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Digital Technology in Clinical Trials

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


Speakers

  • Paul  O'Donohoe, MS, MSc

    Paul O'Donohoe, MS, MSc

    • Scientific Lead, eCOA and Mobile Health
    • Medidata Solutions, United States

    Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports internal teams and Sponsors around the implementation of industry and regulatory best practices in studies using eCOA. 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.

  • Sonya  Eremenco, MA

    Sonya Eremenco, MA

    • Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
    • Critical Path Institute, United States

    Sonya Eremenco is Associate Director of the Patient-Reported Outcome (PRO) Consortium and Acting Director of the ePRO Consortium at the Critical Path Institute. 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.

  • Lauren  Oliva, PharmD, RPh

    Lauren Oliva, PharmD, RPh

    • New Technologies Global Regulatory 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. In her time at Biogen she's served in regulatory policy and strategy roles and launched a widely used regulatory intelligence service. Lauren 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.

  • Julie  Dietrich, MS

    Julie Dietrich, MS

    • Vice President, Clinical Operations
    • Genfit Corp, United States

    Julie Dietrich is the Vice President of Clinical Operations at Genfit Corp. Leading this function from clinical program design through study execution allows for the introduction of innovative approaches for clinical research, including new uses of digital solutions. She has led company-wide initiatives related to patient centricity and evidence generation planning and is committed to collaborating with patients throughout drug development. Julie has over 20 years of experience in the biopharmaceutical industry, previously holding Clinical Development and Medical Affairs positions at Amgen and Bristol-Myers Squibb.

  • Harlan M. Krumholz, MD

    Harlan M. Krumholz, MD

    • Harold H. Hines, Jr. Prof of Medicine and Director, Center for Outcomes Research
    • Yale University, United States

    Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and the Director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital, where he leads initiatives to improve the quality and outcomes of clinical decisions and healthcare delivery. He founded HugoHealth, a patient-centric platform to engage people as partners in research and leverage the secure movement of digital health data. He is a member of the National Academy of Medicine, American Society for Clinical Investigation, and Association of American Physicians. Dr. Krumholz received a BS from Yale, an MD from Harvard, and a Masters in Health Policy and Management from the Harvard School of Public Health.

  • Jonathan Raymond Andrus, MS

    Jonathan Raymond Andrus, MS

    • Chief Business Officer
    • Clinical Ink, United States

    Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current offerings, including DM, QMS, implementation services and IWRS. Prior to BioClinica, Mr. Andrus worked in pharma consulting and with CROs. Jonathan served as chair of SCDM in 2008 and 2013 and is now the Treasurer. He is also a member of DIA (Advisory Council and Data/Data Standards Track Chair) and ASQ. He earned his BA and MS from Temple University’s School of Pharmacy and is a CQA and CCDM®.

  • Doug  Peddicord, PhD

    Doug Peddicord, PhD

    • Executive Director
    • Association of Clinical Research Organizations (ACRO), United States

    Following a career as a clinical psychologist, Doug Peddicord came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Congressional Fellow in 1994. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves as Executive Director of the Association of Clinical Research Organizations. Dr. Peddicord speaks frequently on the subject of the particular role of clinical research companies (along with the sponsor, investigator, IRB, and regulator) in the system that provides for the protection of human research participants, as well as on broader issues relating to the conduct of clinical research, including health information privacy and the globalization of clinical trials.

  • Jennifer  Goldsack, MA, MBA, MS

    Jennifer Goldsack, MA, MBA, MS

    • Executive Director
    • Digital Medicine Society (DiMe), United States

    Jen Goldsack is the Executive Director 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 501(c)(3) 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.

  • Jules T Mitchel

    Jules T Mitchel

    • President
    • Target Health LLC, United States

    Dr. Mitchel is President and co-founder of Target Health LLC., a New York City-based full service eCRO dedicated to all aspects of Drug and Device Development. He also leads 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.

