Sonya Eremenco is Director of the Patient-Reported Outcome (PRO) Consortium. Sonya has over 20 years of experience in PRO (and other clinical outcome assessment) instrument development, with a focus on multicultural development, linguistic validation, and electronic implementation. Prior to joining C-Path’s PRO Consortium staff, Sonya was Director, ePRO New Products, at Evidera, Inc. She currently serves on the Steering Committee of ISOQOL’s Translation and Cultural Adaptation Special Interest Group. Sonya holds a Bachelor of Arts in Cultural Anthropology from Duke University and a Master of Arts in Multicultural Communication from DePaul University.

Jennifer Goldsack is the Chief Executive Officer of the Digital Medicine Society (DiMe). Founded in 2019, DiMe is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. DiMe is a 501c3 non-profit organization dedicated to advancing digital medicine to optimize human health. We do this by serving professionals at the intersection of the global healthcare and technology communities, supporting them in developing digital medicine through interdisciplinary collaboration, research, teaching, and the promotion of best practices.

Erin currently works as a Clinical Trials Specialist at the NHLBI and brings a strong background in clinical research, including management, education, and regulatory responsibilities. Erin is a RN and has a degree in the Health Sciences from The George Washington University School of Medicine.

Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical operations and data management teams. His early career includes experience in pharmaceutical consulting and contract research organizations. Andrus serves on the board and executive committee of the Society for Clinical Data Management (SCDM), is a co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative, serves as co-author on eCOA Consortium publications, and has been on the advisory boards of CDISC and DIA.

Lindsay Kehoe, M.S., C.G.C., is a senior project manager at the Clinical Trials Transformation Initiative (CTTI), where she manages the development and implementation of CTTI projects. She has convened teams around disease progression modeling, embedding trials into clinical practice, and using digital health technologies to advance novel endpoint acceptance. Along with her colleagues, Ms. Kehoe is accelerating progress toward the CTTI Transforming Trials 2030 Vision. Prior to CTTI, she served as a clinical trial lead and on the IRB at Children’s National Medical Center. She is a certified genetic counselor and has worked for industry in early phase drug development and post marketing surveillance.

Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in clinical trials. Bill is an active member of the C-PATH ePRO Consortium, is a member of the scientific leadership board of the Digital Medicine Society, and leads a group on wearable technology within DIA's Study Endpoints Community. Bill provides eClinical commentary on LinkedIn and Twitter (@billbyrom).

Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, digital health, and companion diagnostic matters. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Oncology and Medical Device-related matters.

As Medical Director at Kayentis, I aim at consolidating the medical and scientific expertise of our organization, and at securing we consider patients as partners. This is in this spirit that I proudly contribute to developing patient centric eCOA solutions, supporting digitalization of clinical trials and expanding our scientific legitimacy. I have worked in both preclinical and clinical research for more than 20 years in several big pharmas, and acted as Clinical Pharmacology Point of contact and Early Development Strategy Lead for Complex Generics for Pfizer essential Health before joining Kayentis.

Dr. Mitchel is a President and CEO of THI Pharma Services. He also created the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitchel recently served on the Executive Committee of CTTI where he represented the Steering Committee. Dr. Mitchel has held positions at Ayerst Laboratories, Pfizer Laboratories and Pfizer Consumer Health Care. Dr. Mitchel is currently Adjunct Professor of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy (Rutgers), Adjunct Clinical Professor in the Department of Dermatology (SUNY Stony Brook School of Medicine) and Lecturer at New York Medical College.

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is 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. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium.

Lauren Oliva is US lead for Global Regulatory Policy at Biogen. She oversees the development and execution of R&D’s policy roadmap to advance Biogen’s neuroscience and rare disease portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder initiatives to advance the adoption of new technologies. Lauren is actively engaged with the Critical Path Institute, CTTI, and the National Academies’ Drug Forum. Lauren has over 10 years of experience in the pharmaceutical industry. She received her PharmD from Rutgers University, Ernest Mario School of Pharmacy and has previously served as adjunct faculty and lecturer at MCPHS University in Boston, MA.

