IPAC-RS has launched a Roundtable webinar series on digital devices for 2021. Presented by subject matter experts in the pharmaceutical sciences, this is a unique opportunity to learn about the latest research and regulatory trends focused on digital devices.
The first webinar in the series, What is a Digital Biomarker and Why Is It Important? is scheduled for Friday, September 10, 2021 from 9:00 – 11:00 AM US ET. Click HERE to register.
Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group
Lee Nagao, Ph.D., Senior Director Science, Regulation & Policy, Faegre Drinker Biddle & Reath LLP, IPAC-RS Secretariat
Marissa Dockendorf, Ph.D., Director, Global Digital Analytics & Technologies, Merck Research Laboratories
Bryan J. Hansen, Ph.D., Associate Principal Scientist, Global Digital Analytics and Technologies, Merck Research Laboratories
James Blakemore, Ph.D., Senior Consultant, Strategy Group, Medical Technology Division, Cambridge Consultants
Joe Corrigan, CEng MIMechE, Head of Intelligent Healthcare, Global Medical Technology, Cambridge Consultants
Webinar Program and Abstracts:
I. Welcome and Overview of Webinar
Moderators: Marta Lombardini and Lee Nagao
II. Realizing the Vision of Digitally Enabled, Patient-Centric Clinical Trials
Marissa Dockendorf and Bryan Hansen, Merck Research Laboratories
The rapidly advancing field of digital health technologies provides an excellent opportunity to reduce patient burden, collect higher quality data, enrich clinical trial datasets, and ultimately enable a patient-centric drug development paradigm with more rapid and informed clinical decisions. This presentation will provide an overview of the following key elements of Merck & Co.'s digitally-enabled clinical trials initiative, including enabling technologies and examples of clinical trial use: (1) patient-centric sampling, (2) smart dosing, (3) digital biomarkers, and (4) digital platform. The synergistic power in jointly implementing these approaches, obstacles and challenges to adoption, and opportunities for precompetitive collaboration will also be addressed
III. The Progression of Digital Biomarkers in Clinical Trials and Beyond
Joe Corrigan and James Blakemore, Cambridge Consultants
As a developer of connected pharmaceutical aerosol devices, and beyond into diagnostics and industrial systems, Cambridge Consultants is well placed to observe the progression of industry trends in digital adoption and digital biomarkers. As digitisation takes hold, and access to healthcare-focused digital information management systems becomes more interconnected, there is greater scope for development of digital health solutions. Digital clinical trials improve patient access, recruitment and retention, can speed data collection and analytics and allows for precision interventions. Because of the high value of the segment, development of digital biomarkers has attracted investment from pharma, medical device and consumer device backgrounds. The overall trend is from digitisation of information toward transformation of the patient care paradigm through real-time diagnostics and molecular biomarkers with analytics that can be acted on by the patient or caregiver. The Covid-19 pandemic has accelerated investment in the development of telehealth solutions and the development of decentralised clinical trials. From a technology perspective this means that connected systems have been a priority, allowing new entrants to gain a foothold with connectivity solutions. More precise, less invasive diagnostics, along with artificial intelligence/machine learning and edge compute platforms, are permitting data acquisition to progress from narrowband to broadband allowing greater insight to be derived from clinical trials and the potential for modified interventional strategies at the point of care.
IV. Moderated Q&A Session with the speakers
Click to view Speaker Bios. Feel free to share the registration information with interested colleagues.