Clinical strategy at BIO‑Europe 2026
Nov 9–11, 2026 Cologne, Germany ~5.8k attendees Website
30 organizations at BIO-Europe 2026 present work in clinical strategy: 19 service providers and 11 drug developers. Between them they bring 43 presentations to the program. Most represented: Bayer (7 on the program), Miltenyi Biomedicine (3 on the program), Graythan Regulatory Services (2 on the program). 9 of them have their own page in this guide. As of Sep 29, 2026.
Format
Top represented
Showing 1–15 of 30 organizations
| Organization | BIO-Europe 2026 Attendance |
|---|---|
Bayer Leverkusen, Germany | ◆Platinum Sponsor |
Life sciences company with pharmaceuticals, consumer health and crop science divisions. | Talk Tue Nov 10 09:00–09:30 An Outlook into the Year 2050: Navigating the Future of Efficiency and Innovation How AI, global expansion and patient community outreach may reshape the way clinical trials are run, and what to change now to prepare. Panel Tue Nov 10 15:00–15:25 Inside the Incubator: What It Really Takes to Build a Biotech Company Today What incubators backed by big drug companies look for in young biotechs, and how they help founders with money, advice and partners. Panel Tue Nov 10 17:00–17:45 Resilient by Design: Reinventing Biopharma Alliances in a Fragmenting World How drug companies are reshaping research and manufacturing partnerships to stay reliable as political tensions and supply chain risks divide the world. Business of BiotechBiomanufacturing Strategy Panel Tue Nov 10 16:30–16:55 The Role of Innovation in Biopharma Growth How new ideas and technologies drive growth for drug companies, and how to keep innovating while scaling up, with real examples. Panel Wed Nov 11 10:00–10:45 AI Regulations: Driving Innovation While Navigating Compliance What rules cover AI in drug development, where European and US regulators agree, and how rules could help rather than hinder innovation. Panel Wed Nov 11 09:00–10:00 Collaborative Innovation in CDMO Partnerships How drug companies and contract manufacturers develop new therapies together, with examples of what makes these partnerships work and where they struggle. |
Miltenyi Biomedicine Bergisch Gladbach, Germany | |
Clinical-stage company of the Miltenyi Group developing CAR-T and other cell therapies for cancer and autoimmune disease. | Panel Tue Nov 10 10:00–10:45 Accelerating Access to Innovative Therapies for European Patients Through Integrated Decision-Making How approval, benefit reviews and pricing decisions could run side by side instead of one after another, so European patients get new medicines sooner. Panel Tue Nov 10 09:30–09:55 From Clinical Success to Commercial Readiness: Strategic Lessons in Bringing Advanced Therapies to Patients Lessons from preparing cell and gene therapies for launch by planning manufacturing, approval and reimbursement alongside the clinical trials. Talk Wed Nov 11 09:30–09:55 Bridging Therapeutic Areas: Navigating the Oncology–Autoimmune Convergence in Cellular Therapies What changes when cell therapies first developed for cancer move into autoimmune disease, from acceptable safety risks and trial endpoints to manufacturing. |
Regulatory consultancy advising drug developers on regulatory and commercialization pathways, including gene therapy applications. | Panel Mon Nov 9 14:00–14:45 Community Conversations – Session 1 Attendees join small-group lunch tables on a topic of their choice, from regulatory strategy and global launches to hiring talent and managing partnerships. Business of BiotechRegulatory Strategy Panel Mon Nov 9 15:00–15:45 Community Conversations – Session 2 A second round of the same small-group lunch tables, letting attendees switch to another topic such as regulatory strategy, launches or partnerships. Business of BiotechRegulatory Strategy Panel Tue Nov 10 13:00–13:55 Unlocking APACs Clinical Trials Potential: Navigating Regulatory Pathways, Bridging Strategies and Market Access Across the Region How to run clinical trials and win approval in Japan, Korea, Taiwan and Southeast Asia, and when studies in local patients pay off. |
A Atrogi Stockholm, Sweden | |
Develops oral small molecules for type 2 diabetes and obesity that increase glucose uptake in skeletal muscle. | Panel Tue Nov 10 16:00–16:45 AI and Innovation in Clinical Trials: Transforming Operations and Accelerating Development How AI can speed clinical trials, from drafting trial plans and finding patients to computer-simulated patients that cut how many real ones are needed. Panel Tue Nov 10 10:00–10:45 Cardiometabolic innovations beyond GLP-1 – Where are we now? Which drug approaches beyond GLP-1 medicines are drawing attention for obesity, diabetes and heart disease risk, and where money and partnerships are going. |
Biogen Cambridge, Massachusetts | |
Develops and markets therapies for neurological and neurodegenerative diseases, including multiple sclerosis and Alzheimer's disease. | Panel Tue Nov 10 16:00–16:45 AI and Innovation in Clinical Trials: Transforming Operations and Accelerating Development How AI can speed clinical trials, from drafting trial plans and finding patients to computer-simulated patients that cut how many real ones are needed. Panel Tue Nov 10 15:00–15:45 Mastering the Shifting Regulatory Landscape: Leveraging the Biotech Act for Innovation and Global Success How the EU Biotech Act shapes cell and gene therapies, and how Europe compares with UK and US programmes for rare and personalised treatments. |
