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Day One - Wednesday, November 29, 2006
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PRE-CONFERENCE TUTORIAL*
Safety
Surveillance, Risk Assessment and Risk Management using Registries
and Large Streamlined Studies
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| Registries and large streamlined studies (LSSs) are being used with increasing frequency for post-approval safety surveillance, risk assessment, and risk management. There are multiple and often conflicting definitions as to what constitutes a LSS or a registry and ongoing debate regarding how these programs should be conducted and when they can most successfully be utilized. This workshop, led by industry experts Annette
Stemhagen, DrPH, FISPE and Gerald Faich, M.D., MPH, FISPE, will address these issues.
7:30 am Coffee and Pre-Conference Registration
8:00 Facilitator’s Welcome and Opening Remarks
8:15 Utilization of Registries and Large Streamlined Studies for Safety Monitoring and Post-Marketing Risk Assessment
9:00 Practical
Issues in the Conduct of a Safety Registry: Site Recruitment, Patient
Recruitment and Retention, Regulatory Reporting and Analyses
9:45 Networking Coffee Break
10:00 Experiences with Large Streamlined Studies – Successes & Challenges Case Study
10:45 Experiences with Registries – Successes & Challenges Case Study
11:30 Close of Pre-Conference Tutorial
About your tutorial leaders:
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Gerald
Faich, MD, MPH, FISPE, Senior Vice President Epidemiology & Risk
Management, United BioSource Corporation
is the Senior Vice President of UBC's Epidemiology and Risk Management Group and is a
recognized leader in drug safety and pharmacoepidemiology. His
research interests are risk assessment, pharmacoepidemiology and the
design and conduct of registries and streamlined trials for phase IIIb and IV. Before joining UBC, Dr. Faich served in senior management positions at FDA and Corning and provided high-level consulting on safety and risk issues. He is currently a visiting scholar at the University of Pennsylvania and past President of the International Society for Pharmacoepidemiology. From 1983 to 1990, Dr. Faich was the Office Director in charge of statistics and postmarketing surveillance for drugs and biologics at the FDA. There he revitalizedthe adverse reaction reporting system, revised reporting regulations, expanded staffing and pharmacoepidemiologic research. He co-chaired the original CIOMS International Adverse Reaction Working Group and was a founding board member of the International Society for
Pharmacoepidemiology.
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Annette
Stemhagen, DrPH,
FISPE, Vice President Epidemiology & Risk Management, United
BioSource Corporation
is the Vice President of UBC's Epidemiology and Risk Management, where she provides strategic
consultative services to pharmaceutical and biotechnology clients in
epidemiology, safety surveillance, and risk management. Dr. Stemhagen has more than 25 years of public health epidemiological research experience,
including 15 years in safety surveillance of pharmaceutical, biotech and vaccine products. She has specific expertise in design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies and actual use and observational studies for products in Phase IIIb and post approval. Dr.
Stemhagen has designed and evaluated risk assessment studies, including more than 10 regulatory-mandated long term safety studies. She has also developed risk intervention programs, risk management evaluation studies, and Risk MAPS. In 2004, Dr.
Stemhagen was appointed as the industry representative to the FDA Drug Safety and Risk Management Advisory Committee.
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John
Clark, MD, MSPH, Senior Director, Epidemiology & Risk
Management, United BioSource Corporation
is the Senior Director of Epidemiology and Risk Management at UBC.
Dr. Clark provides consultation to pharmaceutical, biotechnology and
medical device clients in areas such as adverse event reporting and
evaluation, signal detection, statistical assessments of potential
signals, structure and management of safety departments, risk
management planning and RiskMAPs, and the use of external adverse
event-related databases such as FDA AERS, DAWN, and TESS. Dr. Clark
also works with sponsors to product-specific signaling and
surveillance programs that meet the expectations of regulatory
authorities. Dr. Clark has worked in the field of adverse event
surveillance for 19 years. In 1987 Dr. Clark joined the US Food and
Drug Administration as a medical epidemiologist and safety analyst.
Since 1990 Dr. Clark has worked for several pharmaceutical
companies, large and small, with a focus on medical monitoring in
clinical trials, pharmacovigilance analyses, and global safety
assessment and strategy.
