Cambridge Healthtech Institute’s Third Annual

Digital Innovation in Clinical Trials

Digital Biomarkers and Real-World Evidence Enabling Patient-Centric Clinical Development

June 2-4, 2020


TUESDAY, JUNE 2

7:30 am Registration and Morning Coffee

PLENARY SESSION: DIGITAL TRANSFORMATION IN HEALTHCARE

8:30 Chairperson’s Opening Remarks

8:35 Bringing Digital to Life: Transforming Healthcare and Patient Experience Using Human-Centered Design and Digital Solutions
Neil Gomes, MBA, Med, CSM, CSPO, Executive Vice President for Tech, Innovation & Consumer Experience, Enterprise Chief Digital Officer, Thomas Jefferson University & Jefferson Health
In this keynote presentation, Neil Gomes, Chief Digital Officer and Executive Vice President for Technology Innovation and Consumer Experience at Thomas Jefferson University and Jefferson Health, provides insights into how healthcare organizations can start to disrupt themselves by leveraging their experience in the industry to develop a better experience for their patients. This translates into developing not just digital health solutions, but creating new business models for healthcare that are focused on access, convenience, and experience; developing clinical process that embrace the principles of human-centered design; and making strategic investments in developing a culture of continuous transformative innovation at healthcare organizations. With the insights and real-world examples that utilize modern technologies such as artificial intelligence and machine learning, augmented and virtual reality, robotic process automation, dynamic decision systems, etc. that are part of this presentation, you will be able to embrace, define, and lead the consumer-focused, design-driven, and technology-enabled future of healthcare.

9:00 Driving Digital Transformation Success
Claus Jensen, PhD, Chief Digital Officer & Head of Technology, Memorial Sloan Kettering Cancer Center
While digital transformation is a hot topic in most organizations, statistics show that 9 out of 10 digital transformation initiatives actually fail to meet expectations – and the numbers having improved much since the emergence of Digital 2.0 imperatives. Join this session to discuss why digital transformation is so difficult, and what to do about it in order to improve your odds of success.

9:25 Delivering Digital Health in a Consumer Health World
Chet Robson, DO, MHCDS, FAAFP, Chief Clinical Officer, Walgreens
As patients take on more of the role of consumer it is valuable to understand how consumers discover, navigate, choose and utilize digital resources. This session explores how one retail healthcare company delivers digital assets for personal health, patient engagement, clinical research, and digital therapeutics.

9:50 Sponsored Presentation (Opportunity Available)

10:15 Coffee Break with Exhibit and Poster Viewing

11:00 The Future of Health Has Arrived: The Rise of Smart Health Communities
Asif Dhar, MD, MBA, Chief Health Informatics Officer, Principal, Deloitte Consulting LLP

11:25 Digital Health Is Here: How Will It Affect Your Health and the Health of Your Business?
Joseph C. Kvedar, MD, Professor, Dermatology, Harvard Medical School; Senior Advisor, Virtual Care, Partners HealthCare
The stark reality is that soon there will not be enough clinicians to care for our citizens sufficiently. Instead of relying on the more traditional and already overburdened one-to-one model, we must adopt technology that enables one-to-many care delivery models. In particular, artificial intelligence (AI) and other emerging technologies allow for outsourcing of routine tasks to machines, creating space in the schedule for human interaction between clinician and patient. How can we apply digital and telehealth to improve care delivery, patient and clinician satisfaction, and clinical outcomes?

11:50 PANEL DISCUSSION: Drivers in Digital Transformation

Moderator: Neil Gomes, MBA, Med, CSM, CSPO, Executive Vice President, Tech, Innovation & Consumer Experience, Enterprise Chief Digital Officer, Thomas Jefferson University & Jefferson Health

Panelists to be Announced

12:30 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Session Break

DIGITAL TECHNOLOGY-ENABLED CLINICAL TRIALS

2:00 Chairperson’s Remarks

2:05 Clinical Trials in the Digital Age: Moving from Site-Centric to Patient-Centric Clinical Trials
Lisa Shipley, Vice President, Global Digital Analytics and Technologies, Merck Research Laboratories
Current clinical trial paradigms are limiting. They are site-centric, confounded by non-adherence and lack real-time feedback during the conduct of the trials. Smart Trials is an initiative aimed at transforming long-term clinical trials at Merck through application of mobile health technologies. Components of Smart Trials include: 1) smart dosing/adherence technologies, 2) smart at home sampling technologies, 3) digital biomarkers, and 4) smart analytics. This combination of “smart” components will augment access to clinical endpoints in outpatient settings, reduce the logistical burden of difficult to enroll trial populations, enable real-time decision making in clinical trials, and improve the quality of information being utilized for analyses.

