Archives: Speakers

Clinical studies expert and people leader with >26 years of experience in both Pharmaceutical Industry and Academic Research Organization within Operations, Medical Affairs and Global Development as well as within Headquarter and affiliate organizations. Expertise across the product lifecycle: clinical trial design, trial conduct and read-out, health authority interactions, medical affairs strategic/scientific planning and execution – Cross-functional/matrix leadership and people management responsibilities, including leadership for self-organized and empowered teams and collaboration with a number of multicultural internal and external stakeholders – Empathetic and creative mindset with passion for developing, empowering, coaching and mentoring others – always keeping the patients at the center.

Leading the scaling and development of trustworthy GenAI solutions at Roche for the benefit of worldwide patients. As Responsible AI and AI Governance Lead at Roche Digital Technologies, I have deep experience designing and operationalizing AI risk, ethics & governance frameworks in healthcare.

•Proven track record implementing Enterprise-scale Responsible AI risk controls, technical guardrails and leading high-impact initiatives in partnership with Legal, Security, Ethics and Corporate AI strategy.
•Experienced in AI risk mitigation, bias mitigation and privacy-preserving technologies, building the foundations for ethical AI innovation.
•In my previous role as GenAI Product Owner, I led the development of large-scale customer-facing solutions

Pharmaceutical professional with more than 27 years of experience in the pharmaceutical industry, having held various international leading positions with focus on clinical development and medical affairs across several therapeutic areas. More than 17 years experience in Biosimilar development including:
– Successful development up to approval several Biosimilars in the EU and US
– Presentation at EMA-, FDA- and PMDA meetings of various type
– Set up of quality management systems, including SOP implementation

Serves as Vice-Chair at the Biosimilars Medicines Group at Medicines for Europe

Holds a Ph.D. in Biochemistry, a postgraduate Diploma in Pharmaceutical Medicine, and a Masters in Project Management from the George Washington University.

After 15 years in the pharmaceutical and medical device industry, Ivo Schauwecker continued his career in clinical and human research for another 13 years at the AO Foundation. Since 2024, he has been working at ETH Zurich, where he has led the Research Ethics Group since 2026. In this role, he has broadened his expertise beyond human research to encompass research ethics more generally.

During his time at the AO Foundation, Ivo Schauwecker played a key role in developing the internationally recognized AO PEER clinical research education program. He taught in numerous countries and supported the establishment of local faculty structures. He continues to contribute to clinical research education as a consultant for the AO Alliance.

Alongside his work at ETH Zurich, Ivo Schauwecker is deeply committed to volunteer engagement. As President of EUPATI Switzerland, the national branch of the European Patient Academy, he advocates for the meaningful and equitable involvement of patients in all phases of research and development of healthcare solutions.

He also serves as a patient partner on the Positive Life Advisory Board of the AIDS Federation Switzerland, contributing his perspective to support patient-centered initiatives.

My career began at the patient’s bedside — where science meets humanity and every decision carries real consequence. Then came the most profound life lesson of all: becoming the patient myself. That experience grounded me — both as a provider and a receiver of care — and continues to shape everything I do. Every diagnosis carries a story, every therapy holds a promise, and every decision can change a life.

My passion lies in rare diseases, where patients often wait the longest for answers, and where scientific excellence and empathy must go hand in hand. I’ve had the privilege of collaborating with brilliant minds across the globe — physicians, researchers, patients, and policymakers — and I’ve seen firsthand that true progress happens when we connect ideas across borders, disciplines, and perspectives.

My experience in medical affairs, clinical development, education, patient partnership, product management, operations, and commercial strategy, was built by complex launches across geographies, challenges in evidence generation and nurturing cross-functional alliances to strengthen and advance both medical understanding and patient access to appropriate care.

My international mindset was developed from living and working in seven countries across three continents. I thrive in diverse, matrix environments where creativity, compassion, and collaboration drive performance. I’m energized by people, inspired by purpose, and committed to advancing patient care through thoughtful leadership, integrity, and innovation.

My mission is simple yet profound: to bridge patient perspectives, clinical insights, and corporate strategy to accelerate better solutions for patients. Every project, product, and partnership is an opportunity to improve a life — and breakthroughs mean nothing unless it reaches the people who need it most. To me, leadership in rare diseases is not a title, but a responsibility — to inspire, to connect, and to act with purpose.

I am an enterprise data, AI and digital transformation leader in pharma R&D, currently heading Data & Analytics in Clinical Operations at Novartis, with a focus on strengthening decision quality at scale by integrating trusted data, AI-enabled capabilities and human judgment.

