8:00 a.m.
Registration & Continental Breakfast

8:30 a.m.

Chairperson’s Welcome & Speed Networking

This fun and fast-paced forum is designed to provide you with a unique and fun opportunity
to share your goals for this conference while getting to know your fellow conference attendees and their most pressing concerns.

David Heck, Business Development Director, Life Sciences
Lionbridge Life Sciences
Conference Chairperson

9:00 a.m.

Collaborating with Patient Advocacy Groups
to Increase Enrollment in Rare Disease Clinical Trials
BioMarin partners with rare disease patient advocacy groups to increase awareness of and participation in clinical trials.  Determining which advocacy groups to partner with and the extent of involvement is critical.

Case studies will be discussed on ways to incorporate patient voices throughout the drug development process, including online listening projects and patient advisory boards.   In addition, a case study on the use of social media to increase recruitment and discussion of the study among the patient community will be described. 

You will leave this session with new ideas on how to effectively collaborate with patient advocacy groups by:

• Identifying ways to build and maintain powerful partnerships with patient advocacy groups.
• Understand what patients are communicating about through listening projects
• Identifying ways to use social media to increase awareness and trial participation

Kim Mooney, MS, CGC Manager, Patient Adv
BioMarin Pharmaceutical, Inc.

9:30 a.m.

Idea Exchange: Questions, Feedback, Collaboration

9:35 a.m.

Strategies for Cost Effective and Efficient
Patient Recruitment

Traditional media has been overshadowed by new and more cost effective digital strategies for patient recruitment.  The question of how to spend your media budget to get the most qualified potential patients remains and has become even more complicated with the introduction of cutting edge digital and mobile technologies . How can you build a successful, engaging media plan to save time and money on patient recruitment?
Through real-life application, you will learn strategies and approaches to help you:

• Understand digital media and how to use it effectively to target patients for your trial
• Use Traditional media as a compliment, not a definitive solution
• Track media campaigns for optimization and effective ROI

Leslie Kipke-Ives, Sr. Manager Patient Recruitment Services
PPD, INC.

10:05 a.m.

Idea Exchange: Questions, Feedback, Collaboration

10:10 a.m.

Morning Refreshment & Networking Break

10:20 a.m.

Patient Engagement For Clinical Trials:
Common Challenges and Peer-to-Peer Advice

This is your chance to discuss with fellow attendees and speakers what your most pressing engagement, recruitment, and retention concerns are in clinical trials and what solutions you hope to gain during this training.  We will address the group’s list of issues and questions throughout the conference.  All participants will be encouraged to contribute to the discussions connecting and collaborating on hot topics around patient centricity.

10:50 a.m.

How to Leverage Clinical Trial Matching Technology to Increase Patient Awareness and Enrollment in Clinical Trials

BresatCancerTrials.org (BCT) was inspired by two breast cancer patients who in 1998 wanted to consider clinical trials as an option for care but were not referred by their oncologists. They were “engaged, empowered, and equipped,” but unlike today’s e-patients, frustrated by the absence of online resources available for health consumers. Thus was born BCT: an online clinical trial matching service for independent trial seekers like themselves.

Developed in collaboration with UCSF and NCI, BCT was successfully evaluated as a Bay Area research pilot and then launched as a non-profit, nationwide service in 2008.  In addition to trial matching, BCT provides consumer-friendly trial summaries and a Trial Alert Service that notifies users whenever new studies match their situation.  It currently lists over 500 breast cancer research studies and attracts over 6000 visitors a month.

Over the past 5 years, BCT continues to add content, improve navigation, and add features designed to broaden outreach. In this session, you will hear lessons learned from operating BCT as a consumer-oriented clinical trial matching service and the potential for adapting its underlying CTMatch technology for use in other settings and disease domains.

This patient-centric initiative will share the latest strategies for:

• Patient engagement: from consideration of trials to enrollment
• Overcoming barriers that prevent BCT users from enrolling in trials
• Designing a user-friendly navigator Portal for facilitated access to BCT
• Ensuring adaptability of CTMatch technology beyond breast cancer

Elly Cohen, Assistant Professor, Program Director, BreastCancerTrials.org
UCSF

11:20 a.m.

Idea Exchange: Questions, Feedback, Collaboration

11:25 a.m.

Morning Refreshment & Networking Break

11:35 a.m.

Leveraging Patient Communities for Clinical Trial Recruitment

Patients with specific medical conditions often band together online for information and support. Learn ways that clinical trial recruiters are leveraging such communities to attract patients to clinical trials via an examination of:

• Advantages of leveraging 3rd party pre-existing condition-specific communities versus creating and managing online communities on your own
  
• Options to effectively reach communities of patients:
  • Online
  • At the Pharmacy
  • Via Physician’s Offices
• Pros and Cons of database strategies versus just-in-time recruitment
  
• Patient perspectives on the value of clinical trials and the appropriateness of marketing them.

Dennis Upah, Executive Vice President, Enterprise Markets
Remedy Health Media

Ann Bartlett, Diabetes Patient Expert
HealthCentral.com

12:05 p.m.

Idea Exchange: Questions, Feedback, Collaboration

12:15 p.m.
Lunch On Your Own -- But Not Alone!

Join a group of your colleagues for lunch with an informal discussion based on a patient engagement hot topic. Take this opportunity to join others in a small, interactive group setting to network and brainstorm solutions to your most pressing patient engagement, recruitment and retention concerns.

1:45 p.m.