  • J. Jason  Lundy, PhD

    J. Jason Lundy, PhD

    • Principal
    • Outcometrix, United States

    J. Jason Lundy, PhD is a measurement scientist specializing in the development and analysis of COAs. Before co-founding Outcometrix, Jason was the Director of the ePRO Consortium and the Associate Director of the PRO Consortium at C-Path. In these roles, Jason worked on numerous COA qualification projects in collaboration with FDA and industry colleagues. His experience navigating the DDT Qualification process provided the opportunity to engage in frequent FDA discussions on the evidence needed for the regulatory review of COA measures.

  • Paul  Upham

    Paul Upham

    • Head, Smart Devices
    • Genentech, A Member of the Roche Group, United States

    Paul has 25 years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics. Prior to Roche / Genentech, Paul was with Becton Dickinson, as Worldwide Director of Strategic Marketing. Prior to that role, Paul was the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes. Paul holds four issued patents in medical software and drug delivery devices and is also a co-author of numerous peer-reviewed articles in medical informatics and diabetes.

  • Kristen  Valdes

    Kristen Valdes

    • Founder and Chief Executive Officer
    • B.Well Connected Health, United States

    Kristen Valdes is the founder and CEO of b.well. Kristen is a transformative force in today’s healthcare marketplace, spearheading the conversation on how empowering consumers can transform healthcare delivery. She is a seasoned healthcare executive with over 20 years in the industry and has dedicated her life to pioneering inventive solutions. This quest has been largely driven by her powerful personal story as the mother of a child suffering from a significant autoimmune disorder. Prior to founding b.well, Kristen was a Vice President at United Healthcare running Medicare Advantage plans across 12 states.

  • Dan  Tierno, MA, MBA

    Dan Tierno, MA, MBA

    • Associate Director, Project and Portfolio Management
    • Daiichi Sankyo, Inc, United States

    Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training scientists for rare disease therapeutic development, innovations in drug development and clinical trials, commercialization of cell and gene therapies as well as defining and generating value via portfolio management. Mr. Tierno holds his Honors M.B.A. from the Zicklin School of Business at Baruch College, and his M.A. in Biotechnology from Columbia University.

  • Adria  Martig, PhD

    Adria Martig, PhD

    • Senior Director, Research Programs
    • Parkinson's Foundation, United States

    Adria Martig, PhD is Senior Director of Research Programs at the Parkinson’s Foundation where she is responsible for ensuring scientific accountability of research grant and fellowship programs and fostering relationships with the scientific community. With nearly a decade of experience in managing biomedical research programs, Adria is passionate about advancing research, technology, and education programs that enhance human health and treatments for disease. Adria holds a PhD from University of Washington and completed her postdoctoral training at University of Pittsburgh.

  • James  Beck

    James Beck

    • Chief Scientific Officer
    • Parkinson’s Foundation, United States

  • Christine  Manta, MS

    Christine Manta, MS

    • Research Manager
    • Elektra Labs, United States

    Christine leads research for the Elektra Labs Atlas platform, which supports pharma, biotech and contract research organizations (CROs) deploying connected technologies to measure digital biomarkers in remote research and clinical care. She also supports the Digital Medicine Society as a research lead. Prior to joining Elektra, Christine supported the Clinical Trials Transformation Initiative (CTTI)’s systematic review of feasibility studies using mobile technologies in clinical research. Christine has worked on research teams at Christiana Care’s Value Institute, University of Pittsburgh Medical Center (UPMC) and Children’s Hospital of Philadelphia (CHOP).

  • Dan  Milam

    Dan Milam

    • Vice President, Global Engagement
    • Society for Clinical Research Sites, United States

    With over twenty years of experience working in the pharmaceutical, CRO, and site sectors, Dan has gained a wide perspective and understanding of the needs of the industry as a whole that aid to facilitate and build strong alliances. His focus is on expanding SCRS’ global footprint and the inclusion of all industry stakeholders in SCRS initiatives with the goal to foster sustainability for clinical research sites.

