J&J Innovation Event: Clinical Evidence Generation in the Digital Age: Decentralized and Site-Less Trials

Clinical Evidence Generation in the Digital Age: Decentralized and Site-Less Trials
Location: 
ONLINE VIA WEBINAR
Event Date: 
Wednesday, June 17, 2020
10:00am–12:30pm EDT

Getting to a brick and mortar healthcare and research facility isn’t always practical or convenient. Luckily, remote monitoring and other decentralized ways of collecting data are on the rise. Hospitals are finding remote patient monitoring (RPM) equipment to have a strong ROI. The University of Pittsburgh Medical Center reduced hospital readmissions by 76% and held a patient satisfaction score of over 90% by merely equipping patients with tablets and RPM equipment. [1]

Similarly, virtual clinical trials can significantly reduce costs and time involved in a traditional trial. Nearly 70% of potential clinical trial participants live more than two hours away from a study center, limiting their opportunities to benefit from possibly life-changing therapies. [2] Virtual trials open patient recruitment far beyond the geographical limitations of site-based clinical trials. Remote trials also have the potential to improve patient retention, expand the diversity of the patient population, and allow for greater patient compliance.

It’s evident that remote monitoring via telemedicine and portable devices has many benefits, but do the positives outweigh the potential risks? What are the regulatory, data privacy, cybersecurity, and technical considerations for scaling of such solutions?

Key experts in the field will discuss the current landscape of digital technologies aimed at decentralizing clinical trials, making them more efficient and bringing them closer to where most patients live.

Sources:

[1] https://www.businessinsider.com/remote-patient-monitoring-industry-explained

[2] https://www.nationalacademies.org/news/2019/08/virtual-clinical-trials-a-new-model-for-patient-engagement

 

Speakers:

Jennifer Goldsack, MChem, MA, MBA, OLY

Executive Director of the Digital Medicine Society (DiMe)

Jen Goldsack serves as the Executive Director of the Digital Medicine Society (DiMe). Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.

Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian and World Championship silver medalist.

Sean Khozin, MD, MPH

Global Head of Data Strategy for Janssen, Johnson & Johnson

Sean Khozin, MD, MPH is an oncologist, physician-scientist, and research affiliate at MIT. Dr. Khozin is the Global Head of Data Strategy for Janssen/J&J, focusing on incorporation of data science and advanced quantitative methods (including AI/ML) into R&D activities. He joined the company from US FDA’s Oncology Center of Excellence, where he built and led the Center’s bioinformatics capabilities and efforts. He was also the founder of Information Exchange and Data Transformation (INFORMED), US FDA’s first data science and technology incubator designed as an agile sandbox for de-risking solutions through foundational research and public-private partnerships aimed at improving therapeutic development and advancing national public health priorities. ​

Prior to his tenure in federal government, Dr. Khozin was the cofounder of Hello Health, developing an integrated telemedicine, point-of-care data visualization, and analytical platform for optimizing patient care and clinical research. The company’s core technology offerings were first operationalized in a multidisciplinary network of clinics called SKMD that he founded and for which he served as the Chief Medical Officer.

Robert M. Califf, MD, MACC

Head of Clinical Policy and Strategy for Verily and Google Health
Adjunct Professor, Duke University and Stanford University

Robert M. Califf, MD, MACC, is the Head of Clinical Policy and Strategy for Verily and Google Health for Verily and Google Health. Prior to this Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, MD, Professor of Cardiology. He served as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-2016, and as Commissioner of Food and Drugs from 2016-2017. A nationally and internationally recognized leader in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf is a graduate of Duke University School of Medicine. Dr. Califf was the founding director of the Duke Clinical Research Institute and is one of the most frequently cited authors in biomedical science.

Bob Zambon, PhD

Senior Director, Data Strategy & External Innovation, Janssen Research & Development, LLC

Dr. Zambon is the Senior Director, R&D Data Strategy & External Innovation, in Janssen Pharmaceuticals R&D. In his role, Dr. Zambon leads and supports strategic data science and innovation focused partnerships and initiatives for Janssen R&D focused on the usage of innovative technologies, analytics, data, and collaboration to accelerate and advance global R&D efforts  across Janssen’s therapeutic areas.  Dr. Zambon is also leading data efforts for the Heartline study, a first-of-its-kind siteless and completely virtual clinical study done collaboratively by J&J and Apple.

Dr. Zambon has close to twenty years of experience in the life sciences industry with experience in strategy development, program management, clinical research, product development, sales force training, client management, regulatory affairs, analytics, and market research.  He’s led and supported research programs in the areas of cardiology, orthopedics, immunology, infectious disease, and medical countermeasures. 

Dr. Zambon received his Ph.D. in Molecular & Cell Biology at the University of Maryland and his B.S. in Biotechnology at Rutgers University.

 

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571-482-2737

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