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

A little over 10 years of experience, as a Pharmaceutical Physician, with proven record of leading clinical studies successfully as Principal Investigator in multiple therapy areas; I founded AMELI-BIOGROUP, a physician-led clinical research site(s) established with the core intention of delivering high-quality, ethically grounded, and patient-centered clinical trials. Trained in Emergency Medicine in London, UK, with a focus on Infectious Diseases, Tropical Medicine, and Aviation Medicine, I was deployed to West Africa during the Ebola crisis, where I served. In recognition of service, I was awarded the Queen Elizabeth II Ebola Medal for Service in West Africa. Encountering some unanswered inherited conditions in my career led me to form AMELI-BIOGROUP LTD.—to raise awareness and to advocate for patients—guided by clinicians who understand patient care firsthand and prioritize safety, scientific rigor, and meaningful participant engagement.

Justin Bandura is the Patient & Site Engagement Team Lead for Obesity, Liver Health and Cardiorenal at Boehringer Ingelheim. He has previously held roles in medical device, sales, project management, and legal affairs. His passion for global cross-Human Pharma collaboration and strategic partnerships has been instrumental in driving innovation in study start-up and conduct across Boehringer’s trial pipeline. Justin is deeply committed to engaging external stakeholders with clarity and purpose, ensuring trial sites feel heard and supported, and helping position Boehringer as a sponsor of choice in patient and site engagement.

Carrie Ben Said is a visionary leader in global clinical trial operations and currently serves as Clinical Trial Teams (CTT) Center of Excellence (CoE) Head at Novartis Pharma AG. She has driven the formation of the CTT CoE and orchestrated a global transformation of CTT ways of working across more than 300 teams, positively influencing over 5,000 associates. Under her leadership, the initiative strengthened team dynamics and fostered a culture of collaboration and continuous improvement. Carrie also established a cross-functional leadership network spanning 40+ functions and oversaw the launch of a coaching academy for CTTs that accelerated transformation by 30%. Her work exemplifies scalable innovation, strategic collaboration, and a deep commitment to excellence in drug development. Carrie brings a rich blend of clinical, academic, and operational expertise to global drug development. She has led cross-functional CTTs as a Study Leader, overseeing strategic planning and execution of Phase I–IV trials in NSCLC, pNET, NET, and MCL, while effectively managing multiple studies with precision and impact. Her foundation in patient care including four years in neonatal and pediatric intensive care with ECMO certification—and academic research as part of Mt. Sinai’s Cardiothoracic Surgical Trials Network uniquely informs her science-driven, patient-centric approach to clinical excellence. She holds a Master's degree in Public Administration (Global Health Policy & Management) from New York University and earned a Bachelor's of Science in Nursing from the University of Texas.

Physician (Dr. med.) with 20 years of experience in the pharmaceutical industry: Medical Affairs, Drug Development (Lead of international project teams), In-Licensing, (Pharmaco)Epidemiology, Controlling/Project Budgets/Analytics in Clinical Operations. After heading a Data & Analytics Team for Clinical Operations, Frank recently moved into a Subject Matter Expert (SME) role advising on performance metrics, dashboards and various other topics related to Digital Transformation.

I am a Clinical Operations Lead at Novo Nordisk, with experience across the pharmaceutical and CRO industries, supporting clinical trial start-up and trial delivery. I bring both trial execution and trial oversight experience, with my current focus on the pre-planning and start-up phase—ensuring operational feasibility from a HQ, affiliate, site and participant perspective. I collaborate cross-functionally to translate operational needs into workable study plans, provide operational input to protocols and drive stakeholder alignment throughout the start-up process. I apply an end-to-end mindset to ensure that initiation activities set the foundation for high-quality, compliant trial execution.

Niklas BLOMBERG is the Executive Director of Innovative Health Initiative JU (IHI.europa.eu). Niklas joined IHI, the European public-private partnership for health research and innovation, in 2024. Prior to IHI, he spent 10 years as the founding Director of the European life science research data infrastructure ELIXIR (Cambridge, UK) and 14 years with AstraZeneca, leading teams across Sweden and the UK. Niklas is a Swedish national with undergraduate studies in biochemistry at the University of Gothenburg and a PhD in structural biology and bioinformatics from the European Molecular Biology Laboratory (EMBL) in Germany. In the IHI Public-Private partnership, Niklas enjoys the unique opportunity to bring together industry, academic, and civil society across the healthcare sector—from pharmaceuticals and biotechnology to medical technology and big data—and drive projects that address public health needs, improve patients' lives, and boost the competitiveness of Europe's health industries.

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.

Elena Bolanos Cascales is the Head of Global Clinical Operations for Europe Mid East and Africa (EMEA) Region. She leads a team across 24 countries providing end to end site-facing operational capabilities with key goal of delivering the clinical development programs with high quality on time and on budget. From her early days in Spain, Elena is passionate about making an impact in patients’ life through the acceleration of clinical research to have longer and healthier lives. Over 32 years in several pharma a biotech industries, she developed a good understanding in clinical development processes across multiple geographies. Before becoming Head od EMEA GCO, Elena served as Head of EMEA Head of Growth Countries, where he provided strategic direction to increase clinical research in those countries, with focus in underserved populations. Prior to joining J&J, Elena worked in Lilly for 26 years, where she starter her career in Clinical Research, and in Amgen, where she led the Global Site management and Data Management Organizations, developing a deep understanding of different cultures and geographies. Elena has designed, led, and executed several transformational projects that have resulted into improved efficiency and substantial savings in clinical development, while creating very effective partnerships at European and global level to leverage expertise. She is also passionate about developing and leading teams through success. Elena has lived in Spain, United Kingdom and Switzerland, giving her a dep appreciation of different cultures a how diverse perspectives can enrich progress in Healthcare. Elena in Pharmacist, and earned an MBA from Instituto de Empresa (IE), Madrid. She lives in Basel, Switzerland.

