He studied Technical Engineering in Computing Management at the University of Burgos. He developed most of his professional career in the R&D automotive field until 2009. He was diagnosed Hodgkin's Lymphoma in 2008. Due to this circumstance, he decided to become involved in patient advocacy, first as a volunteer in his home town, and later on moving to Madrid to start working on a profesional full time basis in 2009. Between 2009 and 2013 he worked at the Spanish Group for Lymphoma, Myeloma and Leukaemia Association and for the Spanish Group for Cancer Patients, first as Technical Manager and later as International Affairs Manager. In 2014, he joined the executive office of Myeloma Patients Europe as Project, a European (MPE) umbrella federation of multiple myeloma patients, as Project Manager. During the next years, the organisations undergoes a sustainable growth in terms of governance and accountability. As part of his duties at MPE his main focus areas were patient involvement in clinical research, access, European health policy and capacity building among member organisations. In September 2018, he started providing consultancy to the European group of lung cancer patients, Lung Cancer Europe (LuCE). His main role is to develop a set of projects aiming to improve access to treatment and care for lung cancer patients, raise awareness about the disease and improve the skills of the European member groups of LuCE to help them tailor initiatives to improve support, advocacy and outcomes in their own countries. In April 2023, Alfonso was promoted to a new role as Policy Officer in Lung Cancer Europe (LuCE). He is also the Director of Patient Engagement at Patvocates. During all his professional career, he has been involved in several multistakeholder workgroups and advisory boards, both at a national and international level. He is currently based in Madrid.

With over 25 years of experience in clinical research and pharmaceutical development, Ivet Aldabó has a robust background in managing international clinical trials across various therapeutic areas. Currently, she oversees external customer strategies for sites and patients in Clinical Development & Operations at Bayer, focusing on innovative approaches to enhance partnerships and collaboration. Previously, Ivet served as Head of Clinical Project Management for Women's Health indications, where she led high-performance teams and ensured compliance and quality in critical studies. Ivet began her career as a clinical and research study nurse and investigator at Hospital Clinic in Barcelona, providing her with a comprehensive understanding of clinical trial operations, site challenges, and the importance of site culture on site performance.

Dr Alp has more than 30 years of clinical research experience as an academic cardiologist, clinical trialist, and commercial drug development expert. Before joining Clinical ink, he was Senior Vice President and Head of Cardiometabolic Research at Medpace, a global clinical research organization. Previously, Dr Alp was Vice President and Global Head of Cardiovascular Drug Development at ICON. He also simultaneously held appointments as a Consultant Interventional Cardiologist at the John Radcliffe Hospital, Oxford and a senior academic appointment in Cardiovascular Medicine at Oxford University. Dr Alp trained in medicine at London University and Oxford University, completed a PhD in Immunology at Cambridge University, with a further post-doctoral DM degree in Cardiology at Oxford University. He has also authored more than 70 peer-reviewed publications and books.

Moe Alsumidaie, currently the Chief Editor at The Clinical Trial Vanguard, is dedicated to providing the clinical research community with the latest and most detailed information on clinical trials. His extensive experience includes leading roles in enhancing clinical trial processes through innovative technology and strategic management. As the Head of Research at CliniBiz, he has significantly improved the efficiency and affordability of clinical trials using automation and AI, and at Annex Clinical, Moe spearheads the development of advanced data integration and visualization solutions. His career also includes impactful tenures at Applied Clinical Trials Magazine as an Editorial Advisory Board Member, as a guest lecturer at Rutgers University, and at leading organizations such as Stanford, Mt. Sinai, Abbott, Roche and Genentech, where he has been instrumental in optimizing clinical operations and implementing novel procedures in clinical trials quality control.

Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment. Nadir is a member of the Institute of Innovation Through Health Data, and various cross pharma leadership boards. He led an EIT Health consortium project, EHR2EDC aiming at connecting healthcare and research and involved in several European IHI/IMI Consortia. Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry

Mette Andersen, General Manager, Data, Analytics & Insights Solutions, brings experience from previous roles at Merative and IBM and holds a Harvard Business School. She has a robust skill set that includes Research, Social Entrepreneurship, Chemistry, Nanotechnology, Physics and more.

Diana Andrade is the Founder & Managing Director of RD Privacy, bringing over 12 years of expertise in privacy and data protection within the pharmaceutical and life sciences sectors. As a European-qualified privacy attorney and Data Protection Officer (DPO), she specializes in guiding small biopharma companies through GDPR compliance and ensuring the protection of sensitive data throughout clinical research. Diana's tailored approach helps streamline complex regulations, fostering a secure environment for innovation in the industry.

Artem Andrianov, PhD, MBA is the CEO & Founder of Cyntegrity, the company behind the GxP-validated, Microsoft Healthcare AI-certified MyRBQM Portal. A mathematician turned life-science entrepreneur, he has spent 15 years turning raw clinical data into on-demand risk intelligence for global Phase I–IV programs. Artem advises sponsors and CROs on inspection-ready RBQM strategies and is a regular SCOPE and DIA podium presence.

A patient recruitment and engagement specialist with a decade of experience in clinical trial communications, Emily believes that genuine collaboration with Sponsors and their stakeholders is the cornerstone of successful trial recruitment. With a focus on engagement strategies that prioritize health equity and inclusivity, Emily works closely with patients, caregivers, physicians and subject matter experts to co-create and deliver impactful solutions that support clinical accessibility for all.

With nearly 20 years of experience in data and technology across multiple industries, Chris has spent the last decade in the pharmaceutical sector, working in both biopharma and CRO environments. With a strong background in data analytics, he has always positioned himself as a conduit between unlocking the potential of new technologies and delivering real business impact. Passionate about the power of data and AI to transform clinical trials, he now leads innovation efforts at Thermo Fisher Scientific to reimagine trial oversight, accelerate execution, and ultimately improve outcomes for patients.

Petko is based in Sofia, Bulgaria, and brings over 15 years of experience in the clinical research industry. He currently leads the Clinical Functional Service Provider (FSP) division at Fortrea, where he is responsible for driving strategic initiatives and delivering tailored solutions that align with client needs. Petko began his research career in academia, working on non-interventional studies as a research assistant and coordinator. Since transitioning to the industry, he has held a series of progressively senior leadership roles across clinical operations, project management, strategic partnership management and FSP. He is passionate about building and successfully executing highly customized models designed around customers’ needs. He holds a Bachelor’s degree in Physiotherapy from the National Sports Academy in Sofia, Bulgaria, and a Master’s degree in Research in Biomedical Sciences from the University of Montreal in Canada.

Professor Dr. Dorothee B. Bartels is a trained epidemiologist (Harvard School of Public Health, PhD and Habilitation Hannover Medical School), senior thought leader in (pharmaco)epidemiology, Real World Data (RWD) strategies, and evidence generation, both, based on established methods and (gen)AI. After several senior global leadership roles in the pharmaceutical industry, she moved into the innovative-digital space, i.e. in the innovation hub of Boehringer Ingelheim as Chief Digital Science Officer, to X, Moonshot (Alphabet) as Clinical and Real World Strategy Lead, and to Aetion (a software company analyzing claims/EHR) as Chief Digital Officer. Dorothee is founder of HeDa (HealthData)-Advisors, providing strategic and execution advice for real world data insights and evidence generation. She holds several board positions and is teaching on a regular basis advanced pharmacoepidemiology in academia.

Andrea Bastek, Ph.D., is VP of Market Strategy at Florence Healthcare. Her team's mission is to identify the biggest challenges in clinical trial operations and harness technology to solve them. Prior to Florence, Andrea spent 15 years working in clinical trial operations in the cardiac medical device industry. She holds a Ph.D. in Bioengineering from Georgia Tech as well as a BS and MS in Biomedical Engineering from Tulane University.

Liz Beatty is the Co-founder and Chief Strategy at Inato, the global technology company on a mission to bring clinical research to all patients, regardless of where they live. Liz is focused on advancing Inato’s corporate strategy, including efforts to promote diverse patient representation in clinical research as well as developing partnerships and driving growth globally. Previously, Liz headed digital clinical trials at Bristol-Myers Squibb, where she held various roles across clinical operations including site management, protocol management, recruitment and retention, and most recently digital innovation. She began her career as a clinical research coordinator at the Yale Multiple Sclerosis Research Center, bringing a unique site and sponsor perspective.

Meri is the co-founder of Lindus Health. We run radically faster, more reliable clinical trials for life science pioneers. Meri was previously a health and biotech VC investor, and serial clinical trial participant, where he saw how clinical trial outcomes could be improved for both sponsors and patients.

Łukasz received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially, he was involved in preclinical development programs at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on, Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In the study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country, and site levels.

Maria Lizza Bowen brings over 3 decades of pharmaceutical industry experience to her current role as Head of Protocol Excellence, Clinical Science at Daiichi Sankyo. She has developed deep expertise across the drug development spectrum, from preclinical laboratory studies through quality manufacturing and oncology clinical research. Throughout her career, Maria has led global Phase I through Phase III clinical trials and programs, contributing to successful NDA submissions and FDA approvals for targeted therapies including Pomalyst®, Turalio®, and ENHERTU®. At Daiichi Sankyo, she drives strategic protocol innovation within Clinical Science, advancing protocol optimization and DocGenAI integration initiatives. Previously, she held senior positions at Bristol Myers Squibb, Novartis Pharmaceuticals, and Sanofi Pasteur, with particular expertise in oncology and hematology clinical research. Maria is also a published author of "Reflect: A Perspective on Understanding Your Reality and Becoming Unstuck" and continues to write on topics spanning pharmaceutical industry insights and professional development. Core Expertise: • Protocol Development and Innovation • Clinical Science Leadership • Oncology Clinical Research • Strategic Drug Development

Xavier Briand obtained his Master's degree in analytical chemistry from the University of Rennes, France, in 2000. After spending a year in a biotech company, he worked as a research scientist at Novartis for eight years, focusing on physicochemical profiling for drug development. In 2009, he transitioned to the role of Information Scientist in the Biobanking and Sample Management group, acquiring more responsibilities and now operating on a global level. His roles included supporting researchers in identifying human samples and managing internal biorepositories. In 2014, he led the implementation of a sample tracking system for the research division. In 2018, he established a long-term sample storage outsourcing model. Thanks to his expertise, he delivered seminars at universities. Currently, as Associate Director, he co-leads the deployment of a global sample inventory platform for all Novartis clinical samples, focusing on improving the accuracy of sample metadata collection at the source. He is interested in new technologies in general, has developed a blockchain-based informed consent tracking platform through a consortium, and is currently exploring AI opportunities. He is also part of various biospecimen consortiums to enhance global practices.

Nicholas Brooke is the founder of The Synergist. For more than a decade, he has been the driving force behind its mission to build the conditions for collective action, shaping pioneering initiatives in patient engagement, precision medicine, investor engagement, women’s health, clinical trial data network, and the Patient Engagement Professionals Society. He served as the founding Executive Director of Patient Focused Medicines Development (PFMD) from 2015 to 2025, establishing it as the global reference point for patient engagement. An economist by training, Nicholas brings together strategic insight, digital innovation, and coalition-building, making him a leading architect of multi-stakeholder collaboration in global health. Through The Synergist, he continues to guide a portfolio of high-impact programmes, ensuring they deliver systemic and sustainable change.

As the Head of Data Visualization and Application Development at Biogen, I am passionate about understanding user needs to maximize the benefits of data and technology. My goal is to address the complex question: "What does it mean to have the right tools?" With a background in statistics, programming, and application development for clinical trials, coupled with a Masters in Human-Computer Interaction, I am dedicated to creating solutions that enhance user experience and drive innovation.

>22 years in clinical research at various quality assurance and clinical operations roles at CROs and pharma. Recently focusing on risk-based quality management at UCB (e.g., study complexity assessments, risk-proportionate approach to study monitoring models, and risk-focused oversight of service providers). Extensive experience in managing regulatory inspections at the clinical investigator sites and sponsor. UCB's representative in EFPIA working groups for ICH E6 R3 (2020-2025) and US-EU GCP Inspection Mutual Recognition Agreement (2019).

I’m a research and clinical integration leader working at the intersection of data, science, and healthcare delivery. Currently, as Director of Clinical Integration at the Cancer Research UK Cambridge Centre, I’m focused on designing systems for the new Cambridge Cancer Research Hospital that support integrated care models, combining robust data infrastructure, clinical workflows, and translational science. I work closely with NHS teams, academic collaborators, and industry partners like GE Healthcare to deliver a precision medicine approach to cancer treatment. I'm also the Development Director the Integrated Cancer Medicine (ICM) Programme at the University of Cambridge, where I lead on embedding research directly into clinical pathways—ensuring innovations in cancer diagnostics and AI are brought from lab to bedside efficiently and ethically. With a PhD in Biophysics from the University of London, I have a technical background in molecular biology, bioinformatics, and computational biology. My early career at the Wellcome Trust Genome Campus included projects at the Sanger Institute and EMBL-EBI, focused on RNA informatics. Since joining the University of Cambridge, my teams have led data integration workstreams for multidisciplinary research programmes, including major clinical trials such as RECOVERY (COVID-19) and the UK’s first kidney cancer screening study. I’m passionate about building pipelines that support predictive and prognostic AI in cancer—from data acquisition to clinician-facing tools. I also bring experience in programme and project management (PRINCE2/Agile), and have led operational responses during critical periods, including Cambridge’s COVID-19 research coordination. Outside of work, I serve as a trustee and former board chair for third-sector organisations, including Camcycle—an award-winning active travel charity—where I contribute to strategy, governance, and stakeholder engagement.

