Archived Content
Day 1 | Day 2
Monday, November 5
7:15-8:05am Conference Registration
8:05 Chairperson’s Opening RemarksRandy H. Goodman, Ph.D., Manager, Pricing and Reimbursement Practice, Scientia Advisors
8:15 Re-Imbursement, Non-Imbursement, Pre-Imbursement, Pro-Imbursement and Un-Imbursement: A Brave, New World
Allan Korn, M.D., CMO & Senior Vice President, Clinical Affairs, Blue Cross and Blue Shield Association
Generating evidence through clinical trials defines utility, not value. Since most new (non me-too) pharmaceutical products create market monopolies, affordability is not foremost in the minds of drug developers. Those who finance the delivery of care must, however, remain focused on it. The evidence, and what we might do with it, will be deciding factors in determining the sustainability of the private-sector health care enterprise in the United States. Possible future scenarios will be discussed.
9:00 Sanofi Aventis and Medco to Bring Payer View to R&D
Sheikh Usman Iqbal, M.D., MPH, MBA, Senior Director & Head, Oncology, Global Evidence & Value Development (EVD), Medical Affairs, Global R+D, Sanofi
Teresa K. Wilcox, Ph.D., Senior Research Leader, Health Economics, United BioSource Corporation
10:00 Coffee Break in Exhibit Hall
10:30 Real World Evidence Development: Providing Clarity to Decision-Makers
Marcus Wilson, Pharm.D., President, HealthCore, Inc.
Rising healthcare costs coupled with disappointing outcomes of care are driving demand for more evidence of value and safety derived from real world experience. In addition, with the rapid proliferation of HIT deployment, electronic healthcare data are becoming more available. This presentation will focus on recent trends on real world evidence development and efforts to use these data for research.
11:00 What Are the Key Data Needs of Payers: A Country (US) Perspective
Amy Guo, Ph.D., Head US HEOR, Novartis Oncology
The US payer landscape is characterized by many players, with different evidentiary requirement and is rapidly evolving. The data required for regulatory approval may not be sufficient for reimbursement. The speaker will discuss the data needs of public and private payers, as well as the data needs of other key players with impact on payers. The speaker will also discuss potential actions before and after a product launch to include country input into the global clinical development program.
11:30 Policies Surrounding the Role of Government in Pharmaceutical Access and Reimbursement
Robert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.
12:00pm Advancing Real World Evidence with Health IT InnovationChristopher Jones, Ph.D., Vice President, Health IT Strategy, Digital InfuzionAs the life sciences industry balances simultaneous challenges of cost reduction and R & D expense with new medical advances such as gene sequencing, there are risks and opportunities emerging in real world, data-driven knowledge. This talk will look at some of the new models and health IT innovations that can help re-invent notions of "evidence" beyond RCT and other traditional publication methods.
1:25 Chairperson’s Opening RemarksLarry Z. Liu, M.D., Ph.D., Senior Director, Global Health Economics & Outcomes Research Market Access, Pfizer Primary Care BU
1:30 Accelerating Real World Data into the Development Process
David Recker, M.D., Vice President, Clinical Development, Takeda
While the traditional approach to drug development has been to follow accepted scientific practice of holding as many variables as possible constant and then assessing the variable of interest, RCT’s need to better incorporate the variability associated with the real world while trying to maintain scientific validity as much as possible.
2:00 The Learning Healthcare System: Producing Evidence in the Course of Delivering Usual Care
Louis Fiore, M.D., Executive Director, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Department of Veterans Affairs
Clinical Effectiveness Research that is research designed specifically to inform healthcare systems (including comparative effectiveness and cost effectiveness research), uses the healthcare delivery system itself as its own natural laboratory. This presentation will explore embedding clinical effectiveness research in the healthcare system using the Department of Veterans Affairs ‘Point-of-Care Research Program’ as a model.
2:30 Use of Real World Data for Comparative Effectiveness Research: An Example of Lipitor Studies
Larry Z. Liu, M.D., Ph.D., Senior Director, Global Health Economics & Outcomes Research Market Access, Pfizer Primary Care BU
Lipitor is probably the most used medication by millions of patients across the globe. Its rich, real world experience has offered great opportunity to conduct comparative effectiveness research as required for access and reimbursement decisions.
3:00 Panel Discussion: Clinical Trials to Meet Reimbursement Evidence Platform (Sponsorship Opportunity Available)Moderator: Douglas J. Moeller M.D., Medical Director, Claims Performance & Advanced Diagnostics Management, McKesson Health Solutions
Do conventional clinical trials still makes sense for therapeutics? For diagnostics?
Clinical Validity (the treatment works) vs clinical utility (how good is good enough)?
Are peer reviewed journals still the Gold Standard or does other evidence pass the test?
How do we properly publicize the evidence that we have?
Can concurrent clinical trials be developed via that Internet, for special interest groups (e.g. muscular dystrophy)?
Panelists:
David Recker, M.D., Vice President, Clinical Development, Takeda
Larry Z. Liu, M.D., Ph.D., Senior Director, Global Health Economics & Outcomes Research Market Access, Pfizer Primary Care BU
Sheikh Usman Iqbal, M.D., MPH, MBA, Senior Director & Head, Oncology, Global EVD, Medical Affairs, Sanofi
3:45 Refreshment Break in Exhibit Hall
4:15 Interactive Breakout Discussions
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest to them and become an active part of the discussion at hand.
Topics:
Working with Government Agencies on Achieving Your Reimbursement GoalsRobert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.Use of Real World Data for Comparative Effectiveness ResearchLarry Z. Liu, M.D., Ph.D., Senior Director, Global Health Economics & Outcomes Research Market Access, Pfizer Primary Care BU
A Payer and a Pharma Company: is Collaboration Possible?S. Rebecca Chiappinelli, RPh, Director, Business Development, Prospective Effectiveness Research & HEOR, HealthCore, Inc.
5:15 Welcome Reception in Exhibit Hall
6:00 End of Day
6:00 - 9:00 pm DINNER SHORT COURSE*
Systems for Evidence Creation and Evidence Dossiers for Payers
Randy H. Goodman, Ph.D., Manager, Pricing and Reimbursement Practice, Scientia Advisors
Grant Bagley, M.D., J.D., HillCo PartnersThis course is designed to provide participants an overview of the topic of effective evidence generation, dossier production, targeted evidence materials, evidence submission and dissemination to key stakeholders for successful product commercialization in North America.
The presentation will convene basic concepts and fundamental understanding of the key terminology and issues involved in evidence review, market access, product pricing, and coverage policy decisions as well as the emerging principles of demonstrating high medical-value and clinical comparative effectiveness.
Areas to be discussed will include the various methods and tools to document unique product value(s); role of the patient stratification (e.g., differential clinical benefit, sub-classification, pharmacogenomics, etc.) and the attributes of evidence platforms that can assist with coverage and payment decisions.
Finally, in the context of health care and payment reform a review of the wider policy issues will be addressed.
* Separate registration required
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