EuroBiotechMag 2026/01

Interview

ISSN 2364-2351 | A 60711 |

Life Sciences and Industry Magazine Spring Edition 2026 | Volume 25 | 20 €

Alexis Vandier, Global Head of Servier Ventures, on the creation of the new corporate investment fund

A new generation of biotech contenders

Startups to watch in 2026 Macrocycle Boom

Portugal Rising

CDMO Landscape

Combining small molecule strengths with biologic promise

Inside one of Europe’s emerging biotech innovation hubs

The figures behind Europe’s evolving CDMO market

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INTRO

European Biotechnology | Spring Edition | Vol. 25 | 2026

Europe’s pivotal choice: Vaccination is health security The COVID 19 pandemic demonstrated that Europe can move fast, take risk, and deliver world class vaccines when political will, science and capital are aligned. Treating vaccines as strategic assets, backed by sustained political and financial support, will be key to maintaining Europe’s long-term investment in public health and innovation.

Europe treats vaccination as a cornerstone of collective health security, economic strength, and societal resilience. Coordinating domestic policies, council recommendations, and European level funding, it supports next generation platform innovation, boost uptake, and tackle hesitancy. This integrated framework positions the European biotech sector as a global leader in vaccine development and pandemic preparedness.

CARSTEN RUDOLPH, PhD is a cofounder of Ethris and the lead inventor of its SNIM® RNA Technology. His deep expertise is delivering mRNA specifically to the lungs. He is the inventor of 15 patents/applications and has authored more than 120 scientific publications. Carsten is affiliated with the Dr. von Haunersche Children’s Hospital, part of Ludwig Maximilian University in Munich. He obtained his pharmaceutical degree from the Freie Universität Berlin.

A recent example is the European Commission’s commitment to spend €225 million to accelerate the development of next generation flu vaccines. The initiative will explore multiple vaccines in parallel via precommercial procurement contracts with three European consortiums and organizations. One of those is ­NOFLU, a pan-European initiative of seven partners, including Ethris. NOFLU supports the advancement of an mRNA-based mucosal vaccine against pandemic influenza, leveraging our technology. mRNA based vaccines and innovative approaches like mucosal delivery are relevant work to deliver improved protection against respiratory viruses, and an approach Europe is investing in.

NOFLU brings together complementary expertise spanning mRNA formulation and delivery, preclinical research, and clinical trial execution up to commercialization. It showcases a European model that is collaborative, platform-centric and milestone-driven.

Sustaining Europe’s leadership in vaccine innovation and pandemic preparedness requires two reinforcing pillars: continuous political and financial support at European and national levels, and robust venture capital investment in early-stage innovation. Public funding derisks breakthrough platforms and ensures that preparedness is not left to market cycles alone, while private capital drives speed, scalability and translational excellence across the biotech ecosystem. Aligning these forces will strengthen Europe’s long■ term resilience and foster public health.

Picture: © Buero Monaco GbR

Carsten Rudolph

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CONTENTS

European Biotechnology | Spring Edition | Vol. 25 | 2026

COVER STORY

10 European Startups to watch in 2026

10 TECHNOLOGY

Macrocycles: big is the new beautiful

24 DEEP DIVE

Can biotech finally fix infertility?

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06

Biotech News

Newsflash January-March 2026

10

Startups to watch

Isomorphic Labs, Draig Therapeutics, Adcytherix, Orbis Medicines, NanoPhoria, DISCO Pharmaceuticals, Aerska, Vandria, Phagos, Seamless Therapeutics

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Interview

Alexis Vandier, Global Head of Servier Ventures

20

Business

Europe’s distinct biotech venture studio model

22

Opinion

Can Europe finance and keep its biotech winners?

28

Interview

Ali Tavassoli, Co-Founder and CSO, Curve Therapeutics

42

Innovation

Can gene silencing transform rare disease research?

46

Intellectual Property

Is the Unified Patent Court affordable for small biotechs?

52

Drug Development

Algae cultivation gets easier for biopharma

58

Association News

SLAS, BIOTECH AUSTRIA, ELRIG, yebn

62

Events

Chemspec Europe 2026, German Biotech Days 2026

64

Biopeople

Leadership moves and career changes

66

Index

Company list, Preview next issue

IMPRINT European Biotechnology (ISSN 2364-2351) is published quarterly by: Knowbio GmbH, Jacobsenweg 61, D-13509 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, Email: service@european-biotechnology.com, Internet: www.european-biotechnology.com; Publisher: Joachim Eeckhout; Editorial Team: Dr. Georg Kääb, Uta Mommert, Maren Kühr, Advertising: Oliver Schnell, +49-30-264921-45, Christian Böhm, +49-30-264921-49, Andreas Macht, +49-30-264921-54; Distribution: Nancy Weinert +49-30-264921-40; Graphic Design: Michaela Reblin/ Martina Willnow; Production: Martina Willnow; Printed at: Möller Pro Media® GmbH, European Biotechnology Life Sciences & Industry Magazine is only regularly available through subscription with a Knowbio bundle subscription: €80 for private individuals (students €40) incl. VAT, €120 plus VAT for corporates. Prices includes postage & packaging. Ordered subscriptions can be cancelled within two weeks directly at Knowbio GmbH. The subscription is initially valid for one calendar year and is automatically renewed every year after. The subscription can be cancelled at any time and is valid until the end of that calendar month. Failures of delivery, which Knowbio GmbH is not responsible for, do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied, and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: © jannoon028 - Freepik.com/ glimmeringdepths - Freepik.com; © Knowbio GmbH

Pictures: © Kelli McClintock auf Unsplash; Sevan Habeshian & Christian Heinis; Svitlana Hulko-freepik.com

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CONTENTS

European Biotechnology | Spring Edition | Vol. 25 | 2026

SPECIAL

EDITORIAL

SPECIAL

Print that lasts

Portugal’s biotech industry Portugal is stepping out of Europe’s biotech shadows. New science parks, faster clinical trials, fresh funding and a new generation of startups are giving the country something it long lacked: real momentum and a clearer path to scale.

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Lab automation + data science

Pictures: © annamartianova80 - stock.adobe.com; macrovector - Freepik.com; Caleb Foster - stock.adobe.com; knowbio

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Laboratory automation is evolving fast. What used to be a patchwork of isolated device solutions has steadily moved toward smarter, interconnected labs. And now that robotics is pushing the field one step further, a fully autonomous research environment no longer feels like science fiction.

SPECIAL CDMO Landscape Europe 36 How Europe’s external ­manufacturing ecosystem is evolving

Print journalism, at its best, is built to outlast the moment. Online is where we chase the breaking update; a magazine is where we earn the reader’s time. It invites slower journalism: reporting that can breathe, arguments that can be tested, and stories that carry context rather than noise. In marketing language, print should be “evergreen”; useful today, and still worth keeping on a shelf months from now.

The format itself encourages focus.

That idea guided this first edition of 2026. You’ll find fewer quick hits and more long-form pieces, written to go deeper into the science, the business, and the people behind it. We’ve aimed for stories designed to last beyond deal announcements, trial headlines, and fleeting trends. And when I say “we,” it is a collective effort: this issue welcomes new writers, whose voices strengthen the magazine and whose names you’ll see at the end of their ­articles.

You’ll also discover a new feature: our first-ever “startups to watch” selection. Covering this industry puts us in the front row to discover the next generation of biotech builders. Predictions are always risky, but we’ve made them carefully, and we hope our shortlist sparks your curiosity (and, ideally, holds up).

Old habits don’t disappear entirely and news still matters, but this time, we’ve gathered it in one dedicated section for clarity and convenience. It begins on the next page, so if you’re ready, turn it over and enjoy the read!

39 The European CDMO Model, Powering Biologics Innovation 40 Mitigating regulatory risk with holistic CMC strategies

Joachim ­Eeckhout CEO

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BIOTECH NEWS

Newsflash January French pharma group Servier and Insilico Medicine announced a collaboration worth up to $888 million for a multi-year research and development collaboration to discover and develop oncology therapies using Insilico’s AIdriven drug discovery platform and Servier’s cancer development expertise.

Amgen has agreed to acquire Dark Blue Therapeutics (UK) in a deal valued at up to $840 million, as the biopharmaceutical company continues to build out its early-stage oncology pipeline. As a result of early collaboration with the Dark Blue, Evotec will share in the proceeds of the transaction.

Just weeks after closing a sizeable financing round, Cologne-based Disco ­Pharma has unveiled a collaboration with Amgen with a potential value of up to $618 million (p. 12).

Polish JPB Biologics reports positive top-line results from a Phase I clinical trial of JJP-1212, its first-in-class anti-CD89 antagonist being developed for IgA-mediated inflammatory diseases. The data clear the way for Phase II studies starting later this year.

Four years after its initial series A round, Engitix has completed a $25 million series A extension. The Londonbased biotech is developing therapies that target the extracellular matrix in solid tumors and fibrosis.

Swiss biotechnolog y company ­ ECregen has raised CHF 10 million (€11 T million) in seed financing to advance therapies designed to restore immune function by regenerating the thymus, an organ central to T-cell development.

French start-up Enodia Therapeutics has secured €20.7 million in seed fund-

European Biotechnology | Spring Edition | Vol. 25 | 2026

ing to advance its early-stage pipeline of targeted protein degradation.

triple-negative breast cancer and ovarian cancer.

Bit.bio has raised $50 million in a series C round to support the next phase of its human cell programming business. The Cambridge-based company develops defined human cells using its opti-ox technology, supplying reproducible cell types to researchers and drug developers for use in drug discovery.

Infinitopes, a U.K. cancer vaccine biotech, has expanded its seed round to $35.1 million after a second close that added about $15.4 million to existing commitments. The financing was co-led

by Octopus Ventures and new investor Amplify Bio.

The Novo Nordisk Foundation has committed up to DKK 5.5 billion (€736 million) to the BioInnovation Institute, a Copenhagen-based hub for life science and deep tech entrepreneurship. The long-term funding, running from 2026 to 2035, aims to strengthen Denmark’s innovation capacity while helping Europe turn scientific excellence into companies, jobs and solutions.

Genmab and AbbVie hit a setback with epcoritamab, after the bispecific Tcell-engaging antibody failed to deliver a survival benefit in a phase 3 study in relapsed or refractory diffuse large Bcell lymphoma (DLBCL). The E­ PCORE DLBCL-1 trial missed its primary endpoint of overall survival. While epcoritamab did slow d ­ isease progression and performed better across several secondary measures, the survival miss overshadows the readout.

GSK plc has agreed to acquire California-based RAPT Therapeutics in a deal valued at $2.2 billion (€ 1.88 billion), expanding its respiratory, immunology and inflammation portfolio with a late-stage food allergy candidate. The transaction gives GSK global rights to ozureprubart, a long-acting anti-IgE monoclonal antibody now in phase IIb clinical development.

The French preclinical-stage biotech E­ rVimmune closed a €17 million series A round to bring its lead candidate cancer vaccine into the clinic. ErVac01 contains epitopes for human endogenous retroviruses (HERVs) and is intended for the treatment of ‘cold’ tumours such as

IO Biotech is preparing for further restructuring. The Copenhagen-based biotech said that it is exploring strategic alternatives, including a merger, asset sale, business combination, or potential liquidation, and warned that it may need to implement additional workforce reductions and cost-cutting measures as the process unfolds.

Ellipses Pharma (UK), which develops cancer therapeutics, announced a collaboration and licensing agreement with China-based Innolake Biopharm Co. Ltd to develop a clinical-stage, firstin-class antibody–drug conjugate (ADC), EP0028, for solid tumors.

Genmab has stopped enrolling patients in an early-stage clinical trial for an experimental cancer drug it gained through the acquisition of ProfoundBio in April 2024 for €1.52 billion. This pause underscores a broader reshaping of its oncology strategy.

Belgian investment company Gimv will stop making new investments in life sciences and instead focus on four core platforms: consumer, healthcare, smart industries and sustainable cities, alongside its long-term investment program Anchor.

Dresden-based experts in sequenceprecise gene repair, Seamless Therapeutics, have secured a heavyweight partner. The company has entered into a global research collaboration with Eli Lilly, to apply its technology platform of specific recombinases to the development of gene therapies for hearing loss. For Seamless, the collaboration ›››

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BIOTECH NEWS

Newsflash could generate total funding of up to $1.1 billion if milestones are successfully achieved (see p. 14).

European Biotechnology | Spring Edition | Vol. 25 | 2026

at $16 per share, bringing in about $200 million in gross proceeds with its stock now trading under the ticker AGMB.

›››

German Boehringer Ingelheim group has entered into a licensing and development partnership with Shanghai-based Simcere Pharmaceutical Group to advance a novel bispecific antibody for the treatment of inflammatory bowel disease.

French biotech company Sensorion announced a €60 million reserved offering including a €20 million strategic investment from Sanofi. The remaining €40 million subscribed by existing shareholders Redmile Group, Artal, and Sofinnova Partners, alongside new investors.

February French biopharma company Ipsen has entered a global collaboration and option agreement with San Diego-based biotech Origami Therapeutics to advance a small-molecule protein degrader program targeting a rare, inherited neurodegenerative disorder.

Newly formed French biotech Kahimmune Therapeutics has signed an exclusive licensing agreement with Gustave Roussy and SATT Paris-Saclay, securing rights to a technology platform designed to identify tumor antigens derived from the “dark” or non-coding genome.

PharosAI, a cancer research consortium bringing together King’s College London, Queen Mary University of London, Guy’s and St Thomas’ National Health Service (NHS) Foundation Trust and Barts Health NHS Trust, has partnered with 10x Genomics to generate large-scale multimodal cancer datasets from archived NHS tumor samples using 10x’s Xenium spatial biology platform. (p. 14) Belgium-based Agomab has gone public on Nasdaq after pricing its IPO

Stockholm-based BioArctic is receiving SEK 127 million (about €11.9 million) in royalties from the Alzheimer’s disease therapy Leqembi (lecanemab).

Dublin-based biotech company Aerska, has raised €32 million in a Series A financing to advance its lead technology toward clinical development. The round was co-led by EQT Life Sciences through its LSP Dementia Fund, alongside age1, and brings the company’s total funding to €50 million since its seed round in October 2025.

The France-based 4Moving biotech has closed a €12 million financing round to advance its lead programme, 4P004, toward a Phase 2a proof-of-concept readout in knee osteoarthritis.

Australian–Swiss plasma specialist CSL is relying on technology from Switzerland for recombinant polyclonal immunoglobulins (IgG). With Memo Therapeutics (Switzerland), the company has closed a collaboration and option agreement with a potential value of up to CHF 265 million.

Zurich-based oncology biotech Araris Biotech AG has entered into a research collaboration with an option to license with Japan’s Chugai Pharmaceutical, a subsidiary of Roche. The aim of the partnership is to develop next-generation antibody–drug conjugates.

French biopharma THX Pharma has signed a strategic licensing deal with Biocodex, an independent French pharmaceutical group, to advance two drug candidates in three rare genetic disorders with high unmet need.

French biotech GENFIT will receive a $20 million commercial milestone payment after Ipsen reported $208 million in full-year 2025 net sales of Iqirvo in primary biliary cholangitis, surpassing

the $200 million threshold set out in the companies’ 2021 licensing agreement.

Munich-based Immunic, Inc. (listed on Nasdaq as IMUX) has launched a follow-on private placement of up to US$400 million. At the same time, the biotech is pressing ahead with its transformation in preparation for the potential commercialisation of its lead asset.

Denmark-based Lundbeck has reported positive top-line results from the intravenous arm of its phase IIb PROCEED trial of bocunebart (Lu AG09222) in migraine prevention, ready for phase III discussions with regulators.

The European Innovation Council has funded the collaborative GLIOBREAK project, bringing together Swedish biotech Beactica Therapeutics and the Belgian KU Leuven Institute for Single-Cell Omics to advance Beactica’s small-molecule candidate, BEA-17, as a precision immunotherapy for glioblastoma.

Newron Pharmaceuticals has secured up to €38m to advance Phase III trials of evenamide, a drug that, if successful, could represent one of the first circuitmodulating therapies in schizophrenia.

Swedish startup CubaseBio has raised €5.9 million in blended financing to advance its next-generation 3D spatial transcriptomic technology. Voima Ventures and Nordic Science Investments led the private financing. Illumina Ventures, Almi Invest, Life Science Invest and several genomics-focused private investors also participated.

The share price of London-based Compass Pathways soared over 30% after the company reported that its synthetic psilocybin formulation COMP360 had met the primary endpoint in the second of two pivotal phase III trials in treatment-resistant depression, confirming consistent results across 839 patients and clearing the path toward first regulatory filing of a classic psychedelic for a psychiatric indication.

BIOTECH NEWS

European Biotechnology | Spring Edition | Vol. 25 | 2026

Newsflash Dutch venture capital firm Forbion has led a $75 million investment in US-based Altesa BioSciences, positioning the biotech to run a phase IIb trial in chronic obstructive pulmonary disease (COPD) patients in the second quarter.

A pause in the collaborative Alzheimer trial of Johnson & Johnson and partner AC Immune from Switzerland raises some questions. Whether the pause has something to do with overall recruting difficulties or with the application of the drug under investigation is not yet clear.

Edinburgh-based Lario Therapeutics has received $2.4 million (approximately €2m) in grant funding from The Michael J. Fox Foundation and Wellcome to expand its drug discovery platform targeting voltage-gated neuronal calcium channels implicated in several central nervous system disorders. The approach is based on genetic findings that could open up new avenues for treating Parkinson’s disease and post-traumatic stress disorder.

UK-based Syndex Bio has announced the launch of its proprietary methyl-copying PCR platform alongside the close of an oversubscribed $15.5 million seed financing round led by ARCH Venture Partners, with participation from +ND Capital, OMX Ventures and Meltwind Advisory LLP. A group of vaccine developers, biotech firms and public health institutes, including Bavarian Nordic, Ethris GmbH, IDT Biologika GmbH and Sanofi, has secured framework contracts under a €225 million EU initiative to accelerate the development of next-generation influenza vaccines.

Italy’s Angelini Pharma has signed a multi-year research collaboration and licensing agreement with Massachusettsbased Quiver Bioscience to discover new treatments for genetic epilepsies, in-

cluding developmental and epileptic encephalopathies. Under the agreement, Quiver could receive up to $120 million in milestone payments plus royalties if Angelini advances drug targets emerging from the collaboration.

O x fo r d - b a s e d B r a i n o m i x ha s added £4.8 million (approximate ly $6.5m/€5.5m) to its Series C financing, bringing the total round to £18.8 million ($25.4m/€21.5m) and providing fresh capital to accelerate the US rollout of its AI-powered imaging platforms for stroke and lung ­fibrosis.

As a co-investor in the USD 25 million Series B round, Beiersdorf AG is signalling that AI is becoming strategically important for skin research. The Hamburg-based group is participating through its venture unit in the AI biotech Turbine, founded in Budapest and now also headquartered in London.

Denmark’s Novo Nordisk has signed a collaboration with Boston-based Vivtex Corporation to develop next-generation oral biologic medicines for obesity, diabetes and associated metabolic diseases. Vivtex is eligible to receive upfront payments, research funding and milestone payments totalling up to $2.1 billion (approximately €1.78bn), as well as tiered royalties on net sales of any resulting products.

Argenx delivered positive Phase 3 results in ocular myasthenia gravis (oMG) and its first full year of operating profitability. Together, the announcements show a company expanding its lead medicine into a new patient population while doing so from a position of financial strength.

Aicuris Anti-Infective Cures AG, which specializes in active ingredients for infectious diseases, is being acquired

by Japanese pharmaceutical company A ­ sahi Kasei for almost €800 million (around US$920 million). The company had obtained its own approval and is

currently in late-stage clinical development with active ingredients.

Oxford-based immunology specialist S­ itryx has entered into a new agreement with Boehringer Ingelheim aimed at advancing a novel small-molecule programme in autoimmune and inflammatory disease. The deal could be worth US$500 million in total, but the breakdown of the payments in upfront and milestones was not disclosed in detail.

March UCB has struck a global licensing deal with Hong Kong–based Antengene for ATG-201, a CD19/CD3 bispecific Tcell engager (TCE) designed to deplete B cells in autoimmune disease.

Paris-based kyron.bio has signed a strategic partnership Servier to glycoengineer an antibody selected by the French pharma group. This agreement marks an early proof-of-concept deal designed to show the company can reliably “dial in” a specific, pre-defined N-glycoform on a therapeutic antibody.

Servier is also spending US$2.5bn to buy California-based Day One Biopharmaceuticals, gaining a key approved drug for difficult childhood brain tumours along with several promising pipeline candidates.

Italian drugmaker Alfasigma has struck a licensing deal to take over global rights to linerixibat, GSK’s late-stage candidate for cholestatic pruritus in primary biliary cholangitis (PBC), in a transaction that could be worth up to $690 million to the British pharma group.

Roche and Zealand Pharma reported that patients in a phase 2 readout for petrelintide – their amylin-based obesity drug – achieved up to 10.7% mean weight loss at 42 weeks, but shares in both partners fell sharply as investors questioned whether the candidate can stand out in an ■ increasingly crowded field.

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START-UPS

European Biotechnology | Spring Edition | Vol. 25 | 2026

10 European Startups to watch in 2026 Ten young European biotechs are heading into 2026 with the kind of momentum that can quickly turn promising science into defining data: first clinical entries, platform-to-pipeline transitions, and funding rounds large enough to accelerate execution. Some are pushing new modalities into hard disease areas, while others are compressing discovery timelines and expanding what’s druggable. What they all share is a clear momentum that makes them especially worth following this year.

To build this list, we applied a simple set of filters before making our final selection:

› Companies must be headquartered in Europe,

› Founded in the last 5 years (2021 or later)

› Raised funding in the last 24 months (2024 or later) Our list is also focused on biopharma companies and we excluded diagnostics,

lab equipment/tools, and medtech from our selection.