I am dedicated to harnessing data to tackle complex challenges in the pharmaceutical sector, particularly within clinical operations to streamline drug development and enhance patient access. With a background in Data & Analytics Strategy, I specialize in solving problems and improving protocol design from an operational perspective. As an educator, I teach a modeling course at the university, mentoring aspiring data professionals. My focus is to leverage data-driven insights to optimize decision-making and contribute to more accessible treatments for patients.

As Head of Delivery for Patient Recruitment and Enablement, Antonia Cardew leads a team of Patient Recruitment Leads and specialist functions to manage and oversee the delivery of patient engagement strategies for clinical trials, including direct-to-patient outreach, site support materials and patient websites. Antonia has more than 14 years’ experience working in the medical communications and clinical trials industries, 12 of which were spent at IQVIA.

Javier Carmona is Head of Scientific Strategy at the Vall d'Hebron Institute of Oncology (VHIO) in Barcelona and Chief Scientific Officer at Cancer Core Europe, a consortium of seven leading cancer centers across Europe. Currently chaired by VHIO Director Josep Tabernero, Cancer Core Europe advances precision oncology through collaboration in translational research and early-phase clinical trials. Javier holds a PhD in cancer epigenetics and continued his training in precision oncology under the mentorship of José Baselga at Memorial Sloan Kettering Cancer Center in New York City. He later served as a Deputy Editor at Nature Medicine, where he oversaw editorial portfolios in cancer biology, clinical oncology, and biomedical applications of artificial intelligence. In addition, he is a Professor of science communication at the University of Navarra and the Autonomous University of Barcelona.

Grzegorz (Greg) Cinciala is a Sr. Director, Clinical Quality Operations Lead in Oncology. His responsibilities include management of operational quality, supplier oversight, regulatory inspections and overall risk-based quality management (RBQM) strategy. Grzegorz has 15 years of Clinical Research experience, primarily in E2E Clinical Data Management Execution, building and leading high-performing teams across many Therapeutic Areas, leading cross-functional initiatives on data-driven optimization of clinical trials execution. Grzegorz holds a Master of Science degree in medical biotechnology from the University of Medical Sciences in Poznan, Poland.

Steve Clark was diagnosed with stage 4 colorectal cancer in 2013 and has since become an active patient advocate. He is a regular speaker for audiences of patients, healthcare professionals, researchers, and industry representatives as well as volunteering with several charities including being a Campaigns Ambassador for Cancer Research UK. Steve is a patient representative to several studies and study groups and has been co-author on several papers focussed on improving patient care. In 2017 he set up www.StriveForFive.org, a not-for-profit organization with the mission to give hope to fellow patients with stage 4 cancer and to advocate for improved care for those with advanced cancer. He is a Patient Engagement Consultant for the pharmaceutical industry with Redwood Brand Curators and has worked in UK and global pharma for over 35 years in business management and global marketing. Steve is a former Chairman of the Pharmaceutical Marketing Society and was awarded Healthcare Communications Advocate by Communiqué.

Damian Colehan is a Commercial leader at H1, specializing in addressing clients' unique needs across both clinical and medical specialties. In his role, Damian serves as a key liaison between clients and both customer success and product teams, ensuring that H1’s medical and clinical suite of product offerings leverages the latest advancements in data AI and DE&I performance data to drive more diverse and effective clinical trials.

With over 30 years of working in Life Sciences Damian now focuses on helping the industry promote more equitable patient access to trials, spanning areas such as protocol optimization, site selection, and principal investigator identification. Damian holds a BA in Business Management from the University of Bradford UK.

I am a Clinical Research professional with over 20 years of experience at the site, CRO, and Sponsor levels. I have 10 years of Global Feasibility experience combined at a CRO and 2 different Sponsors. My Global Feasibility experience includes benchmarking, enrollment rate modeling, country strategy and selection, timeline planning, site identification and site selection. Prior to working in Global Feasibility, I worked in Management and Operations at a site network in Southeast USA.

With 20 years of experience and industry roles spanning across small to large CRO and Sponsor organizations, Jodi attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, she transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials. Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams. With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations. She is highly passionate about establishing internal and external cross-functional communication processes, effective issue escalation pathways and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

Building on a strong academic research background in pre-clinical molecular oncology at Oxford and MIT, I have also developed significant industry experience combining medical affairs, clinical development and trial design, health economics and health outcomes research. My industry experience spans UK and Europe, supporting pipeline, pre-launch and marketed products. I have been commended for my innovative and collaborative contributions for evidence generation to support products.

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

Leila Cupersmith, CEO of Choice ClinOps, is a global expert in oncology and rare disease clinical trial operations—from study concept through closure—with 20 years of hands-on experience. She has led 20+ trials across 30 countries—including 11 global oncology programs delivered ahead of schedule and under budget—and contributed to five blockbuster FDA approvals. Specializing in complex study rescue, M&A integration, DCTs, early and under-budget study delivery, and stakeholder alignment, Leila and her team of seasoned experts partner with small and mid-size sponsors to eliminate bottlenecks, accelerate timelines, and maximize ROI through innovative, faster, leaner, and more resilient trial delivery. Her portfolio includes multiple multimillion-dollar clinical trial rescues and M&A integration across 30 countries where she reduced delays by 30–40% and recovered millions per clinical trial in projected overspend.

Through a career in healthcare spanning 20+ years, and as current Head of Content and Strategy at Cuttsy + Cuttsy, a specialist patient engagement communications agency, Stacey has always advocated for the need to ask the questions that really matter and that help to create meaningful change. Her passion lies in identifying where and how we can do better for patients, by making patients part of the discussion.

Graduated from a doctorate in industrial pharmacy and specialized in management of clinical operations, I am working for Sanofi as global study leader. Since joining Sanofi in 2020, I have managed several Phase I and II studies in various therapeutic areas (rare diseases, rare blood disorders, I&I, respiratory diseases, etc.). Over the past three years, I have been an active member of Sanofi's Business Expertise Solution team as a Phase I expert. In this role, I contribute to process improvement to optimize activities within the department. I am now also deeply involved in the Sanofi reduced monitoring initiative and I continuously support global study leaders in their daily activities to ensure smooth and efficient study management. I am always seeking to put my skills at the service of a company that works to find therapeutic solutions for the benefit of improving the quality of everyone's life.

Danny is a former pharmacist turned software engineer and product manager, leveraging his diverse background to revolutionize healthcare through AI. At myTomorrows, he leads the development of TrialSearch AI, a peer-reviewed, generative AI tool that simplifies clinical trial discovery and access for physicians and patients. With a passion for innovation, Danny showcases how the intersection of healthcare, technology, and design can create groundbreaking solutions that positively impact lives.

Aurélie Dequelson is a strategic leader in RBQM with over 20 years of experience in global drug development. She built her expertise through a solid background in clinical trials operations and trial monitoring, in diverse pharmaceutical companies, before taking on global leadership roles in risk-based quality strategies. As Head of Risk Surveillance at Novartis, she leads the end-to-end RBQM strategy, fostering a proactive risk culture, data-driven oversight, and quality by design across trial portfolio. Passionate about meaningful innovation, she is known for her ability to drive impactful change through clarity, strategic mindset, and a strong focus on continuous improvement.

Peter has distinguished himself as an accomplished clinical operations executive leader having served as both a sponsor (Pfizer, Shire and Vertex) and as a service provider (Quintiles/IQVIA and WCG Clinical) throughout his 28+ year career. More recently Peter has been appointed as a board member of MD Group and sits on the Patient Advisory council for the Michael J. Fox Foundation for Parkinson's Research (MJFF). Peter is a resident of Paris, France and continues to promote the emphasis on investigative site relationships, patient engagement and clinical trial participation.

As Vice President of Portfolio Management at TransCelerate, Rob's current role includes oversight of a portfolio of projects that include digital transformation, pragmatic trials, and real-world data. He is a member of the Vulcan Advisory Committee. From 2018-2021, Rob was the Deputy Chief Health Officer at IBM Watson Health, where he led external collaborations to implement digital COVID Trial screening tools and leveraged his industry experience to guide software developers working on life sciences offerings. He joined IBM after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations with a global footprint that included the US, UK, Australia, and China. Rob’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept, and delivering critical data for product labeling. He also led the development of a number of late-phase oncology projects leading to successful product approvals. In 2015, Rob launched a Clinical Innovation and Digital Platforms Team at GSK where he focused on identifying, evaluating, and piloting emerging technical solutions to automate different areas of clinical trial design and implementation. Under his leadership, Rob’s team launched the first industry-sponsored Apple Research Kit Study to assess disease burden in rheumatoid arthritis patients in a real-world setting. He also led the Common Protocol Template and Digital Data Flow work streams sponsored by TransCelerate. He was also one of the team leads for the Clinical Trials Transformation Initiative (CTTI) sponsored Mobile Clinical Trials Novel Endpoints project. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

Craig Dorer-Abadia, Executive Director, Project Management, Oncology, at Worldwide Clinical Trials has first-hand experience in large, global, multi-site oncology clinical trials, Craig knows intimately the many moving parts that keep a study on track. An accomplished clinical operations specialist and project manager, he has been supporting or overseeing clinical research for more than 20 years.

Keith Dorricott is an independent consultant and Director of DMPI Ltd since 2016. He developed his process thinking whilst at Kodak Ltd and is a Lean Sigma Master Black Belt. He has worked in two large CROs leading corporate process improvement for 10 years. He provides expert training and consulting services in metrics (KPIs, KRIs, QTLs), process improvement, and root cause analysis in clinical trials. He provides leadership to the Avoca Quality Consortium on metrics across the clinical trial spectrum including RBQM, QbD, and DCT. He is a member of the Scientific Advisory Board at the Centre for Pharmaceutical Medicine Research at King's College London. Keith's passion is improving the effectiveness and efficiency of processes by working with those on the ground who are running those processes.

Dana F. Durst Executive Director, Site Activation & Regulatory Therapeutic Lead, Oncology Dana F. Durst, Executive Director, Site Activation & Regulatory Therapeutic Lead, Oncology, at Worldwide Clinical Trials has more than 16 years of clinical research experience. Her experience ranges among a broad span of therapeutic areas including oncology, gene therapy, NASH, dermatology, ophthalmology, and cardiovascular studies extending from Phase I-IV. She has overseen all aspects of startup as well as maintenance activities in a variety of countries worldwide in both early and late phase trials, and with both small, agile clients and large clients.

Maria Dutarte is the Executive Director of the European Patients’ Academy (EUPATI) since 2020. Maria has previously worked for the European AIDS Treatment Group (EATG) coordinating patient involvement in a number of training initiatives and scientific projects. She has also worked for different scientific and international organisations, e.g. French National Research Center for Scientific Research (CNRS), International AIDS Society (IAS), The Global Fund to Fight AIDS, Tuberculosis and Malaria and The International Foundation for Science (IFS). Her educational background is in International Education and Communications.

Kaspars Eiduks leads business development projects at Baltacon, where he focuses on connecting trial sponsors, CROs, and other healthcare stakeholders across Europe and Asia Pacific region. With a pharmacy degree and in-depth knowledge of the EU pharmaceutical market, he helps clients navigate regional complexities and unlock new opportunities in clinical trial sourcing and supply strategy.

Jessica Ekey leads IQVIA’s Connected Devices Strategic Solutions team, creating innovative solutions for capturing digital health technology data for global clinical trials. With deep expertise in integrating device solutions into study design, Jessica has helped shape IQVIA’s device capabilities across clinic-based, hybrid and decentralized trials in many therapeutic areas including respiratory & cardiovascular. Her leadership spans device strategy, vendor qualification, systems validation and operational delivery, with a focus on eSource capabilities. With nearly 20 years of experience in clinical research, Jessica has previously worked directly with Early Phase Sites to automate operations and transition to eSource data collection.

Marie is currently Head of Patient Engagement & Recruitment at BMS responsible for growing, developing and supporting a team to accelerate recruitment and enrollment globally. Prior to her role at BMS, she was the Global Head of Investigator & Patient Engagement at Johnson & Johnson.

Marie specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness and consent through to compliance and adherence. Marie has worked on a wide range of therapeutic areas across neonatal, pediatric, adult and geriatric studies.

Marie’s unique Commercial and Clinical insight, as well as her spirit of partnership, encourages and ensures successful collaboration. She defines what it means to be a leader in today’s rapidly changing healthcare industry. Marie has a genuine and singular passion to improve the lives of patients – a passion that motivates and energizes her colleagues and everyone with whom she interacts.