Julia Brodsky is Vice President, Data Strategy & Products within R&D Data Science & Digital Health at Johnson & Johnson. She leads a team focused on establishing an AI-ready, innovation-driven data ecosystem that integrates, standardizes, and productizes high-value R&D data—enabling scientists to rapidly apply AI/ML and generative AI, while embedding rigorous data governance and stewardship to ensure integrity, quality, and compliance. With more than 20 years in pharmaceutical data science and analytics, Julia is recognized for building enterprise-wide data strategies and scalable data platforms in close partnership with technology teams to unlock the value of data assets. Prior to joining J&J in May 2025, she served as Vice President, Head of Strategic Data Products at Novartis US Oncology, where she built and led a shared services organization delivering data and visualization analytics across all US business units, supporting 1,000+ users. Earlier, Julia held senior roles at Symphony Health Solutions; Organon and Sanofi. She has also served on scientific advisory boards and industry councils. Julia holds a BA in Computer Science and both a PhD and MS in Statistics from New York University.

I am an English man living in Madrid for 7 years. Shortly after moving I was diagnosed with pancreatic cancer. I thought I would be dead in a few months as my father had been who died of PDAC 40 years ago. Fortunately I am still here, at least for the moment, having gone through chemo radio and whipple. Now I live a pretty normal life divividing my time between patient advocacy work, spiritual assistance to others, carpentry and motorcycle journeys. In April and May 2026 I spent 7 weeks on the bike alone from Madrid to eastern Turkey. My own little pilgrimage in a way to where Sufism was strong for centuries and where the origins of our civilizations began in eastern Turkey (and Syria)

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.

Alessia Cantamessa is an RBQM specialist with deep expertise in protocol risk assessment, CtQ factor identification, and operational trial oversight. A pioneer in clinical AI integration, she focuses on bridging the gap between advanced technology and proactive risk management. Her work centers on leveraging AI-supported tools to standardize risk identification, ensuring study quality is robust, scalable, and audit-ready.

Dr. Guillermo Carbonell is a Senior User Experience Researcher at BI X, the digital innovation lab of Boehringer Ingelheim. With a background in cognitive psychology and human–computer interaction, he applies qualitative and quantitative research methodologies to guide product teams in creating digital solutions that serve users while delivering business value. Over the past year, Guillermo has worked closely with the Patient & Site Engagement team, co-creating with site coordinators to shape more usable trial technologies and processes. His work focuses on reducing technology burden, supporting sustainable site operations, and ultimately improving patient outcomes.

A global life sciences and healthcare executive leading change, transformation and innovation in patient engagement and clinical trials, through diverse and inclusive patient & HCP recruitment and collaboration, and leadership in equitable healthcare.

With over 12 years of experience in the Healthcare industry, I am Practice Head of Solution Design, Insights, Analytics & Data Science at GCO, Novartis, where I lead a network-based Product team of 40+ associates across solution design, data engineering, and analytics. I am passionate about problem-solving, and I have a strong track record of delivering innovative and impactful solutions and organizational transformation leveraging Data and Human-Centric Design thinking. Recently as a Digital transformation leader, I have successfully led and executed multi-million-dollar project delivery and transformation globally across Commercial and Drug Development, by collaborating with various Business Unit heads and Senior Leaders. I have also been instrumental in redefining and conceptualizing Planning as a Product and drove concept designs for digital Products across Portfolio acceleration, Site Selection, Competitive Intelligence, patient-centric solutions, Gen AI, and LLM-based use cases in Drug Development. Additionally, I serve as a strategic board advisor/Growth advisor, where I also partner with startups, scale-ups, and established organizations to accelerate their growth and transformation, using cutting-edge AI-driven strategies and tools.

30-year industry experience across CROs & Pharma working in Clinical Operations, Business Development & Procurement. Following a Biology Degree, I started my career as CRA working for Icon before moving into Business Development at Covance and subsequently Kendle (now Syneos). I joined Bayer in 2003 heading up a European Clinical Outsourcing function. As the outsourcing function developed and ultimately moved into the Global Procurement function at Bayer I assumed greater responsibility. Responsibilities have included leading regional teams across Europe & Asia for Pharma Development sourcing activities and Global teams responsible for Pharma Development Category strategy. During this time I was also heavily involved in the management of key supplier partnerships. I moved back into Bayer R&D to take a role leading an agile team to identify and manage a portfolio of future solutions supporting new approaches to clinical trial Planning and conduct to deliver faster, better, cheaper trials. Subsequently moving to the Alliance & Partnership Management function in my current role as Strategic Alliances Lead, leading the Bayer's key strategic projects with external suppliers to enable the organizations ongoing transformation.

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.

Ventsislav Dobrev is a seasoned healthcare and life sciences professional with over two decades of experience across pharma, medtech and healthtech. He has held leadership positions at large organizations including IQVIA, Novartis, Ypsomed and Roche. Currently, he leads a global function at Roche which is responsible to integrate digital biomarkers in clinical trials.

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.

Marcus is a Senior Manager of Feasibility at Biogen with 10+ years’ experience shaping data-driven feasibility strategies that set studies up for operational success. He focuses on strengthening feasibility methods and decision-making so teams can align early on the right operational approach and deliver studies faster and smarter.

Caroline is Clinical Innovation Leader at Janssen, where she leads transformational innovation projects that have the goal to shape the future of clinical trial execution at Janssen and position Janssen as a role model in patient-centred clinical research. She is passionate about empowering patients with their data and optimizing our trial designs to make clinical trials easier to participate in, such as virtual studies. Caroline has a background in Clinical Operations and Medical Affairs. She received her MSc in Biomedical Sciences in 2002 from the Antwerp University and her executive MBA from the Antwerp Management School in 2012.

Candice Fitzgerald is a pharmaceutical executive with 25+ years of experience in clinical operations and medical affairs across multi-national pharmaceutical companies (Roche, AstraZeneca, Alexion, Boehringer-Ingelheim, and Novo Nordisk). She has held various positions at Vice President level, setting strategic direction and vision, implementing and leading global organisational transformative change, cross-functional initiatives enhancing pipeline execution, evidence gap identification, and launch readiness. Other accomplishments include delivery of new target operating models (hybrid FSP / FSO), digital transformations, and customer engagement models that significantly enhanced productivity across the clinical development value chain. Her global leadership and executive oversight experience spans early to late stage development across 50 countries with diverse cultures and complexities. Originally from Australia, she has enjoyed an international career, moving to Germany with her family in 2021, and is currently located in Zurich, Switzerland. Candice holds a Master's Medical Science (Drug Development), University of NSW, Australia; a Bachelor of Applied Science (Health Information Management), University of Sydney, Australia; and a Harvard Certificate Executive Program for Senior Life Sciences.