  • Matthew  Noble

    Matthew Noble

    • Vice President Product Manager
    • Medidata Solutions Worldwide, United States

    Matt joins us bringing a broad spectrum of experience working in planning and development of study design and budgeting. He has worked with a number of large sponsor and life science organizations to design and implement tools to create and optimize clinical trial budgets. Matt is a Product Manager at Medidata Solutions, where his responsibilities include product ownership of the Medidata Grants Manager suite. Prior to Medidata, Matt spent 7 years as a product manager in financial services.

  • Rachel  Chasse, MS

    Rachel Chasse, MS

    • Director of Innovation
    • Digital Medicine Society (DiMe), United States

    Rachel Chasse is the Director of Innovation at the Digital Medicine Society (DiMe), fostering collaboration and connection within the growing digital medicine community. She leads programming for DiMe’s educational offerings and supports development of the nascent field to enhance patient care. Previously, Rachel worked in Digital Medicine 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.

  • Michael  Benecky, PhD

    Michael Benecky, PhD

    • Senior Director, Global Regulatory Affairs
    • UCB, United States

    Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in located in Research Triangle Park, North Carolina. Mike is a Subject Matter Expert in the Regulatory Aspects of Digital Medicine. Successful projects at GSK included launch of the MyAsthma mobile medical device app in the UK, execution of the PARADE Virtual Clinical Study in Rheumatoid Arthritis Patients and implementation of digital adherence technology within respiratory medicine clinical trials. In April 2020, Mike joined UCB as a Senior Director, Global Regulatory Affairs where he provides regulatory strategy for UCB Teams seeking to implement wearable sensor technology in clinical trials.

  • Elizabeth (Nicki)  Bush, MHS

    Elizabeth (Nicki) Bush, MHS

    • Senior Advisor and Head, Patient-Focused Outcomes Center of Expertise
    • Eli Lilly and Company, United States

    Elizabeth (Nicki) Bush is Senior Advisor and Head of the Patient-Focused Outcomes Center of Expertise 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.

  • Ariel  Dowling, PhD

    Ariel Dowling, PhD

    • Director of Digital Strategy
    • Takeda Pharmaceuticals, United States

    Ariel V. Dowling, PhD is a Director of Digital Strategy within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, Ariel oversees the strategy, assessment, and deployment of digital devices in clinical trials across the organization. She was previously a Senior Clinical Data Scientist at Biogen where she managed the wearable sensors deployed in clinical trials for Parkinson’s Disease. Ariel was the algorithm team lead at MC10 Inc and a senior research scientist at BioSensics LLC. Ariel holds an MS and PhD in Mechanical Engineering from Stanford University and an AB and BE in Mechanical Engineering from Dartmouth College. She currently serves on the Strategic Advisory Board of the Digital Medicine (DiMe) Society.

  • Melissa  Dupont

    Melissa Dupont

    • Patient Network Manager
    • Sanofi, United States

    Melissa has over 15 years’ experience in the pharmaceutical industry, having gained leadership experience in the management and oversight of trial operations for Global Phase I through Phase IV trials. Therapeutic area experience includes; Neuroscience, Cardiovascular, Metabolic Disease, Pain, Dermatology, Oncology, and Immunology & Inflammation; were she has led several pivotal clinical studies, she has facilitated a number of piloted initiatives including; participating in the TransCelerate Biopharma Patient Technology workstreams where she Leads the Vendor subteam. In her current role at Sanofi, Melissa focuses on ensuring patient insights are incorporated early on in clinical research and continued throughout the development lifecycle.

  • John  Edwards

    John Edwards

    • Senior Infrastucture and Security Architect
    • Clinical Ink, United States

    As Senior Infrastructure and Security Architect, John is responsible for ensuring the inherent security, availability, and reliability of Clinical Ink's platforms, including the adoption of cloud-based services for delivering eSource, eCOA, and ePRO capabilities. Mr. Edwards has over 25 years implementing and supporting various information technologies in both the public and private sectors, more than half of which has focused on security and compliance.