Mr. Wenzel worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with and for contract research organizations, technology partners and clinical trial sponsors. His areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials. He has been on the program committee of several Drug Information Association meetings and is chairing a session at this year’s DIA Annual Meeting.

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations for the DHCoE to advance health equity. This includes the use of patient-generated data and managing bias in DHTs and improve transparency. Additionally, Annie helped incubate and continues to support to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). Previously, Annie was the Director of the Partnerships team in CDRH.

Prem Sreenivasan has interests in clinical trials and digital health initiatives supporting advances in decentralized trials, and wearables. He had supported projects with cross-functional stakeholders in clinical development, medical information, commercial and field medical specialists. Prem received his Ph.D. in Microbiology and Molecular Genetics from the University of Vermont and a post-doctoral fellowship at The Rockefeller University, New York. He is a member of several professional organizations serving as a past president in several professional organizations. He has established longstanding collaborations with academic research centers globally and authored over 50 peer-reviewed publications.

Sylvain has acquired extensive experience in IRT through various roles within Calyx over his 10+ years in the company. It allows him to grasp where IRT can make a difference based on the protocol design, and accordingly advise clinical trial teams what solution is the most suitable for each trial. Sylvain is a key member of the Calyx IRT product core team, acting as an advocate for end-users, as well as sharing his vision with the team to push the boundaries of IRT.

Rachel Chasse is a Digital Operations Lead at AbbVie. operationalizing digital health technologies for success in clinical trials. Previously, she was the founding Director of Innovation at the Digital Medicine Society (DiMe), fostering collaboration and connection within the digital medicine field, leading DiMe's scientific programming and strategic vision. Before DiMe, Rachel worked in the Digital Medicine group at Pfizer, operationalizing digital innovation for inclusion within clinical trials. Before Pfizer, she worked in dementia research supporting patients and their families at Washington University in St. Louis where she earned her Master of Science in Clinical Research Management.

Dr. Granville provides insight, guidance, and a collaborative approach to build DIA’s thought leadership, research and content strategy to support innovation and building efficiency in drug, device and diagnostics development. She brings 2 decades of regulatory science-related research experience to her role at DIA. Her research career focused on developing data to support regulatory decision making in the fields of tobacco regulatory science, preclinical and molecular toxicology, nonclinical drug development, and public health. She holds a BS in Biology from Yale University, an MSPH in Environmental Health from UNC Chapel Hill and a PhD in Biochemistry and Molecular Genetics from George Washington University.

Sheila has more than 20 years of industry experience including marketing, product management and strategy roles in life sciences technology companies. She spent 15 years at PHT Corporation (now ERT) in a variety of marketing and executive leadership roles helping to drive the company’s growth and the industry adoption of electronic clinical outcome assessments (eCOA). At eClinical Solutions, Sheila manages all aspects of marketing including branding, communications, lead generation and product marketing. She enjoys finding creative ways to tell customer stories, and building products and services that help clinicians, data scientists and technologists do the challenging and important work of bringing life-saving new therapies to market.

For over a decade, Adam has conducted clinical trials as a coordinator, monitor, project manager, and director within academia, sites, CROs, pharma, and tech. He currently serves as Sr. Director of Clinical Operations & Customer Success at Curebase, a software and services provider for decentralized clinical trials (DCT). Adam also serves as adjunct faculty at The George Washington University in the graduate program in clinical research. Every day, he leverages his wide-ranging experience to tackle the most pressing challenges related to operationalizing DCTs. In doing so, Adam and his team are among a select number of individuals who have done enough in-the-trenches work to understand current best practices in the DCT space.

A patient-based clinical technologies expert with over 25 years of clinical research experience, Scottie serves as the Executive Director of the eCOA Consortium at Critical Path Institute. Beginning his career in clinical data management, Scottie first encountered ePRO technology back in 2003, taking a role as ePRO lead at Wyeth’s Vaccine Research Unit. Establishing himself as an industry SME and thought leader on ePRO and eCOA, he served as the Head of Patient Technologies and Global Head of ePRO at Wyeth and then Pfizer until 2011. He launched his own consulting firm in 2013, supporting a range of industry entities with eCOA strategy and implementation, He joined C-Path in 2021.

