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Silvia Alonso Rodriguez, Associate Director, Operations Lead, TSEM (Translational Science & Experimental Medicine), AstraZeneca
Silvia is currently working at AstraZeneca as Associate Director-Operations Lead in TSEM (Translational Science & Experimental Medicine) in early R&I and has a particular interest in the areas of Innovation, Patient Centricity, and Digital Health. She joined AZ in 2019 as a Biosamples Project Lead within PMB and Silvia’s first involvement in a PCS case study triggered her interest in decentralized trials and the patient centricity work. Prior to AstraZeneca, Silvia worked at the University of Cambridge and before that at various life science, pharma, and biotech organizations in Switzerland and Spain, such as Roche Glycart, ETH Zurich, 4-Antibody AG, Covance CLS (now Labcorp), INIBIC (Instituto de Investigacion Biomedica A Coruna)-Hospital Infantil Teresa Herrera and Centro Oncologico de Galicia (COG). Silvia has a scientific background and holds a biomedical clinical laboratory degree obtained in Spain.
Katie Baca-Motes, Chief Strategy Officer, CareEvolution / Scripps Research Digital Trials Center
Working with collaborators around the globe on research efforts showcasing the potential for accelerating the transformation of healthcare-better prevention, faster diagnosis, improved treatments-through innovation in digital health and the continued advancement of a digital, decentralized clinical trial model which can serve as the roadmap for transforming healthcare delivery. Katie Baca-Motes brings 14+ years of experience running large-scale research programs. She’s known for bringing innovation to the field of clinical research; for example, bringing the practice of A/B testing to build the mSToPs study cohort, one of the first remote site-less clinical trials. As the Co-Investigator and Director (2016-2021) of The Participant Center component of the All of Us Research Program (administered by the National Institutes of Health), she led the teams who built out a national infrastructure that enables “anyone, anywhere” to enroll in the program and she led innovations in digital and community-level engagement and in participant retention practices. She’s partnered in pioneering efforts such as working on some of the first studies to utilize patient-mediated EHR capture via SMART on FHIR. In early 2020, she co-founded the Scripps Digital Trials Center and launched DETECT, a COVID-19 research platform using wearable data for early detection and understanding progression of disease, factors for Long COVID, and vaccine response. In 2021, she launched the PowerMom Consortium, focused on accelerating maternal health research and decreasing health disparities. Katie’s expertise includes strategic partnerships, clinical trial enrollment, decentralized clinical trial structure, remote patient/participant monitoring, patient motivations, incentive structure, and behavioral economics. She’s passionate about bringing communities together to tackle health challenges, improving representation in research, and decreasing health disparities.
Richard Ballerand, Patient Advocate, EUPATI Fellow, NICE Technology Appraisal Committee Lay Member
A patient advocate and digital health engagement advisor who is active across British and European health sector, Richard's roles include: EUPATI Representative, ERA4Health Strategic Advisory Board, Advisory Board, Healthcare Transformation Academy, EIT Health, Diversity in Clinical Trials Research Group, Cancer Research CRUK, Co-chair, THIN Advisory Committee (The Health Improvement Network), Patient Expert Board, Paris-Saclay Servier Research & Development Inst., Executive Group, useMYdata (movement of patients, relatives, and carers), Public Governor, Chelsea and Westminster Hospital NHS Foundation Trust, Patient Group Consultative Forum + Medical Devices RegsGroup, MHRA, Fellow, EUPATI European Patients’ Academy on Therapeutic Innovation, Fellow, Royal Society of Medicine (serves on Medicine and Society Council). Richard draws on extensive lived family experience of British, French, and American healthcare systems - including advocacy, clinical trials, and care coordination. Having sustained a traumatic brain injury during his doctoral studies, he has particular interests in those with invisible disabilities and the challenges facing both ex-military and diverse communities. https://www.ballerand.net @RMBallerand
Luiz Barberini, Head, External Manufacturing Operations, Bayer SA
MBA, mechanical engineer, ASQ’s CQE and APICS’ CSCP & CPIM certified, with post-graduations in Marketing, Logistics and Transports, has worked for almost 30 years in activities related to Supply Chain, Production, Procurement, Demand management and Logistics. Ford Motors Co., Rhone-Poulenc, British American Tobacco, Pfizer, Takeda Pharmaceutical and Merck, Sharp & Dohme are some companies where he has worked for and added value through his knowledge and experience. Currently works as Operations Manager for Latin America External Manufacturing Operations Consumer Health at Bayer. Besides this role, teaches and coordinates courses of Negotiation, Supply Chain and Demand Management for some major post-graduation schools in Sao Paulo. Plan is to conclude his Masters in Supply Chain/Production Engineering by March 2022. In his personal life, loves to use his time with his family & dogs, but also traveling. Additionally, he is also an avid target shooter, teaching gun principles at the state Police Association.
Dorothee B. Bartels, PhD, Chief Digital Officer, AETION
Dorothee B. Bartels is Global Head of Real World Evidence and Digital Sciences at UCB after having been Clinical and Real World Data Strategy Lead at X, Moonshot (Alphabet). Before, she used to be Corporate Head of Global Epidemiology at Boehringer Ingelheim (BI) for 10 years and for nearly two years Chief Digital Science Officer in the digital incubator of BI. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. Her research is focused on secondary data use and data linkages, on innovative real world data analysis approaches, new strategies for faster drug developments and approvals, and digital epidemiology, in particular combining AI/ML and traditional epidemiological methods.
Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH
Deirdre currently serves as SVP, R&D Strategic Operations for CSL. In this role she leads a multi-functional “nerve center” for R&D designed to leverage and connect capabilities across the organization to integrate the business management of R&D; enable data driven insights & decisions; provide operational excellence; enable high performing teams and embed patient focus into the delivery of a diverse and innovative portfolio. Strategic Operations includes Clinical Development Operations, R&D Project & Portfolio Management, Integrated Business Operations, R&D Enabling Technology, R&D Patient Partnerships, and R&D Japan. Previously Deirdre has led Clinical Development Operations organizations at Nektar Therapeutics, Endo Pharmaceuticals, and Otsuka Pharmaceuticals. She also held significant leadership roles establishing innovative models dedicated to bringing clinical trials to community physicians and their patients. Additionally, her background includes working in a CRO and a start-up software company. This diversity of experience has given her a broad and global perspective of the clinical research industry. Deirdre strives to be a servant leader who operates with humble confidence and a healthy curiosity about people, projects, and process. Her leadership expertise is in creating inclusive teams and environments that allow for innovation, performance excellence, and personal development. She has been awarded an HBA Rising Star and PharmaVoice 100 of the Most Inspiring People for Change Agent category. Deirdre’s professional passion is in partnering with patients and their providers for increased and optimized opportunities for clinical trials. Personal passions include family, travelling, a well-crafted cocktail, a good book, and any reason to laugh!
Dylan Bechtle, Associate Director, Regulatory Policy and Intelligence, The Janssen Pharmaceutical Companies
Dylan is an Associate Director in Janssen's Global Regulatory Policy and Intelligence group. In his current role, Dylan is responsible for US policy-shaping activities on the topics of decentralized clinical trials, clinical trial diversity, and advanced therapies. Dylan played a formative role in the Decentralized Trials Research Alliance (DTRA) Workstream 4B, which focused on regulatory gaps for the conduct and operationalization of decentralized trials. Subsequently, he has remained involved in DTRA's regulatory forum which addresses the evolving regulatory landscape surrounding DCTs and drives the creation of work-product to guide sponsors, sites, and CROs through this regulatory landscape. Prior to joining Janssen, Dylan worked for a variety of roles at Genentech including in regulatory policy, where he focused on similar topics as those he covers in his current role. Dylan has BAs in Molecular and Cell Biology & History from UC Berkeley, an MS in Biotechnology from Johns Hopkins University, and is currently in his third year of a part-time JD program at American University Washington College of Law (AUWCL). He lives in Washington DC with his wife.
Frank Berger, PhD, Global Clinical Operations, Head of Analytics, Boehringer Ingelheim Pharma GmbH & Co. KG
Physician (Dr. med.) with 20 years 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. He is currently Global Clinical Operations, Head of Analytics at Boehringer Ingelheim Pharma GmbH & Co. KG.
Laurence Birch, CEO, Anju Software
With over 30 years’ experience in industry-leading SaaS and Life Science Technology organizations, Laurence (Larry) P. Birch has held leadership positions in General Management and Finance, focusing on delivering optimal solutions from corporate strategy to financial health. He earned an MBA and MM Degree from Northwestern University's Kellogg Graduate School of Management, and a Bachelor of Science Degree in Finance from the University of Illinois.
Johanna Blom, PhD, Associate Professor, Behavioral Neuroscience; Chair, Ethical Committee for Research, University of Modena and Reggio Emilia
Dr. Johanna MC Blom, Associate Professor in Psychobiology and Pediatric and Behavioral Neuroscience, University of Modena; Former Associate Director of the Part-time Graduate Program in Developmental Psychology, and Associate Prof. of Psychobiology and Behavioral Brain Sciences, Johns Hopkins University, Baltimore, USA. Coordinator of the long-term follow-up of children with cancer and the use of psychotropic drugs, AIEOP; Member of PANCARE, SIOP, and the International Guideline Harmonization Group (IGHG) for the development of Psychosocial and Neurocognitive surveillance guidelines for survivors of childhood cancer. She is currently Chair of the Ethical Committee for Research of the University of Modena and Co-coordinator of the IMI-JU project FACILITATE. Expert in multidisciplinary behavioral toxicity studies linked to child abuse and severe and chronic diseases in childhood. Experience in longitudinal follow-up studies and innovative data driven network analysis as a tool to detect and predict the driving forces of disability using digital data. Her current interests lie in (digital) assessment tools to detect early signs of cognitive and behavioral problems and designing decision tree algorithms by using network analysis and dynamic mapping to understand the driving factors of the trajectory that moves a patient from being at risk to full blown pathology especially during adolescence and test the effectiveness of treatment by linking them to outcome values dynamically recorded in an ecologically valid way.
Natalia Buchneva, Risk Management Lead, Clinical Data & Innovation, UCB
More than 19 yrs 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 (2020-2022) and US-EU GCP Inspection Mutual Recognition Agreement (2019).
Ruben Buendia Lopez, PhD, Associate Director, Data Science, AstraZeneca R&D
Ruben Buendia is a data scientist for insights in cardiovscular disease at AstraZeneca. His current position is focused on machine learning and data analitics for large heart failure clinical trials. It is now a decade ago since he was awarded with a PhD in Biomedical Engineering by the Royal Institute of Technology in Stockholm (KTH). Since then, he has spent half of his career in academia and the other half in AstraZeneca.
Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR, The Janssen Pharmaceutical Companies of Johnson and Johnson
Over many years, I built up a broad experience in IT. Going from business oriented, working with senior executives on how IT solutions could best support them, to technically oriented knowhow in architecting IT infrastructure and applications. Roadmaps, investment decisions, application development, implementations and operations are very familiar. My passion for being intellectually challenged in order to create solutions, combined with my eagerness to guide and work with teams with a positive can-do mentality in order to grow, have been key elements in my career. Although I got to know multiple technologies and many different business areas, I see 2 elements that always return: the importance of insights from data for the business and team working. My servant leadership style, my optimism, my diplomatic attitude, my drive to come to solutions and my eagerness to learn new technologies and approaches are my key strengths. I’m passionate being in a business and innovation supportive role addressing technology challenges. My purpose is to grow the business through more efficient and smarter functioning thanks to insights from data and decision supporting technology solutions.
Raul Castellanos Moreira, MD, PhD, Rheumatology Medical Lead for Spain & Portugal, Bristol Myers Squibb Co.
Raul Castellanos Moreira is a Medical Doctor specialized Rheumatology. He has a PhD from the University of Barcelona which was focused on precision medicine with prognosis & treatment prediction biomarkers. After enjoying an over 10 year career in the hospital clinical practice and academia he joined pharma industry at Bristol Myers Squibb in 2021. His current position as the Rheumatology/Fibrosis Medical Lead for Spain & Portugal at BMS. Now Raul, is leading the medical affairs agenda, collaborating in the clinical development of various molecules at different stages and has great interest in the implementation of new technologies (such as AI, big data) in the generation of real world evidence.
Lindsay Chandler, Clinical Research Program Manager, Phase I Multi-Indication and Thoracic Clinical Trials, Providence Portland Cancer Institute
Lindsay Chandler, BA, CCRP, is the Program Manager for all Phase I Multi-Indication and Thoracic Clinical Trials at Providence Portland Cancer Institute. She was most recently the Research Administrator over the Clinical Trials Unit in the Department of Dermatology at Oregon Health & Science University. In her 18 years of research experience, she has held roles in clinical trial coordination and regulatory management in both oncology and behavioral neuroscience fields.
Greg Cinciala, Director, Risk Evaluation & Adaptive Integrated Monitoring, Clinical Trials, MSD
Grzegorz Cinciala is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In his role of Risk & Analytics Lead he is accountable for ensuring that sound risk evaluation and central analytics principles are incorporated into clinical research programs conducted by Merck Research Laboratories. This includes operational risk evaluation and central analytics management through translation of critical data & processes into Risk Evaluation deliverables and execution of Quality Tolerance Limits, Key Risk Indicators, and central analytics components. Grzegorz collaborates with other Clinical Development functions, Quality Assurance, Ethics’, and compliance, to ensure alignment and development of the REAIM capabilities. Grzegorz has more than 10 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 and being involved in Society of CDM groups focusing on RBDM and Innovation council. He is committed to developing an RBQM center of excellence at MSD and has been leading MSD’s inaugural execution of E2E RBQM via Analytics. Grzegorz holds a Master of Science degree in medical biotechnology from the University of Medical Sciences in Poznan, Poland.
John Corcoran, Director, Decentralized Trial Solutions, Q2 Solutions
John Corcoran is a seasoned Director of Decentralized Trial Laboratory Solution at Q2 Solutions, a wholly owned subsidiary of IQVIA. With more than 20 years of experience in the decentralized clinical space, John has cultivated a deep understanding of the challenges and opportunities associated with bringing studies to participants, and has developed a reputation as a leading expert in the field of decentralized trial solutions. Throughout John’s career, he has been instrumental in the design, implementation, and management of innovative decentralized trial solutions that have helped to streamline the clinical trial process and improve patient access to cutting-edge treatments. John’s expertise in leveraging technology to create seamless, patient-centric trial experiences has led to numerous successful studies across a range of therapeutic areas. As a Director of Decentralized Trial Laboratory Solution, John brings a strategic approach to trial design and execution, working closely with cross-functional teams to ensure that studies are efficient, effective, and meet the needs of both sponsors and participants. John is a passionate advocate for patient-centric research and is dedicated to advancing the field of decentralized trial solutions through ongoing innovation and collaboration. In John’s current role, he oversees the development and implementation of decentralized trial laboratory solutions, ensuring that studies are conducted in compliance with regulatory requirements and industry best practices. John is a respected thought leader in the clinical research community and is frequently invited to speak at industry events and conferences.
