
In Partnership with FreseniusChairperson -
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- Women in Advanced Therapies Congress
Theatre 1&2 (Rubi & Zafir) -
- Women in Advanced Therapies Congress
- Roundtable
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- Women in Advanced Therapies Congress
- Roundtable
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- Women in Advanced Therapies Congress
- Roundtable
In Partnership with Advantera -
- Women in Advanced Therapies Congress
- Roundtable
Focus: progression into senior roles in pharma, biotech, and startups -
- Women in Advanced Therapies Congress
- Roundtable
Focus: the operational reality of building companies and careers in CGT/biotech -
- Women in Advanced Therapies Congress
- Roundtable
Focus: refine how you present your experience, expertise, and ambition -
- Women in Advanced Therapies Congress
- Roundtable
In Partnership with FreseniusChairperson -
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- Women in Advanced Therapies Congress
- Roundtable
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- Women in Advanced Therapies Congress
- Roundtable
4:15 PM
1 Session
6:30 PM
1 Session
8:00 AM
1 Session
9:00 AM
1 Session
9:05 AM
1 Session
9:15 AM
1 Session
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- Plenary
Theatre 1&2 (Rubi & Zafir)From legislation to execution: What ATMP developers must change now in regulatory, CMC and evidence planning to stay aligned with EU reform over the next 12 months. Fixing fragmentation where it hurts: Practical steps regulators and industry can take to reduce national divergence in inspections, QP release and hospital interfaces without waiting for full harmonisation. AI without regulatory regret: How to deploy AI in development, manufacturing and PV with audit-ready governance that accelerates approval rather than triggering high-risk compliance delays. Making Europe the smart first move: How tighter EMA-NCA coordination and reliance can shorten timelines and restore Europe as a credible first-launch region for advanced therapies.Speakers
9:50 AM
1 Session
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- Plenary
Theatre 1&2 (Rubi & Zafir)Speed breaks first: Why Europe still loses ATMP programmes at the trial-start and scale-up stages and what can be fixed in the next 12 months around approvals, site readiness and cross-border trial execution. Scale without fragmentation: How disjointed manufacturing capacity, inconsistent incentives and weak CDMO coordination slow R&D momentum and what more joined-up European models could unlock faster progression from clinic to commercial. Return signals matter: How reimbursement uncertainty, grant complexity and IP anxiety dilute investor confidence and which policy and payer signals would materially improve Europe’s risk-reward profile for ATMP R&D. Where innovation leaks out: Identifying the points where advanced therapies quietly leave Europe (post-Phase I/II, before pivotal trials, pre-commercial scale-up) and how to retain them without protectionism.Speakers
10:30 AM
1 Session
11:15 AM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)Efficacy data as a scaling input, not an endpoint: How Phase I expansion and Phase II data should actively inform tech transfer, manufacturing readiness and comparability so scale-up and fundraising don’t expose hidden weaknesses later. Stress-testing early efficacy before others do it for you: What parameters, thresholds and failure modes teams should be interrogating before investors, partners or regulators do and how structured checklists and smarter analytics reduce late-stage surprises. AI as a discipline enabler, not a shortcut: Where agentic AI and advanced analytics can genuinely improve signal detection, cohort stratification and consistency and where over-reliance creates false confidence or audit risk. Cleaner data, faster confidence: Practical lessons on improving data hygiene, standardisation and traceability in early trials how teams accelerate learning without increasing burden or compromising quality. The data grey zones that derail value: Who really owns early efficacy data, how it contributes to IP and patent strategy, and where unclear data rights or provenance quietly undermine partnering and valuation discussions.Speakers -
- Operational & Commercial Performance
Theatre 2 (Rubi)
11:30 AM
1 Session
11:45 AM
2 Sessions
12:00 PM
1 Session
12:15 PM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)A view on the latest clinical trials, innovations and trends coming out of Europe, US and further afield and what practical coordination would make cross-border trials, faster, simpler and more attractive? From trial to treatment: How can we boost the flow of ATMPs through clinical development and into commercial use, and where are the real bottlenecks in Phase I and II? Europe’s unfair advantage: What does Europe have that other regions do not, from investigator-initiated trials and Catapult infrastructure to talent inflows, including more recent trends from the US. How do we use this to our advantage? How can we make it easier for clinical trials to be approved in Europe: Balancing national authority, ethics, and evidence, and still compete with China, Asia, and other fast-moving regions? Patients at the heart: Engaging patients better at home and across borders, and where are the easy wins in last-mile trial delivery and access?Speakers -
- Operational & Commercial Performance
Theatre 2 (Rubi)Cost isn’t just efficiency it’s architecture: How advanced facilities change the cost curve of CGT production, from automation and digitalisation to scale, standardisation and multi-product flexibility. Collaboration as infrastructure, not outsourcing: Lessons from structuring partnerships, funding criteria and internal alignment What this unlocks for the ecosystem: How facilities like this shift what’s possible for developers, partners and patients and what smaller companies should take away now when planning their own manufacturing strategies.