I’m Director and TA Lead for Feasibility and Portfolio Delivery in SM&M at AstraZeneca. I focus on global feasibility strategy and operational delivery across oncology studies (Lung Cancer). I’m passionate about making clinical research more efficient and impactful.

I’m an experienced clinical research professional with over 25 years of expertise in the pharmaceutical industry. A biologist by training, I began my career at Hoechst Marion Roussel as a Clinical Research Associate (CRA) before joining Sanofi in 2004 through a series of industry mergers. At Sanofi, I have held progressive leadership roles, including Local Study Manager and Regional Study Manager, demonstrating expertise in clinical operations and study management. Since 2022, I have served as an Early Development Project Leader in Oncology, guiding innovative oncology treatments through critical early development phases. For the past four years, I have been an active member of Sanofi's Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) working groups, championing the implementation of advanced monitoring strategies to enhance clinical operations.

I am Montserrat Farnos Sabate, currently Feasibility Strategist at Bayer Hispania in Sant Joan Despí, Barcelona since October 2019. My academic journey includes a pre-clinical research role at the Hospital Clinic de Barcelona's Immunology Department and a Master's degree in Clinical Trials. Over the years, I have gained extensive experience in the pharmaceutical industry. I have held various positions at Bayer Hispania, where my main focus was on strategic planning, customer-centric approaches and Feasibility. My roles included serving as a CLM Sp in Feasibility and as CLM and CRA, where I consistently aimed to align clinical trial operations with strategic goals while ensuring a strong emphasis on meeting customer needs and conducting thorough feasibility studies. I have also had the opportunity to teach Immunology at Barcelona University and work in scientific translations at INFOCIENCIA. My research interests are reflected in my numerous publications, which include pivotal studies on the accessory molecules CD5 and CD6, published in reputable journals like the Journal of Biological Chemistry and the Journal of Immunology and PNAS. These publications highlight my contributions to advancing scientific understanding in immunology and biochemistry. My expertise in data-driven feasibility assessments and clinical trial management has enabled me to make significant contributions to clinical research.

Experienced Clinical Program Lead with a strong background in clinical trial operations, vendor management, regulatory submissions (EMA/FDA), and cross-functional coordination. Proven ability to lead complex early- and late-phase oncology trials, develop core study documents, and manage stakeholders effectively. Passionate about innovation in biotech and delivering high-quality results in regulated environments.

Emma is a Director within Project Management in Trialmed’s Early Development Services group. Emma has global experience within in various roles and settings such as local and global CRO and pharma companies. Emma’s experience managing clinical trials spans across various therapeutic areas and geographical regions in multiple early development designs from first in human healthy volunteer into phase Ib patient centric recruitment through to multi country phase III trials.

Emma holds a bachelor’s degree in Sports Therapy from the University of Hertfordshire and a master’s degree in Clinical Research from the University of Cranfield.

Ashley has over 13 years of industry experience in both large CROs and Sponsor organizations, with a wealth of knowledge spanning from Clinical Operations, Quality Assurance, Project Management and Vendor Oversight. While working in these various areas within the industry she began to realize the importance of bridging the gap between sponsor and vendors and creating a 'One Team' mindset. Through her development of relationships with vendors she has been able to advocate for her employers while also empowering the vendor to bring forth their expertise to allow both teams to succeed. Ashley enjoys advancing the vendor relationships through partnership initiatives, recognition of superior work and open communication.

• 20+ years of experience focused on data management and clinical programming.

• 15+ years in various project-specific positions in Data Management, further progressing into systems specialization.

• An early adopter and advocate of EDC usage, she now focuses primarily on improving integration and efficiency within EDC systems. She is also a certified database designer. Sharon´s indication experience includes in-depth oncology, early phase escalation designs, neurology and rare disease.

Olivier Flexas is an experienced leader with 25 years of experience in the pharmaceutical industry. Currently serving as Digital Product Line Owner, Olivier has consistently emphasized digital innovation and user experience in all the projects he has led. Throughout his career, Olivier has worked in various business areas, ranging from research activities to commercial activities, including manufacturing activities. For the past 7 years, he has been dedicated to advancing clinical studies and promoting access to therapeutic solutions in development to the largest number of patients, while prioritizing diversity through solutions that accelerate recruitment or through Decentralized Clinical Trials (DCT), which use digital technologies to conduct clinical trials remotely. Additionally, Olivier recognizes artificial intelligence (AI) as a key driver of innovation, leveraging AI to enhance efficiency and outcomes in clinical research and patient care.

Joanna brings over 20 years of managerial and technical experience in clinical research industry delivering business and data transformation solutions. She has extensive experience in clinical and non-interventional risk-based quality management, innovation, and change management methodologies driving operational efficiencies. Her technical experience, background in analytics and process improvement bring critical value to technology implementation ensuring trial execution for patient safety and reliable data to answer the trial scientific questions. With her expertise and enthusiasm, Joanna supports new ways of working with clinical data, knowing that the growing scale of accumulated data requires us to establish an entirely new relationship with it.

With more than 25 years of experience in healthcare and clinical research, David brings a wealth of expertise to the field. His background spans nine years in clinical laboratory settings—both in hospital and cardiology practices—and eight years in clinical research. Over the past four years, David has specialized in eClinical sales and implementation, supporting both pharmaceutical and medical device trials. He has successfully managed and deployed over 25 studies across diverse therapeutic areas in the U.S. and global markets. David’s expertise lies in eClinical implementation and process redesign, with a focus on optimizing monitoring, safety, data management, and clinical site operations. His leadership continues to shape the future of clinical trial efficiency and innovation.

With more than 20 years of experience in life sciences and healthcare, Serena has spent the past decade at Thermo Fisher Scientific advancing digital solutions to support biopharma and biotech partners. She focuses on products that enhance collaboration, streamline engagement, and deliver greater operational and data transparency across clinical development. Building on her background in asset strategy, preclinical development, and commercialization, she brings emerging technologies—such as agentic AI—into practical solutions that align with sponsor needs and accelerate program success.

Amy is passionate about bringing together data and expertise to inform clinical trial strategy and design. Focusing on operational efficiency in trial planning, bringing the science alongside the perspectives of patients and trial sites. Amy is an established leader in data-led strategic feasibility, study start-up and patient engagement. She has led the creation and implementation of these capabilities in global pharmaceutical companies. Combined with a background in clinical trial and program management she also has extensive experience in complex global clinical trial delivery across a broad range of therapeutic areas and phases. She has been in the pharmaceutical industry for over 20 years and is currently the Head of Feasibility and Study Start-Up at Jazz Pharmaceuticals.

Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology. With a post-doctoral position at ICI in the UK. Subsequently, Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, she has amassed a 25-year career with the company- taking on roles of increasing demand and responsibility. Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall does not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies. In this capacity, Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single-center studies to global programs involving hundreds of sites and thousands of patients. Her responsibility covers the selecting, negotiation, contracting, managing, and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality, and cost. She was responsible for ensuring Clinical Development for Aclidinium bromide from an Operational point of view in COPD. Since November 2014, fully focused on DERMATOLOGY development with 3 R&D sites in Europe, the biggest in Barcelona (Sant Feliu de Llobregat), the second in Reinbek, and the most recent one acquired in Swizerland-Lugano- (Polichem). But also in close collaboration with Almirall US, a company that was acquired by Almirall back in December 2013 (AQUA Pharmaceuticals). Managing Global Clinical Trials from Phase I to Phase IV, in several therapeutical areas Respiratory, Dermatology, Migraine, Allergy, and Gastrointestinal. CRO Selection and Management. Deliverables in Clinical Trials. Metrics and Performance in Clinical Trials. Active participant in forums like PCTs, PCMG, DIA Clinical Forum, Outsourcing Clinical trials in Europe Conferences, etc.

Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

Annie Gilbert is a Global Patient and Site Engagement Lead at Boehringer Ingelheim responsible for shaping, developing, and implementing patient and site journey strategies during clinical development, to create customer value across all countries and regions. Previously Global Patient Advocacy Relations Manager at Boehringer Ingelheim and Patient Research Manager at Merck, she is an established and well published patient advocate and researcher with 30+ years’ experience in the pharmaceutical industry including more than 20 years in Patient Engagement. Other roles include Global Market Access Manager with Lundbeck A/S in Copenhagen and Public Affairs Director with Wisper Public Affairs, UK. Annie has managed numerous advocacy and patient access projects on behalf of healthcare organizations across diverse therapeutic areas, including pulmonology, rheumatology, gastroenterology, dermatology, and rare diseases.

Dr. Bernhard Glombitza has evolved through progressively increasing responsibilities in project and people management, beginning as a project leader and culminating in roles as Head of Clinical Operations for EMEA, APAC, and LATAM. He played a pivotal role in the successful launch of the Xarelto project, managing an interdisciplinary team of over 500 global employees, which significantly contributed to its market approval and commercial success. Transitioning into Clinical Operations, he leads large organizations with up to 1000 FTEs across 40 countries, achieving a 25% increase in productivity through innovative resource management and organizational restructuring. Currently, he is introducing the Dynamic Shared Ownership model in Clinical Operations, empowering decentralized decision-making and optimizing talent allocation to drive impactful results.

Jess received her PhD in Biochemistry from the University of Birmingham and after a number of roles within commercial and non commercial clinical research over a 10 year period, joined Roche in 2017. Jess has been part of the Global Quality and Compliance organisation since joining Roche with roles in CAPA management, Process Excellence and Service Provider Management. As a passionate member of the Roche RBQM CoE, she is leading and delivering an enterprise E2E RBQM approach with a focus on Immunology as a disease area.

Zee Zee Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market & ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

With over 13 years of experience in the pharmaceutical industry, my experience spans across the pharma value chain (RDC continuum) right from trial recruitment optimization, pre-launch planning, market potential assessment to launch readiness, operational excellence and business performance analytics. Extensive experience in driving diverse teams through change and delivering high-impact results. Currently I am responsible for driving data-driven discussions with key senior stakeholders to optimize and streamline global clinical operations and facilitate portfolio strategy and planning. Passionate about innovation, collaboration, and continuous improvement of the medicines development process by leveraging new meaningful technologies, combining data with human insights to ultimately deliver solutions for patients. I hold a Master’s degree (MBA) in pharmaceutical marketing and Bachelor's degree in Pharmacy (B.Pharm).

Dr. Negin Hajizadeh is a Real World Evidence Principle Scientist at Bayer AG. She brings her experience as a pulmonary and critical care physician in addition to her experience with observational data from electronic health records and medical claims data to projects seeking to inform drug development and clinical trial design at Bayer. She completed her medical school at the Dartmouth School of Medicine in the United States, internal medicine training at Tufts University in the United States, and her pulmonary and critical fellowships at Yale University School of Medicine in the United States. She also holds a Masters in Public Health from the Yale School of Public Health. Dr. Hajizadeh joined Bayer in 2002 after a 20 year career in academia leading NIH, AHRQ and PCORI funded research projects. She lives in Madrid, Spain with her family.

Duncan, CEO of Triumph Research Intelligence (TRI), is a seasoned business leader with over 20 years of experience in the life sciences technology sector.

Duncan has helped drive innovation in risk-based monitoring and ICH E6 (R3) compliance. At TRI, he leads the development of OPRA -an advanced cloud-based platform for central and risk-based monitoring - and oversees a suite of services designed to support efficient, practical, and compliant adoption of RBQM across clinical operations.

Janie Hansen is a seasoned professional in Business Systems Transformation within Global Development Information Systems at Daiichi Sankyo, Inc. With over 20 years of experience as a business and integration architecture consultant in clinical systems, she has a proven track record of turning concepts into reality. Her expertise lies in delivering successful technology solutions and maximizing the value of technology investments in the pharmaceutical industry. Most recently, she has focused her efforts on leading transformative initiatives that leverage the potential of Generative AI.

Samreen Haque is the Associate Director, Product Implementation at Saama where she has spent the past three years managing strategic client partnership and leading the early client adoption of Saama’s AI-Powered Document Generation clients. Prior to Saama, Samreen worked at several biotech companies, including Komodo Health. Her experience spans many health care spaces, including clinical research, lab science, medical device implementation, and data product development. As a result, Samreen has a unique knowledge of the challenges in clinical trials, as well as the innovation that shapes and drives them. Samreen has a Bachelor’s in Physiology and Neuroscience from University of California, San Diego.

Terttu recently joined Syneos Health to lead the delivery of clinical projects from a sites and patients perspective. Her teams' activities range from feasibility, country/site selection to site management and monitoring. Driven by a passion to unlock the potential of participation to a clinical trial for all patients, she includes innovative ways of working wherever possible and impactful. Terttu graduated from Maastricht University in the Netherlands as a Medical Doctor and spent several years in surgery and Ob/Gyn clinics before joining the pharmaceutical clinical development ecosystem, in which she now has 20 yrs experience in Clinical development in different roles such as principal investigator in a clinical research centre, therapeutic director in a CRO, country and regional head for clinical study units in Sanofi, global head for Trial Operations (including data management) and head of the Clinical Innovation Office in Sanofi. Leveraging her experience as a PI, the well-being of patients and the support of investigators in trials has been a driving force in Terttu's work in the industry. With the development and implementation of innovations along the development journey she aims to make clinical trials ready for the future—a mission that has gained urgency as the global pandemic has propelled the health care industry into the 21st century in unprecedented ways.

