Cambridge Healthtech Institute's Inaugural
Site Selection & Feasibility
Strategies for Selecting High Performing Sites
May 13-14, 2019
The ability to identify and select high-performing sites is key to effectively launching a clinical trial. CHI’s Site Selection & Feasibility conference features best practices and case studies on successful site selection techniques using novel,
patient-centric and data-driven approaches.
Final Agenda
Monday, May 13
7:25 am Conference Registration and Morning Coffee
8:25 Chairperson’s Opening Remarks
8:30 Foolproof Feasibility: Matching Standard of Care with Clinical Feedback and Site Intelligence
Matt Cooper, Business Development & Marketing Director, NIHR Clinical Research Network (CRN)
In the UK the National Institute for Health Research (NIHR) has developed a unique national strategy for delivering reliable feasibility reports using a multi-pronged approach. This foolproof approach to achieving accurate feasibility information is underpinning
research delivery success in the UK and has contributed to record-breaking “time and target” performance results (74%) for commercial contract research (74% figure is based on 466 commercial studies that closed in financial year 2017/18,
346 of which recruited 100% of their target within planned timescales).
9:00 Site Selection for New Indications: Enhancing the Feasibility Process for a Successful Trial
Amanda Moore, Associate Director, Clinical Operations & Development, SAGE Therapeutics
In this talk, we will look at the strategy behind finding the best sites when moving into an indication that is new for you and/or your company. Whether it’s rare disease or a highly prevalent therapeutic area, the early pathway in this new space
is critical to retain long-term relationships and interest. Creative approaches and operational strategy to ensure success when pioneering a program in a new indication will be explored, as well as how using these approaches can bring renewed energy
into all indications.
9:30 Extended Q&A
10:00 Networking Coffee Break
10:30 Site Budgeting & Contracting under ICH GCP 6 Amendment
Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University
The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. This session will explore the changes to provide a better understanding of how they impact conduct of clinical trials, site budgeting and contracting.
Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.
11:00 Interactive Group Discussion: Site Budgeting & Contracting
11:30 Enjoy Lunch on Your Own
12:45 Session Break
1:25 Chairperson’s Opening Remarks
Jillian Cormier, Director, Portfolio Business Development, ERT
1:30 PANEL DISCUSSION: Data Collected from RBM: Looking at Data Trends Across Sites & How the Data Affects Site Selection Decisions
Patrick Zbyszewski, Vice President, Data Management, Onconova
Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.
Nechama Katan, Associate Director, Central Monitoring Lead, Risk Based Monitoring, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
Topics to be discussed:
- Based on RBM data and statistical monitoring, are data trends emerging across sites and studies?
- Where is the industry headed in optimizing and adopting use of RBM data for predictive analytics and clinical ops decision-making?
- How are pharma/biotech and CRO companies leveraging the wealth of data that they are collecting from RBM for clinical ops decisions, especially around study quality, data quality/integrity, site selections, and site capabilities?
- What are the current challenges in using RBM data for predictive analytics? What would improve the ability to use RBM data for predictive analytics?
- How is RBM data being combined with other technologies and data sources to enhance clinical trial decision-making? What are future uses of RBM data?
2:30 Grand Opening and Refreshment Break in the Exhibit Hall
3:15 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. 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.
4:15 Welcome Reception in the Exhibit Hall
5:30 Close of Day
5:30 Dinner Short Course Registration
6:00-9:00 Recommended Dinner Short Course*
SC1: Central Monitoring Deconstructed from Raw Data to Monitoring Actions: An In-Depth Walk Through
Tuesday, May 14
7:25 am Morning Coffee
7:55 Chairperson’s Opening Remarks
8:00 Using Site Contracting Performance Metrics in Site Selection – Do You Have Access to the Right Data to Understand How the Site Performs?
Linda Sullivan, MBA, Executive Director, Metrics Champion Consortium
This presentation will explore why site contracting cycle times vary by country, discuss approaches organizations are using to reduce cycle time results, and review the data your organization should be reviewing to gain insights about which sites perform
well in the context of local regulatory and ethical review requirements.
8:30 Creating Effective Site Partnerships to Drive Site Performance – Being the Sponsor/CRO of Choice
Dennis Salotti, COO, The Avoca Group
Execution in clinical research relies on several key interdependent relationships, most notably the interface between investigative sites, CROs and Sponsors. Avoca and ACRP have partnered on research to characterize, from the site perspective, the attributes
that drive quality in clinical research when working with Sponsors/CROs. This presentation will summarize key insights that arose from this research with supporting quantitative and qualitative data.
Essex Center
9:00 Interactive Group Discussion: The Intersection of Patient Recruitment and Study Sites
9:30 Leveraging Predictive Analytics to Enable Predictable Study Operations
Mark Springer, Associate Director, Consultative Services, IQVIA Technologies
Clinical supply budgets remain a big area of untapped potential efficiencies for both sponsors and CROs. While suppliers have focused on improving accuracy of their estimates, it’s usually in isolation and is often impacted by unexpected activities
of upstream stakeholders. This session will share details of a collaborative approach that allows a clinical supply organization to leverage existing clinical technology for enrollment and timeline planning to inform their supply strategy.
10:00 Coffee Break in the Exhibit Hall
Essex North & Center
10:45 PLENARY KEYNOTE SESSION: Enabling Patient-Centric Clinical Trials
10:45 Chairperson Remarks: Patient-Centric Trials: How to Engage the Patients in a Clinical Study
Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC
Basker will share the results of the patients’ interaction and what is important to them and what keeps them engaged in a trial. He will also share his personal vision of how Digital technologies can help in this space.
10:55 KEYNOTE PRESENTATION: Patient-Centric Trials: Moving from What’s the Matter with Patients to What Matters to Patients
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Lisa Shipley, Vice President, Global Digital Analytics, Merck
The overall percentage of potential patients that participate in clinical trial is very low. Engaging patients and removing barriers to patient participation in clinical trials is critically important to the development of new therapies to improve human
health. Digital technologies are poised to improve patient participation and experience and shift from a site-centric to a patient-centric model. Pharmaceutical companies and CRO’s are exploring a number of different paradigms deploying technologies
such as, telemedicine, wearables, and home-sampling.
11:15 KEYNOTE PANEL DISCUSSION: Going Virtual – Moving towards Patient-Centric, Site-Less Trials
Lisa Shipley, Vice President, Global Digital Analytics, Merck
Linnea Olson, Lung Cancer Patient Advocate
Laura Whitmore, Director, R&D Innovation, Corporate Projects, Otsuka
Michelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer
With the rise and integration of new technologies into clinical trials – mHealth, wearables, sensors, the internet of things – there is an unprecedented opportunity for revolutionizing how the industry performs clinical trials. New technology
can help move clinical trials from sites directly into patient homes.
- Virtual trials, decentralized trials, remote trials, site-less trials: What are we all talking about?
- What are the latest successes and failures?
- What are the barriers and challenges? How is the industry leveraging technology to make this a reality?
- What are patients saying about their experience with virtual trials?
- What does this mean for the future of clinical trials?
11:50 KEYNOTE PRESENTATION: Prescription of Digital Therapeutics: The Time has Arrived!
Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai
12:20 pm Networking Lunch & Dessert Break in the Exhibit Hall
1:20 Close of Conference. Stay on to Attend Site Activation & Study Start-Up