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Day Two - Thursday, November 30, 2006
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8:30 Chairperson’s Opening Remarks
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8:40 Strategy in the Age of Risk Management
Kimberly Thompson, Associate Professor of Risk Analysis and Decision Science, Harvard School of Public Health and MIT Sloan School of Management, and Author of ‘Risk in Perspective’
This presentation will introduce the age of risk management. Offering both humor and insights, the presentation will address key issues of strategy relevant to leaders in the biopharmaceutical industry and frame the choices and trade-offs that leaders must manage to promote growth and success for the industry. This presentation will arm participants with an understanding of several key concepts required to effectively manage risk: uncertainty, variability, and time. It will stimulate discussions about how the biopharmaceutical industry can help to better put risks in perspective, motivate the need for investment in improved risk communication by the industry and individual companies and leaders, and offer some tools and suggestions.
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9:30 The Importance of Routine Post-Marketing Surveillance
Robert G. Sharrar, M.D., M.Sc., Executive Director, Clinical Risk Management & Safety Surveillance, Merck & Co., Inc.
Product safety has always been of concern to pharmaceutical companies. Because of the increased emphasis on new risk management activities such as data mining, observational epidemiologic studies, risk management plans, and risk minimization action plans, some companies under utilize the data that is collected by the passive, spontaneous reporting system. This session will discuss the limitations, strengths, and utility of the spontaneous reporting system.
- Understand the limitations and strengths of the spontaneous reporting system
- Learn how to use the system to identify and collect data on rare adverse events that are not seen in clinical trials
- Learn how to use the data to evaluate reported adverse experiences
- Learn how to collect data on drug use in individuals who were excluded from clinical trials
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10:15 Networking Coffee Break
(Sponsorship Available)
10:45 Shifting the Paradigm from Post- to Pre-Approval Drug Safety: Approaches and Processes to Reduce Risk
Lucette Doessegger, M.D., Drug Safety, Global Head Licensing and Early Development, F. Hoffmann-La Roche Inc.
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STUDY |
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11:30 Pandemic Influenza Vaccines and
Pharmacovigilance: What to Expect in a Pandemic Situation?
Patrick M. Caubel M.D., MBA, AVP, Head of Pharmacovigilance North America, sanofi-pasteur
Routine pharmacovigilance practices will not be applicable to a pandemic situation. There is a need to re-focus on the most critical tasks:
- Risk monitoring and threat assessment
- Strengthening preparedness including developing relevant tools and guidelines
- Ensuring effective communication among stakeholders (manufacturers, regulatory agencies, public health partners and the public)
- Providing scientific opinions on safety evaluation and risk management
In a pandemic situation the level of
required safety data needs to be
redefined. This common agreement between industry and
regulators will
have a huge impact on resource planning for pharmacovigilance
activities.
- Learn the specificities of vaccine safety
and pharmacovigilance
planning
- How to prioritize risk assessment
activities in a pandemic
situation
- How to design innovative approaches to
vaccine safety
monitoring
- How to establish crisis co-ordination
internally and develop key
partnerships
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| 12:15 Lunch on Own or Luncheon Workshop
(Sponsorship Available) |
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STUDY |
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1:45 Pharmacogenetics a Key Tool in Pharmacovigilance
Andrew Rut, M.D., Lead Physician and VP Global Safety & Pharmacovigilance, GlaxoSmithKline
The human genome project has completed recently and facilated the development of high-throughput technologies for genetic analysis. This talk will describe how to apply genome science to deliver safe and effective medicines to patients. It will cover the successes in this area, the criteria for application of pharmacogenetics to safety questions and how the regulatory environment is responding to these challenges.
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2:30
Networking Refreshment Break
(Sponsorship Available) |
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3:00 End-to-End Safety Signal Detection and Management Program: Providing Disciplined Flexibility to an Inquisitive Mind
Atsuko Shibata, M.D., Ph.D., MPH, Director, Global Safety, Amgen Inc.
Proactive pharmacovigilance through a product lifecycle has been touted as a future direction for drug safety. It is a chal lenge to codify and standardize an act of safety signal detection - whether it means a traditional clinical review of case series or an application of advanced statistical methods for large-scale data mining - and subsequent activities of data analysis and decision making; this is due in part to the relative infancy of the field and absence of clear regulatory requirements unlike for individual case report processing. This presentation will describe key elements of a future-state signal detection and management program, which will be integrated into a larger context of risk management and minimization. The audience will learn:
- Importance of putting a signal detection and management program in a context of risk management and minimization
- Key functionalities of a successful signal detection and management system
- Operational considerations for building an effective signal detection and management program
- Power of cross-fertilization between business process development and technological advances
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Special Cross-Functional Presentation from Benefit Risk Management and Portfolio Management Departments |
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3:45 Applying Decision Analysis Methodology to Signal Triage
Bennett Levitan, M.D., Ph.D., Associate Director, Portfolio Planning, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chuen Yee, M.D., Senior Director, Surveillance, Epidemiology and Biostatistics, Benefit-Risk Management, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Drug surveillance is the systematic collection and analysis of adverse events (AEs) with a focus on identification and evaluation of safety signals from postmarketing data. These activities are critical for proactive risk identification and assessment. One of the most notable challenges to surveillance is to effectively review a very large volume of adverse event reports and determine which reports are prioritized for further investigation.
The Benefit Risk Management and the Portfolio Management Departments collaborated to develop a multi-attribute model to systematically prioritize AEs for investigation. We identified three key objectives that physicians consider during triage: AE novelty, strength of supporting evidence, and medical impact. We honed a large list of potential inputs to eleven key AE properties grouped into these objectives. Early test results showed the special attention physicians give to confounding by treatment indication, presence of reports of positive rechallenge and expectedness of an AE. With repeat testing of a revised model, we found good correlation between model and physician rankings. We expect this model will increase efficiency and reproducibility in signal triage, as well as provide greater transparency and a means to document decisions.
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4:30 Executive Forum Closes |
For more information, please contact:
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute
Phone: 541-665-1236 E-mail: mlieberman@pharmaseries.com
For exhibit and sponsorship information, please contact:
Laura Ames, Cambridge Healthtech Institute
Phone: 781-972-5479
Email: lames@healthech.com
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