2014 Archived Content

 

Cambridge Healthtech Institute’s Fourth Annual 

Global Site Selection, Feasibility Assessment,
Operations and Site Management
 

Improving Timelines and Outcomes with Strategy, Data and Execution
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL 


Data-driven global site selection, an optimized 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 trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize data and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. CHI’s 4th Annual “Global Site Selection, Feasibility Assessment, Operations and Site Management” will cover the topics one should consider when planning and implementing a trial.


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Mon February 3 See all Short Courses 


TUESDAY, FEBRUARY 4 

7:00 am Registration and Morning Coffee

8:00 Organizer’s Welcome

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


Opening Plenary Keynotes And Panel:
Keeping The Patient In Mind
 

8:05 Chairperson’s Opening Remarks 

Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP

8:15 Plenary Keynote Introduction 

Nancy Mulligan, Senior Director, Operations, Patient & Physician Services, United BioSource Corporation


8:20 Plenary Keynotes and Panel

What Does a Trial Mean in the Era of Real-Time Measurement?

Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe

The Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer”

Christine Pierre, President, The Society for Clinical Research Sites (SCRS)

PANEL: Perspectives from a Cast of Characters Needed for Any Successful Study Execution

 

Keynote Details 


9:45 Grand Opening Coffee Break in the Exhibit Hall



NEW STRATEGIES FOR GLOBAL PLANNING 

10:45 Chairperson’s Remarks
KevinMcNultyKevin McNulty, Director, Product Marketing, Life Sciences, Intralinks, Inc. 





10:55 Let’s Jam: Optimizing Clinical Trial Planning and Design

JackieKentJackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly & Co.

There is not a single solution that will solve all of the issues with Feasibility and Country Allocation. Come and learn about an approach to these very important factors when designing a clinical trial. The Jam process will share an innovative approach to clinical trial planning, feasibility and country allocation. It will cover information about process, information, people and technology approaches to use to help with this complex area. This solution will build better relationships between study teams and clinical operations; it will decrease protocol amendments and overall reduce cycle times within your clinical trial. It will also provide information that is more reliable and complete than in the past.

11:20 Empowering Patients in Clinical Research: Pfizer’s Blue Button Project

JenniferWulffJennifer Wulff, MBA, Director, Clinical Innovation, Pfizer

Pfizer recently launched its Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data.  Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments.  In this session Pfizer will share more on why they have launched this initiative, initial learnings, and where the project may go in the future.

11:45 Strategic Approaches to Improve Global Trial Planning and GCP Readiness

BrunoGagnonBruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc.

Appropriate planning is key to risk-reduction in global clinical trials. Accurate predictability around site performance and GCP compliance is hard to achieve, especially in rare disease indications or when using new or naïve investigators. In this presentation, we will review some key success factors for protocol optimization, site start-up, monitoring oversight, data clean-up and inspection readiness.  Emphasis will be given on how to apply lessons learned from Regulatory Inspection findings early in the project and ensure highest level of team performance while remaining compliant.
 

12:10 pm Next-Generation Feasibility AnalysesInventiv   

Irina Ringler, Director, Feasibility & Clinical Informatics for inVentiv Clinical Trial Recruitment Solutions

Traditional approaches to feasibility analyses are often based on intuition, prior experience and paper. These approaches sometimes yield good results, but are not sustainable, are inconsistent, and can lead to poor predictability and long cycle times. Effective feasibility analyses demand more sophisticated approaches that can incorporate the many factors that contribute to a successful study. In this session, we will discuss approaches to leveraging data, analytics, internal and external expertise to gather protocol and investigator intelligence prior to engaging sites with a feasibility questionnaire.

12:35 Luncheon Presentation: Data-Site Selection Strategies for Orphan DiseasesCiteline 

SylviaMareckiSylvia Marecki, Ph.D., Senior Director, Product Management & Strategy, Product Management, Citeline

Drug development activity aimed at orphan diseases continues to increase. Identifying and recruiting clinical investigators with relevant expertise and who have a high potential to perform is paramount. This presentation will review a case study providing data-driven strategies for country and site selection in this increasingly competitive space.

1:15 End of Morning Session


Selecting Winning Sites And Keeping Them Happy 

1:25 Chairperson’s Remarks

SylviaMareckiSylvia Marecki, Ph.D., Senior Director, Product Management & Strategy, Product Management, Citeline





1:35 Summary Level Clinical Site Data: A Method of Site Selection and Ranking Sites for Audits and Feasibility

NadiaBrackenNadia Bracken, Clinical Program Manager, Clinical Operations, Biotie Therapies

This presentation will discuss best practices to improve site selection process and the development of a lean method to determine adequacy of a site during feasibility for a multicenter trial. I will explain how to track each site’s historical performance; identify top performers; weed out underperformers for future trials using retrospective data; evaluate, rank, and summarize site start-up metrics, recruitment and retention of participants, completeness and quality of data, individual subject outcomes, and other operational and administrative factors using descriptive statistics. Also discussed is how to identify, predict, and mitigate potential risks prior to inspection and conduct of future trials and a review of CDER’s Inspection Planning Draft Guidance for Industry: Summary Level Clinical Data published December 2012.

2:00 Site Engagement For The 21st CenturyBBK 

Stumm_MatthewMatthew Stumm, Principal, Creative & Media Strategy, BBK Worldwide

Investigative sites are where the recruitment rubber hits the enrollment road. And today’s modern site is “not your father’s” site of yesterday. With the technological aptitude, immediacy, and desire to connect over distances as the hallmark characteristics of most professionals today, the sponsors who transform the way they engage sites will take the lead in the race to successful recruitment and also develop long-term partnerships with unsurpassed investigator and site relations. Matthew Stumm, principal, creative and media strategy, BBK Worldwide, will take you through some of the ways you can apply new media to create and sustain an engaging recruitment milieu that focuses site staff efforts, provides motivation, fosters connection, and simplifies common arduous site staff activities.

2:25 Investigator Perspective: How to Avoid the Need for Therapy in a Sponsor-Investigator Relationship (Drugs Are Not Always the Answer!)

RobertDrackerRobert Dracker, M.D., Medical Director, Summerwood Pediatrics; Member, Pediatric Advisory Committee, FDA

Sharing the perspective of a P.I. this presentation will offer some tangible lessons for study sponsors and trial project leaders. Topics include: 1. Insuring that the objectives and design of the clinical study are understood and straightforward and ultimately embraced by the Investigators. 2. Convincing the study site and the participants of the importance and patient-centric nature of the research goals. 3. The role of communication and responsiveness to improve study feasibility and the initiation process. 4. Insuring that the Study Sponsor knows what they want, how to get what they want and when they want to get it!

2:50 Intelligent Monitoring: Combining Risk, Event and Analytics-Based MonitoringAris Global 

Jessica Schell, Clinical Solutions Engineer, Aris Global

Early adopters of risk-based monitoring have primarily focused on the analysis of EDC data to drive partial SDV. This session examines how already available technologies can combine operational and study management data to quantify risk, identify trigger events and provide dynamic analytics to promote truly ‘intelligent’ site monitoring and management.

3:05 Refreshment Break in the Exhibit Hall



4:05 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.

CLICK HERE to view the current topics and moderators


5:15 Welcome Reception in the Exhibit Hall

6:15 End of Day



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