Monday, May 11, 2009

Main Conference

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.

Optimization of
Patient Recruitment Strategies

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

Hosted by12:15 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

5:30 Networking Cocktail Reception with Exhibit Viewing 

6:30 PM Close of Conference Day

Go to Day 2