Gracy Crane, PhD, Global Regulatory Policy Lead for RWD, Roche Products Ltd.
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.
Kevin Dolgin, Associate Professor, IAE University of Paris; Co-Founder, Observia
Kevin Dolgin is the Co-Founder of Observia - an organisation that designs and manages patient adherence programs in France, as well as providing research and consulting about patient support throughout the world. Kevin is also a part-time professor at IAE in Paris (Universite de Paris I, Pantheon-Sorbonne), Via IAE he has also taught in business schools in Vietnam and China, as well as for the Global Partners MBA program in partnership with the University of Atlanta (USA).
Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
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.
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Jennifer Duff, General Manager, Zelta, Leadership, Merative
Jennifer has over 25 years of experience in Life Sciences, specializing in enabling and scaling industry-leading services and technology solutions with clients. As General Manager of Zelta, she's responsible for harnessing the power of Merative's unified CDMS, combined with her consulting and services team, to solve complex challenges.
Prior to Merative, Jennifer held executive leadership roles at IBM Watson Health and Accenture Global Life Sciences. She also has an MBA in Biotechnology and Healthcare Management.
Kelly Dumais, PhD, Director, eCOA Science & Consulting, eCOA Science, Clario
Dr. Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently the Director of eCOA Science and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)
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.
Kimbra Edwards, PhD, Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
Kim Edwards is the Senior Director of Health Communication Services at the Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is a non-profit organization focused on increasing awareness and understanding of clinical research participation. Kim helps oversee the creation of easy-to-understand trial resources for patients, participants, and the public. This work utilizes a patient- and community-centric approach to build accessible and engaging content. Kim earned her BS in Neuroscience from Trinity College and PhD in Developmental and Brain Sciences from University of Massachusetts Boston.
Si Mohammed El Guerche, Global Operations Portfolio Lead, Bristol Myers Squibb Co.
Si Mohammed El Guerche is dedicated to overseeing clinical trials and connecting trials to participants with several years of experience in clinical trial, operational expertise, and extensive industry relationships. Joining Bristol Myers Squibb in December 2020, he is working on clinical trial operations and strategy teams. In 2022, he joined the TransCelerate Patient Experience initiative and is supporting the team from the last year.
Joanna Florek-Marwitz, Head, Risk Management & Data Quality, UCB Biosciences
Joanna brings 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 trials operations across all therapeutic areas and is an expert in applying program management, integrated risk-based quality management, process improvement, innovation, and change management methodologies. Joanna has led many large-scale, global initiatives within the pharmaceutical industry that include clinical data management and analytics, process optimization and technology improvements, driving operational efficiencies and working relationship with customers for operational service excellence. Her technical experience, background in analytics and process improvement brings critical value to technology implementation ensuring trial execution for patient safety and reliable data to answer the trial scientific questions.
Tomasz Foks, Associate Director, Risk-Based Quality Management Centralized Monitoring, AstraZeneca
Tomasz Foks is Associate Director, Risk-Based Quality Management in Centralized Monitoring at AstraZeneca. He has worked in clinical research for ten years, most recently as a certified Risk Manager, leading RbQM process in multiple clinical studies in various therapy areas. Tomasz is responsible for the delivery and execution of solutions aimed at identifying materializing risks in clinical studies to safeguard data integrity and patient safety.
Darcy Forman, Chief Delivery Officer, Science 37
Darcy Forman is the Chief Delivery Officer for Science 37, where she has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions. Darcy has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution.
Adriano Galati, PhD, Director Digital Safety Behavioral Science & Design, PV & Scientific Development, Roche
Adriano Galati is Digital Safety Director at Roche with focus on patient safety, digital health, risk identification and management, health and safety data analytics, patient and HCP engagement. He has conducted research on understanding human behavior for the design of novel user-centric solutions for patients with multiple sclerosis and neurodegenerative disorders. He is involved in user experience design and modeling of user behavior that support and drive engagement of digital solutions for large-scale clinical studies. Before, he was Sr. Research Scientist at the Walt Disney Company (R&D) where he was leading research for a wide spectrum of user-centric solutions. Adriano Galati holds a PhD in Human Computer Interaction from the University of Nottingham (UK), a MSc in Data Analytics and Machine Learning from the University of Utrecht (NL).
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, MSD
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 MSD, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with MSD's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.
Marta Garcia, PharmD, Chief Patient Officer, R&D, Servier
Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master 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 towards patient centricity within clinical development, recently taking on new responsibilities as R&D Patient Officer. The development and coordination of the patient-centric activities within Clinical Development programs, support of global and local teams, identification of best-practises and development of KPIs are the main priorities of my new activity.
Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA
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 do 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 centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering 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 Operational point of view in COPD. Since November 2014, fully focus 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 the one adquire in Swizerlan -Lugano- (Polichem). But also in close collaboration with Almirall US, company that it 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, Migrain, 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.
Chris Gardella, Vice President, Sales, Sales, H1
Chris Gardella has more than 24 years of expertise in healthcare across multiple pharma companies, agencies, and technology firms, including an extensive understanding of the challenges with data exchange within the U.S. healthcare ecosystem. At H1, he leads the commercial sales organization. He holds a bachelor’s degree in Business from the University of Pittsburgh and an M.B.A from St. John’s University.
Christine Goffe, Team Lead, Study Data Risk Manager, Risk Management & Data Quality, UCB SA
Passionate about sciences and technologies, Christine studied Bio-Engineering at the Catholic University of Louvain (UCL) in Belgium. After several years in Clinical Data Management in an academic environment, she joined UCB in 2012 as a training manager for the Global Quality Assurance and Patient Safety departments. In 2016, she joined the Risk Management and Data Quality team when the department was created. Her first role in the team was Study Data Risk Manager (SDRM), and then she took the lead of the SDRM team at the end of 2020. The team is responsible for Data Surveillance Oversight activities, using Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) and data visualization tools to detect data anomalies and trends at study, site, and study participant level in a timely manner. Since 2022, Christine represents UCB at the TransCelerate workstream related to ICH E8 R1 and ICH E6 R3. Her areas of expertise are centralized monitoring and data surveillance oversight.
Ivana Golubovic, EUPATI Fellow, Hereditary Angioedema (HAE) Serbia
Ivana Golubovic is a rare disease patient, advocate, and expert in clinical development. She is the founder of the national organization for hereditary angioedema and has led many national and regional patient engagement projects. Having over the years participated in several clinical studies as a patient, she also developed an interest for clinical research and started her career in the CRO industry, where she has held several business development positions. Ivana's combination of personal patient experience, along with her technical expertise and business acumen, gives her a deep understanding of the patient journey and involvement in all phases of clinical development.
Joseph Goodgame, President, Co-Founder, Remarque Systems
We're pleased to introduce Joe Goodgame, a renowned leader in technology and healthcare. A data enthusiast with over 25 years of experience, Joe's expertise lies in innovative healthcare and life sciences technology applications.
Joe excels in converting complex business challenges into effective technology solutions. With several successful platform implementations under his belt, he skillfully navigates the intricacies of a regulated environment, using technology as a tool for meaningful change.
