Strategies to enable remote ingestion monitoring, patient engagement and quality data.
The pharmaceutical industry has a legendary focus and a deep commitment to making patients’ lives better through innovation in pharmaceutical care. In Deloitte’s 2019 Global life sciences outlook publication, pharma and biotech spend on R&D reached US$177 billion worldwide and the cost in 2018 to bring a product to market set records at US$2.168 million. There are countless tools that exist to help researchers confirm study participant adherence to study medication regimens, but until the advent of digital pills, these tools were only directionally accurate. Directly observing patients undergoing therapy is costly and close to impossible in our unique COVID-19 universe, and there is no widespread definitive way to absolutely confirm ingestion of medication.
Digital pills offer the potential to help researchers truly understand connections between medication adherence and patient outcomes. Digital pills in clinical trials can help researchers have more confidence in their data, including data linking dose to time of ingestion, and dose to medication levels, as well as real-time notifications of missed doses. If a researcher sees that a patient has not taken their study medication, it can allow for immediate intervention. Having such accurate data on adherence to medication can reduce the time involved in conducting clinical trials, reduce the amount of study participants needed and provide more connectivity between patients and researchers.
Patients become engaged through the process of viewing personal adherence patterns displayed on their smartphones in real time. They can better evaluate how they are feeling knowing that they have taken their medication. They can feel more connected because their care teams can see the same ingestion confirmation data that is on the patient’s smartphone. Patients feel empowered that they have control of their healthcare and treatment and can easily track their progress.
Healthcare is rapidly shifting toward digital tools that support patients and providers and the growth in remote patient monitoring. Care teams need to have complete and accurate data to help them assess, diagnose and treat patients through telehealth. Digital pills fit into the remote care ecosystem for ease of supporting patients in being treated remotely in the comfort and safety of their home.
etectRx is a digital health company. Their FDA cleared technology, the ID-Cap™ System, uniquely addresses the issue with patient adherence to (oral) medication. Accurate, flexible and elegant digital pill technology allows pharmaceutical companies to rethink approaches to medication adherence, innovate with confidence and accelerate patient outcomes.
The ID-Cap System provides real-time data that confirms ingestion events and enables tracking of oral medication use with a high rate of accuracy. The technology enables fast interventions for maintenance to a prescribed medication regimen for better patient outcomes. The ID-Cap System is an innovative communication technology that accurately shares critical patient data regarding real-world medication-taking with clinicians.
Learn how these technologies have been used in trials to date and how they can address risks to the success of trials that are associated with poor adherence, suboptimal patient engagement and inaccurate adherence reporting.
Susan Baumgartner, PharmD, MBA, Vice President, Product Management & Regulatory Affairs, etectRx
Susan Baumgartner offers a unique balance of clinical and business expertise with 25 years of experience in the pharmaceutical and digital health industries. She is currently the VP of product management & regulatory affairs at etectRx. Baumgartner began her career with Merck & Co. and served in numerous leadership roles in marketing, sales, commercial operations, medical strategies and strategic planning. She also held key executive positions within technology start-ups with a focus on improving medication use and enhancing therapeutic outcomes. Baumgartner earned a Doctor of Pharmacy and MBA degrees with highest honors from the University of Florida. She is an accomplished business executive with expertise in the successful development and commercialization of pharmaceutical products, medical devices and digital health solutions.
Peter R. Chai, MD, MMS, Assistant Professor of Emergency Medicine, Harvard Medical School
Dr. Peter R. Chai is an assistant professor of emergency medicine and medical toxicology at Brigham and Women’s Hospital/Harvard Medical School, and affiliate research scholar at the Koch Institute for Integrated Cancer Research at the Massachusetts Institute of Technology, and The Fenway Institute. He is also research faculty at the Dana Farber Cancer Institute. Dr. Chai’s career focuses around the development and implementation of technological solutions that detect and respond to changes in disease. His arc of translational science ranges from design of novel robotic and sensor systems in animal models to human clinical trials to test the implementation of injectable and ingestible sensor systems and overlying behavioral science architecture to respond to disease states. Dr. Chai is principal investigator on grants from the National Institutes of Health, and other foundation and industry sources to develop a range of electronic devices ranging from ingestible electronic sensors that measure medication adherence, music that alters the experience of pain, robotic systems to understand population exposures to pharmaceuticals and infectious diseases and robotic systems to facilitate contactless care of patients in the emergency department.
(Moderator) Stefanie Kuhner, Global Director for Clinical Technology & Patient Recruitment within Strategic Sourcing & Procurement, Bristol-Myers Squibb
Stefanie Kuhner has 20 years of experience working in Technology and Patient Recruitment and Engagement. Prior to joining BMS, Kuhner worked in Medication Compliance & Adherence building and leading AiCure’s Commercial Organization. She spent 14 years in Patient Recruitment & Engagement with Acurian (AES) before joining the AiCure team and started her career at TransPerfect Translations.
Who Should Attend?
- VP/Director level individuals from pharmaceutical companies that are developing or marketing pharmaceutical products within the United States
- Decision-makers for U.S. pharmaceutical business regardless of work location
- Medical directors
- R&D researchers
- Brand management
- Market access/health economics & outcomes research
- Digital health
- Data analytics
- Medical affairs
- Clinical research and drug development
- Commercial account executives
- C-Suite executive officers
What You Will Learn
In this webinar, participants will learn:
- How the ID-Cap™ System is at the forefront of remote patient monitoring
- How etectRx technology produces unequivocal adherence data
- How adherence data derived from digital pills is useful for clinical trials and for clinicians
- How digital pills can strengthen patient interactions and adherence
etectRx is a digital health company. Our FDA Cleared ID-Cap System uniquely addresses the issue with patient adherence to (oral) medication. Accurate, flexible and elegant digital pill technology allows pharmaceutical companies to rethink approaches to medication adherence, innovate with confidence, and accelerate patient outcomes.
etectRx was founded in 2009 and since its inception has handled its R&D in Gainesville, Florida. Currently, the digital pill system provides real-time, dose-level ingestion event verification. The ID-Cap™ System is used to track ingestion events that monitor and measure medication adherence to provide timely interventions. The system is comprised of the ID-Capsule which contains the ingestible sensor (the ID-Tag), the wearable ID-Cap Reader, and related software, which allows data to be displayed for the patient and clinician. The privately held company has the short-term goal of creating meaningful partnerships to further health care and patient treatment. The long-term goal of etectRx is a chip in every pill.
The team of engineers, computer scientists, clinicians, regulatory leaders and health care experts that make up etectRx envision and develop novel in-body communication solutions using low frequency radio wave technology to solve complex problems in health care. Our FDA cleared ID-Cap System provides real-time, dose-level ingestion event verification that registers adherence at levels greater than 95% accuracy. The system is used to track ingestion events that monitor and measure medication adherence and is all orchestrated around a digital pill. All four components of the ID-Cap System received FDA clearance through a 510(k) process in December 2019. The system elements include the ID-Cap, which is a pharma grade capsule, the ID-Tag, an ingestible sensor, the wearable ID-Cap Reader, a Patient Mobile App and a Clinician Dashboard.