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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 

Workshop Leader: Joan Chambers, COO, CenterWatch

Panelists:

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

Bonnie Brescia, Founding Principal, BBK Worldwide

Michael 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
 8:15 Chairperson’s Opening RemarksMatt 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 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 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 by10:40 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 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

Matt 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
12:00 pm Luncheon Presentation
A Data-Driven Approach to Site Selection can Increase the Average Enrollment Performance of your Global Clinical StudyZorba 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
 1:25 Chairperson’s RemarksSuzanne Collins, Director, Operations, Trifecta Multimedical


 

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

Gabriele 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 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
 2:30 What Emerging Biopharmaceutical Companies Need To Know about Study Start-Up 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 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
 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.

 

5:30 - 6:30 Networking Cocktail Reception