2021 Keynote Information

Celebrating its 12th successful year, SCOPE Summit 2021 takes place March 2-4, 2021 as a fully virtual event. During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation. Over the course of three stimulating days of in-depth discussions in 23 different conferences, 5 plenary keynote sessions, the 5th annual Participant Engagement Awards, the new China Clinical Development Partnering event and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management and operations, including: De-Centralized Trials, Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Telemedicine, 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 expanded coverage on Medical Device Clinical Trial Operations and Regulations and Clinical Supply. SCOPE attracted more than 2,200 leaders in clinical operations and research in 2020, and we look forward to you and your team joining us in the first ever virtual SCOPE!

TUESDAY, MARCH 2, 2021

THE ACCELERATION OF DRUG DEV DUE TO THE PANDEMIC

8:00 am CASE STUDY: Working Under Pressure COVID-19 Edition: Pfizer’s Vaccine Trial Decision-Making Strategies and Technology-Boosted Operations

Demetris Zambas, Vice President and Global Head, Data Monitoring and Management, Pfizer


Brett Wilson, Senior Director, Vaccines TA Lead Data Monitoring & Management, Global Biometrics & Data Management, Global Product Development, Pfizer Inc.


Ralph Russo, Senior Director and Global Head, Clinical Database Management, Pfizer


Nicholas KitchinNicholas Kitchin, MD, Senior Director, Senior Director, Vaccine Clinical Research and Development, Pfizer


Helen Smith, Senior Director, Clinical Study Team Lead, CD and O, Pfizer


Liping ZhangLiping Zhang, Senior Director and Vaccines TA Lead, Statistical Programming and Analysis, Pfizer


Darren CowanDarren Cowan, Executive Director & Area Head USA, Canada, Pfizer


Beth PaulukonisBeth Paulukonis, Executive Director, Study Management Group Lead, Clinical Development and Operations, Pfizer


9:30 am FIRESIDE CHAT: Accelerated Drug Development in Response to the Pandemic:  Lessons Learned and Key Drivers

Moderator: Deborah Borfitz, Senior Science Writer, Clinical Research News & Bio-IT World


Ken Getz, MBA, Founder, CISCRP; Deputy Director, Center for the Study of Drug Development, Tufts University School of Medicine


/images/librariesprovider15/agenda/21/speaker-photos/russo_ralph-circular.jpgLeonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA


CREATIVITY AND ENGAGEMENT IN RECRUITMENT AND RETENTION COMMUNICATIONS: SCOPE’S PARTICIPANT ENGAGEMENT AWARDS

SCOPE’s 2020 Participant Engagement Award

3:15 pm SCOPE's 2021 Participant Engagement Awards

CREATIVITY AND ENGAGEMENT IN RECRUITMENT AND RETENTION COMMUNICATIONS

https://www.scopesummit.com/participant-engagement-award


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


Kelly McKee, Senior Director, Patient Recruitment and Registries, Medidata; Co-Creator of the SCOPE Participant Engagement Award


Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Project Manager, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP)


Ramona Burress, Associate Director, Diversity & Inclusion in Clinical Trials, Janssen R&D LLC


Irfan Khan, MD, CEO, Circuit Clinical - TrialScout


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


wednesday, MARCH 3, 2021

ENHANCING PATIENT-SITE CENTRICITY AND CLINICAL INNOVATION THROUGH TECHNOLOGY

10:55 am COVID-19: How an External Event Redoubled Janssen’s Culture of Innovation

Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), Janssen



11:20 am Option 1 Virtual Investigator Meetings During COVID-19 & Beyond 

Steven SulkinSteven Sulkin, Founder & CEO, SimuLyve International, Inc  


Marina Ziehn, PhD, Global Medical Affairs Director, Novartis Pharmaceuticals  

Markus Krüer, MD, Head of Clinical Project Management, Merz Therapeutics  

Nico Wegener, MD, Senior Clinical Project Manager, Merz Pharmaceuticals, GmbH 

Richard Scher, MD, FACS, Medical Director, Clinical Science, Board Certified Otolaryngologist-Head & Neck Surgeon, Merz Aesthetics, North America 


11:20 am Option 2 New Players and Innovators in Clinical Trials, the Impact of Non-Pharma Entrants...Meet Salesforce and CVS Health

Shwen-GweeShwen Gwee, VP & Head, Global Digital Strategy, Bristol Myers Squibb Co


Gary Gabriel, PhDGary Gabriel, PhD, Healthcare and Life Sciences Lead, Salesforce


Lou SanquiniLou Sanquini, Vice President, Life Sciences Group, CVS Health


THURSDAY, MARCH 4, 2021

MOVING TOWARD PLATFORM THINKING TO TRANSFORM PHARMA & THE TOKENIZATION OF TRIAL PARTICIPANTS, SOCIAL DETERMINANTS OF HEALTH (SDOH)

9:00 am INTERACTIVE PANEL: Moving Toward Platform Thinking: Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma

Moderator: Adama Ibrahim, EMBA, Director, Digital Solutions, Novartis


Hassan Kadhim, MBA, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, Bristol Myers Squibb


Craig Lipset, MBA, Former Head, Clinical Innovation, Pfizer; Venture Partner, Boston Millennia Partners (BMP) & FundRx; Advisor, People-Centered Research Foundation (PCRF)


Mohammed Ali, VP Digital Analytics & Performance, GlaxoSmithKline


Disa Lee ChounDisa Lee Choun, Head, GCSO Innovation, UCB Pharma


11:25 am Option 1 Tokenization of Our Clinical Trial Participants

Kyle-HolenKyle Holen, Head, Development Design Center, AbbVie Inc.


11:25 am Option 2 Social Determinants of Health (SDoH) and Its Relevance to Clinical Trials

Laurie Myers, Director, Global Health Literacy, Merck & Co Inc