12:30 PM
1 Session
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- Operational & Commercial Performance
Theatre 2 (Rubi)CAR-T has delivered transformative clinical outcomes, but its manufacturing model still resembles the early biologics era: complex, bespoke, variable and difficult to scale economically. Antibodies became a global therapeutic class only after stable cell lines made reproducible, scalable and platform-based manufacturing possible. This session asks whether lentiviral vector production is approaching the same inflection point — and what must change before CAR-T can move from specialised treatment to broader standard of care.The antibody parallel: What CHO-based manufacturing teaches us about moving from artisanal production to industrialised biologics.When early LV shortcuts become late-stage constraints: How transient, programme-specific production choices can create cost, variability and comparability burdens that only become visible when the therapy starts to succeed.CMC debt starts early: Why vector-production choices made for speed can become late-stage liabilities for cost, comparability and scale, especially as LV moves beyond ex vivo CAR-T toward in vivo applications.The pool-based bridge: How stable LV producer pools can accelerate early clinical material generation while preserving a route toward clonal producer cell lines for late-stage and commercial manufacturing.
12:45 PM
1 Session
1:00 PM
1 Session
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- Workshop
Panel: Designing advanced therapies that survive scale: from early decisions to commercial readinessWorkshop Room (Rossini 1&2)Advanced therapy developers face intense pressure to accelerate timelines, but speed without early discipline across CMC, delivery, analytics, and manufacturing can introduce risks that surface later and derail progress. This panel will examine why promising programs often stall between initial clinical signal and late-stage advancement, and how early strategic decisions set a foundation for scalability, comparability, cost control, regulatory confidence, and patient access. Drawing on experience across nucleic acid therapeutics, nanomedicine, viral vectors, and cell therapy, the discussion will explore which elements teams should lock in early versus where flexibility is essential. Panelists will also highlight the technical assumptions most likely to break under scale-up, regulatory scrutiny, or commercialization pressure—and how to proactively de-risk.Speakers
2:00 PM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)• Development of human receptor–targeting capsids (TfR1 CapX) to enable efficient, translatable blood–brain barrier crossing and broad CNS gene delivery• Preclinical data showing improved CNS biodistribution and compatibility with scalable AAV manufacturing processes• Strategies for facilitating access to novel capsids through industry and academic collaborations -
- Operational & Commercial Performance
Theatre 2 (Rubi)Scaling MSC manufacturing remains a major challenge in cell therapy development, particularly as processes move from early research into clinical and commercial production. This presentation reviews four platform strategies for MSC expansion — planar static systems, multilayer vessels, microcarrier-based stirred bioreactors, and fixed-bed/intensified adherent systems — and compares their suitability across different stages of development. The session will discuss scale-up versus scale-out considerations, key tradeoffs in scalability and process control, and practical ways to de-risk transfer from R&D to production. Attendees will leave with a clearer framework for selecting fit-for-purpose MSC expansion platforms and designing more robust manufacturing workflows.
