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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.


Speakers

  • Sonya  Eremenco, MA

    Sonya Eremenco, MA

    • Executive Director, PRO Consortium
    • Critical Path Institute, United States

    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, MA, MBA, MS

    Jennifer Goldsack, MA, MBA, MS

    • Chief Executive Officer
    • Digital Medicine Society (DiMe), United States

    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  Iturriaga, MSN

    Erin Iturriaga, MSN

    • Clinical Trials Specialist
    • National Heart, Lung, and Blood Institute (NHLBI), United States

    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.

  • Jonathan  Andrus, MS

    Jonathan Andrus, MS

    • President and Chief Operating Officer
    • Clinical Research IO (CRIO), United States

    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 upcoming eCOA Consortium publications, and has been on the advisory boards of CDISC and DIA.

  • Lindsay Stiles Kehoe, MS

    Lindsay Stiles Kehoe, MS

    • Project Manager
    • Clinical Trials Transformation Initiative (CTTI), United States

    Lindsay Kehoe is a project manager at the Clinical Trials Transformation Initiative (CTTI), currently managing the implementation of CTTI's digital Novel Endpoints project. Prior to joining CTTI, she coordinated genetic and rare disease clinical trials at Children’s National Medical Center and served on the hospital's Institutional Review Board. Early in her career, Ms. Kehoe worked in early phase drug development at Millennium Pharmaceuticals (now Takeda Oncology) and then post-marketing laboratory surveillance at Sanofi Genzyme. She has a genetic counseling degree from Boston University School of Medicine and a genetic counseling fellowship at the University of Virginia.

  • Bill  Byrom, PhD

    Bill Byrom, PhD

    • Principal, eCOA Science
    • Signant Health , United Kingdom

    Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 25 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, JD, MPH

    Megan Doyle, JD, MPH

    • Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
    • Amgen, United States

    Megan Doyle is an attorney and policy professional with more than 13 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.

  • Estelle  Haenel, DrSc, PharmD

    Estelle Haenel, DrSc, PharmD

    • Medical Director
    • KAYENTIS, France

    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.

  • Jules  Mitchel, PhD, MBA

    Jules Mitchel, PhD, MBA

    • President and CEO
    • THI Pharma Services, United States

    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, MS, MSc

    Paul O'Donohoe, MS, MSc

    • Senior Director, eCOA Product and Science
    • Medidata Solutions, United States

    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, PharmD, RPh

    Lauren Oliva, PharmD, RPh

    • Director, Global Regulatory Policy & Digital Health Policy Lead
    • Biogen, United States

    Lauren Oliva is the Global Regulatory Policy Lead for New Technologies at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health technologies and gene therapy to enable Biogen’s neuroscience 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.

  • Keith  Wenzel

    Keith Wenzel

    • Senior Director, Scientific Data Organization
    • Parexel International, United States

    Mr. Wenzel has 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 and speaking at this year’s DIA Annual Meeting.

  • Anindita  Saha

    Anindita Saha

    • Assistant Director, Digital Health Center of Excellence, CDRH
    • FDA, United States

    Anindita (Annie) Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, strategic planning, and operations for the newly formed DHCoE to empower digital health stakeholders in advancing healthcare. Additionally, Annie supports CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs) including patient-reported outcomes (PROs), and patient-generated health data (PGHD).

  • Prem  Sreenivasan, PhD

    Prem Sreenivasan, PhD

    • Director
    • HITLAB, United States

    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  Berthelot, MSc

    Sylvain Berthelot, MSc

    • Director, Solution Consultant
    • Calyx, United Kingdom

    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, MS

    Rachel Chasse, MS

    • Digital Operations Lead
    • AbbVie, United States

    Rachel Chasse recently was the Director of Innovation at the Digital Medicine Society (DiMe), fostering collaboration and connection within the growing digital medicine community and led DiMe's scientific programming, their diversity, equity, and inclusion efforts, and patient engagement strategy. Previously, 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.

  • Fan  Gao

    Fan Gao

    • Principal
    • ZS, United States

  • Courtney  Granville, PhD, MPH

    Courtney Granville, PhD, MPH

    • Global Associate Director, Research and Scientific Programs
    • DIA, United States

    As Global Associate Director Research & Scientific Programs, Dr. Granville provides insight, guidance, and a collaborative approach to build DIA’s research and thought leadership 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 has worked in academic, government, and industry laboratories leading both clinical and non-clinical research studies, assuring IRB and GLP compliance where relevant.

