Cambridge Healthtech Institute’s 12th Annual

Protocol Development, Feasibility, and Global Site Selection

Improving Outcomes through Patient-Centric Trial Design, Digital Innovations, Modeling and Execution

February 8 - 9, 2022 ALL TIMES EST

Analytics-driven global site selection, optimized protocol development and effective feasibility assessment process are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to protocol development, trial planning, and execution. To overcome challenges in clinical trial design, planning, operations, and management, leaders should learn from the best practices of their peers, utilize data and analytics to support decision making, and improve communication and relationships between Sites, Patients, CROs, and Sponsors. CHI’s 12th Annual “Protocol Development, Feasibility and Global Site Selection” will cover the topics one should consider when planning and implementing a data-driven and patient-centered trial. Advisory Board: Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer Inc. Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare Sandra Smyth, Director, Global Feasibility and Site Intelligence, AstraZeneca Chris Hoyle, CEO and Founder, Elite Research Network Melissa Easy, Vice President, Head, Clinical Technologies, IQVIA

Monday, February 7

8:00 am SCOPE’s Inaugural Masters of Clinical Research Golf Tournament

Connect with your peers and colleagues at SCOPE's Inaugural Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.

9:00 am Conference Registration Open (Gatlin Foyer)
2:00 pm User Group Meetings (ROOM LOCATIONS: St. John's 30 & 31 & St. John's 32)

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations.  We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you.  Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

KEYNOTE LOCATION: Gatlin A1 & A2

EVENING KICK-OFF PLENARY KEYNOTE & PARTICIPANT ENGAGEMENT AWARDS

5:00 pm KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
Tarra Shingler, MS, Senior Vice President, Global Business Solutions, StudyKIK
5:10 pm KEYNOTE PRESENTATION: Engaging and Understanding Patient Behavior to Improve Accessibility, Retention and Outcomes
Panel Moderator:
Dana Edwards, Chief Commercial Officer, Circuit Clinical

Patient-centric drug development that incorporates patient experience coupled with behavioral science and real-world evidence is evolving the way in which sponsors and regulators bring new medicines to the patients. This executive panel will discuss emerging trends along with case studies that demonstrate how understanding patient need, beliefs and their healthcare journeys influences participation in clinical trials and impacts outcomes.

Panelists:
Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi
Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer Inc.
Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
Thad Wolfram, President, Matrix Clinical Trials, Matrix Clinical Trials
5:45 pm KEYNOTE PRESENTATION:

SCOPE's 2022 Participant Engagement Awards Introduction

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC
5:50 pm KEYNOTE PRESENTATION:

SCOPE's 6th Annual Participant Engagement Awards

Panel Moderator:
David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 6th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. 

Participant Engagement Awards Judges

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata


Participant Engagement Awards Contestants: 

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gratton, Co Founder & CEO, CureClick LLC

Gwenn Oakes, Program Director, Global Trial Optimization, Merck

Adam Kleger, InVibe

Ian Greenfield, Tryl

Jeff Smith, Tryl

    Panelists:
    Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.
    Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata
    Irfan Khan, CEO, Circuit Clinical
    Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
    Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative
    Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata
    Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.
    Melissa Jane Bime, CoFounder & CEO, Infiuss Health
    Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health
    Fabio Gatton, Co-Founder & CEO, THREAD Research (formerly inVine Labs)
    Adam Kleger, Head, Client Solutions, inVibe Labs
    Gwenn Oakes, Director, Global Trial Optimization, Merck & Co., Inc.
    Jeff Smith
    Ian Greenfield, CEO, Tryl
    6:35 pm SCOPE's Kick-Off Networking Happy Hour (Gatlin Terrace)
    7:45 pm Close of Day

    Tuesday, February 8

    7:15 am Registration Open (Gatlin Foyer)
    7:15 am Morning Coffee (Sponsorship Opportunity Available)

    KEYNOTE LOCATION: Gatlin A1 & A2

    NEW NORMAL IN PERI-PANDEMIC CLINICAL TRIALS & CONNECTED HEALTH AT SCALE

    8:05 am KEYNOTE PRESENTATION:

    Organizer's Welcome Remarks

    Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
    Peyton Howell, Chief Commercial & Strategy Officer & President, Consulting, Parexel
    8:15 am KEYNOTE PRESENTATION:

    Fireside Chat: Fit-for-Future Data Operations in a Post-Pandemic World

    Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.
    Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR)and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.
    Cynthia Pan, RPh, Senior Director, Therapeutic Area Operations Leader, Global Clinical Operations, Regeneron

    The COVID-19 pandemic continues to reshape our world and our approaches to clinical trials. During the last 20 months, the risk-benefit ratios of many innovative methodologies and technologies have inversed. Risk-averse organizations have grasped the realities that these new innovative methods are now the only means to efficiently execute clinical trials.  This new reality and the ongoing need for real-time data collection and consumption require new creative and live data flows. An additional ramification of this evolution has been a significant improvement in the level of collaboration required and realized within our organizations and with our external partners and technology providers. Let us discuss how we can cement this “New Normal” to not only maintain the momentum but to ensure these valuable innovations are sustainable.

    9:10 am KEYNOTE PRESENTATION:

    Case Study: Moving Beyond the Promise of Connected Health, Learning from Implementation at Scale

    Adama Ibrahim, Director, Digital Solutions, Technology, Platforms, Data & Digital Global Drug Development, Novartis Pharma AG
    Justin Wright, MD, Vice President, Global Head Connected Health, Novartis

    At Novartis Global Drug Development, we have a vision to accelerate digital products by developing one or more “connected health” solutions (connected device, wearable, software as medical devices) into our drug programs over the next 5 years. This showcase of the Connected Health group, formed to deliver the vision, will focus on presenting the real work that has been done as a collaboration to bring these digital health tools to clinicians, patients, and to pharma research that improve the overall health care experience and improve access to trials. How does an integrated patient experience deliver more value to patients, providers, and payers? How do you give patients their own digital data so they can be more engaged in their treatment plans? How can Connected Health improve clinical workflow, communication, data exchange, and clinical research? How do you do this at scale, beyond a pilot?

    9:55 am Grand Opening Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

    ROOM LOCATION: Gatlin A4

    DIGITAL INNOVATIONS FOR PATIENT-CENTRIC DESIGN AND FEASIBILITY

    Todd Kole, Vice President, Clinical Project Services, Almac Clinical Technologies, Almac Group
    11:00 am

    Leveraging Digital Innovations for an Integrated Patient-Centric Strategy Across the Value Chain of R&D

    Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi
    Terttu Haring, MD, Global Head, Clinical Digital Innovation, Sanofi

    At Sanofi R&D, Patient Centricity is defined as the “commitment to listen and translate patient insights into actions that develop new healthcare solutions with meaningful outcomes, address unmet needs and improve health-related quality of life." To deliver meaningful solutions to patients, an ecosystem must exist to address their needs holistically and improve the research experiences. Current, upcoming, and future innovations in technology provide new opportunities to engage and collaborate with patient advisors, (potential) trial sites, and health data, opening new ways of making trial participation possible for more individuals, including those traditionally underrepresented in clinical development.

    11:30 am

    Re-Defining Feasibility to be Future Perfect

    Sandra Smyth, Senior Director, Global Feasibility and Site Intelligence, Development Operations, AstraZeneca

    At AZ, we re-defined our feasibility approach placing emphasis on indication landscape assessments and early strategic engagement with sites. Maximizing indication landscaping, we build foundational datasets that subsequent projects can leverage. This means our downstream design assessment and protocol feasibility is more efficient, and our investigators are engaged earlier in the process. Learn more about our re-designed feasibility process, tools, and how we collaborate to re-use insights for reliable predictability.

    12:00 pm PANEL DISCUSSION:

    Diversity and Inclusion in Early Protocol Design and Clinical Trial Optimization

    Panel Moderator:
    Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare

    As the diversity topic continues to gain momentum it is clear we cannot truly address this only in our recruitment campaigns at the start of a study. What can we do earlier in the process to ensure we are not unintentionally excluding or making it harder for diverse populations to participate? Join this fireside chat to hear examples of where we can proactively approach this important topic.

    Panelists:
    Lorena Kuri, Head, Diversity Strategy, Bristol Myers Squibb Co.
    Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
    Dave Hadden, President, Pro-ficiency
    • Identify how using the right tools for remote training can improve the performance management of sites
    • Exploring how best to implement virtual training to reduce protocol deviations
    • Finding the right virtual training supplier who can simulate critical protocol challenges by using lifelike, online scenarios that allow learners to practice decision making in a consequence-free environment
    • Remote Site Performance Management tech – what’s available and what would work with your study
    1:00 pm Transition to Lunch
    Travis Caudill, Vice President, Feasibility, Site Identification, and Clinical Informatics, ICON
    Ashley Schwalje, Director, Strategic Partnerships, Informa Pharma Intelligence

    Informa Pharma Intelligence and ICON plc partnered to deliver next-gen trial feasibility by enhancing Informa’s predictive analytic, Citeline Study Feasibility, and powering it with combined datasets from both organizations.  Our goals were to accelerate timelines, select more high performing sites, optimize operational performance, and reduce manual effort involved in scenario modelling.  This session will focus on applications of Citeline Study Feasibility in ICON’s strategic feasibility work.

