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
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
James Riddle, Executive Vice President, Kinetiq, a Division of Quorum Review IRB
5:05 Empowering Humans to Own Their Own Data
Scarlet Shore, Product Manager
& Platform Lead, Project Baseline, Verily
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.
5:30 SCOPE’s 2019 Participant Engagement Awards Introduction
Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly
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
Chairperson: David Sall, President & CEO, Patient Enrollment Advisors;
Co-Creator of the SCOPE Participant Engagement Award
Angela Radcliffe, R&D Practice Lead, Life Science,
Capgemini Invent
Kelly McKee, Head, Patient Recruitment, Vertex; Co-Creator of the
SCOPE Participant Engagement Award
Shwen Gwee, General Manager, Digital
Accelerator, Global Drug Development, Novartis
David Fuehrer, CEO, GRYT Health, Two-Time Cancer Survivor
Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly
Micah 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
8:15 am Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
8:20 Chairpersons’ Introduction
Matt Miller, President, Co-Founder, StudyKIK
Jerome Chiaro, Chief Patient Advocate, Co-Founder, StudyKIK
8:25 Keynote Kick-Off: Digital Trends That Are Changing the Healthcare Experience
Emmanuel Fombu, MD, MBA, Global Commercial Strategy and Digital Innovation, Johnson & Johnson
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
Moderator: Bonnie Brescia, Founding Principal, BBK
Worldwide
Gerald Dryden, Jr., MD, PhD, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville
Linda Glaser,
MD, PhD, Medical Director, Coastal Biomedical Research, Inc.
Annie
Finstein, Patient
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
Moderator: Lynne Becker,
Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS) Program Management Office (PMO), Deputy Assistant Director Information Operations, Defense Health Agency (DHA)
Thérèse Johnsen, Associate Director, Patient Engagement Management, Novartis
Chris O’Brien, MBA, Vice
President, myHealthTeams, Board Member, MHE Research Foundation
Elizabeth Allardice, Family Advisory
Board, Concussion Legacy Foundation
Alyssa 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
2:10 pm Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
2:15 Chairperson’s Introduction
Jackie Kent, Senior Vice President, Head, Product, Medidata
2:20 INTERACTIVE PANEL: Welcome, Pharma, to AI. Here’s What You Have Been Missing.
Moderator: David Vulcano,
MBA, Vice President, Research Compliance & Development, Hospital Corporation of America (HCA)
Niall O'Connor, Chief Technology Officer, Genospace (Sarah Cannon, the Cancer Institute of HCA Healthcare)
Ron Williams, CEO, Global Business Evolutions
Balazs 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
Moderator: Munther Baara,
MS, Head, New Clinical Paradigm, Pfizer
Michelle Shogren, Head of Innovation in Portfolio and Operations, Bayer
Lauren Bataille, Senior Associate Director, Research
Partnerships, The Michael J. Fox Foundation for Parkinson’s Research
Laurie Myers, Global Health Literacy Director, Merck (MSD)
David P. Leventhal, MBA Senior Director, Clinical Innovation Operations Center of Excellence,
Pfizer
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