Cambridge Healthtech Institute’s 8th Annual

Clinical Technology and Innovation

Disruptive Technologies for Data and Trial Management

February 20-21, 2019

Digital technology, mobile solutions, novel data collection modalities and integrative systems are becoming game-changing features of modern clinical trials. However, the adoption of novel technology solutions to improve overall outcomes and garner operational efficiencies has been slower than expected. Cambridge Healthtech Institute’s 8th Annual “Clinical Technology and Innovation” conference will feature a broad array of topics such as blockchain technology, machine learning, digital trends, and their adoption and implementation in clinical research. We are looking forward to hosting a practical and productive knowledge and experience exchange.

Final Agenda

Arrive early and attend Part 1 (Tues-Wed): Sensors, Wearables and Digital Biomarkers in Clinical Trials

Wednesday, February 20

11:30 am Registration Open (Convention Level)

12:30 pm BRIDGING LUNCHEON PRESENTATION: Configuration in ePRO: Making Design More Collaborative and Delivering Better Results

Kyle Hogan, Director, eClinical Solutions, Clinical Ink

You will learn how the authoring tool allows Clinical Ink project managers to focus on continuous collaboration in design and iterative improvements starting with early decisions and regular feedback. You will see how rapid and regular prototyping supports that feedback cycle, improves sponsor study team confidence and delivers better quality ePRO solutions with fully integrated patient engagement experiences.

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Plenary Keynotes (Regency PQ)

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)

Regency O

4:05 Chairperson’s Remarks

Pam Duffy, IT Lead, Core Clinical Solutions & Services, Pfizer

4:10 The Hitchhiker’s Guide to MountainView – A True Story about an Exciting Journey

Holzapfel_KirstinKirstin Holzapfel, Head, Clinical Data Process Technology, Data Sciences & Analytics, Bayer AG

What if you found yourself in a world where system integrations are coming out of one hand, patient data collected by mobile devices floating seamlessly into your data repository, data flow processing and transformations happening, meta data driven and being triggered in an instant manner, searches delivering comprehensive overviews covering data and associated documents, and support is given to keep you on top of your clinical study? Bayer’s Mountain View Program is striving to make this picture real.

4:40 CO-PRESENTATION: Under the Hood of Investigator Grant Budgeting

Shelley Douros, Associate Director, Design & Planning, IQVIA Technologies

Brenda Medina, BBA, Director, Development Science Business Operations, Biomarin

This session will review and highlight best practices of the protocol into finances, including using consistent benchmarks and automating the site budget execution process. In addition, it will highlight how to create holistic budgets using benchmarks while effectively tracking the financial lifecycle through API adoption.

5:10 Changing the Clinical Paradigm: Striving for End to End Automation

Duffy_PamPam Duffy, IT Lead, Core Clinical Solutions & Services, Pfizer

Players in the drug development industry are actively looking at ways to apply a plethora of technologies to improve quality, speed up the process and focus on the patient. Is this really changing the paradigm? The new clinical paradigm will be fed by data intelligence, based on standards and driven by automation. We’ll share plans and experiences in driving change in several areas including data ingestion, site relationships, study optimization and intelligent document generation.

5:30 Future Perfect: Personalized Homes and Personalized Medicine

Bergethon,_PeterPeter Bergethon, Vice President, Quantitative Medicine & Clinical Technologies, Biogen

In the near future, sufficient numbers of sensors will be found throughout houses, cars, clothes and everyday objects to enable multiple orthogonal views of each person over varying time intervals. Individuals in their personal spaces will be evaluated and their clinical state captured and characterized and then mathematically cross-referenced to create populations of highly correlated but distinct individual entities. This digital future will enable remote clinical diagnosis, trials and therapeutics.

5:50 Telemedicine in Clinical Trials

Spiller_NinaNina Spiller, Vice President, Clinical Management, Otsuka Pharmaceutical Companies

This talk will feature experiences to date with telemedicine use in clinical trials, including considerations for protocol design, study startup activities and trial oversight. Vendor landscape (current capabilities and wish list for future offerings) and anticipated future use in clinical trials will be discussed.

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee

8:15 Session Break

Regency O

8:20 Chairperson’s Remarks

Chairperson to be Announced, Omnicomm

8:25 Revolutionizing Clinical Trial Design and Set-Up with Digital Data Flow

DiCicco_RobertRob DiCicco, Principal Consultant, TransCelerate Biopharma, Inc.

Currently, there exists an average lag time of four months between protocol completion and study start. Furthermore, third-party conversion of data to SDTM lengthens cycle time and presents limits for traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort. This new Transcelerate initiative aims to move the drug development process from a current state of manual study start-up asset creation to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.

8:55 The Future of Healthcare: Humans and Machines Partnering for Better Outcomes

Fombu_EmmanuelEmmanuel Fombu, MD, Director, Digital Health Solutions, Novartis

We live in a world where data can help us make more informed decisions about how to navigate traffic, who to date, what to buy, who to network with and how to better manage our finances. But when it comes to our personal health and wellness, we have no roadmap. We need something to show us where we are in terms of our health, with landmarks for risks and opportunities. A GPS that makes it easier to move toward our personal health goals. A new way to look at health and life.

Regency O

9:25 Using Janssen Autism Knowledge Engine to Measure Facial Affect: An Example of Implementation of Biosensors in Clinical Trials

Bangerter_AbiAbi Bangerter, DEdPsy, Clinical Research Manager, Janssen Research & Development

Biosensors can be used to detect clinical population differences, and may be useful for stratification and outcome measurement. For example, facial expression of affect is impaired in autism spectrum disorder (ASD). With the Janssen Autism Knowledge Engine (JAKE®), we measured posed and spontaneous facial expressions in ASD and a reference sample via automated facial expression analysis software. Significant group differences suggest facial affect may be useful in ASD clinical trials.