2:15 PM
3 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)The uncomfortable truth: Where early CMC and manufacturing assumptions quietly inflated cost of goods as programmes moved toward later-stage development and why these issues only surfaced under scale pressure. Autologous vs allogeneic: the real trade-offs: What this programme learned about labour, yield, throughput and logistics and how those realities reshaped modality strategy and long-term commercial viability. Fixing cost upstream, not at launch: Which changes to process design, starting materials, automation and site strategy most materially shifted the COGS trajectory and which ‘optimisations’ made no real difference. What we’d lock in earlier next time: The specific CMC and manufacturing decisions this team would make in Phase I/II today to avoid expensive re-engineering later. -
- Operational & Commercial Performance
Theatre 2 (Rubi) -
- Innovation Zone
Workshop Room (Rossini 1&2)
2:25 PM
1 Session
2:30 PM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)AAV demand has outpaced infrastructure: Why current production models struggle to meet clinical and commercial demand and which upstream, downstream and process innovations are finally closing the efficiency and scalability gap. Toxicity is the gating factor not delivery: How the field’s understanding of AAV-associated toxicities (including hepatotoxicity, neurotoxicity, TMA and cardiotoxicity) has evolved and which mitigation strategies are showing real-world impact today. Designing safety in, not reacting later: How advances in vector engineering, capsid design, dosing strategies and patient selection are reducing risk earlier in development shifting toxicity management upstream. Monitoring, intervention and control: The latest approaches to AAV monitoring, immune response management and clinical intervention protocols and how these are being operationalised in trials. Next-generation vectors and rare disease potential: How emerging AAV variants and next-gen vector platforms aim to expand the therapeutic window, improve tissue targeting and further mitigate toxicity particularly in rare disease indications.Speakers -
- Operational & Commercial Performance
Theatre 2 (Rubi)
2:45 PM
2 Sessions
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- Operational & Commercial Performance
Theatre 2 (Rubi)Session Overview Advanced therapies are stretching not just science and regulation but the very design of capital itself. Across Europe, a growing sentiment has emerged that traditional venture capital may be misaligned with the biological, manufacturing and regulatory realities of cell and gene therapies. Yet without VC, many of these breakthroughs would never leave the lab. In a tightly moderated debate format, founders, investors, manufacturers and system leaders will debate whether capital is truly neutral, or whether time horizons, governance models and incentive structures actively shape clinical and commercial outcomes. A serious, examination of what kind of capital advanced therapies actually need and whether Europe is funding innovation effectively, or simply funding it familiarly. Audience vote before and after the debate will reveal whether minds have changed.Speakers -
- Innovation Zone
Workshop Room (Rossini 1&2)
2:55 PM
1 Session
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- Innovation Zone
Workshop Room (Rossini 1&2)Allogenetics introduces ex vivo transplant gene therapy in transplant medicine. We have shown for the first time that fine-tuning of antigen-presentation by addressing the universal MHC-system leads to prevention of transplant rejection without the need for immunosuppression.Our development and regulatory pathway for this first-in-class ATMP from a highly relevant lung-transplant study in pigs to its first-in-human application will be introduced.Speakers
3:00 PM
1 Session
3:05 PM
1 Session
3:15 PM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)The inflection is measurable: What recent in vivo clinical readouts are showing about delivery efficiency, expression control and safety—and where performance is becoming reproducible rather than exceptional. Pipeline momentum since 2025: How the surge in preclinical and early clinical in vivo programmes is reshaping target selection, platform choice and development timelines and where early friction is already informing smarter design. Indications set the limits (and the upside): Where clinicians are seeing real promise today for in vivo approaches (solid tumours, gastric cancers, sarcoma, liver and CNS), and where biology or delivery still constrains reach. Portfolio decisions, not modality wars: How investors and big pharma are balancing in vivo alongside ex vivo strategies—and what this signals about future modality mix, sequencing and coexistence.Speakers -
- Operational & Commercial Performance
Theatre 2 (Rubi)
4:00 PM
1 Session
4:30 PM
10 Sessions
5:30 PM
1 Session
6:00 PM
1 Session
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CellBri will be hosting an exclusive visit to our new demonstration facility at Cosymbio in Barcelona. Join us for an exclusive tour of our new demonstration lab at Cosymbio in Barcelona on September 8 at 6:00 PM, following Advanced Therapies Europe.Explore the CellFAB One N and n-MagS™ platforms, engage with our team, and discover how CellBri is helping advance cell therapy manufacturing through flexible, automated workflow solutions.Complimentary transportation, food, and refreshments will be provided. RSVP is required to reserve your seat on the shuttle and secure your place on the tour.Whether you're looking to evaluate new technologies, discuss manufacturing challenges, or explore future collaborations, we look forward to welcoming you to the CellBri Demo Lab. Attendees to meet in the hotel lobby prior to departure prior to boarding the shuttle to the demo lab Reserve a spot here: https://www.eventbrite.com/e/cellbri-barcelona-demo-lab-tour-tickets-1999307251810?aff=oddtdtcreator
9:00 AM
1 Session
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Join us for an exciting session where innovative biotech start-ups pitch their groundbreaking ideas and solutions. Watch as they present to a panel of expert investors, who will provide real-time feedback, insights, and guidance. This is a unique opportunity to explore cutting-edge advancements in the biotech space and gain valuable perspectives from both entrepreneurs and industry leaders.Speakers
10:30 AM
1 Session
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- Plenary
Theatre 1 (Zafir)From optional to inevitable: Where agentic and analytical AI are already changing discovery and early CGT development and what must be true for AI to become a trusted, default tool rather than a pilot experiment. Beyond prediction to intervention: How next-generation AI is moving past predictive modelling into active roles in target identification, vector and capsid design, and optimisation of early development decisions, shortening timelines without eroding scientific judgement. Data foundations determine outcomes: What clinical and preclinical data strategies, governance models and hygiene standards must be in place to unlock advanced AI capabilities—while staying inspection-ready as the EU AI Act comes into force. Regulation without paralysis: What the EU AI Act actually means for CGT developers: where the real risks sit, where flexibility exists, and how teams can avoid over-engineering compliance or freezing innovation through misinterpretation. Building AI-ready CGT organisations: Who the right collaboration partners are, what internal structures need to change, and which skills and talent profiles are now essential to embed agentic and analytical AI into product design, not bolt it on.Speakers
11:15 AM
1 Session
11:45 AM
2 Sessions
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- Operational & Commercial Performance
Theatre 2 (Rubi)Capacity solved, complexity exposed: Why increasing CGT manufacturing capacity alone doesn’t unlock commercial success and how variability, flexibility and operational friction now limit real-world adoption. Cost is shaped upstream, not at launch: How manufacturing design choices (automation, standardisation, tech transfer models) determine long-term cost of goods and why many programmes lock in commercial constraints far too early. Industrialising without over-engineering: Where teams overbuild manufacturing systems that don’t match demand, and how smarter, modular and adaptable approaches support both early launches and long-term portfolio growth. Manufacturing as a commercial lever: How robust, repeatable production directly influences payer confidence, hospital readiness and willingness to adopt and why manufacturing strategy must now align with access strategy. What ‘commercial-ready manufacturing’ really means: The capabilities CGT programmes need before approval comparability, change control, scalability and supply reliability to avoid post-launch resets.Speakers -
- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)
12:00 PM
2 Sessions
12:15 PM
2 Sessions
12:30 PM
2 Sessions
12:45 PM
2 Sessions
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- Cell & Gene Therapy Clinical Pathways
Theatre 1 (Zafir)Understanding the AGORA model:How collaborative, hospital-anchored models like AGORA are reshaping access to gene and cell therapies for rare and ultra-rare diseases. We cannot scale without hospitals: How developers and health systems must rethink roles, incentives, and workflows to make access viable and sustainable. Delivery through partnership, not heroics: Which partnership models are most likely to work in Europe and why no single stakeholder can solve access alone. Confronting the economics honestly: The real financial and operational constraints behind expanding access to advanced therapies and how teams are navigating them without diluting innovation.Speakers -
- Operational & Commercial Performance
Theatre 2 (Rubi)Why COGS stays stubbornly high: The recurring technical and operational drivers of cost across CGT programme from starting materials and batch failure rates to logistics and facility utilisation. Where cost reduction is real (and where it isn’t): Which technologies, process innovations and production models have delivered measurable COGS impact and which promised efficiencies fail under GMP reality. Decentralised, centralised, or hybrid: What emerging European production models (hospital-adjacent, intermediary hubs, modular facilities) reveal about balancing cost, control and scalability. Designing for flexibility, not perfection: How building manufacturing systems that tolerate change (dose, indication, geography) reduces long-term cost more effectively than over-optimised early builds.
