Global Site Selection, Feasibility Assessment, Operations & Site Management Header 

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Sunday, February 6, 2011

Pre-Conference Workshop* with CenterWatch:

1:00 - 2:00 pm Workshop Registration

2:00 – 5:30 Optimize the Process of Site Selection, Study Activation and Patient Recruitment

This workshop focuses on the strategies, tools and technologies for site identification and selection, study and budget planning, and explores a variety of new initiatives that sponsors, CROs and investigative sites are implementing to improve patient recruitment and retention effectiveness. Specifically, the workshop focuses on the following critical areas:

  • Site Identification, Assessment and Selection: Strategies and metrics employed by Sponsors and CROs in this process 
  • Study and Budget Planning: Positioning your site for success in the study and budget planning process 
  • Patient Recruitment: Exploring a variety of new approaches to improve patient recruitment and retention 

Joan ChambersWorkshop Leader: Joan Chambers, COO, CenterWatch

 

 

 

 

 

Panelists:

Nye PeltonNye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly

 

 

 

 

 

 

Bonnie BresciaBonnie Brescia, Founding Principal, BBK Worldwide

 

 

 

 

 


Michael JayMichael Jay, Vice President, RxTrials

 

 

 

 


 

*Separate registration required

 


Monday, February 7, 2011

7:30 am Conference Registration and Morning Coffee

 

REGULATORY CHALLENGES IN US
& EMERGING MARKETS
 

(Shared Session with Drug Development Latin America)

Sponsored by
BBK 
8:15 Chairperson’s Opening Remarks
Matt Kibby, Market Intelligence, BBK Worldwide 







8:30 Regulatory Challenges and Expectations in Emerging Markets to Effective Clinical Trial Development

Michael Young, MPH, Senior Manager, Worldwide Regulatory Affairs - Emerging Markets, Pfizer, Inc.

Today, more than ever, clinical research is experiencing a geographical shift in country selection, and clinical trials are truly becoming more and more “global.” One of the industry’s goals is to execute simultaneous global development. That is, to use global data to develop a single dossier (e.g., Clinical Trial Application) that supports the next critical phase of development, enabling simultaneous submissions to and approvals from health authorities and ethics committees globally. There are a number of barriers that significantly restrict simultaneous development, ultimately delaying the availability of innovative drug therapy to emerging markets and limiting patient access to new and preventative treatment. Presentation topics: Regulatory barriers in the AP and LA regions to simultaneous clinical development; Industry’s expectations of a health authority’s regulatory framework; Clinical elements to the ideal clinical trial infrastructure.

9:00 FDA Inspections of Clinical Research Sites

Jeanne MorrisJeanne Morris, President, J2 Quality Consulting Inc.; former Investigator, FDA

This presentation discusses what to expect during FDA inspection of a Clinical Investigator site. Applicable federal regulations will be reviewed as well as common citations and problems. Presentation will identify ways that sites and sponsors can best prepare for the inspection to influence a positive outcome.

 

9:30 Ethical Challenges in Site and IRB Selection in Multi-Regional Clinical Trials

Marjorie SpeersMarjorie Speers, Ph.D., President and CEO, Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Managing multi-regional clinical trials poses legal, drug regulatory and ethical challenges. In this presentation, Dr. Speers will describe four common misunderstandings about IRBs/ECs that can lead to regulatory challenges, delays in starting trials, and unnecessary risk exposure. While virtually all sponsors follow ICH-GCP, they are also bound to in-country laws that govern the conduct of research and the ethical review of trials by IRBs/ECs. Informed consent processes, protection for vulnerable populations, initial and continuing review processes, and training will be discussed. She will illustrate the challenges and solutions using Brazil, China, India, and Mexico.

10:00 Networking Coffee Break in Exhibit Hall

 

SITE SELECTION AND FEASIBILITY 

Sponsored byTrifecta10:40 Chairperson’s Remarks
Suzanne Collins, Director, Operations, Trifecta Multimedical 




10:45 Site Selection: How to Improve Site Selection and Reduce the Percentage of Zero Enrolling Sites

Nye PeltonNye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly

Optimal site selection should begin early in the trial design process. By using historical data on enrollment, start up timelines, and IRB type, an initial list of potential sites is developed. Key investigators are then approached to gain detail feasibility feedback. This contributes to improved final trial trials design as well as early enrollment projections. Finally and in depth set of questions, relating to potential enrollment barriers is created to use during the final site recommendation assessments, done by our CDLs.