2:30 Operationalizing Digital Wearable Devices in Large Clinical Trials – Lessons Learned and Still Learning
Carrie Northcott, PhD, Director, Early Clinical Development, Digital Medicine, Pfizer
Atopic dermatitis is often accompanied by nighttime scratching and reduced sleep. Quantitatively evaluating nighttime scratch and sleep via accelerometry using digital wearables to continuously monitor patients in their “home environment” could provide insight into the disease and effectiveness of treatments. However, even having quantitative, accurate, unbiased technology won’t yield meaningful results, if the study’s logistics and executions – and the technology’s usability – have not been carefully considered and evaluated.

2:55 Digital Dreaming – Finding a Better Path
Katherine Vandebelt, Global Head of Clinical Innovation, Oracle Health Science Global Business Unit
Charting a new path is never easy. For centuries, the only way European ships could get to Eastern Asia was sailing around South America. King Charles I of Spain wondered, “Could we create a passage through the isthmus of Panama to connect the Atlantic and Pacific Oceans?” While it would take over three more centuries to make that dream a reality, it happened. We are at a similar point in clinical research. We know there is a better path. Unlike dreams of the Panama Canal in the 16th century, we are in a place in history where the technology, the science and the innovation exist to figure out how to make our dreams a reality.

3:20  Presentation to be Announced 

3:45 Sponsored Presentation (Opportunity Available)

4:00 Refreshment Break with Exhibit and Poster Viewing

PLENARY SESSION: BRIDGING SILOS: AN INTEGRATED APPROACH TO DIGITAL HEALTH

4:45 Chairperson’s Remarks

4:50 Commercialization, Regulatory and Partnering Strategies with Provider, Payers, Hub, Industry for Digital
Karan Arora, MBA, Chief Commercial Digital Officer, Global Vice President, AstraZeneca

5:15 Sponsored Presentation (Opportunity Available)

5:30 PANEL DISCUSSION: An Integrated Approach to Data Silos, Collaboration and Patient-Centricity

6:00 Welcome Networking Reception with Exhibit and Poster Viewing

7:00 Close of Day

7:00-9:30 Dinner Short Course (separate registration required)


WEDNESDAY, JUNE 3

8:00 am Morning Coffee

PLENARY SESSION: DIGITAL HEALTH INNOVATION

8:30 PANEL DISCUSSION: Investing in Digital Health Innovation
Moderator: Lisa Suennen, Lead, Digital & Technology Group, Manatt Ventures; Managing Director, Manatt Health
Panelists: David Kim, Managing Director, DigiTx
Additional Panelists to be Announced

9:30 Coffee Break with Exhibit and Poster Viewing

10:15 Chairperson’s Remarks
Lisa Suennen, Lead, Digital & Technology Group, Manatt Ventures; Managing Director, Manatt Health

10:20 Delivering Global Comprehensive Virtual Care at Scale
Lewis Levy, MD, FACP, CMO, Teladoc

10:45 Presentation to be Announced

11:10 Presentation to be Announced

11:35 Sponsored Presentation (Opportunity Available)

12:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Session Break

DIGITAL BIOMARKERS

1:25 Chairperson’s Remarks
Daniel R. Karlin, MD, MA, CEO, HealthMode

1:30 Naturalistic Measurement with Digital Technology and the Convergence of Clinical Trials and the Real World
Daniel R. Karlin, MD, MA, CEO, HealthMode
Measurement in clinical trials is progressing from intermittent, imprecise, and oriented around site visits to highly granular, continuous, and oriented around the participant’s life. Making sense of this progression requires understanding the past and current means of measurement, the process for moving toward better measures, establishing a vision for the future, and developing a strategy to get there. Using examples from our work, Dr. Karlin will address past, present, and potential future states in cough, bowel habits, agitation, pain, and oncology. For each, he will provide an example of where this biological phenomenon is relevant in clinical trials, describe its historical measurement, present a development pathway toward a future state, and provide a vision of that future state, in which the real-world collection of data enables better understanding of diseases and their treatment.

1:55 Picking the Right Device for Your Digital Biomarker
Joseph Kim, MBA, Senior Advisor, Digital Health, Eli Lilly
Digital approaches can transform research beyond just participant engagement and enrollment. The rapid evolution of wearable devices and mobile health (mHealth) technology in clinical trials combined with patient-centric data generation provides the potential for better science and drug development measures. But which device is the best? They all are – depending on what you’re trying to do. The lack of know-how to understand and validate devices, data, algorithms are slowing the integration of novel digital endpoints into clinical trials.

2:20 Faster, Smaller, Better: Choose Three! Quantitative Tools that Are Powering Digital Measures in Development
Peter Bergethon, MD, FAAN, FANA, Vice President and Head, Digital and Quantitative Medicine, Biogen, Inc.
Medicine is best viewed as an application of systems science in which the patient is a system and the state of that system is characterized by measurable properties. The change in state over time (dynamics) allows for characterization of the growth, development, health and disease states of a person as they change. The explicit recognition of the time dependency and the interaction of system observables provides a method of the quantitation of the health state and a rigorous paradigm for improving clinical trial PTRS and decreasing cycle time. Specific examples will be reviewed.