From the pool of eligible companies, our editorial team made an opinion call to pick the final ten, prioritizing those with a recent catalyst event (first-in-human, major partnering, or a step-change financing) that could make the next 1224 months decisive. We then ranked the final ten by the size of their most recent disclosed funding round.

Without further ado, here’s our list of startups to watch in 2026:

1. Isomorphic Labs Isomorphic Labs is Alphabet /Google DeepMind’s drug-discovery spinout turning AlphaFold – the AI breakthrough that predicts protein structures – into a drug design engine for small molecules.

Profile Founding: 2021 Headquarters: London, UK Focus: AI drug discovery Clinical Stage: Preclinical Funding stage: Series A Total funding: $600m (€555.4m

After years in platform-build mode, it is now gearing up to enter the clinic: CEO ­D emis Hassabis recently said at the World Economic Forum in Davos that the company is preparing to dose its first patients, with trials expected to start by the end of 2026. Commercial momentum has also kept pace. In January 2024, Isomorphic signed multi-target discovery deals with Lilly and Novartis worth nearly $3bn in potential milestones (including $45m and $37.5m upfronts), and it expanded the Novartis collaboration in February 2025. A $600m first external ­financing led by Thrive Capital follo­wed

on March 31, 2025, funding the push . from model-building to medicines.

www.isomorphiclabs.com

Picture: © Kelli McClintock auf Unsplash/Isomorphic Labs

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2. Draig Therapeutics Draig Therapeutics is a neuropsychiatry spinout from Cardiff University and SV Health Investors developing small-molecule medicines that target core neurotransmission pathways in major brain disorders.

Its lead asset DT-101 has completed Phase 1 safety work and is now moving into Phase 2 for major depressive disorder, with a global study that started at the end of 2025. The company also has additional clinical-stage programs and is advancing highly selective GABAA receptor modulators toward the clinic in 2026.

Draig emerged from stealth with unusually mature assets for a young European startup, backed by a large $140m (€120m) Profile Series A announced on 18 June 2025, giving it the firepower Founding: 2024 to run multiple trials in parallel and quickly broaden beyond Headquarters: Cardiff, UK . depression.

Focus: Brain disorders Clinical Stage: Phase 2 Funding stage:Series A Total funding:: $140m (€120m)

www.draigtherapeutics.com

3. Adcytherix Adcytherix is part of the new wave of European antibody-drug conjugates (ADC) companies betting that the next step-change in efficacy will come from novel payload classes, not just new antibodies. Formed by the team behind Emergence Therapeutics (acquired by Eli Lilly in 2023 for a three-figure million amount), Adcytherix is building a proprietary ADC pipeline led by ADCX-020, which entered a Phase 1 for locally advanced or metastatic cancer patients in February 2026, a fast timeline that has helped it stand out in a crowded ADC field. That momentum is backed by rare early firepower: after a €30m seed at incorporation (June 2024), Profile Adcytherix closed a €105m Series A on 16 Oct 2025 to fund Founding: 2023 . the first clinical entry and expand additional programs.

Headquarters: Marseille, France Focus: Antibody-drug conjugates in cancer Clinical Stage: Phase 1 Funding stage:Series A Total funding:: €135m

www.adcytherix.com

Picture: © MockupX - Freepik.com

4. Orbis Medicines Orbis Medicines is developing orally available macrocycle drugs (“nCycles”) designed to hit targets typically addressed by injectable biologics, aiming for biologic-like potency with pill-like convenience. Its nGen platform combines automated chemistry with machine learning to systematically explore macrocycle design, building a pipeline around validated blockbuster targets.

The company remains preclinical, but its financing cadence has been unusually strong for a young European biotech: it emerged from stealth with a €26m seed in Feb 2024 and folProfile lowed with a €90m Series A on 6 Jan 2025, bringing total capFounding: 2021 ital raised to €116m. In parallel, Orbis has been widening its Headquarters: Copenhagen, Denmark technology stack via a research collaboration and option-to-liOral macrocycle Focus: medicines cense with Vivtex entered in 2024 to support next-generation Clinical Stage: Preclinical orally dosable nCycles, signalling an aggressive push to transFunding stage:Series A late platform output into development candidates. (see p.25) .

Total funding:: €116m

www.orbismedicines.com

START-UPS

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STARTUPS TO WATCH

European Biotechnology | Spring Edition | Vol. 25 | 2026

START-UPS

European Biotechnology | Spring Edition | Vol. 25 | 2026

5. NanoPhoria NanoPhoria Bioscience is developing inhalable cardiovascular biologics using a proprietary “nano-inmicro” lung-to-heart delivery platform built on calcium-phosphate nanoparticles. Its lead asset NP-MP1, a first-in-class peptide targeting cardiac L-type calcium channels for Heart Failure with reduced Ejection Fraction (HfrEF), has shown efficacy in preclinical models and is now being pushed through IND-enabling and into early clinical development. Momentum accelerated in the past two years: NanoPhoria secured an €17.5m EIC Accelerator commitment in Feb 2025 to support progress toward first-in-human studies, then followed with €83.5m on Profile Oct 6, 2025, securing Italy’s largest Series A in history to fund Founding: 2022 GMP scale-up, regulatory work and early trials, and to exHeadquarters: Milan, Italy . pand beyond heart failure.

Focus: Cardiovascular diseases Clinical Stage: Preclinical Funding stage: Series A Total funding: €104,5m

www.nanophoria.com

6. DISCO Pharmaceuticals DISCO Pharmaceuticals is building what it calls a “surfaceome” discovery engine, mapping the full set of proteins on tumor cell surfaces to uncover new, cancer-selective targets for antibody medicines. The bet is straightforward: better targets unlock better ADCs and T-cell engagers, expanding beyond the relatively small set of cell-surface antigens that dominate today’s oncology pipelines. DISCO’s first programs focus on small cell lung cancer and microsatellite-stable colorectal cancer, with multiple lead ADC candidates being pushed toward IND-enabling work as the company aims for clinical entry. Momentum over the past two years includes a Profile €36m seed round in 2025, alongside a CEO handover to forFounding: 2022 mer Takeda/Atlas oncology leader Mark Manfredi, and an exHeadquarters: Cologne, Germany clusive licence agreement with Amgen to develop novel canFocus: Bispecific ADCs and T-cell engagers Clinical Stage: Preclinical cer therapies targeting cell-surface structures with a potential Funding stage: Seed . value of up to US$618 million.

Total funding: €36m

www.discopharma.de

7. Aerska Aerska is tackling one of neurogenetic medicine’s hardest bottlenecks: systemic delivery to the brain.

The company is developing RNA interference (RNAi) therapies paired with an antibody-oligo conjugate (AOC) “brain shuttle” designed to ferry payloads across the blood–brain barrier, aiming to replace invasive CNS dosing with more scalable administration. The story of the company has moved fast: Aerska launched out of stealth with a $21m (€17m) seed on Oct 1, 2025, then closed a $39m (€32m) Series A on Feb 9, 2026, bringing total funding to $60m (€49m) as it pushes the platform toward clinical Profile Founding: 2025 . readiness and builds a CNS pipeline.

Headquarters: Dublin, Ireland RNAi medicines for Focus: CNS disease Clinical Stage: Preclinical Funding stage: Series A Total funding: $60m (€49m)

www.aerska.com

STARTUPS TO WATCH

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START-UPS

European Biotechnology | Spring Edition | Vol. 25 | 2026

8. Vandria Vandria is a Swiss clinical-stage biotech advancing first-in-class, oral small molecules that induce mitophagy, aiming to restore mitochondrial function and dampen chronic inflammation in age-related disease. Its lead asset VNA-318 is brain-penetrant and is being developed for Alzheimer’s disease. The program delivered positive first-in-human Phase 1 topline data in late 2025, supporting the next step toward patient studies. The company’s momentum has been underpinned by a two-step Series A completed in 2024: an initial $20.6m (~€19m) financing to take VNA-318 into the clinic, followed by a second close bringing the Series A to Profile $30.7m (~€28.4m), extending the runway for subsequent efFounding: 2021 . ficacy work and pipeline expansion.

Headquarters: Lausanne, Switzerland Focus: Mitophagy/mitochondrial therapeutics Clinical Stage: Phase 1 Funding stage: Series A Total funding: $30.7m (~€28.4m)

www.Vandria.com

9. Phagos Phagos is developing bacteriophage-based medicines – viruses that selectively kill bacteria – as a precision alternative to antibiotics, starting with animal health, where antimicrobial resistance is becoming a practical constraint. What sets it apart is the combination of microbiology + AI to design tailored phage cocktails quickly, and an unusual regulatory foothold: the company says it holds the first authorisation to market personalised veterinary phage treatments in the EU. With that, Phagos is shifting from R&D to deployment in the field, while building a platform it ultimately wants to extend into human health. The company raised €25m Series A in Profile 2025 to scale commercial rollout and its discovery tech, folFounding: 2021 . lowing a €2.4m seed in 2022 Headquarters: Paris, France Focus: AI-enabled phage therapies Clinical Stage: Commercial in animal health Funding stage: Series A Total funding: €27.4m

www.Phagos.com

10. Seamless Therapeutics Seamless Therapeutics is developing a next-generation gene-editing approach based on programmable recombinases, enzymes long used in research that have been re-engineered to make large, precise DNA insertions/excisions at defined genomic sites, without relying on the cell’s DNA-repair pathways as CRISPR does. The company is still preclinical, but it has been steadily moving from toolmaking toward therapeutics, positioning the platform for first clinical evaluation. Momentum over the past two years has come less from splashy financings than from strategic validation: after reporting it had raised $25m (~€21m) Profile Founding: 2022 in seed financing in 2024, Seamless signed a global research Headquarters: Dresden, Germany collaboration and licensing deal with Eli Lilly on Jan 28, 2026 Programmable recombinase Focus: to develop recombinase-based genetic medicines for hearing gene editing Clinical Stage: Preclinical loss in a partnership worth over $1.12bn (~€0.93bn) in potenFunding stage: Seed . tial payments plus royalties.

Total funding: $37.5m (~€31.7m)

www.Seamlesstx.com

STARTUPS TO WATCH

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ADVERTORIAL

European Biotechnology | Spring Edition | Vol. 25 | 2026

AI meets biotech: Europe’s new investival Artificial intelligence is reshaping biotechnology, diagnostics and drug discovery. At the same time, Europe is competing globally for capital, talent and technological leadership. bio:cap aims to strengthen this ecosystem by connecting investors, startups, researchers and policymakers in a new international investival in Berlin.

Picture:© Messe Berlin GmbH

bio:cap

From June 9–11, 2026, Berlin will host the premiere of bio:cap, a new international investival dedicated to the intersection of life sciences and artificial intelligence. The event takes place at the CityCube on the Berlin exhibition grounds and brings together investors, startups, research institutions and companies from biotech, diagnostics, TechBio and AI. Europe is uniquely positioned to lead in life sciences. World-class universities, hospitals and research institutes generate breakthrough discoveries, while ambitious start-ups are transforming scientific excellence into globally relevant innovations. bio:cap aims to strengthen this momentum by connecting research, capital and industry in one international platform.

The event is designed to span the entire innovation cycle – from fundamental research and technology transfer to venture financing and policy frameworks. Its goal is to accelerate the translation of scientific discoveries into scalable companies and real-world medical solutions while strengthening Europe’s competitiveness in life-science innovation.

The conference programme, developed in collaboration with media partner Handelsblatt, focuses on themes shaping the sector.

These include Europe’s position in the global race for biotechnology innovation, the growing role of artificial intelligence in research and drug development, and emerging therapeutic platforms beyond mRNA. Additional sessions address regulatory frameworks, infrastructure requirements, and investment strategies for scaling life-science innovation.

Internationally recognised leaders from science, industry and venture capital will contribute their perspectives. Among them is Nobel Prize laureate Prof. Dr. Stefan W. Hell, whose work in super-resolution microscopy transformed biological imaging. Industry insights will be provided by Stefan Oelrich, Member of the Board of Management at Bayer AG and President of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Entrepreneurial perspectives come from Rodger Novak, co-founder of CRISPR Therapeutics, and Thomas Clozel, CEO and co-founder of Owkin.

The event will also bring together global pharmaceutical companies such as Pfizer and AstraZeneca, highlighting the importance of collaboration between industry, startups and academic research institutions in advancing the next generation of life-science innovation. bio:cap is organised by Messe Berlin in cooperation with Charité – Universitätsmedizin Berlin, the Berlin Institute of Health in the Charité (BIH) and the Hasso Plattner Institute (HPI), representing Ber-

lin’s strong ecosystem of research, medical innovation and venture capital.

Curated matchmaking sessions and dedicated investor areas will facilitate collaboration across the international lifescience ecosystem. Throughout the three days, additional side events across Berlin will create further opportunities for informal exchange and networking. One highlight will be the official bio:cap Investival Party on June 10 at the historic AVUS Tribüne, a landmark grandstand of Berlin’s former AVUS motor racing circuit.

“Berlin has become one of Europe’s most dynamic life-science locations,” says Lara Formichella, Project Lead bio:cap at Messe Berlin. “With bio:cap we want to create a platform where scientific excellence, entrepreneurship and capital come together to accelerate innovation in biotechnology and AI." ■ Contact us: bio:cap 2026 June 9–11, 2026 | CityCube Berlin, Germany More information and registration: www.biocap-europe.com biocap@messe-berlin.de

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INTERVIEW

European Biotechnology | Spring Edition | Vol. 25 | 2026

Inside Servier’s new €200M venture fund With the launch of Servier Ventures announced in January and a €200 million commitment to biotech investment, Servier is stepping up its engagement in early-stage i­nnovation in oncology and neurology. European Biotechnology Magazine spoke with ­Alexis Vandier, Global Head of Servier Ventures, about the fund’s strategy, investment ­focus, and ­Europe’s role in the global biotech ecosystem.

VENTURE CAPITAL

EuroBiotech_Why did Servier decide to build its own venture arm with Servier Ventures, rather than continue investing through external funds or partnerships?

Alexis Vandier_Servier was already active

on several fronts. We had research collaborations, classical business development partnerships, and we were limited partners (LP) in several venture capital funds. Over time, however, we saw a gap emerging, both from our side and within the biotech ecosystem.

Biotech companies were increasingly coming to us when partnering discussions overlapped with fundraising needs.

At the same time, corporate venture capital has become a more important driver of innovation globally, and there is growing evidence that biotech companies can benefit from having corporate investors.

For Servier, the gap was structural. We cover the full value chain, from early research to development, which is relatively unique today. Very early on, research collaborations work well. Very late, traditional licensing or mergers and acquisitions make sense. But in between, when companies are no longer pure platforms but not yet fully mature assets, it was difficult to find the right vehicle.

This stage, typically late preclinical, is when companies need both capital and industrial input: support on CMC (Chemistry, Manufacturing, and Controls), regulatory strategy, and development planning. Servier Ventures was created to fill that gap and to engage more directly with innovation, rather than remaining one step removed as an LP.

EuroBiotech_What types of technologies or assets are you particularly interested in?

Vandier_Our focus remains firmly on

ALEXIS VANDIER brings 25 years of experience at the intersection of science and business in biopharma.

He held senior leadership positions, including Global Asset Lead Oncology at Servier, CEO of OSE Immunotherapeutics, and Vice President at Ipsen. Alexis also contributed to corporate strategy and business ­development at Sanofi. Beyond ­operational roles, he has served as an advisor for Extens and BNP Paribas Développement and sat on the Advisory Board of Paean Biotechnologies. With strong dealmaking expertise, including inlicensing across diverse markets, he was recently appointed Global Head of Servier Ventures, Servier’s new strategic corporate venture fund.

drugs and therapeutic molecules that align with Servier’s strategy. When we refer to “technology”, it often reflects the early-stage nature of biotech. At seed or preclinical stages, companies frequently sit between a platform and an asset.

Take neurology or neuro-oncology, which are key focus areas for us. A major challenge is crossing the blood–brain barrier, which often requires combining delivery technologies with specific molecular targets. That is what we mean by technology.

We will not invest in medtech or standalone AI platforms. AI can be part of the story, but only if it clearly supports the development of a defined therapeutic asset. We are not interested in platforms where the path to a drug remains unclear.

EuroBiotech_How narrowly defined is your investment thesis within oncology and neurology?

Vandier_We invest where we believe Ser-

vier can add real value. This is a strategic fund, and some investments may one day become part of Servier’s portfolio, perhaps one or two out of ten.

Initially, we will stay closely aligned with Servier’s business development priorities to ensure long-term relevance.

That said, Servier is evolving rapidly, and Servier Ventures can also be a way to explore new modalities for the future.

Picture: © Franck JUERY

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INTERVIEW

European Biotechnology | Spring Edition | Vol. 25 | 2026

We allow some flexibility, particularly on modalities, but not a complete divergence from Servier’s core focus. For example, cell and gene therapies are not currently a priority and are unlikely to be early investments.

EuroBiotech_ At what stage do you intend to invest, and how do you balance early scientific risk with strategic relevance?

Vandier_We do not aim to create compa-

nies ourselves; excellent seed funds already play that role. We typically come in after that phase, often at a second seed or Series A, focusing on late preclinical assets.

This is where we believe we can add the most value. Once an asset reaches Phase I or II, discussions naturally shift toward partnering or licensing, which is handled by our business development teams. Servier Ventures sits upstream of that process.

EuroBiotech_What does access to Servier’s expertise look like for portfolio companies?

Vandier_We offer access to capabilities

as well as scientific, clinical and industrial networks. This can include mentoring, expert input, or connections to leading hospital centers in oncology and neurology. We also have laboratory capabilities, for example at Paris Saclay (France), that can be accessed when relevant.

However, flexibility and independence are essential. Portfolio companies remain fully autonomous. We do not require preferential rights or exclusiveness. The goal is to help companies reach their full potential. If a partnership emerges later, that is a positive outcome for everyone.

Picture: © Franck JUERY

EuroBiotech_What weaknesses do you most often see in early-stage biotech companies, and what convinces you to invest?

Vandier_A frequent challenge is the tran-

sition from a strong scientific idea to a team capable of execution. That often links back to funding, because building the right team requires resources.

R&D at Paris-Saclay

Another issue is focus. Companies sometimes pursue multiple directions instead of focusing on the area with the highest potential.

What excites us is highly differentiated science, first-in-class approaches, even if they carry more risk. As a venture investor, we can take risks that are not always possible in later-stage business development. Our research expertise helps us assess preclinical data realistically, including the limitations of disease models.

EuroBiotech_Why start with a European focus, and how do you view the European biotech ecosystem today?

Vandier_Europe is where we know the

ecosystem best, and proximity matters.

Our largest R&D footprint is in France, which makes close interaction easier.

That said, innovation is global, and expansion beyond Europe is clearly possible in the future.

Europe’s main strength is scientific excellence, from hospitals, academic centers and research institutes across the UK, France, Benelux, the Nordics, Germany, and Southern Europe. Historically, the weakness was scale-up financing beyond early stages, forcing companies to move too early to the US. But there is improvement. Larger European funds are emerging, and recent successful exits are reinforcing the ecosys-

tem. We are in a much better place than a decade ago.

EuroBiotech_How will you measure the success of Servier Ventures in ten years?

Vandier_Financial return does matter of

course, but it is not the only metric. Servier is governed by a foundation, with profits reinvested into R&D. Our ultimate measure of success is delivering real innovation to patients: approved medicines that make a difference, particularly in areas like neurology and aggressive cancers where unmet needs are enormous.

EuroBiotech_ And to finish on a more personal level, what excites you most and what concerns you most about building Servier Ventures today?

Vandier_What excites me is the demand.

Since the announcement, the response from the ecosystem has been overwhelming. There is a real need, and Servier can play a meaningful role, especially in supporting European innovation.

What concerns me most is the geopolitical context. Innovation should be global, and patients benefit when scientists collaborate across borders. I hope tensions do not undermine our collective ability to work together for patients ■ worldwide.

Valentin Hammoudi

17

ADVERTORIAL

European Biotechnology | Spring Edition | Vol. 25 | 2026

Research and Innovation: Life Sciences made in Europe The EU is redefining its innovation landscape, making research and innovation key drivers for Life Sciences competitiveness. A series of regulatory initiatives – the European Innovation Act, sector-specific reforms in pharma, ­biotech and medical device law, and a harmonised health data framework – aim to accelerate research, improve data access and bring innovations to market faster. This reform agenda could reshape the EU’s innovation landscape.

POLICY

› Irina Rebin, Life Sciences Partner at Taylor Wessing

Making Europe the world's most attractive location for Life Sciences by 2030 across the value chain from research to market. This is the ambitious goal set by the European Commission in its Life Sciences Strategy 2030 published in July 2025. It serves as a framework for horizontal initiatives and, as a soft law instrument, guides subsequent legislation. Key measures include targeted funding, removing regulatory barriers, improving access to health data, and stronger public-private partnerships. For decades, Europe has been a leader in this field thanks to its strong research base. But it is losing ground to other global players (such as the U.S. and China) in turning research into real-world solutions due to challenges such as fragmented funding and inno-

vation systems, regulatory complexities and slow market uptake.

Cross-Sectoral Framework The Compass for a Competitive EU embeds these ambitions in a broader economic strategy. It addresses structural disadvantages compared to the US and China, particularly regarding capital mobilisation, scaling of start-ups and deep-tech companies, and regulatory complexity. The emphasis lies on simplification, EU market integration and modernisation of existing legal frameworks. Innovation is thereby anchored as a guiding principle of regulation.

To close the innovation gap, the Compass announces the following measures: The European Innovation Act, planned as a regu-

lation for Q1/2026, is intended to create a horizontal framework that removes administrative barriers, aligns existing rules with innovation objectives and establishes comparable conditions across the Union. The ERA Act focuses on research and investment conditions, seeks to strengthen public and private R&D investment, reaffirms the 3% GDP target and enhances coordination between the EU and Member States as well as cross-border research and technology transfer. The 28th Regime is conceived as a uniform legal framework to reduce fragmentation and facilitate cross-border start-ups, scaling and financing. Together, these initiatives aim at structural de-fragmentation and EU-wide scalable framework conditions.