*Separate registration required
United BioSource Corporation delivers evidence-based solutions to enhance the medical and commercial potential of pharmaceuticals and biotechnology. Our capabilities include design and implementation of clinical trials and registries; epidemiology and risk
management; outcomes research and health economics; electronic data capture; interactive voice response and web systems for clinical trials; reimbursement strategy; and investigator education and training.
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| 11:00 Main Conference Registration
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| KEYNOTE
PRESENTATIONS |
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12:30 A Quality by Design Approach to Product/Process Understanding and Post Approval Safety
Mansoor A. Khan, R.Ph., Ph.D., Director, Division of Product Quality Research, FDA |
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1:15 The Art and Science of Balancing Benefit and Risk
John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc.
There is increasing interest in approaches to balancing benefit and risk. There is an emerging consensus that current methods have significant limitations. Moreover, there is no clear framework for incorporating formal approaches to balancing benefit and risk in the drug approval process. This session addresses the need for benefit and risk framework, reviews the state-of-the-art in balancing benefit and risk, and considers the merits of proposed alternatives to current methods, including quantitative approaches to balancing benefit and risk.
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2:00 Establishing and Sustaining a Proactive Drug Safety Risk Management System
Jill Robinson, R.Ph., MBA, Vice President, Global Safety Surveillance & Epidemiology, Wyeth
Risk management is the overall and continuing process of minimizing risks throughout a product’s life cycle to optimize its benefit/risk balance. Risk information emerges continuously throughout a product’s life cycle, during both the investigation and marketing phases through both labeled and off-label uses. Risk management to be a continuous process of (1) learning about and interpreting a product’s benefits and risks, (2) designing and implementing interventions to minimize a product’s risks, (3) evaluating interventions in light of new knowledge that is acquired over time, and (4) revising interventions when appropriate. This talk will highlight what is needed in establishing and sustaining a proactive PV/drug safety risk management system.
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2:45 Networking Refreshment Break (Sponsorship Available)
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3:15 Essentials of Post-Marketing Safety Agreements: A View from the Business
Joanna L. C. May, Business Alliance Consultant, Global Product Safety, Eli Lilly and Company
Many pharmaceutical companies are utilizing business partners as a means to achieve strategic intent. Drug Safety
department are putting safety agreements in place to ensure safety obligations to regulatory agencies are met by the
Parties. Negotiating the arrangements of the safety agreement to ensure compliance by both partners can be a complex process. This session will examine the basics for post-marketing pharmacovigilance safety agreements. It will also address some of the potential issues that may arise in negotiating post-marketing safety agreements.
• Types of post-marketing agreements
(Co-Marketing, Co-Promotion, In-license, Out-license, Supply, Divestiture, Joint Venture)
• Content requirements of alliance agreements
• Challenges in merging processes and procedures between two companies
• Case study |
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4:00 The Drug Safety Imperative: Redefining the Pharmaceutical Industry’s Value Proposition
Andrew F. Branca, Senior Vice President, Drug Safety Risk Management, Cambridge Healthtech Associates
Today, drug safety is the single greatest force driving change within the pharmaceutical industry. Although the safety of its drugs is not a new concern to the industry, the entry into the safety dialogue of an ever broadening variety of stake holders, and the severity of the consequences for making an apparent safety misstep, have never been greater. Collectively, these dynamics will drive the emergence of a pharmaceutical industry whose value proposition differs profoundly from that of today. This session outlines the current and emerging drug safety dynamics driving the industry, discusses some of the changes likely to result both within and outside pharma, and explores broadly how the value proposition of tomorrow’s pharmaceutical industry will differ from that of today’s.
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| INTERACTIVE
PANEL |
4:45
Redefining Drug Safety Risk Management
• Costs and opportunities of Phase IV risk management programs
• Identifying how your risk management plans can be utilized as a new promotion tool
• How marketing can make best use of post-approval study findings
• Meeting marketing objectives through effective dissemination of trial data
• Examining successful implementations of effective drug safety initiatives
• Do big pharmas need a Chief Safety Officer? |
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5:30 Networking Cocktail Reception (Sponsorship Available)
6:30 Close of Day One
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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
E-mail:
lames@healthech.com
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