  • Kelley  Erb, PhD

    Kelley Erb, PhD

    • Director, Digital and Quantitative Medicine
    • Biogen, United States

    At Biogen, Kelley oversees a portfolio of projects aimed developing, validating, and implementing novel clinical measurements for neuromuscular disease programs across the portfolio, including ones implemented with digital health technology. He holds a B.S. in mechanical engineering from Lehigh University and a Ph.D. in anatomy and neurobiology from Boston University School of Medicine.

  • Dan  Gottlieb, MPA

    Dan Gottlieb, MPA

    • Principal
    • Central Square Solutions, LLC, United States

    Dan Gottlieb is a clinical informaticist, software consultant, and trainer focused on helping developers and organizations leverage FHIR-based standards. Working with Harvard Medical School, Boston Children's Hospital (BCH), and other commercial and non-profit organizations, he has created and deployed healthcare apps, clinical decision support services and population health analytic tools. Building on this experience, he collaborates with developers around the world to design and improve open standards through the HL7 organization, and the Argonaut and SMART Projects. An experienced software developer, he has led software teams at BCH, the New York City Department of Health, and JPMorgan. Dan has a masters degree in health policy from NYU.

  • Jonathan Solomon Helfgott, MS

    Jonathan Solomon Helfgott, MS

    • Executive Director, Global Regulatory/Clinical Affairs
    • Stage 2 Innovations, United States

    Jonathan S. Helfgott is Faculty/Program Coordinator for the MS in Regulatory Science program at Johns Hopkins University where he teaches and advices students. Additionally, he is the Executive Director at Stage 2 Innovations. Prior to joining Stage 2 Innovations in early 2015, Mr. Helfgott was formerly the Associate Director for Risk Science, within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research (CDER). Prior to joining CDER in 2010, Mr. Helfgott worked at the FDA’s Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO).

  • Ryan  Howells, MHA

    Ryan Howells, MHA

    • Principal
    • Leavitt Partners / CARIN Alliance, United States

    Ryan Howells is a Principal at Leavitt Partners. Ryan has worked with the White House, VA, CMS, CCIIO, ONC, & OCR on health care issues & is a frequent speaker at major industry events. Ryan currently helps lead the CARIN Alliance, a multi-sector, public-private alliance focused on providing consumers digital access to their health information. Ryan is a member of the CMS Medicaid Information Technology Architecture (MITA) Governance Board, Carequality's Steering Committee, ONC's Digital Identity Taskforce, and board observer for a major technology company. Ryan received his master’s in health administration from USC where he was a Dean’s Merit Scholar & bachelor’s degree in English from BYU.

  • Kristin  Kostka, MPH

    Kristin Kostka, MPH

    • Associate Director, OMOP Data Network
    • IQVIA, United States

    Kristin Kostka is an Associate Director at IQVIA running the OMOP Data Network and a perennial collaborator within the Observational Health Sciences and Informatics (OHDSI) community – a global, multi-disciplinary community of more than 200 organizations aimed at improving patient outcomes through large scale analytics. In her work, Kristin partners with hospitals, payers and healthcare providers to help organizations unlock the power of institutional data and connect with the world’s largest observational health data network.

  • Bray  Patrick-Lake, MS

    Bray Patrick-Lake, MS

    • Director, Strategic Partnerships
    • Evidation Health, Inc., United States

    Bray is the Director of Strategic Partnerships at Evidation Health. She develops collaborations to support the design and implementation of participant-centered studies and measures, and serves on the All of Us National Advisory Panel and the Digital Medicine Society Scientific Leadership Board. Previously, Bray served on the National Academies of Sciences, Engineering, and Medicine (NASEM) Health Science Policy Board, led engagement for the Duke Clinical Research Institute Project Baseline Study Coordinating Center, and served as co-chair on the Advisory Committee to the NIH Director that authored the Precision Medicine Initiative's Cohort Program. Bray holds a BS degree from the University of Georgia, and an MFS degree from National

  • Barry  Peterson, PhD

    Barry Peterson, PhD

    • Wearable Devices
    • Independent Consultant, United States

    Dr. Peterson has extensive experience with the application of actigraphy and physiological measurements in pharmaceutical clinical trials. After 20 years of academic research on acute lung injury and respiratory measurement techniques, he joined Pfizer's Clinical Technology group to develop and validate technologies for clinical trials. Eleven years later he joined Philips Respironics to develop actigraphy analysis algorithms and promote the use of wearable devices in clinical trials. He also joined the Clinical Trials Transformation Initiative (CTTI) and helped write the recommendations to the FDA on the use of wearable devices in clinical trials (2018). He is now an independent consultant and CTTI member.

