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Tuesday, February 5
7:30 am Conference Registration and Morning Coffee
8:25 Chairperson's Opening RemarksChristopher Milne, Ph.D., Professor, Director, Research, Center for the Study of Drug Development, Tufts University Medical School - Biography
8:30 Featured Presentation: Post-Marketing Study - A Common Tool for Safety, Outcomes and Comparative Effectiveness Research
Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc. - Biography
The presentation will discuss why and how a company should select the best suitable type of post marketing studies in support Safety, Outcomes, and Comparative Effectiveness research according to business needs. The presentation provides ideas for global thinking of post approval safety studies (PASS) that fulfill regulatory safety surveillance requirements worldwide, e.g., PMR and FUM, as well as the need for risk assessment.
8:55 Post-Marketing Calculus: Solving the Value Equation!
Christopher Milne, Ph.D., Professor, Director, Research, Center for the Study of Drug Development, Tufts University Medical School - Biography
Proving value for your product has never been more crucial or more challenging on a number of different levels. Organizational - companies have to rearrange internal resources and expand external linkages to create an effective market access function. Geographic - value is in the eye of the beholder and framing it must account for distinctly local perspectives. Stakeholder - companies must reach down to more granular levels within payer organizations and address a broader set of stakeholder concerns. Market - these are becoming increasingly segmented in both emerging and established markets and value must be titrated with patient access schemes.
9:20 Featured Presentation: Impact of CER on Drug Development
Dean Hakanson, M.D., Head, Health Economic & Outcome Research, US Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation - Biography
This presentation will review the important trends in comparative effectiveness research (CER) in the US. The US payer, public and commercial segments which make up our complex healthcare financing process, has embraced comparative effectiveness research. The Patient Centered Outcomes Research Institute (PCORI) will establish a national research agenda that will demand comparative data. This trend places significant demands on the pharma industry to generate data and evidence across the spectrum of RCTs, pragmatic trails, prospective observational trials (registries) and retrospective observational research. These trends are driving an evolution in drug development from a sole focus on the FDA to strategies that address payer needs and the assessment of value.
9:45 Understanding the Differences in Safety Monitoring for Post-Marketing StudiesMarsha Jones, Associate Director, Safety, REGISTRAT-MAPIThe ability to obtain important data to complete safety reports can be challenging. This presentation will discuss the type of data that is essential to completion of reports without requesting unnecessary information. Understanding which information is needed makes case processing improves: cost, time-management, and investigator relationships.
10:00 Coffee Break in the Exhibit Hall
10:40 Chairperson's Remarks
10:45 Post-Marketing Studies: A European Perspective
Colin Hayward, M.D., Head, Global Medical Affairs, Premier Research - Biography
Adding the European perspective with respect to post-marketing studies will allow individuals and companies to effectively plan into their development programs European PMS's that are fully aligned with US needs and help them to meet their safety and health outcome goals. This presentation will give an insight into European regulatory attitudes to post-marketing studies and address challenges in performing them and how they can be incorporated into a clinical trial program.
11:10 Simulating Registries and Post-Marketing Studies
Badri Rengarajan, M.D., Medical Director, Archimedes, Inc. - Biography
Registries and post-approval studies generate useful insights. However, they can be expensive and time-consuming. Simulation modeling with virtual patients and a virtual care delivery system allows us to conduct clinical exploration rapidly and cost-effectively with multi-year study results generated today at a fraction of the cost of a real-world trial.
11:25 The Role of Technology in the ‘Clinical Research-Real World’ Continuum
Judith Teall, Director, Clinical Excellence, Exco InTouch - Biography
With the ever more demanding and empowered 21stC patient being placed at the centre of clinical programmes, and the wealth of available data capture options, communication planning has become a critical activity. This presentation will explain how the utilisation of technology is not restricted to either clinical research or real world environments, and discuss how stakeholders can optimise its integration to capture high quality data, accurately assess adherence, monitor safety efficiently and improve overall health outcomes.