CT Cellula Therapeutics Epalinges, Switzerland | |
Swiss cell therapy biotech spun out of the University of Geneva. | Panel Wed Nov 11 10:30–10:55 Building a Clinical Strategy for First-in-Class Therapeutics How bold phase 3 trial designs, such as adaptive trials that change as data arrive, can help a first-of-its-kind rare disease drug succeed. Panel Wed Nov 11 11:00–11:45 Mission-Driven Investments: Balancing Capital and Clinical Impact Funding barriers that hold back clinical trials, ways to cut their costs, and investments that weigh patient benefit alongside financial return. |
Consultancy advising pharma, medtech and digital health companies on China-Europe policy, regulation, market access and expansion. | Talk Tue Nov 10 09:30–09:45 Before the Deal: What Western Buyers Must Resolve About China-Origin Evidence and Policy Risk What Western buyers should check before buying rights to a China-developed drug, from whether its trial data satisfy European regulators to political risk. Panel Tue Nov 10 09:45–10:45 China’s Clinical Revolution: From Regional Player to Global Innovation Engine Why global drug companies license more drugs from Chinese biotechs, and how China's fast trials and changing rules can speed worldwide development. |
◆Platinum Sponsor | |
AI company offering AI-powered clinical development services and software, from protocol design and data management to regulatory documents. | Talk Mon Nov 9 09:00–10:00 Doctor-to-Doctor: A PI-Led Pathway into Japan Using AI, DCT, and Registration-Directed Investigator-Initiated Trials to Reach Japanese Patients Faster How trials led by the right Japanese doctor, rather than a contract research company, can take a drug toward approval in Japan. Clinical StrategyRegulatory Strategy |
Parexel Durham, NC | ◆Platinum Sponsor |
Clinical research organization providing clinical development, regulatory consulting and market access services to biopharmaceutical companies. | Panel Tue Nov 10 14:00–14:25 Navigating the Evolving Regulatory Landscape: Strategies for Clinical Success in an Era of Transformation How rare disease drugs can win approval with few patients, how FDA leadership changes shift priorities, and how real-world data can strengthen applications. |
AB Agilex Biolabs Adelaide, Australia | |
Australian bioanalytical laboratory providing regulated bioanalysis, toxicology and immunology testing for clinical trials. | Panel Tue Nov 10 14:30–15:00 Accelerating First-in-Human: Why Australia is the Fast Track to the Clinic Why Australia suits a drug's first trials in people, with supportive rules, engaged doctors and data that European and US regulators accept. |
Alithia Life Sciences Melbourne, Australia | |
Australian clinical research consultancy supporting Phase I to III trials with project and site management, monitoring and data management. | Panel Wed Nov 11 09:55–10:25 What Starts Down Under Doesn’t Stay Down Under: Australian Clinical Data as a Global Launchpad How companies use clinical data gathered in Australia to move into multinational trials, raise investment and launch products worldwide. |
AP Alkeus Pharmaceuticals Cambridge, Massachusetts | |
Develops gildeuretinol, a deuterated vitamin A, for Stargardt disease and other retinal diseases. | Panel Tue Nov 10 09:45–10:45 China’s Clinical Revolution: From Regional Player to Global Innovation Engine Why global drug companies license more drugs from Chinese biotechs, and how China's fast trials and changing rules can speed worldwide development. |
AH AOP Health Vienna, Austria | |
Austrian pharmaceutical company developing and marketing therapies for rare diseases and critical care. | Panel Tue Nov 10 14:00–14:25 Navigating the Evolving Regulatory Landscape: Strategies for Clinical Success in an Era of Transformation How rare disease drugs can win approval with few patients, how FDA leadership changes shift priorities, and how real-world data can strengthen applications. |
Avion CRO Melbourne, Australia | |
Australian contract research organization specializing in imaging for clinical trials, including central reads, dosimetry and radiopharmaceutical studies. | Panel Tue Nov 10 14:30–15:00 Accelerating First-in-Human: Why Australia is the Fast Track to the Clinic Why Australia suits a drug's first trials in people, with supportive rules, engaged doctors and data that European and US regulators accept. |
Australian not-for-profit organization providing human research ethics committee review for clinical trials and other health research. | Panel Wed Nov 11 09:55–10:25 What Starts Down Under Doesn’t Stay Down Under: Australian Clinical Data as a Global Launchpad How companies use clinical data gathered in Australia to move into multinational trials, raise investment and launch products worldwide. |
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