Keynote Information

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Artificial Intelligence (AI), Sensors and Wearables, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Biomarker Strategy, Clinical Supply Chain, Precision Medicine, and Biospecimens and Central Lab Solutions. SCOPE attracted 1,700 leaders in clinical operations and research in 2018, and each of our conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field.

Monday, February 18, 2019

MONDAY USER GROUPS, KICK-OFF KEYNOTE, Participant Engagement Awards

2:00-5:00 pm User Group Meetings & Hosted Workshops (Sponsorship Opportunities Available)

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:00 Pre-Conference Plenary Keynote Opening Remarks

Speaker to be Announced, Quorum Review

5:05 Empowering Humans to Own Their Own Data: A Fireside Chat with Verily

Shore_ScarletScarlet Shore, Product Manager & Platform Lead, Project Baseline, Verily


Gwee_ShwenShwen Gwee, General Manager, Digital Accelerator, Global Drug Development, Novartis

Project Baseline is developing tools and strategies to empower everyday people to better understand and manage their health through the return of individual research results. Launched in April 2017, Project Baseline will recruit 10,000 participants to better characterize health and the transition to disease. Scarlet will briefly present an overview of Project Baseline and some of the insights from their efforts to-date. This will be followed by a fireside chat with Shwen to discuss some of the novel approaches and key considerations for changing the way we run clinical studies.

5:30 SCOPE’s 2019 Participant Engagement Awards Introduction

Speaker to be Announced

5:35 SCOPE’s 2019 Participant Engagement Awards

In Memory of Jerry Matczak #BeLikeJerry #SCOPE2019

Creativity and Engagement in Recruitment and Retention Communications

Designed to inspire innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials, this award embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments.


Deadline for submission is November 30th, 2018 SCOPEsummit.com/participant-engagement-award

Sall_DavidChairperson: David Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement Award


Radcliffe_AngelaAngela Radcliffe, GM, Clinical Trial Solutions, PulsePoint


Kelly_McKeeKelly McKee, Head, Patient Recruitment, Vertex; Co-Creator of the SCOPE Participant Engagement Award


Gwee_ShwenShwen Gwee, General Manager, Digital Accelerator, Global Drug Development, Novartis


Fuehrer_DaveDavid Fuehrer, CEO, GRYT Health, Two-Time Cancer Survivor


Kim_Joe-2Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly


Lieberman_MicahMicah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)


6:15 SCOPE’s Kick-Off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available)

7:15 Close of Day

Tuesday, February 19

DIGITAL TRENDS CHANGING HEALTHCARE EXPERIENCE & DOCTOR-PATIENT-CAREGIVER PERSPECTIVES ON TRIALS AND ENGAGEMENT

8:15 am Organizer’s Welcome

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

8:20 Chairpersons’ Introduction

Miller_MattMatt Miller, President, Co-Founder, StudyKIK


Chiaro_JeromeJerome Chiaro, Chief Patient Advocate, Co-Founder, StudyKIK


8:25 Keynote Kick-Off: Digital Trends That Are Changing the Healthcare Experience


Gwee_ShwenShwen Gwee, General Manager, Digital Accelerator, Global Drug Development, Novartis

AI and Machine Learning. Blockchain. Chatbots and Voicebots. As technology continues to advance at a rapid pace, the biopharma industry, and in particular the clinical development area, struggles to keep up and adopt/integrate these novel platforms with how they operate. This talk will cover some of the current digital trends that are changing the clinical trial experience, including examples from within and outside the biopharma industry, as well as some of the external forces from other industries that are shifting customer expectations.

8:45 Do Engagement Tools Live Up to Their Hype? Doctor and Patient Perspectives on Study Participation

Brescia_BonnieModerator: Bonnie Brescia, Founding Principal, BBK Worldwide

Doctor: Elliot Rosenstein, MD, Institute for Rheumatic and Autoimmune Disease at Overlook Medical Center

Patient: Annie Finstein

It is generally thought that engagement programs (e.g. apps, travel, and reimbursement tools) enhance the patient and site experience within a clinical research study. But do they really? This interactive session will feature a doctor and a patient who can provide first-hand insight into using these engagement tools and what their effectiveness truly is. This session will be part of BBK Worldwide’s Pharma15 Live! web series that tackles some of today’s most compelling issues and brings them to the forefront for discussion.

