8:00 a.m.
Continental Breakfast & Networking

8:30 a.m.
Chairperson's Opening of Day Two

Jeffrey Zucker, Senior Director & Global Head, Feasibility & Patient Recruitment
INC RESEARCH

8:45 a.m.

How To Leverage The Role Of Your Clinical Research Associates (CRAs) To Support Successful Subject Recruitment And Study Conduct

Many companies are choosing to spend more time and resources on clinical trial monitoring and relationship building.  To achieve success, a company must work to change the perception of the sponsor-site relationship.  As a result, CRAs should begin to treat their sites more like customers so they can build better working relationships.

Benchmark best practices with a former Patient Recruitment Specialist from sanofi-aventis, as you learn how to empower your CRAs to liaise with study sites more effectively for maximum productivity.  While reviewing examples of opportunities where CRAs can be more involved in all aspects of the clinical trial process, you will learn:

• Practical ideas to improve site relationships – including tips for defining goals and expectations when discussing enrollment plans
• Benefits of better site communication
• Steps to ensure the ROI of territory development activities

Gretchen Goller, Director of Patient Recruitment
PRA INTERNATIONAL
Former Patient Recruitment/Compliance Strategist – Operations
SANOFI-AVENTIS US, INC.

9:30 a.m.

Using Mobile Technology To Improve Patient Recruitment Results

There is a well known need for clinical research technologies to ‘catch up with their patients.’  Mobile phones are a classic example of this issue, where the vast majority of trial participants have mobile phones and are using them to send/receive text messages. This offers an exciting opportunity for studies to use mobile phones (and text messaging, in particular) to accelerate recruitment and enrollment timeframes. 

United BioSource Corporation and Omniscience Mobile have partnered together on multiple clinical studies for various pharma sponsors in recent years.  Sharing these experiences, this session will demonstrate how text messaging can be incorporated in traditional patient recruitment advertising to drive improved results.  With a pragmatic eye for the key implementation considerations, this session will help you understand:

• Relevant market data on the use of mobile phones and text messaging
• Exactly how text messaging is incorporated in patient recruitment advertising
• Tracking ROI on text messaging as a response mechanism
• Using text messaging to track media spend ROI
• Detailed results from previous clinical studies
• Lessons learned during early implementations
• The type of studies and patient populations that are well-suited for incorporating this technology

Patient recruitment is one of the easiest (and most important) areas to use technologies preferred by study patients. Come learn how you can add this tool to your recruitment efforts and start achieving results immediately!

Tess Drahzal, Director: Patient and Physician Services
UNITED BIOSOURCE CORPORATION

Jeff Lee, CEO
OMNISCIENCE MOBILE

10:45 a.m.

How To Make Clinical Trials More Patient-Friendly: Insights From The World’s Largest Online Patient Community

Historically, knowledge of what motivates patient interest in research has been limited to reports from physician investigators or anecdotal feedback from CROs and other patient recruitment organizations.  With the rapid growth in individuals seeking health-related information online and the emergence of social media, opportunities to engage patients about the design of and participation in clinical trials has increased significantly.

MediGuard.org—a free medication monitoring service with over 2.5 million consented members in the US, UK, France, Germany, Spain, and Australia—regularly engages in direct-to-patient research activities including clinical trial feasibility, clinical trial recruitment, observational research studies, and compliance/adherence programs. 

This enlightening session will share key findings from survey results from over 2500 patients across 32 different patient protocol feasibility assessments. You’ll gain important insights into how you can design studies that are more acceptable to patients, including the:

• Variances in the levels of patient engagement and receptiveness to research based on their specific condition
• Factors correlated to patient interest in study participation and the significant drivers
• Importance of subject compensation in study interest
• Actions that can improve enrollment and patient retention

If you’re interested in hearing more about what your patients are saying and how to make your clinical studies more patient-friendly, then you won’t want to miss this session!

Elisa Cascade, MBA, Vice President, Global Operations
MEDIGUARD.ORG

11:30 a.m.

Using Social Media To Engage Patient Opinion Leaders To Advance Your Clinical Trials And Research

Patient communities rank among the most active and engaged groups in the social networking space.  Pharmaceutical companies and research teams can build more dynamic platforms by reaching out to key patient communities to help promote and review their current research objectives.

