W:10 Digital Biomarkers in Pharma R&D: Technical Challenges and Strategies for Advancing Personalized Medicine
Room Location: Waterfront 1B/1C

Tuesday, April 16 | 12:30-4:00 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 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 Chairperson’s Remarks

Amir Lahav, ScD, Rare Disease Research Unit, Pfizer

12:40 How the Patient Home Will Be a Digital Biomarker Marketplace

Timothy Aungst, PharmD, Associate Professor, Pharmacy Practice, MCPHS University

Increased technological innovations in smart devices worn by consumers and integrated into their daily lives has led to increased touch points and data acquisition. Wearables, digital assistants, and associated technology may pose a novel means for pharma to tap directly into a patient life to monitor daily actions and markers on their health. 

1:25 Using Digital Biomarkers, Disease Surveillance, and Real-World Data to Maximize Chances for a Successful Clinical Trial

Amir Lahav, ScD, Digital Innovation Lead, Rare Disease Research Unit, Pfizer

Digital biomarkers derived from biometric, physiologic, and mobility measures have a significant impact in advancing our capacity for tracking disease progression away from the clinic. Advances in wearable intelligence and passive sensor technology increasingly allow the remote monitoring of human activity in free-living conditions and naturalistic home settings. Is the home environment indeed the optimal place for finding the right endpoints? Can this digital transformation lead to better clinical trials? What it the added value? What are barriers for success?

2:10 Coffee Break

2:30 Using Wearable Technologies to Enable Novel Endpoint Development and Remote Data Collection in Clinical Trials

Elena Ismailova, PhD, CSO, Koneska Health

Wearable technologies are rapidly changing how clinical trials are designed, conducted, analyzed, and interpreted. Moving traditional disease assessments from doctors’ offices to the at-home environment offers several advantages, including smaller required sample size and robust data more likely to reflect patient functional status. We have successfully deployed our integrated approach, combining device-based objective measures with electronic patient reported outcomes (ePRO), across different therapeutic areas including respiratory diseases, neurological disorders, and safety monitoring.

3:00 Harnessing the Power of the Digital Exhaust and Digital ATM in Wellness Programs

Graham Jones, PhD, Professor, Medicine, Clinical and Translational Science Institute, Tufts Medical Center

Clinical decision-making using diagnostic, prognostic, and monitoring biomarkers requires coordination between the healthcare and technology industries and careful design of longitudinal efficacy studies. Community health providers and pharmacies are poised to play a pivotal point of care role by helping capture prodromal diagnostic data and incorporating biomarker monitoring into wellness programs. A model for the pharmaceutical in¬dustry to embrace these patient engagement opportunities is outlined.

3:30 Speaker Q&A

4:00 End of Workshop

INSTRUCTORS:

Timothy Aungst, PhD, Assistant Professor, Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences

Timothy Aungst, PharmD is an Associate Professor of Pharmacy Practice at MCPHS University, Worcester, MA. He is passionate about the role of digital health in patient care. His first pursuit in the field was writing for multiple companies on mHealth and Digital Health, with a focus on mobile apps for patient utilization and recommendation for prescribing my providers. Since then, he has conducted research on digital health technologies in the pharmacy space and published in multiple peer review journals and spoken at multiple venues on the topic. He hopes to inspire the pharmacy profession to further integrate digital health into patient care and raise awareness on the future possibilities posed in the coming decades.

Eli Goldberg, Data Scientist, Innovative Digital Endpoint Analytics (IDEA), Novartis Institutes for Biomedical Research

Eli leads the development of novel respiratory and passively sensed digital biomarkers in early clinical trials for Novartis Institutes for BioMedical Research (NIBR) in Cambridge. In addition, he leads one of NIBR’s intrapreneurship venture efforts, a novel MIT-Novartis collaboration that focuses on accelerating the incorporation of passive sensing technology into clinical trials. Prior to joining Novartis, Eli founded and managed SelfAware Engineering, a respiratory disease focused digital medtech and AI startup, and Amarach Consulting, a data science and environmental engineering firm, and was a postdoctoral data science research fellow in the institute for chemical and bioengineering at ETH Zurich.

Elena Ismailova, PhD, CSO, Koneska Health

Dr. Elena Izmailova is a clinical scientist with a unique background bridging technology innovation, scientific strategy, and business management. Her main interests lie in biomarker discovery, development, and utilization in the context of clinical trials. Elena is currently Chief Scientific Officer of Koneksa Health, an innovative technology company that accelerates development of new medicines by leveraging wearable technologies to collect real world data, enabling the biopharmaceutical industry to execute more efficient and successful clinical trials. Prior to her appointment with Koneksa Health, Elena led the wearable device clinical innovation group at Takeda Pharmaceuticals, where she created a comprehensive digital roadmap for technology-enabled clinical development. Elena joined the pharmaceutical industry in 2003.  At Millennium Pharmaceuticals she led cross-functional teams to develop and deploy clinical biomarker strategies, and directed the bio-analysis function responsible for biomarker assay development, validation and implementation across multiple therapeutic areas and in global clinical trials.  She additionally established fruitful collaborations with investigators at several major teaching hospitals, leading to discovery and characterization novel disease biomarkers, and resulting in multiple publications and conference presentations. Elena holds PhD in Biology.  She completed postdoctoral training at Massey Cancer Center/MCV and at Children’s Hospital/Harvard Medical School.  She has also held a visiting scientist position at the Whitehead Institute of MIT.

Graham Jones, PhD, Professor, Medicine, Clinical and Translational Science Institute, Tufts Medical Center

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 has 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 has held a number of leadership roles in the academy including pro-vice chancellor, vice provost and institute director, most recently Director of Translational Research at the Tufts Clinical and Translational Science Institute (CTSI) in Boston MA. 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.

Amir Lahav, ScD, Rare Disease Research Unit, Pfizer

I’m a neuroscientist and biomedicalist working at the intersection of clinical innovation, digital biomarkers, and patient technology. I strive to transform the way we do clinical trials while understanding barriers to change. I believe in the power of real-world data. I’m working to validate novel digital endpoints that are clinically meaningful for patients, families, and regulators. This could reduce cost and duration of clinical trials, and may help mitigate some of the inefficiencies in drug development process. I’m also developing digital solutions for improving patient experience and retention in clinical trials using engaging gamification strategies. I served as a scientific medical advisor for several companies and hospitals and have contributed to the development and design of a number of inventions in the medical device space. As a composer and trained musician, I have always been fascinated by how motion and sounds shape the human brain, and have conducted several studies to examine these sensory-motor effects across different brain imaging modalities and digital rehab technology. I’m grateful for the time I spent in academia as a prof. of Pediatrics, Epidemiology, and Neurology faculty at Harvard Medical School. I have had the pleasure of mentoring a matrix group of talented students and research fellows. With their help, I published 45 scientific publications and have given over 130 conference presentations in US and Europe.