Digital Technology in Clinical Trials
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
- 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.
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 Raymond Andrus, MS
- Chief Strategy 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®.
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
- 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
- Global Policy Lead, Digital Health, Diagnostics, and Combination Products
- Amgen, United States
Megan Doyle is an attorney and policy professional with more than 10 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 Diagnostics, Digital Health, and Combination Products.
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 T. Mitchel, PhD, MBA
- President and CEO
- THI Pharmaservices, United States
Dr. Mitchel is a Principal Consultant at 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
- 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
- Global Regulatory Policy Lead, New Technologies
- 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.
- Head, Smart Devices
- Roche / Genentech, 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.
- 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.
- Assistant Director, Digital Health Center of Excellence, CDRH
- FDA, United States
Anindita (Annie) Saha is the Director of External Expertise and Partnerships (EEP) in FDA/CDRH. Annie leads CDRH’s Patient Preference Initiative and helps coordinate MDUFA IV efforts in patient engagement and science. She is leading research projects in patient preferences and patient-reported outcomes. EEP manages regulatory science, Network of Experts, public-private partnerships, and fellowships. Annie has a B.S. in Bioengineering and Minor in History from the University of Pittsburgh.
- Associate Director
- Colgate-Palmolive Company, United States
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 DiMe's scientific programming, leads 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.
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 biomedical product 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.
- Honorary President
- Society for Clinical Research Sites, United States
Casey Orvin is President of the Society for Clinical Research Sites (SCRS), a global organization representing over 9500 clinical sites in 47 countries. Prior to joining SCRS, he successfully led a network of research sites conducting clinical trials for pharma, vaccines and medical devices. Under Orvin’s leadership, several crucial partnerships were formed which fueled the company'd rapid growth. With nearly 20 years of experience working at and with the site community, he previously served as EVP of Synexus, where he led the BD and Commercial teams for over 200 sites in 14 countries. Orvin is champion for clinical research sites and feels very strongly that site success impacts everyone in clinical research.
Sheila C Rocchio, MBA
- Chief Marketing Officer
- eClinical Solutions LLC, United States
Sheila Rocchio has more than 20 years of experience with 17 years in marketing, product management and strategy leadership roles in life sciences technology companies. She spent 15 years at PHT Corporation (now ERT) in a variety of executive leadership roles helping to drive growth and industry adoption of electronic clinical outcome assessments (eCOA) Systems. At eClinical Solutions, Sheila is responsible for all aspects of marketing and product management. Sheila has been a frequent speaker at industry events on topics including the shift to mobile technology for patient-driven outcomes and engagement and the application and opportunities for artificial intelligence and machine learning in clinical research.
- Director of Clinical Operations
- Curebase, United States
Demetris N. Zambas
- Vice President and Global Head, Data Monitoring and Management
- Pfizer, United States
Anne M Hopkins
- Mgr Med Info Comp Reg
- Pharmacia, United Kingdom
- Executive Director
- Critical Path Institute, United Kingdom
Conrad Bessant, PhD
- Mebomine, United Kingdom
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.
Michelle Crouthamel, PhD
- Director of Digital Health and Innovation
- 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 impact. As the Director of Digital Health & Innovation at AbbVie, Michelle leads digital strategy and implementation. 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. Michelle has a Doctorate degree from the Fox Business School, Temple University and a Master's degree from the Institute of Neuroscience, Yang-Ming University, ROC.
Douglas Drake, MBA
- Senior Director, Customer Solutions
- Clinerion Ltd, Switzerland
Douglas Drake, MS, MBA, is originally a life science researcher with a passion for digital enablement of better patient care. With over 30 years of experience working in various aspects of diagnostics, therapeutic research and drug discovery, Douglas has broad experience in transformative technologies, data sciences, global business development and applying these to improving patient engagement and the patient journey.
Valerie Powell, MS
- Vice President, Research Services
- Healthivibe, A Division of Corevitas, LLC, United States
Valerie Powell has over 30 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She leads a team of Research Specialists in conducting a range of qualitative and quantitative research methodologies to uncover insights into the patient experience. Her consultative approach allows her to assist research sponsors in applying these insights to impact change within their organizations and optimize their patient initiatives. 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.
Preconference Short Courses
Digital Technology in Clinical Trials Resource Kit