2:45 Sponsored Presentation (Opportunity Available)

3:00 Refreshment Break with Exhibit and Poster Viewing

DIGITAL BIOMARKERS (CONT.)

3:45 Chairperson’s Remarks
Daniel R. Karlin, MD, MA, CEO, HealthMode

3:50 Enhancing Clinical Understanding through Sensor-Based Data Generation 
Lauren Bataille, MS, Director, Digital Strategy Lead, Novartis
This presentation will describe how Novartis’ Medical Affairs Unit is investing in novel sensor technology to gain a more holistic understanding of the patient experience across multiple therapeutic areas. Focus will be on technology selection, implementation strategies, and opportunities for scale.

4:15 Talk Title to be Announced  
Shyamal Patel, PhD, Director, Head of Data Science, Pfizer

4:40 PANEL DISCUSSION: Digital Biomarkers
Moderator: Daniel R. Karlin, MD, MA, CEO, HealthMode

5:30 Close of Day and Registration for Short Course

6:00-9:00 Dinner Short Course (separate registration required)


THURSDAY, JUNE 4

8:00 am Morning Coffee

SENSORS, WEARABLES, AND IoT IN DIGITAL HEALTH

8:30 Chairperson’s Remarks

8:35 The ‘Tyranny of Distance’ to Cancer Patient Outcomes: Implementation Strategies of Remote Monitoring to Broaden the Umbrella of Cancer Care
Christopher M. Hartshorn, PhD, Program Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health
It is well documented that patients who reside greater than 50 miles, or in dense urban areas 50 minutes, from major medical centers have decreased outcomes than those who do not. This ‘tyranny of distance’ problem can be reduced by way of cancer care strategies that include digital health tools (e.g., apps, ambient sensing, and wearable sensing devices) that allow care to be brought to the patient. This talk will focus on several initiatives at the National Cancer Institute aiming to enable the broad implementation of digital health tools.

9:00 How Is Wearables-Driven Digital Health Shaping Non-Critical Care?
Ravi Kuppuraj, PhD, CEO/Digital Innovator, Connected Sensing – General Care Solutions, Philips
The continued adoption of digital health solutions in the management of post-acute and chronic care is well underway. The benefits from these endeavors span across the quadruple aim that healthcare strives for, positive clinical outcomes, cost and financial benefits, caregiver experience and finally patient benefit and experience. However, challenges from business models to logistics and compliance, continue to exist. In addition to these, there are also issues of data privacy and security, and the overall patient experience, all of which will directly influence the overall success and potential of these solutions. We will examine these challenges and constraints, as well the emerging solutions and methods that are transforming digital health and healthcare overall.

9:25 Clinical Wearables as a Source for Real-World Evidence
Carlos Agell, Program Manager & Principal Member of Technical Staff, Connected Health, imec
Starting out as a device for early adopters, wearables now represent a mass market product with 300 million units sold worldwide in 2019. Reaching fields such as entertainment, payments and wellbeing, 10 years after the launch of the first Fitbit the wide-spread impact in the consumer market cannot be compared with the minor adoption within the clinical and medical research scene. Medical grade wearables, proven against golden reference devices are a first milestone. Proving medical endpoints with such wearables is the next stage. In this talk IMEC will be presenting how medical wearables transitioned from proving functionality to being used in hospital and ambulatory conditions for medical research and development. Example applications in the fields of cardiac monitoring, respiration CHF, COPD and stress monitoring will be discussed. The fine-grade information collected by wearables, their pervasiveness and continuous operation enable new frontiers towards real-world data gathering within RCT and bring new dimensions in unraveling real-world evidence.

9:50 Sponsored Presentation (Opportunity Available)

10:05 Interactive Breakout Discussions Coffee Break

PLENARY SESSION: EVIDENCE-BASED DIGITAL MEDICINE

11:00 Chairperson’s Remarks

11:05 How Digital Health, Digital Medicine, and Digital Therapeutics Can Reshape Provider, Payer, Pharma, and Patient Collaboration
Ashish Atreja, MD, MPH, Assistant Professor, Chief Innovation Officer, Medicine, Icahn School of Medicine at Mount Sinai

11:30 Using Digital Solutions to Drive Real-World Research
Stella Safo, MD, MPH, Chief Clinical Transformation Officer, Vice President, Prospective Research, Premier, Inc.
This session will evaluate how digital solutions, from clinical decision support tools to population health performance management platforms, accelerate the breath of insights that can be gleaned from real-world research studies.

11:55 PANEL DISCUSSION: Real-World Impact of Digital Medicine
Moderator: Ashish Atreja, MD, MPH, Assistant Professor, Chief Innovation Officer, Medicine, Icahn School of Medicine at Mount Sinai

12:30 pm Close of Conference

 

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