• Software Engineering Leader with 16 years of clinical experience and 30 years of technology experience. • Strong leadership abilities and experience building and managing technical organizations building highly scalable, extensible, and maintainable software solutions in health care, media and advertising, and commercial software development. • Technical excellence in Clinical Information Systems, N-Tier Architectures, Data Warehouse Architectures, Web Application Architectures, Search Architectures, Reporting & Analytic Technologies, Data Modeling, Dimensional Modeling, Object-Oriented Programming, Software Test Methodology, Validated Systems Development. • Naturally Curious, Collaborative, Positive.

A technologist with over 23 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions.

Jennifer Kelly is the Vice President of Operations at HealthiVibe, LLC. Ms. Kelly has experience and expert knowledge in the healthcare industry from over 17 years managing global operations and project delivery. She has vast experience managing biopharmaceutical-sponsored programs in a wide variety of therapeutic areas across Phase II-IV clinical trials, registries, REMs, risk management, and commercial HUB programs.

In 2008, Alison Luckman joined Amgen, Inc. within their Global Study Management function – progressing through a number of roles within Amgen’s Global Development Operations. More recently, Alison moved into the Innovation and Process Improvement team, where her focus is on optimizing the processes relating to protocol design and authoring. Alison is also a Product Lead for the Delivery and Build team for the TransCelerate’s Digital Data Flow initiative.

Passionate about empowering patients and Pharma deliver better medicines using digital innovation and virtual clinical trials, Karla has over 20 years experience directing programs and leading international teams. Having implemented over 50 complex projects which resulted in bringing 5 new products to market. Karla has enhanced the effectiveness and efficiency of business processes and staff engagement with more than 20 direct reports in over 10 countries and 15 different nationalities. Karla is currently focusing on the strategy to drive decentralized trials and focus on more virtual elements in clinical trials whilst ensuring compliance with regulations and involving patients

Valerie Powell has over 35 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She is the Chief Patient Officer of CorEvitas, ensuring the organization's services center on and address the needs of patients worldwide. As EVP, Valerie also oversees business growth and delivery for Patient Experience Team of CorEvitas, where research teams use a range of methodologies to uncover insights into the patient lived experience. Ms. Powell is passionate about learning what matters most to patients and finding the most effective ways to motivate and engage them across the product lifecycle.

Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading Slinical Systems and Digital Operations. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie, such as wearables, sensors, and apps. Aman has total 15 years of experience in the eClinical industry and this role for over five years.

Ieuan Clay joined the Digital Medicine (DiMe) society in 2021 as Chief Scientific Officer, where he is responsible for scientific strategy and output. He lectures at ETHZ and FHNW in Digital Health, and is an Editorial Board Member at Karger Digital Biomarkers. Following his PhD at the University of Cambridge which focused on technology and analytics development, he joined Novartis Research in 2010, where he built and led the Digital Endpoints group within Translational Medicine (early clinical portfolio). In 2019, he joined Evidation Health, initially focusing on research strategy and then joining commercial to help build their Heart Health on Achievement health programs. linktr.ee/ieuanclay

Michelle Crouthamel is a recognized industry leader who integrates digital health in pharmaceutical development and collaborates broadly with academics, tech, consortia, and health authorities to create impacts. As the Head of Digital Science at AbbVie, Michelle leads digital strategy and implementation in RCT and RWE. Prior to joining AbbVie, Michelle led many successful R&D programs at Merck and GSK. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health.

Dr. Hughes is a scientist and leader with nearly 20 years of experience in behavioral and life sciences, focusing particularly on the role of access to information in human behavior and health outcomes. She is a former advisor to national governments on stigma in healthcare and clinical research in epidemics and infectious disease, and has spent the last several years in leadership roles in the clinical trials industry, focused on science and strategy in the implementation of electronic data collection systems for clinical trials.