11:50 Lunch on Your Own
1:25 pm Chairperson's Remarks
1:30 Strategic Uses of Post-Marketing Epidemiology Safety Studies
David Lilienfeld, M.D., Principal, Write for the Pharm, LLC- Biography
Information afforded by epidemiologic studies in the post-marketing approval setting can address several safety issues for which no other means may be available to address. The role of epidemiologic surveillance in REMS programs is one example of such studies. Epidemiologic studies allow for the identification of those persons in the target population for whom the benefit-risk balance is not favorable. However, there are other safety-related roles that epidemiologic studies may play during life-cycle management. These roles include not only the assessment of the frequency of adverse events in the target population or confirming a safety signal, but also the type and extent of adverse events associated with off-label use, as well as identifying potentially new uses for the pharmaceutical associated with a better safety profile. Examples of these used of post-marketing safety epidemiology studies will be presented.
1:55 Developing a Comprehensive Pharmacovigilance Program
Steven Du, M.D., Ph.D., President and CEO Long Pharmaceuticals, LLC - Biography
2:20 Development of Post-Marketing Pharmacoepidemiology Study Assessing Long-Term Drug Safety
Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc. - Biography
With the passage of the FDAAA in 2007, there has been intense interest in pharmacoepidemiologic studies using large health care databases to conduct safety surveillance studies of marketed drugs. The presentation will describe the experience in developing a prospective, multi-national, multi-year database study to assess the drug safety with input from FDA commensurate to mechanism of action, biological plausibility, clinical trial evidence, and/or findings from studies of other similar agents.
2:45 Post Marketing Research: Sponsor, Physician and Patient Perspective
Kathleen A. Mandziuk, RN, Senior Scientific Affairs Director, Late Phase Services, PRA - Biography
3:00 Refreshment Break in the Exhibit Hall
3:40 Panel Discussion: Designing a Comprehensive Post-Marketing Plan: It Takes a Village
Moderator: Christopher Milne, Ph.D., Professor, Associate Director, Center for the Study of Drug Development, Tufts University Medical School - Biography
- Proving value for your product has never been more crucial or more challenging on a number of different levels.
- Organizational - companies have to rearrange internal resources and expand external linkages to create an effective market access function
- Geographic - value is in the eye of the beholder and framing it must account for distinctly local perspectives
- Stakeholder - companies must reach down to more granular levels within payer organizations and address a broader set of stakeholder concerns
- Markets - these are becoming increasingly segmented in both emerging and established markets and value must be titrated with patient access schemes
Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc.
Dean Hakanson, M.D., Head, Health Economic & Outcome Research, US Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
Colin Hayward, M.D., Head, Global Medical Affairs, Premier Research
Josephine Sollano, Dr.P.H., Head, Global Health Economics and Outcomes Research and Medical Communications, Pfizer Oncology Global Medical Affairs
4:30 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 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: Role of Late-phase studies in support of comparative effectiveness researchModerator : Bill Row, Senior Director, Clinical Operations Americas, Monitoring & Site Management, REGISTRAT-MAPI• Value Proposition: Retrospective vs Prospective design
• “Meaningful Use” and data collection implications
• Real-world Experience
TABLE: Post-Marketing Studies in EuropeModerator: Colin Hayward, M.D., Head, Global Medical Affairs, Premier Research• Objectives of performing post-marketing studies in Europe
• Knowledge of European legislation for post-marketing studies
• Designs of post-marketing trials vs Pre-authorisation studies.
TABLE: Post-Marketing Studies for Safety ResearchModerator: Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc.
TABLE: Developing a Company-Wide Post-Marketing PlanModerator: Josephine Sollano, Dr.P.H., Head, Global Health Economics and Outcomes Research and Medical Communications, Pfizer Oncology Global Medical Affairs
5:30 Welcome Reception in the Exhibit Hall
6:30 End of Day
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