Mette Flindt Heisterberg, Competency Development Specialist, Novo Nordisk. Mette has a background in academic research and has a PhD degree from Basic and Clinical Research in Musculoskeletal Sciences, Faculty of Health and Science, University of Copenhagen. Since 2017 Mette has worked at Novo Nordisk within Clinical Operations as trial manager and within the latest years as project manager on different innovative improvement projects.

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.

Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master's in Public Health from Liverpool University. Over 25 years of international experience within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications, and Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases. In the last 2 years, my main professional interest has shifted toward patient-centricity within clinical development, recently taking on new responsibilities as an R&D Patient Officer. The development and coordination of patient-centric activities within Clinical Development programs, support of global and local teams, identification of best practices, and development of KPIs are the main priorities of my new activity.

Eusebio García is a Senior AI Engineer and Data Scientist with over five years of experience applying artificial intelligence and advanced analytics in healthcare and life sciences. His work focuses on large language models (LLMs), natural language processing, Machine Learning and retrieval augmented generation to build secure, auditable decision support systems for regulatory, medical, and research workflows. At Bayer, he designs and deploys cloud native generative AI platforms that support evidence synthesis, feasibility assessment, and early stage study design by orchestrating multiple AI components across data aggregation, analysis, and scenario exploration. His work aims to reduce manual effort, accelerate insight generation, and enable more robust and timely R&D decision making.

Awara Gbéblewo is an Associate Director and Site Engagement Lead at CSL with over 15 years of experience in global clinical operations and strategic site partnerships. Shae has led complex clinical programs across Europe, North America and APAC working with lead organizations including Bristol Myers Squibb, Bayer and Boehringer Ingelheim. Her expertise spans site engagement strategy, clinical trial execution, operational excellence and cross functional leadership in global environments. She specializes in strengthening collaborations between sponsors, CROs and clinical sites to accelerate trial delivery while improving patient access and experience. Throughout her career, she has lead initiatives aimed at improving diversity and enhancing partnerships with healthcare institutions and local communities. Awara is passionate about shaping the future of clinical research through innovative engagement models and global collaboration.

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.

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.

Alejandro Gonzalez is a Senior Manager in Digital Innovation and Execution at Genmab with extensive experience in statistical programming, clinical trial data standards, exploratory analysis, and digital innovation. His work focuses on building controlled, reproducible AI-enabled workflows that augment clinical experts, reduce operational burden, and support scalable validation in regulated clinical environments. He is actively involved in advancing practical AI operating models that balance efficiency with transparency and human accountability.

Alessio Graziano is the Director of Study Start-Up within Research & Development & Sciences at CSL. In this role, he leads global clinical study start-up delivery and oversight, ensuring efficient, compliant, and timely site activation across complex, multi-country clinical programs. With extensive experience in clinical operations and study start-up governance, Alessio partners closely with internal and external stakeholders to drive operational excellence, cycle-time performance, and risk mitigation from study award through first site activation. He brings a strong focus on metrics-driven oversight, continuous improvement, and scalable start-up frameworks aligned with ICH-GCP and global regulatory requirements. Based in Italy, Alessio operates in a global, matrix environment, supporting cross-functional teams and senior stakeholders across regions to ensure consistent delivery, transparency, and accountability throughout the study start-up lifecycle.

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.

Dr Daphne Hazell is a GP, clinical research leader, and CEO of the Primary Care Research Alliance (PCRA), a rapidly growing UK network enabling commercial clinical trials across primary care. With over 20 years’ experience in NHS general practice and clinical research, she brings a unique combination of frontline clinical insight and strategic leadership in trial delivery. She is also Founder and Medical Director of Clinical Research Solutions, a CRO supporting sponsors in MedTech and real-world evidence studies, and Founder of a small boutique research nursing delivering decentralised clinical trials in community settings. Dr Hazell has led the development of research infrastructure spanning millions of patients, mentoring practices to transition from research-naïve to commercially active sites. Her work focuses on improving feasibility, site selection, and delivery reliability in primary care.

Nick brings over 30 years of experience in global clinical development, with a strong track record in driving operational excellence and transformation. Nick’s career includes leadership roles at major pharmaceutical companies such as Johnson & Johnson, GSK, Novartis, Altana Pharma, Chiron Biopharma, and Pfizer, as well as senior positions in the CRO sector. His expertise spans clinical operations, study and project management, data management, vendor oversight, and inspection readiness to MHRA, EMA, and FDA standards. Nick holds a BSc (Hons) in Pharmacology from the University of Edinburgh. He is passionate about advancing clinical development to improve patient outcomes and is active in supporting medical education and community initiatives in the UK. Outside of work, Nick enjoys spending time with his family, traveling, and staying active through sports such as squash. He’s also an avid follower of rugby and cricket.

Sara Huehls, MS, MBA—Associate Director, AI & Automation Lead, CDD Hub | Eli Lilly and Company Sara Huehls leads AI and automation strategy for Eli Lilly's Clinical Development and Design Hub, where she drives cross-functional evaluation, deployment, and change management for AI solutions across the CDDA Tech Agenda portfolio. With a Master's in Data Science and an MBA, she brings an unusual combination of technical depth and organizational change expertise to a portfolio spanning TMF automation, investigator-facing tools, process automation, and AI capability building. A certified PROSCI practitioner and two-time Lilly Innovator Award recipient, Sara is known for translating AI strategy into durable adoption—moving teams from tool deployment to genuine capability change. She also co-developed a graduate data science course with Indiana University using de-identified clinical trial data.

Lars Hulstaert is a member of the R&D Data Science. Lars has more than 5 years experience in data science, from building complex machine learning pipelines to leading teams of data scientists & data engineers. Much of Lars’ current work is focused on leveraging data science to support site selection, customer engagement, personalization & pharma R&D and commercial strategy. Before joining Janssen, Lars worked as a Data Scientist at Microsoft. In this role, he worked with strategic customers to develop data science solutions. Lars has experience working in Engineering and R&D teams to pilot new machine learning technology. Lars has a master degree in Machine Learning from Cambridge University, where he won a Google Award for his research work in NLP.