Melissa heads up Patient Recruitment & Engagement and Clinical Forecasting at Fortrea. With 26 years of industry experience, my lazar focus remains with the patient and their caregivers- and what we can do as an industry to make clinical trials human-friendly and able to become part of care option, without putting them through excessive testing and data collection without a meaningful clinic endpoint.

Farrell Healion is the Founder & Principal Consultant of OptiTrial, a consultancy specialising in Digital Health Technologies and Decentralized Clinical Trials. OptiTrial partners with sponsors and technology providers to design strategies, select suppliers, and implement solutions that make trials faster, simpler, and more effective for patients, sites, and sponsors. With over 13 years’ experience across both supplier and sponsor organisations, Farrell has led growth, innovation, and transformation in clinical trial technology. Passionate about human-centred, value-driven solutions, he focuses on patient- and site-centric approaches. His award-winning thought leadership includes roles with the DTRA and as Co-Chair of the C-Path eCOA Consortium.

Equipped with a background in economics from Mannheim University, Markus has spent the last ten years advising biotech and pharmaceutical companies on digital & data topics in both the development and commercial space. Joining Vertwo Advisory as Principal in 2022, he is leading teams to develop and implement digitalization strategies and projects primarily in the clinical, regulatory, and medical environment.

Diedre is an accomplished clinical research leader with over 25 years of experience in

the biopharmaceutical industry. Currently serving as the Clinical Trial Program Early

Planning Lead for Immunology & Inflammation at Sanofi, she brings extensive expertise

in clinical development strategy and operations. Throughout her career, she has led

teams to successful delivery of clinical programs and process transformation projects.

A champion of process improvement and digital transformation, she has consistently

driven operational excellence through innovation to accelerate projects. As an aspiring

AI-driven leader, she actively integrates cutting-edge technologies and data-driven

approaches in clinical trial planning and execution. Her expertise spans clinical trial

innovation, strategic partnerships for recruitment success, and digital transformation

initiatives.

Known for developing critical alliances and managing cross-functional teams, Diedre

excels at strategic planning, clinical operations management, and innovation, with a

current focus on developing integrating AI-enabled approaches to accelerate drug

development in the immunology and inflammation therapeutic area.

With a keen focus on strategic initiatives and cultivating robust customer relationships, Dan spearheads efforts to bring innovative technology solutions to the forefront for life sciences organisations, ultimately benefiting patients worldwide. Dan's passion for advancements in digital health drives RWS towards excellence and forward-thinking solutions in the industry.

As the Director of Customer Experience at IQVIA Laboratories, Gavin brings more than 19 years of expertise in central laboratories within the clinical trial space. A strong leader and innovator, he has experience of developing and delivering strategic solutions. In his role, he oversees the development and implementation of company-wide initiatives that improve delivery to external customers, including investigator sites. Gavin holds a degree in Chemistry from University of Glasgow.  

Dr. Amber Hill founded Research Grid (R.grid) to automate clinical trials to cut costs, reduce delays, and increase patient engagement and retention. Her expertise is in end-to-end medical research, patient engagement, and smart software systems. Prior to R.grid, her career in biomedical neuroscience, AI, and clinical trials (UCL, Harvard, MIT) spans across 15 years in world-leading research institutions where she has built neurological deficit-scoring tech and previously founded a global non-profit supporting patient involvement in research. Dr. Hill has been an expert feature for top publications like the Wall Street Journal, Tech Crunch, and Essence Magazine. She has also received several honors such as the Royal Academy of Engineering fellowships and listed as one of The Financial Times: 100 Most Influential Women in Engineering. Research Grid has subsequently been backed and recognised by leading institutions from the likes of Google, Amazon, Morgan Stanley, the Royal Academy of Engineering, The London Stock Exchange, Plug and Play Health, and several others in the U.S. and Europe. Dr. Hill continues to drive forward her vision to make clinical trials admin-free for more successful medical treatments for everyone, everywhere.

Skye leads the Clinical Solution Consulting team at Citeline. A PhD biochemist with over 10 years of life science CRO and CCO experience, delivering tangible business outcomes end-to-end across strategy, product development, clinical operations commercialization, and growth. He focuses on leveraging enabling technologies to accelerate the development of new medicines, having seen firsthand how data-driven insights and advanced analytics/AI can unlock real value for patients and companies. He is passionate about disrupting the status quo and advancing holistic health agendas, engaging with the community as speaker, mentor, and advocate for innovation in life sciences.

Heather Horville is a business professional with experience in sales, presales, marketing, customer success, and operations across multiple industries. Today, she leverages these skills as a Solutions Consultant, helping clients solve problems and find success through clinical trial financial software at Greenphire-Suvoda. She is passionate about patient advocacy and care, as well as product and operational improvements to optimize clinical research for the sponsors, CROs, and sites that use our solutions.

Commercial Director and patient advocate with over a decade of experience in healthcare communications. Jon is passionate about putting people at the centre of healthcare conversations and believes that truly understanding your audience is key to delivering communication that drives meaningful change.

As the Head of Clinical Sampling in Precision Medicine and Biosamples at AstraZeneca, I spearhead the global strategy for clinical human biological sampling, enhancing clinical trial efficiency across diverse therapeutic areas. Leading a talented team of Biosampling experts and leaders, I focus on innovation, streamlining operations, mitigating risks, and delivering strategic value. My leadership emphasizes integrity, collaboration, and adaptability, driving our commitment to excellence and AstraZeneca's mission of advancing cutting-edge science for better patient outcomes.

Jeff Huntsman is the Chief Commercial Officer at EmVenio responsible for the overall commercial strategy and revenue generation. Mr. Huntsman joined EmVenio in 2024 with more than 30 years of experience in the Life Sciences space, where he has led global commercial teams selling pharma services solutions across the clinical development and regulatory lifecycle.

Prior to joining EmVenio, Mr. Huntsman ran a consulting firm providing strategic advice to private equity, venture capital and emerging growth companies. Earlier in his career, he was the Chief Commercial Officer at Sitero, Citeline, ConnectiveRx, and LIQUENT. He has held executive leadership roles at Clarivate, Parexel, Thomson Reuters, and Rogers Communications as well as having served as a Health Care Advisor at Warburg Pincus and Growth Capital Partners.

Mr. Huntsman earned a Bachelor of Science in Marketing and Political Science from Ball State University in Muncie, Indiana.

Gracia is a Clinical Trial Manager, member of the global Diversity Advisory Board and UK lead in underrepresented communities at the pharmaceutical company Boehringer Ingelheim, with a focus on managing lung studies to help bring new treatments through the clinical trial process to public accessibility. She has 13 years experience in the field of clinical research, successfully delivering new studies with a focus on oncology. Throughout her career she has been driven by a passion for improving patient outcomes and wants to ensure that clinical trials aim at improving patient care for all people, regardless of their background.

An innovation award winning pharma industry advisory consultant, operational strategy expert, blockchain advocate, technology enabled clinical trials (direct to patients/Virtual Trials) and patient engagement thought leader with over 20 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON, Biogen and Novartis). An R&D transformation change champion. Part of the DIA Patient Engagement Voluntary Community Leadership team. Driver for change through identifying unmet needs and opportunities, developing digital strategies, implementation and expansion of disruptive digital platform technologies Drug Development pathways.

Ross Jackson is a patient recruitment and outsourcing consultant, based in Manchester, England. He’s the author of the industry standard Amazon best-selling books - ‘Patient Recruitment for Clinical Trials using Facebook Ads' and 'The Patient Recruitment Conundrum' - and has advised and consulted on well over a hundred successful patient recruitment projects. Having started out with digital marketing in 1998, Ross quickly developed a specialism in the healthcare niche, evolving into a focus on clinical trials and the problems of patient recruitment and retention. Over the years Ross branched out from the purely digital, and now operates in an advisory capacity helping sponsors, CROs, sites, solutions providers, and others in the industry to improve their patient recruitment and retention capabilities, plus implementing the ClinOpsClarity outsourcing framework for vendor selection and oversight.

Sid leads the Global Development Data Science team, responsible for enhancing clinical trial operations with industry-leading advance analytics and best-in-class linked datasets. Sid’s team also leads several first-in-industry innovations including registries linking clinical trial data with real-world data (RWD) via tokenization to enable real-world effectiveness studies and long-term follow up (LTFU) and a first-in-industry, hybrid External Control Arm (ECA) in neuroscience resulting in groundbreaking real-world evidence generation prior to licensure. Sid is a champion and strong supporter of harnessing the power of technology to advance and transform healthcare. He is passionate about accelerating clinical research and increasing diversity, equity, and inclusion (DEI) in clinical trials by leveraging artificial intelligence and machine learning (AI/ML) models, advancing patient matching using RWD, and reducing patient burden by enabling decentralized/virtual trials – with the goal of bringing lifesaving and -enhancing therapies to patients faster. A recent example of impact is the award-winning ML-driven model, which predicted COVID-19 hotspots with over 90% accuracy, driving highly targeted site selection and shortening enrollment by 6-8 weeks. Prior to joining Janssen, Sid was VP of products at ConcertAI where he was responsible for building the next generation Real World Evidence (RWE) platform, eurekaHealth, which accelerated use of RWD and data science for a variety of R&D and commercial use cases at several leading biopharma companies. Prior to that, Sid was VP of Product Strategy at NantHealth where he managed and oversaw delivery of a broad portfolio of capabilities, including clinical decision support, combining molecular insights with standard of care treatment guidelines and oncology prior authorization. Sid has 20 years of leadership experience in healthcare, data and technology serving patients, biopharma, payers, and providers. Sid holds a Bachelor of Science with a double major in Computer Science and Management Information Systems. In addition, Sid has completed an Executive Management Program at MIT focused on Management and Leadership.

Agata Jarocka is the Associate Director, Quality Investigations & Analytics at AstraZeneca Poland, where she is dedicated to advancing clinical quality and inspection readiness through innovative analytics. Agata manages technical operations for critical tools and leads the analytics team's activities, with a strategic focus on quality management excellence. She optimizes ETL processes and develops scalable data models to enhance operational efficiency. The projects Agata oversees prominently focus on ensuring inspection readiness, leveraging analytics to deliver quality signals, identify potential risks, and improve decision-making processes. Her dedication to continuous improvement and innovation is evident through her contributions to high-impact projects and collaboration on solutions supporting Study Quality Oversight.

I’m a life sciences professional with 12 years clinical trial experience in biosample operations management with an academic background in Microbiology and Bioprocessing. My experience covers CRO central laboratory testing, biomarker vendor management and clinical trial management on regional and global levels. In my current role as a Biosample Operations Portfolio Lead, I’m accountable for the strategic and operational oversight of biosample collection and management across the early-phase clinical development portfolio. I’m passionate about challenging the status quo of biosample management practices and striving to introduce innovation in this space, hence I have been leading or contributing to a number of digital solutions.

Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management. Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 30,000 organizations, 100+ connected applications, and over 700,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.

Kimberley Kallsen is a cell biologist with public health expertise and +9 years of international pharma industry experience. She has a proven track record in patient-centricity and clinical development, with strong engagement of healthcare professionals and patients, as well as cross-functional collaboration and international networking. Currently, she is Head of Global Clinical Development & Operations Patient & Site Engagement at Boehringer Ingelheim. In this role, she is leading the global patient- and site-centric clinical development strategy to create the best trial experience for patients and trial sites.

Francis Kendall is an accomplished senior leader with extensive experience in the field of biometrics and drug development. With an MBA qualification and a people-focused leadership style, he has successfully led teams and implemented strategic change initiatives in multicultural environments. His notable roles include serving as the Head of Statistical Programming, Data and Data Sciences at Biogen, where he manages a that oversees key initiatives such as Data Stewardship, Data Science, and effective evidence delivery. Prior to that, he held positions at Astra Zeneca, Cytel, Roche, Pfizer, Novartis, Nycomed, Sandoz UK, and Hoechst UK, where he made significant contributions to statistical programming, data analysis, and strategic planning. Francis holds various qualifications, including being a Chartered Manager, Chartered Statistician, and member of professional organizations such as PHUSE and the Chartered Management Institute. He has also published articles in prestigious journals, demonstrating his expertise in artificial intelligence, machine learning, and clinical development.

Dr. Seyed Khaligh-Razavi is the Head of Scientific Research at Care Access, a pioneering organization transforming clinical trials through innovative operational models, site networks, and patient-centric initiatives.

With over a decade of experience in healthcare, clinical research, and digital health innovation, Seyed is passionate about advancing patient-centric trials and improving access to underrepresented populations through operational and technological breakthroughs. At Care Access, he oversees scientific strategy, research initiatives, and the dissemination of insights to accelerate industry-wide transformation.