Sector-Specific Reforms Alongside horizontal architecture, the EU has initiated sector-specific reforms in pharma, biotechnology, and medical device law to ensure high protection standards, accelerated procedures, proportionate regulation, and improved investment incentives.

The Pharma Package represents the EU’s most significant pharma law reform in over 20 years. In December 2025, the Council and Parliament reached an agreement on a new regulation and directive, revising existing rules. The Package aims to ensure fair access to safe, effective and affordable medicines while strengthening competitiveness. The reform recalibrates incentive and

Picture: © Taylor Wessing Partnerschaftsgesellschaft mbB

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European Biotechnology | Spring Edition | Vol. 25 | 2026

ADVERTORIAL

use), aiming to reduce legal fragmentation and inconsistent requirements. The EHDS Regulation entered into force on March 26, 2025, and is being implemented gradually; most obligations will apply four years later (first milestone in March 2027 with essential implementing acts).

Picture: © Taylor Wessing Partnerschaftsgesellschaft mbB

Initiatives to Promote Research and Innovation

protection mechanisms central to investment decisions: The new '8+1+1+1' rule provides 8 years of data protection, followed by 1 year of marketing protection, with possible one-year extensions for addressing unmet medical needs, for qualifying combination productsand for additional therapeutic indications with significant clinical benefit. A transferable voucher incentivizes priority antibiotics, granting an extra year of market protection. Market exclusivity for rare disease medicines is reduced from 10 to 9 years. Breakthrough rare disease medicines may benefit from up to 11 years of protection. The regular approval period drops from 210 to 180 days.

The proposed Biotech Act addresses the innovation-intensive core of biopharmaceutical research and forms part of the Life Sciences Strategy 2030. The regulation is expected to enter into force by the end of 2026, once the legislative process is completed. It covers the entire life cycle of health-related biotechnology, from research and financing to clinical development, manufacturing and market access.

The draft provides for accelerated approval procedures, expansion of industrial capacities and targeted financing instruments for late-stage development and scale-up.

It introduces legally defined categories of “strategic” and “highly effective” projects benefiting from priority procedures, administrative support and improved funding access. The proposal further integrates digitalisation and AI, establishes regulatory support structures such as networks and sandboxes and envisages selective adjustments to protection mechanisms, par-

ticularly in the area of SPCs. Notably, the Clinical Trials Regulation’s multinational approval times are shortened (106 to 75 days), and EU templates standardised. Decentralised/minimal-intervention studies and harmonised data protection are implemented, accelerating and harmonising the CTR. The reform of the MDR and IVDR aims to streamline the regulatory framework for medical devices and IVDs, making it more efficient and innovation-friendly. Key measures include simplifying qualification requirements for regulatory personnel, abolishing the fixed validity for certificates, introducing flexible recertification, adjusting classification rules for lower-risk products, and limiting requirements for “proven technical products”. Administrative burdens shall be reduced through more targeted documentation and reporting, clearer rules for post-certification changes, and reduced notified body involvement for low-/ medium-risk products. The reform supports innovation by introducing priority assessments for breakthrough and orphan devices, making in-house manufacturing more flexible, and establishing regulatory sandboxes. The amendment is expected to be adopted in Q2/2027.

Health Data Infrastructure With the European Health Data Space, the EU is establishing a harmonized legal, technical, and organizational framework for secure and standardized access to electronic health data for secondary use (including research and innovation) and improved patient access (primary

In addition to its legislative efforts, the European Commission supports several initiatives to promote research and innovation: The Accelerating Clinical Trials in the European Union (ACT EU) is a joint initiative of the Commission, EMA, and HMA, launched in January 2022, aiming to improve the initiation, design, and conduct of clinical trials and integrate clinical research into healthcare. MedEthicsEU, introduced early 2024 by ethics committee representatives, seeks to harmonize and coordinate working methods and procedures, develop common guidelines, and enhance transparency in legal/ethical evaluation of clinical trials. Project COMBINE was launched mid-2023 by the Commission and national authorities to address regulatory challenges in combined studies. It tests a coordinated "all-in-one" assessment procedure, bundling approvals to reduce administrative burden.

Looking Ahead Becoming the world's most attractive location for Life Sciences by 2030 – a very ambitious goal, but one that represents a clear political commitment and signal from the European Commission recognising the importance of Life Sciences as a central pillar of the EU economy. This new reform program embeds research and innovation as regulatory goal, using crosssector initiatives to reduce fragmentation, streamline approvals, provide incentives, supported by harmonised health data infrastructures. Europe’s attractiveness for Life Sciences companies and investors now depends on coherent implementation of the comprehensive agenda to prove that regulation can also act as a catalyst ■ rather than just an obstacle.

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BUSINESS

European Biotechnology | Spring Edition | Vol. 25 | 2026

Europe’s distinct biotech venture studio model For decades, biotech companies were formed around a discovery: a promising biological signal, a novel target, a platform emerging from academic research. Now a different formation model is gaining momentum: venture studios. These entities don’t just fund startups, they assemble them, testing hypotheses, building teams and infrastructure, and only then spinning out companies designed to scale.

VENTURE STUDIOS

The shift reflects a frustration with the traditional path. Drug development remains slow, expensive and uncertain. Failure rates in early-stage biotech are high and capital efficiency is under constant scrutiny. Against that backdrop, venture studios have moved from the margins into the mainstream, particularly in the United States.

A venture studio differs from traditional venture capital in one important respect: it builds companies internally rather than investing in startups that arrive fully formed. Ideas are generated, validated and structured within the platform before external financing scales the entity.

The studio provides shared infrastructure, operational leadership and strategic oversight across multiple portfolio companies.

Building biotech from within The approach gained visibility in biotech through firms such as Flagship Pioneering (formerly known as Flagship Ventures). Founded in 1999 by Noubar Afeyan and Ed Kania, Flagship has built companies including Moderna and several other successful platform-based ventures.

In his recent annual letter, Afeyan framed biotechnology not as incremental optimisation but as a series of “manmade miracles” produced step by step through the scientific method. “These miracles are made. These are not sudden miracles that come in a flash,” he wrote.

They proceed step by step, if the science is sound and the conditions are right.”

Flagship’s model reflects that logic. Scientific hypotheses are incubated inside the platform, tested and iterated before being launched as standalone companies with dedicated management teams.

Expertise and capital are concentrated at the platform level, while individual programmes advance independently.

The scale of this model is supported

by US conditions: deep venture markets, fluid licensing between academia and industry and regulatory capacity able to process large volumes of innovation. The result is a hub-and-spoke structure, multiple programmes advancing in parallel from a central scientific core.

Europe’s life sciences ecosystem is organised differently and venture studios remain a minority formation model. Academic spin-outs and founder-led startups still account for the majority of new biotech companies, but a small number of groups are experimenting with more integrated approaches to company creation within Europe’s own capital and research environment. Two strategies illustrate how that experimentation is unfolding.

Engineering biology upstream Belgium-based AQYLA BioVentures presents itself as a European TechBio venture builder focused on internal target origination. Rather than sourcing assets externally, the company develops biological theses within its platform before launching dedicated development subsidiaries.

The idea behind the model grew out of founder Florence Bosco’s experience. “I studied process engineering. Because of that, I tend to see everything as a process,” she says. “Innovating in the way R&D is getting done is powerful because you can impact each and every project.”

At 25, Florence Bosco became the first employee of a startup developing a bioreactor technology for the production of vaccines, monoclonal antibodies and gene therapies. The technology is now part of the Cytiva portfolio and used by large pharmaceutical companies for the production of their gene therapies.

“This is where I got the virus of biotech entrepreneurship and where I forged my professional DNA of sourcing the best capabilities around the world to assemble dedicated, lean, project-driven operational partnerships.”

She later ran a university bio-incubator for five years, contributing to the creation of ten spin-offs before leading a startup herself. It was during that period that she began to question the prevailing model.

“What really struck me were these long stories about how a target had been discovered, one hypothesis at a time, how narrow the exploration of biology was and how poor the control the entrepreneur had on the choice of the target, which was purely discovered in academic silos without cross-fertilization. It appeared to me literally as a hook-a-duck game leading to nine failures out of ten.”

AQYLA’s response is to reinvent target discovery. The platform integrates single cell multi-omic datasets, gene regulato-

BUSINESS

European Biotechnology | Spring Edition | Vol. 25 | 2026

ry network inference and disease-relevant in vitro models to discover novel targets and stress-test them before formal incorporation. “The long-term ambition is to significantly increase R&D efficiency for bolder pharma innovation and better patient outcome,” Florence Bosco says. “As a venture builder, we do that by changing the game in biotech entrepreneurship.”

STARLIGHT Therapeutics, focused on retinal disease, is the first programme launched under this framework, securing €1.8mn in seed funding following internal biology modelling and target nomination.

Engineering risk architecture Instead of starting with target origination, some European players step in later, shaping how assets are structured, financed, and moved into clinical development.

Revital Rattenbach, chief executive of France-based 4P-Pharma, rejects the idea that her company is “an asset aggregation platform.” “We operate as a biotech start-up studio built around a disciplined model of drug regeneration, identifying promising compounds and redefining their biological rationale in an untreated serious disease, and r­ ebuilding a coherent clinical and regulatory strategy around them,” she says.

Once a programme reaches sufficient maturity, it is structured into a dedicated subsidiary. 4Moving Biotech in osteoarthritis and 4Living Biotech in acute respiratory distress syndrome are examples of this model.

“However, 4P-Pharma remains the strategic and scientific engine,” Rattenbach explains. Translational strategy, regulatory pathway design, clinical development planning and intellectual property structuring are centralised, while execution and financing remain asset-specific.

“We operate as a hybrid: decentralized clinical vehicles supported by a centralized platform. This enables precise capital allocation, clear governance, and independent value creation milestones for each program.”

Structure designed for resilience “Drug development is highly binary,” Rattenbach says. “The probability of success for any individual asset remains limited, even with strong science and rigorous execution.” In that context, building long-term continuity requires more than capital structuring, it requires organizational resilience.

By legally and financially separating programmes, risk is compartmentalised. “If a clinical or regulatory setback occurs, it remains limited to that specific program.” At the same time, expertise is preserved at the platform level. “This creates two effects. First, risk is compartmentalized at the asset level. Second, the broader organization remains stable even if a single program encounters setbacks.”

In that sense, the studio is “not only a capital allocation model; it is a framework for sustainability.”

The distinction with the United States lies less in ambition than in structure.

“The U.S. venture studio model benefits from deep capital markets and a dynamic licensing environment between universities, biotech companies and large pharmaceutical groups. This supports large hub-and-spoke structures with multiple programs moving in parallel. Europe operates in a different context. Capital markets are more fragmented, public funding plays a significant role, and academic ecosystems are often more nationally organized.”

European studios therefore combine private investment, public support and strategic partnerships, often with a focus on capital efficiency and disciplined asset selection. Some convergence may happen as European financing ecosystems continue to mature. “I believe Europe will maintain specific characteristics, particularly a focus on scientific depth, structured development, and careful capital allocation”, Rattenbach said.

In that sense, the European model may not replicate the U.S. system but rather ■ evolve to reflect its own strengths.

Nicole Verbeeck

21

Therapeutic antibody discovery & development

From Target to Lead

OPINION

European Biotechnology | Spring Edition | Vol. 25 | 2026

Can Europe finance and keep its biotech winners?

The recent resurgence of life sciences IPOs in the US highlights a persistent ­structural imbalance: Europe generates world-class science but struggles to finance and retain it. The ­European Life Sciences Coalition was created to address this gap by mobilizing institutional ­capital and strengthening the policy framework needed to scale European innovation at home.

CAPITAL

The first weeks of 2026 have marked a strong reopening of the US biotech IPO window. Within days, six life sciences IPOs priced successfully, alongside a direct listing and multiple follow-ons, collectively raising more than $1 billion despite broader market volatility. Notably, Agomab, a European company, chose to list directly on Nasdaq – reinforcing a clear longterm trend.

Over the past six years, 66 of 67 EU biotechnology companies that went public listed outside the European Union. The message from founders and investors is consistent: while Europe offers exceptional science and talent, it lacks the depth of capital and market infrastructure required to finance and scale companies competitively.

European life sciences venture capital represents just 7% of the global market, compared to 63% in the US. EU pension funds allocate approximately 0.02% of assets to venture capital, versus nearly 2% in the US. Fragmented capital markets and non-harmonized regulatory processes further complicate scaling companies locally.

A coalition for structural change The European Life Sciences Coalition (ELSC), created in association with Invest Europe, brings together leading venture capital firms, research institutions, and ecosystem stakeholders managing more than €24 billion in assets and supporting over 1,400 companies.

The Coalition is not an investment vehicle. Its mission is systemic: to mobilize both private and public capital and remove

CEDRIC MOREAU, Sofinnova Partners Cedric is a Partner in the Sofinnova Partners Crossover Strategy. He joined Sofinnova in June 2018 from Oddo BHF. Prior to this, he was Director at Bryan Garnier & Co, where he completed several sizable cross-border transactions, including Galapagos, DBV, Ablynx, and Celyad. In total, he has managed more than €2 billion in European healthcare transactions. He is also Chair of the Oversight Committee of the European Life Sciences Coalition, which launched in February 2026.

structural barriers that limit Europe’s competitiveness.

In the near term, the ELSC is establishing a direct and constructive dialogue with institutional investors – including pension funds, insurers, and banks – to encourage

greater allocations to life sciences venture capital. It is also engaging with EU policymakers to advocate for more integrated capital markets, improved regulatory conditions, and stronger research and clinical infrastructure.

Concrete proposals under discussion include encouraging minimum portfolio allocations toward life sciences VC to strengthen competitiveness, creating a simple and efficient European fund-of-funds investing across the biotech ecosystem, and advancing, with urgency, the development of a unified, less bureaucratic European capital market, including a dedicated stock exchange capable of supporting high-growth companies from IPO through scale.

From invention to retention Success will be measured by tangible shifts in capital flows and ecosystem strength.

Europe should not only invent breakthrough science; it must also finance, scale, and retain it.

If institutional allocations increase, capital markets deepen, and regulatory fragmentation is reduced, Europe can build a sustainable pipeline of life sciences champions. The objective is not to replicate the US model, but to create a European framework capable of matching its scientific excellence with competitive financing capacity. The current US IPO momentum underscores what is possible when capital, policy, and markets align. Europe has the science. The task now is ensuring it has the ■ financing architecture to match.

Cedric Moreau

Picture: © Sofinnova Partners

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9

Floors

Macrocycles: big is the new beautiful In the evolving landscape of drug discovery and new design, scientists and pharmaceutical innovators ­continually strive to develop therapies that are both highly s­ elective and clinically effective, while addressing targets ­previously deemed “undruggable”. In recent years, macrocycles – a class of large, ring-shaped molecules – have emerged as a compelling solution at the crossroads between t­ raditional small molecules and large biologics, offering a blend of high specificity, rich chemical diversity and promising pharma­ cological profiles.

DRUG DESIGN

European Biotechnology | Spring Edition | Vol. 25 | 2026

Pictures: © Curve Therapeutics; Journal of Medicinal Chemistry 2023 DOI: 10.1021/acs.jmedchem.3c00134

W

hat if synthetic large molecules could be designed to fit almost any receptor pocket imaginable? While this may sound like a new frontier in drug development, the underlying idea is far from new. A wide range of protein scaffolds has already been explored and advanced from preclinical research toward the clinic, including Pieris’ lipocalin scaffold in Munich and the DARPin-based molecules developed by Molecular Partners in Zurich. Although Pieris ultimately failed to deliver on the promise of an antibody-like structure with greater flexibility and smaller size, Molecular Partners is now entering the clinic, where the first data will reveal whether this approach can carve out a place in the biologics space. But a new player has now entered the scene, and this time size seems to matter less than ever.

Fueled by advances in chemistry, machine learning, and automated discovery platforms, macrocycle drug discovery has surged into the spotlight, attracting major biotech investors, global pharmaceutical companies, and ambitious European startups alike.

What are macrocycles?

At their core, macrocycles are organic compounds in which the atoms form a

large ring structure. Formally, they contain a circle of at least 12 non-hydrogen atoms in a single contiguous loop. This cyclic topology grants them distinct conformational properties compared with simpler linear molecules: they are preorganised and semirigid, which can dramatically enhance how they bind to biological targets.

Macrocycles cover a diverse chemical space that overlaps neither with traditional “Rule of Five” small molecules (designed for ease of oral absorption) nor with large biologics such as monoclonal antibodies. This hybrid space lets macrocycles combine the high target affinity and selectivity often associated with biologics with the cell permeability and, increasingly, oral bioavailability more typical of small molecules.

This feature makes macrocycles particularly valuable for tackling protein-protein interactions, flat or groove-like binding surfaces, and other challenging targets that have frustrated small-molecule efforts for decades.

Early success and history Macrocycles are not entirely new to medicine, their therapeutic potential has been recognised for decades. Indeed, some of the earliest and most successful macrocycle drugs were discovered

TECHNOLOGY

in nature. The immune-suppressant cyclosporine, isolated from a fungus in the early 1970s, transformed transplant medicine by suppressing T-cell activation and helping prevent organ rejection.

Natural macrocyclic compounds and their derivatives have since made their way into numerous approved medicines, particularly in infectious disease and oncology. Yet, historically, most macrocycles approved to date have been natural products or closely related derivatives rather than synthetic designs.

This presents an important nuance: although macrocycles have long been known to be effective drug molecules, designing and synthesising them de novo – especially with properties amenable to oral dosing – has proven difficult.

The complexity of macrocycle chemical space made systematic exploration extremely challenging until recently.

Why macrocycles matter today In the past decade, technological and scientific advances have begun to unlock macrocycles as a practical and versatile drug class. Several factors are converging to propel macrocycle innovation: › Enhanced binding capabilities: Macrocycles can often achieve higher affinity and selectivity for difficult targets than linear small molecules, thanks to

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their cyclic, pre-organised structures.

› Broader chemical space: Modern synthetic and computational methods now allow exploration of vast libraries of macrocycle candidates, making it more feasible to identify compounds with drug-like properties. › Improved oral bioavailability: Many newer macrocycles are being deliberately designed to overcome traditional absorption barriers, bringing oral macrocycle therapies within reach. › Technology platforms and AI: Highthroughput synthesis, DNA-encoded libraries and machine learning are now being used to design, generate and screen macrocycle libraries at unprecedented scale, accelerating discovery and reducing risk.

European Frontrunners Collectively, these innovations are positioning macrocycles not as a niche modality but as a strategic drug class capable of addressing unmet therapeutic needs across oncology, immunology, cardiovascular disease and beyond.

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In Europe the two most prominent pioneers in this space are Orbis Medicines, a Copenhagen-based biotech founded in 2021 with backing from Novo Holdings and Forbion, and Curve Therapeutics, founded in Southampton (UK) in 2019.

Orbis has developed a platform called nGen that integrates high-throughput chemistry, large-scale assaying and machine learning to explore macrocycle chemical space systematically. From initial libraries of billions of potential compounds, the platform rapidly synthesises and evaluates hundreds of thousands of candidates to pinpoint those with desirable therapeutic attributes, particularly oral bioavailability and membrane permeability (see also p. 11).

The goal at Orbis is to deliver “nCycles” – orally dosable macrocycle drugs – against targets traditionally validated by blockbuster biologics. By targeting both intra- and extracellular proteins, Orbis hopes to broaden the potential disease indications beyond what most small molecules or biologics can achieve. This approach addresses the longstanding challenges of macrocycle design, and, as

Example of fitting a macrocycle molecule to a pocket of interest

research published in top journals has suggested, represents a potential leap forward in translating macrocycle science into real medicines.

Curve Therapeutics is harnessing the power of gene-encoded screening, to identify a new generation of therapeutics to address a broad range of intracellular targets. Curve’s macrocyclic platform involves screening Microcycle ® libraries (vast collections of small cyclic peptides) inside mammalian cells, resulting in the discovery of functional hits against targets in their dynamic and pharmacologically relevant forms. Microcycles are compact, rigid macrocycles which behave like small molecules, allowing for the discovery of novel, and more effective drugs.

Curve completed its £40.5 million Series A financing in 2024, and has since made significant progress in advancing its proprietary drug discovery platform, and establishing a pipeline of potential first-in-class programmes. Curve had also received earlier validation on the potential of its Microcycle platform through a collaboration with MSD worth up to $1.7 billion, cementing its status as an established pioneer in the field.

The transition from an academic start up to a recognised and visible player in the field has clearly accelerated with the investment from well-established institutions. The UK biotech secured £40.5 million in Series A funding from investors including Advent Life Sciences, Epidarex Capital, Pfizer Ventures, Columbus Venture Partners and British Business Bank.

The capital has enabled the company to strengthen its leadership team with several senior appointments, including Simon Jones as CFO/COO, Andre Hoekema as chair of the board, Cora Griffin as head of business development and Rab Prinjha as chief R&D officer.

Curve is building its strategy around its proprietary Microcycle platform, developed from two decades of research led by co-founder and CSO Professor Ali Tavassoli (see interview on page 28).

The technology enables high-throughput screening of drug candidates directly in living mammalian cells, allowing for

Picture: © Sevan Habeshian & Christian Heinis et al. https://www.nature.com/articles/s41467-022-31428-8

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European Biotechnology | Spring Edition | Vol. 25 | 2026

the evaluation of biological activity in a more physiologically relevant setting than conventional discovery methods.

The company believes this approach could help address one of the persistent challenges in drug discovery: targeting intracellular proteins that remain difficult to access with existing modalities such as antibodies.

Curve’s internal pipeline initially focuses on intracellular oncology and I&I targets, with proceeds from the Series A round earmarked to advance these programmes towards clinical development.

Looking ahead, the company aims to expand both its internal pipeline and partnered programmes while securing additional pharmaceutical collaborations

Global macrocycle momentum Momentum in the macrocycle field is not limited to Europe. Major pharmaceutical companies are actively partnering with

innovative macrocycle biotechs to build next-generation pipelines.

