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)

NEXT-GENERATION CLINICAL TRIALS
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.

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

Douros_ShelleyShelley 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)

Medidata 7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)

Troy SchneiderTroy Schneider, Director, Imaging Strategy, Medidata


Halek_SarahSarah Halek, Head, Innovation Design, ICON Medical Imaging

Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification, edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility and access.

8:15 Session Break

DIGITAL HEALTHCARE TO RESHAPE CLINICAL TRIALS
Regency O

8:20 Chairperson’s Remarks

Chairperson to be Announced, Omnicomm

8:25 Real World Insights & Collaboration in Protocol Development

DiCicco_Robert Rob DiCicco, Deputy Chief Health Officer, IBM Watson Health

Today the cost of a poorly developed protocol is reflected in expensive amendments, delayed study start-up and recruitment periods, and ultimately delays to file and launch. Utilization of real-world data and insights early in protocol development is an opportunity to optimize selection criteria and avoid costly delays across the study and product development life-cycle.

8:55 How We Know What We Know in Clinical Trials

Daniel Karlin, MD, Director of Biotech Ventures, CEAi, Inc.

The ubiquity of mobile technologies that contain sensors capable of collecting clinical quality data, the emergence of novel analytical techniques, the availability of transmission and storage resources to support the collection of huge amounts of data, and computational resourced to execute demanding models have brought us toward the integration of latent and trial data, but have also revealed the limits of our current understanding of the relationships between what we have been able to measure and the underlying physiological processes. Dr. Karlin will discuss the opportunities and obstacles we have encountered on this journey into a new era of data, information, and knowledge in clinical trials.

CASE STUDIES OF DIGITAL ENDPOINTS
Regency Q

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

Bangerter_Abi Abi 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_Elise Elise 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 CO-PRESENTATION: Streamline Clinical Operations with End-to-End Processes

Cohen_EvjatarEvjatar Cohen, Vice President, Global Life Sciences and Healthcare, Appian


Greg Ferrao, Global Regulatory Affairs, Labeling Implementation Manager, Sanofi

With complex data and processes, an innovative and streamlined approach to Clinical Operations is required. Appian is facilitating innovation in the clinical space through a powerful low-code application platform, enabling the creation of solutions that can support pre-clinical and clinical success. In this session, Evi Cohen, VP of Global Life Sciences & Healthcare, Appian and Greg Farrao, Labeling Implementation Manager, Sanofi will delve into how Appian’s platform helped transform Sanofi’s pre-clinical operations.

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

CASE STUDIES OF DIGITAL ENDPOINTS (CONT.)
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_Kinjal Kinjal 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_David David 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

Paul Greene, PhD, Senior Vice President, Clinical Solutions CNS, Syneos Health

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

BLOCKCHAIN: GAMECHANGER IN CLINICAL RESEARCH
Regency Q

Chairperson’s Remarks

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

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

Baara_Munther Munther 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.

12:40 Blockchain and Pragmatism: A Necessary Marriage

Waife_Ronald Ronald 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.

1:00 INTERACTIVE PANEL: Blockchain in Clinical Research

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

Panelists: Munther Baara, MS, Head, New Clinical Paradigm, Pfizer

Professor Dr. Dorothee Bartels, Chief Digital Science Officer, BI X GmbH, Boehringer Ingelheim

Greg Plante, Principal, Digital Health & Technology, IQVIA

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

Accenture 1:25 LUNCHEON PRESENTATION: Intelligent Operations: Envisioning a Better Way to Deliver R&D Outcomes

Jennifer Duff, Managing Director, Life Sciences, Accenture

The research and development landscape is changing and new technology is presenting complex challenges to traditional ways of working. In order to successfully navigate this change, the industry needs to transform their core ways of working. Accenture will share perspective on how these forces are shaping the future of R&D Operations, elaborate on how Accenture is partnering with the industry to enable the pivot, and how this transformation is key to long-term success and improved outcomes.

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