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

ENHANCING THE FEASIBILITY PROCESS

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 Presentation to be Announced

10:00 Networking Coffee Break

SITE BUDGETING & CONTRACTING

10:30 A Systematic Approach to Study Start-Up: Improving Site Activation

Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

The success of a trial heavily relies on the strong bond between trial operations and project management throughout the life cycle of the trial. Systematic assessment of risk factors and key performance indicators at a start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. This session will discuss best practices to expedite start-up phase: Develop a sound business strategy for a more efficient study start-up; Determine key performance indicators and risk factors contributing to the delays at the start-up phase; and Implement mitigation strategy in order to avoid delays and allow for successful launch of a clinical trial.

11:00 Talk Title to be Announced

Rakiyya E. Ali, JD, Director, Head of Site Budgets & Contracts, Business Operations, Site Budgets & Contracts Group, Regeneron

11:30 Sponsored Presentation (Opportunity Available)

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:45 Session Break

DATA TRENDS ACROSS SITES & CLINICAL OPS DECISION MAKING

1:25 Chairperson’s Opening Remarks

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 - Detailed Agenda

Tuesday, May 14

7:25 am Morning Coffee

Employing Site Metrics and Improving Site Performance

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.

9:00 Data Analytics for Improved Site Feasibility

Speaker to be Announced

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall


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

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


 

Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC


 

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 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:35 pm Dessert Break in the Exhibit Hall

1:20 Close of Conference. Stay on to Attend Site Activation & Study Start-Up



TO SUBMIT TOPIC IDEAS OR SPEAKER REFERRALS, CONTACT

Lee Yuan
(+1) 781-972-5404
lyuan@healthtech.com

TO SPONSOR & EXHIBIT, CONTACT:

(Companies A-O)
Ilana Quigley

(+1) 781-972-5457
iquigley@healthtech.com

(Companies P-Z)
Patty Rose
(+1) 781-972-1349 
prose@healthtech.com

TO BE A MEDIA PARTNER, CONTACT:

James Prudhomme
(+1) 781-972-5486
jprudhomme@healthtech.com