Prior to joining Care Access, Seyed served as Chief Scientific Officer at Cognetivity Neurosciences, where he was instrumental in developing and bringing to market an AI-powered cognitive assessment tool. Under his leadership, the product achieved clinical validation, and regulatory approvals. Seyed holds a PhD in Brain and Cognitive Sciences from Cambridge University and has held research roles at prestigious institutions such as MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL).

Myles Kirby is Vice President at Faculty, one of Europe’s leading applied AI companies and the developer of Faculty Frontier™, an AI Decision Intelligence platform widely used by life sciences and pharmaceutical organizations globally. In his role, Myles oversees the commercialization of Faculty’s products and leads the company’s go-to-market strategy. Before joining Faculty, Myles was a business strategist at Accenture, advising global clients on digital transformation and innovation. He has also held senior roles across both the private and public sectors, where he helped organizations harness technology and data to drive strategic growth and impact. He is a frequent speaker on how enterprises can responsibly scale AI and decision intelligence to deliver measurable business outcomes.

Global Director for Public Private Partnerships at Novo Nordisk. Former head of The Data Analytics Centre at the Danish Medicines Agency, co-chair for HMA / EMA Big Data Steering Group. 20+ years’ experience in data management, analyses and data visualisation having previously worked in academia and pharmaceutical industry. Has headed up activities in EU Framework Programmes (large HIV observational studies), TransCelerate Biopharma, co-chair for HL7 Vulcan advisory board. Co-founder of PHAIR: Pharmacovigilance by AI Real-time analyses, applying FHIR resources to health care data in DK for real time safety surveillance. Previously involved in EHDS pilot work and DARWIN EU advisory board.

Olgica Klindworth is VP, Data Quality and Risk. Prior to joining Medidata, Olgica spent 10 years at PPD leading Data Management teams, building Data Management capabilities, and overseeing the execution of several clinical trials across various therapeutic areas. Over the past six years at Medidata, Olgica has spearheaded the development of Data Analytics and Centralized Monitoring processes and capabilities with PPD. She has participated in and led several RBQM initiatives and has spoken as a subject matter expert at several industry conferences. Olgica received her Bachelor of Science in Microbiology from the University of Texas at Austin and a Master of Science in Analytics from Texas A&M University.

Sven Knapinski leads the newly established Site Partnerships Team at CSL. He and his team are excited to make a difference by deepening the relationship with key clinical research sites and institutions, expanding CSL’s site network, centralizing internal knowledge, and fostering streamlined internal and external information exchange. Sven has 18 years of Clinical Development experience most of it linked to Clinical Trial Management. After his PhD in Biology, he started his career in a CRO and gained some experience in the medical device industry before he joined CSL (Vifor) 10+ years ago.

Kendra Korte is a Technical Solutions Consultant at Perceptive, where she has spent over two years helping biopharmaceutical clients optimize their clinical trial operations through tailored Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) solutions. Prior to her current role, she served as a Senior Solutions Designer, where she specialized in designing and implementing technology-driven strategies to support complex global studies.

Kendra brings a unique blend of technical expertise and communication skills to her work. Her ability to translate complex technical concepts into actionable insights has made her a trusted partner in clinical innovation and a compelling voice in industry discussions.

Alexander Krupp is responsible for the development of Bayer’s medicines in stroke prevention from early development to clinical with a strong focus on holistically integrating regulatory, safety, medical, evidence, access, and commercialization into thoroughly integrated roadmaps. He has previously been responsible for building a development platform for cell- and gene therapies and worked in ophthalmology, neurology, rare diseases and digital strategy. With a PhD in neuroscience, as a molecular oncologist and certified paramedic, he combines a deep passion for people and science with the pragmatic skill for visionary while down-to-earth execution.

Mateusz is a director of Risk-based Quality Management in the Centralized Monitoring Team at AstraZeneca. He is responsible for the implementation of RbQM principles into the study, design, and execution, working with cross-functional teams to generate and execute risk management and study monitoring strategies, and delivering capabilities for data analytics to detect and address emerging risks. He also supports process improvements and innovation within his team.

I studied Mathematics and Physics (Würzburg, Germany), followed by PhD in particle physics at CERN (Geneva, Switzerland). Since 2017 as Statistician and Scientists in various projects ranging from natural sciences (Particle & Astrophysics), social sciences, industrial production (Detectors & Electronics) and clinical trials (Oncology & MedTech). Consulting statistical aspects of in clinical trials since 2017. Now at B.Braun Aesculap (MedTech) as Biometrician and Datamanager, leading the Centralized Monitoring and RbQM activities.

Tero Laulajainen joined UCB in April 2017 and he provides leadership for clinical program delivery, clinical project management, medical writing, strategic clinical partnering, site and patient engagement, as well as clinical data management and clinical operations innovation teams at UCB covering all UCB sponsored clinical trials phI-IV. His ambition is to build best-in-class clinical operations organization creating unique, positive experiences for patients and investigator sites and thereby making UCB’s clinical studies patient- and site-preferred, while continuing to achieve scientific leadership, enhanced quality and industry-leading efficiency. He is enthusiastic about bringing our solutions earlier to patients and combining newest technologies with our clinical science and clinical operations ecosystem in a patient centric way. Prior to joining UCB Tero Laulajainen was Head of Clinical Operations at Roche Diagnostics (2010-17) during which he was overseeing planning, design, and execution of clinical studies in diagnostics environment giving him a good understanding of opportunities that exists using diagnostics and medical devices to drive personalized health care. In his over 25-year professional career in the pharmaceutical industry Tero Laulajainen has also worked for Novartis (Head Clinical Operations – Europe North), Eli Lilly (Clinical Project Manager) and Orion Pharma (Research Scientist).

Nicolas Le Bec is a QA professional with extensive expertise in Quality Management Systems (QMS), GxP auditing, and Quality by Design (QbD), grounded in a background as both a pharmacist and chemical engineer (MSc). He has significant experience in global pharmaceutical companies, currently serving as Director, Quality Risk Immunology / Neuroscience / Cardiovascular at Bristol Myers Squibb, where he has led quality strategy, compliance, and inspection management for multiple therapeutic areas. Previously, he held senior roles at Actelion (Johnson & Johnson) and Santen, overseeing GCP/GMP audits and inspection readiness programs across Europe. Nicolas is skilled in risk management (ISO 31010, ICH Q9), project leadership, and cross-functional negotiation, with proven ability to guide teams through regulatory inspections and quality process improvements. Fluent in French, English, Spanish, and Thai, he thrives in international environments and is recognized for his mentoring and team leadership. Additionally, he is active in sports and education, coaching badminton and tutoring biology and chemistry.

Sheri Lee is the CEO and Principal Consultant at Premier Regulatory Consulting (PRC), a leading boutique firm specializing in providing strategic guidance and expertise to companies worldwide. PRC assists corporations in navigating complex regulatory and quality landscapes to ensure compliance with local and international regulations. Her work at PRC is a culmination of the skills acquired throughout her career. Sheri’s strong background in the pharmaceutical industry was fostered during her time spent at the US Food and Drug Administration (FDA). Sheri spent 10 years at FDA in positions of increasing responsibility with a global scope. At FDA Sheri was the National BIMO Program Expert in the Office of Medical Products and Tobacco Operations. Prior to that she held a position as a National Recall Officer for the Office of Enforcement and Import Operations. During the start of her professional career she worked at non-profits, national and local organizations, hospitals managing clinical trials and developing public health initiatives. After Sheri left the FDA she held various leadership positions in the pharmaceutical industry, at Pfizer, Bayer and Organon to name a few. These roles provided her with invaluable experience managing diverse teams, driving organizational growth, building strategic partnerships, and achieving operational excellence. She brings a deep understanding of the industry's challenges, trends, and regulatory landscape. Her expertise spans a wide range of areas, including recalls, clinical trials, regulatory affairs, pharmacovigilance, and quality. She also has skills in manufacturing quality, ensuring compliance with strict regulations for drugs and devices. Sheri is a native New Yorker, who resides in Atlanta Georgia with her husband Darius and their two children Quinton and Lauren. She also enjoys spending time with family and friends, her two dogs Levi and Milo, practicing yoga and traveling.

Driven by a passion for reducing time-to-patient and transforming the life sciences industry, I am dedicated to empowering patients and enhancing the business ecosystem. My work focuses on the human aspect of the Drug Development Cycle, delivering strategic solutions that foster innovation, prioritize patient needs, and promote patient empowerment. I am one of the founders of Partners4Patients Foundation, whose mission is to catalyze goodwill and provide decisive support in setting up and organizing multi-stakeholder alliances while putting patients in the driver's seat. In 2020, I joined admedicum as a Senior Partner, becoming Co-Owner in 2022. Our team excels in patient-focused initiatives, integrating patient-centric practices into daily operations across Europe, the US, and Asia. Our consecutive wins of the International Life Sciences GHP Best Patient Engagement & Access Expert award in 2022 and 2023 underscore our commitment to excellence. With over 20 years in the life sciences sector, including over a decade as CEO of Clinical CRO and Biotech & Medtech startups, my deep industry knowledge is an asset. As CEO of PSR Orphan Experts (acquired by Ergomed Plc in 2017), I advanced progress by implementing lean principles and focusing on Rare Diseases, earning recognition with the CEO Today Europe 2018 award and the International Life Sciences GHP Drug Development CEO award.

Joe Lengfellner is a dedicated digital health innovator with a passion for applying technology strategies in clinical research. He strives to enhance the experiences of patients, clinicians, and research teams by implementing cutting-edge solutions that streamline processes, bolster communication, and optimize data management. As the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), Joe has spearheaded numerous large-scale research technology initiatives, such as the implementation of MSK's Clinical Trial Management System (CTMS), the development and deployment of eConsent for research, the management of the Electronic Data Capture (EDC) ecosystem, and leading the implementation of Epic for research at MSK. Joe is deeply interested in streamlining clinical data pipelines from EHR systems to research platforms, aiming to reduce the data management workload on sites and simultaneously enhance data quality while also lowering costs for both sites and sponsors. A strong advocate for collaboration, he believes in forging partnerships among clinical research sites, technology vendors, and industry sponsors to develop clinical trial technology solutions that benefit all stakeholders and ultimately accelerate the pace of clinical trial execution. In addition to his role at MSK, Joe leads the Clinical Research Innovation Consortium, a group designed to spearhead innovation within the clinical research industry. Under his leadership, the consortium works to foster collaboration and drive forward-thinking solutions that address the evolving challenges in clinical research. Through his work with the consortium, Joe is committed to shaping the future of clinical research by promoting innovation and excellence across the industry.

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/; www.SCOPEsummit.com; www.SCOPEsummiteurope.com

Twenty years of clinical research experience in both Pharma and CRO, focusing on global feasibility, site selection and study start-up for early and late phase clinical trials. With a keen eye towards optimizing clinical trial execution through informed data-driven decisions, Nadia looks to enhance site feasibility by leveraging real-world insights for optimal feasibility planning.

Stacey Limauro, Vice President of Clinical Operations at Deciphera Pharmaceuticals, has over 25 years of industry experience across all Phases of clinical development in both small and large Pharma organizations. In her current role, she provides leadership and oversight for the entire clinical development operations team and portfolio at Deciphera, including contributing to the operational strategy and implementation of process development and improvement within the department. One of Stacey’s most influential accomplishments was leading the successful approval of Deciphera’s first drug, QUINLOCK in 2020 for the treatment of GIST. She enjoys working with high-performing cross-functional teams to bring therapeutic treatments to patients in need. She received her BS in Chemistry from Trinity College in CT, and an MS in Biochemistry from Boston College in MA.

Gonzalo is currently the Global Head of R&D Patient Advocacy at Johnson & Johnson, responsible for creating the advocacy strategy and capabilities through all the stages of clinical development. He brings over 20 years of experience in patient advocacy and corporate affairs. Gonzalo began his career leading advocacy programs with oncology patient organizations in his native Spain and has held global roles with increasing responsibility in the UK and Switzerland. Most recently, he served as the Global Executive Director of Patient Engagement in Neuroscience at Novartis, collaborating with senior leaders across research, development, and commercial organizations to integrate the patient community perspective throughout the entire drug discovery, development, and launch continuum.

Tim Lyons is General Manager of Anju Software’s eClinical Division, where he leads strategy and execution across product management, software development, and operations. With more than a decade of experience in data systems design, clinical project management, and operations leadership, Tim brings a deep understanding of the challenges sponsors and CROs face in trial start-up and data management. At Anju, he focuses on building high-performing teams and delivering AI-powered solutions that accelerate study builds, improve compliance, and create measurable value for customers. His practical, problem-solving approach makes him a trusted voice on how technology can transform clinical trials.

Reamonn Madden is a member of the clinical operations innovation group and leads the OneDCT working group within Novartis, leveraging over five years driving the execution of DCT elements in trials and over a decade in trial management and data management.

With 16 years in the pharmaceutical industry, I am the Head of Product Experience at Evinova, where I lead cross-functional teams to collaboratively implement industry-leading product experiences for our suite of clinical development digital products. In my prior role as Product Director for the Control Tower at AstraZeneca, I led strategic initiatives to enhance clinical trial processes through data-driven methodologies. My expertise lies in optimizing clinical trials through technology and data analysis, focusing on enhancing trial efficiency and experience with AI and machine learning advancements.

Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.

Viviane Manghi is the Director of Strategy and Site Solutions at Labcorp, with a background spanning clinical operations, central laboratory services and clinical consulting. She brings a cross-functional perspective to optimize trial delivery and focuses on shaping strategies that enhance site engagement, streamline workflows and enable more innovative trial delivery models. Passionate about innovation and collaboration, she helps bridge operational realities with long-term strategic goals in clinical development.

Toni Mathieson has held the position of Chief Executive for Niemann-Pick UK (NPUK) since 2005. She brings personal experience to this role, gained as a parent of three children affected by Niemann-Pick type C, plus professional skills gained during her career in marketing and human resources. Toni has proven experience of providing the patient perspective in over 20 years as a patient advocate, representing NPUK in their collaborative work with UK and International stakeholders in the rare disease field. As a Trustee of the International Niemann-Pick Disease Alliance (INPDA), Toni works with 28 patient groups in 21 countries, to facilitate progress in the field of Niemann-Pick diseases. She is also a founding Director of the International Niemann-Pick Disease Registry (INPDR), a disease-specific registry aiming to increase understanding and facilitate progress in research and therapy development. Toni is current chair of the UK LSD Patient Collaborative, a group of UK based patient organisations representing those affected by Lysosomal Storage Disorders (LSDs), working together to enhance wellbeing, advance standards of care and to positively influence research and therapy development. She also holds the position of Patient Public Voice member on NHS England’s Metabolic Disorders Clinical Reference Group.

Sarah McClure is a Global Data Engagement Lead, Clinical Studies Unit, at Sanofi. Her pharmaceutical career spanning over 20 years has included site monitoring, local and global project management, technology and process solutions and implementation efforts. Sarah current role is leading the relationship with data source vendors and ensuring appropriate aggregation of data sources so that Sanofi can leverage data driven decisions.

Dan is vice president of business development and Marketing at Imperial Clinical Research Services. Dan is a seasoned executive who specializes in identifying income opportunities, building strategic partnerships, and managing contract negotiations. A prolific and popular thought leader, Dan has presented at numerous industry conferences and events, has conducted workshops and sessions on patient engagement, and has been published numerous times in industry books, trade magazines, and journals.

Shawn McKown is a COA/eCOA subject matter expert with 20+ years of experience in the clinical trials space.

Throughout his career, his primary areas of focus have been COA Linguistic Validation, making meaningful contributions to COA science and methodology, building and growing client relationships, and successfully driving revenue growth.

Shawn’s areas of expertise include linguistic validation, COA licensing, clinical trial diversity, pediatric cognitive debriefing, eCOA globalization, BYOD globalization, use of novel AI tools within COA/eCOA processes, and effective development of eCOA libraries.

Catherine is accountable for Clinical Biosampling within Astrazeneca drug projects, Laboratory Alliance and Technology developments in biosampling practice. Catherine is also accountable for AstraZeneca's Biobanking and Human Biosample Governance. The Institute of Leadership and Management awarded Catherine a fellowship in recognition of her work on pharma leadership, in developing leadership training and inspiring junior leaders. With a background in academic science within university and hospital settings, Catherine retains an understanding of the needs of patients, clinicians, and the challenges of delivering quality clinical research, within a global healthcare setting.

Murali Menon serves as Chief Revenue Officer (CRO) at Docuvera Software Co. (DSC), where he is at the forefront of enabling digital transformation for life sciences and regulated industries. With a career spanning two decades, Murali brings deep experience across enterprise content management, customer success, and the deployment of technology solutions that address the unique compliance and business challenges in highly regulated sectors. At Docuvera, he is responsible for the go-to-market strategy for professional services and sales, helping pharmaceutical companies transform how they create and manage regulatory documentation.

Murali holds an Master of Science (MS) in Electrical Engineering from the University of Houston. Widely endorsed for his hands-on business analysis, IT consulting and project management skills, he is recognized as a trusted advisor, a solutions-oriented leader and partner by clients and colleagues. Murali is currently based in the Raleigh-Durham-Chapel Hill area.

As the vice president of the Patient Suite at IQVIA, Anthony Mikulaschek is responsible for the commercialization of IQVIA's eCOA, eConsent, and IRT platforms. This includes pricing and sales strategies, opportunity configuration, market needs review, IQVIA technology market placement, and strategy. Anthony has extensive experience in validated system configuration, implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 37 years. This includes 29 years of experience in the pharmaceutical sector.

Christian Milliet has 28 years of experience in the pharma industry, leading Clinical Operations teams across Europe, USA, Latin America, and APAC. His expertise encompasses all phases of drug development in a multitude of therapeutic areas. He is currently Head of Site & Healthcare Ambassadors at CSL Behring. Previously, he worked for Vifor Pharma, Novartis, Serono, and Covance. In his current role, Christian leads a group of 130 team members across 35 countries, responsible for clinical trial planning and delivery, including feasibility, site selection, start-up, recruitment, monitoring, and clinical oversight. His focus is also on creating strategic relationships to successfully deliver the CSL portfolio, including clinical programs and real-world evidence studies.

Peter Morley is the environmental impact lead for clinical trials at Novo Nordisk. With over 25 years of experience in clinical operations, Peter is dedicated to finding innovative approaches and implementing practical solutions that reduce the environmental footprint of clinical trials while benefiting the wider industry and society. He collaborates with both public and private sector partners to accelerate action through initiatives such as the Sustainable Markets Initiative (SMI) Health Systems Task Force, the Low Carbon Clinical Trials (iLCCT) group, and the Sustainable Healthcare Coalition (SHC).

Marina Morrison is an accomplished leader with over 20 years of experience in patient recruitment and retention across Phases II–IV and all therapeutic areas. She is widely recognized for her innovative thinking, cross-functional collaboration, and proven track record in transforming global business models in the life sciences industry. Her expertise spans patient and HCP insights, medical education, clinical data analytics, vendor management, and patient journey mapping, with a strong focus on rare diseases, pediatrics, women's health and emerging biotech programs. In October 2024, Marina joined Ercules, a dynamic consulting and execution group based in Italy specializing in clinical research recruitment and retention. Ercules partners with sponsors to deliver patient- and HCP-centered education and engagement strategies across multiple indications, with a particular focus on rare diseases and pediatric populations. Throughout her career, Marina has pioneered patient recruitment and retention strategies at global scale, integrating digital, educational, behavioral, and community-based approaches to improve access, diversity, and long-term trial participation. She is passionate about driving innovation in clinical research and building collaborative solutions that empower patients, caregivers, HCPs, and study teams alike.

With 17 years of clinical research experience, Katarzyna Moscicka (Kasia) plays a key role in shaping clinical trial feasibility strategies at PSI. She has expertise across oncology, hematology, gastroenterology, infectious diseases, rare diseases, and respiratory indications. Kasia drives country and site selection processes, aligning feasibility solutions with regulatory requirements, standards of care, and market positioning. A strong advocate for data science and technology, she uses advanced analytics and digital tools to optimize feasibility assessments and patient enrollment strategies. Kasia integrates predictive modeling and real-world data to keep PSI’s strategies at the forefront of clinical trials. With a pharmacy degree from the Medical University of Warsaw and post-graduate studies in marketing and management, Kasia leads a global team of over 50 professionals across 27 countries. She supports Sponsors with customized feasibility strategies to maximize clinical trial success. Kasia also presents innovative feasibility approaches at global industry events. Based in Zug, Switzerland, her leadership ensures PSI remains a trusted partner for high-quality solutions in complex clinical studies.

I am Julia Movshovich, Associate Director of the Central Monitoring group within the Data Surveillance team and a Global TA Lead at Pfizer. With a keen eye for detail and a passion for ensuring quality and compliance, I oversee risk-based monitoring processes, ensuring quality and compliance. In my current role, I lead central monitoring activities for studies in Pfizer’s risk-based monitoring model across assigned Therapeutic Area. Collaborating with other Global TA Leads to implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality central monitoring processes to meet expected quality, timelines, and deliverables. Previously, I held various positions at CRO, where I was involved in central monitoring activities for RBM strategies, specification, development, validation, and delivery of standard data integration and reporting solutions. I also managed the delivery and ongoing maintenance of analytics solutions for RBM studies, including project management, requirements analysis and stakeholder liaison. I have 5 years of experience in the Risk Based Monitoring and 9 years in Clinical Trials. My educational background includes a BSc in Computer Science, a MA in European Studies, and a BA in Economics.

Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of clinical outcome assessments (COA) and the use of digital health technologies (DHTs) in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked at the intersection between science and technology to navigate for better solutions.

At uMotif, she provides Scientific Leadership across the organization, ensuring that the scientific voice is embedded across all functional areas to inform rigorous scientific practices. Flo holds an MSc and PhD in Social, Genetic, and Developmental Psychiatry from Kings College London – which included the development of a new PRO.

Begonya Nafria is Patient Engagement in Research Coordinator at Sant Joan de Déu Children's Hospital (Barcelona-Spain). She has long experience in the field of patient and family participation in research initiatives. Her personal history as a caregiver for an adult with cerebral palsy has linked her to various projects and initiatives in the field of defending patients' rights. Her areas of expertise focus on the participation of paediatric patients in research and specifically in the field of clinical trials.Relevant aspects of hes curriculum are: CIBERER collaborator, EUPATI member, eYPAGnet Coordinator, Kids Barcelona Coordinator (YPAG of Hospital Sant Joan de Déu), member of the EFGCP Children's Medicines working group and member of the working group of patients and families of EnprEMA (European Network for Pediatric Research of EMA). She is also a reviewer for various journals specialized in the subject of patient participation in research and rare diseases, and a teacher in seminars, courses and conferences.

Degree in Biology from the University of Navarra, MBA in Biotechnology Company and Master in Monitoring and Coordination of Clinical Trials. Head of the Internationalization Platform and Head of Institutional Relations at the Hospital La Paz Institute for Health Research. For more than 15 years I have been managing international projects, mainly European calls, including FP7, H2020 and Horizon Europe, but also NIH calls, from the identification of the call to the last steps of the project management

Finished a master’s in biomedical engineering in 2019 and started working in the International Commercial Department for a Mobile Hospital Software company (performing tasks of project management, product development, commercial and product training and commercial presentations both nationally and abroad, acquiring experience in Hospital Environment and in Bedside Point of Care). In 2021 integrated a Site Feasibility international team at Pfizer, where he was responsible for pivoting site intelligence data into interactive visual platforms, allowing stakeholders to select the optimal sites, using a variety of data sources such as performance / enrollment metrics and diversity. Currently a part of the same team, but after a reorg, a more strategic vision has been required. Defining business level requirements for algorithms for Clinical Trial Site Intelligence / Feasibility projects and organization-wide methodologies for identifying highly performing clinical trial sites were some of the developed tasks. Lately, most developments have been in analyzing the Feasibility process, assessing where generative AI and LLMs can be integrated and seeing to their actual implementation.

Archana Nayak is a Senior Data Scientist in Advanced Insights and Solutions within Bhargava Reddy's group at Johnson & Johnson. She joined J&J in 2021; in her role, Archana views herself as a storyteller who transforms data into powerful narratives that drive meaningful actions. She operates at three key levels: strategically engaging with stakeholders to understand business challenges and design tailored data solutions; tactically ensuring that projects have the right team, balancing priorities, and addressing data accessibility issues; and operationally leveraging optimal computing platforms and secure code bases. Looking ahead to 2025, Archana's main focus areas include delivering purposeful site management risk-based monitoring tools, embedding GenAI capabilities in compliance processes, and supporting her team with custom dashboard solutions and training for clinical trial design. She is committed to bridging data science with real-world impact, enhancing workflows, and aligning with J&J’s 2030 sustainability goals. Archana is eager to connect with the wider community to discuss the future of advanced analytics and its impact on daily tasks. She welcomes conversations on these topics and is open to networking opportunities.

Felix Nensa is Professor of Radiology with a focus on AI at the Institute for Artificial Intelligence in Medicine, Senior Consultant Radiologist at the Institute for Diagnostic and Interventional Radiology and Neuroradiology and the Scientific Director of the Data Integration Center at the University Hospital Essen. He also has a certified medical qualification in medical informatics. He leads a research group that develops machine learning-based solutions for healthcare. His focus is on practical solutions that need to work in a clinical context. His particular interests include interpretability, user trust and interaction capabilities. He is the founder of the digital health platform SHIP. Felix is speaker and principal investigator of the WisPerMed Research Training Group of the German Research Foundation, board member of the Information Technology Working Group of the German Radiological Society, coordinator of the MII method platform "Open Medical Inference" (OMI), Editorial Board Member and Section Editor AI of the European Journal of Radiology, Associate Editorial Board Member of Investigative Radiology and co-founder of the emerging technologies in medicine (ETIM) congress. He also co-founded several start-up companies.