11:15 Building Quality into the Site Selection Process

Colleen Gorman, Ph.D., Senior Director, Site Selection Business Process Owner, Worldwide R&D, Pfizer Inc.

This presentation will share a real life story of how Pfizer addressed the gaps and pain points within the site selection process and conducted a complete process re-design to build quality and consistency into the global site selection process. In addition, how this links to our global feasibility process will be discussed.

11:45 Clinical Operational ExcellenceSponsored by
Pharmica Consulting small

Matt KiernanMatt Kiernan, Partner, PHARMICA Consulting

Clinical operations departments across the industry are continually being asked to do more work with fewer resources.  To overcome these challenges, PHARMICA Consulting works with companies large and small to launch Operational Excellence initiatives. We specialize in data integration, metrics, SharePoint study management and investigator portals, as well as project management capabilities.  This presentation will highlight some of our Clinical Operational Excellence case studies, all of which made a real difference and were a resounding success for the organizations.
 



Sponsored by
Citeline
12:00 pm Luncheon Presentation
Zorba LiebermanA Data-Driven Approach to Site Selection can Increase the Average Enrollment Performance of your Global Clinical Study
Zorba Lieberman, co-founder, Citeline, Inc.This session will elucidate the connection between investigators' patterns of clinical trial participation and their potential for high patient enrollment performance. The ROI of selecting investigators using study level activity data will be quantified.

Sponsored by
Trifecta MultiMedical 
1:25 Chairperson’s Remarks
Suzanne Collins, Director, Operations, Trifecta Multimedical


 

1:30 Site Selection and Study Planning for Emerging and Poverty Related Diseases

Gabriele PohligGabriele Pohlig, Ph.D., Project Leader, Clinical Research Scientist, QA Manager, Medicines Research, Swiss Tropical and Public Health Institute

The development of drugs against diseases affecting poor and vulnerable populations was long neglected, but has recently gained significant momentum. However, increasing research is carried out and respective capacities are needed to allow the conduct of clinical trials. In addition, health transition, i.e. the shift from communicable to non-communicable diseases, will bring new challenges and opportunities in the near future.

2:00 Site Selection of Global Phase I Units

Erica ElefantErica Elefant, Senior Clinical Scientist, Discovery Medicine Clinical Pharmacology, Bristol-Myers Squibb

There is a recent trend to conduct Phase I studies globally. An effective Phase I unit is key to the success of generating quality data that will support a compound’s development. Many sponsors do not have experience with the facilities and performance of Phase I research centers globally. In addition, sponsors are relying on Hub staff or CROs to evaluate these sites in different countries. This session will present the challenges when selecting Phase I sites globally and best practices to overcome these challenges.

Sponsored by
BBK 
2:30 What Emerging Biopharmaceutical Companies Need To Know about Study Start-Up
Matt Kirby Matt Kibby, Market Intelligence, BBK WorldwideMore and more, start-up companies are required to complete early phase studies before securing licensing agreements or being acquired. Typically these firms have fewer human resources and less clinical operations experience than their big-Pharma suitors. This session will explore the special needs of emerging companies and how well-executed feasibility and study start-up can impact corporate value.


2:45 Afternoon Refreshment Break in Exhibit Hall 

3:15 The Global Site Feasibility Process: Cost-Effective Techniques for Finding High Performing Sites

Adam RuskinAdam Ruskin, Ph.D., D.V.M., M.P.H., Director, Clinical Operations, Emergent Biosolutions

A number of techniques performed in-house including use of software, literature searches and referrals typically yield much higher enrollment in global clinical trials at a fraction of the cost of outsourcing site feasibility. After initial searches, targeted questions can weed out uninterested and low enrolling parties. Targeted strategies in country selection also play into minimizing countries and sites while maximizing average per-site enrollment. This strategy efficiently locates high enrolling sites, prevents entry of the majority of non-and low-enrolling sites into your study, and has been used effectively in a wide number of therapeutic areas.