  • Perspectives from a doctor and a patient regarding usage of engagement tools – i.e. travel and reimbursement apps
  • Shifting the conversation from return-on-investment to return-on-impact.

9:05 INTERACTIVE PANEL: Why Do We Need Caregivers in Clinical Trials; Exploring Real-Life Applications in Engagement and Retention

Becker_LynneModerator: Lynne Becker, Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS) Program Management Office (PMO), Deputy Assistant Director Information Operations, Defense Health Agency (DHA)


Johnsen ThereseThérèse Johnsen, Associate Director, Patient Engagement Management, Novartis


O'Brien_ChristopherChris O’Brien, MBA, Vice President, myHealthTeams, Board Member, MHE Research Foundation


Williams_StuartStuart Williams, Impact Ecosystems Architect, Inplace Impact


Allardice_ElizabethElizabeth Allardice, Family Advisory Board, Concussion Legacy Foundation


Lanzi_AlyssaAlyssa Lanzi, Ambassador & Researcher, Patient-Centered Outcomes Research Institute (PCORI)

Why do we need caregivers in clinical trials? We have oversimplified our lifestyles in many areas but burdened our healthcare. Persons became doctors or nurses to care for others, delivering empathy to their patients. Technology is inhibiting, perhaps limiting these touchpoints, leaving patients to search for compassionate care. Caregivers are quickly becoming essential to a person’s healthcare, as well as to complex, confusing and overwhelming clinical trials. How do we integrate this new and essential component in helping us achieve successful clinical trial experiences?

  • What a caregiver is not: Are caregivers an extension of a healthline or a patient? Are there legal or ethical implications?
  • How involved can a caregiver be? Should they be compensated?
  • Who chooses a caregiver? What are the HIPPA or IRB challenges?

9:35-10:35 Grand Opening Coffee Break in the Exhibit Hall

Wednesday, February 20

OPPORTUNTIES AND CHALLENGES IN ARTIFICIAL INTELLIGENCE (AI), PATIENT CENTRICITY, PRIVACY

2:10 pm Organizer’s Welcome

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

2:15 Chairperson’s Introduction

Speaker to be Announced, Medidata Solutions

2:20 INTERACTIVE PANEL: Welcome, Pharma, to AI. Here’s What You Have Been Missing.

Vulcano_DavidModerator: David Vulcano, MBA, Vice President, Research Compliance & Development, Hospital Corporation of America (HCA)


Jackson_EdmundEdmund Jackson PhD, Vice President& Chief Data Scientist, Hospital Corporation of America (HCA)


Williams_RonRon Williams, CEO, Global Business Evolutions


Balazs_FlinkBalazs Flink, MD, Head, Clinical Trial Analytics, Bristol-Myers Squibb

Artificial intelligence (AI) has been utilized in other industries outside of life sciences with varying degrees of sophistication. As pharma learns AI’s place in the life sciences industry, it may benefit from learning what other large companies have accomplished with AI and their lessons learned.


  • How are healthcare delivery systems using AI to better deliver care and improve efficiencies?
  • What similar problems have non-healthcare industries solved with AI?

2:50 INTERACTIVE PANEL: Patient Centricity and Data Permissions

Lipset_CraigModerator: Craig Lipset, Head, Clinical Innovation, Pfizer


SHOGREN_MICHELLEMichelle Shogren, Head of Innovation in Portfolio and Operations, Bayer


Bataille_LaurenLauren Bataille, Senior Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson’s Research


Myers_LaurieLaurie Myers, Global Health Literacy Director, Merck (MSD)


Perlmutter_JaneJane Perlmutter, PhD, President & Founder, Gemini Group


The Patient Centricity and Data Permissions panel will feature technologies and approaches to enable patient centricity of clinical trials and to ensure the patient data rights and good practices.

  • Building a patient-centric framework that is both effective and compliant
  • Converging patient-facing technology capabilities, the real challenges
  • Streamlining direct-to-patient activities and creating a user experience to improve research and outcomes
  • Creating the infrastructure to comply with best practices for patient data rights and permissions

3:20-4:05 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing

Register!

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


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