With over 20 years of experience at the intersection of science, technology and business, I have led global teams and enterprise programs across research, clinical development, informatics and finance. My work focuses on translating complex data, digital and AI opportunities into scalable capabilities, trusted decisions and measurable business impact.

Across Roche and Novartis, I have built and scaled AI-driven and analytics enabled capabilities supporting critical decisions across the drug development lifecycle, including study planning, protocol feasibility and design, predictive site selection, competitive intelligence and benchmarking, performance modelling and simulation, operational risk management and intelligent summarization of clinical content. These capabilities have improved decision speed, consistency, resource optimization and portfolio execution across therapeutic areas.

I bring a systems perspective to enterprise transformation, combining pharma R&D domain knowledge, technology depth, data and AI strategy, product thinking, governance and change leadership. My leadership focus is on building future ready teams and operating models that enable organizations to move from experimentation to trusted, adopted and value-generating capabilities at scale.

Maria Koutsopoulou is heading Global Development Operations (GDO) within the healthcare business of Merck KGaA, Darmstadt, Germany. In this role, Maria leads and manages all operations related to the conduct of Merck KGaA/EMD Serono clinical study portfolio – from Phase I to Phase IV studies, including investigator-sponsored studies (ISSs), in all therapeutic areas. Maria’s remit also includes bringing highly innovative, patient-centric operational designs and approaches to the development programs while overseeing operational and clinical data flow as well as utilizing technology and digital innovations to accelerate and simplify studies across the portfolio.

Maria has more than 25 years of global clinical development experience in both the CRO and pharma industry, from early development to post-launch. She has a keen focus on accelerating drug development, elevating the R&D efficiency to the next level and she brings an entrepreneurial and innovative spirit to serve patients in need. In previous roles, she successfully led various clinical operations functions at the local, regional, and global levels. Maria comes with a wide range of international experience after serving in leadership roles in China, the U.S., and Europe. Maria joined Merck KGaA, Darmstadt, Germany in 2007 and was most recently Head of Clinical Trial Execution. Maria received her undergraduate degree in Biomedical Sciences from the University of Applied Sciences, in Athens Greece, and her degree in Applied Languages & International Relations from the University of Strasbourg, France.

Physician Scientist with Big-Pharma & Biotech Drug Development expertise in Immunology/IBD/Cell Depletion/CAR-T/TCE/Derm/T2-Inflammation/Respiratory/Fibrosis/Renal. Advanced multiple assets from pre-clinic into clinic & from Ph1 into Ph2/3.

CMO of GRANITE-BIO: Clinical-Stage I&I Biotech developing novel Immune-Cell Depletion antibodies. FIC Innate/Myeloid immune reset (CCR2-monocyte depleting mAb Minokitug). Biomarker-guided adaptive IBD Monolith trial. NOVARTIS Option-to-Acquire deal. www.granitebio.com

Former CMO of QUELL Therapeutics: CAR-T/Treg Therapies for Autoimmune Diseases (Liver, Kidney, Tx, T1D, IBD). AstraZeneca partnership deal. www.quell-tx.com

Former Immunology/Translational Medicine Leadership roles at Roche & Novartis. Involved in various Global Drug Development programs (Ph1/2/3: B-cell depleters, ianalumab, secukinumab, iptacopan, canakinumab, NLRP3, remibrutinib, tocilizumab, JAKi/filgotinib)

MERCK Immunology advisory board member

AI-based Drug Development project RN.AI with Fabian Theis (Helmholtz)

Tina has over ten years of experience in pharmaceutical market intelligence, three years of experience in drug discovery, and a proven track record of disease and competitive analysis. Prior to her roles at GlobalData, Tina was an Engagement Manager with consulting firm Lifescience Dynamics, covering CI deep-dive and monitoring projects, as well as MR and MA projects. Prior to joining Lifescience Dynamics, Tina was the Director for Immunology at GlobalData, where she spent over four years managing the production of syndicated reports, product forecasts, and analyses in autoimmune diseases. Prior to that role, Tina served as a Senior Analyst for the Immunology therapy team. Prior to joining GlobalData, Tina was an analyst at Datamonitor, covering the Immunology-Inflammation portfolio, where she authored numerous in-depth analyses of products and companies, bespoke client deliverables, and produced sales- and patient-based indication-specific forecasts. Before joining Datamonitor, Tina worked as a research scientist within GSK’s drug discovery medicinal chemistry unit. Prior to that role, she worked within the early drug development unit at Evotec, a drug-discovery alliance and development partnership company. Tina holds a Master’s degree in Medicinal Chemistry from University College London.