8:00 a.m.
Registration & Continental Breakfast

8:30 a.m.

Chairperson's Welcome & Presentation:
Building A Successful Recruitment Campaign Using A Balance Between Investigator Site Engagement And Patient Outreach

Gaining a full understanding of the impact patient recruitment efforts have on clinical trials has been an ongoing process involving more and more research professionals in both industry and academia.  Those who have been working in the field for some time have witnessed an evolution that continues to gain momentum.  The focus of efforts in the patient recruitment field has shifted and diversified rather significantly over the last decades from being driven by primary communication with the investigators to more creative and direct ways to reach out to potential subjects.

Blending investigator and patient engagement and motivation can be the key to a successful recruitment campaign for many clinical trials.  Of course, no one plan, strategy, or tactic is applicable to every clinical trial, but there are fundamental aspects that nearly every study should be based upon - - a recruitment plan, whether enrolling 10 or 10,000 patients, with milestones to measure success and full contingencies to employ when enrollment is off track.

Come explore the world of effective patient recruitment as you discuss how to combine strategies and tactics that involve both investigative site engagement and patient outreach.

• Achieving a balance between these key areas as driven by the patient population, countries being utilized, and many other factors
• Treating each trial individually - no two are alike
• Building a highly-tailored and specific plan that considers the use of the ever-growing amount of tools available in the industry through engagement, communication, and motivation of both your sites and patients

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

9:30 a.m.

Break-Out Blitz! Network And Discuss Your Challenges With Your Fellow Conference Attendees

This session will open the conversation by connecting you with other conference participants and gain greater understanding into many similar issues, concerns, and challenges that your peers are also facing. Become acquainted with your fellow conference attendees in this fun and fast-paced forum!

9:50 a.m.

Morning Refreshment & Networking Break

10:15 a.m.

How To Improve Patient Participation And Access Using Virtual Clinical Trials

Clinical trials are long and complex research studies that rely on the self-sacrifice of patient participation and data sharing. In recent years, a number of interesting trends in healthcare have emerged: patients are much more engaged in participatory medicine; they’re willing to share their health data to benefit public health and research; and they turn to the Internet for health information.

In June 2011, Pfizer announced plans for leveraging these patient trends to conduct the first-ever randomized clinical trial under an investigational new drug (IND) application where patients can participate entirely from home – no matter how far from the investigator site. As a Participatory Patient-Centered (PPC) clinical trial pilot, Pfizer expects the new model to provide new opportunities for patients to access clinical studies. As partners in the research, patients will have access to all study results and their own clinical data. Patients can then use this data to manage their own health and wellness, and even share the data with their doctors.

The pilot to test this new approach is “REMOTE” - - Research on Electronic Monitoring of Overactive Bladder (OAB) Treatment Experience - - the results of which will be compared to a previous brick and mortar trial for OAB treatment. By examining this innovative project, you will walk away with a number of ideas on how to:

• Use multimedia/video and online testing to secure patient consent
• Manage your patients in an entirely remote manner including shipping all blinded study medication to patients at their homes
• Save time and obtain better quality, more reliable data
• Increase patient compliance and lower withdrawal rates

Craig Lipset, Head of Clinical Innovation
PFIZER

11:00 a.m.

Best Practices In Patient Recruitment Outsourcing – Why The Patient Should Be At The Center Of Your Strategy

Patient recruitment firms continue to evolve and learn, gaining new decision support data and metrics along the way. However, pharma sponsors have not kept pace with regard to providing more sophisticated input to the outsourcing process.

This presentation will peel back the curtain on the prevailing conventions for patient recruitment outsourcing and offer you novel alternatives to improve your engagement efficiency. You’ll leave this session prepared to create a more collaborative environment where finally, the patient is placed at the center of the strategy.

• Dynamics of local adoption for recruitment tactics
• Alternatives for supporting strategy development
• The patient-centric model and how to apply it to your organization’s efforts

Joseph Kim, Director of Clinical Operations
SHIRE PHARMACEUTICALS LTD.

11:45 a.m.
Lunch On Your Own -- But Not Alone!

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.

1:15 p.m.

Building An Organizational Culture That Supports New Patient Engagement Technologies

Patient engagement technologies have been available for many years, but adoption of these innovative tools is still not widespread among clinical trials for many reasons.  One key area that will assist with increasing adoption levels is to build an organizational culture that supports new patient engagement technologies.  At its core, this is a change management exercise. Since change never happens easily, a methodology must be followed in order to achieve the desired result. Specifically, a clear vision must be set, the organization has to be aligned with that vision and all employees/members of the organization must be motivated to prepare for and adapt to the changes needed.

• Establishing a sense of urgency and creating a powerful guiding coalition
• Communicating the vision through all possible vehicles
• Developing a knowledgeable implementation team
• Empowering others to act and making the changes stick

Michael Burton, Senior Director, Site Management and Patient Recruitment
THEOREM CLINICAL RESEARCH

2:00 p.m.

How To Harness Social Media And The Internet To Recruit Potential ePatients: A Step-By-Step Process

Recent reports have shown that the Internet is currently the most popular resource for seeking health information -- even more so than consulting with medical professionals. It’s clear that the Internet is changing the way people think about their medical care. Consequently, pharma organizations can benefit from this strategic change by accessing a new, motivated pool of patients for clinical trials. This strategy can reduce patient advertising costs while reaching a larger and more focused audience quicker than more traditional recruitment methods. However, the lack of regulatory guidance in this area has impeded many companies from this approach.

