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Day Two
Wednesday, November 14, 2007
7:30 am Breakfast Workshop or Morning Coffee
(Sponsorship Available. Contact Arnold Wolfson at 781-972-5431)
8:30 Chairperson’s Opening Remarks
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KEYNOTES |
| 8:45 Proactive Risk Management – Philosophy, Strategy & Tactics |
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J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy, Purdue Pharma L.P. |
| Proactive Risk Management requires regular assessment and minimization of risks associated with the products that comprise
their portfolio. The long-term view of risk requires these be done throughout a product’s life-cycle and, in the case of drug products that are subject to volitional misuse, an approach that goes beyond passive surveillance and seeks information on populations that were never intended to have the product. An integrated approach within the company is key, requiring coordination from manufacturing, through the supply chain, to the patient. |
| 9:30 Decreasing Liability and Improving Brand by Employing a Proactive Communication and Risk-Management Strategy |
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Vikram Dev, M.D., Head, Drug Safety, AstraZeneca |
- Meeting patients’ demands for complete openness of drug safety information
- Educating an engaged patient and provider community on products’ benefits and risks
- Strategies to decrease liability, improve brand and better serve patients
- Approaches for communicating risk information to patients and providers
- Employing a broad risk communication campaign using multiple media, registries, patient advocacy groups, and online, two-way communication with patients and providers
- Supporting enrollment, education, reporting, and effective outcome measurement through online registries
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10:00 New Approaches in Risk Communication, Labeling and Packaging to Optimize Medical Product Benefit while Minimizing Preventable Harm
- Devising and proposing Risk Management Plans (RiskMAPs) as a condition of product approval
- Best-practice guidelines for implementing risk management plans that guarantee efficient safety standards
- Understanding strategic, legal and regulatory aspects of safety within a drug’s overall profile
- Approaches for communicating risk information to patients and providers
- Taking a proactive and preventative approach to damage control
10:30 Networking Coffee Break
| 11:00 am The Other Side of the Benefit-Risk Ratio: Outcomes Research as a Means of Demonstrating Product Benefit |
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Peggy Schrammel, Executive Director, Late Phase Development, PharmaNet |
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Donald B. Chalfin,
M.D., MS, FCCP, FCCM, Associate Professor, Epidemiology and
Population Medicine, Albert Einstein College of Medicine and CSO, Analytica International |
Much discussion has centered on quantifying and conveying to patients the risks associated with the use of new therapies. Single measures of risk are difficult to develop and their meaning can remain ambiguous to patients. The field of outcomes research has refined a number of methods for quantifying and conveying product benefits to patients, providers and payers. This session will provide an overview of some of these methodologies and illustrate how using these measures of product benefit can assist both health care practitioners and patients alike in making better treatment choices. At the conclusion of this session, attendees will be able to:
- Understand the difficulties of conveying product risk in a meaningful way to patients
- Identify measures of product benefit that have been refined by the outcomes research community
- Learn, through case studies, how a wider recognition of these methodologies could assist in clinical decision making
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| 11:30 Practical Thinking Process in Selecting Safety Studies to Support Post-Marketing Safety Surveillance and Risk Assessment: Balance Feasibility, Cost, and Scientific Rigor |
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Sean Zhao, M.D., Ph.D., Executive Director, Global Safety, Amgen Inc. |
- Fulfilling post-approval safety commitments (PASC) and supporting risk management plans
- Confirming identified safety signals
- Determining public health impact of safety issues
- Studying pattern of utilization and determining background rate of safety observations
- Describing natural history of disease after a new product is introduced into the market
- Major considerations of selecting safety studies and advantages and disadvantages of commonly used study methodologies, including:
- Open label extensions
- Post-clinical trial follow-up
- Safety clinical trials
- Large simple safety studies
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- Observational studies
- Registries
- Prospective/retrospective database analysis
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| 12:00 Embracing the Shifting Paradigm from Post- to Pre-Approval Safety |
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John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. |
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J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy, Purdue Pharma L.P. |
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Judith M. Sills, PharmD, Vice President, Medical Safety Operations, Integrated Medical Safety, Novartis Pharmaceuticals Corporation |
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Sean Zhao, M.D., Ph.D., Executive Director, Global Safety, Amgen Inc. |
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Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval, Covance, Inc. |
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Uwe Maennl, Vice President and Global Head of Pharmacovigilance, PAREXEL |
12:30 Luncheon and Strategic Solutions Presentations
(Sponsorships available)
| 1:45 pm Cutting-Edge Techniques for Risk Assessment: Analyzing and Reporting Data |
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William L. Holden, M.D., Vice President, Pharmacovigilance & Global Head, Pharmacoepidemiology, sanofi pasteur |
- Utilizing legacy data to enable better decision making
- Maximizing the effectiveness of signaling programs
- MedDRA and its application to data mining/risk-benefit analysis
- Data mining techniques for analyzing and classifying signals
- Applications, limitations, and analysis of safety databases and mining
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| 2:15 A Globally Usable Risk/Benefit Management Tool |
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John Parkinson, Ph.D., Head, General Practice Research Database (GPRD), MHRA |
Risk Management Plans are now required by a number of regulatory authorities and a natural desire by the industry is that one plan, perhaps with some minor modification, will suffice. A data analysis hypothesis strengthening methodology has been developed that can take streams of electronic health data, exposure and events, from one or a number of countries and provide absolute, risk and benefit outputs, stratified as required. This tool and topic are timely and important because:
- The risk management tool box has until now almost been empty
- The pharma industry have stated they want a global approach
- The pharma industry want to deal with risk and benefit as a whole
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2:45 Networking Coffee Break
| 3:15 Leveraging Drug Registry Tools to Assess Safety and Performance |
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Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management, United BioSource Corporation |
- Designing and utilizing registries to maximize their potential as a risk management tool
- Utilizing registry initiatives to track ROI and continuing improvements
- Ensuring the use of best practices in adverse drug reaction (ADR) reporting
- Supporting enrollment, education, reporting, and effective outcome measurement through online registries
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| 3:45 Drug Safety in Biologicals |
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Nilima Justice, M.D., Sr. Director, Product Safety Surveillance, Novo Nordisk, Inc. |
The agency is trying to expand systems to detect safety issues for blood, vaccines, and biotech therapies. This presentation will discuss this while looking at new approaches to drug safety and risk mitigation in biologics.
- How do biological products (biologics) differ from conventional drugs
- Events commonly seen with these products
- Safety monitoring for biologics and risk management plans
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| 4:15 Risk Management Approaches: RevAssist® and S.T.E.P.S. ® |
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Carmen Castaneda, M.D., Senior Medical Reviewer, Worldwide Drug Safety, Celgene Corporation |
The safety of drugs and risks associated with drug use is of public health concern. This presentation will provide an overview of Celgene’s risk management programs. It will describe the pros and cons of such risk management programs.
- Learn the components of RevAssist® and S.T.E.P.S.® programs
- Gain insight on the “upsides” and “downsides” of RevAssist® and S.T.E.P.S.®
- Learn measures of effectiveness of RevAssist® and S.T.E.P.S.® programs
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4:45 Chairperson’s Closing Remarks
5:00 Executive Forum Closes
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