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Tuesday, February 7

7:30 am Conference Registration and Morning Coffee

 

ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS

Shared Session with Electronic Data in Clinical Trials 


8:15 Chairperson’s Opening Remarks

Ramita Tandon, Global Head of Late Phase Clinical Trials, PAREXEL International  

8:30 KEYNOTE PRESENTATION: Clinical Innovation and Pfizer’s Virtual Trial

Craig Lipset, Head, Clinical Innovation, Pfizer Worldwide Research & Development

The time, cost, and complexity of clinical trials today is largely unsustainable -- The future of clinical trials is dependent upon innovation. Mobile, health information technology, and telemedicine are just some of the key tools to enable clinical innovation. In 2011, Pfizer announced the launch of the “Virtual Trial”, a novel integration of these tools to enable a disruptive new clinical trial model. This session will provide an update on the Virtual Trial and share other exciting opportunities for clinical innovation.

8:55 Cancer Patients, Symptoms and Product Labeling - A Path Forward

Tom Hare Tom Hare, VP, Development Operations, Incyte Corporation 
Symptoms are common in patients with cancer. Symptom burden is a major indicator of disease severity, progression, and improvement. Despite the prevalence and importance of symptoms information about them is largely absent in trial data and drug labels. The optimal time to evaluate symptoms is during drug development as an integral part of well-controlled clinical trials. Careful attention must be given to instrument selection, development and establishing effective communication pathways with regulatory agencies in order to help insure a successful outcome. .

9:20 A Full System Approach to Electronic Data and Integration with the Patients’ EHR

John Parkinson, Ph.D., Head, GPRD, MHRA Medicines & Healthcare Products Regulatory Agency

Separate silos of CT and EHR data are not in the best interest of patients. A fully validated EHR is the way forward. Such a system enables many types of clinical trials.


 

9:45 Interactive Question and Answer Session with Speakers

10:00 Coffee Break in the Exhibit Hall

 

REGISTRIES AND OBSERVATIONAL STUDIES

10:40 Chairperson’s Remarks
David Parrish, Chief Business Architect, Digital Infuzion 

10:45 Current Challenges in Comparative Effectiveness Research (CER) and Future Directions in Registries and Observational Studies

Michael del Aguila, Ph.D., Senior Director; Head, Health Outcomes and Payer Support Group in US Medical Affairs, Genentech

How can we produce data that is both reliable and and relevant?  Evidence-Based Medicine (EBM) and hierarchies of evidence prefer randomized controlled trials (RCT), while Comparative Effectiveness Research (CER) emphasizes real world information.  This talk will describe the key issues and controversies in evaluating the quality and usefulness of evidence, give examples of key trends in evidence development and dissemination, outline a roadmap of possible future scenarios, and develop a conceptual framework for resolving the paradox.  The presentation will also discuss the value and future roles of various study types (registries and observational studies, adaptive trials and pragmatic trials, electronic health records) and emerging data sources (internet registries and social media); and the importance of rigor in study design, conduction, analysis and interpretation.

11:10 Strategic and Operational Challenges in Late-Phase Research and Observational Studies

Carmen Bozic, M.D., Senior Vice President and Global Head, Safety and Benefit-Risk Management, Biogen Idec




 


11:35 Developing Global Regulatory Strategy for Phase III/IV Studies in Emerging Markets

Helen EdelbergHelen Edelberg, M.D., Vice President, Regulatory Affairs (Consultant), Aptalis Pharma

A global regulatory strategy is critical to the success of registrational and postapproval clinical trials involving emerging markets. Global product development plans need to consider local regulatory requirements -- particularly, quality and stability testing, population pharmacokinetics, and local population enrollment -- as well as local and regional differences in clinical practice and standard of care. These requirements present unique challenges for those sponsors engaged in co-development or licensing in emerging markets.
 
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:25 Chairperson’s Remarks
David Parrish, Chief Business Architect, Digital Infuzion 

1:30 PASS and Registries in the EU and US: Are They Different?

Elleanor SegalEleanor S. Segal, M.D., Independent Biopharmaceutical Consultant

This talk will compare drug vs. disease registries by looking at two published programs and will outline the differences between a health authority required post-authorization safety commitment and a “nice-to-have” program, including a discussion of a few of the differences between EU and US regulatory needs.

 


2:00 Challenges of Orphan Disease Registries in the Post-Marketing Environment

Emma JamesEmma James, Senior Project Manager, Evidence-Based Medicine Center of Excellence, Genzyme a Sanofi Company

Orphan diseases provide a unique challenge in obtaining data to demonstrate a product’s efficacy, safety, and value. Increasingly, regulators are requiring disease registries be established as part of post-marketing commitments, while reimbursement authorities are also requiring evidence of long-term effectiveness. In such rare populations, registries may be the only way to capture longitudinal data on a sufficiently large cohort of patients to be able to draw meaningful conclusions; however, in an era of increasing post-marketing requirements and growing interest from a variety of stakeholders, there are practical challenges associated with implementation of these registries, and a continued need to evolve our thinking to adapt accordingly.

