Benchmarking Drug Safety and Pharmacovigilance (PH138)

Data, Practices, and Metrics

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Published 2010
155 Pages
500+ Metrics
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Reinforce Your Drug Safety Team
Benchmarking Drug Safety and Pharmacovigilance is a data-driven guide to optimizing the performance of your company's drug safety efforts. Designed with both clinical-stage and marketed products in mind, this study details budgets and outsourcing, structure and staffing, activities, timing, and communications. Beyond providing quantitative analysis, the report includes top safety executives' creative solutions to ongoing challenges and their unique perspectives on current trends.
Leverage and maximize your resources
Drug safety is an essential function, but it is not immune to the budget cuts occurring across the industry. If companies do not fund drug safety adequately, however, they can open themselves up to risk. What's more, drug safety teams must have the flexibility to evolve, stay on technology's cutting edge and keep up with ever-changing safety demands.
Budgets and Outsourcing
Win more resources and defend the budget you already have, even as other groups face cuts. See how other teams balance workloads via outsourcing to gauge your own mix of in-house/outsourced tasks.
Structure and Staffing
Use our benchmarks to reinforce your thinking around group structure and tools. Identify the types of positions necessary to run the smallest of safety operations as well as the best structures for companies of all sizes.
Activities
Learn how several groups throughout the drug
safety organization structure must play an active role in the company's pharmacovigilance activities. Metrics include activities timing and communication strategies to encourage better knowledge transfer.
Trumpet the value of your team
Because drug safety and pharmacovigilance are necessary functions, your team may not spend much time thinking about ROI. In fact, drug safety veterans say it is crucial to communicate successes and prove strategic value. Discover how other groups address this challenge and work to build a drug safety culture in their organizations.
Improve communication with FDA
Drug teams must stay up to date on all agency changes, but that sometimes means working under one governing guidance while a contradictory draft guidance awaits approval. Implement best practices to resolve such confusion as you improve your company's communication processes with regulatory agencies, including the Food and Drug Administration.
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Companies Included in Pharmacovigilance Research
- Abbott Laboratories
- Bausch and Lomb
- Cerexa
- ClinQuest Inc.
- Cubist Pharmaceuticals
- Drug Safety Alliance (DSA)
- Elan
- Ferring Pharmaceuticals
- Genzyme
- GlaxoSmithKline
- InterMune Pharmaceuticals
- Isis Pharmaceuticals
- Jazz Pharmaceuticals
- Johnson & Johnson
- Labopharm
- Novartis
- Ortho-McNeil Janssen
- Otsuka
- Pfizer
- Progenics Pharmaceuticals
- Solvay
- Stromedix
- Taro
- Vical Inc.
- ViroPharma
- VIRxSYS
- ZARS Pharma
- ...plus more
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Pharmacovigilance Metrics
Chapter 1: Budgets and Outsourcing
Budget Data
- Total and US-only drug safety financial metrics and budgets
- Drug safety budget allocation
- Budget centralization (dedicated budgets versus funded by various departments)
- Departments that contribute to non-centralized drug safety budgets
- Budget coverage (number of investigational and marketed drugs covered
- Percentage of drug safety budgets allocated to various global markets, including the US, UK, France, Spain, and Japan
Outsourcing
- Percentage of companies that outsource some portion of their drug safety budget
- Percentage of drug safety budget outsourced, by company
- Types of products and pharmacovigilance activities covered by vendors
- Types of vendors employed (e.g., those who provide turn-key solutions versus ad hoc services)
- Where companies spend outsourcing dollars (percentage of overall outsourcing dollars dedicated to each country)
Chapter 2: Structure and Staffing
Structure
- Drug safety structures and team makeup
- Percentage of companies with in-house teams to manage drug safety/pharmacovigilance
- Centralized versus decentralized structures
- In-house departments' drug safety responsibilities
- Other departments with some oversight of drug safety groups
- Percentage of investigational compounds for which in-house drug safety groups conduct activities
- Percentage of marketed drugs for which in-house drug safety groups conduct activities
Staffing
- FTEs dedicated to drug safety
- Percentage of staffing positions held by contract employees
- Percentage breakdown by position
- Percentage of staff dedication by activity
Chapter 3: Pharmacovigilance Activities, Timing and Communications
Activities
- Phase in which drug safety activities begin
- Percentage of drug safety groups performing different specific activities
- Phase in which companies begin safety and technology services/IT solutions (database hosting, migration, maintenance and support)
- Phase in which companies begin the following:
Internal Processes
- Phase in which clinical development gets involved in drug safety on a brand
- Phase in which medical affairs gets involved in drug safety on a brand
- Phase in which legal gets involved in drug safety on a brand
- Phase in which risk management gets involved in drug safety on a brand
- Phase in which regulatory gets involved in drug safety on a brand
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Pharmacovigilance Report Sample
The following excerpt is found in Chapter 2, "Structure and Staffing." The full report discusses in-house drug safety team responsibilities for companies of different types.
Small companies show the largest variation when delegating drug safety responsibilities. This finding illustrates the many different corporate structures that are found across small companies. Figure 2.14 (data shown in full report) shows that 57% of small companies' drug safety teams work with both investigational and post-marketed drugs. Drug safety teams at 29% of small companies work exclusively on investigational products - the highest among the different company size categories. For many small companies, investigational compounds are the only drugs in their portfolios. Perhaps when these investigational drugs reach the post-marketing stage, the pharmacovigilance will be done using the same drug safety group. That is the logical evolution of the drug safety team as a product progresses through its lifecycle.

This excerpt is taken from Chapter 1, "Budgets and Outsourcing." The full report contains real-company strategies and insights concerning budget
Budgeting Process
As stated earlier, even drug safety departments are not immune to the across-the-board cost-cutting trend that has emerged throughout the pharmaceutical industry. With this in mind, Cutting Edge Information examines some drug safety teams' budgeting processes, as well as the methods that many teams use to justify the return on investment for drug safety activities.
At Company C, the vice president of pharmacovigilance prepares an annual budget and submits it to the budget review committee. After the committee's approval, the request eventually goes to the board of directors for final approval. According to one interviewed executive, within Company C's budget, the basic, required drug safety activities speak for themselves. For other initiatives, such as a request for an investment in new software, the budget review committee might seek a discussion with the team, review the request, and then render a final decision.
Though the company does not develop a per-brand budget, the types of brands are a consideration in the final numbers. The interviewed executive explains that the amount budgeted per brand depends on factors such as class of drugs (as each class would have very different safety requirements). The newness of brand classes is another consideration, as newer categories are inherently more risky because there is less information available about these drugs' potential adverse effects on patients.
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