1:00 PM
1 Session
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- Operational & Commercial Performance
Theatre 2 (Rubi)The cost equation is breaking :Are allogeneic therapies genuinely approaching a manufacturing inflection point and if so, what does that mean for the long-term viability of autologous models that still struggle to generate margin? Rethinking how and where ATMPs are made: What Europe’s decentralised production models (including Spain and the Nordics) reveal about alternative paths to scalE and whether point-of-care, intermediary hubs, or hybrid models can materially change COGS. Breaking from the herd on CMC: Where technology, process innovation and supply-chain redesign (starting materials, import/export, last-mile delivery) can actually reduce cost and which bets companies need to make now rather than waiting for ‘the next platform’.Speakers
1:30 PM
2 Sessions
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- Workshop
Workshop Room (Rossini 1&2)Join VIVEbiotech together with its partners Kiji Therapeutics and Genewity for an interactive panel exploring how lentiviral vector-based therapies are advancing across the full development pathway—from early-stage innovation to clinical and commercial readiness.The session will feature real-world insights from ongoing programs, including the clinical advancement iPSC-MSC engineered cell therapies for the treatment of broad range of inflammatory diseases such as GvHD, as well as the progression of a gene therapy program for Severe Combined Immunodeficiency (SCID) preparing for regulatory submission and commercial phase.Following brief introductory remarks, the panel will focus on key challenges such as vector design, process development, scaling for GMP manufacturing, and aligning early decisions with regulatory and commercialization requirements.Lunch will be served during this session.Speakers
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2:45 PM
1 Session
2:50 PM
1 Session
3:05 PM
1 Session
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- Plenary
Theatre 1 (Zafir)What it takes to build a decentralised CAR-T manufacturing model in practice, and where the original “point-of-care” vision met operational reality. Key lessons from running multi-site GMP manufacturing, including comparability, consistency, and control across a distributed network. How regulatory expectations, potency requirements, and analytical strategy evolved—and shaped what was possible in a decentralised setup. Why the programme ultimately wound down, what alternatives were explored, and which elements of the model still have value for the wider CGT field.
3:25 PM
1 Session
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- Plenary
Theatre 1 (Zafir)The next modality frontier is not guaranteed: Which modalities are genuinely emerging as the next growth engines, whether cell therapies face structural headwinds or reinvention, and what lessons Europe should take from genomics, RNA and adjacent fields that have already lived through hype cycles. Competition is no longer just scientific: How macro forces such as trade policy, capital mobility, industrial strategy and regional risk tolerance are shaping where advanced therapies are developed, manufactured and commercialised heading into 2027. US, China, Middle East: different bets, different rules: What each region is truly optimising for, speed, cost, control, talent or scale, where they are strongest, and how realistic collaboration or co-development actually is for European companies. The grey market risk Europe cannot ignore: How sub-standard stem cell products and loosely regulated therapies emerging in some markets could distort patient trust, pricing and standards globally, and what responsibility Europe has in setting and defending quality benchmarks. Compete, collaborate, or draw lines: As other regions push aggressively on cost and speed, how Europe should think about manufacturing strategy, supply chain resilience and risk boundaries, and where cooperation strengthens Europe versus where it weakens it.Speakers