Daniela is an experienced expert in clinical research, with over 30 years of professional experience in nursing, clinical trials, and study coordination. After completing her training and working as a registered nurse, she transitioned into clinical research in 2008. Since then, she has worked as a study coordinator and team leader in oncology and neurooncology, including positions at leading German university hospitals, a contract research organization (CRO), Freelance Study Coordinator and currently conducts clinical studies at a neurology practice in Munich. Since 2019, she has served as Chair of the German Association of Non-Physician Clinical Research Staff (BUVEBA e.V.). In this role, she is strongly committed to enhancing the visibility and professional recognition of study coordination, as well as advocating for the introduction of mandatory, standardized training in this field. Her particular focus is on bringing greater attention—within the scientific community, policymaking, and the public—to the central role of non-physician clinical research staff in the success of clinical trials. She especially emphasizes the importance of study coordinators in ensuring high-quality patient care, structured study management, and the maintenance of quality in trial conduct. She actively contributes to multiple initiatives focused on advancing Germany as a leading clinical trials location and increasing public awareness of the vital role of clinical research.

I have over 10 years of Regulatory Affairs experience working globally with expertise in early and late-stage drug development as well as life cycle management of drugs. My work spans the regulatory assessment of clinical endpoints, clinical outcome assessments, and data-driven analyses for regulatory acceptability across FDA, EMA and other global agencies. I contribute to labelling strategies that address transparency, clinical interpretability, and consistency between clinical trial outputs and label claims, working cross-functionally to ensure labels remain scientifically robust, regulatorily defensible, and suitable for prescriber and patient facing communication.

Shafaat Ali Khan, MB, BS, Eli Lilly and Company Associate Director – Investigator Engagement Clinical Research Lead (CRL) Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials, driving efficiency and innovation in the field. With a strong focus on patient empowerment, Ali is on a mission to enhance patient education and improve access to novel investigational therapies and diagnostics. By leveraging advanced technologies and patient-centric approaches, Ali strives to break down barriers and ensure that more individuals can benefit from cutting-edge treatments. Recognizing the absolute need for achieving greater diversity in clinical trials, Ali is dedicated to promoting inclusivity and equity within the research landscape. By actively seeking to engage diverse patient populations, Ali aims to eliminate disparities in healthcare outcomes and contribute to more comprehensive and representative data. Ali's unwavering commitment to accelerating drug development is fueled by the desire to bring life-changing therapies to patients faster. He leads multidisciplinary teams at Lilly, to closely collaborate with sites and investigators to drive innovation across the drug development lifecycle. Combining his extensive expertise in clinical research with a genuine passion for improving patient outcomes, Ali is a catalyst for change in how clinical trials are conducted.

Garo Kiledjian is the Founder and CEO of SGM Alliance, a 501(c)(3) nonprofit advancing Sexual and Gender Minority (SGM) inclusion in clinical research, life sciences and healthcare ecosystem. He also serves as COO for Trialogic, a site network for the largest global HIV healthcare provider. A personal loss to AIDS inspired Garo’s dedication to addressing healthcare disparities for marginalized communities. His diverse experience in administration, research, pharmacy, and finance strengthens his leadership. Garo served on the Executive GALA Committee for the National LGBTQ Task Force, a historic advocacy group focused on grassroots legislative and policy changes in DC. He holds a Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

Dr. Naveen KK has worked in healthcare, CRO & ITES industries for 18+ years; he has experience working across pharmacovigilance, risk-based monitoring, cardiac safety services, and connected devices. Physician with MBA & Lean Six Sigma Black Belt Certification. He is currently working as Executive Director & Global Head, Central Monitoring, Medical Data Review, and Clinical Trial Safety in Labcorp.

Sven Knapinski has led CSL’s Site Engagement Team since 2024, driving initiatives to strengthen strategic partnerships with clinical research sites and institutions. He focuses on expanding and diversifying CSL’s global site network, centralizing organizational knowledge, and enabling more streamlined, effective engagement across Sponsors, CROs, and sites. With nearly 20 years of experience in Clinical Operations, primarily in Clinical Trial Management, Sven brings deep operational expertise and a strong focus on execution. He holds a PhD in Biology and began his career in a CRO, followed by experience in the medical device industry, before joining CSL (Vifor) over 12 years ago.

As Owner and Managing Director of LKL Consulting AS, I bring over 35 years of experience in the life science industry, including 25 years in leadership roles. My expertise spans clinical operations, medical affairs, and local/regional/global leadership. Through interim and consulting services I create value for organisations by combining strategic analysis with impactful execution, achieving strategic objectives and driving measurable business success. I have a strong track record of delivering complex strategic objectives, increasing performance, driving business transformation, leading high performing teams and building strategic partnerships. My leadership philosophy is strongly people focused, inspiring & empowering others through fostering a culture of trust, accountability and collaboration. What sets me apart is my unique combination of deep industry expertise, successful leadership in both country and international roles, and the energy I bring to every challenge. I’m passionate about driving innovation, delivering value, and making a difference for patients.

Dr. Maria Koufali is the first NIHR Life Sciences Industry Director. She provides pan-NIHR leadership of the strategy to transform engagement with the life sciences sector and the delivery of industry-led clinical research across the UK. Maria brings over 20 years’ experience spanning government, the NHS, academia and industry partnerships, with a focus on system-level leadership, strategic business development and trusted relationship management with the life sciences industry. Her work is focused on driving growth and competitiveness through enhanced clinical research delivery, clearer national interfaces and long-term partnerships with industry. Prior to this role, Maria established and led the UK Vaccine Innovation Pathway, working closely across government, the NHS, regulators and the global life sciences industry to accelerate vaccine and immune therapy trials. She has held senior leadership roles across the NHS, academia and the wider research system, and was awarded the NHS Leadership Academy Nye Bevan Award for Executive Health Leadership.

Arun Krishnamurthy is a Product Director for Risk-Based Quality Management (RBQM) at Novo Nordisk, based in Denmark. With over 20 years of experience in clinical development and operations, Arun has led enterprise-level strategies spanning process optimization, technology enablement, and organizational change. Prior to joining Novo Nordisk in 2011, Arun was with Accenture, where he held leadership roles in Clinical Data Management, delivering large-scale, outsourced solutions for global pharmaceutical clients. At Novo Nordisk, he has held leadership positions across Data Management, Biostatistics, IT, and Clinical Operations, driving transformation and digitalization initiatives. Arun currently leads a cross-functional program to embed a coordinated, proportionate, Quality-by-Design-driven and data-centric approach to risk and quality management—strengthening decision-making, cross-functional collaboration, operational excellence, and patient safety.