Alyson Gregg, Director, Patient Insights, Janssen Pharmaceuticals, Inc.
As the Director of patient insights for Janssen, Alyson is focused on leading Janssen to incorporate direct patient insights on clinical trial protocol and work with compound development teams to modify trials as appropriate, to improve the patient experience and clinical trial success. Alyson has over 25 years of experience at Johnson & Johnson.
Jason Gubb, Co-Founder, ClinOpsClarity
An experienced VP with over 25 years of experience in clinical operations strategy and leadership, Jason has an applied knowledge of leveraging data and analytics, digital technology, and collaborative partnerships. Jason provides consulting services for biotechs, pharma, vendors, and CROs to develop innovative approaches to optimise protocol designs, modernise clinical trial conduct and accelerate delivery strategies. Jason is the Co-Founder of ClinOpsClarity, which provides a bespoke service for scoping, selecting, and onboarding outsourcing partners, and the Co-Founder of Emergent Teams, which equips teams to navigate constant change and thrive in today’s fast-moving world. Jason is also a member of the ClinEco Advisory Board.
John Hall, PhD, Senior Vice President Europe & Asia Pacific, EMEA Asia Pacific Commercial, CluePoints SA
John is a senior life sciences executive with over 20 years of experience in the life sciences industry. He is currently SVP at CluePoints, a leader in the field of RBQM, where he leads commercial activities across Europe and Asia Pacific and CluePoints decentralised trial strategy. Prior to joining CluePoints, John was Head of Life Sciences at Huma, a digital health and decentralised trial tech provider, and held various commercial, product and corporate development leadership at IXICO, an AIM listed neuroscience imaging and digital biomarker company. John spent his early career in research, studying for a PhD in Proteomics and Transcriptomics at the University of Durham and sponsored by Amersham Biosciences (now GE Healthcare).
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Duncan Hall, CEO, TRI
Duncan has over 25 years’ experience in the life sciences technology sector. Duncan started TRI in 2013 with the specific aim of making Risk-Based Quality Management (RBQM) simple and accessible in all clinical trials. He has overseen the development of OPRA, the user friendly RBQM platform that integrates risk assessment and management with central monitoring. Duncan’s extensive RBQM knowledge and approachable style make him a much sought-after speaker at industry events.
Kevin Hancock, Director, Sales Engineering, Exostar
Kevin Hancock has 20+ years' experience in secure collaboration with distributed teams and
Partners in highly regulated markets, leading Sales Engineering, Customer Success,
and Professional Services Teams across a broad technology spectrum. This included
Agile Development and DevOps tools and practices; Zero Trust Networking; and Identity and
Access Management just to name a few. Focusing on driving adoption, managing change,
and helping customers learn, Kevin joined Exostar in 2021 as Director, Sales Engineering.
Terttu Haring, MD, Former, Head of Global Clinical Operations, Sanofi
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 where ever 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 wellbeing 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 Harris, Director, Senior Global Patient Engagement, Fortrea
Melissa has 20+ years of industry experience with five years tenure at Fortrea creating patient centric patient engagement and recruitment programs for all phases of studies including pediatric, rare and hard-to-reach patient populations. She works to harness the benefits of applying innovative solutions toward patient recruitment while driving health literacy and patient-led trials to reduce study burden and integrate studies into everyday life.
Farrell Healion, Senior Director Emerging Technologies, Global Clinical Solutions, AstraZeneca
Farrell Healion is currently Senior Director Emerging Technologies, Global Clinical Solutions at AstraZeneca, where he leads the operational readiness delivery to scale up new technologies to be used in their clinical trials. He previously led their Digital Patient Solutions team that deliver patient-facing Digital Health Technologies(DHTs) such as eCOA across the AstraZeneca portfolio. Starting out as an eCOA Developer at CRF Health, Farrell then moved through various technical leadership roles eventually leading the Technical and Project Management Office in Signant Health before moving to AstraZeneca. He is passionate about scaling up the use of patient and site-centric new DHTs in Clinical Trials, getting involved with various industry work groups such as DTRA and the eCOA Consortium. He is also the 2023 winner in Pharmatimes International Clinical Researcher of the Year award in the Decentralised Solutions category.
Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi
Megan has 25 years of operational experience; she started her career as a Phase I research associate before moving through various clinical operations positions in the industry. Megan joined Sanofi 9 years ago in Medical Affairs Clinical Operations and is currently the Head of Clinical Study Units Europe Region working in R&D across all key therapy areas and phases in EU, including rare disease, MS/neurology, immunology and oncology.
Ignacio Hernandez-Medrano, MD, MSc, Founder, CMO, Corporate, SAVANA, Medsavana SL
Dr. Ignacio H. Medrano is a Consultant Neurologist with training in Healthcare Management and experience in Clinical research strategies (formerly responsible for +500 researchers). A Singularity University graduate, he is a founder at Mendelian in the UK (AI for diagnose of rare diseases) and at Savana (Clinical Research using AI on Electronic Medical Records). In 2021 Forbes praised Dr Ignacio H. Medrano, including him in the list of the 100 most creative Spaniards in the business world; in 2023 he was included in the list of the 23 changemakers. From the European Commission to the British Royal Academy of Science, Ignacio is a well-known international speaker.
Rachel Horovitz, Vice President, Product Strategy, Medidata, a Dassault Systemes company
Rachel Horovitz is a VP of Product Strategy at Medidata AI. As part of her role, she leads the launch of innovative solutions, with the goal of improving decision making in clinical trial planning and execution for life science customers. The most recent example is the launch of the Diversity Analytics module to support more diverse trials. Prior to Medidata, she advised healthcare and technology companies on strategic issues and decisions at Bain and Rothschild. She holds a Master in Biomedical Engineering from the University of Bern in Switzerland, an MBA from the MIT Sloan School of Management, and a BS in Economics from The Wharton School, University of Pennsylvania.
Dan Hydes, CEO, IgniteData
Dan Hydes led the critical work shaping and refining the value proposition, commercial model and global scaleup strategy for Archer, IgniteData’s EHR-to-EDC system-agnostic technology, and has responsibility for the strategy and commercial areas at IgniteData.
He previously co-founded a business that successfully ran projects ranging from bringing together groups of clinicians for expert symposiums to recruitment feasibility for clinical trials. Dan has also led large commercial teams for global media organisations.
Adama Ibrahim, Vice President, Digital Strategy & Change Management, Novo Nordisk
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.
Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals
Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.
Ryan Jones, CEO, Florence Healthcare
Ryan Jones started his career at BCG, and then joined Microsoft's SharePoint team to help the web’s largest sites make information understandable and accessible with document management technology. Before founding Florence, he was President of Pubget (acquired by Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide.
Jones has an AB from Dartmouth College and an MBA from UC-Berkeley.
Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institute
Mr. Kern is a patient-based clinical technology expert with over 25 years of clinical research experience and serves as the Executive Director of the eCOA Consortium at C-Path. Beginning his career in clinical data management roles at several CROs and pharmaceutical companies, Scottie was first exposed to Electronic Patient Reported Outcome (ePRO) technology back in 2003. Enthused by the potential of this technology and its direct interaction with patients, Scottie took a role as the functional lead for ePRO at Wyeth’s Vaccine Research Unit in 2004, one of the earliest dedicated enterprise-level ePRO ownership roles in the industry. Establishing himself as an industry SME and thought leader on ePRO and Electronic Clinical Outcome Assessments (eCOA), he went on to serve as the Head of Patient Technologies and Global Head of ePRO at Pfizer. Scottie launched his own consulting company in 2013, via which he supported a range of pharmaceutical companies with eCOA strategy and implementation. Scottie joined C-Path in 2021.