  • Ruth  Schneider, MD

    Ruth Schneider, MD

    • Assistant Professor - Department of Neurology , Movement Disorders (SMD)
    • University of Rochester Medical Center, United States

    Dr. Schneider graduated from Brown University in 2006 and received her MD from the University of Rochester School of Medicine and Dentistry in 2010. She remained at the University of Rochester completing a neurology residency in 2014 and a movement disorders fellowship in 2015. She specializes in the care of patients with movement disorders, including Parkinson's disease, essential tremor, and dystonia. Her primary research interests include the assessment and treatment of neuropsychiatric features of neurodegenerative diseases and the use of novel tools and technology to enhance clinical care and further research.

  • Katherine  Zarzar

    Katherine Zarzar

    • Manager, Outcomes Measurement, Patient-Centered Outcomes Research
    • Genentech, A Member of the Roche Group, United States

    Ms Zarzar focuses on improving the execution of COA strategies to generate patient-relevant evidence. Her past experience includes 3 years supporting the development and delivery of PCOR strategies at Roche, and six years at TransPerfect leading the design and oversight of linguistic validation programs for a variety of sponsors. Past publication topics include linguistic validation methodology, development of measures in a global context, and improving translation and eCOA delivery in global trials. Katie is passionate about designing systems that enable development and implementation of robust patient-centered outcomes strategies, as well as exploring new technologies and methods for capturing the patient experience.

  • Bill  Byrom, PhD

    Bill Byrom, PhD

    • Vice President, Product Strategy and Innovation
    • Signant Health , United Kingdom

    Bill leads product strategy and innovation, and the ePRO Science team 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).

  • Seya  Colloud, PharmD

    Seya Colloud, PharmD

    • Global Regulatory Director
    • F. Hoffmann-La Roche Ltd, Switzerland

    Seya Colloud is a pharmacist by training and holds a Masters in International Drug Regulatory affairs from University Paris-Sud, (France). She works as Global Regulatory Director in the personalized healthcare team for F. Hoffmann La Roche in Switzerland. Her area of expertise and interest include medicine and digital health regulations. She is particularly interested in the regulatory frameworks at the interface between software as medical device and medicinal product development, including novel outcomes to measure diseases.

  • Jessilyn  Dunn, PhD

    Jessilyn Dunn, PhD

    • Assistant Professor of Biomedical Engineering
    • Duke University, United States

    Jessilyn Dunn is an Assistant Professor of Biomedical Engineering and Biostatistics & Bioinformatics at Duke University. Her primary areas of research focus on biomedical data science and mobile health; her work includes multi-omics, wearable sensor, and electronic health records integration and digital biomarker discovery. She is currently PI of the CovIdentify study to detect and monitor COVID-19 using mobile health technologies. Dr. Dunn was an NIH Big Data to Knowledge (BD2K) Postdoctoral Fellow at Stanford and an NSF Graduate Research Fellow at Georgia Tech and Emory, as well as a visiting scholar at the US Centers for Disease Control and Prevention and the National Cardiovascular Research Institute in Madrid, Spain.

  • Daniel Rollings Karlin, DrMed, MA, FAPA

    Daniel Rollings Karlin, DrMed, MA, FAPA

    • Chief Executive Officer
    • Healthmode, Inc., United States

    Dr Karlin is the CEO at HealthMode.co, and Chief Medical Officer at NightWare. He was previously the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine at Pfizer, having passed through a number of roles on the way to this position including Senior Director, Quantitative Medicine, Group Lead for Human Biology and Medical Informatics with Pfizer’s Neuroscience Research Unit in Cambridge, MA. He is an Assistant Professor at Tufts Medical Center in Boston, and had been the Director of Psychiatry Informatics, and the Associate Training Director for Psychiatry. His primary research interests are neuropsychiatric drug development, medical informatics, cognition in clinical medicine, and methods for medical education.

