Cambridge Healthtech Institute’s 10th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management  

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

February 19-20, 2020


Analytics-driven global site selection, an optimized protocol development and feasibility assessment process, and effective site management 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, CROs, and Sponsors. CHI’s 10th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” will cover the topics one should consider when planning and implementing a data-driven and patient-centered trial.

Stay on and attend Part 2 (Thurs-Fri): Improving Study Start-Up, Site Activation and Trial Performance

Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open

2:00 - 5:00 pm User Group Meetings

2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific Symposium*

*Separate registration required. Must be a Best Value registered attendee.

5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Morning Opening Plenary Keynotes

9:40 Grand Opening Coffee Break in the Exhibit Hall

INCORPORATE PATIENT INSIGHTS ON PROTOCOL DESIGN AND EARLY TRIAL DESIGN WITH DTP MODEL, SIMULATION, DIGITAL PROTOCOLS

10:40 Chairperson’s Remarks

Venkat Sethuraman, PhD, MBA, Global Clinical Lead, R&D Excellence Practice, ZS Associates

10:45 The Direct-to-Patient Approach for Trial Design and Planning: The Feasibility of Adopting a DTP Model

Sosa_AntonietaAntonieta Sosa, Director, Janssen Clinical Innovation

Explore key factors that need further understanding in the direct-to-patient model and look at what aspects of the model have to be vetted with key functional groups such as regulatory, legal, quality, and health care compliance. Revisit key factors to determine when a virtual, hybrid or traditional model is the best approach or fit for a clinical trial, therapeutic area and overall success of the trial.

11:15 CO-PRESENTATION: Augmented Reality (AR)/Virtual Reality (VR) Simulations to Incorporate Site and Patient Insights on Protocol Design

O’Neill_BrendanBrendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer

Site Partner, Speaker to be Announced

In this presentation, Pfizer will share their approach on incorporating site and patient input into protocol designs using protocol simulations. Protocol simulations have provided key insights to avoid study operation pitfalls and prepare our sites for study execution. Pfizer has partnered with sites around the globe to build this capability and will co-present with a site to share their experience to date.

11:45 The Benefits of Cloud-Based, Digital Protocol Development

Holen_KyleKyle Holen, MD, Head, Development Design Center, Research and Development, AbbVie

Digitizing a protocol into discrete common core elements and making it available in a cloud-based environment allows for seamless transfer of information as well as customized analytics on how the process can be improved. Further, data on protocol development can also be used to create predictive algorithms to inform the risk of protocol amendments, post production changes, delays in budgets and ethics approvals.

12:15 pm CO-PRESENTATION: Are your Traditional Protocol Design and Recruitment Methods Missing the Mark?

Earl Seltzer, Senior Director, Global Feasibility at Covance, Covance
Branon_LoniLoni Branon, Senior Director, Citeline’s Sitetrove and Citeline Engage, Pharma Intelligence-Informa

Rising clinical trial protocol complexity and competition for sites, investigators, and patients are contributing to increasing trial timelines and costs. Identifying strategies for optimizing a trial protocol at all stages is essential to ensuring your protocol is feasible and on the path to success. Please join us in reviewing how protocol feedback and customized recruitment tactics can help keep your clinical trial on track.

12:45 Transition to Lunch

12:50 Luncheon Presentation to be Announced

1:20 Coffee and Dessert Break in the Exhibit Hall

IMPLEMENTING DATA-DRIVEN SITE SELECTION USING ADVANCED ANALYTICS, DATA SCIENCE MODELING, AND CLINICAL INSIGHTS

2:15 Chairperson’s Remarks

George Tiger, Vice President, Global - Business Development, Almac Group

2:20 CO-PRESENTATION: Designing a Feasibility Intelligence Platform to Merge Advanced Analytics, Data Science Modeling, and Clinical Insights

Everill-Flinders_MichelleMichelle Everill, Senior Director, Head of Global Feasibility, Janssen


Sasu_MiranuMiruna Sasu, PhD, Clinical Operations and Data Science, Janssen

This co-presentation will share a case study that details the building of a feasiblity intelligence tool that merges advanced analytics, data science modeling, and clinical insights. The reasons behind it, the roadblocks encountered during development and implementation, and the successes acheived will be shared by two members of the team, each of whom had a different role in the story.

2:50 CO-PRESENTATION: Challenges and Successes in Building and Implementing a Data-Driven Site Selection Approach

Smyth_SandraSandra Smyth, Global Feasibility & Site Intelligence Director, AstraZeneca


Feldberg_GabrielaGabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca

In an environment of growing complexity, the need to utilize advanced analytical techniques is more pressing now than ever to ensure selection of the optimal investigators for a study. This presentation will be a lively discussion sharing the challenges and successes in building and implementing data-driven site selection to ensure the teams have the meaningful information needed, at the time needed, to make the best decisions for their studies.

3:20 Paradigm Shifters for Site Selection: Are We Looking at the Right Site Attributes to Build Predictive Algorithms and Analytics Platforms?

Serra-Ortiz_OriolOriol Serra, MBA, Head, Site Intelligence & Selection, Global Product Development, Pfizer

Are past historical site metrics a good predictor of future performance? Can we look at other site attributes traditionally not factored into feasibility analysis? This presentation will provide a real-world demonstration on how a new methodology can improve transparency and collaborative efforts to optimize study execution and build new relationships with otherwise often overlooked investigators.

3:50 Presentation to be Announced

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

4:25 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.