One of the most high-profile examples is the partnership between Swiss pharma giant Novartis AG and Californiabased macrocycle specialist Unnatural Products (2026). Under this agreement, Novartis has licensed macrocyclic peptide programmes aimed at cardiovascular disease, paying upfront and milestone fees that could total up to US$1.7 billion, with tiered royalties on future sales.

Unnatural Products – which integrates AI and advanced chemistry to generate macrocyclic peptides with enhanced permeability and drug-like profiles – has also secured partnerships with other global players. In 2025, for example, it agreed a sizeable collaboration with argenx (Amsterdam) to develop drugs for challenging immunology targets.

These collaborations reflect a broader industrial recognition that macrocycles are an emerging modality with strategic

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value, capable of complementing and, in some cases, extending beyond traditional biologics and small molecules.

Together, these features make macrocycles well suited for difficult targets, broad therapeutic areas and complex disease biology, which are areas where existing modalities offer limited potency, specificity or patient convenience.

Opportunities and challenges The combination of platform technologies, AI-driven design, and strategic industry partnerships suggests that macrocycles may soon become a mainstream therapeutic modality.

With oral macrocycles now appearing in late-stage clinical programmes and major pharma backing collaborations, the next decade could see these molecules realise their long-heralded promise ■ in a wide range of diseases.

Georg Kääb

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Interview

ALI TAVASSOLI, CO-FOUNDER AND CSO, Curve Therapeutics, is also Professor of Chemical Biology at the University of Southampton and has been awarded the Interdisciplinary Prize by the Royal Society of Chemistry in recognition of his brilliance in research and innovation, and contribution to scientific progress.

EuroBiotech_Prof Tavassoli, macrocycles occupy a distinctive and traditional niche in modern drug discovery. Where does the new interest stem from?

Ali Tavassoli_Macrocycles are certainly

not new to medicine; cyclosporine transformed transplant medicine over fifty years ago, and nature has been making macrocyclic compounds for far longer than that. The scientific community has been studying these molecules intensively for decades, not just as therapeutics but as tools to understand fundamental drug properties. Cyclosporine itself became a model system for studying cell permeability of cyclic peptides, with researchers spending years unpicking how this large, rule-breaking molecule crosses membranes, and those insights have helped the entire field. What's changed is our ability to apply that accumulated

European Biotechnology | Spring Edition | Vol. 25 | 2026

knowledge systematically. For decades, we were limited to isolating macrocycles from natural sources; now we have synthetic and genetically encoded methods for rapid synthesis of large cyclic peptide libraries and computational tools to design them rationally. The current surge reflects a genuine maturation of the modality from the convergence of decades of foundational research reaching a tipping point. This isn't early-adopter enthusiasm; it's the science finally catching up with the therapeutic promise we've long recognised.

EuroBiotech_For decades, antibodies have appeared to dominate biopharmaceutical development. While there have been refinements – new fragments, payload conjugation and other modifications – is the pharmaceutical industry genuinely seeking entirely new therapeutic modalities?

Tavassoli_Absolutely, and the reason is

straightforward: antibodies, for all their success, cannot reach the majority of disease-relevant targets. They're confined to extracellular and cell-surface proteins, which represent a minority of the druggable proteome. Intracellular targets, including protein-protein interactions, drive much of disease biology and beyond, yet they remain largely inaccessible to biologics and unsuitable for the in-house small molecule libraries of big pharma.

This limitation is understood acutely, and the interest in new modalities; whether targeted protein degraders, cyclic peptides, or other macrocycles, reflects a genuine strategic need in drug development. Companies are looking for tools that combine the selectivity of biologics with intracellular access. That's precisely where macrocycles become compelling.

EuroBiotech_With tools such as AlphaFold and generative AI now enabling the design of molecules from scratch, could a macrocycle platform be seen as overly complex or academically driven? Or is the opposite true – that macrocycles provide the ideal structural framework and building blocks for AI-driven synthetic drug design?

Tavassoli_I'd argue strongly for the latter,

but with an important caveat. AI tools like AlphaFold have transformed our understanding of protein structure, but generating a three-dimensional model is only the starting point; you still need molecules that can engage those targets with the right properties. Companies such as Isomorphic Labs have made tremendous progress in this area. However, the limiting factor for AI-driven drug design isn't computational power; it's the quality and scale of training data. For cyclic peptides and macrocycles, the datasets needed to train reliable predictive models either don't exist or are fragmented across proprietary silos. This is where a platform approach becomes essential. What is needed is high-quality, internally consistent data on macrocycle structure-activity relationships, permeability, and metabolic stability that can be used to train and validate predictive models. Macrocycles are actually ideal substrates for AI-driven design precisely because their conformational constraints and modular architectures create a defined chemical space that machine learning can navigate effectively, provided you feed it the right data.

The complexity that once made macrocycles challenging is now an asset, but only if you've built the experimental foundation to support it.

EuroBiotech_We have seen several novel modalities with new scaffolds, do you sense genuine industry appetite for the macrocycle platforms?

Tavassoli_The difference between macro-

cycles and some earlier alternative scaffolds is that macrocycles already have an extensive clinical track record through natural products and their derivatives.

The proof of concept for the modality itself exists; what has now been demonstrated is that de novo identified macrocycles can achieve drug-like properties, particularly oral bioavailability, sufficiently to make them viable clinical candidates. Several programmes industry-wide are approaching or entering the final stages of clinical development, so I expect the next year or so to be decisive. ■ Georg Kääb

Picture: © Curve Therapeutics

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Can biotech finally fix infertility?

According to the WHO, one adult in six ­globally is affected by infertility, but beyond this statistic,­­infertility is best understood as a couple’s problem, even when the under­lying biology sits with one partner. The way we currently ­handle infertility issues is more about bypassing biology through procedure, with in vitro fertilisation (IVF) as its backbone. But while IVF is indispensable, success rates still vary, pushing biotech to step in and find new solutions.

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European Biotechnology | Spring Edition | Vol. 25 | 2026

Pictures: © Toa Heftiba, Getty Images, Anna Hecker on Unsplash, Svitlana Hulko-freepik.com

I

nfertility care is now heavily structured around assisted reproduction technology (ART). IVF and its close relatives have become the default pathway, largely because they give clinicians control over the part of reproduction that can be influenced reliably, such as fertilisation and early embryo development.

But even in this highly optimised setting, outcomes still vary widely from one couple to the next. According to the European Society of Human Reproduction and Embryology (ESHRE), in 2020, the mean pregnancy rate per embryo transfer was about 33% after IVF and intracytoplasmic sperm injection (ICSI), about 36% after frozen embryo transfer, and around 51% after egg donation, with a success rate higher in younger patients.

IVF works often enough to have become the backbone of treatment, but it still leaves a lot of biology unaddressed.

Implantation is a clear example. Successful implantation depends on a dialogue between embryo and endometrium, and when that dialogue fails, the embryo simply doesn’t take, in many cases without a clear explanation.

Reviews of recurrent implantation failure describe it as a persistent clinical phenomenon, affecting an estimated 10% of couples undergoing IVF and embryo transfer1. If you can improve endometrial receptivity, reduce inflammation, or shift the local environment in a measurable way, you could theoretically raise the odds of success without changing the IVF process itself. Another blind spot is that assisted reproduction often works around underlying biology rather than correcting it, especially in cases of male factor infertility. Technologies such as ICSI can bypass many sperm-related barriers by design, but it’s not a direct treatment of the male reproductive problem itself.

Over time, ICSI also expanded well beyond clear male-factor indications in many settings, and there has been criticism that it is used where it doesn’t improve outcomes and may add cost and complexity. A 2025 analysis in Reproductive BioMedicine Online argues that

ICSI should be limited to couples with male infertility, describing widespread overuse in ART4.

This is also where the female-centred dynamic of infertility care becomes hard to ignore. Even when infertility originates in the male partner, the most established solutions tend to move the clinical burden toward the female body: ovarian stimulation, egg retrieval, embryo transfer, and hormonal support. That’s not because clinics ignore male factors, but because the dominant toolbox is procedural and couples-focused, and the interventions that reliably change outcomes have historically been built around the female cycle and the IVF workflow.

“Although infertility is 50% men related, there is no ­approved treatment ­addressing this segment. There is no ­standard of care for half the population.”

Florent Ferré, CEO of Igyxos

“The issue that we are facing with IVF is that more and more women don’t respond well to the hormonal stimulation, which is the first part of the IVF treatment, and therefore are not very successful when they go through the procedure. This is why there is a need for more effective treatment,” said Florent Ferré, CEO of Igyxos, a fertility-focused biotech based in France.

Much of the current innovation isn’t trying to replace IVF or promise cures.

It’s trying to intervene in the unresolved steps where IVF has blind spots.

Treating biology upstream One reason fertility care has become so tightly organised around IVF is that it offers predictable control that drugbased approaches have struggled to deliver consistently. Hormone biology, in that setting, has often been used less as a way to correct underlying dysfunction and more as a means of making IVF cy-

cles work through ovarian stimulation protocols, trigger injections, and luteal phase support. Endocrine signalling, in other words, has largely been folded into the IVF workflow rather than treated as a therapeutic target itself.

On the female side, hormone manipulation is central to controlled ovarian stimulation, but primarily to optimise egg yield and timing rather than restore ovarian function. On the male side, medical options are even more limited. “Although infertility is 50% men related, there is no approved treatment addressing this segment. In a couple, even if infertility is men-related, the healthy wife will go through the IVF, meaning there is no standard of care for half the population,” said Ferré.

Outside a narrow set of endocrine deficiencies or surgically correctable conditions, most male-factor infertility is managed procedurally: if sperm parameters are poor, IVF with ICSI can bypass the problem, but it does so without addressing the biological cause.

Targeting male infertility biology may become increasingly important over time, too. “Over the last 25 years, we have seen more and more sperm decline. We are looking at a decline of 2% to 2.5% every year. If this trend stays on track, by 2040, almost half of the men will be in a situation of low concentration,” noted Ferré.

According to Igyxos’ CEO, the first reason why the male factor of infertility has been overlooked comes from a cultural bias. “Also, infertility related to men was not well understood. And looking at the available data, it’s probably only since the 2000s that more studies confirmed that it’s not a woman’s issue, but a couple’s issue.”

That upstream gap, where reproductive biology sets the odds before IVF begins, is where Igyxos positions its approach. The French company is developing IGX12, a monoclonal antibody designed to potentiate the follicle-stimulating hormone (FSH), a regulator of gamete production in both sexes. The idea is not to administer FSH itself as a hormone therapy, which is already

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widely used in fertility care, but to modulate its activity.

Exogenous FSH is indispensable in ovarian stimulation, but its broader use as a therapeutic intervention has been harder to establish. In male infertility in particular, administering FSH has produced mixed results. Some patients show improvements in sperm parameters, while others do not, and clinicians have had a hard time predicting who will benefit.

Igyxos thinks that better pharmacology could change that equation. Improving FSH signalling can lead to better parameters upstream and more consistent ovarian responses in women undergoing ART, as well as improved spermatogenesis in men with compromised sperm production. Downstream, this would mean fewer failed cycles, less extreme stimulation, and, in some cases, a reduced need to default immediately to the most invasive procedural options.

“Experiences such as ObsEva’s have shown how difficult it is to demonstrate a clinical benefit on ultimate endpoints like ongoing pregnancy or live birth, endpoints that are long, variable, and unforgiving.”

Agnès Arbat, CEO of Oxolife

“In animal models, IGX12 has been able to restore spermatogenesis in cases of azoospermia, the worst possible scenario2. If we are able to translate these data in human, then IGX12 could become a first-line option for men facing low concentration,” explained Ferré.

In women, the strategy for the phase 2 trial of IGX12 is to address those who respond poorly to the first step of IVF, gonadotropin stimulation.

Comparable efforts remain rare, but they do exist. In the U.S., ReproNovo is also pursuing oral therapies targeting hormonal dysfunction and impaired spermatogenesis rather than procedur-

al workarounds. Another U.S. company, Celmatix, is working on upstream hormone-pathway programs, including one involving FSH, but frames the problem primarily through ovarian health.

Other companies, such as New Yorkbased Gameto, are also working on fertility with a more upstream, biology-driven approach. Its ovary-in-a-dish platform is designed to model meiosis and early oocyte development in vitro, stages of egg formation that are currently not directly manipulable within IVF workflows.

Improving IVF odds without replacing it Fertilisation and early embryo development can be managed and optimised in the lab, but whether an embryo actually establishes a pregnancy still depends on biological parameters: endometrial receptivity, immune signalling, uterine contractility, and early placentation.

If you can make the uterus more receptive at the moment of implantation, you might raise success rates without changing the IVF process itself.

Oxolife is currently working on that segment. The Barcelona-based company is developing OXO-001, a non-hormonal oral drug that acts on the endometrium to enhance implantation during IVF and ICSI cycles. “Unlike current IVF workflows, which focus primarily on selecting the best embryos, OXO-001 acts directly on the endometrium. It modulates the expression of proteins involved in adhesion, invasion, and the completion of embryo implantation, improving the uterine environment rather than compensating for its limitations,” explained the company’s CEO, Agnès Arbat.

OXO-001 is an adjunct therapy aimed at increasing the probability that an embryo transfer results in a pregnancy and, ultimately, a live birth. In phase 2, Oxolife reported an ongoing pregnancy rate at 10 weeks of 46.3% versus 35.7% in the placebo group, and a live birth rate of 42.6% versus 35.7%.

But with implantation adjuncts, early signals don’t always survive scale-up.

“Implantation is an exceptionally com-

plex biological process, and experiences such as ObsEva’s have shown how difficult it is to demonstrate a clinical benefit on ultimate endpoints like ongoing pregnancy or live birth, endpoints that are long, variable, and unforgiving.”

ObsEva was once seen as one of Europe’s most promising fertility-focused biotechs, with a strategy around drugs designed to improve pregnancy outcomes by acting on uterine biology rather than the IVF procedure itself.

Its most advanced program, nolasiban, targeted oxytocin receptors and was developed as an oral treatment intended to improve implantation and pregnancy rates during embryo transfer. Uterine contractions around the time of transfer were thought to interfere with implantation, and dampening that activity could, in theory, create a more receptive environment for the embryo.

Early studies suggested potential benefits, and the program progressed into late-stage development. But in phase 3 trials, nolasiban failed to demonstrate a meaningful improvement in live birth rates. Without a clear efficacy signal on the endpoints that matter most to patients and regulators, ObsEva’s program collapsed. The company ultimately filed for bankruptcy in early 2024.

The lesson is not that implantation biology is irrelevant, but that endpoints can be unforgiving. Programs that position themselves as IVF adjuncts must show not just biological activity, but a clear and clinically meaningful improvement over procedures that are already effective.

Treating the fertility environment For a large subset of patients, infertility is a chronic state, and endometriosis is the clearest example of that category.

Endometriosis affects roughly one in ten women of reproductive age, and it is strongly associated with infertility. The clinical effect is that many patients are funnelled into ART, not because IVF is the ideal treatment, but because it is the most reliable workaround once the un-

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derlying condition has already altered reproductive potential.

Indeed, a recent study led on more than four million women over 30 in the U.K. suggests that women suffering from infertility issues are twice as likely to be diagnosed with endometriosis3. However, the same study suggests that endometriosis patients had 4 times more chances of pregnancy compared to women with infertility due to other factors. The study also specified that this was particularly true when the disease was diagnosed early.

While endometriosis is common, it is often diagnosed late, and delays can stretch for years, up to a decade, before patients receive a diagnosis. A delayed diagnosis logically compresses the reproductive timeline.

This diagnostic delay is where new approaches to fertility are beginning to emerge. One example is Viramal, a company focused on women’s health conditions that sit upstream of fertility outcomes, including endometriosis. Rather than positioning itself as an IVF outcomes company, Viramal targets the tissue environment that makes conception harder in the first place, particularly when the disease is diagnosed late.

Viramal’s lead program, VML-0501, is being tested in phase 2b as a locally delivered treatment for endometriosis. The treatment acts directly on the pelvic tissue, and while pregnancy isn’t the primary endpoint, the company argues that addressing the inflammatory environment has consequences on fertility.

Viramal is not alone in approaching infertility through the lens of reproductive tissue health. A small group of biotechs is exploring how chronic inflammatory and structural conditions of the reproductive tract shape fertility.

In Europe, Gesynta Pharma is pursuing a non-hormonal strategy in endometriosis with vipoglanstat, an mPGES-1 inhibitor designed to dampen inflammatory pathways without suppressing ovarian function. Like Viramal, the premise is that improving the underlying tissue environment may preserve or restore fertility indirectly, even if pregnancy itself is not

the primary trial endpoint. In late 2025, Gesynta started phase 2 for vipoglanstat in the U.K. In the U.S., companies such as Forendo Pharma, acquired by Organon in 2021, have pursued non-hormonal strategies aimed at modulating endometrial and pelvic tissue biology, looking into alternatives to systemic hormone suppression to preserve reproductive potential. However, in 2025, the company announced its endometriosis candidate, OG-6219, did not meet its endpoint in phase 2.

Another emerging, still highly exploratory, biological angle in fertility research is the role of the reproductive tract microbiome in implantation and early pregnancy. Certain microbiome profiles could be associated with both favourable and unfavourable prognosis in IVF settings, though the field is far from validated clinical tools and remains an active area of basic research rather than a therapeutic category.

A small number of groups in Europe are looking into whether modulating the reproductive microbiome could influence fertility. The Netherlands-based ARTPred initiative has run clinical investigations looking at how urogenital microbiome composition might predict implantation outcomes before IVF, and is also exploring targeted probiotic formulations for cases with unfavourable profiles. Similarly, Denmark’s Freya Biosciences is developing microbial immunotherapy approaches focused on modulating inflammation associated with vaginal dysbiosis, an imbalance in the vaginal microbiota that can disrupt local immune signalling that has been linked to reproductive outcomes.

ity occupies an uncomfortable category in healthcare financing. Clinically, infertility is a couple’s condition, with male biology contributing materially to outcomes. Financially, however, it is still often bundled into women’s health, with all the market-sizing shortcuts that label can trigger.

Women’s health is frequently described as underfunded; only 1% of healthcare research and innovation goes to female-specific conditions beyond oncology. “Women’s health” is often treated as a narrow vertical, frequently reduced to reproductive care. Yet women’s health outcomes extend far beyond reproduction and reproduction itself is not a women-only issue.

The companies emerging now are not replacing IVF so much as trying to make parts of reproduction less of a black box.

This new wave of companies will live or die on unforgiving endpoints, but also on whether the field can be framed as a mainstream medical need rather than a niche category.

As Florent Ferré put it, borrowing a characteristically French expression, “Il faut remettre l’église au milieu du village,” literally, to put the church back at the center of the village. In other words, there are still quite a lot of misconceptions around fertility, and the record needs to be set straight in order for the ■ field to accelerate.

Jules Adam

Ma, Junying et al. “Recurrent implantation failure: A comprehensive summary from etiology to treatment.” Frontiers in endocrinology vol. 13 1061766.

5 Jan. 2023, doi:10.3389/fendo.2022.1061766

1

Kara, Elodie et al. “First in class monoclonal antibody potentiating human follicle stimulating hormone activity improves spermatogenesis in azoospermic rodent models.” Frontiers in endocrinology vol. 16 1668945. 14 Oct. 2025, doi:10.3389/ fendo.2025.1668945

2

The elephant in the room: funding IVF has made the infertility burden more manageable, but it has also shaped the field around what clinics can control procedurally while leaving the hardest biology to variability and repeated cycles.

The investment story sits awkwardly on top of that, largely because fertil-

Saraswat, L., et al. (2025). Infertility and endometriosis: a 30-yearlong national population-based study of prevalence, association and pregnancy outcomes. Human Reproduction.

3

Somigliana, Edgardo, et al. “ICSI for Non-Male Infertility: From Ineffectiveness to Gender Bias?” Reproductive BioMedicine Online, vol. 50, no. 3, Mar. 2025, p. 104706, https://doi.org/10.1016/j. rbmo.2024.104706.

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CDMO LANDSCAPE

European Biotechnology | Spring Edition | Vol. 25 | 2026

How Europe's external manufacturing ecosystem is evolving Today, 90% of biotechs outsource manufacturing to CDMOs. Outsourcing decisions are no longer straightforward cost-benefit analyses. Geopolitical volatility and unprecedented demand for advanced modalities have made CDMO partnerships existential. Pharma and biotech leaders face fundamentally different pressures, tensions that take center stage at CDMO Live Europe 2026 (19–21 May, Rotterdam).

OUTSOURCING

A market in rapid growth The European CDMO market is expanding at 7–7.6% CAGR, with valuations clustering around €35–€42 billion in 2025–2026 and forecasts reaching €60–€89 billion by 2034–2035. Germany leads with 30% market share, while France is the fastestgrowing market, driven by €1.87 billion in pharmaceutical investment for manufacturing capacity.

PharmaSource analysis of CDMO news announcements over the last 12 months shows that 30% were related to Europe, with US manufacturing at 46% as Amer-

ica-first policies encourage investment.

This reflects Europe's critical strategic importance in global supply chain resilience.

Growth varies significantly by modality: › APIs command the highest share (between 42–64% of market revenue), reflecting sustained demand for generic and specialty chemicals. › Biologics and monoclonal antibodies are expanding with new capacity additions, though competitive pricing has emerged as post-pandemic buildouts mature. › Sterile fill-finish (vials, prefilled syringes, cartridges) is the most strategically

constrained segment, with explicit supply/ demand imbalances driven by ­biologics pipelines and the growth of GLP‑1 medicines creating capacity pressures › Highly potent APIs and bioconjugates (ADCs) are in high demand, with capacity expansions supported by long-term manufacturing contracts tied to GLP‑1 peptide demand.

This expansion is underpinned by increasingly supportive regulatory frameworks. The EU's Critical Medicines Act aims to encourage supply security through manufacturing across multiple European sites. The EU Biotech Act is expected to accelerate biotech innovation and development timelines.