Soundarya Palanisamy is a Principal Industry Advisor based in Germany and is part of the Global Health and Life Sciences Practice at SAS. She supports clients by providing guidance on their journey of digital transformation through the usage of AI, analytics and technology. She specializes in machine learning, text mining and analytical life cycle management enabling her to unlock insights that optimize processes and spearhead innovation in the healthcare and life sciences domains. From her previous experience, she possesses a profound understanding of regulatory data science. She has a bachelor’s degree in computer science from Anna University and a master’s in cognitive science from the University of Freiburg.

Rajesh Patel is a seasoned product leader with over two decades of experience driving innovation, strategy, and customer-centric solutions in the technology sector. As Senior Director of Product Management, he leads the product vision and execution of the technology strategy for financial management in clinical trials—an area critical to operational efficiency and compliance in life sciences.

Thirupathi lead initiatives to harness artificial intelligence, machine learning, and real-world data to accelerate drug development and deliver innovative healthcare solutions. With expertise spanning data strategy, advanced analytics, and GenAI, he has been a key driver of digital transformation across research, clinical, and commercial domains. He is also a frequent speaker at international conferences, sharing insights on the application of AI and real-world evidence in the pharmaceutical industry.

Zbigniew Pietras is a Director of Clinical Data Science at AstraZeneca with over 6 years of experience in the pharmaceutical industry. He specializes in building and implementing decision support systems that transform complex clinical processes, successfully delivering initiatives with global reach that impact operational efficiency. Prior to joining AstraZeneca, he held research positions at academic institutions including the University of Cambridge, where he earned his PhD. He leverages both rigorous academic knowledge and practical industry experience to create effective data-driven solutions for clinical trials.

Dr. Santiago Ponce-Aix is a medical oncologist and clinical researcher specializing in therapeutic innovation and precision medicine. He currently leads the Oncology Department’s Therapeutic Innovation and Precision Medicine program at Hospital Universitario 12 de Octubre, where he designs and oversees cutting-edge translational research and personalized therapy initiatives. Santiago brings more than 15 years of experience across leading European cancer centers, including Gustave Roussy, the Spanish National Cancer Research Centre (CNIO), and Fundación OncoSur. Renowned for his strategic vision and collaborative approach, he builds high-performing teams and partners with pharma and biotech companies to accelerate novel cancer therapies and transform patient care.

Lauren Price is a Director of Product Management for CTMS, bringing over 20 years of experience in healthcare and clinical research. Previously, Lauren worked in a cardiac cath lab, where she developed a deep understanding of patient care and cardiology. She later transitioned to clinical research at Duke Clinical Research Institute, serving on the Clinical Events Committee and working as a Clinical Research Associate (CRA) and Study Manager. Her expertise includes managing global studies across multiple therapeutic areas. When first joining Medidata, Lauren worked in Professional Services to support clients enabling CTMS. Lauren now leverages her diverse background to drive innovative product development that enhances clinical workflows and improves patient outcomes. Passionate about bridging the gap between clinical needs and technological solutions, she is committed to advancing the healthcare landscape through thoughtful product strategy and development.

Johann Proeve has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, and the ‘Best presentation on RBQM’ at the 2024 PHUSE Connect conference, Johann is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, Johann has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM and SCOPE. Additionally, Johann has published numerous thought leadership articles for media, including ACT, Contemporary Clinical trials, and DIA Journal. Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).

Allison Proffitt is a science writer with a background in biology and chemistry, research experience in cancer biology, and an expanding repertoire in biotech, AI, and battery chemistry. She serves as the editorial director for the Healthtech Publishing media group, a growing collection of online news sites. In addition to Bio-IT World, her work has been published by Nature Biotech, Chemical & Engineering News, and the Economist Intelligence Unit. She has a bachelor’s degree in communication of science, engineering, and technology from Vanderbilt University and a Master’s degree in science and medical writing from Johns Hopkins University.

Guido Radack, previously serving as Vice President of Digital Transformation in Clinical Development & Operations at Bayer, is a senior life sciences professional with over 29 years' experience. At Bayer he held leadership roles in Digital Transformation, Clinical Development, and Strategic Initiatives. He has driven enterprise-wide digital strategy to modernize clinical operations, including decentralized trials, real‑time sensor data capture, and cross‑functional digital governance. He also engages broadly in healthcare innovation across industry coalitions and conferences. Actively involved with Inconsult GmbH, he frequently represents the firm at major events like the Disruptive Technology for Clinical Trials conference and DIA Europe 2025.

Susana Ramos is an Early Planning Therapeutic Area (TA) Lead in Immunology & Inflammation at Sanofi, where she serves as the primary Global Clinical Study Unit (CSU) strategist for Dermatology & Rheumatology programs. With a PhD in Pharmaceuticals from the University of Barcelona, she brings 21 years of industry expertise in clinical research. Since joining Sanofi in 2004, she has progressed through key roles including Clinical Research Associate, Clinical Project Lead, Regional Trial Manager in Europe, and Global Feasibility Lead in Oncology. In her current role, she drives strategic alignment between global strategy and local implementation, providing unified direction for clinical trial planning and execution. She leads data-driven recommendations for protocol development, feasibility assessments, and site selection while maintaining a portfolio-level perspective to anticipate future program needs and accelerate study execution across the CSU network.

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Chief Products and Innovation Officer at Saama Technologies. With over 30 years of experience in information technology and analytics, including more than a decade in healthcare and life sciences, Prasanna brings a wealth of knowledge and expertise to his role. Previously, as Global Head of AI/ML, Clinical Data Sciences at Pfizer Research & Development, Prasanna worked closely with stakeholders, vendors, business SMEs, machine learning developers, and data scientists to foster innovation and advance the adoption of AI in clinical data sciences. His tenure at IBM Watson as a Watson Solution Architect was marked by significant achievements in implementing AI systems for a diverse range of clients. An accomplished speaker, Prasanna regularly presents at major industry conferences, including SCDM, DIA, SCOPE, DPharm, Tufts University CSDD, and Outsourcing Clinical Trials (OCT). He is also the holder of an IBM patent titled "Monitoring Clinical Research Performance," further cementing his status as a leading authority in leveraging technology for clinical development in the pharmaceutical industry. Prasanna continues to drive transformative advancements in AI and machine learning, delivering groundbreaking solutions to accelerate clinical research and development.

Dr. Bhargava Reddy has over 16 years of experience working in the pharmaceutical industry. He is currently Head of Advanced Insights at Janssen Pharmaceutical supporting clinical operations by providing data science solutions. Prior to this role, he was Associate Director of Advanced Analytics at UCB. In this role, he was responsible for the development and application of machine learning methodologies supporting clinical decision making within Immunology and. He was also leading the analytics work supporting Risk Based Monitoring. Prior to this role, he managed a statistical programming group and was also overseeing a large statistical programming group offshore. Dr. Reddy has published several methodology papers in peer reviewed academic journals in the areas of machine learning and deep learning. He is actively involved as an associate editor for the Frontiers in AI journal and also as a reviewer on several journals. He has a Ph.D. from Oklahoma State University and MS from Northwestern University.

Christa is a driven and dedicated Clinical Research Professional with over 15 years of international experience in clinical research and more than 3 years of project management expertise across both pharmaceutical and CRO environments. Her background spans a diverse range of therapeutic areas. She is currently a Senior Program Manager at myTomorrows.

Pharmaceutical professional with a strong background in preclinical research and a strategic focus on patient engagement. I have experience across the drug development, from early-stage research to patient-centered initiatives. In recent years, I have shifted my focus toward patient engagement, working to integrate the patient voice into drug development processes. I am passionate about fostering collaboration between researchers, healthcare providers, and patients to ensure that treatments are not only scientifically sound but also aligned with patient needs and experiences.

Eliana is US based and has been in the research industry for 30 years, prior to research she spent 10 year in pharma. She has had many roles in research from Business Development to Vendor to business operations. her greatest tole is patient and giving voice to those who don't have one. Eliana is a two time cancer survivor and currently active in a trial for CSA which has been recently approved.

Clinical Operations Manager with over a decade in clinical research, leading global trials across Europe. Experienced in driving studies from design to delivery with a focus on collaboration and quality. Passionate about advancing clinical research to bring new treatments to patients faster, while building and mentoring strong, motivated teams that make a real difference in global health.

Matthieu Ruffin is a seasoned professional with 20 years of experience in clinical operations within large and mid-size pharmaceutical companies. He has strong leadership skills, having led global study leadership and development operations. Matthieu has successfully driven clinical operations strategies and delivered on business goals across key therapeutic areas and various types of clinical trials, from early- to late-phase trials. Currently, Matthieu serves as the Vice President, Head Study Leadership at Novartis, where he leads the global Study Leadership organization to ensure timely and quality execution and delivery of global clinical trials across all Novartis Development programs. He is accountable for the Novartis Clinical Trial Team model, related tools, and operational excellence. Matthieu ensures cross-functional excellence in clinical trial execution and leads the biospecimen scientist organization responsible for the operational execution of clinical biospecimen samples. Previously, Matthieu held the position of Global Head Development Operations, at Advanced Accelerator Applications (AAA), a Novartis company, where he led the Development Operations organization focusing on RadioLigand Therapy (RLT). He was accountable for delivering clinical trials from early to late phases in the AAA portfolio and drove timely and efficient trial execution in collaboration with global medical affairs, legal, research, and regulatory affairs functions. Matthieu holds a Postgraduate Degree in Combinatorial Chemistry and Drug Design, and a Master of Science Degree in Analytical and Organic Chemistry from the University of Orléans in France.

A scientist turned founder, Zina spent a decade in cancer drug discovery before leading clinical research at Parexel and PhIII oncology trials at AstraZeneca. Driven by the vision of a cancer-free world, she built Yendou to accelerate research, streamline operations, to deliver life-saving treatments faster.

Medical Biology (1991) Four years in farma, twenty years in hospital cardiology research department and 10 years managing director of WCN Dutch cardiovascular research network.

Josephine is a learning and communications specialist with over 18 years of experience in the pharmaceutical industry. Currently, she serves as a leader in the Clinical Customer Centricity (CCC) team at Bayer, where she is committed to placing Customers—Patients, Participants, and Sites—at the core of their clinical development efforts. She drives the co-creation and implementation of innovative strategies that foster a holistic understanding of their customers, build long-lasting partnerships, and enhance customer experiences. Her extensive background and proven leadership enable her to effectively drive engagement, improve efficiency, and accelerate timelines in clinical development.

Nina is the co-founder and CEO of Avenna Ltd. Her mission is to make healthcare for chronic inflammatory disease (CIDs) more preventive and personalised. By developing more effective, affordable, and accessible precision medicine solutions we can enable early detection and treatment personalisation for variety of CIDs. Nina has background in finance, business, and healthcare and worked in large multinational companies including Nomura, Bloomberg and Schlumberger, as well as several entrepreneurship ventures.

Currently working as Director of Strategic Feasibility for AstraZeneca's CVRM portfolio. Before this, led clinical trials as a Global Study Leader, Regional Country Study Manager, and CRA across various pharma companies and CROs. With a background in pharmacy, the career began as a Study Coordinator and pharmacist at an Early Phase Clinical Site.

Leigh is a Clinical Research Professional with 20 years of experience working at both the site and sponsor level. She has spent the past 8 years working at the sponsor level in a Global Feasibility role. This entails benchmark analysis, country strategy and selection, enrollment rate modeling, timeline planning, and site identification and selection. Leigh also served as a Disease Intelligence Lead responsible for developing category-wide feasibility and enrollment strategies and innovations to ensure successful delivery of the portfolio. Prior to working in Global Feasibility, Leigh worked as a Clinical Operations Head and Project Manager for a large US site network.

Alla Smyshlyaeva, MBA, leads the commercial and marketing teams at PSI CRO AG. With PSI since 2005, Alla has overseen the development of some of the company’s key initiatives, including but not limited to strategic proposals, knowledge management, vendor management, and clinical trial planning platform, INTELIA™.

Lindsay leads Citeline's Patient Engagement and Recruitment division and is responsible for helping guide, grow, and deliver on our Patient Engagement and Recruitment solutions. She has over 15 years of experience in scientific and clinical research & development, and real-world data strategy and solutioning for clinical investigation. Lindsay holds an MS in Epidemiology from Columbia University, an MA in Biopsychology from the City University of New York, Hunter, and a BA in Psychology from the University of Rhode Island

Stathis Stathelos is a Senior Director of Feasibility and Portfolio Delivery at AstraZeneca. With over 17 years of experience in the pharmaceutical industry, he specializes in clinical development and strategic operations. Stathis leads global execution strategies for Haematology and Oncology clinical trials, emphasizing data-driven feasibility and patient-centric solutions. Prior to AstraZeneca, he held pivotal roles at Regeneron and Amgen, optimizing clinical protocols and resource management. A Project Management Professional (PMP) and registered pharmacist, Stathis combines his profound understanding of therapeutic areas with a passion for innovation and strategic leadership in clinical development.