5:10 Welcome Reception in the Exhibit Hall

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share

Mike Nolte, Chief Executive Officer, Signant Health

8:15 Session Break

IMPROVING FEASIBILITY AND SITE SELECTION WITH PATIENT FEEDBACK, EHR STRATEGY & STRATEGIC PHARMA-SITE-CRO RELATIONSHIPS

8:20 Chairperson’s Remarks

Chairperson to be Announced, QPS, LLC

8:25 Engaging with Patients in Design and Execution of Trials: Ways to Make Clinical Trials More Patient-Centric

Hashimoto_LaniLani Hashimoto, Clinical Program Benchmark Manager, Patient Engagement & Recruitment, Novartis

To provide more effective ways to engage with patients in the design and execution of clinical studies, TransCelerate’s Patient Experience Initiative developed tools in collaboration with Patients, Sites, Sponsors and CROs. Learn more about how the publicly-available Patient Protocol Engagement Toolkit and Study Protocol Feedback Questionnaire Toolkit may lead to greater patient engagement and partnership between patients and sponsors to design and execute clinical protocols that create better patient experiences.

8:40 Protocol Development in Collaboration with Educated Patient Advocates

Shikova_DanielaDaniela Shikova, General Manager, FindMeCure Foundation

Eupati (European Patients’ Academy) and FindMeCure Foundation are working on a mutual project to help match experienced patient advocates with sponsors and CROs who are looking for help with protocol development. We identified the clear need for preparing the industry for gathering feedback and a way to implement it, and at the same time educate patients on how to provide actionable feedback. The synergy between both will bring new generation protocols that are better aligned with patients’ needs.

8:55 CO-PRESENTATION: EHR Trial Strategy, Implementation and Case Studies

Fang_JaneJane Fang, MD, MS, Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials, AstraZeneca


Eckerd_MarieMarie Eckerd, Feasibility and Recruitment Partner, Director, AstraZeneca

Electronic health records (EHR) are the new norm to drive decision making from early data mining through patient recruitment in clinical trials. End-to-end experience is limited as both sponsors and sites initiate new workstreams covering site engagement, data queries, resources, and geographic presence. AZ will present a year-long overview of how EHR is embedded throughout clinical development to drive patient-centered decisions.

9:25 Successful Strategic Partnerships Between CROs and Pharma: Methodology to Improve Data-Driven Global Site Selection

Andrews_JuliaJulia Andrews, Strategic Feasibility Manager, Program Delivery, UCB

CROs are important future gatekeepers for investigative sites and patients. During this session we’ll discuss key practices to effectively collaborate with your strategic CRO partner during feasibility to build a site list, select high quality sites and improve communication and relationships between Sites, CROs, and Sponsors.

9:55 CO-PRESENTATION: Randomization Methodology Implementation of Basket, Umbrella, and Platform Designs

Ross_JenniferJennifer Ross, Lead Biostatistician, Almac Group


Nicholls_GrahamGraham Nicholls, Director, Biostatistics, Almac Group

The Randomization set-up of innovative trials, such as Basket, Umbrella and Platform designs, should consider initial Randomization requirements as well as future possible adaptations. This presentation will show how collaboration is essential amongst the key stakeholders (including Biostatisticians from study/sponsor, vendor(s), IDMC / Bayesian, and clinical manager from Sponsor and CRO) during the design phase to ensure the initial Randomization scheme is implemented to meet the initial, mid-term and long-term goals of the study.

10:25 Coffee Break in the Exhibit Hall

PERFORMING STUDY FEASIBILITY AT THE SITE & NEW METHODS FOR PREDICTING SITE PERFORMANCE

11:20 Chairperson’s Remarks

Valeria Nicoli-Carr, Global Director, Patient Services, Patient Services, mdgroup

11:25 CASE STUDY CO-PRESENTATION: Performing Study Feasibility at the Site -- The Right Study at the Right Time

Tindell_LisaLisa Tindell, RN, Senior Director, Clinical Research Operations, Minneapolis Heart Institute Foundation (MHIF)


O'Black_TamaraTamara O’Black, JD, Senior Director, Compliance, Quality & Regulatory, Minneapolis Heart Institute Foundation (MHIF)

Each year, MHIF successfully launches over 30 new studies and enrolls nearly 600 patients. As an independent, non-profit research center, our infrastructure supports application of an established, comprehensive feasibility process to swiftly assess new study opportunities in a systematic fashion. We’ll discuss the critical steps necessary to effectively evaluate new studies and the robust metrics that illustrate our success.

11:55 INTERACTIVE PANEL: New Methods for Predicting Site Performance: Looking Beyond the PI to Ensure Speed and Quality

Kremidas_JimModerator: Jim Kremidas, Executive Director, ACRP


Rowe_JonathanJonathan Rowe, PhD, Executive Director, Head of Clinical Development Quality Performance and Risk Management, Pfizer


Burrow_DavidDavid Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, CDER, FDA

The clinical research community struggles with site selection and accurately predicting site performance. Many assumptions on which sites will deliver are off as is our understanding for the reasons. This panel will delve deeper into this and will discuss:

  • PIs are responsible for the trial conduct but who really makes things happen?
  • What are the “best practices” for assessing site support staff?
  • What determines who the PI selects to provide support in conducting a protocol?

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Humanizing Patient Engagement through Behavioral Sciences

David Kiger, Chief Commercial Officer, Datacubed Health

During this presentation, we will describe the advantages of modern design and UX (user experience) concepts, like those used in consumer apps. We will show how these standard modern approaches yield a more rewarding patient-centric experience. We will describe several innovative concepts used to nudge and track patients, to create a 360-degree experience for participants, clinical sites, and primary care physicians.

1:00 Coffee and Dessert Break in the Exhibit Hall

2:00 Close of Conference


Stay on and attend Part 2: Improving Study Start-Up, Site Activation and Trial Performance

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts