The impact of a therapeutic intervention on health outcomes isn’t caused by the efficacy demonstrated in pivotal confirmatory studies, but by the effectiveness the intervention demonstrates in the real world when used by patients. A major cause for the gap between efficacy in confirmatory studies and the real world is due to social determinants of health, which according to WHO, ADA, and others account for 30-55% of the impact on health outcomes. *
Characterizing social determinants of health in development programs by means of validated psychometric and behavioral instruments is critical to begin deriving digital therapeutics to effectively mitigate this gap.
When engaging in patient focused drug development, it’s imperative to have a holistic approach to individuals, their predispositions, and their life choices in order to embrace the whole human that ultimately will benefit from the innovation. This can only happen when insights are captured through a seamless site and patient experience solution.
Join this webinar to explore the importance of social determinants of health in achieving optimal health outcomes for cardiometabolic diseases, such as obesity, type 2 diabetes, and ischemic heart disease. The speakers will discuss the promise of digital therapeutics to augment drug therapeutic interventions.
* https://www.who.int/health-topics/social-determinants-of-health
Speakers
C. Michael Gibson, MS, MD, CEO, Baim Institute for Clinical Research; Professor of Medicine - Harvard Medical School; Interventional Cardiologist - Beth Israel Deaconess Medical Center (Moderator)
Michael Gibson, M.S., M.D., pioneered our understanding of the open artery and the open microvasculature hypothesis in the setting of heart attack. As an innovator, Dr. Gibson invented measures of coronary blood flow that are widely used today.
A practicing interventional cardiologist, cardiovascular researcher, and educator, Dr. Gibson is also the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. He founded and is the Editor-in-Chief of WikiDoc.org and WikiPatient.org, widely viewed open source textbooks of medicine.
Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials which eventuate in international approval of life-saving drugs and devices. He is currently leading the HEARTLINE trial of the Apple Watch, the first large “Virtual” randomized trial which will enroll up to 180,000 patients—one of the largest randomized patient trials in history.
Dr. Gibson obtained his BS, MS, and MD degrees at the University of Chicago, did his internship, residency, and chief residency at the Brigham and Women’s Hospital and his cardiology fellowship at the Beth Israel Deaconess Medical Center, both at Harvard Medical School.
Christian Born Djurhuus, MD, PhD, BSc, Owner, Djurhuus Consulting
Dr. Christian Born Djurhuus is a Medical Product Development expert specializing in molecules and technology. Over his 18 years in Global Pharma in Europe and the U.S. he had achieved successful NDA, sNDAs, and MAA within diabetes and cardio metabolic disorders, as well as CE class 2b and 510Ks for combination devices.
For the past 4 years, Dr. Djurhuus has led the Digital Transformation of Development in Novo Nordisk, bringing together medicine and technology. He has deep experience in leading full-stack software development teams within the GCP/SaMD space.
Dr. Djurhuus is a firm believer that future medical products, as well as medical product development, must be digitally augmented.
Mona Khalid, VP, Value Demonstration, Health Economics and Patient Access, Endpoint Health Inc.
Mona Khalid is Vice President, Value Demonstration, Health Economics and Patient Access at Endpoint Health Inc, a biotechnology company focused on precision medicine. With a career spanning over 18 years in the life sciences industry, Mona has a track record of highlighting the value of medical interventions, particularly from the patient perspective.
Mona was previously at Galapagos, where she was Vice President, Real World Evidence, Outcomes Research and Epidemiology. Prior to this she was Vice President of Outcomes Research and Development at the International Consortium of Health Outcomes Measurement (ICHOM), where she led the generation of 28 condition-specific standard outcome sets including Patient Reported Outcomes (PROs) to represent the patient perspective across a number of disease areas including diabetes, stroke, and inflammatory bowel disease.
In her previous role as Global Head of Evidence and Value Generation at Takeda Pharmaceuticals, she was responsible for leading strategies for designing and selecting clinical outcomes assessments for use in randomised controlled trials and registries. In addition, she led the global strategy for real-world evidence generation as new, innovative medicines were launched and made available for use in clinical practice.
During Mona’s career, she has worked on launching several therapeutics in the biologics, small molecule, and stem cell therapy spaces, including Entyvio®, Alofisel®, and Jyseleca®. Mona has particularly strong therapeutic area expertise in endocrinology and metabolic diseases, respiratory, and immune-mediated inflammation.
Prior to her tenure in the life sciences industry, she held academic roles at the Institute of Child Health, University College London specializing in newborn screening and implementation. She has undertaken management leadership training at the MIT Sloan School of Business and holds a BSc. (Hons) in biology from the University of Waterloo (Canada), an MSc. in biomedical science at St. George’s University, London (UK), and initiated her PhD in epidemiology at University College London (UK).
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) at the Sorbonne, in Paris.
Jonathan Goldman, MD, CEO, Clinical Ink
Jonathan 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.
Who Should Attend?
This webinar will appeal to professionals in the following fields/job titles:
- Medium-to-large pharma and CROs
- Director/VP/Head of Clinical Operations and Digital Innovation/Engagement
- Diabetes/Cardiometabolic Therapeutic Head/Lead
- Chief Medical Director
What You Will Learn
Attendees will gain insights into:
- The importance of observing behavioral science in the management of people with cardiometabolic and other chronic diseases
- How behavioral science instruments can be deployed in development programs to characterize behavioral metrics
- Enabling Investigators to Evaluate the risk of non-adherence by clinical trial patients in a structured manner
- Avenues for how digital therapeutics can be developed to mitigate aspects of social determinants of health and achieve more effective outcomes of interventions
Xtalks Partner
Clinical Ink
Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the detection of hypoglycemia, support the next generation of clinical trials and ultimately the clinical management of patients.
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