30 episodes

Oracle Health Sciences Vice President of Global Innovation, Kathy Vandebelt, interviews industry experts and leaders on pressing topics in the Life Sciences industry.

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    • Technology

Oracle Health Sciences Vice President of Global Innovation, Kathy Vandebelt, interviews industry experts and leaders on pressing topics in the Life Sciences industry.

    Ep. 30: Collaborating to scale the use of health sensor data

    Ep. 30: Collaborating to scale the use of health sensor data

    Access to relevant and trustworthy data to make accurate and timely healthcare decisions is critical. Cohesive industry collaboration is key to removing barriers to data access and increasing adoption of sensors in health science. In this episode, Jennifer Goldsack, Chief Executive Officer of non-profit Digital Medicine Society (DiMe) discusses a multistakeholder Sensor Data Integration collaboration designed to provide clear direction on how sensor data can fulfill its potential to enhance patient lives.

    • 41 min
    Debunking the myths of clinical trials; leveraging the realities

    Debunking the myths of clinical trials; leveraging the realities

    Clinical research is the study of health and illness in people. It’s about putting people – the participants and volunteers – at the center of finding out if a new treatment is safe and effective. What clinical research and clinical research participation means is often discussed and frequently shared. In this episode, Ken Getz, Executive Director and Professor of Tufts Center for the Study of Drug Development (CSDD), and Elisa Cascade, Chief Product Officer of Science 37, offer insights on the realities and complexities encountered in conducting clinical research around the world.

    • 38 min
    Celebrating clinical trial volunteers

    Celebrating clinical trial volunteers

    International Clinical Trials Day, celebrated each year on May 20th, commemorates the day that James Lind began the first randomized clinical trial in 1747. It also provides an opportunity to recognize and thank everyone involved in clinical research. In this episode, Bruce Hellman, Co-founder and Chief Patient Officer at uMotif offers a practical perspective on what it means to be patient-centric in trial design - including diversity, digital literacy, and the availability of hybrid clinical trial models.

    • 26 min
    Using RWE to deliver better treatments for patients

    Using RWE to deliver better treatments for patients

    The use of mobile devices, social media, wearables, and other biosensors continues to expand year on year. The curation and analyses of health-related data is accelerating, and these data provide the potential to answer questions previously thought infeasible. When a researcher is seeking answers to a health question, when is it appropriate to use real-world data (RWD) and when it is appropriate to conduct clinical research? In this episode, Dr. Susan Dallabrida, CEO, SPRIM Consulting, and Dr. Carla Rodriguez-Watson, Director of Research, Reagan-Udall Foundation for the FDA, share their extensive experiences with RWD and real-world evidence (RWE).

    • 42 min
    Ep. 26: Facilitate clinical research in Europe

    Ep. 26: Facilitate clinical research in Europe

    The European Union (EU) has been on a path to harmonize the clinical trial process and requirements since 2004 starting with the Directive. The next step came 10 years later, in 2014, with the Clinical Trial Regulation (CTR). This year, as of January 31, the Clinical Trials Information System (CTIS) went live and supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries and the European Commission. In this episode, Marieke Meulemans from GCP Central and Sebastian Payne from Deloitte share how clinical research and patient health in the EU will benefit from the streamlined regulatory processes and a new portal.

    • 46 min
    Ep. 25: Raising awareness for unknown illnesses

    Ep. 25: Raising awareness for unknown illnesses

    There are more than seven thousand rare diseases in the world – 95% of which have no known treatment. The term rare diseases is a cruel misnomer – in fact they aren’t that rare, and importantly, the definition of what constitutes a rare disease differs by country. To raise awareness, Rare Disease Day is recognized on the last day of February annually. In this episode, industry leaders Joan Chambers, senior director of marketing and outreach at CISCRP, and Scott Schliebner, executive VP and chief strategy officer at M&B Sciences, discuss the importance of improving access to treatment and medical representation for individuals with rare diseases and their families.

    • 37 min

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