Sponsored by
Trifecta 
3:45 Accelerating Study Start-up with Hybrid Training Strategies 

Suzanne Collins, Director, Operations, Trifecta MultimedicalDespite best efforts, study start-up can be delayed due to circumstances beyond the control of the Study Team.  These challenges can result from site non-compliance with training and regulatory requirements, global regulatory approval timelines, as well as internal and external budget & resourcing constraints.  This presentation will review how hybrid training strategies can reduce study start-up timelines and budget/resourcing impact through the delivery of cost-effective, standardized “Just in Time” training to sites globally.

 

 

4:00 Interactive Panel

Looking Ahead: Driving Innovation in Study Start-Up

Mark RidgeModerator: Mark Ridge, MBA, Senior Director, Global Business Operations, Pfizer, Inc.

 

 

 

 

 

 

Panelists:

Evan Tzanis, Director, Clinical Affairs, Specialty Care Business Unit, Pfizer, Inc.

Peter DiBiasoPeter DiBiaso, Senior Director, Clinical Planning & Performance, Clinical Development Operations, Vertex Pharma





 

Nye PeltonNye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly

This panel will take an interactive approach to discussing the current environment of study start-up, current trends in addressing the gaps, as well as future innovations that will revolutionize the study start-up area. 

 

  • What are the major opportunities for continued improvement?
  • What solutions are you thinking about?
  • Where will the industry be in 5 years?

 


4:30 Informal Break-out Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive 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.

TOPIC 1: Site Feasibility Strategies for Start-Up Companies

Moderator: Adam Ruskin, Ph.D., D.V.M., M.P.H., Director, Clinical Operations, Emergent Biosolutions

• Are personnel, software or vendors the best source to maximize enrollment with minimal costs when budgets are an issue?
• As most companies are small or start-ups but have the same responsibilities for finding high enrolling, compliant sites, is more or less oversight required than from a larger pharma or biotech company?
• Can start-ups be even more efficient at enrollment than their larger counterparts?

TOPIC 2: An Investigational Discussion on How to Leverage Technology to Enhance Site Selection

Moderator: Abbe Steel, Executive Director, Trial Enhancement Solutions, United Biosource Corporation

• Review current statistics
• Discuss current physician practices (with iPhones and other technologies)
• Brainstorm ideas and future opportunities

TOPIC 3: The Need for Improved Operational Efficiencies in Site, CRO, and Sponsor InterationsModerator: Srini Kalluri, Founder, President, & CEO, Forte Research Systems, Inc.• What are the main challenges for each stakeholder – Site, CRO, and Sponsor?
• Where are the big opportunities for industry-wide efficiencies?
• Please share your success story.  How have you used technology to improve efficiency through better integration of stakeholders?

TOPIC 4:  Maximizing ex-US Enrollment through Regionally Adapted Recruitment StrategiesModerator: Aaron Rasch, Vice President, Asian Operations, Summit Analytical, LLC
• You must be present to win, ie having a presence in China 
• Understand the true capabilities of site staff (CRCs, Investigators, etc.,)
• Be sensitive to local perceptions of clinical research and directly address them 
• Adequately support EDC with bilingual materials and training 
• Know who is in charge and get their support

TOPIC 5: Web Based Certification for Sites and Study Start-UpModerator: Dax Kiger, Director, Business Development,  Trifecta MultiMedical• Pros and Cons of web based training 
• Certification considerations
• OUS considerations

TOPIC 6: Challenges in IRB Selection for Domestic Clinical TrialsModerators: Rich Green, Director & Carmela Houston-Henry, Director, BRANY Central IRB• Are all IRBs the same? What are the top 5 Criteria for choosing a central IRB?
• What would the perfect IRB look like to a sponsor? Sponsor/IRB collaboration:  Is it a conflict of interest?
• Pros and Cons of choosing a central IRB

TOPIC 7: Site Consultation – The Post Selection ProcessModerator: Matt Kibby, BBK Worldwide
• Helping sites maximize efforts with structured and efficient planning
• Pre-emptively addressing concerns and preparing sites to move toward study completion
• Consulting sites with study difficulties and implementing mid-course corrections.

TOPIC 8: Preferred Site PartnershipsModerator: Chris Hoyle, Executive Director, Elite Research Network• What are the key elements of a preferred site partnership?
• How to implement and maintain preferred site partnerships within your organization
• What do sponsors, CROs, and sites hope to achieve with preferred site partnerships?

5:30 - 6:30 Networking Cocktail Reception

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