  • David  King, MBA

    David King, MBA

    • Manager, R&D IT Innovation
    • Bayer , United States

    Currently leading a small team of technologists exploring innovative technologies to support Life Sciences R&D. It is a blast! Topic areas include: AI / Data Science, IoT, Lab Automation, AR/VR, Digital Product Development, Digital Devices in Clinical Trials, Blockchain, FAIR Data Areas of Expertise: Leading Organizational Change Digital Transformation Innovation Methodologies Project Management GxP Validation Full Software Development Lifecycle Specialties: German - Level B1

  • JP  Pollak, PhD

    JP Pollak, PhD

    • Senior Researcher-in-Residence
    • Cornell Tech, United States

  • Carol  Roberts

    Carol Roberts

    • Executive Committeee Member
    • Pbcers Organization, United States

    I am a member of the PBCers Organization's Executive Committee (which is an all volunteer organization), as well as a person living with Primary Biliary Cholangitis for over 20 years. My responsibilities with the organzation include making decisions with other members of the committee on the day to day activities of the organization as well as managing our social media sites in offering support to our membership.

  • Karlin  Schroeder, MA

    Karlin Schroeder, MA

    • Senior Director, Community Engagement
    • Parkinson's Foundation, United States

    Karlin Schroeder, M.A., is the Senior Director of Community Engagement at the Parkinson’s Foundation, where she leads the Parkinson’s Advocates in Research program (PAIR). Through this program, Karlin creates and directs projects to incorporate patient expertise into research design and implementation with industry, academic centers and government. Her special interests include metrics and improving diversity in patient engagement in research. She is a steering committee member with the Clinical Trials Transformation Initiative, working on the Quality by Design initiative. She is also a member of Patient Focused Medicines Development. Karlin has a B.S. in psychobiology and psychology and an M.A in health advocacy.

  • Wade  Schulz, MD, PhD

    Wade Schulz, MD, PhD

    • Assistant Professor
    • Yale University School of Medicine, United States

  • Veronica  Contreras, JD

    Veronica Contreras, JD

    • Data Privacy Officer, Counsel
    • eResearchTechnology, Inc., United States

    Veronica Contreras works at ERT, a Global Data Management Technology Company, headquartered in Philadelphia, PA, and is the company's global Data Privacy Officer, Counsel. Veronica is responsible for the company's data privacy compliance program, including without limitation: compliance with GDPR, HIPAA , CCPA compliance; on-going administration (and maintenance) related to data privacy policies and procedures, privacy (and security) risk assessments, data privacy compliance training, and client-related audit requirements. A lawyer by training, Veronica earned her JD from the Western Michigan Cooley Law School and her BA from the University of Wisconsin - Madison.

  • Luca  Foschini, PhD

    Luca Foschini, PhD

    • Co-founder and Chief Data Scientist
    • Evidation Health, United States

  • Thomas  Haag

    Thomas Haag

    • Principal Consultant
    • Cardinal Solutions Consuting, LLC, United States

    Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity oversight for all Novartis digital development and new technology initiatives. This included transition to an e-technology-ready quality management system for the Novartis clinical trial process. More recently, he was the VP of Quality Assurance at CRF Health, where he focused on Data Integrity improvements around the company’s ePRO and eConsent services. He established Cardinal Solutions Consulting, LLC in November 2018.

  • Deven  McGraw, JD, LLM, MPH

    Deven McGraw, JD, LLM, MPH

    • Chief Regulatory Officer
    • Ciitizen, United States

    Deven McGraw is the Chief Regulatory Officer for Ciitizen, a consumer health technology start-up. Prior to joining Ciitizen, she directed U.S. health privacy and security through her roles as Deputy Director, Health Information Privacy at the HHS Office for Civil Rights (the office that oversees HIPAA policy development and enforcement) and Chief Privacy Officer (Acting) of the Office of the National Coordinator for Health IT. Widely recognized for her expertise in health privacy and security, she directed the Health Privacy Project at the Center for Democracy & Technology (a nonprofit civil liberties organization) for six years and led the privacy and security policy work for the HITECH Health IT Policy Committee.