Navigating complex pressures Manufacturing partnership decisions have become extraordinarily complex. Pharma external manufacturing leaders are seeking to move from transactional relationships toward strategic partnerships, driven by geopolitical volatility, capacity constraints, and the strategic imperatives of supply chain resilience. Long-term manufacturing contracts now underwrite capacity investment, while sponsors are embedding digital, sustainability, and resilience requirements into negotiations from the outset. ›››

Picture: © armmypicca - Freepik.com

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Pharma Leaders

Biotech Leaders

Geopolitical Risk & Resilience Tariffs, US sourcing pressure, and regionalization have moved from background to dominant strategic question. Multi-site, dual-sourced supply networks now essential for portfolio security.

Partner Prioritization Early-stage work deprioritized by large CDMOs. Critical need for CDMOs who take small companies seriously – the “true partner, not subcontractor” gap remains acute.

Cost & Performance Unexpected cost increases and renegotiations common. Balancing accountability with relationship preservation increasingly difficult.

Funding & Timeline Pressure Runway anxiety reshapes decisions. Speed and cost efficiency prioritized over optimal tech selection and scale planning.

Navigating Landscape Too many similar CDMO claims with insufficient comparison methods. Capability verification and differentiation remain challenging.

Advanced Modalities Need for specialized mAbs, bispecifics, ADCs, and CGT capability. Hard to verify claims reliably; reliance on references and due diligence remains high-friction.

››› Recent PharmaSource research reveals divergent concerns shaping partnership dynamics. Large pharmaceutical companies prioritize geopolitical risk mitigation, cost stability, and portfolio optimization across fragmented CDMO landscapes. Early-stage biotech, conversely, struggles with capacity access, partner

prioritization, and rapid commercialization timelines.

These competing priorities are reshaping how CDMOs segment their customer base and design service offerings.

Sponsors now expect CDMOs to implement AI and digital manufacturing tools, yet a significant gap persists between

their capability and pharma/biotech expectations. Recent PharmaSource research reveals that 92% of sponsors ask for digital requirements in negotiations, while only 60% of CDMOs report operating at advanced maturity levels.

Regulatory pressure – particularly EU GMP Annex 1 standards – reinforces that European CDMOs must compete on specialized expertise and reliability, not price alone. Decarbonization is a strategic imperative: pharma companies pursuing netzero commitments are discovering that 70–80% of their carbon footprint sits in Scope 3 (their supply value chain), making CDMO manufacturing practices a material lever in emissions reduction.

Future of external manufacturing

Data provided by Fuliginous Management Consulting

At a time when drug supply chains are under unprecedented pressure, the need for strategic, trusted manufacturing partnerships has never been greater. CDMO Live Europe 2026 (19–21 May, Rotterdam) is firmly established as Europe's #1 event for external manufacturing.

600 external manufacturing professionals will convene across three days. The 40+ expert speaker roster includes manufacturing heads and CMC directors from MSD, Roche, Johnson & Johnson, Bayer, BMS, Daiichi Sankyo, Takeda, Sandoz, Polpharma, and others, bringing authentic, battle-tested perspectives on partnership strategy.

For organizations navigating Europe's complex manufac turing landscape, CDMO Live Europe 2026 (19-21 May, Rotterdam) is the must-attend event of the year. Secure your ticket at www.CDMOLive.com.

■ Luke Bilton, Co-Founder, PharmaSource

Pictures: © metamorworks - stock.adobe.com, PharmaSource

36

Where dedication delivers Biologics Rezon Bio is a science-driven European CDMO specializing in the development and manufacturing of mammalian biologics. Headquartered in Poland, we provide fully integrated solutions from cell line development to commercial supply. With state-of-the-art facilities, world-class teams and a legacy of biosimilars development and global commercialization, Rezon Bio brings together deep scientific expertise, digital transparency and cost-efficiency to help clients move their biologics programs from concept to market with confidence.

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CDMO LANDSCAPE

European Biotechnology | Spring Edition | Vol. 25 | 2026

Picture: © PharmaSource

European Biotechnology | Spring Edition | Vol. 25 | 2026

ADVERTORIAL

The European CDMO Model, Powering Biologics Innovation Europe continues to play a pivotal role in the global biologics landscape, combining scientific excellence, regulatory maturity and a strong industrial foundation.

MANUFACTURING

As biologic modalities grow more complex, and development timelines accelerate, the ability to transform innovation into robust, scalable, and compliant manufacturing has become a critical determinant of success.

Europe is at the heart of advanced biologics development In this dynamic environment, CDMOs are evolving rapidly. They are increasingly expected to support drug development from the earlies stages, seamlessly integrating process development, analytics, quality and large-scale manufacturing considerations from the outset.

3PBIOVIAN was built around this integrated approach. As a pan European CDMO, the company supports biologics and advanced therapy programs from early development through clinical supply and commercial manufacturing, acting as a long-term partner rather than a transactional service provider.

Picture: © 3PBIOVIAN

Early decisions that have a lasting impact For biotech and pharmaceutical companies across Europe, the objective is clear: to transform promising science into reliable products that can efficiently progress through clinical development into commercial supply. In this process, early decisions around a drug candidate’s manufacturability, scalability, and regulatory alignment often determine the long-term viability of the program.

Technological breadth and industrial integration 3PBIOVIAN’s capabilities span a wide range of expression systems and modalities, including microbial and mammalian platforms for recombinant proteins, as well as viral vectors, plasmid DNA and advanced therapy products. This technological breadth allows development programs to evolve with flexibility, selecting the most appropriate manufacturing route as scientific and clinical needs change.

With GMP manufacturing sites in Spain (Pamplona) and Finland (Turku), ­3PBIOVIAN combines industrial-scale capabilities with the agility demanded by Europe’s innovation driven biotech ecosystem. Its services cover both Drug Substance and Drug Product and are designed as a seamless pathway rather than a sequence of disconnected steps.

Quality, People and Execution A strong quality culture forms the foundation of 3PBIOVIAN's organization, and is reinforced by multidisciplinary teams with extensive experience across development and manufacturing. In an industry where precision in execution is as vital as innovation, the expertise of people, the strength of collaboration, and the consistency of processes are what truly set organizations apart.

Supporting Europe’s next generation of therapies As biologics pipelines grow increasingly complex, European CDMOs are assuming

­ PBIOVIAN has GMP manufacturing sites 3 in Spain (Pamplona) and Finland (Turku).

a more strategic role in shaping development outcomes. Combining extensive experience and track record with technological breadth, regulatory expertise, and an integrated end to end offering, 3PBIOVIAN exemplifies how modern European CDMOs are helping transform promising concepts into therapies that ultimately reach pa■ tients.

Contact us: 3PBIOVIAN www.3pbiovian.com

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CDMO LANDSCAPE

European Biotechnology | Spring Edition | Vol. 25 | 2026

Mitigating regulatory risk with holistic CMC strategies As advanced therapeutic medicinal products (ATMPs) and other next-generation biologics move toward approval, Chemistry, Manufacturing and Controls (CMC) continues to be the most frequent source of regulatory concern. This article highlights recurring CMC barriers and best practices to mitigate approval delays or refusals.

BEST PRACTICE

› Martin Mewies, Ph.D., is director, regulatory affairs, CMC, at Cencora

As more advanced therapeutic medicinal products (ATMPs) and other next-generation biologics seek regulatory approval, the development challenges these products encounter is gaining prominence.

Assessments from regulatory authorities consistently show that Chemistry, Manufacturing and Controls (CMC) remains the area of greatest concern.

Last year, the US Food and Drug Administration (FDA) published more than 200 complete response letters (CRLs) that had been issued between 2002 and 2024 for products that have since been approved1, providing greater transparency into the agency’s decision-making process.

Additionally, FDA has rejected or delayed several new cell and gene therapy (CGT) biologics license application (BLA) submissions due to problems with manufacturing readiness. According to the manufacturers of these products, deficiencies included process control gaps, inadequate stability data, unvalidated analytical methods, and ongoing issues following Good Manufacturing Practice (GMP) inspections2.

These CMC and GMP issues are welldocumented in Europe, where most biological products and all ATMPs go through the Centralised Procedure (CP) with the European Medicines Agency (EMA). The agency has a long-established documentation framework and each product is subject to European public assessment reports (EPARs)3, whether approved or denied authorization. The release of the CRLs from FDA now al-

MARTIN MEWIES, PH.D., is director, regulatory affairs, CMC, at Cencora.

He has nearly 30 years of experience in protein biochemistry, with over 20 years in biologics CMC / regulatory.

lows observers to more rigorously assess areas of respective interest and concern between the health authorities.

Shining a light on CMC One of the core challenges with developing an ATMP is characterizing the process and getting well-understood critical quality attributes (CQAs.) Having those robustly understood and justified is key to unlocking a lot of the other CMC challenges4. A frequently identified CMC issue is poten-

cy, particularly getting a relevant potency assay that links to a meaningful CQA that accurately reflects the mode of action of the product. While potency issues are not new, the more complex the therapy, the harder it can be for manufacturers to convince regulators that their CQAs are meaningful and justified and will link back into the clinical efficacy that needs to be demonstrated in clinical trials.

This is relevant not only for potency but also for comparability – another issue highlighted in the CRLs. This refers to the pre- or post-change data when scaling, transferring sites, or changing materials. These changes inevitably occur during product development, particularly with biological products. Unless comparability is linked to meaningful CQAs it is hard to make a compelling case to support those changes.

The same is true for stability. Without stability data linking back to meaningful attributes of the product, it is hard to demonstrate that within reasonable parameters the product is stable over its shelf life and during transfer and transport. Steps to avoid negative findings from the regulators include generating real-time data early, carrying out degradation mapping, and establishing an interim shelf-life supported by a well-justified extension plan.

The CRLs also identify challenges with regards to manufacturers’ control strategies – another issue commonly highlighted in EPARs. They also reinforce the need to have an appropriate manufacturing environment, ensuring that all

Picture: © Cencora

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CDMO LANDSCAPE

European Biotechnology | Spring Edition | Vol. 25 | 2026

facilities comply with standard GMP requirements, including sterility assurance.

ATMPs are often made in small facilities using novel manufacturing technologies, nonetheless, the same requirements for GMP sterility assurance still apply. Positioning CPP/CQA controls within a riskbased quality framework, such as ICH Q9(R1) 5, can demonstrate proactive compliance and inspection readiness.

Manufacturers must ensure they build in all the compendial requirements governed by the European Pharmacopoeia that control sterility and appropriate control and characterization of the process6.

ATMP CMC risk lifecycle curve

Pictures: © Cencora

Taking an inclusive approach ATMPs are inherently complex products, and small personalized products present even greater challenges. But having the appropriate quality control and processes in place is fundamental to product safety and should be built in from the outset.

Embedding a holistic approach or best practices into the organization from concept through development and product submission can help to mitigate the CMC issues that have resulted in CRLs in the U.S. and marketing application refusals in Europe. Some best practices manufacturers can put in place include: › Work cross-functionally to evaluate assays and guide decisions across the full development and commercialization lifecycle. › Engage the health authorities early to seek scientific advice, leveraging programs like PRIME (where relevant) in Europe, the Innovative Licensing and Access Pathway (ILAP) in the UK, and the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot in the U.S. Raise as many CMC hotspot topics as possible during these interactions. › Consult key opinion leaders and thirdparty experts to gain diverse therapeutic-area perspectives and to help build robust plans for monitoring and managing process changes. › Future-proof the development process to pre-empt evolving regulatory expectations by focusing on data integration

ATMP CMC risk lifecycle curve

(a priority for health authorities) and taking a forward-looking approach to the indicators regulators are looking for before and after inspections.

The CMC challenges facing ATMPs are inherent to the nature of the products and their novelty in the market. As guidelines evolve and as new interpretations of the guidelines emerge, the requirements will become more defined, which will make it easier to identify areas of discrepancy.

By understanding what regulators expect – through assessment of CRLs and EPARs and seeking good scientific advice – manu­facturers can better understand this complex and dynamic environment and mitigate risk with their CMC processes. ■

1 FDA Embraces Radical Transparency by Publishing Complete Response Letters, FDA, July 2025. https:// www.fda.gov/news-events/press-announcements/fda-

embraces-radical-transparency-publishing-completeresponse-letters 2 Why gene and cell therapies are stalling at the FDA, Drug Discovery News, Aug 2025. https://www.drugdiscoverynews.com/why-gene-and-cell-therapies-arestalling-at-the-fda-16527

EMA. European public assessment reports: background and context. https://www.ema.europa.eu/en/ medicines/what-we-publish-medicines-when/european-public-assessment-reports-background-context

3

Johanna I, Daudeij A, Devina F, et al. Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit.

Immuno-Oncology and Technology, October 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC10772236/

4

5 Q9(R1) Quality Risk Management, FDA, May 2023. https://www.fda.gov/regulatory-information/searchfda-guidance-documents/q9r1-quality-risk-management 6 European Pharmacopoeia (Ph. Eur.) 11th Edition, European Directorate for the Quality of Medicines & HealthCare. https://www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition

Disclaimer: The information provided in this article does not constitute legal advice. Cencora strongly encourages readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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INNOVATION

European Biotechnology | Spring Edition | Vol. 25 | 2026

Can gene silencing transform rare disease research?

There are an estimated 7,000 plus rare diseases today, and more being i­dentified all the time. A rare disease is a condition that affects fewer than 1 in 2,000 people. 80% have a known ­genetic origin, but they can also be caused by a range of other factors like a compromised immune system, infections or allergies.

RARE DISEASES

One in 17 people will be affected by a rare disease at some point in their lives, so while they are rare individually, it’s not all that rare to feel the impacts of these diseases. This amounts to 3.5 million people in the UK, 30 million people across Europe and 300 million worldwide.

Seven in 10 rare diseases affect children, and more than 3 out of 10 children with rare conditions will die before their fifth birthday. Sadly, the majority of rare diseases currently have no effective treatment, as only 1 out of 20 rare diseases has an approved treatment.

Rare diseases represent a major challenge for healthcare systems, drug developers, and governments worldwide.

Their low prevalence makes rare diseases challenging to diagnose, treat, and research due to limited patient data and clinical expertise.

Prevention is better than a cure; in the case of rare diseases, often devastating and life-limiting for the patients, early identification of the disease and early clinical care is key. However, getting an accurate diagnosis often takes years, with a tremendous cost for patients and healthcare systems. More than a third of rare disease patients receive a final diagnosis more than 5 years after experiencing symptoms.

A significant challenge in the road to curing rare diseases is the cost, which is typically much higher than creating drugs for less common disorders. The pool of patients able to take part in clinical trials is small – as is the market.

Historically, major pharmaceutical companies have shied away from re-

DAN WILLIAMS, is the co-founder of Oxford-based biotech SynaptixBio and an accomplished biopharmaceuticals leader with two decades of industrial experience from bench to operational and ­scientific executive roles. During his career Dan has served as Vice ­President of Research Operations at Adaptimmune PLC. and Chief Product Officer at Meatable B.V.

searching rare diseases primarily because they were not considered commercially viable, as small patient populations meant low returns on investment compared to blockbuster drugs for common conditions. While the effects of rare diseases on families are no less tragic than those of more common disorders, big pharma does not deal in emotions and

tends to invest in research with more economic incentives.

That means smaller biotechs are more commonly involved in the research of rare diseases, but of course, they deal with more stringent budgets. Although this trend has begun to shift in recent years, largely due to regulatory incentives, rare diseases are still ‘rarely’ a priority for those larger pharmaceutical companies.

Even when the funding is available, data is scarce and fragmented. Sufficient data is needed for meaningful analysis, but patients are often spread across the world, many likely unaware they even have a rare disease. The data that is recorded can be siloed across hospitals, research centres and pharmaceutical companies, making collaboration a laborious task.

SynaptixBio’s mission to cure H-ABC One example of such a rare disease is Hypomyelination with Atrophy of the Basal ganglia and Cerebellum (H-ABC).

H-ABC is the most common and severe subtype of the TUBB4A-related leukodystrophy group of diseases, a fatal and currently incurable disease of the central nervous system (CNS) that affects mainly babies and young children.

This progressive, genetic neurodegenerative disorder affects around 1600 babies and children worldwide every year and makes up around 9% of leukodystrophies. Mutation in the TUBB4A gene leads to a failure to lay down myelin

Picture: © Jacqueline Cross Photography Ltd

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© 2199_de/iStock

2026

German Biotech Days 21. & 22. April 2026 Leipzig | Germany

INNOVATION

European Biotechnology | Spring Edition | Vol. 25 | 2026

SynaptixBio is developing antisense oligonucleotides to treat a range of severe leukodystrophies

around the nerves, resulting in seizures, muscle contractions, uncontrollable limb movements and issues with speech. Life expectancy depends on severity of the disease and many die by their late teens.

While there is currently no cure for this disease, adequate management of the symptoms can significantly improve the quality of life of the patients. Therefore, getting the right diagnosis as early as possible is key in the management of the disease.

Gene silencing technology and its applications The human genome contains around 20,000 protein coding genes, each a template for a protein that plays a role in the body’s structure, function and regulation. A small percentage of gene variants, whether hereditary or non-inherited, trigger the production of disease-causing faulty proteins, leading to disease.

Diseases caused by changes in proteins range from mild to severe, and include rare diseases, cardiovascular disease, cancer and other disorders.

Treatment approaches for genetic diseases have focused on managing symptoms through small molecule and biologic therapeutics. Newer approaches target the genetic mutations themselves, by replacing (gene therapy), removing (gene editing) or muting (gene silencing) the genetic code.

The gene silencing approach works by targeting mutations and preventing or reducing the expression of disease-causing proteins, and the naturally occurring mechanisms include antisense oligonucleotides (AsO) and RNA interference (RNAi) strategies.

Antisense oligonucleotides are stabilised single- or double-stranded synthetic oligonucleotides that bind to the target DNA, triggering the cleaving of the target mRNA (messenger RNA) by RNase.

In the RNAi process, after administration, small interfering ribonucleic acids (siRNAs) and microRNAs (miRNAs) bind to the mRNA, either inhibiting the translation of the mRNA into protein, or inducing its degradation. With both approaches, each oligonucleotide is specific to a single mutation, but mixtures could be used to treat a disorder associated with a number of genetic variants.

Research into antisense oligonucleotides is thriving, particularly in genetic disorders, neurological diseases, and cancer. SynaptixBio is developing antisense oligonucleotides to treat a range of severe leukodystrophies, including the rare disease, TUBB4A leukodystrophy.

SynaptixBio’s TUBB4A antisense oligonucleotide, SB-19642, is a DNA molecule with RNA ‘wings’ that binds to the mRNA. It is highly specific, targeting only the aberrant tubulin, allowing the other tubulins to continue to play their physiological roles. SB-19642 has shown encouraging results in preclinical animal

models, including a reduction in toxic protein levels linked to the mutation and SynaptixBio has selected the candidate to begin Phase I clinical trials.

The road ahead Gene silencing looks like a breakthrough for rare disease research not because it removes every barrier, but because it tackles a core constraint head-on: many rare diseases are driven by specific genetic mutations, and AsOs and RNAi can reduce the expression of the disease-causing proteins at the source. SynaptixBio’s work in H-ABC illustrates why that matters. In a condition that is fatal, hard to diagnose early, and has no approved treatment, a mutation-targeted AsO candidate like SB-19642 offers a plausible route to slowing, or potentially halting, progression in a way that symptom management alone cannot.

At the same time, gene silencing doesn’t solve the challenges of rare diseases, such as delayed diagnosis, scarce and fragmented data, and small clinical trial populations. If gene silencing is to fulfil its promise, it will need to be paired with earlier identification and stronger collaboration across hospitals, research and companies. But as modern approaches mature, they strengthen the case that rare disease research can become more feasible and more investable than it was in the blockbuster-drug era. ■ Dan Williams

Picture: © Jacqueline Cross Photography Ltd

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European Biotechnology | Spring Edition | Vol. 25 | 2026

ADVERTORIAL

Where Life Science Scales in Basel The Basel region is one of the world’s leading life-science clusters. P ­ harmaceutical companies, biotech firms and research institutions benefit from a unique combination of talent, infrastructure and international collaboration. As the industry continues to grow, the demand for ­scalable laboratory and office environments within this innovation ecosystem is increasing.

REAL ESTATE

The Basel life-science cluster is widely recognised as one of the most important innovation ecosystems in the global pharmaceutical and biotechnology industry. International companies, research organisations and start-ups operate within a dense network that combines scientific excellence with strong industry collaboration.

As research activities expand and new technologies move closer to clinical application, the need for suitable infrastructure for research and development continues to grow. Companies launching new research programmes or expanding their operations increasingly require environments that combine advanced laboratory facilities with flexible office space.

At the same time, many organisations aim to remain within the established Basel cluster in order to benefit from access to specialised talent, academic institutions and international partners.

Picture: © SONUVO

Allschwil: a growing life science hub One location that meets these requirements is Allschwil, just outside the city of Basel. In recent years, the Bachgraben district has developed into an important extension of the region’s life-science ecosystem. Situated in the tri-national region of Switzerland, Germany and France, the area provides access to a large international workforce as well as to a strong network of research institutions, pharmaceutical companies and clinical partners.

Within this environment, SONUVO offers approximately 35,000 m² of laboratory and

SONUVO in Allschwil offers approximately 35,000 m² of laboratory and office space within the Bachgraben life-science district in the Basel region.

office space designed to support professional research organisations. The buildings were originally developed for the international pharmaceutical company Actelion and therefore meet demanding standards in terms of functionality, safety and technical infrastructure.

Designed by the renowned architecture firm Herzog & de Meuron, the site combines modern laboratory environments with flexible office layouts and specialised areas for research, technical operations and support functions. Two buildings allow different usage profiles: while building H89 focuses primarily on laboratory infrastructure, building G06 provides modern office environments that complement research activities.

With its combination of infrastructure, flexibility and location within the Basel life-science cluster, SONUVO provides a scalable environment for international companies seeking to expand their research and development activities in one of Europe’s most dynamic innovation ecosystems.