How Integrating Patient Advocates into the Research Continuum Will Expedite Clinical Trials
and Bend the Cost Curve Down

Ninety-four percent of patients told survey researchers at ResearchAmerica that their physicians never recommended a clinical trial to them. It is no wonder that clinical trials accrue between one percent and five percent of patients, depending on the therapeutic indication.  Unless we can come up with strategies to expedite patient entry into clinical trials, the pipeline--which would otherwise be robust and productive--will be jeopardized.

 Patient advocates can help and not hinder the biopharmaceutical industry by being integrated at every rung of the research continuum--from protocol design committees where we can help sponsors enhance and expedite patient participation in clinical studies while:

• Reducing "Screen Fails"
• Increasing patient compliance and medication adherence
• Decreasing the numbers of patients “Lost To Follow-up” due to disclosed clinical trial results in a fashion that is understandable to pharma’s target patient population

This session will explore how patients and patient advocates can benefit
pharma's bottom line by:

• Integrating their voices into the drug pipeline from the very beginnings of protocol design meetings to drafting clinical trial results
• Navigating molecular profiling and sequencing results for patients in order to best identify relevant clinical trials
• Advocating the reimbursement of molecular diagnostics and novel therapeutics.

Marcia K. Horn, President and CEO
(ICAN) International Cancer Advocacy Network

2:15 p.m.

Idea Exchange: Questions, Feedback, Collaboration

2:20 p.m.

How to Improve Subject Retention and Accuracy of Data for 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.  Consideration must be made with the patient population that is targeted and how the ePRO tools may be used to enhance subject retention.  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. 

This session will share key criteria for utilization of ePRO in a trial and patient considerations, including:

• Pointers for discussion  items and decisions to  be considered
• Engagement of the sites for using the ePRO in a clinical setting
• Criteria for adopting ClinRO in clinical trials and the advantages and disadvantages
• Potential impact on budgets and resourcing using ePRO and ClinRO

Elizabeth Kurkimilis, Senior Clinical Operations Manager
Celgene

2:50 p.m.

Idea Exchange: Questions, Feedback, Collaboration

2:55 p.m.

Afternoon Refreshment & Networking Break

3:05 p.m.

Collaboration For Patient Enrollment
To Optimize Patient Recruitment Spending

Only 6% of patients that respond to a recruitment advertisement end up enrolling into the study – for many reasons.  Unfortunately, the industry loses 94% of these highly motivated patients due to a lack of technology to match those patients to other trials that sponsor is conducting.

This session will review the Referral Plus™  program that programmatically matches patients who disqualify from one study to others they may qualify for using a proprietary geo-therapeutic matching algorithm.

The ReferralPlus program has expanded into an industry-wide collaboration of over 20 pharmaceutical companies and CROs to help optimize patient recruitment spend while improving the chances for patients to find studies they qualify for.

The Referral Plus™ program provides:

• Sponsors an opportunity to leverage patient recruitment budgets across multiple studies
• Patients a much higher probability of qualifying for a study
• Sites additional options to provide to patients

Case studies from the original three pilots will be presented showing significant reductions in cost per randomized patient and cycle times.

Lisa LaLuna, Sr. VP, Corporate Development & Innovation
ePharmaSolutions

3:35 p.m.

Building a Bridge between Central Recruitment and Your Sites for Optimal Patient Engagement

Sponsors invest a good deal of time, effort and resources into the selection of sites and yet it’s a common meme in the industry to expect failure in more than half. In fact, fifty percent of clinical research sites enroll one or no patients in their studies. (Pierre, "Recruitment and Retention". 2006) To supplement these efforts, sponsors turn to centralized recruitment and retention providers to fill in the gaps and accelerate enrollment.  But is this model working?  Not often.  The current model is broken, pitting centralized recruitment and retention one-size-fits-all strategies against the sites in an unhealthy competition to claim patient accruals. 

There is a better way.  In this presentation, you will examine how early planning and coordination between sites, sponsors, and the CRO can shift the model to one that embraces clear responsibilities and shared goals to reduce site failure and improve patient engagement for optimal recruitment and retention.

In this session, you will learn how to:

• Embrace a “no site left behind” mentality that encourages proactivity vs. contingency planning
• Employ a new model for providing holistic centralized support 
• Harness the unique strengths of sites and central recruitment vendors to optimize enrollment timelines and eliminate wasteful overlap in budgets
• Eliminate competition between central support and your sites to shift focus where it belongs: the patient

Angela Radcliffe, VP, Director Clinical Trials
Hudson Global

Deborah Tyler, Senior Clinical Study Manager
Takeda Development Centers America, Inc.

4:05 p.m.

Idea Exchange: Questions, Feedback, Collaboration

4:10 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

4:40 p.m.

Idea Exchange: Questions, Feedback, Collaboration

4:45 p.m.

How To Identify, Enroll and Retain Patients with Chronic Conditions

As the Baby Boomer population comes into the retirement age and our population increases in longevity, a greater number of patients are being diagnosed with chronic conditions such as Hepatitis C, diabetes, arthritis, and heart disease.  The pharmaceutical and biotech industries are working diligently on a number of clinical trials to improve treatment regimens for these and other chronic conditions and as a result, researchers are being called upon shift their thinking and create unique and effective patient-centric engagement and education tools to deliver to this ever-growing population throughout the duration of clinical trial process and beyond.

Through this session you will discover approaches to assist you with:

• Strategies for identification and engagement of your target patient population to ensure bolus recruitment
• Overcoming barriers to patient compliance and medication adherence
• Tips for creating effective retention plans

Jennifer Melione, Global Trial Optimization Specialist
MERCK

5:15 p.m.
Day One Wrap Up

5:30 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.