Eric Klaver, DCT Regulatory Director, IQVIA
Eric Klaver, DCT Regulatory Director at IQVIA, brings 30+ years of clinical research experience from roles varying from data management to post-trial access. His focus has been on compliance in clinical trials, through training and auditing and has trained clinical research staff around the world and has audited, and supported audits and inspections on an international stage. Currently, Eric focuses on the continued compliance of the IQVIA DCT strategy and platform.
Olgica Klindworth, Vice President, Data Quality and Risk Management Solutions, Medidata
Olgica Klindworth is a VP, Data Quality and Risk Management Solutions at Medidata, focusing on Data Quality Technology including development of AI driven data surveillance approaches. Prior to joining Medidata, Olgica spent 17 years at PPD, 10 years in data management leading Data Management teams, building Data Management capabilities and overseeing execution of a number of clinical trials across various therapeutic areas. Olgica has also spearheaded development of Data Analytics and Centralized Monitoring processes and capabilities at PPD. She has participated in or led a number of data quality, innovation and RBQM initiatives and served as a subject matter expert or speaker in a number of industry conferences. Olgica received her Bachelor of Science in Microbiology from University of Texas at Austin and Master of Science in Analytics from Texas A&M University.
Marta Kocyk, PhD, Central Monitoring Lead, Central Monitoring and Data Analytics, GlaxoSmithKline
I am a Central Monitoring Lead with 7 years of experience in Clinical Trials in 3 pharmaceutical companies. In my everyday work, I try to have a comprehensive approach to clinical data, because, before Central Monitoring, I worked as Data Manager as well for several years. I’m also a former scientist in Neuro and Molecular Biology, with PhD grade, with practical laboratory experience and medical personnel cooperation.
Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Global Regulatory Affairs, Janssen R&D
Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and scientific roles, he has gained deep understanding of broad aspects of the patient journey in clinical trials from recruitment and engagement through data capture. Kai is a Director in the Janssen Clinical Innovation group, working within the digital health focus area delivering scalable solutions for digital transformation of clinical trials. In his role, Kai leads digital health innovation projects, focusing on direct-to-patient / decentralized trial methods and novel digital endpoints.
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Janssen Pharmaceutical Companies of Johnson and Johnson
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 Janssen Pharmaceutical Companies part of 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. Recently, 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. Her passion is closing the gap for patients with unmet needs and exploring the right digital technologies to accelerate the implementation of end-to-end patient solutions.
Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center
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, and the management of the Electronic Data Capture (EDC) ecosystem 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.
Melissa Lewis, Vice President, Client Relations and Services, Clinical Studies, AXON Communications
Melissa Lewis is a medical communications consultant and certified clinical research associate with her Master's in Global Health Policy and 17+ years of hands on experience in clinical studies. She is driven to become a game-changer in research, focusing her efforts on partnering with Sponsors to reduce study burden on patients and site staff. Her mission and goal is to better understand and uncover the needs of underrepresented populations and bridge access gaps to facilitate equitable inclusion in clinical research.
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
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. He is continuously onboarding companies and leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. 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
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.
Elinor Lobner-Olesen, Director Change Management, Novo Nordisk A/S
Elinor is Director of Change Management in the Global Data Management area at Novo Nordisk, and is currently heading a large transformation project across the global DM unit, including the implementation of risk-based approaches in collaboration with the NN RBQM team. She has been head of data management and standards departments as well as Chair for the Standards Governance team at Novo Nordisk. Additionally, she has experience leading several large IT projects across the Clinical Development area. Elinor has 20 years of industry experience spanning areas of IT Project Management, Vendor Management, Risk-based Monitoring, Data Standards and Data Management
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis
Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.
Andrew Mackinnon, Vice President, GM, eConsent, Customer Value, Medable
With 20 years of experience in managing clinical trials at large Pharma, Biotech, and CRO companies, Andrew Mackinnon, VP & GM, eConsent at Medable, leverages his broad operational expertise to improve how the deployment of decentralized methodologies is utilized. As General Manager for eConsent, Andrew Mackinnon oversees the development of the eConsent product, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high-quality, effective, and efficient decentralized clinical trials.
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
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.
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Dr. Malikova has over 15 years of experience in the clinical research field, with 8 years’ experience on executive level. She has managed Phase I - IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS). She also holds professional certification in Clinical Safety and Pharmacovigilance by Drug Information Association (DIA). In her current role as the Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical research operations, financial management, quality assurance, risk management, strategic planning, billing and regulatory compliance assurance and macro-management of research programs. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).
Jeppe Manuel, Principal R&D Data Privacy Specialist, Novo Nordisk
Jeppe G. Manuel is a Principal R&D Data Privacy Specialist in Novo Nordisk and is responsible for driving and aligning Novo Nordisk’s privacy by design efforts across the global R&D organisation. His main focus is clinical research, improving data utilisation and digitisation initiatives, hereunder decentralised clinical trials, by ensuring the clinical processes and systems are aligned with data privacy regulations and data ethics principles. As a R&D subject matter expert, Jeppe supports communication, training, and knowledge sharing on data ethics and data privacy across Novo Nordisk and is involved in several cross-industry initiatives focusing on better use of clinical data. Jeppe joined Novo Nordisk in 2015. He has 15+ years of experience from the pharmaceutical industry, primarily within Regulatory and Clinical, working with Enterprise Content Management, Digitalisation, Information Management, Data Privacy and Data Ethics. Jeppe holds a master’s degree in Library and Information Science.
Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Sylvia Marecki is Senior Director and Head of the Operational Design Center within Global Development Operations at EMD Serono. Her team brings data-driven decision making to study design and operational planning, driving efficiency and innovation in study planning and execution. Prior to joining EMD Serono, Sylvia led development and commercialization of data-driven analytic products and services at Citeline/Informa, DRG (Clarivate), and TriNetX, empowering informed decision-making across clinical and commercial functions at all stages of the product life cycle. She received her Doctorate in Pathology and Immunology from Boston University School of Medicine.
Jesus Martin-Garcia, CEO, GENEURO
Jesus began his career in 1983 at the World Economic Foundation, and in 1989 at McKinsey & Co where he led studies in the pharmaceutical and food industries. By 1993, he chose the entrepreneurial path by creating, investing and leading start-ups in Switzerland and the United States. He was for example a co-founder of LeShop in 1996, which became the Swiss leader in e-commerce and was sold to Migros, Switzerland’s biggest retailer. In 2003, he created Eclosion, a public-private partnership for translating scientific discoveries in the field of life sciences into innovative drugs with disruptive potential. This unique structure was instrumental in the creation of GeNeuro, which was led by Jesus since its creation in 2006. Jesus holds a bachelor's degree in industrial sciences, a master in Law from Geneva University and an MBA from Harvard Business School. He serves on the board of several biotech companies and employer associations, and is the President of the Association of Geneva Life-Science Industries.
Angela May, PhD, Head DCT Strategy & Implementation, Clinical Operations, Bayer Plc
Angela has 20 years of experience working in clinical research, primarily with a pharmaceutical company. She has a strong operational background, with significant experience in various roles in study and program management, mainly in the cardio-renal therapeutic area, and including large Phase 3 outcome trials. In her current role, Angela leads a group with specialist operational expertise in designing and implementing DCT in interventional clinical trials, including hybrid and fully-remote approaches. She and her team are also working to help develop broader capabilities and infrastructure to support DCT approaches in the future.