    1:35 pm Coffee and Dessert Break in the Exhibit Hall (Gatlin Ballroom BCD)

    ANALYTICS AND MODELING FOR STUDY PLANNING, SITE FEASIBILITY, AND ENROLLMENT PREDICTION

    Dave Hadden, President, Pro-ficiency
    2:35 pm

    Advanced Predictive Modeling to Predict Enrollment and Project Milestone Dates (Time to Endpoint Maturation)

    Li Wang, PhD, Senior Director & Head, Statistical Innovation, AbbVie, Inc.

    This presentation will share the proposed advanced predictive modeling methodology and results to predict enrollment and key milestone dates (time to endpoint maturation). The methodology can be used to predict milestone dates for time-to-event trials like in Oncology and for fixed duration trials like in Rheumatology. R-shiny dashboard and a cloud-based application are also developed with the goal to help every study team. The talk will also share the evolution of our thinking, the process of development and the challenges we have faced thus far.

    Paul Bidez, Industry Vice President, Life Sciences, Manufacturing & Automotive, Sales, Appian
    Tom Coleman, Strategic Account Executive, Sales, Appian

    The life sciences industry has been exploring ways to accelerate the study start-up processes from design through execution to get products to the patients who need them faster. Hear from our experts on how a low-code platform can help improve the efficiency of the study start-up process and product life cycle. We'll discuss how to bring people, process, and data together across clinical operations and make automation work for your organization.

    3:35 pm

    Using AI and Analytics to Predict Best Performing Sites

    Olga Bershevits, PhD, Advisor, Design Hub Data Insights, Eli Lilly & Co.

    Using AI and analytics, we can speed clinical trial enrollment and accelerate overall clinical development timelines by predicting and including best performing sites into the study. An integrated set of data and advanced analytical tools allows users to identify best performing site based on historical performance and site health. Diversity and decentralized trials and their effect on site selection will be also discussed.

    3:50 pm

    How Janssen’s Feasibility CoE Leveraged Data and Analytics to Deliver Rapid Enrolment Across a Diverse and Representative Participant Group

    Gina Rothenberger, Global Feasibility Therapeutic Area Head, Infectious Disease and Vaccines, Janssen Pharmaceuticals, Inc.

    How Janssen’s Feasibility CoE leveraged data and analytics to deliver rapid enrolment across a diverse and representative participant group for Janssen’s phase 3 COVID-19 vaccine trial, Ensemble 1. In this presentation, we will share key strategies used to optimize site selection for Ensemble 1, to ensure diverse recruitment targets were met across age, ethnicity, and co-morbidities while also satisfying aggressive timelines, all through the evolving pandemic. This required a multi-faceted approach layering quantitative and qualitative data in support of the efforts which resulted in record breaking enrollment, 3 months from FPI to LPI, 43,000 patients enrolled with impressive diversity.

    Gen Li, PhD, President & Founder, Phesi

    With the industry under more pressure than ever to ensure high success rates for clinical programs, we look at the key questions across the development cycle that if answered correctly can ensure a successful trial. We explore how, by leveraging the power of patient-centric data science and the world's largest clinical development database, biopharmaceutical companies are unlocking the insight required to ensure shorter cycle times, fewer amendments and deliver faster cures.

     

    INTERACTIVE BREAKOUT DISCUSSIONS

    4:35 pm Find Your Table and Meet Your Moderators
    4:40 pm Interactive Discussions

    Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

    5:25 pm Welcome Reception in the Exhibit Hall (Gatlin Ballroom BCD)
    6:40 pm Close of Day

    Wednesday, February 9

    7:15 am Registration Open (Gatlin Foyer)
    BREAKFAST PRESENTATIONS

    Come enjoy a breakfast with your peers while listening to your choice of two compelling industry presentations.

    Kyle Hogan, President, Datacubed Health

    Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

    Andrea Valencia Dremelj, Director BioPharma Business Operations, Biopharma, SOPHiA GENETICS

    Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

    8:15 am Session Break

    ROOM LOCATION: Gatlin A4

    REIMAGINING PROTOCOL FEASIBILITY AND SITE SELECTION WITH RWE, MACHINE INTELLIGENCE…AND HUMAN INTUITION

    Nina Pruitt, MA, VP, Global Strategic Marketing, Commercial, Clinical Ink
    8:25 am

    Enabling “Superminds” to Select Right Site On-Time: Combining Human Intuition with Machine Intelligence

    Oriol Serra Ortiz, Vice President, Link for Clinical, Veeva

    Inspired by the interplay between humans and machines in chess, during this presentation we will showcase to the audience how combining human intuition and machine intelligence can help create Superminds that amplify the power of making evidence driven decisions in trial design and site identification in today’s clinical trials environment.

    Fareed Melhem, SVP, Acorn AI, Medidata, a Dassault Systèmes Company
    John Van Hoy, Executive Director, Data Science & Advanced Analytics, PPD, part of Thermo Fisher Scientific

    PPD and Medidata Acorn AI have a deep collaboration based on a shared vision that data can power better clinical trial planning and study management. As biopharma companies require better site feasibility and forecasting to manage studies, we have collaborated to build predictive models and technology combined with data to deliver real-time trial management. In this session, we’ll share the impact of these models, how they’re being deployed, and insights gained.

    9:25 am

    Reimagining Protocol Feasibility and Country-Site Selection with RWE and Deeper Analytics

    Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi
    Siva Thiagarajan, MBA, Leader, R&D Practice, ZS Associates

    Sanofi's vision is to use technology and data to disrupt the clinical research model and enable systematic data value (comparison, simulation, automation, innovations) to adapt protocols and clinical operations design for patients, sites, and effectiveness of the study (optimize recruitment and enhance accuracy of enrollment projections). This talk will show how we set up the evidence-based program to define an integrated landscape from study design up to study start-up.

    Bazgha Qutab, Principal, ZS
    Ken Getz, TBC, Tufts University
    10:25 am Coffee Break in the Exhibit Hall

    DEVELOPING A PROTOCOL SIMPLIFICATION AND OPTIMIZATION CAPABILITY DURING THE PANDEMIC

    Wayne Baker, Chief Commercial Officer, Greenphire
    11:25 am

    Developing a Protocol Simplification/Optimization Capability through Pandemic Response

    Mike Jacobs, Senior Director, Study Optimization and Assessment Planning, Bristol Myers Squibb Co.
    Gaelan Ritter, Senior Director, Innovation and Digital Health, Bristol Myers Squibb Co.

    This new capability is a novel approach to protocol development. Building trials with a ‘quality by design’ approach will provide a better understanding regarding how trial designs can impact our patients, sites, resources, and downstream trial costs. Study teams are now provided with analytics that will drive more informed and proactive decision making upfront in the design process. The desired outcomes are centered around improvements in quality, speed, and cost.

    11:55 am Transition to Lunch
    Zach Hales, Associate Director, Product Management, Greenphire
    Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites
    Steve Wimmer, Director of Partnerships, 1nHealth

    While we are still facing collective uncertainties, one this is certain; the clinical research community is working together to ensure trials can continue and that we are supporting sites and participants. in this session, you will hear from a panel - representative of the participant, site, and solution provider voice - on experiences with decentralized trials and how associated technology and processes can drive the future of clinical research.

    12:30 pm Coffee and Dessert Break in the Exhibit Hall (Sponsorship Opportunity Available)
    1:30 pm Close of Part A Conference. Join Plenary Keynotes and stay on for Part B of SCOPE Summit!*

    KEYNOTE LOCATION: Gatlin A1 & A2

    DIVERSITY, EQUITY & INCLUSION (DE&I) AND SPEAKING THE LANGUAGE OF BUSINESS AND LEADERSHIP

    1:30 pm KEYNOTE PRESENTATION:

    Welcome Remarks from CHI and the SCOPE Team

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

    Thank you all for being here from the SCOPE team: Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz

    1:35 pm KEYNOTE PRESENTATION:

    Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative

    Meghan McKenzie, Principal, Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

    Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. Many of us have been focused on this in our work and/or in our advocacy, both inside and outside of our organizations for some time. Why is inclusivity so important to PIs and patients? Why is it both a moral and a business imperative? Learn why representation in clinical research matters for your patients and how it shapes good science. The face of the world is changing and your success is tied to reaching ethnic minorities.

    2:00 pm KEYNOTE PRESENTATION:

    Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership

    Panel Moderator:
    Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

    What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population?  Where are their voices being heard and what can we learn from the cultural experiences they weave into their research methodologies and daily practices? Panelists will share their perspectives on how the Black voice should be included in advocacy and public and private aspects of clinical research. 

    Panelists:
    Karriem Watson, PhD, Chief Engagement Officer, NIH
    Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.
    Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute
    2:45 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Gatlin Ballroom BCD)





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