2018 Archived Content

Cambridge Healthtech Institute’s 7th Annual

Clinical Technology and Innovation:

Disruptive Technologies for Data and Trial Management
February 14-15, 2018 | Hyatt Regency Orlando | Orlando, FL

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 7th 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.

Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation: Introducing Consent Engineering: The Simplest and Safest Way to Create, Manage and Automate Consent Solutions In-House

Eric_DelenteEric Delente, President, Patient Consent, DrugDev (an IQVIA company)

The benefits eConsent provides for patient satisfaction and internal efficiencies cannot be overstated, yet the time and expense involved can make it cost-prohibitive for some clinical trials. Consent Engineering is a new SaaS technology solution enabling sponsors to bring eConsent entirely in-house. Featuring an interface as familiar and intuitive as Microsoft Word, Consent Engineering will completely change the way the industry does consent. Join us for the world’s first look at this exciting new solution!

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine’s Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson’s Remarks

Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

4:05 Blockchain Disruption: How Blockchain Will Change Our Industry

Munther_BaaraMunther Baara, Senior Director, Development Business Technology, 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. All this puts the patient in control of their health and wellbeing, rather than being along for the ride: How it works; Key benefits; Empowering the patients with control over their data.

4:30 Exploration of Where Machine Learning Will Help in the Product Development Process in the Pharmaceutical Industry

Francis_KendallFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche

The talk will explore how Machine Learning is and will change how Product Development is carried out in the industry from improving efficiencies, gaining more insights on products, improved surveillance of products, especially safety and its use in IoT devices.

4:55 CO-PRESENTATION: Leveraging Digital Transformation to Unify Process, Connect Data, and Turbocharge Innovation in Clinical Operations

Evi_CohenEvi Cohen, Vice President, Global Pharma & Life Sciences, Appian




Mike MontelloMike Montello, Vice President, Global Head, R&D Solutions Information Technology, IQVIA

Conducting and managing a successful, safe clinical trial is complicated. With massive data and complex processes at the core, it’s no surprise innovation in Business Process Management (BPM) is behind many successful trials.

5:25 Intelligent Clinical Trial Design, Planning and Conduct

Balazs_FinkBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

As technology evolves and AI solutions become more sophisticated, there is a natural demand to test and apply them in areas that were traditionally expert opinion-guided. This presentation is about early experiences and challenges of pharma companies - including BMS - that are starting to apply AI in the R&D space to promote precision oncology, identify targets, design and plan trials and translate strategy to efficient operational execution.

Cognizant5:50 Reception Hosted by Cognizant Technology Solutions

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation: Clinical Trial Operations Insights Evolved via Accenture Life Sciences Cloud

Chandi_KodthiwadaChandi Kodthiwada, Product Manager, Accenture Life Sciences Cloud (ALSC), Accenture

Chances are you have spent a meaningful amount of time on one of the below questions: How do you assess your Clinical Trial operational efficiency? How do I stay on top of Site behavior? How do you maintain Vendor-Oversight? In the presentation, we will go through Accenture Life Sciences Cloud(ALSC) - Clinical Operations Insights Platform(COIP) and our work with Metrics Champion Consortium(MCC) to answer the above questions.


8:30 Chairperson’s Remarks

Julie Dietrich, MS, Director, Development Design Center, Amgen

8:35 Remote Data Monitoring: Ideal Model versus Current Practices

Charles_RomanoCharlie Romano, Vice President, Global Clinical Operations, Peachtree Bioresearch Solutions

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints. Key findings from a survey of patients in four therapeutic areas will also be presented, focusing on factors important to the design and conduct of clinical trials involving mobile devices.

9:00 CO-PRESENTATION: How Technology Can Enable Patient-Centric Clinical Research

Julie_DietrichJulie Dietrich, MS, Director, Development Design Center, Amgen

Sindhya Govind, Specialist Business Systems Analyst, Amgen

Presentation highlights will include: Opportunities for technology to be part of a patient-centric strategy and improve patients’ experience with clinical research.

almac 9:25 Achieving Process Efficiencies & Compliance Throughout the Clinical Supply Chain - Reducing Risk & Streamlining Operations

Theodora_SarverTheodora Sarver, Manager, Product Management, Almac Clinical Technologies

Until now, managing accountability and returns has been a tedious, time consuming, and error prone process due to a lack of compliance, standardization, and fragmented record keeping. During this session, we will explore today’s most holistic solution for accountability and reconciliation tracking. This session will show you how to: - Strengthen and improve site compliance - Cut costs and speed study close-out - Produce and maintain complete and detailed records across the chain of custody.

