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Tuesday, February 7

7:30 am Conference Registration and Morning Coffee

 

ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS 

Shared Session with Managing Post-Marketing Studies (Phase IIIb-IV) and Registries 


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 HareTom 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, 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


10:40 Chairperson’s Remarks
Ramita Tandon, Global Head of Late Phase Clinical Trials, PAREXEL International   

10:45 EDC and Beyond – eXRO

Adrian HsingAdrian Hsing, Senior Director, Clinical Operations, Elan Pharmaceuticals

EDC has brought tremendous benefits for clinical trials: improved quality, shortened timeline and ultimately lower cost. However, the water remains unchartered in the world of clinician reported outcomes. This presentation describes the dichotomy of benefits and risks of electronic data collection for clinician reported outcomes, as well as the rationale and process in implementing electronic data collection for clinician reported outcomes.

 

11:10 Clinical Research Investigative Sites and the Use of Electronic Health Record Systems: How to Help Sites Help Themselves

Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.

This session will review the practical considerations for clinical trial sites using EHRs, including the benefits of the EHRCR Functional Profile. The document is intended as a practical guide to assist clinical research site personnel in: Understanding and complying with regulations when participating in clinical research; Selecting or upgrading an EHR system to hold data which could potentially become source data to support regulations applicable to drug or medical device clinical trials or development activities; Identifying best practices in implementing and maintaining an EHR system, especially if it may hold data that could become source for clinical trials; and Clearly differentiating system-supported requirements from requirements that must be met through site processes.

Sponsored by
OmniComm
11:35 A Beginner’s Guide to Web ServicesKeith Howells

Keith L. Howells, Senior Vice President, Product Development, OmniComm

Most clinical research applications are now outsourced, but we still need to share data between them. Conventional integration strategies via batch loading no longer work, because the applications are in physically separate data centers. The new strategy is to share data over the internet using web services. This session will provide an introduction to how web services work and give real-world examples, such as synchronizing enrollment data between an IVRS and EDC.

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

 

INTEGRATING SYSTEMS AND SOLUTIONS 

1:25 Chairperson’s Remarks
Keith L. Howells, Senior Vice President, Product Development, OmniComm 

1:30 Incorporating and Integrating the eClinical Systems and Practices of Two Organizations: Lessons Learned in the Latest Set of Mergers

Timothy JoyTimothy Joy, Director, Global Clinical Data Services, Pfizer, Inc.

This presentation will feature strategic steps and key lessons learned during the merger between Wyeth and Pfizer. The audience will learn about the two year effort to consolidate and integrate e-clinical data and systems with the least amount of impact on study teams and Investigator sites.

 

2:00 A Medical Data Portal Surfacing Multi-Source Content and Visualizations

Catherine Celingant, Senior Director, Medical Systems Innovative Technologies, Millennium: The Takeda Oncology Company

To enhance drug development efficiency, Millennium’s Medical Informatics team and R&D stakeholders delivered a portal with multi-source content that is able to provide clinicians with advanced visualization capabilities. We will review the technologies utilized, benefits realized, lessons learned and next steps.


Pharmapros2:25 Next Generation Trial Management: Integrating Clinical & Operational Data

Brion Regan, Head, Strategic Development, PharmaPros Corporation

This presentation will focus on the need for harmonizing clinical and operational data to streamline the management of clinical trials. Emerging web-services capabilities are enabling true best-of-breed solutions that can be implemented quickly and efficiently through Software-as-a-Service models.

2:40 Refreshment Break in the Exhibit Hall


3:10 Chairperson’s Remarks

Keith L. Howells, Senior Vice President, Product Development, OmniComm 

3:15 Case Study: Lessons Learned from an EDC Implementation at a Large Academic Cancer Center

Marina Nillni, EDC Program Manager, Dana-Farber Cancer Institute

This presentation will describe why Dana-Farber/Harvard Cancer Center (DF/HCC) decided to implement an EDC program for its intramural clinical trials program, how it went about selecting a solution, and its approach to implementation. It will also describe the challenges and benefits of the program 6 years from its initiation. The perspective is that of an academic medical center, so DF/HCC’s EDC experience both as a site and sponsor will be highlighted.

3:45 Optimizing the Design and Conduct of Clinical Trials via Electronic Healthcare Data

Aaron Kamauu, M.D., M.S., M.P.H., President, Anolinx LLC

Secondary use of healthcare data as real world evidence has become a forefront for clinical research. This presentation will describe approaches to effectively leverage rich sources of electronic healthcare data for a variety of drug development activities. Specific examples will include: gaining valuable insights from healthcare data for protocol design optimization, the use of patient geographic distribution maps to support site identification, and results of EHR-based patient recruitment at clinical trial sites.

4:05 Sponsored Presentation (Opportunity Available)

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 1:  EHR for Clinical Research in the USA and Europe

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

• Validating - validated EHR data
• Obtaining tight valid coding
• Point of care randomization

TABLE 2:  EDC for Clinical Research at a Large Academic Center

Moderator:  Marina Nillni, EDC Program Manager, Dana-Farber Cancer Institute

• Differences between an AMC and a Pharmaceutical company when implementing an EDC solution
• Challenges to overcome: user adoption, investigator participation, trials volume and lifecycle
• Benefits of EDC for an AMC

TABLE 3:  EHR and Clinical Research Sites: Benefits and Pains

Moderator: Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.

• Implementing and maintaining an EHR system
• Differentiating system-supported requirements from trial/site processes requirements
• Selecting or upgrading an EHR system  

TABLE 4:  Integrating Applications through CDISC ODM

Moderator: Brion Regan, Head, Strategic Development, PharmaPros Corporation

• Basics of Integrating 2 applications
• The need for vendor extensions to the ODM
• Real-world Experience

TABLE 5:  Practical Experiences in Producing SDTM Data Sets

Moderator: Keith L. Howells, Senior Vice President, Product Development, OmniComm

• Mapping tool or programming?
• How long does it take?
• Real-world Experience

TABLE 6: EDC and Medical Data and Investigator Portals

Moderator: Catherine Celingant, Senior Director, Medical Systems Innovative Technologies, Millennium: The Takeda Oncology Company

• Differentiating in-house vs. external-facing portals
• Strengths and challenges of both types of portals
• The role of medical data portals in in-house medical data review

TABLE 7: EDC System Mergers Provoked by M&A

Moderator: Timothy Joy, Director, Global Clinical Data Services, Pfizer, Inc.
 

 

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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