Monday, May 11, 2009
Hosted by
 8:00AM
Pre-Conference Workshop Registration and Morning Coffee
8:30 Interactive Open-Forum Format“Key Issues that are Shaping the Recruitment Industry”
As specialized providers in the clinical research industry, Patient Recruitment Organizations (PROs) must take the lead in addressing current trends that affect the recruitment market. DAC will lead the workshop attendees in an open forum discussion surrounding three key industry challenges and discussion of solutions towards those challenges. Two topics will be identified by the facilitators, and the third topic will be decided upon by the group. The presenters will record the outcomes of the meeting, produce and develop a white paper for industry publication with all attendee’s names. Publication opportunities will be identified and reported during the meeting.
Objectives:
Address key issues within the recruitment industry today
Identify future trends that will shape the PRO’s role
Discuss solutions to key recruitment challenges
Presenters:
Melynda Geurts, Chief Operating Officer, Operations, D. Anderson & Company
Susan Campbell, Senior Director, Business Development, D. Anderson & Company
* Separate registration is required.
10:30 End of Pre-Conference Workshop
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10:00 Main Conference Registration
11:00 Organizer’s Welcome and Chairperson’s Remarks
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute
Matthew R. Dauphin, Associate Director, Global Clinical Programs, Clinical Research & Development, Shire Development Inc.
11:05 KEYNOTE: Increasing Investigator Site Performance & Productivity
Brian York, Director, Feasibility and Patient Recruitment, Amgen
There are a high number of non-performing centers that lead to increased clinical trial costs and cycle times:
Performance at enrolling centers is not being optimized
We need to better manage our site performance
Maintaining existing PI relationships
Building new PI relationships
Keeping PIs motivated to work on our studies
This presentation will focus on:
Ideas on how to manage, establish and cultivate site relations in an increasingly competitive marketplace
Show how better site relations translate into improved enrollment
Develop methodologies to ensure alignment of internal site facing functions such as therapy areas, operations and the medical liaisons
11:45 Recruitment Planning Starts Earlier Than You Think
Katherine Valentine, Senior Manager, Clinical Trial Management, Clinical Operations, Genentech, Inc.
Recruitment plan development begins prior to protocol finalization. Utilizing key tools and soliciting feedback from Investigators and Study Coordinators enables the development of a robust recruitment plan that mitigates risk. Case studies will be discussed.
Begin development of the recruitment plan prior to protocol finalization
Incorporate feedback from internal and external sources to develop a robust recruitment plan
Learn from Genentech’s experience implementing new recruitment plan processes
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12:15 PM Luncheon Co-Presentation
Recruiting Recipes that Will Cook-up Immediate Results
Lance Nickens, President, The Patient Recruiting Agency (TPRA)
Christine Pierre , President, RxTrials
During this lunch time session your senses will be stimulated with real life ingredients to ensure tasty success for your sites with successful study enrollment.
Recruitment recipes that will create immediate results.
Thinking outside the box can help meet enrollment goals.
It doesn’t have to be Filet Mignon but realizing the difference of professionally designed recruiting creative can make a huge impact.
Offering sites adequate media budgets to achieve your recruiting goals; Is it a sponsor’s responsibility?
1:45 INTERACTIVE PANEL: Can Sponsor/CRO Collaboration Yield an Effective Recruitment Strategy?
Moderator: L. Joshua Davis, Managing Director, LJD Consulting
Tim Warneke, Senior Director, Clinical Operations, King Pharmaceuticals
Joshua Schultz, Vice President, Clinical Research Services, PAREXEL International
Peter Keim, Associate Director, Process Optimization, Clinical Operations, Novo Nordisk Pharmaceuticals, Inc.
Tara Gladwell, MBA, Senior Director, Clinical Operations, Rho, Inc.
As pharmaceutical and biotechnology companies enter a third decade of outsourcing to contract research organizations (CROs), the industry has seen an increased shift in the responsibility and accountability for recruitment activities. What blend of human resource, company experience, innovative tools, and investigator networking is required to optimize a recruitment strategy for a Phase III in the 21st century? Coupling the sponsor’s mastery of the science with the CRO’s expertise in both medical and operational aspects of the therapeutic area, a properly managed team can build an effective strategic approach to almost any recruitment challenge. Given many of the recruitment experts in our industry now work with CROs, capitalizing on this strength can provide both financial and opportunity cost savings for the program.
KEY DISCUSSION TOPICS:
What are the greatest enrollment challenges to overcome in a typical Phase III program?
Provide an explicit example where at least two of these challenges were met.
With regard to the sponsor/CRO team, who is accountable for enrollment success?