  • Simone  Knab

    Simone Knab

    • Clinical Data Architect
    • SK Data Consulting, Pty Ltd, United States

  • Herve  Monchoix

    Herve Monchoix

    • Strategic Innovation Leader
    • BD Medical, France

  • Sheila C Rocchio, MBA

    Sheila C Rocchio, MBA

    • Chief Marketing Officer
    • eClinical Solutions, United States

    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.

  • Adam  Samson

    Adam Samson

    • Director of Clinical Operations
    • Curebase, United States

    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.

  • William M Simpson, MD

    William M Simpson, MD

    • Professor of Family Medicine
    • Medical University of South Carolina, United States

  • Scottie  Kern

    Scottie Kern

    • Executive Director
    • eCOA Consortium, United Kingdom

    A patient-based clinical technology expert with over 25 years of clinical research experience, Scottie serves as the Executive Director of the ePRO Consortium at C-Path. 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.

  • Todd  Greenwood

    Todd Greenwood

    • Senior Director of Client Solutions
    • ZS Medullen, United States

  • Conrad  Bessant, PhD

    Conrad Bessant, PhD

    • Mebomine, United Kingdom

  • Muhammad  Bilal

    Muhammad Bilal

    • Sr. Director, Clinical Data Management and Biostatistics
    • Topstone Research, Canada

  • Steven  Chartier, MS

    Steven Chartier, MS

    • Sr. Director of Engineering
    • Calyx, United States

    • 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.

  • Raj  Indupuri, MBA

    Raj Indupuri, MBA

    • Chief Executive Officer
    • eClinical Solutions, United States

    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

    Jennifer Kelly

    • Vice President, Operations
    • HealthiVibe, a division of CoreEvitas, LLC, United States

    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.

  • Alison  Luckman

    Alison Luckman

    • Development Operations Innovation Director
    • Amgen Ltd, United Kingdom

    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.

  • Karla  Mackenzie, MS

    Karla Mackenzie, MS

    • Head of CRA Oceania
    • LEO, Australia

    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

  • Malcolm  Morrissey, PhD

    Malcolm Morrissey, PhD

    • Associate Director Statistics and Product Support Services
    • Calyx, United Kingdom

  • Valerie  Powell, MS

    Valerie Powell, MS

    • Chief Patient Officer, CorEvitas and Vice President, Patient Experience
    • Corevitas, LLC, United States

    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. Valerie also oversees business growth and delivery at HealthiVibe, the 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, MPharm, MS

    Aman Thukral, MPharm, MS

    • Director, Global Head-Digital Operations and Clinical Systems
    • AbbVie, Inc., United States

    Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading clinical systems such as EDC, IRT, ePRO, CDR, Medical Coding. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie, such as wearables, sensors, and apps. Aman has obe 14 years of experience in the eClinical industry and this role for over five years.

  • Ieuan  Clay, PhD

    Ieuan Clay, PhD

    • Chief Scientific Officer
    • Digital Medicine Society (DiMe), Germany

    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, PhD

    Michelle Crouthamel, PhD

    • Head, Digital Science, Global Clinical Development
    • AbbVie, Inc., United States

    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.

  • Lindsay  Hughes, PhD, MS

    Lindsay Hughes, PhD, MS

    • Principal Scientific Advisor
    • Clario, United States

    Dr. Hughes is a scientist with over 15 years of experience in behavioral and life sciences, focusing particularly on the role of human behavior in optimizing health outcomes through prevention, care, and treatment. She is currently a Principal Scientific Advisor at ERT, a global data and technology company that helps to minimize risk in clinical trials. She provides dedicated support to a number of pharmaceutical company sponsors and is the subject matter expert for vaccines and infectious diseases. She has taught courses at the CDC, USAID, and has held international workshops on these issues in more than a dozen countries.

  • Sarah  Krug, MS

    Sarah Krug, MS

    • Chief Executive Officer
    • CANCER101, United States

    Sarah Krüg is the CEO 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 Founder 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 the Pediatric Disease Management clinical pathways at MSKCC.

  • Elizabeth  Kunkoski, MS

    Elizabeth Kunkoski, MS

    • Health Science Policy Analyst, OMP, CDER
    • FDA, United States

    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.

  • Stephanie  Manson

    Stephanie Manson

    • Senior Director, HEOR Excellence
    • Novartis, United States

  • James  McNames, PhD

    James McNames, PhD

    • Professor
    • Portland State University, United States

    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

    Craig Mooney

    • Vice President, Scientific E-tech Enabled Services
    • Calyx, United States

    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.