Like other patient recruitment strategies, Internet-based advertising must be properly planned to effectively enhance patient recruitment and target motivated patients.

During this session, you’ll walk through LEO Pharma's journey of introducing social media into their recruitment strategies.  Examining each step – from vendor selection through program implementation – you’ll gain a greater understanding of the impact and potential roadblocks that can occur.  You’ll also acquire tips for success in your own electronic recruitment program, including how to:

• Identify which social media method would be most appropriate for your clinical trial
• Tap into patient advocacy blogs as well as physician and disease-specific websites
• Utilize search engine marketing – including geo-locating ad placement
• Implement tools to measure your results (i.e. Google Analytics)
• Recruit within the current regulatory guidance on using social media tools

Rodney Butt, Principal
HAMILTON MEDICAL CONSULTANTS GROUP
Former Head, Clinical Operations
LEO PHARMA INC.

3:00 p.m.

How To Increase The Accuracy Of Your Clinical Trials By Implementing Electronic Patient Reported Outcomes (ePRO) And Clinician Reported Outcomes (ClinRO)

The FDA issued guidance on the use of ePRO in Dec 2009. The decision to incorporate ePRO in clinical trials is multifaceted and must be considered carefully by the study team. Consensus by the team must be achieved prior to embarking on the use of ePro. Additionally, Clinician Reported Outcomes (ClinRO) is a hotly-debated industry topic and should be considered early in the design process and may influence how the data will be presented.

• Key criteria for choosing to use ePRO in a trial and the considerations that must be made
• Pointers on discussion and decisions that should be made
• Criteria for adopting ClinRO in clinical trials and the advantages and disadvantages
• The potential impacts of using ePRO and ClinRO (budget, time, manpower, etc.)

3:45 p.m.

Identifying And Engaging Rare Disease Patients Via Alternative Avenues: How To Develop Relationships And Work With Cooperative Groups, Advocacy Groups, And Key Opinion Leaders

The development of new drugs requires sponsors to evaluate the safety and efficacy of their compound in a given patient population. In most instances, sponsors are able to rely on data and existing published medical literature that effectively describe symptoms, management and outcome measures unilaterally or in comparison with other disease modalities or treatment options.

Orphan indications, or rare diseases, do not have the luxury of robust “best practices” and historical data that make the development and regulatory pathways less complex or clear.   The National Institutes of Health defines an orphan or rare disease to be one that affects less than 200,000 patients per year in the United States.  Consequently, developers of orphan drugs have to better understand their target indication, work closely with key opinion leaders (KOLs) and clinicians, work harder to reach their patients and educate regulators on disease state and the impact of their drug on patient outcomes. 

This session will discuss alternative avenues for identifying and engaging patients with orphan disease states to participate in clinical trials.  Regulatory and legal considerations will be discussed as well.  You’ll gain a broader understanding of the challenges to patient recruitment in specialized disease states and learn effective solutions to overcoming those challenges, including: 

• Leveraging alternative avenues to increase trial enrollment
• Understanding what these options are and what they aren’t
• Staying within the boundaries of legal and compliance regulations
• Managing relationships with KOLs

Lynn Sutton, RN, NP, Vice President Clinical Services
ALLOS THERAPEUTICS

4:30 p.m.

Academic Medical Centers And Clinical Trials - Can They
Peacefully Coexist?

Over the past decade, clinical trial work has migrated out of the traditional academic medical center into community-based practices as well as overseas.  Part of the driver of this change in site location has been the recognition that academic centers have been less efficient in getting trials activated, and academic physicians often less successful in recruiting and retaining subjects.  The migration of clinical trials away from academic centers has served to marginalize key opinion leaders and their participation in trial work.
 
The Albert Einstein College of Medicine and Montefiore Medical Center have made a concerted investment in re-engineering their infrastructure to support and attract trials to their center, physicians and patients. In the past year, they have assembled an office to offer support, guidance and help to principal investigators and their study coordinators.
 
In this informative session, through the experiences of The Albert Einstein College of Medicine and Montefiore Medical Center, you will hear about the efforts to increase the efficiency and effectiveness of clinical trial activation, management, and implementation, as you learn of the:

• Nature of the problem
• Re-design of processes and systems to support and streamline trials
• Approval and activation within an academic medical center
• Build out and design of an Office of Clinical Trials designed to facilitate and not obstruct successful trial completion

Barrett Katz, M.D., M.B.A., Executive Director, Office of Clinical Trials
MONTEFIORE MEDICAL CENTER
Frances DeJur Chair in Ophthalmology -&- Professor of Ophthalmology,
Neurology & Neurosurgery
ALBERT EINSTEIN COLLEGE OF MEDICINE

5:15 p.m.

End of Day One

5:20 p.m.

Networking Reception: Please Join Us!

We invite you to join us for a drink as you relax with your peers. All conference attendees and speakers are welcome to join us for this special opportunity to continue networking. Don't miss this chance to benchmark new ideas over complimentary drinks!

Sign up during the day for dinner with a group. Take advantage of New York City’s fine dining while you continue to network with your colleagues.

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