LEARNING OPPORTUNITIES:
Actual studies illustrating how difficult recruitment challenges were met.
Similarities and differences between the accountability for patient recruitment and retention – CRO versus sponsor.
How to utilize such accountability to motivate teams to build and manage a recruitment strategy plan.
2:30 Networking Refreshment Break with Exhibit Viewing
3:00 Do You Have an Implementable Protocol?
Brendan O’Neill, Associate Director - Global Trial Optimization, Merck Research Labs
We spend so much time trying to identify the best investigators and recruitment strategies for our development programs, but do we even know if the patients we are looking for even exist? This presentation will outline and discuss the impact of medical and operational feasibility before the protocol is finalized and site selection activities commence. Once you have finalized your patient definition, you can then transition into strategy planning.
3:30 Supplementing Traditional Site Relationships in Clinical Trials by Partnering Clinical Operations and Medical Affairs – A Novel Approach to Enhancing Patient Identification, Accrual, and Retention
Ross D. Pettit, M.D., Vice President, Clinical Operations, ARIAD Pharmaceuticals, Inc.
There are significant challenges to enrollment of clinical trials on the current trial landscape in the United States (and globally). This is particularly challenging in rare disease. The “traditional” trial execution model employed by most organizations does not fully address the needs of sites in supplementing the patient accrual process. Smaller companies lack the resource to fully exploit the tools available to them including partnering with Medical Affairs to increase and suitable leverage site communications.
This discussion will examine a case study outlining a mutual collaboration between a clinical operations group and medical affairs company to enhance recruitment.
The audience will be offered an alternative approach to consider in patient recruitment and hear about lessons learned from this approach in a global trial program in a rare disease.
Sponsored by
4:00 Program-Level Branding: Solving Complex Patient Recruitment Needs
Donna Beasley, Vice President of Operations & Marketing, Praxis Communications
There is a single prevailing driver of today’s most powerful trend…the tremendous pressure to cut drug development time and costs, while at the same time improving safety. Easier said than done, but there are clearly innovators that are stepping up to the challenge and seeing the results of such changes. And many times change is sparked simply by thinking in new ways. Program level planning for a compound isn’t a new thought. But how some are utilizing the thinking is. Consider applying that level of planning from protocol feasibility to more specific tasks associated with each protocol’s completion. That is what some sponsors are doing with measured success in the patient recruitment arena.
Program-level thinking is broader strategic thinking that saves time and money
Explore the benefits of this type of planning execution
See examples of how to apply deeper strategy for long term success
4:15 Informal Break-out Discussions
Attendees will join a table with their peers and a moderator to discuss some of the more poignant questions facing the industry. 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 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.
Table #1: Global Regulatory Strategies to Deal with Recruitment of Patients in Placebo-Controlled Studies
Alex Kudrin, M.D., Ph.D., former Senior Manager, Global Clinical Development, GlaxoSmithKline Biologicals (Belgium)
Regulatory, ethical considerations of placebo/comparator studies in different parts of the world
How to overcome hurdles of low recruitment in placebo controlled trials
Regulatory views on the study designs
Table #2: How to Deal with the Growing Size/Complexity of Clinical Trials
Alex Lancksweert, Director, Performance Metrics & Benchmarking, Global Clinical Operations, GlaxoSmithKline R&D
Table #3: When Do You Need to Hire a Patient Recruitment Service Provider?
Matthew R. Dauphin, Associate Director, Global Clinical Programs, Clinical Research & Development, Shire Development Inc.
Table #4: How Can Operations Influence Patient Definition and Protocol Design?
Brendan O’Neill, Associate Director - Global Trial Optimization, Merck Research Labs
Do you have the tools, networks or data available to simulate changes to your inclusion/exclusion criteria?
When will it have a significant impact?
Table #5: Challenges and Opportunities for Optimizing Patient Recruitment in Latin America
Jeff Goldfarb, Vice President, Oncology, MMG
Table #6: Centralized Campaign Versus Site Specific Campaigns: What Works the Best for the Study?
Lance Nickens, President, The Patient Recruiting Agency (TPRA)
Table #7: When Should a Risk Share Model Be Utilized?
Melynda Geurts, Chief Operating Officer, Operations, D. L. Anderson International, Inc.
Table #8: How can we Accurately Project Site and Patient Recruitment in Order to Ensure Trial Milestone Deliverables?
Kurt Shampine, Senior Vice President, Life Science Solutions, ProModel Corporation
Why is projecting site and patient recruitment so difficult?
Do we have the data to support an accurate analysis?
What role can optimization take in delivering critical trial milestones?
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5:30 Networking Cocktail Reception with Exhibit Viewing
6:30 PM Close of Conference Day
Go to Day 2