Danielle Middleton, PhD, MBBChir, Associate Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca
Danielle gained a BSc with Honors in Medicinal Chemistry, and a PhD in Organic Chemistry, prior to studying for her medical degree (MBBChir) at the University of Cambridge, UK. Danielle worked for 10 years in the NHS, gaining the equivalent to board certification in General Practice, before moving into industry. Initially, as a Scientific Advisor MD at Signant Health, and subsequently, into her current role at AstraZeneca. Danielle works collaboratively and cross-functionally, covering all therapeutic areas to provide medical/clinical input into device and/or digital programs, and supporting those device and digital programmes through the entire lifecycle, from development to post-marketing.
Tony Mikulaschek, VP, eCOA, IQVIA Technologies
As Vice President of eCOA at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.
Alexandra Moens, Director Product Marketing, Marketing, H1
Alexandra Moens is a PharmD who has been part of the clinical industry for over 6 years. Her scientific background and experience working with pharmaceutical partners hand-in-hand have positively impacted clinical teams to get new insights to successfully manage their portfolio strategy in the fast-evolving clinical industry.
Xavier Morato Arus, PhD, Deputy Director, Clinical Trials, Ace Alzheimer Center, Barcelona
After graduated in Pharmacy, I performed my PhD in the Neuropharmacology and Pain research group in the University of Barcelona. My work was focused on studying relevant protein-protein interactions, testing potential new treatments using both in vitro and in vivo models and studying and validating the use of novel biomarkers in neurodegenerative diseases. In 2018, I started a new role as a Postdoctoral Research Assistant in Laboratorios Dr. ESTEVE to design and implement new in vitro HTS assays. In 2019 I was certified as a tenure-track lecturer teacher by the AQU agency and taught in different courses in the University of Barcelona. In January 2020, I started leading an international study to validate the specificity and sensitivity of a new biomarker for Parkinson’s disease using the ultrasensitive SIMOA assay in Karolinska Institutet. Since January 2021, I’m working in ACE Alzheimer Research Center Barcelona, in the Clinical Trials (CT) Unit participating in CT related with dementia treatment. Here, we design our own CTs (ACE-2020-EGb761, iACE-ss) and other global CT from pharmaceutical companies, participate in international boards to improve CT management and promote research projects (i.e. ADpheresis, DROP-AD) to validate novel biomarkers for an early detection of the disease and find novel therapeutical approaches. I have participated in international congresses with both, posters and oral presentations and being involved in the writing process of more than 20 scientific articles published in peer-reviewed international journals and research projects.
Stephen Nabarro, PhD, Head, Clinical Operations & Data Management, Cancer Research UK
Steve Nabarro is Head of Clinical Operations and Data Management in the Cancer Research UK Centre for Drug Development. In this role Steve champions public and patient involvement across their portfolio of early phase oncology trials. Prior to joining CRUK Steve completed a PhD at University College London in paediatric cancer immunotherapy, which was followed by a post-doctoral fellowship at the Medical Research Council Laboratory of Molecular Biology.
Manuel Neukum, COO, EvidentIQ Group GmbH
Manuel Neukum has a passion for IT and Life Science. Joining the EvidentIQ group in 2011, he brings a solid background in Computer Science, Business Administration, and Leadership. With over a decade of industry experience, he excels in executive management, seamlessly integrating IT into Life Science to streamline end-to-end processes for clinical trials. Armed with a master's in Business Administration and a Bachelor of Science, he hails from Kempten, Germany.
Joe Newman, PhD, Respiratory SpR, Clinical Research Fellow, Aparito and Garmin Health
Joe is a respiratory physician and a British Heart Foundation Clinical Research Fellow at the Heart and Lung Research Institute, University of Cambridge. His current research is designing and developing digital and remote endpoints for decentralised clinical trials. Joe works closely with Aparito, Garmin Health and PHA UK through Aparito's Patient Group Accelerator programme to co-design, test and deploy novel endpoints with patients.
Sylvain Nicolas, Global Head, Transformation and Performance Office, Clinical Operations, Sanofi
Sylvain Nicolas is graduated in statistics; he spent his career in the pharmaceutical industry and held several positions in R&D Biostatistics, spanning across phases and diseases. He championed and implemented several innovations around data analytics and modeling, as well as Big Data around clinical trials. Sylvain is currently the Head of the Transformation and Performance Office of the Clinical Sciences and Operations at Sanofi R&D. As part of his current role, Sylvain is also co-leading Act4Patients, a 5-year business transformation program, one of the strategic initiatives of Sanofi aimed at reinventing clinical trials and clinical operations. It will leverage many new/future digital approaches and solutions and benefit actors of the clinical research and health ecosystem.
Nichole Noel, Associate Director, Digital Clinical Trial Recruitment, Merck & Co.
Nichole Noel, Associate Director, Global Trial Optimization, has worked for Merck & Co., Inc., Rahway, NJ USA, for 8 years. The intersection of health and technology is a huge passion, and she has largely focused her career on how digital technologies can be used to engage and reach people all over the world. Nichole currently supports clinical trial awareness and recruitment via a multichannel digital strategy including MSD’s global clinical trials web platform. Nichole holds a Master of Science in Digital Innovation in Marketing from Temple University and a Bachelor of Science in Management Information Systems from Philadelphia University.
Paul O' Donohoe, Senior Director, eCOA Product and Science at Medidata Solutions
I am currently Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider where I am responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal teams and partners around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies. I am passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and was previously the Industry Vice-Director of the C-Path ePRO Consortium. Previously, I worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. I moved into the health consulting field with United BioSource Corporation where I worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, I was Director of Health Outcomes at CRF Health, an eCOA provider, where I led their health outcomes team. I have a MSc in Cognitive and Clinical Neuroscience.
Caroline O'Connor, Senior Vice President, Channel & Partnership Solutions, Commercial, YPrime
Caroline O’Connor is Senior Vice President of Channel and Partnership Solutions at YPrime responsible for developing and growing strategic relationships with our global CRO partners. Holding numerous senior leadership positions in her career, she has over 10 years of experience in eCOA, Patient Engagement, and RWD tech solutions to support clinical and post-marketing studies, and over 28 years in the Life Science industry in software and services companies spanning the entire drug development process.
Wilrike Pasman, PhD, Scientist and Consultant, TNO
Scientist with a track-record in food and lifestyle intervention studies at TNO; the Netherlands Organisation for Applied Scientific Research. I have experience with RCT in clinical centers as well as in primary care and/or academic settings. Human intervention studies evolved and more and more 'at home studies' by subjects themselves are performed.
Jim Phillips, Vice President, Account and Partnership Management, TriNetX
With over 20 years of experience in healthcare IT and life sciences, I am a seasoned executive who leads the partnerships and account management team at TriNetX, the global health research network that optimizes clinical research and enables discoveries through the generation of real-world evidence.
Alekhya Pochiraju, Senior Product Development Lead, Clinical Operations, Genentech
Alekhya is a Senior Product Development Lead (Clinical Operations) at Genentech where she provides clinical oncology operations expertise. She believes, with the future of healthcare geared towards personalized medicine, biomarkers are a critical element of cancer drug development and cancer therapeutics. Her recent talk at Biomarkers & Precision Medicine USA Congress and Salesforce Women's Summit, focus on health equity disparity among minorities and people of color, specifically on the disproportionate impact COVID-19 pandemic can have. Alekhya holds an undergraduate degree from BMS College of Engineering, India in Biotechnology Engineering and a master's degree from Northeastern University in Biotechnology. Prior to joining Genentech, Alekhya worked in quality technology at Fluidigm and Sanofi-Genzyme.