SONUVO is exclusively marketed by H&B Real Estate AG. Companies interested in establishing or expanding their presence in the Basel life-science cluster can obtain further information about available laboratory and office space at: sonuvo.ch. ■ Contact us: H&B Real Estate AG Lange Gasse 8, 4052 Basel Phone: +41-61-545 03 37 | www.hbre.ch

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INTELLECTUAL PROPERT Y

European Biotechnology | Spring Edition | Vol. 25 | 2026

Is the Unified Patent Court affordable for small biotechs?

The Unified Patent Court and the unitary patent were established to make patent litigation in Europe easier, faster and more affordable. It has been particularly emphasized that the new system was designed to enable small and medium-sized enterprises to enforce their rights more effectively and rapidly. The reality now suggests differently. Litigation in Europe has become quite fragmented, more complex and more expensive than ever – a nice playground for deep pockets.

INTELLECTUAL PROPERTY

The Unified Patent Court (UPC) and the unitary patent came into force in June 2023. The goal was to benefit from a single title (the unitary patent) covering the territory of the European Union. European Patents are granted at the European Patent Office under the European Patent Convention (EPC) for its 39 EPC member states: 27 EU and 12 non-EU states.

Following its grant, the European Patent was split into national patents, each of which had to be enforced before national courts. Thus, in theory, litigation of a European Patent could have meant litigation in 39 European countries. Although, in reality, 80 % of all litigation took place in Germany and then the case was eventually settled in the rest of Europe, it seemed advantageous to have one unitary patent and one court for patent litigation.

What the UPC changed Now, after grant of the European Patent the patent owner may choose the “old route” and may obtain 39 national patents in Europe that are litigated before the respective 39 national courts (if the owner opts-out of the UPC system which will be possible until 2030) or the patent owner may obtain 39 national patents that are all litigated before the UPC (if the owner opts-in the UPC system and insofar those countries are members of the UPC). Alternatively, the patentee may now just obtain the unitary patent that is litigated before the UPC.

Switzerland. To make things even more complicated, patentees may obtain protection for the same invention via a national patent, in addition to a unitary patent, in some of the UPC countries. There is no double patenting prohibition between the unitary patent and a purely national patent in some countries. This means that protection may be available for the same invention as a national German Patent and additionally as a unitary patent with effect in Germany. Both patent rights, that are protecting the same invention, can be separately enforced for the same territory. So, currently, the available patent protection in Europe still seems fragmented and complicated despite the UPC system.

UTE KILGER, PH.D., is partner at Boehmert & Boehmert. The (bio) chemist by training has a track record of more than ten years in the patent departments of large pharmaceutical companies. Dr Kilger is licensed as a German and European patent attorney.

However, as just 18 EU countries are currently UPC countries, in case the patentee wishes protection in all EPC countries, he may obtain one unitary patent and 21 national patents for those EPC countries that are not members of the UPC. Amongst those countries that are not members of the UPC are quite important ones as Great Britain, Spain, and

Still complex in Europe The UPC definitely has arguments in its favor. It is cheaper to nationalize an EP patent into a unitary patent and 21 national patents than obtaining 39 national patents after grant of the EP Patent. This may incentivize smaller companies to request a unitary patent instead of choosing the “old route”. However, if the patent owner wants to have protection in 3 or 4 core countries in Europe only, then the transformation into the unitary patent and the subsequent annuities would be more expensive in comparison to the “old route”. Another advantage is that the UPC offers fast and efficient timelines.

On the other hand, UPC proceedings are very frontloaded compared to EPO

Pictures: © Boehmert & Boehmert

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European Biotechnology | Spring Edition | Vol. 25 | 2026

and national proceedings. This demands strict procedural discipline and careful advance planning, which requires larger lawyer teams because of the very early, comprehensive submissions that leave little room for later adjustments. Bigger lawyer teams require bigger money.

Further, the structure of the UPC enables complex scenarios. While defendants in infringement proceedings may attack patents by a counterclaim for revocation before the competent Local Division, the same patent may be challenged by other parties in central revocation actions before the competent Central Division. Such parallel proceedings put a lot of pressure on the patent owner, who must defend the same patent in multiple fora. If, in addition, national patents and purely national proceedings also come into the litigation play, it seems that the UPC just opened additional dimensions of litigation rather than simplifying it, which showed

INTELLECTUAL PROPERT Y

the Amgen/Sanofi case: at least 4 UPC procedural lines (revocation + appeal + infringement action) and in parallel proceedings before the EPO and proceedings before national courts.

One case, big risk More complex litigation scenarios, frontloaded and fast proceedings, larger lawyer teams and an additional layer of litigation require deep pockets on the patent owner’s end. We also hear calls for the implementation of “common-lawbased instruments” into the UPC system, e.g. discovery tools. Discovery proceedings, however, require intense preparation and would mean an explosion of costs.

In summary, albeit the system was founded to benefit SME’s, it seems that the costs are much too high and thus, the system serves in particular the bigger companies. Moreover, defending and

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enforcing a patent in the UPC system is not only very costly but also carries the risk of losing a valuable patent across the whole of Europe in one single revocation action.

Smaller companies should, thus, carefully design their patent portfolio strategies as well as their litigation strategies and should probably not put all their “patent eggs” into the UPC basket, in particular, not the most valuable ones.

We truly hope that the legislator will prolong the period in which patent owners can choose whether they want to opt-in the UPC or whether to enforce their European Patents before national courts. Otherwise, litigation in Europe will be a game for Goliaths only but not for smaller entities and SME’s, which shall be the motor of innovation  in ­Europe.

Ute Kilger

47

SPECIAL PORTUGAL

European Biotechnology | Spring Edition | Vol. 25 | 2026

Portugal’s biotech industry is growing up For years, Portugal sat just outside Europe’s main biotech conversation: scientifically credible, strong in research, but too small, too fragmented and too thinly financed to compete with the established hubs in Switzerland, the UK, France, Germany or the Nordics. That view is becoming harder to defend. Portugal still does not have the scale of Europe’s top biotech markets, but it is building something more durable than a collection of isolated startups.

BIOTECH CLUSTER

The industry’s own trade group, P-BIO, says that from 2016 to 2020 the combined turnover of its members more than tripled and that 53% of Portuguese biotech companies derive more than 60% of turnover from exports, suggesting that even at an early stage, many firms are built with foreign markets in mind.

AICEP, the national trade and investment agency, says Portugal’s broader health and life sciences ecosystem generated about €29.7 billion in turnover in 2024, with more than 268,000 workers across roughly 124,000 companies. In 2025, health-sector exports rose above €5.6 billion for the first time, according to AICEP, with pharmaceutical preparations accounting for the overwhelming majority. Those numbers say less about the size of pure biotech than about the environment around it, but

they do show why the sector is increasingly treated as an economic priority rather than a niche scientific activity.

In practice, the Portuguese market is less a single biotech industry than a set of overlapping verticals: drug discovery and advanced therapeutics, industrial and food biotechnology, marine and environmental biotech, and a growing layer of platform companies working in precision fermentation, diagnostics, exosomes and digital health. That diversity matters in a small country. It reduces dependence on one therapeutic wave and makes Portugal more resilient than an ecosystem built around a single flagship subsector.

The geography of the industry also helps explain its momentum. Portugal’s biotech map is not dominated by one city in particular. Instead, activity is spread across a

few nodes with distinct identities. Cantanhede, near Coimbra, remains symbolically important because Biocant Park is still the country’s only science and technology park explicitly specialized in biotechnology. Porto and Braga contribute research strength, spinouts and industrial capability. Lisbon provides investor access, international visibility and policy reach. Coimbra sits at the intersection of university science, healthcare institutions and new infrastructure ambitions. This multi-node model can look fragmented from the outside, but it may suit Portugal’s scale better than trying to force a single national center of gravity.

A market with growing ambitions One sign of Portugal's scaling ambition is now visible in Coimbra. In late February

Picture: © macrovector - Freepik.com

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European Biotechnology | Spring Edition | Vol. 25 | 2026

2026, Coimbra’s municipality announced a memorandum of understanding for the Portugal Life Science Park – Coimbra. The project is designed as an integrated life sciences ecosystem for R&D, biotech, medtech and industrial activity, with plans for a total of 76,500 m² of gross leasable area. Once fully developed, it could attract between €100 million and €150 million in private investment and create between 1,200 and 1,500 highly qualified jobs, although those figures remain projections that will depend on the park’s gradual rollout, the arrival of companies and the pace of investment over time. The overall direction is clear: Portugal is trying to move beyond incubation toward physical platforms designed to host later-stage development and production.

Another current signal comes from Óbidos, where local authorities announced in 2025 that startup Valvian, led by Portuguese biotech entrepreneur Nuno Prego Ramos, plans to establish a research and production center in the technology park there. Municipal messaging described it as a major investment aimed at reinforcing Portugal’s position in health, pharmacology and AI-linked innovation. Because the project is still emerging, it should be treated as an ambition rather than proof of industrial transformation, but the fact that such projects are being proposed at all is revealing. For a long time, Portugal’s biotech aspiration was mostly about generating startups. It is now also talking about factories, production resilience and full-stack lifescience infrastructure.

Startups push for scale Capital, long one of the country’s weakest points, is also starting to look less fragile. In June 2025, Biovance Capital, a Lisbonbased venture capital firm focused on early-stage biotech investments, said its life-sciences fund had reached €57 million after an investment from BIAL, the largest Portuguese pharmaceutical company. For European biotech standards, €57 million is not a giant fund, but in Portuguese terms, it is significant: it creates a domestic vehicle with a stated focus on early-stage drug development and Southern Europe, rather than forcing founders to rely exclusively on foreign investors at the earliest stages. Just as important, BIAL’s participation suggests that one of Portugal’s few large innovation-driven pharma groups is trying to build influence beyond its internal pipeline.

BIAL still occupies a category of its own inside Portuguese life sciences. The 100-year-old company says it invests around 20% of turnover in R&D, operates manufacturing and an R&D center in Portugal, and sells products in more than 50 countries. That does not make Portugal a pharma power by itself, but it gives the country something many smaller ecosystems lack: a homegrown company with global commercial experience, deep regulatory knowledge and the ability to anchor talent. In ecosystems like Portugal’s, these firms matter disproportionately because they shape management talent, supplier networks and investor confidence.

The startup pipeline itself is also maturing. In February 2025, Porto-based PFx Biotech secured €9.5 million from the Euro-

SPECIAL PORTUGAL

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SPECIAL PORTUGAL

pean Innovation Council Accelerator to scale production of human milk proteins via precision fermentation, beginning with lactoferrin. That win matters for two reasons. First, it places a Portuguese company inside one of Europe’s most selective deep-tech funding mechanisms. Second, it shows that Portuguese biotech is not limited to classical therapeutics; it is also present in synthetic biology and next-generation food and nutrition ingredients. In March 2025, Exogenus Therapeutics, based in Cantanhede, announced a collaboration with Lonza to develop a GMP-compliant manufacturing process for Exo-101, its lead exosome-based candidate, with the company saying it expects the program to reach patients in 2027. Meanwhile, Immunethep, a University of Porto spinout, received $2 million from CARB-X in February 2025 to advance a vaccine against invasive E. coli infections. Taken together, those cases show a national sector that is diverse in modality and increasingly plugged into international industrial and funding networks.

Clinical research as an edge The country has long argued that its national health system, concentrated hospital networks and trained investigators make it an attractive place for trials, but the bot-

View of Lisbon

European Biotechnology | Spring Edition | Vol. 25 | 2026

10 Portuguese biotech companies to know Company

Stage

Funding disclosed

Exogenus Therapeutics

Founded Focus 2015

Exosome therapeutics

Preclinical

€0.9m early funding

Immunethep

2013

Vaccines and anti-infectives

Preclinical

$2m CARB-X award

BSIM Therapeutics

2011

Transthyretin amyloidosis

Preclinical

Undisclosed

LiMM Therapeutics

2018

Neuro-immune therapies

Preclinical

€12.5m EIC award

Luzitin

2010

P h oto d y namic c an c er Late clinical therapy

Undisclosed

TechnoPhage

2005

Phage therapeutics and biologics

Clinical

Undisclosed

TREAT U

2010

Targeted nanoparticle oncology

Preclinical

Undisclosed

PFx Biotech

2022

Precision fermentation

Early scale-up

€9.5m EIC funding

SilicoLife

2010

Synthetic biology and industrial biotech

Scale-up

Up to €9.8m Series A

Valvian

2024

Immunotherapies and targeted therapies

Discovery

Undisclosed

tleneck was speed and administrative predictability. The policy mood has shifted.

Infarmed, the Portuguese health agency, reported that 115 clinical-trial applications were submitted in Portugal in the first half of 2025, six more than in the same period of 2024. It also said in late 2025 that average assessment times for mono-national clinical trials had fallen from 71 days in 2023 to 45 days in 2024. In March 2026, Portugal enacted Law No. 9/2026, which implements the EU clinical-trials regulation in Portuguese law and strengthens participant protections, including access to free medication after the trial in certain cases. Separately, AICIB, a Portuguese agency that supports clinical research and biomedical innovation, and a multidisciplinary working group that included Infarmed released a model financial agreement for medical-device clinical research, intended to facilitate contracting between sponsors and research centers. None of these steps guarantees a boom in trials, but together they show a system trying to remove friction from one of biotech’s most important enabling layers.

Portugal is also gaining visibility at the networking and branding level, which in biotech is not superficial. Lisbon is hosting BIO-Europe Spring for the first time from March 23 to 25, 2026, with the organizers describing it as Europe’s largest spring-

time biotech partnering event. Hosting a renowned conference does not create an industry, but it does signal that Portugal wants to present itself not merely as a lowcost location for outsourcing, but as a place where biotech companies can be financed, partnered and scaled.

The deeper question is whether Portugal can convert momentum into permanence.

The ingredients are visible: a trained workforce, a research base, recognizable clusters, a maturing clinical-research framework and a handful of companies reaching meaningful technical milestones. Yet the old problems have not disappeared. Portuguese biotech still faces a small domestic capital pool, limited late-stage financing, and the perpetual risk that promising science will leave the country as soon as larger foreign money appears. That is why the current phase matters. Portugal is no longer trying simply to prove that biotech exists there. It is trying to prove that the country can host the full chain: science, startup formation, translational development, clinical studies, specialized manufacturing and international partnering. The answer is not settled yet but in 2026, Portugal’s biotech industry looks less like an emerging curiosity and more like a serious, if still secondary, European ecosystem that is learning how to build scale without losing focus. ■ Joachim Eeckhout

Picture: © vwalakte - Freepik.com

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BIO-Europe by

Spring

Propelling the new wave of innovation BIO-Europe Spring brings together over 3,700 leading executives from around the world, hosting more than 20,000 partnering meetings between biotech companies, startups and academia with pharma companies and forward-thinking investors.

Part of Spring Innovation Week

BIOEUROPESPRING.COM

DRUG DEVELOPMENT

European Biotechnology | Spring Edition | Vol. 25 | 2026

Algae cultivation gets easier for biopharma Algae have seen a small comeback in the biotech industry, though their commercial prospects have so far been held back by their fickle growth behaviour and high production costs.

ALGAE CULTIVATION

But major advancements have been made in collecting algae and growing them under controlled conditions. This has increased the availability of species that can be investigated for their potential to treat diseases.

Today, pharmaceutical applications of algae are a relatively small component of the current market. An EU report suggests that they comprise around 8% of current microalgae use and around 3% of macroalgae use1. Algae metabolites have been shown to have anti-cancer, anti-inflammatory, anti-bacterial and anti-viral effects. A wide variety of animal studies have been conducted but clinical trials on humans are still relatively rare.

Market projections suggest that the value of algae products in general will continue to grow by billions of dollars by the end of the decade2. Europe's microalgae market is projected to have a compound annual growth rate of 9.81% from 2025 to 2032, just behind the markets of North America (10.21%) and Asia (11.39%).

Pharmaceutical applications will likely grow in importance, along with more common uses such as biofuel and food.

For example, everything from over-thecounter nutraceuticals to live algae cells coated in nanoparticles have shown promise in alleviating inflammatory bowel disease (IBD). IBD conditions such as Crohn’s disease and ulcerative colitis afflict up to 6.8 million people worldwide. Their varying presentations and unknown origin make them challenging to treat. Current protocols combine lifestyle and dietary adjustments, and drug regimens which may lead to undesirable side effects. In severe cases, patients may even undergo bowel surgery.

Algae mining Efforts are underway to identify useful compounds to address IBD symptoms in lesser-known species. “We initially narrowed our algae list to species already “domesticated” in cultivation, species sourced in extreme environments that can

Algae4IBD aims to use algae to address inflammatory bowel diseases.

potentially be farmed without being contaminated and species that had potential to address IBD based on their biochemical profile,” says Leonardo Mata, a researcher with Algae4IBD (algae4ibd.eu), an EU-funded initiative aimed at using algal compounds to address IBD symptoms.

Once species that contain bioactive compounds are identified, it is then crucial to find the best possible culture conditions to make the species commercially viable.

Algae farming and its discontents There are three main means of cultivating microalgae. Pond or tank cultivation is the simplest. Large artificial bodies of water are inoculated with the desired algae species and fertilized to encourage growth. They require a large physical footprint and are more subject to environmental variables such as sunlight and precipitation.

“One of the main challenges that any algae cultivator faces is contamination.

Other species can compete and dominate the culture over time,” Mata adds.

The biofilm cultivation method involves the growth of microalgae on surfaces so that they can be scraped off for harvest.

The low space requirements, high density of cells and low cost of harvest make this an appealing option for some species. But the formation of biofilms necessitates the presence of bacteria and other species, which may complicate the refinement of products from the desired algal species.

Picture: © Algae4IBD

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DRUG DEVELOPMENT

European Biotechnology | Spring Edition | Vol. 25 | 2026

Finally, indoor closed photobioreactors, which grow microalgae in tubes, columns or plastic bags, offer several advantages over more exposed systems. They require less real estate, make it easier to control levels of light, temperature, nutrients and carbon dioxide, and are easier to keep free of pest organisms that impact harvest quality. However, they are substantially more expensive to set and to run, making large-scale cultivation less practical.

“When you move from lab research scale in controlled conditions to commercial scale, it is important to reduce the production cost, and it is challenging to scale up at cost in photobioreactors. Traditionally, you need to use systems that are not so protected, and that’s when production challenges happen,” Mata explains.

Hybrid systems use more expensive photobioreactors to nurture algae during certain life stages and then transfer them to cheaper pond systems where they can mature. They may offer increased precision and cost effectiveness.

Macroalgae or seaweeds are traditionally wild harvested, but in Asia are mostly farmed in the sea. Growing it like microalgae in onshore ponds or tanks can provide benefits over wild harvesting.

These include reduced disruption of natural environments, better access compared to sea-based cultivation, and more control of growth parameters such as salinity, light and temperature. But these require high energy usage, and consequently, production costs.

Financial investment, shortages of skilled labour, costs to dewater, and ­difficulties in extracting viable amounts of useful products present additional challenges to commercializing algae production.

Picture: © Algae4IBD

Algae improvements Raceway ponds have become the standard for outdoor algae cultivation. These shallow, usually oval basins reduce shading of the algae due to their shallow-

Photobioreactors offer several advantages for the cultivation of algae

er depth and increased waterflow using mechanical devices such as paddlewheels. Pest outbreaks can be detected more quickly as well.

Biofilm production may be improved by using lignocellulosic materials such as sawdust. The material can be included in the bioreactor and the useful compounds extracted later, rather than scraping it off a surface.

Like any system involving living organisms, algae cultivation operations are dynamic and unpredictable.

“It's very difficult to account for the effects of all the cultivation and environmental parameters and predict how the algae are going to respond when these occur in combination,” Mata says. “We do our best to nail down each parameter in isolation and then test their interactions.”

The life cycle assessments done by ­Algae4IBD aim to streamline these processes, offering key insights into how to cultivate algae in an economically feasible and sustainable manner.

The future of algae Microalgae and macroalgae are incredibly diverse groups. There are approximately 44,000 species of microalgae and cyanobacteria and 12,000 species of macroalgae. In Europe alone, there are some 150 edible algae species recorded.

Only a handful of microalgae species, such as Spirulina and Chlorella, are produced at scale for commercial applications. Macroalgae are mostly farmed in

the sea, but in Europe most biomass, like kelps, is harvested from the wild.

“The advances in algae farming are mostly on the smaller-scale, high-value applications, like food, biostimulants, cosmeceuticals, rather than solving big challenges, like bioenergy, that requires to produce massive amounts of biomass at very low cost,” Mata observes.

He thinks that these refinements may nonetheless be sufficient for the development of targeted biomedical applications, which do not necessarily require high volumes of production, and can maybe be economically feasible to farm in controlled systems, such as photobioreactors.

He is also hopeful about the potential of extremophile species for lower costs of production in open systems.

“These species can survive environmental conditions that no other species can.

That offers a great advantage in terms of adjusting the farming conditions for the target species, preventing contamination,” he explains. “If some of these species actually show results in terms of IBD treatment or prevention, that could be a game changer. We could scale up production at low cost without worrying about contamination.''

■

Richard Pallardy

An overview of the algae industry in Europe – Producers, production systems, species, biomass uses, other steps in the value chain and socio-economic data, Publications Office of the European Union, 2022

1

2 Europe Microalgae Market to 2032, Data Bridge Market Research, 2025

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SPECIAL LAB AUTOMATION

European Biotechnology | Spring Edition | Vol. 25 | 2026

Robots in the lab: Race in automation is heating up A global market approaching US$9 billion, a continent catching up fast – and the ­question of where Europe's mid-sized players fit in. The laboratory of 2026 looks rather different from the one most scientists were and are trained in. Pipetting robots handle sample preparation through the night. AI modules flag anomalies in real time. Cloud-connected instruments talk to each other without human prompting. Let´s dive in.