  • Daniel  Novak, PhD, MBA

    Daniel Novak, PhD, MBA

    • Patient Advisor
    • Parkinson's Foundation, United States

    Daniel Novak, Ph.D. is a Person with Parkinson's and a volunteer for the Parkinson's Foundation where he currently serves as a research advocate, grant reviewer and community volunteer. Previously, he served as the national Chair for the People with Parkinson’s Advisory Committee, Parkinson’s Foundation. He has served as reviewer for PCORI and as a leadership consultant specializing in organizational diagnosis and collaboration. Dr. Novak retired from academia as Department Chair where he led MBA, MPA and doctoral-level research programs. Prior to his academic career, he served thirty-one years at IBM in national and international roles in life sciences, healthcare digital imaging, social network analysis, virtual teams and innovation.

  • Marisa  Rackley

    Marisa Rackley

    • Director Global Operations
    • Vertex Pharmaceuticals, United States

  • James  Riddle, MS

    James Riddle, MS

    • Vice President, Institutional Services and Strategic Consulting
    • Advarra, United States

    James Riddle is the VP of Institutional Services & Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team. Prior to joining Advarra, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers.

  • Isaac R. Rodriguez-Chavez, MHS, PhD, MS

    Isaac R. Rodriguez-Chavez, MHS, PhD, MS

    • Officer, Clinical Research Methodology, Reg Compliance and Medical Policy, CDER
    • FDA, United States

    Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years include: CEO/Founder, 4Biosolutions Biomedical Consulting Firm (Maryland); VP, Research, Texas Biomedical Research Institute, (Texas); Director of HIV Clinical Research Programs, NIH (Maryland); and Senior Clinical Scientist, Schering Plough Corp (New Jersey). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research; and a B.S. in Biology. He has published numerous papers and has been a speaker in multiple global conferences.

  • Susie  Song

    Susie Song

    • Senior Manager, Informed Consent Management Global Clinical Operations
    • Biogen, United States

  • Sameer  Jaiswal, MS

    Sameer Jaiswal, MS

    • Consultant
    • MHM Consulting LLC, United States

    My passion is to improve the lives of patients by supporting the development and deployment of novel medical devices and drug therapies. My passion has led me to develop a deep and broad knowledge of the development and use of technology to improve patient outcomes, and how regulatory affairs and quality assurance can be used as tools to promote best in class product development, improve time to market and increase patient safety. I have In following my passion, I have been privileged to work with some great organizations including over 10 years at Abbots Labs, 5 years at Boston Scientific, Fujifilm Medical Systems, Becton Dickinson and, of course, Clinical Ink where I was head of Quality and regulatory.

  • Thomas  Switzer, MEd

    Thomas Switzer, MEd

    • gRED Digital Health Scientist
    • Genentech, A Member of the Roche Group, United States

    Tom is a Digital Health Scientist in Genentech's Research and Early Development Informatics.  His current focus is on developing technology platforms supporting molecule teams across the early development portfolio.  Tom has over 20 years of clinical development experience, including 8 years of experience in developing and deploying digital technologies in clinical trials. He has been at Roche since 2010 serving in a variety of roles within Clinical Operations and Innovation groups. An Exercise Physiologist by training, he has been continuously tinkering with the various digital gadgets on himself before testing them on other people. He lives in San Mateo, CA with his wife Elizabeth and 4 young children.  

  • Betsy  Williams, PhD, MS

    Betsy Williams, PhD, MS

    • Scientific and Strategic Lead, Patient-Centered Endpoints Solutions
    • IQVIA, United States

  • Elizabeth  Esterl, BSN, RN

    Elizabeth Esterl, BSN, RN

    • Vice President, Operations and Research
    • ClinOne, Inc., United States