Track 2
Thursday, March 8, 2012
Session 1
Patient Advocacy: The Key to the Next Evolution of Clinical Development
10:00AM – 11:15AM
The sleeping giant in clinical development is the patient, both as the crucial resource in clinical trials and as a previously under-utilized source of clinical/molecular data and biospecimens. Increasingly, product innovators are viewing patients as full partners. Novel collaborations with patient advocacy groups – who have access to large numbers of patients with a particular disease, who are motivated to drive and accelerate research, and who can bridge the silos of academe and industry – are emerging. Patient groups can also be supportive to the development of new models, such as adaptive clinical trials, that have the potential to produce better clinical outcomes in a shorter time frame. This session will explore the pro-active role of advocacy groups, how these types of collaborations are taking shape, how they might fuel a new generation of clinical development, what is needed to harness the potential of all the data, and how to avoid some of the common pitfalls.
Moderator
Craig Martin
CEO, Feinstein Kean Healthcare
Panel Speakers
Nicole Boice
President & Founder, RARE Project
Elaine Chiquette, Pharm.D., BCPS
Director, R&D Strategic Relations, Amylin Pharmaceuticals
Robert McBurney
CEO, Accelerated Cure Project for Multiple Sclerosis
William Tulskie, Ph.D.
Chief Executive Officer
HealthCare IT., Inc.
Session 2
Ten Tips to Accelerate Clinical Trials and Do Them Well
11:45AM – 1:00PM
In order to expedite the speed with which clinical trials are completed, it is critical to have a solid foundation for measuring and tracking where key improvements in process and efficiency can be made. There are general areas where sponsors can improve the speed of clinical trial completion, for example: decreasing time for subject enrollment and recruitment, decreasing site contracting time and speeding up site initiations. In this cost constrained environment, however, there is a cost benefit sponsors are willing to accept in order to save time and improve clinical trial performance. Due to the cost of making improvements, it is important to have key processes in place for identifying where changes can have the biggest bang for the buck. Processes for identifying key changes include:
- Developing a balanced scorecard for selecting the right sites and investigators
- Key criteria for streamlining the feasibility process
- Establishing enrollment forecasting methodology
- Optimal incorporation of feasibility and subject enrollment
Once processes such as these are established, key areas can be identified for improvement. This approach has the benefit of decreasing sponsor expense by honing in on specific areas of improvement while accelerating trial performance and efficiency.
Moderator
Richard Malcolm, Ph.D.
CEO, Acurian, Inc.
Panel Speakers
Devin Trejo
Feasibility and Patient Recruitment Manager, Amgen, Inc.
Jeffrey Bacha
CEO, Del Mar Pharmaceuticals
William Schmidt
Vice President, Clinical Development, CG Pharmaceuticals
Darren Hart
Vice President, Clinical Operations, Elan Corporation, plc.
Nancy Pecota
CFO, Aradigm Corporation
Session 3
Emerging Issues in the Conduct of Global Clinical Trials
2:45PM – 4:00PM
Join this dynamic panel as we discuss the issues associated with the conduct of clinical trials outside the US, in particular, in emerging jurisdictions. Topics include: Challenges in managing a global trial; whether and how to use CROs, risks and rewards of conducting trials in China, India, Russia and other emerging jurisdictions; recruitment, cost and time to site initiation; special challenges for virtual or smaller biotechs, including management of CMO and CROs and addressing pressures of financing sources.
Moderator
Maureen Bennett
Chair, Global Life Sciences Group, Squire Sanders
Panel Speakers
Dana Blanton Johnson
Senior Counsel, BioMarin Pharmaceutical Inc.
Mary S. Newman
Senior Vice President, Regulatory Affairs & CMC, SarCode Bioscience, Inc.
Stacie S. Switzer
Assistant General Counsel, Takeda Pharmaceuticals North America, Inc.
Jason H. Staples
Senior Counsel International Legal Operations, Abbott
Session 4
Modernizing our Industry: Developing the Clinical Trials of the Future
4:15PM – 5:30PM
The average drug costs over a billion dollars to develop, and takes more than ten years to get from the bench to the patient. Without question, the costliest, most time-consuming part of drug development is the process of clinical testing, however, most clinical trials are conducted in much the same way that they have been for the last 50 years. Could the cost of conducting clinical trials be reduced? Could we speed up the time in which it takes to get a drug through clinical testing? And, is it possible to design better clinical trials so as to avoid costly late-stage failures? New technologies and approaches now make the answers to all of these questions a resounding “yes”. This panel will focus on the future of clinical trials and what is being done to modernize the process of drug development. Panelists will discuss new recruiting techniques, mobile health technologies for remote patient monitoring, innovative trial designs and industry-wide consortiums that will ultimately revolutionize the way we conduct clinical trials, reducing costs and speeding drug development.
Moderator
Adrian McKemey, Ph.D.
Practice Leader, Product Development and Commercialization, Quintiles
Panel Speakers
Sheila Babnis
Clinical Operations & Innovation, Genentech/Roche
Brad Jacobs, M.D.
Senior Vice President, Mytrus
Andreas Koester, M.D., Ph.D.
Vice President Clinical Trial Innovation & External Alliances
Janssen Healthcare Innovation, a Janssen Pharmaceutical Company of Johnson & Johnson
Lisa La Luna
Senior Vice President, Corporate Development & Implementation
ePharmaSolutions (ePS)
