Cambridge Healthtech Institute's Inaugural

Sensors, Wearables and Digital Biomarkers in Clinical Trials:
( 臨床試験でのセンサー、ウェアラブル技術、デジタルバイオマーカー )

Novel Data Sources and Connectivity for Virtual and Remote Trials

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド




Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE's Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson's Remarks

Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

10:50 Digital Biomarker Development at Roche pRED: How Mobile Technology Can Innovate Clinical Endpoints

Christian_GossensChristian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

Merging the best of two worlds - clinical trials and real world - is now increasingly possible. Mobile sensors are rapidly becoming a part of everybody's lives. They allow for objective, precise and continuous measurements. We share our first real world digital biomarker results based on active tests and passive monitoring data - provided by Parkinson's disease and Multiple Sclerosis patients in clinical trials.

11:15 What Drives the Success (or Failure) in mHealth Platform: Share Learning from GSK PARADE Study

Michelle_CrouthamelMichelle Crouthamel, Digital Platform Leader, GSK

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

11:40 Matching Clinical Needs to Medical Needs

Ieuan_ClayIeuan Clay, Ph.D., Group Lead Digital Endpoints, Translational Medicine, Novartis Institutes for Biomedical Research

Due to advances in technology, our ability to capture data in clinical settings is better than ever. How we match the right technology to a medical need, and how we ensure that we are extracting the relevant information from that stream of data in a robust and sensitive way is the focus of our research. We will present examples and discuss how we are tackling these challenges across different demographics and disease areas.

12:05 pm Integrating Wearable Sensors in Clinical Trials for Monitoring Real-Life Activities at Home: Developing Clinically-Meaningful Endpoints and Gamification Strategies for Compliance

Amir Lahav, Sc.D., Rare Disease Research Unit, Pfizer

This talk will provide a visionary approach to developing and validating digital biomarkers using remote health monitoring of daily activities. The core idea of this approach is to create a patient-centric monitoring system that can objectively quantify meaningful changes in disease progression that would otherwise not be captured by traditional functional assessment in the clinic. This will largely depend on developing data-driven digital tools as well as engagement and compliance strategies for integrating wearable technology into clinical trials in an efficiently productive fashion.

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall


2:00 Chairperson's Remarks

Gahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & Development

2:05 Novel Biomarkers for Use in ASD Drug Development: State of the Science

Gahan_PandinaGahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & Development

Autism Spectrum Disorder is a heterogeneous, complex neurodevelopmental disorder affecting 1-2% of the global population. There are currently no medications indicated for the treatment of core symptoms. Recently, research focus has shifted to the development and potential use of biomarkers to stratify the ASD population, or to assist with measuring treatment outcome change. The presentation will review the current state of the science in development of ASD biomarkers.

2:30 Key Considerations in Integrating Wearables/Sensors Data in Sponsor's Ecosystem (AbbVie)

Aman_ThukralAman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

In pursuit of patient-centric clinical research, sponsors are leveraging wearables and sensors devices in clinical trials. These devices shoot data at a larger volume and velocity compared to traditional systems and require different skills to collect, integrate, and manage patient data. This session will discuss key considerations in integrating wearables/sensors data in sponsor's ecosystem.

2:55 PANEL DISCUSSION: Digital Technology Adoption and Implementation

Christian_GossensChristian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

Gahan_PandinaGahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & Development

Aman_ThukralAman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

Ieuan_ClayIeuan Clay, Ph.D., Group Lead Digital Endpoints, Translational Medicine, Novartis Institutes for Biomedical Research

Michelle_CrouthamelMichelle Crouthamel, Digital Platform Leader, GSK

This panel will discuss: Wearable sensors' impact on trials design and execution, Collecting, integrating, and analyzing wearable devices data, and Driving innovation in patient centricity and PROs.

3:20 Sponsored Presentation (Opportunity Available)


3:50 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev

8:15 Session Break


8:25 Chairperson's Remarks

Chairperson to be Announced, ZS Associates

8:30 Harnessing Digital Technology and Big Data in Clinical Trials and Beyond

Vaibhav Narayan, Vice President, Research and Therapeutic Area IT, Janssen

Measuring physiological and activity-based parameters remotely and continuously via unobtrusive on/off-body sensors or smartphones has the potential to revolutionize our ability to monitor patients between clinic visits and develop objective markers that track disease trajectory. How can we harness such advances in digital technology and big data analytics to enable more informative and efficient clinical studies and develop patient centric digital solutions that improve outcomes in the real world?

8:55 Digital Biomarker Implementation, Presentation and Comparability

Amy_CalvinAmy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and Company

Over the past few years, data generation is beginning to take a new form. It's moving from subjective to more objective, from episodic to contemporaneous, and is being generated through connected digital tools that can be used to quantitatively explain or predict physiological, behavioral, and functional health measures and outcomes. These digital measures are known as digital biomarkers. This presentation utilizes learnings from pilot examples to examine the implementation, presentation and comparability of digital biomarkers.

9:20 Wearables and Sensors Are Changing the Clinical Trial Process, but What's the Return on Investment for Making This Dramatic Change in People, Process and Technology?

Deborah Profit, Ph.D., Vice President, Otsuka Information Technology

The advent of wearables and sensors in clinical trials is changing the paradigm of trial designs, clinical teams, outsourcing practices, and ultimately patient engagement. However, what value does sensor/wearable data and these new trial practices bring, and how quick is the return of investment to the various stakeholders? Otsuka Pharmaceutical Development and Commercialization, Inc. is on the cutting edge of the trial and technology reform, and will share some critical learnings from "the road less traveled".

9:45 Presentation to be Announced

Speaker to be Announced, ZS Associates

10:10 Coffee Break in the Exhibit Hall


11:10 Chairperson's Remarks

Aman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

11:15 Identifying, Developing and Incorporating Technology-Derived Endpoints into Clinical Trials: A 'How-To' Guide on the Agenda

Robert_DiCiccoRob DiCicco, Ph.D., Vice President, Clinical Innovation and Digital Platforms, GSK

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. This presentation will describe recommendations and tools from the Clinical Trials Transformation Initiative (CTTI) that aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

11:40 Making Sense of Sensor Data: A Case Study in Data Quality Evaluation

Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca

Wearable sensor technology brings the promise of improving management of chronic diseases, identification of drug adverse effects, and use of new efficacy endpoints. Future adoption of wearable sensors in clinical studies will depend on the usability of the devices and quality of the data. Currently, several sensors are commercially available, hence, requiring a comprehensive review. We carried out a study to compare them in healthy volunteers and implemented a comprehensive data analysis strategy, which has paved the way for improved designs of future studies involving wearable sensors.

12:05 pm Session Break

12:10 Bridging Luncheon Presentation: Streamline Clinical Trials with the Industry's Only Proven Clinical Operations Suite - DrugDev Spark™

Brett Kleger, Chief Commercial Officer, DrugDev

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)