Veronique Poinsot, B&P Leader, Data Sharing and Transparency, Privacy Champion, Sanofi
Veronique has a background in statistics and programming. After a few years as statistician and programmer, Veronique 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, Veronique was appointed as B&P Leader for Data Sharing and Transparency, as well as Privacy Champion.
Swapna Pothula, Senior Data Management Quality Lead, GSK
Swapna is a clinical data management professional with a deep understanding of the regulatory requirements and industry standards that govern clinical data management. Over the past 11 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. She is passionate about initiatives leading to improved trust & acceleration of clinical research, and is enthusiastic about applying her expertise towards the ultimate purpose of getting ahead of disease & transforming patients’ lives.
Allison Proffitt, Editorial Director, Bio-IT World
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.
Lea-Isabelle Proulx, Patient Voice Partner, Strategy, Portfolio & Clinical Operations, F. Hoffman-La Roche Ltd
Lea is a scientist by training and has been working at Roche for 10+ years. She's currently working as the Patient Voice Partner within the early Research and Development group. Her role consists of working with Project Teams in early clinical research to ensure Patient Communities are an active partner when teams are discussing early development & clinical strategy, taking into account a deeper understanding of patient and caregiver needs.
Edward Ramos, PhD, Director, Digital Clinical Trials, Scripps Research; CSO, CareEvolution, Inc.
I currently work in a dual role helping build and establish a Digital Trials Center. The Center seeks to promote and support broad participation in clinical research studies through a "siteless" infrastructure without sacrificing robust data collection by leveraging digital health technologies. This new venture is done in partnership with both Scripps Research and CareEvolution where I sit as the director of digital clinical trials and principal science officer, respectively. Harnessing the expertise from both of these organizations brings the best of both worlds in helping shift the paradigm of how clinical trials are conducted.
Thomas Rasmussen, Executive Vice President, Principal Consultant, Clinical Practice, Devote Consulting
Professionally supported complex and regulated businesses for more than 20 years, with a focus on clinical development & operations among other things. Supported companies in their efforts to innovate, and ensure solid links between strategic, tactical and operational clinical initiatives.
Bart Roofthooft, Head of Digital Health Solutions, EBIS/DHCoE, Janssen R&D
Bart Roofthooft is the head of Digital Health Solutions team within the Janssen Digital Health CoE (Global Development) organization, supporting the implementation of operationalized digital health technology in clinical trials and assess novel DH capability readiness for deployment across Janssen R&D. He brings 18 years of data management, clinical operations, digital health technology & system/supplier management experience to this role.
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
An optimistic, enthusiastic, leader and scientist with more than 20 years of experience in the pharma industry. I am inspired by patients and driven by science. I enjoy applying my technical knowledge to improve patient’s lives contributing day by day to the development of new medicine as bioanalytical scientific manager. I am passionate about technology solutions that enable decentralised clinical trial. As part of the clinical innovation team, I design the strategy of biosampling patient centric solutions and medical devices technologies. Core competencies: bioanalysis, PK and BM fit for purpose assay validation, GLP/GCP, drug discovery, clinical development, clinical innovation solution, decentralised clinical trials, patient centric technology solutions strategy and implementation, @home biosampling, micro sampling solutions
KK Rumrill, Senior Director & GM, Trial Management, IQVIA Technologies
KK Rumrill has more than 25 years’ experience in product development, customer support, and implementation services teams in clinical trials. She was a key leader in client operations at BBK Worldwide, driving growth in patient recruitment, site engagement, and trial optimization. In 2013, KK moved to TrialNetworks, which was acquired by DrugDev then by IQVIA in 2017. She now leads several key product teams in IQVIA Technologies’ Orchestrated Clinical Trials platform.
Marcel Salathe, PhD, Associate Proffessor, Life Sciences & Technology, Ecole Polytechnique Federale De Lausanne
Marcel Salathe is a digital epidemiologist. He is an associate professor at EPFL where he runs the Digital Epidemiology Lab. Marcel was involved in the development of the decentralized contact tracing protocol implemented by Google and Apple as Exposure Notification. His lab developed MyFoodRepo, and AI-assisted food tracking app. The lab also runs the Food & You study, a digital cohort of over 1000 people on the topic of personalized nutrition. He is the author of the Digital Epidemiology book (https://www.digitalepibook.com)
Patrick Short, PhD, CEO, Sano Genetics
Dr Patrick Short is the co-founder and CEO of Sano Genetics. Through data-driven engagement and at-home genomic testing, Sano has enabled precision medicine clinical research studies in 20+ genetic diseases in the past 5 years. Prior to Sano, Patrick was a researcher in human genetics at the Wellcome Sanger Institute where he focussed on using whole exome and genome sequencing data to study the role of non-coding variation in genetic diseases.
Neil Spooner, PhD, Co-Founder and Chair, Patient Centric Sampling Interest Group (PCSIG)
Neil Spooner (Ph.D., C.Chem., F.R.S.C.) is the Founder of Spooner Bioanalytical Solutions and the Patient Centric Sampling Interest Group. Neil is a Senior Visiting Research Fellow at the University of Hertfordshire, Editor-in-Chief of Bioanalysis Journal, and Co-Chair of the Reid Bioanalytical Forum. He has published over 60 peer reviewed manuscripts and made more than 40 podium presentations at international conferences. Neil has extensive experience in the quantitative bioanalysis of drugs, metabolites and biomarkers in the pharmaceutical industry. His current focus is on working with partners to progress microsampling and patient-centric sampling technologies for the generation of high quality quantitative bioanalytical data.
Inez Sroda, Associate Clinical Project Manager, Clinical Research Unit, Nestle Research Center
I have nearly 10 years of experience supporting clinical trials in the pharmaceutical and medical device industries across US and Europe in a diverse range of therapeutic areas. In 2021 I joined the Clinical Research Unit at Societe des Produits Nestle. The goal of the unit is to investigate the impact of nutrition on health through conduct of clinical studies worldwide.
Robert Staszewski, Associate Director, Clinical Oversight, Systems and Training, United Therapeutics Corporation
Rob has over 18 years of industry experience in clinical trials, both from the CRO and Sponsor perspective. He began at a small CRO, and then moved to United Therapeutics (UT) where he has been for the past 15 years in various positions. Recently he has become an Associate Director, Clinical Oversight, Systems & Training, managing both a Clinical Trial Management System and a Quality Risk Management System.
Andrew Studna, Editor, Applied Clinical Trials, MJH Life Sciences
Andrew Studna is the editor of Applied Clinical Trials. He obtained his bachelor's degree in journalism and public relations from Monmouth University in New Jersey in 2019. Following graduation, he started as an assistant editor with MJH Life Sciences in 2020, splitting time between Applied Clinical Trials and its sister publication, Pharmaceutical Executive. Since, Studna has transitioned to editor of ACT, and is responsible for the day-to-day editorial operations of the single brand.
Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)
Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. Following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and board member of the new Centre of Health Governance, University of Gothenburg. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science, Data Science & AI), Mats is at the forefront of industry technology innovation. Career highlights at AstraZeneca include co-ordination of the European Innovative Medicine Initiative (IMI) EHR4CR project, pioneering trustworthy scalable Federated EHR research platform services (paving the way for commercial platforms such as InSite, TriNetX, Flatiron, Clinarion, and DEEP6). He also spearheaded AstraZeneca’s health data eSource capability build program for clinical trials and co-led the EIT Health-sponsored EHR2EDC project with European hospitals along with Sanofi, Janssen, and ICON. Mats has authored over 70 publications, books, and patents in Science and Economics (Health Data Science, Clinical Science, Medical Informatics, Business Modelling, Innovation & Creativity Management, and Device development.
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG-Pharma
More than 25 years of experience in various areas of Pharma R&D, from IT strategy and operations over Research support, scientific information to Clinical Operations and Development. Over the last decade, significantly expanding responsibility to manage the external clinical study cost and the resources for Clinical Operations.
Ainhoa Ugalde, Director, Risk Evaluation & Adaptive Integrated Monitoring, MSD
Ainhoa Ugalde is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In his role of Risk & Analytics Operations Lead she plays a leading role in ensuring an efficient and strategic utilization of resources and supporting overall REAIM performance oversight: ensuring that sound risk evaluation and central analytics principles are incorporated into clinical research programs conducted by Merck Research Laboratories. This includes operational risk evaluation and central analytics management through translation of critical data & processes into Risk Evaluation deliverables and execution of Quality Tolerance Limits, Key Risk Indicators, and central analytics components. Ainhoa collaborates with other Clinical Development functions, Quality Assurance, Ethics and compliance, to ensure alignment and development of the REAIM capabilities. Ainhoa has more than 19 years of Clinical Research experience, primarily in Country and Regional Clinical trial Operations, building and leading high-performing teams across different process improvement initiatives. She is committed to developing an RBQM center of excellence at MSD and has been part of MSD’s inaugural execution of E2E RBQM via Analytics. Ainhoa holds a Master of Science degree in Pharmacy from the University of the Basque Country, Spain.
Lieven Van Vijnckt, Head, Investigator & Patient Engagement, Infectious Disease and Vaccines (ID&V), Janssen Pharmaceuticals, Inc.
Lieven is the Therapeutic Area Leader for Infectious Disease/Vaccines and Immunology for Janssen (the pharmaceutical company of Johnson & Johnson) focusing on Investigator and Patient/Participant Engagement. In that role, he is responsible for leading strategies around recruitment/retention and engagement in the Janssen clinical programs and making sure these strategies are implemented so they can impact the patients/participants journeys. Lieven has been with Johnson & Johnson since 1999 and has held various positions of increasing responsibility both in Pharmaceutical Sales and Marketing and the last 4 years in Research & Development. He is a trained pharmacist and lives and works in Belgium.
Julia Vassiliadou, PhD, Vice President, Clinical Operations, F2G
Julia Vassiliadou is a Biopharmaceutical executive with over 20 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.
Adrienne Walstrum, Program Director, Merck & Co.
Adrienne Walstrum has worked in clinical trial operations for twelve years. She is currently a Program Director with Global Trial Operations at Merck focusing on feasibility and patient recruitment strategies across the Oncology and Hem-Onc Portfolios. She holds a Master’s of Science in Management with a concentration in Organizational Leadership from Wilmington University.
Adam Wawro, Senior Clinical Data Scientist, AstraZeneca
Adam is a Senior Clinical Data Scientist at AstraZeneca's Centralized Monitoring team. His responsibilities include the design and development of analytical tools supporting the Risk-Based Quality Management operations in the Cardiovascular, Renal & Metabolism, and Respiratory & Immunology therapy areas. His interests revolve around the monitoring of daily and visit assessments, and streamlining the collaboration between different roles within the Centralized Monitoring team. Adam holds a PhD in chemistry and developed his affection for data during his postdoctoral training at Stanford University School of Medicine.
Malgorzata Wegner-Patera, Senior Director, Clinical Trial Safety, AstraZeneca Pharma Poland Sp. z o.o.
Malgorzata Wegner-Patera, graduated from The Medical University in Warsaw. She is a physician by education. She started her work in Clinical Trials in 2002 in Servier, Polska, as Clinical Trial Leader of Phase IV clinical trials. Afterwards, she continued her career in global Phase II and III clinical trials, in Roche, Polska, as Clinical Study Manager in the CEE region. Subsequently, she joined AstraZeneca in 2014 as Global Study Leader in Oncology. In 2017, she started her adventure in the Global Trial Safety Review Center (TRISARC), as member of the leadership team who built the team, process, and tools. Since 2020 she has been heading up the Global Trial Safety Review Center as Senior Director, Clinical Trial Safety, and has led the central team of about 70 scientists, who perform the medical review of data collected in clinical trials. The TRISARC team is responsible for medical review of patients’ data collected in global clinical trials in all therapeutic areas developed by AstraZeneca, with special focus on medical accuracy and consistency of safety data.
Neil Weisman, President, Continuum Clinical
As president of Continuum Clinical, I'm responsible for uniting the 150+ talented, multi-disciplined experts across the globe to deliver success. Since 1999, I've helped build the business from the ground up, and continue to play a hands-on role with sponsors to overcome barriers that impact patient engagement within the clinical development process.
Linda White, Associate Director, Risk-Based Quality Management, Jazz Pharmaceuticals
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.
Agata Wiesiolek, Senior Director, Study Management, AstraZeneca Pharma Poland Sp. z o.o.
Agata Wiesiolek is a graduate of the Intercollegiate Faculty of Biotechnology of the University of Gdansk, Poland. She has been working in the area of clinical trials and with AstraZeneca since 2006. Agata’s current role is Senior Director, Study Management Late-Phase Development in Respiratory & Immunology area, supporting AstraZeneca clinical operations worldwide. Agata’s global experience includes strict project management in clinical trials & leading non-drug project initiatives leading to improvements and optimization ways of working in various Therapeutical Areas for different stages of trials. Agata has been involved in managing and leading clinical research projects for more than 15 years and she also took a part of shaping and transforming AstraZeneca’s global Clinical Trials Site in Warsaw.
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
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).
Harry Yeates, Strategy Director Clinical Trial Experience, Langland
As strategy lead for Clinical Trial Experience at Langland, Harry focuses on ensuring we understand the motivations and priorities of the people whose experience can make or break a study, so we can devise efficient, effective strategies to recruit, educate and support them. That means prospective participants and their partners and families, but also site staff and physicians, so the study is clearly understood, remains top-of-mind, and appropriate emphasis is placed on key moments, such as consent.
Agata Zielak, Director, Centralized Monitoring, GlaxoSmithKline
14 years of experience in clinical operation across many functions. Previously several years of scientific experience in academia: PhD in Biochemistry, Masters in Pharmacy and Biotechnology. Area of interest: building and development of highly functioning teams with quality by design/data analytics/scientific/innovation mindsets.
Mira Zuidgeest, PhD, PharmD, Associate Professor, University Medical Center Utrecht; Academic Lead IMI Trials@Home
Mira Zuidgeest works as Associate Professor at the University Medical Center Utrecht. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and operational. She is board member of the GetReal Institute (www.getreal-institute.org) and led the development of a decision-support tool for randomised clinical trials integrated into routine clinical practice (www.getrealtrialtool.eu). As academic lead for the IMI Trials@Home project (www.trialsathome.com), she researches possibilities of centring trials around patients rather than clinical sites by use of innovative technologies (Decentralised Clinical Trials).