Sofija Krivokapic is a Data Science Lead in the Clinical Quality team within R&D Biopharmaceuticals at AstraZeneca, based in Warsaw, Poland. She designs and deploys scalable AI and NLP solutions for the clinical domain, applying advanced models to detect patterns and surface emerging themes that enable a proactive approach to clinical quality. She develops and leads enterprise-grade Power BI initiatives, translating complex analyses into clear, actionable insights for stakeholders. Her work is backed by a master’s degree in Cognitive Science from the University of Warsaw, with a focus on computational approaches across psychology, data science, AI, and linguistics.

Jason has over 19 years of experience working in Pharma, 14 years of which have been with Janssen. For the last 5 years, he has been a member of Janssen Clinical Innovation where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Janssen. Jason is the Focus Area Leader for Environmental Sustainability in Clinical Research and is leading the transformation of Janssen’s global clinical operations towards sustainability.

Disa has 15+ years of experience working in technology and innovation, especially in the pharmaceutical industry. She is the Head of Integrated Clinical and Operational Analytics at Johnson & Johnson. She was previously at UCB as the Head of Innovation and held other leadership roles. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. In 2017, Disa started a consortium, a cross-industry collaboration on blockchain via PhUSE. She was awarded Top 100 Women in Technology, Financial Times' top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech 2019. Recently, she co-authored a book titled 'Digital Health and Patient Data, Empowering Patients in the Healthcare Ecosystem'. Her passion is closing the gap for patients with unmet needs and exploring the right digital capabilities to accelerate the implementation of end-to-end patient solution.

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

Erbin Lim is a visionary data leader with a relentless passion for leveraging Artificial Intelligence to create transformative business solutions. Armed with a PhD in Computer Science and a wealth of technical expertise across the entire software stack, Erbin is at the forefront of revolutionizing industries through AI-driven innovation. Throughout his career, Erbin has demonstrated an exceptional ability to harness the power of AI to solve complex business problems. He has a track record of translating business requirements into cutting-edge AI solutions, earning him recognition as a trusted advisor among business stakeholders. At Pfizer, Erbin's strategic implementation of data and AI solutions revolutionized clinical trial site selection processes. Through his thought leadership, he introduced advanced Data/AI/ML methods that significantly enhanced data accessibility and decision-making across various business units.

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.

Piotr Maslak is Senior Director and Head of Emerging Technologies at AstraZeneca. He leads global efforts to transform clinical trials with digital platforms and AI – accelerating development and making research more patient-centric. Piotr has a track record of scaling enterprise AI solutions and driving award-winning innovation. Recognized for driving digital transformation in pharmaceutical industry, he is passionate about challenging conventions and shaping the future of clinical research.

Dr. Tariro Makadzange is an infectious disease physician–scientist and the CEO of the Africa Clinical Research Network (ACRN), a pan-African platform advancing equitable participation in global clinical trials. Building on a career spanning academia, industry, and global health, she now leads ACRN’s mission to transform how clinical research is designed and delivered across Africa by strengthening site networks, embedding high-quality operational standards, and enabling locally led trial execution. Under her leadership, ACRN integrates digital infrastructure, data systems, and AI-enabled tools to improve trial efficiency, participant identification, and real-world evidence generation, while advancing policy and regulatory engagement to create a more enabling environment for research on the continent. She is also deeply committed to community engagement as a core pillar of clinical research, ensuring that trials are accessible, trusted, and responsive to local populations. Dr. Makadzange’s work focuses on shifting Africa from a marginal participant to a leading contributor in global clinical development.

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.

Javier Malpesa holds a degree in Chemical Sciences and a master’s degree in Analytical Chemistry from the University of Barcelona, as well as an MBA from IDEC at Pompeu Fabra University. He began his professional career in the pharmaceutical industry in 1997 at Biomedical Systems, and since 1999 he has been associated with the Novartis Group, where he started in the Clinical Operations department as a CRA. Since then, he has progressively taken on positions of increasing responsibility: in 2002 as Development Coordinator for the Cardiovascular, Metabolism and Respiratory areas; in 2008 as Respiratory Medical Advisor; and from 2009 to 2016 as Global Monitoring Operations Head for Spain and, ad interim in 2015, as MSL Head in Rare Diseases. Since 2023, he has held the position of Study Site Operations Country Head for Iberia, as well as the role of Global Drug Development Coordinator also for Spain.

Yu Mao, MBA, PharmD, is Director at Janssen R&D (JRD) of Data Science and Digital Health as well as the DE&I Lead. In her current role, she leads the DE&I data science strategy across the JRD portfolio as well as advances a people first culture. Her focus is on developing novel data driven approaches to advance diversity in clinical trials end-to-end, with the goal to address health disparities and improve patient outcomes. She has been with Johnson & Johnson 5+ years, with strategic and operational experience in both the consumer and pharmaceutical sector. She is an ambassador for innovation and is a strong believer in data science and its ability to transform healthcare. Her foremost passion is for people and always strives to cultivate a strong, patient-focused culture.

Lydia Matombo, BSN, RN, PMP®, ACRP®-CP, is a Clinical Operations and Risk-Based Quality Management (RBQM) leader with more than 24 years of experience in global Phase I–III clinical trials across oncology and multiple therapeutic areas. She most recently served as Director of Clinical Operations at Merck, where she led enterprise-wide RBQM and data integration initiatives aligned with ICH E6(R3), E8(R1), and Quality-by-Design principles. A former trauma ICU nurse, Lydia brings a pragmatic, execution-focused perspective to trial design, site engagement, and risk-based oversight. She is a frequent speaker and session chair at SCOPE, DPHARM, and other global clinical research forums. She currently serves as Co-Founder of Clinavence, where she contributes thought leadership at the intersection of clinical operations, data quality, and modern trial execution.

Robert is a technology and innovation ecosystem gardener, dedicated to defining new methods for developing and deploying novel, value-adding solutions at scale for Novartis. His current mission is to imagine, design, and deploy an AI-powered decision-support backbone and rebuild our drug development processes around this technology core. Passionate about product-centric innovation and agile methodologies, Robert has led the development and scaling of several large-scale analytics and AI platforms across Novartis divisions and managed several technology platforms at scale. He explores data science approaches and partnerships to drive operational efficiency and empower associates with the data and insights they need for daily decision-making. Previously, Robert led strategy projects at BCG and has a background as a researcher in the medical imaging space and as a mechanical engineer specializing in joint biomechanics.