Bob Stevens is the Group CEO for the MPS Society and Rare Disease Research Partners, a patient organisation with a one-of-a-kind patient logistics support and research subsidiary that, although based in the UK, has a global impact. Since 1982 the MPS Society has been providing support to the rare community including 1-1 support both in person or remotely according to the needs of the patient. Other services include benefits advice, psychological support and working with all parts of the healthcare ecosystem to ensure patients gain access to treatments and therapies that can help improve their lives. Bob also has various other roles both in the UK and globally including LSD Global Chair, LSD Collaborative Vice Chair, Fabry International Network Board Member, PMCPA Appeal Board Member , International MPS Network Member. He also is a motivational speaker for the pharmaceutical and “Rare Disease” community. Having been on a “Rare Journey” for nearly 25 years and as a dad of two rare disease boys I have experienced many of the challenges and opportunities in the rare and ultra rare eco system. I do not have a job but a way of life dedicated to ensuring global collaboration and supporting our communities to “Live a rare life better”.

Four decades of drug development experience in government & pharma, in Europe and the US. Last decade in RBQM implementation, setting up Centralized Monitoring processes & tools, developing coherent indicator dashboards for different functions, moving from corrective action to preventive action. Currently focusing on continued implementation of ICH E6, based on R3.

Mats Sundgren, PhD, MSc, is a distinguished authority in Health Data Strategy, serving both industry and academia. With an impressive career spanning over 37 years in the pharmaceutical industry, Mats has made significant contributions across various domains, including Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science, and Data Science & AI. His work places him at the forefront of technological innovation in the field. In 2022, following an illustrious 12-year tenure as the global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats expanded his professional endeavors. He now holds several key roles: Senior Industry Scientific Director and co-founder of the i~HD (European Institute for Innovation through Health Data), Executive Strategic Advisor for IgniteData, which develops a system-agnostic EHR-to-EDC solution for clinical trials, and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology). IMIT includes prominent institutions such as Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology, and Stockholm School of Business. Additionally, he serves as a Board Member of the Center for Health Governance at Gothenburg University. In July 2024, Mats assumed the role of Scientific Adviser for IOMED, a company specializing in AI-powered technology for healthcare data activation. In March 2025, assumed the role of R&D Strategy Advisor for ZS Associates. Mats has an extensive portfolio of work, including over 80 publications, books, and patents in Life Science, Economics, and Social Science. His areas of expertise encompass Health Data Science & AI, Clinical Science, Clinical Trials Management, Business Modelling, Innovation & Creativity Management, and Device Development.

Visionary pharmaceutical executive with over 20 years of global leadership experience in clinical development, process transformation, risk-based quality management, and digital innovation. Known for driving enterprise-level change, shaping strategic engagement models, and delivering operational excellence across large trial portfolio globally. Proven ability to translate complex external and internal dynamics into scalable, patient- and site-centric innovation. Trusted leader with strong regulatory acumen, talent development expertise, and a track record of aligning stakeholders around a shared mission for impact and inclusion.

Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as Vice President of Research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess the quality of clinical trial data. Laura holds a Master’s degree in Biomedical Engineering and a PhD in Applied Mathematics from the University of Liège, Belgium.

Georgios K. Tsivgoulis, MD, PhD, MSc, FESO, FEAN, FAAN currently serves as Professor of Neurology at National & Kapodistrian University of Athens, School of Medicine. He is also a Fellow of the European Stroke Organization (ESO), European Academy of Neurology and American Academy of Neurology. His research interests focus on acute reperfusion therapies in acute ischemic stroke, applications of neurosonology in cerebrovascular diseases, secondary stroke prevention, and clinical trial methodology. Dr. Tsivgoulis serves as the President of the Hellenic Neurological Society and Vice President of the European Stroke Organization (ESO). He is an active editor for many scientific journals, and has authored >500 papers and 16 book chapters. His research has received >13.000 citations (Google Scholar) and his H-index is 57 (Google Scholar). Dr Tsivgoulis has been the recipient of international awards and competitive grants from both academic institutions and industry. Dr Tsivgoulis is married and has one daughter. He enjoys spending his free time with family at home.

Jane Twitchen graduated with a BSc in Medical Physics from the University of Exeter, UK, and commenced her career with Covance, supporting a number of trials investigating radioisotope image optimisation. Having developed a keen interest in processes and systems, she then joined SAS, where she worked in the Alliances team collaborating with partners such as PWC, McKinsey, and Accenture to define and implement solutions for pharmaceutical clients. During her tenure with SAS, Jane was also sponsored to complete her MBA. She proceeded to a number of software and service providers prior to joining Biogen in 2013, initially joining the Global Regulatory Affairs Quality and Operations team and moving to Global Clinical Operations in 2015. In her current role, Jane is Executive Director, Head of Biogen’s Clinical Trial Accelerator Unit and is responsible for delivery of Biogen’s goal to decrease its study start-up cycle times by more than 15%.

Having been in the industry for over 20 years, Miguel has worked in various capacities in informatics, Clinical Operations, and Quality Assurance. In his earlier, most recent roles at Bayer and Roche, Miguel has led Quality Risk Management, Risk-Based Monitoring, analytics-driven oversight, and continuous improvement groups and programs. Since 2019, Miguel has led the development and implementation of the Risk Based Quality Management (RBQM+) approach in Alnylam. Currently, he is Director of Clinical Risk & Analytics (RBQM+) and lead the RBQM+ Risk Management and Centralized Monitoring process and team.

A highly motivated and enthusiastic pharmaceutical industry Senior Clinical Operational Leader and Quality Management Oversight Associate with extensive international experience in the pharmaceuticals, CRO and biotechnology sectors and a reputation of being able to quickly develop people into productive, cohesive and motivated teams. Offers proven leadership skills and a positive approach to change management with a good understanding of training and development as well as a strong commitment to quality and delivery

Zoltan is responsible for leading IQVIA’s efforts to drive the adoption of innovative patient recruitment and engagement methods in clinical trials. This includes working to infuse the patient voice into trial design and developing and scaling solutions to help bring novel treatments to patients including those traditionally underrepresented in clinical trials.

Zoltan has more than 25 years of experience leading global and regional clinical trial operations, including patient recruitment, project and site management, vendor partner management, strategic partnerships and quality management.

Julia Vassiliadou is a Biopharmaceutical executive with over 25 years of experience in clinical operations and medical affairs at local, regional and global level. She joined F2G in 2023 as Vice President Clinical Operations with the responsibility to build and lead the delivery strategy for the rare fungal disease clinical trial portfolio. Prior to this role she was VP Clinical Operations at MiNA Therapeutics accountable for the execution of the clinical trial pipeline across immune-oncology and rare genetic diseases. Julia has acted as VP & Global Head for country clinical operations in GSK, leading the global country clinical operations, comprising 750+ individuals in 20 countries. She was accountable for in-country execution and delivery of the GSK Pharma portfolio across all therapeutic areas. Previous leadership roles include Country Medical Director, Quality, Risk Management and Medical Governance Director-Europe, Senior Scientific Advisor-Respiratory, Head of country clinical operations, Global clinical study lead. She received her undergraduate degree and a Masters in Biology from the University of Athens-Greece, gained a PhD in Reproductive Immunology from Newcastle University Medical School, UK and undertook post-doctoral research in Human Immunology at Harvard Medical School.

David started his career in academia as an environmental epidemiologist working in international institutions from Europe and Canada. He moved to the pharmaceutical industry with multiple global and regional roles and responsibilities within the real-world evidence area. David bridges R&D, medical and market access needs through observational research and visionary solutions. He is an active member of the OHDSI community since several years ago contributing as an industry leader in the implementation of innovative RWE generation strategies.

Matt brings more than 20 years of software and leadership experience in the life sciences industry. Matt started his career as a developer and held various technical and leadership roles at Rollins Corporation, PSCI, Microsoft, Morgan Lewis, and Datalabs. In 2006, Matt co-founded NextDocs, which grew to be a global leader in clinical, quality, and regulatory document management, where he served as CTO, CSO, and Board Director for 9 years. Before joining Trialbee, Matt spent 5 years as General Manager for Life Sciences and VP Strategic Accounts for Aurea Software, which had acquired NextDocs.

Since joining AstraZeneca in 2007, Dr. Jim Weatherall has played a key role in establishing artificial intelligence (AI) as an integral part of research and development (R&D). His team is dedicated to applying AI and related technologies to unlock the full potential of data, enhancing productivity and scientific decision-making. His leadership has advanced innovations aimed at transforming how medicines are discovered and developed, with a focus on positive future impact on patient care. Jim is also the co-founder of the cross-pharma DISRUPT-DS roundtable, AION Labs venture studio, and the Cambridge Centre for AI in Medicine (CCAIM), all of which focus on advancing AI technologies that have the potential to transform drug discovery.

Robina Weermeijer has over 9 years of experience in the pharmaceutical industry. She has held positions in Communications and Patient Engagement in which she worked with patient organizations in a range of disease areas. Currently, she is focused on increasing diversity, equity, and inclusion in clinical trials globally at Boehringer Ingelheim. Her passion for driving positive change in the healthcare industry is rooted in her belief in the power of collaboration and patient-centered care. She firmly believes that by truly listening to patients of diverse backgrounds, and the people around them, pharma can make an even bigger positive impact in people’s lives.

Linda White is an Associate Director of Risk-Based Quality Management at Jazz Pharmaceuticals, with over 15 years of experience in Clinical Operations. Current focus has been on training RBQM process and technology to all departments involved in clinical trials. As part of the leadership of a growing team, we aim to build a culture of Quality by Design and critical thinking into trial design and management.

Madeleine Whitehead has over 15 years of industry experience focusing on clinical process excellence, gained in both Sponsor and CRO settings. Madeleine is passionate about robust, user-centric processes which enable a compliant risk-based approach in the conduct of clinical studies. In her current role at Roche, Madeleine is dedicated to supporting Process Owners of global clinical development processes to created innovative, effective, and efficient mechanisms to operationalize clinical studies. Madeleine is a devotee of Good Clinical Practice who works to promote the understanding, appreciation, and application of GCP in clinical activities.

Executive leader and risk practitioner with deep expertise in Drug Development Risk, Clinical Operations, and Data Analytics across pharma and medtech R&D. I provide global strategic direction for clinical trial risk management, business risk and compliance, TMF oversight, and Transparency—embedding agility, proactive oversight, regulatory readiness and data-driven decision-making into every aspect of trial delivery. I am passionate about building high-performing, resilient teams and fostering a culture of continuous evolution. Proven ability to inspire and influence through change—developing agile, empowered teams that uphold integrity and deliver with purpose. Marion holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM.

Helen Kit-Yi Wong is the Risk-Based Quality Management (RBQM) Strategy & Implementation Lead at Merck Sharp & Dohme (MSD). She is based in Hong Kong. Helen has been in MSD for more than 25 years experiences and worked in various functions, including clinical research, regulatory affairs, operational excellence, clinical quality improvement and clinical quality management. She was the Senior Regional Director, Clinical Quality Management Asia-Pacific in 2016 – 2024. In November 2024, she moved to the current RBQM position. Helen graduated with First Class Honors and a Bachelor’s degree in pharmacy from the University of Sydney, Australia and a Master’s degree in Health Administration from the University of New South Wales, Australia. She is a certified Lean Six-Sigma Black Belt and has a Academy of Clinical Research Professionals (ACRP-CP®) certification.

Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).

A strategic and accomplished leader with more than 20 years of resounding success in providing Medical and research expertise, with extensive experience in policy shaping and governmental affairs. Experiencd in protocol development, support and establishment of interventional studies, study design & efficient conduct across EMEA as well as Asia Pacific(Australia, New Zealand), understanding country and site medical and research need and engagement, drug development process, project management, quality and inspection readiness, statistical analysis and management, publication process on global & local level including the associated regulations and standard operating procedures, supporting all various therapeutic areas and expertise. Demonstrated strong expertise in the following areas • Start-Up, Activation, Initiation, & Strategies • Clinical Monitoring & Clinical Trial Applications • Protocol development, Compliance • Drug Development and Relationship Building, • Research Monitoring & Operations • Medical expertise CRO oversight • Real World Evidence and non interventional studies design, conduct and oversight • Data Analysis & Interpretation • Patient Safety & Quality Improvement • Country and international research regulations and contacts • Strategic Planning & Execution • Risk Assessment & Mitigation • Operational Delivery • Statistical software and biostatistical concept • Training & Development • Site Audits & Inspections, Medical Quality • Protocol Development and Oversight • Strategic Alliances & Partnerships • Clinical Project Management • Feasibility and site selection process • Pharmaceutical Knowledge Track record of success in providing strategic and insightful support to a broad range of academic & institutional research units, clinical research organizations and pharmaceutical research & development, an inspiring team leader with hands-on experience in accomplishing global assignments as well overseeing Middle East, Africa, Australia and New Zealand. Received multiple career promotions as recognition for consistent performance and exceptional contribution in supporting research establishment in the region since 2004. Chairwomen of the Pharmaceutical Research and Manufacturers Association Gulf (PHRMAG) Clinical Research since 2016 with a noble goal to support innovative medical research and develop groundbreaking solutions to improve the lives of many within the Gulf Region.