Sarah Krüg is the Executive Director of CANCER101, a patient advocacy organization whose mission is to help patients and care partners navigate cancer care and partner with their healthcare team to make informed decisions. Sarah is also CEO of the Health Collaboratory, a global innovation hub focused on amplifying the voice of the patient in healthcare innovation and cultivating trust across healthcare. She previously held the position of Global Education Director at Pfizer, as well as Patient Advocacy Relations, where she also established the Global Investigator Initiated Research Program. Prior to joining Pfizer, Sarah spearheaded the development of Disease Management clinical pathways at MSKCC.

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in the Center for Devices and Radiological Health (CDRH) in guidance document development and as a branch chief overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

James McNames has been with the Electrical and Computer Engineering Department at Portland State University, Portland, OR since 1999, where he is currently serving as professor. He is also serving as a Chief Scientist for ERT, Inc. He has published over 150 peer-reviewed journal and conference papers. His primary research interest is statistical signal processing with applications to biomedical engineering. Recently his research has focused on the objective assessment and monitoring of movement disorders and technologies for quantifying human movement with wearable sensors.

Craig Mooney has nearly 30 years’ experience in the clinical development industry, with concentrated focus on optimizing IRT to improve clinical trial efficiencies. Craig brings a unique understanding of IRT from both a delivery and user perspective, having served as the Director of IRT at Bristol-Myers Squibb for most of the past decade and having held roles in clinical operations, IMP packaging, and labeling & logistics. He is considered an industry expert and has been a featured speaker at numerous IRT conferences including positions as Conference Chairman.

Global Head, Clinical Data Management, Sanofi Chair of the SCDM Innovation Committee SCDM Board Member Mr. Nadolny has almost 30 years of industry experience across pharmaceutical, device and biologics as well as technology solution development. Mr. Nadolny is a pragmatic leader focusing on technology, innovation, strategic planning, change management, and the setup of new capabilities. Mr. Nadolny is the Global head of Clinical Data Management at Sanofi. In addition to his SCDM board member role, he leads the SCDM innovation committee which recently released 3 reflection papers on the evolution of Clinical Data Management toward Clinical Data Science. Contact information www.linkedin.com/in/patricknadolny/ patrick.nadolny

Tatiana Piotroff-Smith joined Janssen Pharmaceuticals (now part of Johnson & Johnson) in 2005 as a Protocol Writerprotocol writer. Since then, protocols development and the technology around it became her passion. Tatiana is a Senior Medial Writer and is a Lead for the Protocol Development community of practice. She represents Janssen as a member of the Value and Visibility program. In her free time, Tatiana studies ballroom dancing and volunteers as a doula in a San Diego hospital.

Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer. Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven.

Stephen is an Associate Director at The Janssen Pharmaceutical Companies of Johnson & Johnson currently working in Janssen Clinical Innovation (JCI), a team dedicated to delivering clinical trial efficiencies and innovation for patients, investigators and the industry at large. He has worked across teams at Janssen and J&J for over 12 years in Global Public Health, Global Development, Digital Health, R&D, and IT. With a proven record of improving business performance as a technologist, researcher, and public health advocate, Stephen’s career mission is to dramatically improve healthcare for underserved populations globally by leveraging the latest healthcare technology.

Diane Stephenson is a neuroscientist by training with 30 years combined experience in academic neuroscience and drug discovery. Dr. Stephenson received her undergraduate degree in Biochemistry at University of California and her Ph.D. in Medical Neurobiology from Indiana University. After 25 yrs in industry she transitioned to serve as a leader at the Critical Path Institute. She currently serves as Executive Director, Critical Path for Parkinson’s Consortium, a multinational consortium comprised of diverse stakeholders including industry, patient groups, academics, professional societies and regulatory experts collectively aimed at accelerating treatments for PD. The CPP Digital Drug Development tool (3DT) initiative is advancing PD DHTs

Glen Wunderlich is a Senior Clinical Program Leader in the CNS therapeutic area at Boehringer Ingelheim, currently leading global clinical drug development programs in psychiatry. Dr. Wunderlich earned his Ph.D in neuroscience from the University of Toronto, Canada and has more than 15 years industry experience in all phases of CNS clinical drug development. Since 2008, Dr. Wunderlich has led global clinical development programs at Boehringer for a number of investigational drugs targeting CNS disorders, including Depression, chronic pain disorders, Schizophrenia, and Alzheimer's Disease.

Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio. In this capacity, she and her team advise on the selection, modification and development of clinical outcome assessments (COAs) for use in clinical trials and other research studies, and utilize mixed methods approaches to evaluate the measurement properties of COAs as well as aid in interpretation of the resultant data. Nicki has held patient-centered measurement research and leadership positions in both consultancy and industry.

Matthew Diamond, MD, PhD is the Chief Medical Officer for Digital Health at FDA's Center for Devices and Radiological Health (CDRH), where he is the senior clinical expert and focal point of contact for digital health medical devices and related clinical issues. In his role at FDA, Dr. Diamond oversees digital health policy development and implementation for emerging technologies including artificial intelligence and medical device software. Since March 2020, Dr. Diamond has been a leader on CDRH’s COVID-19 response team.

Megan is Associate Director, Clinical Data Innovation at Jazz Pharmaceuticals. A technology implementer and innovation advocate, she has spent a decade working at the intersection of clinical trials, data, and technology. She began her journey at Accenture delivering one of the industry’s first cloud-based clinical trial data and analytics platforms and further developed her passion for clinical research and personalized healthcare at Genentech. At Jazz, Megan scours R&D to find and leverage untapped data potential through automating acquisition, driving standards, innovating business processes, and delivering analytics applications. Megan is a Chemical Engineer by education with a degree from Northwestern University.

Susan is a clinical trial professional with over 18 years of experience in drug development on both on the CRO and vendor side. Over her career, Susan has been involved in many aspects of clinical drug development from clinical operations to technical training to project management. She most recently joined the Decentralized Clinical Team in 2018 after three years in Covance’s Management Development Program rotating in patient recruitment and engagement, Market Access and mobile health. Susan holds an BS in in Ecology and Evolutionary Biology from the University of Arizona and a Master of Library and Information Science from Rutgers University.

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University, and serves on the Advisory Council for HL7 Project Vulcan and External Stakeholder Board for IMI Trials at Home. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Diagnosed with sickle cell disease in kindergarten, Amy is now an advocate, host of a live video series about sickle cell, and frequent speaker.

In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.

Stephane Millet is the Production Director of the Life Sciences Division at Acolad. In this role, he is responsible for developing strategic processes that will drive operational excellence within the Acolad Group and for ensuring the optimization of workflows and localized content for a highly regulated industry. Prior to joining Telelingua in 2010, Mr. Millet worked as a Translator and Localization Project Manager in diverse operational functions. Mr. Millet is a graduate of the Faculty of Translation Studies, Linguistics and Cultural Studies of the Johannes Gutenberg University in Mainz/Germersheim, Germany.

Mehek comes from a molecular and cell biology background at UC Berkeley where she worked on pioneering CRISPR technologies in Dr. Jennifer Doudna's lab. At Genentech, she led the Direct Data Connection team to build and validate the first end to end product automating the flow of site clinical trial data from sites to sponsor electronic data capture systems with flexible endpoints. She is also a product manager for the Artificial Intelligence team which released a state-of-the-art AI question-answering engine for protocol data. Mehek represents Roche as the eSource value lead for TransCelerate and volunteers on the program management team for Gene Academy, Genentech's student mentoring program.

Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research, regulatory, and clinical drug development. Jeff received his B.A. from Columbia University and M.D. from Yale University. Following his training in internal medicine and basic science research, he served at FDA from 1996-2010 as a medical officer and then Medical Team Leader. In 2010, he left FDA for industry and worked at Genentech/Roche and subsequently at Gilead Sciences before rejoining FDA in February, 2021.