I am a clinical research–focused Learning & Development specialist dedicated to elevating site training from a compliance exercise to a driver of real-world performance. Site training should do more than confirm completion—it should strengthen judgment, reinforce protocol ownership, and shape the behaviors that underpin high-quality trial execution.

Emilio Neto is a clinical research and drug development executive with more than 23 years of global experience leading clinical trial operations and country organizations. He brings deep expertise across Neuroscience and Rare Diseases, as well as Vaccines, Respiratory, Cardiovascular, and Oncology, with experience spanning the full clinical development lifecycle at the intersection of strategy, operations, and execution. Throughout his career, Emilio has led and integrated multiple functions across clinical development, including clinical monitoring, project and program management, therapeutic strategy, feasibility and site selection, patient recruitment and engagement, and regulatory operations. His experience includes navigating complex and evolving regulatory environments, enabling compliant, efficient, and scalable trial execution across diverse global markets. In his current role as Global Head of Country & Site Operations at Biogen, Emilio leads global site and country operations, with accountability for site engagement and clinical monitoring models, EU Clinical Trials Regulation, and patient-centric execution of clinical trials from Phase I through Phase IV. His work focuses on advancing operational excellence, strengthening regulatory readiness, and enabling scalable, high-quality global trial delivery. Emilio holds a PharmD from the University of São Paulo, an MBA from Fundação Getulio Vargas (FGV–EAESP), and a certification in International Business Management from the UCD Smurfit School of Business. He is currently pursuing a Doctor of Public Health (DrPH) at the UNC Gillings School of Global Public Health, where his research focuses on leadership, health systems, and improving representation of underrepresented populations in US clinical trials..

Virginie Normand is Innovative Health Director, R&D at Johnson & Johnson Innovative Medicine. She has deep experience leading complex, high impact transformations, driving innovation to impact, and translating strategies into sustainable value—ultimately accelerating the delivery of medicines to patients.

Lord James O’Shaughnessy is Senior Partner for Global Policy at Newmarket Strategy, one of the UK’s leading independent health and life sciences consultancies, which he co-founded in 2021. James’s career has encompassed several senior policy positions in the UK Government, including the Prime Minister's Director of Policy and as a Minister at the Department of Health & Social Care with responsibility for innovation, research, and life sciences. He has been a member of the House of Lords since 2015. James is Chair of Cambridge University Health Partners, Visiting Professor at the Institute for Global Health Innovation at Imperial College, Trustee at Health Data Research UK, Non-Executive Director of Albion Enterprise VCT, and Patron of the Tessa Jowell Brain Cancer Mission. He carried out a landmark review of commercial clinical trials for the UK government in 2023.

Véronique has a background in statistics and programming. After a few years as statistician and programmer, Véronique entered Sanofi as Programming Group Head for Phase I studies, from 2003 to 2015, in Biostatistics & Programming Department (B&P) within CSO Platform (Clinical Sciences and Operations). Then she took a position as transverse coordinator for implementation of converged standards, processes, and tools in Biostatistics & Programming. In November 2018, Véronique was appointed as B&P Leader for Data Sharing and Transparency, as well as Privacy Champion.

Swapna is a clinical data management professional with a deep understanding of the regulatory requirements and industry standards that govern clinical data management. She is passionate about initiatives leading to improved trust & acceleration of clinical research and is driven by the ultimate purpose of transforming patients’ lives. As a dedicated proponent for patient centric innovation, she is currently championing Individual Participant Data Return. Over the past 12 years, she has held multiple roles within data management and worked on a wide range of clinical trials (Phase I to IV) with diversified parties such as CROs, pharma, and biotech.

Chelsea Ranger is Chief Business Officer at Possibia, a startup developing an agentic platform to advance patient engagement and address process bottlenecks in clinical trials. She has 15+ years in early innovation, commercialization, & startup growth in Nordic health tech and life sciences, as well as a clinical background in hepatology / gastroenterology. As Founder & Chair of Women in Life Science Norway (WiLD Norway), she advances diversity & equity across leadership, board, founder, & investment roles, creating growth pathways for balanced representation and advocating for the direct links to women's health. She also serves as Ambassador for Women’s Health 2040 under the Nordic Charter for Women’s Health 2040, advocating for systemic, evidence-based action to elevate women’s health as a central priority across the Nordic region.

Dr. Bhargava Reddy has over 21 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.

Amy Ripston is the Founder & President of the Biospecimen Management Consortium (BMC), a non-profit organization dedicated to driving sample excellence in clinical research. Founded in June 2024, the BMC mission is to raise awareness of the importance and criticality of biospecimen management, develop industry standards and best practices, and advocate for change within the clinical trial ecosystem through standardization, policy, and thought leadership.

Sharon Rivera-Sanchez is a global health advocate, Triple-Negative Breast Cancer survivor, and the founder of Trials of Color, a nonprofit organization dedicated to bridging health equity gaps by increasing diversity in clinical trials. After participating in five clinical trials and losing her brother to colon cancer, she transformed her personal journey into a mission to redefine the future of clinical research through the lenses of equity and inclusion. An impactful speaker on the global stage, Sharon has presented at ASCO, AACR, DIA (Switzerland), and ESMO (Germany), bringing a vital patient perspective to international audiences. She is a trained Clinical Trial Ambassador through the University of Pennsylvania’s Abramson Cancer Center and recently contributed to FDA drug development sessions powered by GRASP Cancer, effectively bridging the gap between lived experience and medical innovation. Sharon currently serves on several prestigious advisory boards, including the National Cancer Institute and Massey Comprehensive Cancer Center. Through these roles and her leadership at Trials of Color, she continues to champion a future where medical research is accessible, inclusive, and driven by the communities it aims to serve. With 11 years of survivorship, Sharon combines professional strategy with a deep-rooted passion for community engagement. She Pioneered the “Bring a Friend to Clinical Trial” in 2024 where diverse patients have successfully joined different trials. Sharon is currently leading vital awareness campaigns for underserved populations across multiple states, focusing on reducing treatment barriers and improving public policy. Her unwavering dedication to advocacy is fueled by a commitment to driving systemic change and achieving true health equity in global healthcare.