  • Patrick  Nadolny, MS

    Patrick Nadolny, MS

    • Global Head, Clinical Data Management
    • Sanofi, France

    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 Gabriella Piotroff, MS

    Tatiana Gabriella Piotroff, MS

    • Senior Manager, Medical Writing
    • Johnson and Johnson, United States

    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, MS

    Katrina Rice, MS

    • Chief Delivery Officer, Data Services
    • eClinical Solutions, United States

    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  Ruhmel, MPH

    Stephen Ruhmel, MPH

    • Clinical Innovation Lead
    • Janssen Research & Development, United States

    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, PhD

    Diane Stephenson, PhD

    • Executive Director
    • Critical Path Institute, United States

    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, PhD

    Glen Wunderlich, PhD

    • Senior Clinical Program Leader, CNS
    • Boehringer Ingelheim, United States

    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, MHS

    Elizabeth Nicki Bush, MHS

    • Associate VP and Head, Patient-Focused Endpoints and Measurement
    • Eli Lilly and Company, United States

    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

    Matthew Diamond, MD, PhD

    • Chief Medical Officer, Digital Health Center of Excellence, CDRH
    • FDA, United States

    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 L. Dunham

    Megan L. Dunham

    • Associate Director, Clinical Data Innovation
    • Jazz Pharmaceuticals, United States

    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  Foose, MLIS

    Susan Foose, MLIS

    • Director/Enterprise Solutions
    • Labcorp Drug Development, United States

    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 H Lipset, MPH

    Craig H Lipset, MPH

    • Co-Chair
    • Decentralized Trials & Research Alliance (DTRA), United States

    Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty at the University of Rochester Center for Health and Technology. Craig serves on the Board of Directors for the MedStar Health Research Institute, Foundation for Sarcoidosis Research, and for Circuit Clinical. He is a Venture Partner with Boston Millennia Partners. Craig is a past DIA Annual Meeting Chair, and currently serves on the Regional Advisory Committee for North America.

  • Amy  Mason

    Amy Mason

    • Sickle Cell Disease Advocate
    • United States

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

  • Bryan  McDowell, MBA, MSc

    Bryan McDowell, MBA, MSc

    • Vice President, eCOA Clinical Science & Consulting
    • Clario, Switzerland

    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.

  • Stéphane  Millet

    Stéphane Millet

    • Director of Account Management
    • Acolad Life Sciences, United States

    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  Mohan

    Mehek Mohan

    • Product Manager for Technology Development and Artificial Intelligence
    • Genentech, Inc., United States

    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.

  • Vrutangkumar  Shah, PhD

    Vrutangkumar Shah, PhD

    • Postdoc Scholar
    • OHSU, United States

  • Jeffrey  Siegel, MD

    Jeffrey Siegel, MD

    • Director, Office of Drug Evaluation Sciences, Office of New Drugs, CDER
    • FDA, United States

    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.

  • Sébastien  Wischlen, RN

    Sébastien Wischlen, RN

    • Chief Executive Officer
    • CancerDataNet GmbH, Switzerland

    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 N. Zambas

    Demetris N. Zambas

    • Vice President and Global Head, Data Monitoring and Management
    • Pfizer Inc, United States

    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, PhD

    Michelle Campbell, PhD

    • Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
    • FDA, United States

    Michelle Campbell is the Sr. Clinical Analyst 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). Previously, Dr. Campbell was 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.

  • Josh  Cosman, PhD

    Josh Cosman, PhD

    • Director, Digital Science
    • Abbvie, United States

    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.

  • Romain  Finas

    Romain Finas

    • Vice President, Real-World Evidence
    • Alira Health, France

  • Madeline  Geday

    Madeline Geday

    • Senior Director, DCT Office/COE Patient Centriity
    • Astellas, United States

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

  • Fay  Horak, PhD

    Fay Horak, PhD

    • Chief Scientific Officer
    • ERT, APDM Digital Technology, United States

    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  Koduru, MSc

    Vijay Koduru, MSc

    • Associate Director, Statistical Programming
    • Jazz Pharmaceuticals, United States

    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  Khawaja, MA

    Sheila Khawaja, MA

    • Patient Engament Expert| EURORDIS Alumni; Board Chair
    • World Alliance of Pituitary Organizations, Italy

    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, PhD

    Samantha Roberts, PhD

    • Group Director, US Regulatory Policy
    • Genentech, A Member of the Roche Group, United States

    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 and improve the efficiency of drug development and review. Her portfolio includes patient-focused drug development, 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.

  • Kristen  Sowalsky, PhD

    Kristen Sowalsky, PhD

    • Director, Clinical Science and Consulting - Wearables and Digital Biomarkers
    • Clario, United States

  • Simon  Bennett, MSc

    Simon Bennett, MSc

    • Director, EU Regulatory Policy
    • Biogen, United Kingdom

    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.