EUROPEAN PERSPECTIVE

The global laboratory automation market is projected to grow from around US$6.4 billion in 2025 to US$9 billion by 2030, driven by the increasing need for highthroughput screening, shortages of skilled laboratory technicians, and the growing

cent, spurred by China's smart-hospital initiatives, Japan's advances in robotics, and India's expanding diagnostic laboratory infrastructure. China in particular is not merely a growth market for Western vendors; domestic players are emerging with competitive, cost-effective systems.

At SLAS Europe last May in Hamburg, MGI Tech unveiled its PrepALL liquid handling system, featuring AI integration, modular design, and high-precision pipetting aimed at genomics, diagnostics, and synthetic biology workflows. That a Chinese firm chose Germany as its launch platform speaks volumes about competitive intent.

Europe's strengths — and where they are concentrated

adoption of AI and robotics, says a report of Markets&Markets. The pressure to automate is no longer purely about cost efficiency; it is also about survival in a talent market that is structurally short of qualified lab personnel.

The global pecking order North America retains a commanding lead as the region holds approximately 40% of the global market, with Europe at around 30% and Asia-Pacific at 22%.

Asia-Pacific, however, is closing the gap at speed. The region is the fastestgrowing market, with a CAGR of 7.7 per

Europe is not standing still. Germany, Switzerland, and the UK are the continent's primary contributors, with companies such as Tecan Group, Festo and Siemens Healthineers advancing automation for precision medicine and molecular diagnostics. Switzerland's Tecan remains a globally respected precision liquid handling specialist, consistently innovating at the high end of the market. Germany's Siemens Healthineers and Eppendorf occupy strong positions in clinical diagnostics and research instrumentation respectively. France's bioMérieux is a significant force in microbiology automation.

QIAGEN, headquartered in the Netherlands but mainly German, announced three new sample preparation instruments in 2025 – the QIAsymphony Con-

nect, QIAsprint Connect, and QIAmini — planned for rollout through 2026.

A meaningful regulatory tailwind is also at work. Europe's IVDR transition — the updated In Vitro Diagnostic Regulation — is driving a substantial upgrade cycle in clinical diagnostics, pushing laboratories to replace legacy equipment and, in many cases, to automate for the first time. This is creating a window of opportunity, provided the Europeans move quickly enough.

The Mittelstand question Europe's industrial backbone – the midsized, often family-owned enterprises that have long led in precision engineering and scientific instrumentation – faces a structural dilemma that is frankly familiar from other technology transitions. Slow adoption of automation among small and medium-sized laboratories remains a recognised restraint on global market growth, and the dynamic is mirrored within the vendor landscape itself.

European Mittelstand firms often excel at building exceptional individual instruments – a high-performance centrifuge here, an innovative sample storage system there – but the integration layer, the software orchestration, the AI-enhanced workflow management that customers increasingly expect as a bundle, is territory where American and, increasingly, Asian competitors hold an advantage of scale.

The window for strategic investment is ■ open, but not indefinitely.

Georg Kääb

Picture: © Caleb Foster - stock.adobe.com

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European Biotechnology | Spring Edition | Vol. 25 | 2026

SPECIAL LAB AUTOMATION

The lab becomes autonomous Laboratory automation is evolving fast. What used to be a patchwork of isolated device solutions has steadily moved toward smarter, interconnected labs. And now that robotics is pushing the field one step further, a fully autonomous research environment no longer feels like science fiction.

IN THE LAB

Recent editions of analytica, a leading international trade fair for laboratory technology and analytics, have highlighted just how quickly automation is progressing toward ‘Lab 4.0.’” Instead of stand-alone automation islands, labs are beginning to look like integrated, digitally connected ecosystems.

The main drivers are artificial intelligence, open communication standards, robotics, and data-driven process control.

The increasing volume and complexity of

data generated from manifold screening technologies, omics and sample management have catalyzed the development of cutting-edge algorithms rooted in big data analytics and machine learning/artificial intelligence.

From smart to fully autonomous One of the most visible symbols of this shift has been the mobile lab robot “Kevin,” developed by Fraunhofer IPA and

the United Robotics Group. Unlike classic stationary liquid-handling systems, Kevin can move independently between lab stations. It transports samples, refills reagents, and replaces consumables. Robots like this represent a real change in mindset: automation is no longer tied to one fixed workstation, but can operate flexibly across the entire laboratory.

At the same time, AI is becoming central to modern lab automation. AI-supported tools help design experiments, optimize pi-

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SPECIAL LAB AUTOMATION

petting strategies, detect anomalies in analytical data, and predict when instruments will need maintenance. Combined with machine-learning algorithms, these systems enable adaptive workflows that learn from results and improve continuously.

The next stage, now exhibited at the coming analytica end of March in Munich, Germany, goes one step further: the “self-driving lab,” where experiments are not only executed automatically, but also planned and evaluated without human intervention. A major step toward this kind of integration has been the introduction of the “Laboratory & Analytical Device Standard” (LADS), a vendor-independent communication standard designed to connect instruments from different manufacturers and replace the many proprietary “island” solutions that still dominate today. In parallel, cloud-based LIMS platforms, digital twins of lab processes, and standardized interfaces are gaining traction. Together, these technologies make laboratories increasingly remote-operable and allow workflows to be orchestrated through data.

Automata is the goblin in the lab Classic automation continues to advance as well. Fully automated sample-preparation systems can now handle complete workflows, from sample intake all the way to analysis. Modular platforms make it easier to integrate automation into existing routines and expand capacity when needed. Collaborative robots, or “cobots”, are also becoming more common. They work alongside lab staff, take over repetitive or safety-critical tasks, and use sensors to respond to their surroundings.

British Automata is developing fully integrated, AI-ready lab platforms designed to bridge the gap between artificial intelligence and physical experimentation. By combining modular robotics, orchestration software and unified data infrastructure, the company aims to turn traditional wet labs into programmable, autonomous systems, where cobots act like nice goblins doing all the work supervised by a only a handful of technician staff.

After receiving US$50 million in 2022 in its Series B round to advance automation

European Biotechnology | Spring Edition | Vol. 25 | 2026

The LINQ Bench from Automata scales with a lab’s needs, offering customizable configurations to fit any instrument density and lab space requirements.

in the diagnostics laboratory, Automata has just in January raised another US$45 million in a Series C round led by Dimension, with participation from Danaher Ventures (via their Beckman Coulter group), Tru Arrow Partners, Octopus Ventures and Entrepreneurs First. The round includes a strategic investment from Danaher Corporation.

The company now serves five leading pharmaceutical groups, delivering improvements in throughput, reproducibility and efficiency. The new capital will fund global expansion, further software development for closed-loop experimentation, and scaled deployments across pharma, biotech and research organisations. Through its partnership with Danaher, Automata’s platform will integrate with technologies from businesses such as Molecular Devices and Beckman Coulter Life Sciences to provide end-to-end automated lab solutions.

Reproducibility and safety Beyond productivity, sustainability and safety are becoming bigger priorities.

Automated systems can reduce reagent use, lower error rates, and improve reproducibility. They also take routine work off scientists’ hands, making it an important benefit at a time when many labs face persistent staff shortages.

But this raises an uncomfortable question: what will researchers actually do in the lab of the future and could they even

become the bottleneck as the last risky factor where reproducibility is a matter of experience? Watching dashboards filled with control parameters and endless columns of numbers, reflecting the work of robots and instruments, isn’t exactly what most people imagine as scientific work either.

Another open issue is training. It’s not yet clear whether today’s education pathways in research and technical lab professions are keeping pace with the high level of digital and automated infrastructure that equipment manufacturers increasingly present as the ideal lab of tomorrow.

Plenty of material for discussion The bigger question, then, is not whether the lab can run itself, but what meaningful scientific work looks like when it does.

Researchers may move away from routine execution toward defining hypotheses, setting constraints and acceptance criteria, and making sense of outcomes, while stepping in only when the system encounters ambiguity or risk.

To avoid turning scientists into passive dashboard-watchers, training will have to evolve: less focus on manual technique alone, and more on automation, data skills, and cross-disciplinary problemsolving that matches the reality of highly digital labs. As the Young European Biotech Network (yebn) points "Automation does not eliminate scientists. It raises the bar for what being a scientist means."

Picture: © Automata

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European Biotechnology | Spring Edition | Vol. 25 | 2026

SPECIAL LAB AUTOMATION

Picture: © Fraunhofer IPA/Foto: Rainer Bez

The young scientists network sees a changing environment in the lab. "The next generation of biotech professionals will not compete with robots on speed or repetition. They will compete on vision, creativity, and interdisciplinary thinking. Biology is becoming programmable", which in their opinion (see page 61) requires minds capable of bridging wet lab intuition with computational logic where data literacy is no longer optional. Understanding how datasets are structured, how AI models are trained, and how automated platforms operate will define the scientists relevance in the coming decade.

Cobots as a trustworthy partner

KEVIN is an autonomous, mobile laboratory robot developed by Fraunhofer IPA.

The next challenge will be trust. As autonomy increases, labs will need robust validation, audit trails, and governance to keep results transparent, reproducible, and compliant, especially in regulated environments.

With cobots in the lab, some issues have still to be solved, among other topics: › Safety Standards and Spatial Constraints. › Limited Payload and Reach › Workflow Integration.

Ultimately, the lab’s limiting factor may shift from hands-on capacity to data quality. Clean metadata and reliable data pipelines will be what turns automation into true autonomy.

■

Georg Kääb

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European Biotechnology | Spring Edition | Vol. 25 | 2026

A special look at SLAS Europe Conference Featuring 100 exhibitors, keynote and podium speakers, behind-the-scenes access to a leading biotech campus, and a rich ­networking program, SLAS Europe 2026 is designed for professionals at every stage of their careers.

EVENT PREVIEW

The Society for Laboratory Automation and Screening (SLAS) will unite the European life sciences and laboratory technology community in Vienna, Austria, 19–21 May 2026, for the SLAS Europe 2026 Conference & Exhibition.

The 2026 conference features three scientific tracks: Advances in Drug Discovery, Advances in Laboratory Automation, and Screening Applications & Diagnostics. Each track is comprised of four sessions led by subject-matter experts drawn from leading academic and industry institutions across Europe. All session times and locations are available at slas.org/europe2026-schedule.

Abstract submissions are still being accepted for poster presentations until Monday, 27 April. SLAS invites research scientists, engineers, academics, students and business leaders to submit an abstract.

The SLAS Europe conference offers highly interactive platforms to showcase work, engage in detailed discussions with delegates, and network with diverse professionals across the European life sciences.

The conference will open with a keynote address from Willem Mulder, PhD, Professor of Precision Medicine at Radboud University Medical Center and Eindhoven University of Technology. As a biomedical engineer, inventor, and entrepreneur, Mulder reflects the diverse SLAS community and will undoubtedly challenge and inspire all in attendance to

continue shaping the future of life sciences.

The highly anticipated Technology Provider Showcase will take place on Tuesday, 19 May, at the Vienna BioCenter – co-hosted by Vienna BioCenter Core Facilities (VBCF) GmbH. The Vienna BioCenter campus is home to seven research institutions, 2,000 scientists, and 42 biotech startups, making it one of Europe’s most dynamic life sciences ecosystems.

Two half-day sessions are available (morning and afternoon), each with limited space, creating a unique and intimate experience. Both sessions open with a presentation from VBCF, followed by talks from a curated selection of innovative companies and startups: › Akribes Biomedical – utilising protein barcodes to personalise wound treatment. › Myllia – using CRISPR perturbations and single-cell sequencing for drug target screening. › Chan:Pharma – will showcase their automated patch-clamp system. › BioNTech Austria – will present their antibiotic drug screening platform.

Stefan Kubicek, PhD, from the Centre for Molecular Medicine (CeMM), will also present his automated small-molecule screening platform. Early registration is strongly encouraged as spaces are strictly limited. Learn more by visiting slas.org/ europe2026-showcase.

The conference exhibition will feature over 100 exhibitors showcasing the latest technologies, services and products driving innovation in lab automation and life sciences. Delegates will have dedicated time to explore new product demonstrations, exhibitor tutorials, and Solutions Spotlight and SLAS Ignite Theater presentations, as well as visit the 12 emerging start-up companies in the Innovation AveNEW area. Daily social events and meals will offer numerous opportunities for networking and collaboration in a relaxed atmosphere.

Early registration for SLAS Europe 2026 is open, with several options and rates available, including full-conference, exhibition-only, student rate, and more.

Visit slas.org/europe2026 for complete conference details and to register for the Vienna conference.

Ahead of the conference, SLAS will host a free, regional networking event for the life sciences community to connect. Catch the SLAS Meet-Up at ETH Zürich in Basel, Switzerland, (30 April) just ahead of Swiss Biotech Days. This gathering will offer excellent opportunities to build connections across the European life sciences community. Visit slas. org/events-calendar to register for an up■ coming Meet-Up.

VENUE INFORMATION May 19-21, 2026 Vienna ­Congress & ­Convention Center (VIECON) Vienna, Austria › slas.org/europe2026

European Biotechnology | Spring Edition | Vol. 25 | 2026

ASSOCIATIONS

European Partnerships for Biotech UPCOMING EVENTS COOPERATION Austria’s biotech sector is gaining momentum as the EU Bio­

Picture: © freepik.com / natalialba

tech Act opens new opportunities. BIOTECH AUSTRIA and EuropaBio join forces to strengthen innovation, competitiveness, and Europe’s role as a global biotech leader.

European partnerships are essential for thinking big. In 2023, BIOTECH AUSTRIA established several working groups that actively support the association in addressing key topics and positioning them effectively. These groups bring together representatives from across Austria’s biotech landscape.

The EU Biotech Act represents far more than a new European legislative initiative – it is a powerful signal that Europe is ready to rethink biotechnology as a strategic driver of future prosperity and competitiveness. For Austria, this marks an exceptional opportunity, especially as the Austrian government has formally identified life sciences and biotechnology as a strategic key industry. The domestic biotech sector, which has developed with remarkable dynamism in recent years, now stands at the point where vision meets implementation. It is determined not only to be part of Europe’s momentum, but to help shape it as a leading force.

BIOTECH AUSTRIA has long represented the interests of Austrian companies with great dedication. It’s EU Working Group has set a clear goal: not merely to accompany the EU Biotech Act, but to actively contribute to its design. The aim is to bring the voices and needs of the Austrian biotech community into the European decision making process and to ensure that the conditions required for innovation are created - not someday, but now.

Since 2025, BIOTECH AUSTRIA has been a member of EuropaBio. Founded in 1996, EuropaBio is Europe’s leading bio-

technology association, based in Brussels, representing companies and national associations to strengthen innovation, regulatory clarity, and the competitiveness of the European biotech industry.

This partnership is more than a formal cooperation. It reflects a shared understanding: Europe can only assume a global leadership role if the strengths of its member states are combined. Through harmonized regulations, modern funding structures, and a renewed openness to technological breakthroughs, the EU B ­ iotech Act creates a foundation on which start ups, scale ups, and established companies can grow. Working closely with EuropaBio will make Austria’s path even more impactful.

Austria offers excellent conditions for this: outstanding research institutions, passionate founders, a maturing ecosystem, and investors increasingly convinced of the power of biotechnological innovation.

Together, these elements make Austria a model region for the successful implemen-

› April 14, 2026, Vienna Taskforce HR Meeting › April 22, 2026, Vienna 5. BIOTECH CIRCLE AUSTRIA

tation of the Biotech Act. Here, the close interplay of science, entrepreneurship, and regulatory support becomes visible.

Start up, Scale up... Step up!

BIOTECH AUSTRIA’s motto for 2026 – “Start up, Scale up... Step up!” – captures this spirit perfectly. It is both a promise and an invitation: a promise to those who dare to innovate, and an invitation to all who are ready to take the next step with the industry. It stands for courage, growth, and responsibility – and for the belief that Austria can achieve more within the European b ­ iotech context than ever seemed possible.

The EU Biotech Act provides the strategic framework for this ambition. It lowers barriers to innovation, modernizes approval processes, and facilitates collaboration between science, industry, and regulatory authorities. As a result, research projects can be translated into market ready solutions more quickly, European competitiveness increases, and new forms of cooperation – within Europe and beyond – become possible.

BIOTECH AUSTRIA is therefore committed to strengthening an ecosystem that not only allows innovation but actively fosters it. An ecosystem that recognizes the needs of researchers, entrepreneurs, and patients alike. The goal is to elevate biotechnology in Europe to a new level – and to position Austria as one of the key ■ drivers of this transformation.

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ASSOCIATIONS

European Biotechnology | Spring Edition | Vol. 25 | 2026

Leading Science this Spring & Summer UPCOMING EVENTS Discover ELRIG’s quarter two events – three focused

scientific meetings showcasing the newest technologies, models, and strategies redefining drug discovery. Join global experts advancing complex cellular systems, automation, and innovative target screening.

This event unites leaders from pharma, academia, and technology innovation to explore how to build the post‑animal, AI‑enabled drug discovery pipeline. Sessions examine how biologically relevant in vitro models, large‑scale multiplexed assays, and AI/ML are reshaping decision‑making in early discovery.

Delegates will gain insights into redesigning workflows for high‑content cellular readouts, integrating automation to handle data at scale, and preparing R&D teams for next‑generation predictive discovery.

Key Learnings › How to generate and manage large‑ scale, multi‑dimensional cellular datasets. › Practical approaches to engineering complex in vitro models at scale. › How AI and ML can enhance prediction and reduce reliance on animal ■ models.

This meeting showcases advances in complex cellular systems, NAMs, and animal‑replacement technologies reshaping translational research. As science shifts toward human‑relevant, mechanism‑driven models, this event offers practical guidance for adopting organoids, microphysiological systems, and next‑generation co‑culture platforms.

Delegates will explore regulatory momentum, operational considerations, and best practices for embedding these technologies into existing pipelines, ensuring robust and predictive discovery.

Key Learnings › How emerging complex cellular and NAM technologies enhance translational value. › Strategies to reduce or replace animal studies without compromising scientific quality. › Implementation tips for assay design, validation, and operational integra■ tion.

ELRIG is a UK-based, not-for-profit organisation with 25 years’ experience connecting the global life science & drug discovery industry through openaccess, free-to-attend events.

This track highlights breakthroughs accelerating target identification, validation, and screening. Sessions explore functional genomics, CRISPR‑based discovery, AI‑driven repurposing, multi‑omics integration, and novel computational and biochemical screening strategies. Delegates will gain insights through case studies covering emerging modalities including PROTACs, ADCs, molecular glues, and AI‑enhanced digital R&D technologies. Designed for scientists advancing early‑stage discovery, this track provides a clear view of the tools and methods pushing scientific boundaries.

Key Learnings

› How emerging technologies accelerate target identification and validation.

› Best practices for integrating multi‑omics, CRISPR, and AI‑driven approaches. › Insights into novel therapeutic modali■ ties shaping early R&D.

Picture: © ELRIG

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European Biotechnology | Spring Edition | Vol. 25 | 2026

ASSOCIATIONS

UPCOMING EVENTS › April 30 – May 2, 2026, Lisbon, Portugal BioConnect 2026

Stop pipetting and start coding?

AUTOMATION Biotech is entering its automated era. Robots run assays, AI designs molecules, and data drives decisions. For young scientists, the question is not survival, it is leadership. Will you adapt to the new lab, or help define it?

Something fundamental is changing inside European laboratories. Pipettes are still there, but next to them stand robotic arms. Experimental notebooks are being replaced by structured datasets. Algorithms suggest molecules before a human ever touches a bench. The automated lab is no longer a concept, it is emerging as the new standard.

Picture: © Gemini

An chilling shift for biotechs For young biotechs, this shift can feel unsettling. You trained to master techniques, to optimize assays, to troubleshoot experiments late at night. Now machines promise to execute workflows faster and more reproducibly than any human. It is tempting to ask: where do I fit in?

But the real question is different.

Who will design those workflows?

Who will decide which data matter?

Who will interpret unexpected results

when algorithms fail? Automation does not eliminate scientists. It raises the bar for what being a scientist means.

The next generation of biotech professionals will not compete with robots on speed or repetition. They will compete on vision, creativity, and interdisciplinary thinking. Biology is becoming programmable, and that requires minds capable of bridging wet lab intuition with computational logic.

You do not need to become a full-time coder. But data literacy is no longer optional. Understanding how datasets are structured, how AI models are trained, and how automated platforms operate will define your relevance in the coming decade. The most powerful profile in bio­tech 2026 is not purely experimental or purely computational, it is hybrid.

Across Europe, biotech ecosystems are evolving rapidly, with countries increasing investment in digital transformation

and actively fostering innovation. With BioConnect 2026, YEBN’s flagship event, taking place in Lisbon, Portugal stands as a compelling example of this transition, supported by national strategies designed to accelBioConnect erate technological adoption and scientific modernization. As ­BioConnect brings together students, startups, and industry leaders, one message will resonate clearly: the future of biotech belongs not to those who resist change, but to those who embrace technology and help shape it.

This is not about replacing human intelligence. It is about amplifying it.

When repetitive tasks disappear, what remains is strategy. When data flows automatically, what remains is interpretation. When experiments run overnight without supervision, what remains is curiosity and bold questioning.

Automation will not define your career. Your response to it will.

Learn the basics of coding. Join interdisciplinary projects. Ask how your lab handles data. Challenge outdated workflows. Be the person who connects biology with technology instead of choosing between them.

The automated lab does not reduce the need for scientists. It demands better ■ ones. And that is an opportunity.

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European Biotechnology | Spring Edition | Vol. 25 | 2026

Alongside the exhibition, Chemspec Europe 2026 will feature two conference streams designed to give visitors a full view of the sector.

Inside the Moleküle Hub

Chemspec Europe 2026

The Moleküle Hub places the spotlight firmly on how chemistry is manufactured and scaled. Sessions explore how digitalisation, automation and artificial intelligence are reshaping R&D and production, alongside advances in continuous processing and modular production. Visitors can see practical examples of faster, safer and more sustainable chemical development, from lab innovation to commercial delivery.