Tracey Robertson is the Data & Analytics Lead within Clinical Development Operations, bringing deep cross-functional leadership experience spanning digital trials, data strategy, global systems implementation, and organizational transformation. Since joining Boehringer Ingelheim in 2004, she has held strategic roles across Patient & Site Engagement, Biostatistics & Data Science, IT for regulatory systems, and global process innovation, following an early consulting career serving major pharmaceutical clients. She holds a BSc (Hons) in Technology & Business Studies and an MBA in Information Management, complemented by PMP and CSM certifications.

Kayleigh Rogers is the the Head of Business Development and Alliances for Siteworks Clinical Research, a network of clinical research sites based in Germany. She has spent more than 10 years in business development and commercial roles in drug development and clinical trials and is a passionate advocate for continuous improvement in the clinical trials ecosystem.

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.

Experienced Clinical Research Specialist with an extensive background in the application of technological tools in clinical scenarios. High intensity worker with 9+ years’ experience in management of simultaneous projects including planning and design of the solution, on-time delivery reports and highly effective problem solving skills.

Nidhi Saxena is a healthcare leader with 20+ years of experience spanning market research, global operations, data & insights, and patient engagement across multiple Fortune 500 companies. She currently leads Global Patient Engagement Strategy at J&J R&D within Global Development, driving patient-centric innovation and large-scale solutions. Known as a collaborative, solution-driven leader, Nidhi focuses on transformation, patient and site centricity, innovation, and talent development to mobilize for impact.

Stephen's focus and attention remains on unifying the Drug Development process to create a more efficient and streamlined process. Thermo Fisher is the only company providing this significant value add to customers for a true end to end solution. The CDMO & CRO integration is a challenging one and Thermo Fisher is poised as the first and only company to have this offering to deliver ROI to Biotech & BioPharma. Stephen is also leading the Commercial efforts and engagements with VCs globally to bring valuable solutions to their investments with creative financial solutions and opportunity to accelerate the drug development process.

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.

Shalome Sine is a Senior Manager and Quantitative Insights Specialist at the Center for Information and Study on Clinical Research Participation (CISCRP). Shalome believes that the patient's voice can be a powerful force toward building inclusive, efficient clinical trials. Through her work, she hopes to help clinical trial sponsors and teams bring actionable patient insights into practice to improve operational processes. Shalome manages both quantitative and qualitative patient voice projects, specializing in quantitative, survey-based insights from patients and the public. She holds a Master of Public Health from Tufts University and a Bachelor of Science from Penn State University.

Malgorzata Skrzypczak is a Director, Data Surveillance at Pfizer, where she leads global approaches to risk-based quality management and centralized monitoring. She began her career in the clinical trial space over a decade ago, gaining hands-on experience across clinical data, analytics, and programming that continues to shape her leadership approach. In her current role, she defines scalable RBQM strategies and oversees the technical foundations that enable reliable oversight. Her work spans data integration, standardized processes, and the adoption of technology-enabled monitoring models across complex clinical programs. She brings a pragmatic, execution-focused perspective to advancing data-driven oversight in clinical development.

Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics, and innovation adoption. His research often focuses on protocol complexity, clinical trial participant and site burden, and diversity and representation in clinical trials. He also leads the analysis for the PACT consortium, which collects granular data on the use of DCT solutions and metrics of performance for the trials that deploy them. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University. He has worked as a research assistant at Harvard University and at the University of Massachusetts and began at Tufts CSDD as a research analyst.

Stathis Stathelos is a Senior Director of Feasibility and Portfolio Delivery at AstraZeneca. With over 18 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.

I, Jozien Sterck, am the Assoc Director of the Clinical Development Center Netherlands (CDC NL) at Novo Nordisk, where I lead the strategic and operational oversight of the clinical trial portfolio in the Netherlands, aligned with global R&D objectives. I hold a PhD from the Free University Amsterdam and have more than 30 years of experience in clinical research, including progressive leadership roles at Novo Nordisk since 1996. Throughout my career, I have been responsible for the oversight of clinical trials across multiple therapeutic areas, driving trial execution excellence, organisational development, and continuous improvement within clinical operations. I combine scientific depth with strong people leadership and a focus on compliant, high-quality clinical research delivery.

Adrienn Szabo (She/Her) is a clinical operations leader with over 15 years of experience driving global trial execution, patient centric innovation, and operational excellence. As Associate Director of Scientific Recruitment & Retention at Novo Nordisk, she leads high impact teams that shape recruitment, retention, and community building strategies for late phase clinical programs. Known for her visionary mindset, dynamic leadership style, and talent for uniting diverse trial stakeholders, Adrienn has built a career on elevating trial performance through structured insights, exceptional communication, and energizing team cultures.

Lawrence Tallon is the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). He was previously Deputy Chief Executive at Guy’s and St Thomas’ NHS Foundation Trust, where he led the Trust’s approach to strategy, technology, innovation, and improvement. He has extensive experience across the healthcare sector in strategy and leadership roles, including within the Department of Health and Social Care alongside ministers and NHS leaders. Lawrence is committed to patient safety and healthcare innovation, as well as life sciences and risk-proportionate regulation.

Stacy Tegan is the Program Director at TransCelerate Biopharma, Inc., a not-for-profit organization collaborating to converge clinical research and clinical care. In her current role she oversees efforts to digitize clinical trial protocols, increase the integration of EHRs into clinical research processes, and enable pragmatic trials to be conducted at the point of care. She has 20+ years of experience improving regulatory and clinical processes, and expertise in project management, strategic planning, digitization, and change management. Stacy is passionate about taking improving the community, with a history of volunteerism at the Drug Information Association (DIA), youth organizations, and she currently serves on her local Environmental Advisory Council.

Prof Andrew Ustianowski is a consultant and clinical researcher in Infectious Diseases at the Regional Infectious Diseases Unit, Manchester, UK. He has been a PI/CI on over 120 studies and won national and regional awards for research delivery and recruitment. He is the Network Director of the NW Regional Research Delivery Network, National Institute for Health and Care Research, encompassing a population of 7 million, over 30 secondary care sites and several hundred wider care setting sites. He was the interim National Executive Director/CEO for the launch and establishment of the national Research Delivery Network, and was the designer and lead for the UK’s COVID Vaccine Research Programme and subsequently the UK’s Vaccine Innovation Pathway. He trained at Guy’s Hospital, London, within the North Thames Region in Infectious Diseases, Tropical Medicine and General Medicine, and undertook a PhD at University College London.