Sponsored by
OptumInsight 
2:25 Non Interventional Studies: Key Operational Considerations for Achieving Data Quality
Sharyn D'Souza, Ph.D., Vice President, Late Phase, OptumInsight
Non-interventional studies  are  increasingly being used to investigate comparative effectivess,  safety and cost-effectiveness under real world conditions as a result.  generation of valid  data is vital  to gain  broad acceptance of the results.  This presentation addresses  operational  considerations  for ensuring  quality data  through all phases of a study.


2:40 Refreshment Break in the Exhibit Hall

 

OPERATIONAL CHALLENGES IN PHASE IIIb-IV

Shared Session with Global Site Selection, Feasibility Assessment, Operations and Site Management


3:10 Chairperson's Remarks
Suzanne Collins, Director, Operations, Trifecta Multimedical

Sponsored by
bbk logo
3:15 When Enrollment is the True Priority, Which Feasibility, Site Selection and Site Support Methods Apply Equally in Registration and Post-Approval Studies?
Jaime Cohen, Strategic Planning, BBK Worldwide
Despite differences in physician and patient motivations to participate in these research efforts, registration studies and post-approval studies have a great deal in common when it comes to planning methods and recruitment priorities. In this session, we’ll assume that the “Last Patient Enrolled” metric is the most important one and explore the many ways in which study managers risk achieving this goal. As well, we will review recent findings from site surveys that uncover simple operational improvements that significantly improve enrollment.

Sponsored by
United BioSource
3:40 Is There Patient Recruitment in a Post-Marketing Study?
Tess Dorrier, Director, Patient Recruitment Strategies, United BioSource Corporation (UBC)
Observational research doesn’t mean recruitment tactics can’t be used to enroll patients in a study. There are many ways to access patients post decision to treat to enroll for a study. This presentation will address what works and what doesn’t, and considerations to help sites manage enrollment for registries and observational studies.

Sponsored by
McKesson

 

4:05 Success in Post-Market Studies Using an Innovative Direct-to-Patient (through the Pharmacist) Model

Carrie HurwitzCarrie Hurwitz, Corporate Strategy and Business Development, McKesson Corp.

We will present results from a recent case study of a large nationwide post-market study that was successful in finding and enrolling patients through community pharmacists using the McKesson StudyLink Program. We will discuss this proven new approach using a Centralized PI and Direct-to-Patient (through the pharmacist) model.


4:30 - 5:40 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 17: Understanding the Regulatory, Compliance and Risk Implications of Using Social Networking Sites

Moderator:  Eleanor S. Segal, M.D., Independent Biopharmaceutical Consultant

With the increased use of social networking sites such as Twitter and Facebook, patients, healthcare providers and payers are interacting with brands and communities in new ways. It is important to understand the implications of these new communication channels for your company.
• Understanding regulatory framework and FDA scrutiny/guidance
• Having an awareness of regulatory and compliance safeguards to minimize risk
• Addressing issues of patient-to-patient and subject-to-subject communication

TABLE 18:  Keeping Post Marketing Studies Top of Mind

Moderator:  Tess Dorrier, Director, Patient Recruitment Strategies, United BioSource Corporation (UBC)

• Raising awareness in medical community
• Site based recruitment and retention activities
• Activities to support patient retention and minimize lost to follow up

TABLE 19:  Safety vs. Marketing - Do You Have to Choose?

Moderator:  Christopher Milne, Ph.D., Professor, Associate Director, Center for the Study of Drug Development, Tufts University Medical School

• Public health and industry health: Aren’t these compatible goals?
• What are the root causes of distrust of marketing…off-label promotion, DTC advertising,  caveat emptor, etc.?
• How do you build confidence in your company’s capacity for and commitment to product stewardship? How can FDA programs help?

TABLE 20:  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 International 
Lollo Eriksson, Vice President GRO, Start, Feasibility & Clinical Informatics, PAREXEL  

• Understand 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 21:  How to Effectively Recruit Patients for Observational Studies through the Pharmacy

Moderator: Steve Hoffman, R.Ph., Senior Vice President & Chief Pharmacy Officer, McKesson Patient Relationship Solutions

• Identify challenges of patient recruitment for observational studies
• Discuss the advantages of patient recruitment using a centralized investigator, direct-to-patient (though the pharmacist) model
• Learn about new opportunities to engage with and pre-screen patients through their pharmacist, furthering “real world” experience with the drug and/or disease state

5:40 - 6:40 Welcome Cocktail Reception in Exhibit Hall



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Recommended Monday Afternoon Short Course 

EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Clinical Research 

 

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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