In his journey throughout Pharma Clinical Operations, Sébastien acquired profound knowledge in planning and executing phase-I to late-phase clinical trial protocols with additional exposure to multiple roles and companies in the pharmaceutical industry as well as clinical sites and hospitals. His further path led him into the big data space where he is currently applying his skills in managing projects, customer-, partner- and hospital relations as well as consulting activities in the field of Real-World Data collection and analysis, as well as RWD to RWE transformation, integration an harmonization.

Demetris started his career as a Laboratory Scientist and transitioned into the Clinical Development where he held roles of increasing responsibilities in Monitoring, Trial Management and Data Management. He has led multiple Clinical Operations integrations resulting from mergers and acquisitions as well as technology, process and organizational re-engineering projects during his tenures at Schering Plough, Merck, Novartis and Pfizer. Since 2017 Demetris leads Pfizer’s Data Sciences and Risk Based Monitoring functions in a transformation to an internal operating model across multiple geographies. He currently serves on multiple Boards, including SCDM’s Advisory Board, has served on the Board of Trustees and was the 2016 Chair.

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously a reviewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is in patient-focused drug development and the use of patient experience data in the regulatory setting.

Dr. Cosman has 15 years’ experience exploring novel markers of cognition, motor function, and quality of life in healthy aging and neurological disorders. His work has focused on the development of functional measures using scalable research-grade tools and consumer devices in a range of neurological (Parkinson’s, ALS, Ataxia, Alzheimer’s) and non-neurological (Cancer, Cardiovascular) disorders while at Pfizer, Biogen, and Abbvie. This has included leading large, multisite digital validation and natural history studies and developing multiple mobile and wearable platforms for data collection in home or clinic/care settings through pre-competitive academic-industry collaborations.

Madeline provides subject matter expertise, thought leadership and analysis to product design, development, and commercial & marketing functions at ERT.

Dr. Fay Horak is Chief Scientific Officer at APDM Wearable Technology, an ERT company. She is also Professor of Neurology, Behavioral Neuroscience, and Bioengineering and Director of the Balance Disorders laboratory at Oregon Health and Science University. Dr. Horak is a physical therapist and neuroscientist who is internationally known for her research on the physiology of balance disorders and their rehabilitation. Dr. Horak has over 300 peer-reviewed papers and has had over 50 million dollars in federal grants. Dr. Horak has several patents for new technologies to measure and rehabilitate balance disorders.

Vijay is an Associate Director in Biometrics Statistical Programming team and is the CDF Business Systems Manager. He also leads the CDISC Standards, SAS Macros/Tools Implementation within Biometrics at Jazz. In his current role he enjoys collaborating with multiple functional groups. He is passionate about learning about new technologies and bringing innovative solutions for efficient data analysis.

Sheila is a multiskilled professional involved in patient advocacy since 2013 starting at the grassroots level in Italy, where she is based. She is currently bringing the patients' voices in digital health, PLS, health literacy, and FMV. As Chairlady of WAPO, Sheila represents a global community of patient associations/groups needing educational support to make informed choices; access to treatment, awareness campaigns, and improving collaboration with multi-stakeholders.

Samantha Roberts is a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize drug development and review. Her portfolio includes patient-focused drug development, digital health, diversity and inclusion, and model-informed drug development. Prior to joining Roche/GNE, she worked at Friends of Cancer Research (FOCR) where she contributed to the genesis of the Breakthrough Therapy designation and initiatives to expand access to trials. Before FOCR, Dr. Roberts was a post-doctoral researcher at the FDA's Center for Biologics Evaluation and Research. She holds a Ph.D. in microbiology and molecular genetics from Emory University.

As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly senior roles across regulatory product development and lifecycle management. He has been working in regulatory policy since early 2016. Prior to joining Biogen, Simon worked in medical communications in different therapeutic areas. He is a biologist by training with an MSc in medical parasitology.