Stan van Belkum has 8 years experience within the National Institute for Public Health and the Environment (RIVM) initially as quality reviewer and later on as Deputy Head of the Medicines Evaluation Department. He is a Pharmacist by training. In 2001 he joins the Medicines Evaluation Board (MEB) holding different positions, from Programme manager to Head of Departments. During this period he has been member of several national and international working groups on electronic submissions, amongst which ICH M2. From 2013 to 2021 Stan van Belkum has been Deputy Director of the MEB responsible for the all primary business processes and operational management (350 FTE, budget 50M€). In 2021 he switched from the MEB to another competent authority in the Netherlands, the Central Committee for Research with Human Participation (CCMO) as Chief Executive. Main legal responsibility of the CCMO is protecting participants in medical-scientific research together with 12 other Medical Research and Ethical Committees (MREC) the Netherlands. Stan van Belkum is member of the Dutch Clinical Research Foundation (DCRF), the Heads of Medicines Agencies (HMA) and the Accelerating Clinical Trials in Europe (ACT-EU) Steering Group.

Viviënne van de Walle is a physician specialized in clinical research and certified in clinical pharmacology and pharmaceutical medicine. She is the founder of VivHo, a life science consultancy, and PT&R—Partner in Trials & Research, an independent research site in the Netherlands. She serves on the Global Exam Committee for the Certified PI Program (ACRP) and is actively involved in CISCRP, NVFG, ACRP, and SCRS. In recognition of her contributions, she received the Christine K. Pierre Site Impact Award (2022) and Healixia (2025). Vivienne has a strong focus on patient centricity, the use of eCOA and AI in research, and is widely known as the industry’s “unicorn”. With over 25 years of experience, she is a speaker, mentor, and bridge builder, passionate about sharing knowledge and sparking creative solutions: “I love it when you pick my brain.”

A passionate, dynamic, and forward-thinking leader with 20 years of international experience in a variety of leadership roles in the pharmaceutical industry. Skilled in global clinical operations, change and performance management, and building/leading high-performing global teams. Ability to effectively engage, adapt, and lead in a rapidly evolving environment. Passionate about working with people, driving teams, and building network at all levels. Global experience in working across multiple geographical areas including Europe, U.S., Emerging Markets, and Asia Pacific.

Eric is Director of Strategic Projects—Alliance Management (Clinical Operations) at AstraZeneca, where he manages a multi-year program redesigning how Clinical Operations partners with CROs across both the Biopharma and Oncology portfolios. His central lesson from the trenches: changing your sourcing model doesn't just change who does the work—it pressure-tests every assumption in your operating model, from governance to technology to how your own teams are structured. Before AstraZeneca, Eric led growth strategy and advanced analytics at BD (Becton Dickinson) and delivered cross-industry transformation engagements at Deloitte. Based in Barcelona, he works across English, Spanish, and Catalan.

Malgorzata Walczuk is a Director of Clinical Quality Performance at AstraZeneca, where she leads the Analytics Implementation Service and spearheads change management initiatives related to analytics. With 20 years of experience in the pharmaceutical industry, Malgorzata has a robust background in quality and compliance, having successfully led numerous projects aimed at enhancing compliance, proactive quality, and inspection readiness on both regional and global scales.

In his current role, Edward is leading Oncology Strategic Site Partnership within Global Site & Study Operations in R&D Pfizer. Driven by a deep passion for partnerships with sites and networks, Edward is committed to enhancing these key customizable strategic relationships across all Therapeutic Areas, cultivating the best partnership for the treatment of all patients globally. Edward started his career in the NHS in UK before transitioning to the pharmaceutical industry, in which he followed a dedicated carrier path from Clinical Research Associate to Senior Director, Regional Clinical Trial Management. Edward is committed to understanding site needs and fostering collaboration to maximize delivery/simplification of activities, driving impactful initiatives and relationships that elevate standards globally.

Gernot Weber is a data and digital transformation leader with 10+ years of experience across J&J, Merck KGaA (Darmstadt), and Novartis, where he focused on unleashing the power of data and digital to innovate clinical trials. Gernot has led cross-functional teams and multi-product portfolios, developing enterprise data strategies, AI/ML products, and clinical platforms spanning semantic interoperability, protocol automation, and advanced analytics. A particle physicist by training with a PhD from research at CERN (Switzerland) and Fermilab (USA), and an Executive MBA, Gernot bridges science, technology, and business to solve complex problems in global R&D.

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.

Dr. Aleksandra Wlasenko is a Study Director Community Lead at Novartis, where she bridges the gap between complex clinical execution and cutting-edge digital innovation. She leads functional activities within Study Leadership that provide operational support for clinical trial execution across all trials of the portfolio in the Novartis Development organization. With a Ph.D. in biomedicine, an M.Sc. in Biotechnology, and over a decade of experience leading global clinical trials, Aleksandra oversees the strategic execution of Phase 1 Radioligand Therapy (RLT) trials while simultaneously driving the large-scale integration of generative AI across the Study Leadership organization. As a champion for digital transformation, she established a global SME network to scale AI adoption among over 200 Study Leads, focusing on practical governance, human-in-the-loop decision-support tools, and the long-term professional growth of clinical teams. Her leadership is defined by a unique ability to translate emerging technologies into auditable, value-adding operational realities that enhance trial delivery and cross-functional excellence.

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.

Jacklynn Wong is an Associate Director, Program Team Leader on the Investigator and Patient Engagement team at Johnson & Johnson. She leads a team in the development and execution of global patient recruitment, retention, and site engagement strategies across multiple therapeutic areas. Jacklynn is passionate about shaping the future of clinical research through innovative patient-centric approaches and firmly believes that research should be designed with patients' needs at the forefront. Prior to joining Johnson & Johnson, she supported strategic service line growth, patient experience, and frontline operations within integrated health networks and hospital systems. Jacklynn holds a Master’s degree in Healthcare Administration from George Washington University and a Bachelor’s degree in Psychology with specializations in biology and global health from Villanova University.

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.