Covance  Global Specimen Solution9:50 CO-PRESENTATION: Real World Innovation and Application in Pipeline Data Approaches

Kate_DuganKate Dugan, Vice President, Client Operations and Scientific Data Strategy, Global Specimen Solutions, Inc.

John_SpegeleJohn "JJ" Spegele, Vice President, Business Solutions and Enterprise PMO, Covance Central Lab Services, Covance, Inc.

Pharmaceutical companies have collected vast amounts of data during a clinical trial, yet only ~20% of the data is used. Disparate data sources, unaligned data, and incomplete data sets prevent in-life interventions, lead to delays in go to market, and can lead to non-compliance with regulations. In this presentation, we will discuss case studies that empowered translational medicine and clinical operations teams to make decisions that advanced drug development.

10:15 Networking Coffee Break


10:30 Chairperson’s Remarks

Evi Cohen, Vice President, Global Pharma & Life Sciences, Appian

10:35 CO-PRESENTATION: Incubating Digital Innovation Across the Clinical Trial Process

Leyla_RichLeyla Rich, IT Business Partner, Digital Health, Information Technology, Bristol-Myers Squibb

Erin_RossiErin Rossi, Category Manager, Clinical Core Technologies, Global Procurement, Bristol-Myers Squibb

Our internal working group is executing a number of proof-of-concepts (POCs), pilots, and tests in 2017 to evolve the digital clinical trials landscape at Bristol-Myers Squibb aligned to our enterprise strategy and with a focus on patient and site experience. These POCs focus on telemedicine, Quality of Life (QoL) metrics via wearables and sensors, and the use of digital technologies for adverse event reporting in Clinical Trials. As part of the session we will also share the outcomes from these experiments.

11:00 BYOD: A Game-Changer for Sponsors, Sites and Patients

Chris_WatsonChris Watson, PhD, Director, Product Strategy, Digital Patient, ERT

Electronic clinical outcomes assessments (eCOA) are no longer just about how patients feel or function pre-approval. With recent technological advancements, eCOA has become a valuable tool that helps sponsors gain greater insight into patient experiences post-approval – especially in site-less trials. A bring-your-own-device (BYOD) approach, coupled with wireless integration with mobile medical devices, opens up a whole new world of data collection options for trial sponsors, sites and patients. In this discussion, we’ll share success stories and demonstrate why sponsors need to incorporate this approach.

11:25 Transition to Shared Sessions


11:35 Digital Trends Impacting Recruitment, Engagement and Retention

Shwen GweeShwen Gwee, Head, Digital Strategy, Global Clinical Operations, Biogen

Digital technology is connecting more people to clinical trials than ever before and at the same time the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technolgies and approaches are having the greatest impact on recruitment, engagement and retention?

12:00 pm CASE STUDY: The Art and Science of Patient Engagement in the Digital Era – Learning from GSK PARADE Study

Michelle_CrouthamelMichelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline

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.

12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation Initiative

Hassan_KadhimHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim Pharmaceuticals

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?

Moderator: Jim Kremidas, Executive Director, Association of Clinical Research

Professionals (ACRP)

David Vulcano, Assistant Vice President & Responsible Executive for Clinical

Research, Hospital Corporation of America (HCA)

Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates

Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical

Research Professionals (ACRP)

Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites’ needs?

  • Share sites’ perspective on the evolving clinical research landscape
  • Discuss the reasons sites struggle with new processes and technology tools
  • Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact Melissa Dolen at 781-972-5418 or mdolen@healthtech.com.


2018 SCOPE Conference at a Glance


For questions or suggestions about the meeting, contact:

Marina_62x62Marina Filshtinsky, M.D.
Senior Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496
E: mfilshtinsky@healthtech.com

For partnering and sponsorship information, contact:

IlanaIlana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, contact:

RichRich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com