9:40 CASE STUDY: Tele-visits, Wearables, Sensors, the New Landscape of Clinical Trials

Kayson_EliseElise Kayson, Director, Clinical and Strategic Initiatives, the Center for Health + Technology (CHeT); Assistant Professor of Nursing and Senior Associate in Neurology, University of Rochester

The study objective was to develop, implement, and evaluate a model for long-term observation of Parkinson’s disease (PD) clinical trial cohorts using smartphone-based assessments, web-based surveys, and virtual research visits (tele-visits). Demonstrating platform accuracy will facilitate tele-health outcomes as digital biomarkers of PD progression. A remote model represents an opportunity to streamline study conduct, reduce participant burden, and allow the collection of data beyond the usual episodic, in-clinic assessments.

9:55 Presentation to be Announced

10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)

Regency O

11:10 Chairperson’s Remarks

Anthony Costello, Vice President, mHealth, Medidata

11:15 Exploiting the Digital Armamentarium to Fight Heart Failure: Challenges & Opportunities

Patel_KinjalKinjal Patel, Senior Study Manager, Research & Development, Bayer

Worldwide, approximately 26 million people suffer from heart failure (HF). The disease has a high impact on patients’ quality of life and life expectancy with an annual mortality of approximately 30%. The use of emerging technologies, which allow remote and continuous patient monitoring, will lead to a paradigm shift in the conduct of clinical trials in HF. Opportunities and challenges in this field will be discussed in the presentation.

11:30 Remote Autonomous Cardiac Monitoring - Applicability in Clinical Trials

Fauvart_DavidDavid Fauvart, PMP, Associate Director, Janssen Clinical Innovation, Johnson & Johnson

ECGs are an often-used assessment in many Clinical Trial Protocols. The golden standard for ECGs is the 12-lead ECG, which requires study participants to go to the site and which can be quite time consuming for site personnel. Several devices are currently available on the market which allow for consumers to autonomously capture ECGs. Janssen Clinical Innovation is currently testing and developing such a device for usage in a clinical trial setting and in this presentation will cover the initial results and learnings.

Syneos-Health 11:45 New Clinical Research Technologies: The Perspective of the Clinical Research Site

Teresa Hines, Associate Director, Clinical Management, Otsuka Pharmaceutical Development and Commercialization

In today’s clinical research environment there is a progression toward the use of fully paperless technologies like electronic source and e-consent.  These technologies have significant operational impacts on sponsors and CROs, but also on clinical research sites.  Having deployed several trials that are virtually paperless, we will summarize the key findings from sites on the advantages and challenges of the new technological environment, and speak to the implications for deploying new technologies in clinical research.

12:15 pm Transition to Shared Sessions

Regency Q

Chairperson’s Remarks

Ronald Waife, MPH, President, Waife & Associates, Inc.

12:20 Blockchain Opportunities for Patient Data Donation & Clinical Research

Baara_MuntherMunther Baara, MS, Head, New Clinical Paradigm, Pfizer

Imagine a solution that makes it easy to aggregate health data in a secure, trusted, automated, and error-free way; a solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-contract between patient and healthcare stakeholders. This enables patients to aggregate their data from diverse health sources and share what they choose to with their physicians and researchers.

12:35 Blockchain’s Opportunity Today and Potential for the Future

Postings_MalMal Postings, Vice President, Head of Innovation/Emerging Technologies & Chief Architect, Research & Development Solutions, IQVIA

Today blockchain is about a data workflow using general ledger type sharing of information. Here it is important to understand the role of a governing body to engage the stakeholders and own the smart contract rules of working. The future is moving more broadly into trusted distributed data sharing. This will start with enablement of distributed queries and then move into the ability to construct virtual data stacks.

12:50 Blockchain and Pragmatism: A Necessary Marriage

Waife_RonaldRonald Waife, MPH, President, Waife & Associates, Inc.

Biopharma is improving its track record in adopting advances in software and work process. However, the use of blockchain technologies may be too immature and unproven to expect rapid incorporation into clinical research. A productive approach for biopharma may be to select a focused business problem. For instance, the “mining” of data from RWD sources could be more feasible with blockchain security. But biopharma will need to follow best practices for technology evaluation, process impact, compliance assurance, vendor management and user acceptance.

1:05 INTERACTIVE PANEL: Blockchain in Clinical Research

Waife_RonaldModerator: Ronald Waife, MPH, President, Waife & Associates, Inc.

The most significant costs to clinical trials are in time and resources to insure the com-pleteness, accuracy and integrity of patient data. Blockchain technology has the potential to transform and simplify the exchange of data among business partners in clinical re-search. Can blockchain solutions be applied to reduce the time to bring new biopharmaceu-tical products to market while reducing the cost of achieving that objective? The presenta-tions and discussion will address this opportunity and the path to its implementation.

  • What is the realistic path for the adoption of innovations such as blockchain for sponsors, sites and CROs?
  • Do service providers (CROs) play a leading or trailing role in the facilitating for the industry and why?
  • Unlike EDC, blockchain technology requires sites to take an active role rather than waiting for sponsors/CROs to deliver the capabilities. How does that impact adoption?
  • Thoughts on global adoption
  • Thoughts on business process implications and feasibility for transition

1:20 Transition to Lunch

1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

Arrive early and attend Part 1 (Tues-Wed): Sensors, Wearables and Digital Biomarkers in Clinical Trials


SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

Read More…

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions

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Mendel Health

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Syneos Health