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Wednesday, February 8

12:00 pm Conference Registration

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

(Bridging Session between Global Site Selection & Patient Recruitment)

 

INNOVATIVE STUDY START-UP AND ENROLLMENT PLANNING 

Shared Session with Integrating and Leveraging Clinical Trial Operations Data 

 

1:25 Chairperson’s Remarks
Nancy Mulligan, Director, Operations, United BioSource Corporation (UBC) 

1:30 To Source or Not to Source: Getting the Most from Your Internal Staff and Partners for Improved Study Start Up and Enrollment

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

This session will examine a blended sourcing model utilized by a sponsor to optimize the planning and execution of the study site activation and start up process.


 

1:55 Co-Presentation - Case Study: Leveraging Organizational Data Sources to Forecast Clinical Trial Timelines

Otis Johnson, Manager, Global Trial Optimization, Merck & Co.

Ed White, Informatics Analyst, Global Trial Optimization, Merck & Co.

With the increasing constraint on resources in pharmaceutical research, it is becoming more critical to develop timely and accurate forecasts for clinical trial timelines. Realizing this need, Merck has made a unique commitment to the forecasting and expediting of trial timelines over the past 5 years. This session will involve a discussion of forecasting for clinical trial timelines, methods and processes used to develop forecasts, and different forecasting strategies.

2:30 Using Investigator Focus Groups to Assess Protocol Feasibility

Lakisha Rodwell, Global Trial Optimization Specialist, Merck & Co.

2:45 Refreshment Break in the Exhibit Hall

 

OPTIMIZING TRIALS TO ENSURE RAPID AND EFFECTIVE RESEARCH AND SAFETY 

3:10  Chairperson's Remarks 

Nancy Mulligan, Director, Operations, United BioSource Corporation (UBC) 

3:15 Blending Regulatory Requirements and Best Practices in Recruitment and Retention: The IRB Perspective

Richard Penson, M.D., M.R.C.P., Clinical Director, Medical Gynecologic Oncology, Massachusetts General Hospital; Chairman of Dana Farber/Harvard Cancer Center IRB panels C,E, and F
This presentation will offer real world insight to optimizing protocols, and managing trials to ensure rapid and effective research and participant safety. The talk will also share examples and a world class institution’s perspective on best practices. Lastly, key lessons in balancing efficiency, cost and excellence will be presented.

 3:40 Case Study: Utilizing New Strategies and Methods for Two Large Scale Phase IIIb Efficacy Trials

Andrew Cwiertniewicz IIIAndrew Cwiertniewicz III, Senior Clinical Trial Manager, Clinical Operations, Study Management and Logistics, sanofi pasteur

This case study discusses two large scale, fast-paced phase IIIb efficacy trials, enrolling up to 1400 subjects in a day for 10k and 15k sized trials. We utilized and embraced new ideas, such as an advisory panel of clinical research coordinators. They had the first peek into the writing of the protocol and assisted the clinical operations plan for this trial. Our team has also been the first to utilize a control enrollment strategy, which was tremendously successful and gave all sites a fair chance to enroll in fast and furious flu trials. Lastly, the structure of the team and our strategic partnerships were key.

Sponsored by
DAVA Oncology 
4:05 Recruiting Patients for Cancer Trials: Focus on the Physicians!

Martin LeeMartin Lee, M.D, Executive Vice President, Clinical Trial Services, DAVA Oncology, LPCancer clinical trials are widely available, yet less than 5% of patients participate. The reasons for this are complex and include patient, physician and trial-specific barriers. This session will focus on how direct peer-to-peer engagement of clinical trial investigators and their referring physicians accelerates patient recruitments in cancer clinical trials.


4:20 - 5:30 Interactive Breakout Discussion Groups

 

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 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.

TABLE 27: Tylenol for IRB Headaches!