Strategy Stage in focus Chemspec Europe 2026 will take place at Koelnmesse, Germany, on 6–7 May, bringing together the fine and speciality chemicals community for two days of sourcing, insight and discussion across technical and strategic topics.

NETWORKING

Chemspec Europe 2026 will bring together producers, procurement and technical experts from across the fine and speciality chemicals landscape. Spanning a range of industries such as pharmaceuticals, agrochemicals, speciality materials, coatings, personal care, electronics and energy. The event provides a comprehensive view of how the industry is adapting to regulatory pressure, sustainability demands and global supply challenges.

Welcome!

GREETING The fine and speciality chemi-

cals sector is moving fast, and there’s never been a better time to connect in person. Chemspec Europe 2026 brings the community together to explore the ideas and process technology shaping the industry today.

More than 400 global suppliers are expected to be in attendance across the exhibition floor, covering custom synthesis, contract manufacturing, formulation, scale-up and specialist services.

Companies including Albemarle, Brenntag, CABB Group, Johnson Matthey, Saltigo, Sinopec and Yashashvi Rasayan will showcase their capabilities, offering insight into current approaches across the fine and speciality chemicals value chain.

Across the exhibition and conference programme, you’ll find practical insights, lively discussions and direct access to expertise from across the value chain. Whether your focus is innovation, digital transformation or building strategic resilience, Chemspec Europe is a space to exchange ideas, learn from others and make connections that re. ally count.

Christiane Beck Event Director, Chemspec Europe

The Strategy Stage takes a wider view of the forces shaping the fine and speciality chemicals sector. Key discussions cover market resilience, collaboration, talent and growth strategies. Providing insight into how companies are adapting to change and unlocking new opportunities in a complex global landscape.

Together, the exhibition and conference programme provide a clear picture of where change is happening fastest in fine and speciality chemicals and how companies are responding. Chemspec Europe 2026 offers a platform for discussion, insight and connection across the ■ community.

› QUICK FACTS Contact https://www.chemspeceurope.com Content › Two-day fine and speciality chemicals exhibition › Over 400 international exhibitors expected › Two dedicated conference tracks › Focus on innovation, scale-up and strategy › Networking and matchmaking tools

Pictures: © Chemspec Europe

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European Biotechnology | Spring Edition | Vol. 25 | 2026

Explore the German Biotech Days 2026 BIOTECH DAYS 2026 The German Biotech Days (DBT) bring together decision-makers from industry, science, investment and politics to discuss current developments and trends in the industry. The topics range from medical biotechnology and health research to the bioeconomy.

Around 1,100 participants from 21 countries attended the German Biotechnology Days in Heidelberg in 2025 – an impressive testament to the event's growing international appeal.

This tradition will continues in 2026: on 21 and 22 April 2026, the German and European biotech industry will meet at the Kongresszentrum am Zoo. International exchange will once again be a defining feature of the conference. The entire program will be offered in English, reflecting the sector’s

Welcome!

Pictures: © Carolie Pitzke

GREETING The German Biotech Days are

the central annual meeting point for BIO Deutschland members and the entire biotech community. The event is also a platform for increasing international collaboration.

Each year, the conference brings together entrepreneurs, scientists,

growing European and global focus and creating a common platform for discussion, collaboration, and new partnerships.

Host City Leipzig Located in eastern Germany yet well connected internationally, Leipzig offers convenient access via its international airport and ICE high-speed rail station. Located just under 200 km from Berlin, Leipzig is still in the extended radius of the capital

investors, and policymakers to share experiences, showcase innovations, and discuss developments across the sector. The DBT is also an opportunity to reconnect with colleagues, meet new partners, and, quite simply, to see and be seen within the biotech community. I would like to extend a warm invitation to you to join our Community of ­Innovators – and I look forward to meeting you in L­ eipzig.

Dr. Viola Bronsema Secretary General, BIO Deutschland e. V.

city. The biotechnology clusters in Dresden, Erfurt and Prague are well interconnected and accessible and allow for supraregional cooperation.

The Leipzig region is one of the leading locations for life sciences both nationally and globally. With its diverse cluster of bioeconomy, life sciences, healthcare industry, biotechnology, medical technology, pharmaceutical industry, bioinformatics and pharmaceutical and medical logistics, this rapidly growing location covers an comprehensive spectrum of the industry and its sub-sectors.

The city has a proven track record of hosting major life sciences events, most recently as the venue for BIO-Europe.

Partnering and Networking As in previous years, partnering will play a central role at DBT 2026. Participants can arrange one-to-one meetings during the two on-site conference days in Leipzig as well as during an additional digital partnering day held the following week.

At the same time, the event places strong emphasis on personal exchange beyond scheduled meetings. Networking opportunities include a pre-registration reception on the eve of the conference in Europe’s largest tropical greenhouse, extended breaks during the conference program, and the official evening reception in the historic Moritzbastei.

Additional formats such as an “innovation tour” through the BioCity Leipzig offer further opportunities to experience the local life sciences landscape while connecting with colleagues from across ■ the sector.

› QUICK FACTS Contact www.german-biotech.day Why attend › Learn from leaders › Forge strategic partnerships › Showcase your achievements › Explore new markets

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BIOPEOPLE

European Biotechnology | Spring Edition | Vol. 25 | 2026

PEOPLE & POSITIONS

From Merck to Sanofi

Novartis

CHIEF EXECUTIVE OFFICER A surprise

CHIEF FINANCIAL OFFICER In March, Mukul Mehta took over as the new Chief Financial Officer at Basel-based Biotech and Pharma Company Novartis. At the same time, he became a member of the Executive Committee. He succeeds Harry Kirsch, who had been CFO since 2013 and is leaving the company after 22 years.

Mehta is considered to be very experienced in the field of finance. He has also been with Novartis for 20 years and has held various management positions in finance in France, Poland and Norway. This experience has given him a deep understanding of Novartis. He was recently appointed Head of BPA, Digital Finance and Tax, where he will remain until March 2027. Mehta said: “I’ve had the privilege of growing with this company and working alongside exceptional colleagues. I look forward to continuing our journey as a focused medicines company and delivering sustainable value for patients and ■ shareholders.”

move from Darmstadt to Paris: outgoing Merck CEO Belén Garijo is set to take the helm at French pharmaceutical group Sanofi after Paul Hudson unexpectedly failed to secure a contract extension from the board.

Rather than stepping into retirement, Garijo will join Sanofi following the company’s annual general meeting at the end of April. The French drugmaker announced that its board had decided not to renew Hudson’s mandate. After six years in charge, he resigned in mid-February.

At Merck, the succession has long been in preparation. Kai Beckmann, currently head of the Electronics business, is scheduled to succeed Garijo as CEO in May, as announced by the Darmstadt-based DAX group last September. The Spanish executive has led Merck since May 2021.

Expired trust Hudson, who has led Sanofi since 2019, was tasked with revitalising the pipeline and building a successor to blockbuster drug Dupixent, which generates around

US$14 billion in annual sales. On paper, the strategy has delivered momentum: Sanofi’s pipeline comprises 82 clinical-stage projects, 30 of them in Phase III or filed for approval. However, a clear successor to Dupixent has yet to emerge, and several high-profile setbacks among late-stage candidates have weighed on sentiment.

With Garijo at the helm, the group is now entering a new phase – one that will test whether a change in leadership can accelerate the search for the next growth ■ engine beyond Dupixent.

Rentschler Biopharma MANAGEMENT Rentschler Biopharma

SE (Laupheim, Germany) is changing its Executive Board and ‘reorganising its top management team in a strategically important phase’. CEO Benedikt von Braunmühl has left the company. Prof. Dr Uwe Bücheler, Deputy Chairman of the Supervisory Board, has taken over the role of CEO on an interim basis until a new CEO is appointed.

COO Christiane Bardroff will also leave Rentschler in the first quarter to take on a new professional challenge. A succes-

sor has already been found: Dr Veit Bergendahl will take up his new position in April. The doctor of biology will then be responsible for process development, clinical and commercial cGMP manufacturing, engineering and technology, and automation.

The important role of the U.S. for Rentschler is demonstrated by the appointment of Detra Glinatsis. She will take on the newly created position of Head of Business Development, based at the com■ pany’s site in Milford, MA.

Daiichi Sankyo HEAD OF RESEARCH In January, Daiichi Sankyo appointed Dr Veronika Rozehnal as the new head of the Translational ­Research Centre Europe in Martinsried near Munich. She succeeds Dr. Jürgen Müller, who is retiring after almost 30 years of research work at the company. Rozehnal joined Daiichi Sankyo in Veronika Rozenahl 2009. In addition to a three-year period at the Daiichi Sankyo R&D Centre in Tokyo, she held various ■ positions at the Martinsried site.

Pictures: Merck KGaA/DAiichi Sankyo

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European Biotechnology | Spring Edition | Vol. 25 | 2026

eXmoor Pharma CHIEF COMMERCIAL OFFICER Bristol-

based cell and gene therapy CDMO eXmoor Pharma appointed Manuel Balbuena as Chief Commercial Officer at the beginning of March. He brings more than 15 years of experience to his new position at eXmoor Pharma. In recent years, he has held various senior positions in the life Manuel Balbuena sciences sector, including seven years in the CDMO industry for cell and gene therapy and biologics. Balbuena joins from AGC Biologics, where he held senior sales roles across Europe. In his new role, he will lead eXmoor Pharma’s global business strategy, strengthen existing customer relationships, build new strategic partnerships and support the company’s expansion in Europe, the US and other interna■ tional markets.

Pictures: eXmoor Pharma/Novotech/Astoriom

TECregen CHIEF EXECUTIVE OFFICER Swiss biotechnology company TECregen has appointed Dr Klaas P. Zuideveld as its Chief Executive Officer (CEO). Until November 2025, he held the same position at Versameb AG (Basel). Prior to that, he spent twelve years as Senior Project Leader for F. Hoffmann-La Roche Ltd in Basel and Madison (USA), among other roles. At TECregen, Zuideveld will be responsible for strategy and implementation as the company continues to develop its thymopoietic biologics. These are designed to rejuvenate thymic epithelial cells (TECs), restore immune function and strengthen immune resilience. In addition to announcing its successful seed financing, TECregen recently appointed Dr Bo Rode

Hansen, Ph.D., MBA, as Chairman of the Board of Directors. The experienced biotech executive has more than two decades of leadership experience in the pharmaceutical and biotech industries. He was previously CEO of Scandion Oncology A/S and founding president of Genevant Sciences, and has held senior positions at ■ Roche and Santaris Pharma.

Novotech CHIEF EXECUTIVE OFFICER After four years as Chairman of Novotech, Dr Anand Tharmaratnam became the new CEO of the globally active full-service clinical research organisation (CRO). The new CEO will be based at the new global headquarters in Singapore. For the past four years, he has worked closely with his predecessor Dr John Moller, who d e cid e d to step down at the end of 2025, after nine years as CEO. Anand Tharmaratnam is Tharmaratnam a trained intensive care physician and previously he spent 23 years with global CRO Quintiles and its successor organisation IQVIA, including 10 years as head of Asia and Japan on the global leadership committees of the ■ respective companies.

Fortaco Group CHIEF FINANCIAL OFFICER Kimmo Raunio, CFO and Deputy President and CEO of Helsinki-based Fortaco Group Holdco plc, announced at the end of January that he will be leaving the Finnish company. Heikki Saarinen will temporarily assume his position. He will start as CFO and member of the Fortaco Group Leadership Team in April. Saarinen’s previous positions include interim CFO at Bronto Skylift, Valmet Automotive EV

BIOPEOPLE

Power (now IONCOR) and Viessmann Refrigeration Systems, as well as CFO at ■ Teosto r.y..

Hummingbird Heidelberg-based Hummingbird Diagnostics GmbH, a pioneer in the use of bloodbased small RNA diagnostics for the early detection and characterization of cancer, announced the appointment of Vince Lozada as its new chief executive officer. Lozada has more than 20 years of experience in life sciences and technology, including research and development, finance, and business development. Prior joining Hummingbird, Lozada was CFO ■ of Harbinger Health.

CHIEF EXECUTIVE OFFICER

Astoriom CHIEF EXECUTIVE OFFICER The Roch-

dale-based Astoriom has appointed Will Edwards as its new chief executive officer. He succeeds Lori A. Ball, who is taking up a position on the Astoriom board. Edwards is set to initiate the next phase of growth for the company. Astoriom has Will Edwards been in business for more than 30 years and focuses on sample management solutions for research and industry, such as stable storage and sample recovery in emergencies.

Edwards brings broad international leadership experience in storage, logistics and technology to the role. Most recently, he was CEO of Spectrum Storage Group. Prior to that, he worked for Google and Bain Lori A. Ball ■ & Co.

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INDEX / PREVIEW

3P Biopharmaceuticals S.L. (ES). . . . . . . . 39 4P-Pharma (F). . . . . . . . . . . . . . . . . . . . . . 21 A4F Algae for future (PT) . . . . . . . . . . . . . 49 AbbVie Inc. (USA) . . . . . . . . . . . . . . . . . . . 6 AC Immune SA (CH). . . . . . . . . . . . . . . . . . 9 Adcytherix (F). . . . . . . . . . . . . . . . . . . . . . 11 Aerska (IRL) . . . . . . . . . . . . . . . . . . . . . 8, 12 AgomAb Therapeutics (B). . . . . . . . . . . . . . 8 AiCuris GmbH & Co KG (DE). . . . . . . . . . . 9 Alfasigma S.p.A. (IT). . . . . . . . . . . . . . . . . . 9 Angelini Pharma (IT). . . . . . . . . . . . . . . . . . 9 AQYLA BioVentures (B) . . . . . . . . . . . . . . 20 Araris Biotech AG (CH). . . . . . . . . . . . . . . . 8 arGEN-X B.V. (NL) . . . . . . . . . . . . . . . . . . . 9 Astoriom (UK). . . . . . . . . . . . . . . . . . . . . . 65 Bavarian Nordic A/S (DK). . . . . . . . . . . . . . 9 Beactica Therapeutics (SE) . . . . . . . . . . . . . 8 BIO Deutschland e.V. (DE). . . . . . . . . 43, 63 BioArctic Neuroscience AB (SE). . . . . . . . . 8 Boehmert & Boehmert (DE) . . . . . . . . 46, 47 Boehringer Ingelheim (DE). . . . . . . . . . . . . 8 CDMO LIVE. . . . . . . . . . . . . . . . . . . . . . . 47 Celmatix (USA). . . . . . . . . . . . . . . . . . . . . 32 CubaseBio (SE). . . . . . . . . . . . . . . . . . . . . . 8 Cube Biotech GmbH (DE) . . . . . . . . . . . . 55 Curve Therapeutics (UK). . . . . . . . . . . 26, 28 Cytiva (USA). . . . . . . . . . . . . . . . . . . . . . . 20 CZ Vaccines, S.A.U. (ES). . . . . . . . . . . . . CP4 Daiichi Sankyo Europe GmbH (DE) . . . . . 64 Dark Blue Therapeutics (UK). . . . . . . . . . . . 6 DISCO Pharmaceuticals (DE). . . . . . . . 6, 12

Coming up in the Summer edition Q2 2026 PREVIEW The next issue of

European Biotechnology Magazine, published on 4 June 2026, will once again explore the trends, technologies, and business dynamics shaping Europe’s biotech industry.

This Summer edition will spotlight three special topics with strong commercial and editorial relevance: Drug Delivery, RNA Technologies, and a Country / Region Special dedicated to showcasing the strengths of one of Europe’s most dynamic biotech hubs.

Alongside these special topics, the issue will also feature coverage of start-

European Biotechnology | Spring Edition | Vol. 25 | 2026

Draig Therapeutics Ltd (UK). . . . . . . . . . . 11 EBD Group (CH), BIO-Europe Spring. . . . 51 Enodia Therapeutics (F). . . . . . . . . . . . . . . . 6 Eppendorf AG (DE). . . . . . . . . . . . . . . . . . 13 ethris GmbH (DE). . . . . . . . . . . . . . . . . . . . 9 eXmoor Pharma (UK). . . . . . . . . . . . . . . . 65 FGK Clinical Research GmbH (DE). . . . . . 25 Flagship Pioneering (USA) . . . . . . . . . 20, 21 Forbion Capital Partners (NL) . . . . . . . . . . . 9 Forendo Pharma Oy (FIN). . . . . . . . . . . . . 33 Fortaco Group (FIN). . . . . . . . . . . . . . . . . 65 Freya Biosciences (DK). . . . . . . . . . . . . . . 33 Genfit SA (F). . . . . . . . . . . . . . . . . . . . . . . . 8 Genmab A/S (DK). . . . . . . . . . . . . . . . . . . . 6 Gesynta Pharma AB (SE). . . . . . . . . . . . . . 33 GIMV (B) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Grafiti GmbH (DE). . . . . . . . . . . . . . . . . . 27 H&B Real Estate AG (CH). . . . . . . . . . 23, 45 Hummingbird Diagnostics GmbH (DE). . . 65 IDT Biologika GmbH (DE) . . . . . . . . . . . . . 9 Igyxos (F) . . . . . . . . . . . . . . . . . . . . . . 31, 32 IO Biotech (DK). . . . . . . . . . . . . . . . . . . . . 6 Isomorphic Labs (UK). . . . . . . . . . . . . . . . 10 Johnson & Johnson (USA). . . . . . . . . . . . . . 9 JPB Biologics (PL). . . . . . . . . . . . . . . . . . . . 6 Kahimmune Therapeutics (F). . . . . . . . . . . . 8 Lario Therapeutics (UK) . . . . . . . . . . . . . . . 9 MemoTherapeutics AG (CH). . . . . . . . . . . . 8 Merck & Co. (USA). . . . . . . . . . . . . . . . . . 26 Merck KGaA (DE). . . . . . . . . . . . . . . . . . . 64 Messe Berlin, bio:cap 2026 (DE). . . . . . . . 15

ups, an in-depth interview, analysis of emerging technologies, a deep dive into key industry developments, insights on intellectual property and drug development, and profiles of notable people in biotech.

For companies and organisations looking to position themselves in front of a pan-European audience of biotech leaders, innovators, investors, and policy stakeholders, this issue offers a strong platform for visibility and thought leadership.

The booking deadline for advertisements is 21 May 2026.

For the Country / Region Special, we are also inviting regional stakeholders interested in putting their biotech ecosystem in the spotlight to get in touch and help shape this feature.

To book your advertising space or discuss partnership opportunities, contact us now!

Molecular Partners AG (CH). . . . . . . . . . . 25 NanoPhoria (IT) . . . . . . . . . . . . . . . . . . . . 12 New England Biolabs GmbH (DE) . . . . . . 57 Newron Pharmaceuticals S.p.A. (IT). . . . . . 8 Novartis AG (CH). . . . . . . . . . . . . . . . . . . 64 Novo Nordisk Foundation (DK) . . . . . . . . . 6 Novotech (CN). . . . . . . . . . . . . . . . . . . . . 65 Obseva AG (CH). . . . . . . . . . . . . . . . . . . . 32 Orbis Medicines ApS (DK). . . . . . . . . 11, 26 Oxolife (ES) . . . . . . . . . . . . . . . . . . . . . . . 32 Phagos (F). . . . . . . . . . . . . . . . . . . . . . . . . 14 PharmaLex GmbH (DE) . . . . . . . . . . . 40, 41 PIERIS AG (DE). . . . . . . . . . . . . . . . . . . . . 25 Reed Exhibitions, Chemspec Europe (UK).29, 62 Rentschler Biopharma SE (DE) . . . . . . 35, 64 ReproNovo (USA). . . . . . . . . . . . . . . . . . . 32 Rezon Bio (PL). . . . . . . . . . . . . . . . . . . . . 37 Sanofi SA (F) . . . . . . . . . . . . . . . . . . . . 9, 64 Seamless Therapeutics (DE). . . . . . . . . . 6, 14 Servier (F). . . . . . . . . . . . . . . . . . . . 6, 16, 17 Shimadzu Europa GmbH (DE) . . . . . . . . CP2 Sitryx (UK) . . . . . . . . . . . . . . . . . . . . . . . . . 9 SLAS (USA). . . . . . . . . . . . . . . . . . . . . . . . 58 Sofinnova Partners (F). . . . . . . . . . . . . . . . 22 Stadt Leipzig, Leipzig for Life Changers (DE).7 Starlight Therapeutics (USA). . . . . . . . . . . 21 Swiss Biotech Association (CH). . . . . . . . CP3 SynaptixBio Ltd. (UK). . . . . . . . . . . . . . . . 42 Taylor Wessing Partnerschaftsges. (DE).18, 19 TECregen (CH). . . . . . . . . . . . . . . . . . . 6, 65 Vandria SA (CH). . . . . . . . . . . . . . . . . . . . 14

Oliver Schnell +49-(0)30-264921-45 oliver.schnell@ knowb.io

Andreas Macht +49-(0)30-264921-54 andreas.macht@ knowb.io

Christian Böhm +49-(0)30-264921-49 christian.boehm@ knowb.io

Pictures: © Knowbio GmbH

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© Swiss Biotech Association

SWISS BIOTECH DAY 2026

May 4–5, 2026 Congress Center Basel

What you can expect: › Welcome reception on May 3 › Meet over 3,000 senior experts from the life science industry › More than 130 exhibitors and the Global Village with international delegations from all over the world › Innovative biotech start-ups and medium-sized biotech companies › Thematic company pitching sessions and panel discussions › Swiss Biotech Success Stories Awards › Swiss Biotech Report 2026 › Pre-scheduled one-on-one partnering meetings › General Assembly of the Swiss Biotech Association

Host & event manager:

Logistics & marketing partner:

Sign in on our website at swissbiotechday.ch and stay updated about any news.

Full-service biologics CDMO From clinical material to commercial manufacturing LIVE AND INACTIVATED BACTERIAL AND VIRAL BIOLOGICAL PRODUCTS UP TO BSL 2 ASEPTIC FILLING AND LYOPHILIZATION

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