W9. Digital Biomarkers and Wearables in Pharma R&D and Clinical Trials

TUESDAY, APRIL 21 | 12:30 - 3:30 PM

ABOUT THIS WORKSHOP:

There is a wealth of data in the form of digital information from sensors we use daily, from smart watches to fitness trackers, and this data has the potential to uncover new insight in the form of digital biomarkers. This workshop will cover the role of digital biomarkers in clinical trials and drug development, as well as technical challenges related to extracting data from sensors such as wearables and developing analytics, from the infrastructure to the algorithms. This workshop will also address the role of digital biomarkers in real-world practice in wellness programs and the pharmacy, and ultimately outline how digital biomarkers can advance personalized medicine.

WORKSHOP AGENDA:

12:30 pm Workshop Introduction

12:35 Digital Biomarkers: Unlocking Opportunities in Healthcare

Dani Bradnan, MS, Research Associate, Digital Health and Wellness, Lux Research

The hype surrounding digital biomarkers coming out of research institutions today for the early diagnostics of health conditions often overlooks the fact that they enable infrastructural changes in the healthcare industry ranging from decentralized care to better informed decisions about resource allocation. In this talk, we will explore the current landscape of digital biomarkers, and how they can impact different players.

1:05 Use of Smartphones and Wearables for Collection of Real-World Data: Hype and Reality

Larsson Omberg, Vice President, Systems Biology, Sage Bionetworks

We will look at several examples of development of measures from digital health technologies with a focus on some of the lessons learned. We will look at the power offered by frequent in-the-home sampling of data and how these data streams lead to new analytical considerations.

1:35 Refreshment Break

2:00 Digital Adherence Drivers: A Tale of Assumptions and Realities

Graham Jones, PhD, Director, Innovation, Technical Research and Development, Novartis

Combination products offer seemingly ideal venues for deployment of digital inspired solutions to address patient engagement and adherence rates. Successful design requires innovation processes where patient-centricity is embedded in the iteration cycles, allowing near term field testing. A rapid innovation cycle approach to such design will be highlighted along with examples of successful deployment in selected indications.

2:30 Wearable Devices in Drug Development Clinical Trials: Case Studies

Ariel Dowling, PhD, Associate Director, Digital Clinical Devices, Data Sciences Institute, Research and Development, Takeda Pharmaceuticals

Wearable devices are revolutionizing our understanding of human body performance in daily life. This presentation will provide an overview of the use of wearable devices in drug development clinical trials to quantify patient outcome measures and disease progression. Specific case studies in neurology and oncology will be highlighted to illustrate the benefits and hurdles of implementing this technology. This presentation will also provide a rationale for how wearable device data can be used to achieve regulatory approval for new clinical endpoints.

3:00 Q&A with Attendees/Speakers

3:30 Workshop Ends

WHO SHOULD ATTEND:

Bioinformaticians, Software Developers, IT Specialists, Managers, and Directors in Digital Medicine, Digital Health, and Informatics.

INSTRUCTORS:

Bradnan_DanielleDani Bradnan, MS, Research Associate, Digital Health and Wellness, Lux Research

Dani is a Digital Health and Wellness Research Associate at Lux Research with deep expertise in digital therapeutics, digital biomarkers, and FemTech. Prior to her time at Lux, Dani worked as an Environmental Group Manager for a water treatment company, surveying and developing treatment plans for waterborne pathogen outbreaks in healthcare facilities across the United States. Dani graduated with a Masters Degree in biology from the University of Louisiana at Lafayette.

Dowling_ArielAriel Dowling, PhD, Director, Digital Strategy Lead, Data Sciences Institute, Takeda Pharmaceuticals

Ariel V. Dowling, PhD is a Director of Digital Strategy within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, Ariel oversees the strategy, assessment, and deployment of digital devices in clinical studies and related activities across the organization. She advises clinical teams on the selection of digital devices, conducts due diligence on vendors, develops digital sensor implementation protocols and risk mitigation strategies, and assists with data analysis plans for device data. Prior to joining Takeda, she was a Senior Clinical Data Scientist at Biogen Inc where she oversaw the analysis of data from wearable sensors deployed in drug development clinical trials for Parkinson’s Disease. Prior to Biogen, Ariel was the algorithm team lead at MC10 Inc, where she oversaw the development and implementation of algorithms across the full product line and managed all aspects of algorithm testing that lead to a successful FDA submission. She has also worked as a senior research scientist at BioSensics LLC, where she designed algorithms to analyze digital device data from Huntington’s disease patients, stroke patients, and wheelchair users. Ariel holds an MS and PhD in Mechanical Engineering from Stanford University and a BE in Mechanical Engineering from Dartmouth College. 

Jones_GrahamGraham Jones, PhD, Director, Innovation, Technical Research and Development, Novartis

Following his PhD at Imperial College London, Graham was a NATO fellow at Harvard University where he worked with Nobel Laureate E. J. Corey. His independent academic career spanned 25 years and generated >$100 million external funding and 160 peer reviewed publications in the fields of drug discovery, drug delivery, process technology, regulatory science and medical devices. He held a number of leadership roles in the academy including pro-vice chancellor, vice provost and institute director, most recently Professor of Medicine and Director of Translational Research at the Tufts Clinical and Translational Science Institute (CTSI) in Boston MA. In 2018 Graham was recruited by Novartis as Director of Innovation. Graham has been a regular consultant to the pharmaceutical and biotechnology industry and was an advisor to the FDA in the development of the biosimilars approval pathway. He has also been instrumental in establishing and advising a large number of technology-based startup companies who have subsequently raised >$4B in venture funding. Graham sits on several advisory and editorial boards and has been the recipient of numerous awards for scientific and technology development. He was awarded the DSc in 2006 for contributions to medicinal chemistry.

Omberg_LarssonLarsson Omberg, Vice President, Systems Biology, Sage Bionetworks

Dr. Omberg’s research effort focuses on two areas – using remote sensors and mobile phones to measure disease; and collaborative genomic research. Currently his group focuses heavily on open and team based science to get a large number of external partners to collaborate on data intensive problems. This includes establishing norms and methods for measuring disease phenotypes using remote sensors and developing analytical approaches for turning raw signals from sensors into digital biomarkers. Dr. Omberg and the Systems Biology group have been involved in over two dozen mobile health studies ranging from Chronic Anemia to Parkinson's Disease to cardio-respiratory fitness. As a graduate student and postdoctoral researcher at the University of Texas and Cornell University Dr. Omberg developed machine learning and statistical approaches for extracting genomic phenotypes and disease signals from system level biological data. After establishing a data science group at Sage Bionetworks his expertise was applied to coordinating data integration and integrative analysis for the TCGA Pancancer collaboration, The Progenitor Cell Biology Consortium as well as the international ICGC/TCGA Whole Genome Pan-Cancer Analysis among other projects. Dr. Omberg received a PhD in physics from the University of Texas at Austin.

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