Moderator:  Richard Penson, M.D., M.R.C.P., Clinical Director, Medical Cynecologic Oncology, Massachusetts General Hospital, Chairman of Dana Farber/Harvard Cancer Center IRB panels C, E and F

• Plan for success
• Common pitfalls
• Communicating with IRBs

TABLE 28: Identification and Selection of Investigators: Do They Really Have Patients?

Moderator:  Nariman Nasser, Director, Participant Recruitment Service, University of California, San Francisco

• How to design a site feasibility questionnaire to get the most useful data
• Going beyond the chart review to quantify the available patient base
• Comparing aggregate site data to local incidence rate to accurately project patient numbers

TABLE 29:  Patient Recruitment - Challenges and New Approaches

Moderator:  Joan Chambers, COO, Centerwatch

• New strategies around internet, data mining, matching services, patient databases, and collaborations – is one strategy more effective than others?
• Are these strategies boosting patient enrollment and retention rates?  Is there a measurable difference?
• Is convergence of the patient community and industry the strategy for clinical trial success and if so, how is that obtained?

TABLE 30: Planning, Planning and Planning your Enrollment Strategy.  Learn from your Mistakes!

Moderator:  Andrew Cwiertniewicz III, Senior Clinical Trial Manager, Clinical Operations, Study management and Logistics, sanofi pasteur

• Review your metrics from past trials
• Competitive enrollment, controlled competitive enrollment, or just hope to enroll?
• Take what your sites are telling you – than halve it.

TABLE 31: Can You Hear Me Now?  Recruiting/Call Center Operations

Moderator:  Mark Metzner, Director, Recruiting & Marketing, Community Research

• Subject Impact (What Are They Expecting From Us?)
• Regulatory Impact (What Are We Allowed To Say To Them?)
• Contact Challenges (Why Do You Leave a Number Where We Can Never Reach You?)
• Your Site’s Hurdles
• Best Practices

TABLE 32:  Recruiting using a Social Marketing Approach

Moderator:  Nancy Mulligan, Director, Operations, United BioSource Corporation (UBC)

• Reaching potential patients where they are
• Delivering the right message
• Rewarding patients for their contributions (it's HIPAA compliant!)

TABLE 33:  #SYTYCR – So You Think You Can Recruit Using Social Media

Moderator:  Lani Hashimoto, Director, Strategic Development, MMG• Discuss how to you measure the impact and effectiveness of your program
• Share performance measures and share experience and expectations 
• What would make you #tweetwithjoy? 

TABLE 34:  New Challenges Call for Innovative Approaches to Patient Recruitment and Retention for Post Marketing Trials 

Co-Moderators:  Ramita Tandon, Global Head of Late Phase Clinical Trials, PAREXEL 
Lollo Eriksson, Vice President GRO, Start, Feasibility & Clinical Informatics, PAREXEL
• Undertand the various types of options/cutting edge strategies (like Social Media and Electronic Medical Records) and the benefits they offer to the post marketing research enterprise and patient community
• Understand the market forces driving the need for such cost efficient patient recruitment/retention approaches and discuss the trends changing the drug this research area

TABLE 35:  Designing and Implementing a Clinical Enrollment Plan: Strategy Development, Plan Implementation and Contingency Planning

Moderator:  Bonnie Brescia, Founding Principal, BBK Worldwide• Best practices for balancing cutting edge innovations with tried and true recruitment practices
• Maximizing the impact of recruitment resources by developing strategic plan based on activation timelines and staggered program rollouts 
• Taking a proactive, data-driven approach to contingency planning and tactic



 

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RECOMMENDED MONDAY AFTERNOON SHORT COURSE: 

Social Media and Mobile Technology in Supporting Patients in Studies and Registries 

 

2012 Conference At A Glance 

Micah Lieberman 

For topic suggestions and
speaker referrals:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541-482-4709
E: 
mlieberman@healthtech.com 

Ilana Quigley 

For partnering and
sponsorship information:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781-972-5457
E: 
iquigley@healthtech.com 

Rich Handy 

For media and association
partnerships, please
contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com 

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