2020 Keynote Information

Celebrating its 11th successful year, SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, 3 plenary keynote sessions, the annual Participant Engagement Awards, 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 and Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Resource Management, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Artificial Intelligence, Post-Marketing Studies, Observational Research, Accessing and Generating RWD, Clinical Biomarker Strategy, Clinical Supply Chain, Precision Medicine, Clinical Biomarkers and Biospecimens, and Central Lab Solutions, and an all-new track on Medical Device Clinical Trial Operations and Regulations. SCOPE attracted 2,000+ leaders in clinical operations and research in 2019 and each of our conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field.

Tuesday, February 18, 2020

Pre-Conference User Group Meetings, Hosted Workshops, Science Symposium, China Partnering Forum, Kick-Off Keynote, Participant Engagement Award & Happy Hour

2:00 - 5:00 pm User Group Meetings & Hosted Workshops (Sponsorship Opportunities Available) Host a User Group, Workshop or Company Meeting


9:00 am - 5:00 pm Shared Investigator Platform User Group Meeting Full Day

The first official Shared Investigator Platform (SIP) User Group Meeting will unite sites, sponsors, research organizations, technology providers, and product leadership as we continue to evolve the SIP ecosystem together.  Whether you are a new user, veteran, or just beginning to evaluate SIP for your organization, join our User Group Meeting as we share the SIP roadmap, ideate new features, and exchange best practices for successful collaboration across the clinical research community.


2:00 - 5:00 pm Trifecta Annual User Group Forum

Trifecta is a global leader — and a trusted partner — with decades of experience in clinical trial technology solutions. From accelerating study start-up for trials of all sizes to organizing and distributing all critical training and safety data, Trifecta offers a fully integrated, totally comprehensive platform built from the ground up. And through it, we consistently deliver more trial and less error across an entire portfolio of studies. We are proud to be hosting our annual user group meeting at SCOPE.

2:00 - 5:00 pm


*Must be a Best Value registered attendee.

2:00 - 5:00 pm


*Must be a Best Value registered attendee.

5:00 Evening Plenary Keynote Opening Remarks

Matt Miller, President, Co-Founder, StudyKIK

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech

Institute (CHI)

5:05 INTERACTIVE PANEL: Taking the Plunge, Why Now is the Time to Invest in eConsent and Patient Engagement

Moderator: Bill Byrom, Vice President, Product Strategy and Innovation, Signant Health

Increased willingness to take a patient-centric approach to technology adoption to improve data capture, patient understanding, and patient engagement is needed to drive real return on investment for retention, compliance, protocol adherence, and overall study timelines.

  • Why isn’t the pharmaceutical industry moving more quickly to adopt solutions that patients—and sites and study teams—want?
  • What are the key barriers to digitally focused patient-centricity (uncertainty over regulators’ expectations, data safety, privacy concerns)?
  • How do you identify and deploy the right talent to support a patient-centric ecosystem?

5:40 SCOPE’s 2020 Participant Engagement Awards Introduction

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


In Memory of Jerry Matczak, #BeLikeJerry, #SCOPE2020

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.

Submit your work now: http://www.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

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

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

6:20 SCOPE’S Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 Close of day

Wednesday, February 19, 2020


8:15 Organizer’s Welcome

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

8:20 Chairperson’s Introduction

Speaker to be Announced, Covance

8:25 Morning Plenary Keynote: Health Literacy throughout Drug Development – Why It Matters to Pharma and to Patients

Laurie Myers, MBA, Global Health Literacy Director, Global Population Health, Merck & Co., Inc.

Pharmaceutical companies often define their role as inventing new medicines and vaccines; conducting clinical trials; and getting them to patients. However, without health literacy, people do not fully reap the intended benefits of these innovations. This session will highlight why health literacy matters to pharma and patients, then give practical tips to integrate health literacy throughout drug development, including clinical trials, patient labeling, patient education, and packaging.

8:50 Talk Title to be Announced

Amy Abernethy, MD, PhD, Deputy Commissioner, FDA

9:15 INTERACTIVE PATIENT PANEL: Patient Perspectives as an Input to Feasibility and Clinical Trial Design

Amy Froment, Head, Global Trial Optimization, Regeneron

Michael Stadler, Co-Founder and President, CLARINESS

Patient panelists from oncology, CNS, cardiovascular and rare disease

In taking a patient-centric approach to the design of clinical studies, what methodologies should we consider in seeking meaningful patient perspectives? What are the considerations for implementing this approach in an organization to utilize patient perspectives as an input into trial design and operational planning? In this session, you can learn from patients in a panel discussion about their opinions on clinical trials. In addition, the panel will discuss how patient perspectives can be used as an input to feasibility and clinical trial design.

  • Selecting the right tactics to get the patient feedback that you need
  • Considerations for patient insight data as an input into study design
  • Messaging the value proposition for taking time in planning for patient insight development
  • Which types of study can this approach have the most impact in patient-centric

9:40 Grand Opening Coffee Break in the Exhibit Hall

Thursday, February 20, 2020


2:00 Organizer’s Welcome

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

2:10 Chairperson’s Introduction

Speaker to be Announced, Almac

2:15 Afternoon Plenary Keynote: Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

Tammy Guld, Global Lead, Janssen Clinical Innovation

Janssen Clinical Innovation (JCI) was established in 2012 with the goal to address several common challenges in clinical trials through the introduction of transformational innovation. Today, JCI is operating as a mature, autonomous innovation team, having introduced a number of successful innovations – some of which have an impact beyond Janssen. To support its operations, JCI has developed a framework to effectively and efficiently bring innovations all the way from ideation to implementation. This keynote will describe JCI’s view on innovation, key elements of its innovation framework, as well as some remaining challenges which are of interest to the broader industry.

2:40 FIRESIDE CHAT: Digital Healthcare to Re-Shape Clinical Trials

Moderator: Jacob LaPorte, PhD, Co-Founder & Vice President, Global Head of BIOME – The Digital Innovation Lab, Novartis

Emmanuel Fombu, MD, MBA, Physician, Author: The Future of Healthcare

Over a decade of increasing cost and complexity in R&D has driven the pharmaceutical business model to the brink of unsustainability. Digital technologies have the power to fundamentally transform the pharmaceutical development and commercial model, significantly increasing the efficiency and effectiveness of developing new medicines and creating more holistic solutions to deliver more meaningful experiences and outcomes for patients in need. This brave new paradigm, however, will require a fundamental shift in program strategy, organization, and culture to achieve. Come find out from two experts how to drive transformational change in your organization to effectively harness the power of these new digital technologies.

  • What are the key challenges in the development of new medicines; what is pushing the development/ commercialization model to the brink of unsustainability?
  • What are the key technology trends to enable transformational changes in how we develop and commercialize medicines?
  • What are some early indicators that people are starting to put these things together in a meaningful way to drive transformation change in their development model?

3:10 Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing