New treatment options, including glucagon-like peptide-1 (GLP1) agents, are under investigation for treating cardiometabolic diseases such as diabetes, weight management/obesity and metabolic dysfunction-associated steatohepatitis (MASH)/non-alcoholic steatohepatitis (NASH).
Clinical trial sponsors and their CRO partners must address regulatory challenges of capturing behavior, symptoms (electronic clinical outcome assessment [eCOA] and hypoglycemia), physical signs (weight, actigraphy and glucose levels), as well as the practical problems of ensuring compliance and avoiding patient dropouts.
Recent US Food and Drug Administration (FDA) guidance has underscored these issues by mandating lifestyle standardization for obesity and diabetes clinical trials. I addition FDA is requiring hypoglycemia (either symptomatic or triggered by continuous glucose monitoring (CGM) devices) to be incorporated as a novel endpoint in some diabetes trials.
Sponsors of upcoming clinical trials can select the most appropriate and FDA-compliant approach to capture these endpoints in a single GCP environment. Capturing data is only part of the problem. Lifestyle information and adherence advice must be provided in real time to participants and sites with appropriate feedback loops. Hypoglycemia needs to trigger an e-diary and all data should be available in real time to sponsors and clinical research organizations.
To capture all these data in a single system Clinical ink has developed GlucoseReady™, an integrated GCP compliant digital platform. The suite of tools including disease specific electronic clinical outcomes assessments (eCOA), behavioral assessment by the SPUR™ tool, lifestyle standardization, blood (BGM) and continuous glucose monitoring (CGM), digital weight scale and actigraphy. Unique endpoint features include ability of BGM and CGM to trigger hypoglycemia eCOA within the platform.
In this webinar, attendees will obtain recommendations for monitoring cardiometabolic disease in clinical trials and how compliance can be optimized with tracking, behavioral modification and lifestyle standardization tools.
Join panelists Thomas Dougherty, Data Science & AI Innovative Partnership Lead, NovoNordisk (Webinar Moderator); Michael Spence, Senior Director Clinical Laboratory Sciences, Eli Lilly; Jonathan Goldman, MD, CEO, Clinical ink; Kevin Dolgin, Co-Founder, Observia Group; Steve Polyak, PhD, VP, Engineering and Data, Clinical ink; and, David Anderson, PhD, Principal Scientist, Clinical ink, for the live webinar on Tuesday, May 7, 2024, at 11:30am EDT (4:30pm BST/UK).
Speakers
Thomas Dougherty, Data Science & AI Innovative Partnership Lead, NovoNordisk (Webinar Moderator)
Tom Dougherty is currently the Data Science & AI Innovative Partnership Lead at Novo Nordisk. He is responsible for developing external partnerships to accelerate the development of new assets across the portfolio.
Prior to Novo Nordisk, Tom was the Director of RWE Partnerships & Innovation at Pfizer where he launched therapeutic area external data partnerships and novel technologies.
Tom has over 18 years of experience in healthcare with Merck, GE Healthcare, Boston Scientific, and Premier. He received a bachelor’s degree in chemistry and an MBA from Villanova University.
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Michael Spence, Senior Director Clinical Laboratory Sciences, Eli Lilly
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Jonathan Goldman, MD, CEO, Clinical ink
Dr. Jonathan Goldman has 30 years of experience across life sciences as a CEO, Chief Medical Officer, Investor and Senior Executive. He was most recently CEO of Abzena, where he remains a board member and was previously the CEO of Aptuit. He has also held Senior Executive positions at ICON Plc and Point Biomedical in addition to holding appointments as Associate Clinical Professor of Medicine in the division of Cardiology at the University of California San Francisco and as an Attending Cardiologist at the San Francisco Veterans Administration Medical Center.
Jonathan trained in medicine at St. Bartholomew’s Hospital Medical College, in London and in Cardiology at St. George’s Hospital, London. He received BSc, MBBS and MD degrees from the University of London, UK. He was awarded MBAs by Columbia University in New York and the University of California at Berkeley.
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Kevin Dolgin, Co-Founder, Observia Group
Kevin Dolgin is one of the founders of Observia, as well as an Associate Professor at Paris I University (Panthéon-Sorbonne). Prior to Observia, he created Areks, which became part of IMS Health in 2005 where Kevin remained in a thought leadership role until 2010.
Kevin has been widely published in both business and scientific publications and has been a speaker at numerous international conferences. He received a BA from Fordham University (USA), an MBA from INSEAD (France) and a Master of Research (MRes) from Sorbonne University in Paris.
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Steve Polyak, PhD, VP, Engineering and Data, Clinical ink
Steve Polyak currently leads the advanced technologies team at Clinical ink working on full, end-to-end clinical trial solutions that enable wearables, sensors and digital biomarkers for top, global CROs/Sponsors. Steve has a PhD in Artificial Intelligence from the University of Edinburgh in Scotland, UK. For the past 20 years, he has developed and designed many software components and applications across numerous organizations.
Prior to clinical trial work, Steve worked in EdTech with companies like Pearson, Encyclopaedia Britannica and ACT, Inc. At ACT, he developed innovative assessments of teamwork and problem-solving using immersive Situational Judgment Tests. He also collaborated with Amazon Education on the company’s first voice-based product and led agile teams of software developers, testers, data engineers, architects and mid-level managers as part of the research and development unit.
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David Anderson, PhD, Principal Scientist, Clinical ink
Dr. David Anderson is a Principal Scientist at Clinical ink where he leads the Data Sciences team and collaborates with an interdisciplinary team of Engineers and Scientists.
His current work involves integrating data from multiple sensors and assessments, implementing high-dimensional feature engineering pipelines, evaluating scalable machine learning algorithms and developing dynamic real-time dashboard visualizations.
Dr. Anderson is a Neuroscientist by training and education with over twelve years of experience developing hardware and software solutions to evaluate human behaviour and physiology in both laboratory and real-world environments.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Medium-to-Large Pharma and CROs
- Director/VP/Head of Clinical Operations
- Diabetes/Cardiometabolic Therapeutic Head/Lead
- Chief Medical Director
- Director/VP/Head of Digital Innovation/Engagement
What You Will Learn
Attendees will learn about:
- Advances in cardiometabolic disease screening, diagnosis, treatment and management
- Patient-centric platform design, digital profiles and data visualizations
- Secure, good clinical practice (GCP)-compliant risk-based quality management (RBQM) framework for real-time data transfer, pipelines and access
- Remote patient management of sensor and data quality, patient biometrics and compliance
- Connected digital technologies and devices, including CGM, actigraphy and weight scales
- Dynamically triggered electronic patient-reported outcomes (ePROs) to contextualize passive data capture from digital health tools
- Complex library-based eCOAs to capture gold-standard clinical assessments
- Behavioral assessment to evaluate risk for non-adherence and lifestyle standardization and identify behavioral levers to better interact with patients to encourage compliance
Xtalks Partner
Clinical ink
Clinical ink is a global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, behavioral and dropout prediction, eConsent, telehealth, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.
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