When looking to recruit new patients for clinical trials, these communities are often overlooked – but they should not be forgotten. Hear from an involved patient activist how your organization can create a strategic plan that will help you reach out to the appropriate patient community for your clinical trial.

• Discuss the ground rules for pharma sponsors and CROs interested in engaging Health Activists and patients online
• Explore the means for keeping patients active and engaged throughout the life cycle of your clinical research and into the product launch
• Provide examples of those who are effectively collaborating with their patient communities

Alicia Staley, Cancer Health Activist and Patient Expert
STALEY MEDIA SERVICES

Ann Bartlett, Diabetes Patient Expert
HEALTHCENTRAL.COM

Join a group of your colleagues for lunch with an informal discussion facilitated by one of our expert speakers. Take this opportunity to connect with others in a small, interactive group setting to network and brainstorm solutions to your most pressing recruitment and retention concerns.

1:45 p.m.

Innovative Technologies For Patient Recruitment And Engagement: A Panel Discussion On What You Need To Know

Patient recruitment is just one area that has seen advances due to new technology developments. Social media, mobile devices, and open source software solutions are increasing engagement and compliance levels that are imperative for clinical researchers to see a successful trial through to the finish.

A variety of new innovations will be showcased and debated in this lively forum. Take this opportunity to compare and contrast different technologies, firsthand, and get your most pressing questions answered in this lively, interactive forum.

Laura Dalle Pazze, Associate Director, Research Partnerships
THE MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH

Daniel Weddle, President & Founder
SITEAVAIL, INC.

Samuel Whitaker, Co-founder & CEO
GREENPHIRE LLC

2:30 p.m.

Afternoon Refreshment & Networking Break

2:45 p.m.

Third Parties And Clinical Trials: Who They Are And How To Involve Them For A Successful Trial

Human Subject is defined in the Common Rule as a "living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information." The FDA defines a Human Subject as “an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.” In certain types of research, it can be difficult to determine whether a third party (aka secondary subject) involved in a study – i.e. pregnant partners, newborns, caregivers, or family members – meets these definitions and therefore should be classified as a research subject as well.

It is important for both researchers and Institutional Review Boards (IRBs) to consider how a research design might focus on these individuals and the appropriate protections that may be needed, such as: incorporating third parties in the research design of the protocol, obtaining informed consent/authorization, data security and confidentiality protections, and considering the dissemination of hereditary genetic results. By understanding the role that third parties play in research, you will leave this session prepared to:

• Identify when partners, caregivers, and other third parties are research subjects under HHS and FDA regulations and guidelines
• Understand informed consent and HIPAA considerations for third parties
• Implement appropriate protocol language considerations from the
  perspective of an IRB

Deborah Holland, JD, MPH, CIP, Regulatory Attorney
QUORUM REVIEW IRB

3:30 p.m.

The Partnership To Accelerate Clinical Electronic Research (PACeR): A Collaborative Solution For Improving Clinical Trial Modeling, Patient Selection, Trial Management & Safety Surveillance

The goal of the Partnership for Advancing Clinical electronic Research (PACeR) is to increase the speed, quality, and efficacy of clinical studies, helping to provide patients with quicker access to new, treatments and life-saving medicines.  PACeR is achieving this goal by designing and launching an economically sustainable, electronic clinical research data network across New York State to more efficiently identify potential candidates for clinical research trials and manage their care. 

PACeR stands apart from other attempts to improve the clinical research process because of its inclusiveness and responsiveness to the needs of multiple stakeholders.  The Healthcare Association of New York State (HANYS) serves as a neutral partner and coordinator, bringing together multiple medical centers, health systems, community hospitals, patient representatives, pharmaceutical companies, health information technology companies, and others to engage in a multi-year collaborative.  The guiding principle behind this endeavor is the benefit to patients. Ensuring robust patient privacy and consent protections is paramount. 

In this fascinating session, you’ll learn how this forward-thinking collaborative can serve as a viable, practical model for other states, regions, and the nation, by developing solutions to relevant technical, legal, regulatory, economic, and operational issues of clinical studies. 

Gary Mallow, Director, Health Information Technology for Clinical Research
MERCK RESEARCH LABORATORIES

John Murphy, Head of Clinical Analysis
QUINTILES

4:15 p.m.
Chairperson's Recap: Key Takeaways And What To Do When You Get Back To The Office

We’ll recap the highlights of the past two days and ask you to share key insights and next steps with the group.