Research and Markets (http://www.researchandmarkets.com/reports/c89887) has announced the addition of "Addressing Key Challenges in Drug Safety (Strategic Focus)" to their offering.
High profile drug withdrawals and negative public attention has placed drug safety at the top of the pharmaceutical industry’s agenda. This report will examine pharmacovigilance technology solutions designed to alleviate the challenges in drug safety management faced by the pharmaceutical industry and the regulatory agencies.
Scope
- Identifies the key forces driving the adoption of pharmacovigilance technology solutions
- Analyzes the crucial issues that will impede the uptake of drug safety monitoring tools
- Discusses the key functionalities needed for a complete pharmacovigilance solution
- Offers insight into how IT vendors can improve their products
Highlights of this title
Pharma companies must adapt to constantly changing government regulations to ensure compliance and eventual approval of their drug products, and response to these new rules is driving the adoption of pharmacovigilance solutions.
It is essential for pharma companies to implement proactive pharmacovigilance strategies which encompass strong data management systems, signal detection technologies, and adverse event reporting systems to ensure production of a safe and effective drug that will be approved and will maintain a favorable risk-benefit ratio post-approval.
The industry is still skeptical of the benefits provided by signal detection technologies. IT vendors must take an active role in educating companies about these technologies, and position signal detection as an essential tool for developing comprehensive risk management strategies which will not only benefit the company, but ultimately the public.
Key reasons to purchase this title
- Validate your market messaging and positioning in the pharmaceutical industry
- Identify strategies that will increase adoption of pharmacovigilance technologies
- Understand the technology trends that are shaping the future of drug safety
Content Outline:
Overview
Catalyst
Summary
Key Messages
Pressures to adhere to government regulations are driving the adoption of PV solutions
The pharma industry turns to drug safety solutions to ease financial woes
Signal detection in clinical research is a necessity to increase efficiency and reduce costs
In its nascent stages, companies have been reluctant to adopt PV technologies
There are no leading providers of PV solutions, and partnerships are essential
Table of figures
Market Opportunity
Growing drug safety issues are leading to enhanced pharmacovigilance activities
Technology is crucial in developing a comprehensive pharmacovigilance strategy
Post-market surveillance capabilities is essential for a robust PV system
Government regulations are driving the adoption of PV solutions
The FDA has a long standing history of drug safety regulations...and shortage of funds
The FDA becomes more proactive and enhances drug safety and its IT systems with PDUFA IV
FDA will demand more safety data and proactive pharmacovigilance from the industry
New reforms standardize the European PV system
The EMEA pharmacovigilance system is still developing
The pharma industry turns to drug safety solutions to ease financial woes
Safety warnings and drug withdrawals hurt companies business portfolios
Unexpected litigation costs lower the overall bottom line of a company
Pharma companies will save millions of dollars with early detection of an unsafe drug
In its nascent stages, companies have been reluctant to adopt PV technologies
The pharma industrys conservative nature impedes the adoption of PV systems
Companies relate new PV technologies with older, more cumbersome statistical tools
Implementation of PV solutions requires an overhaul of existing IT systems
Customer Impact: Using PV Technologies to promote public health
Signal detection in clinical research is a necessity to increase efficiency and reduce costs
Clinical trials signal detection must provide an intuitive interface
A simple example of how clinical trials signal detection is used for proactive pharmacovigilance
Detection of safety signals during clinical trials can save pharma companies millions of dollars
Consumer knowledge and participation significantly affect pharmacovigilance activities
Consumers require more transparency into the pharmacovigilance process
Pressures to adhere to global regulations increases the uptake of PV solutions
More data and advanced IT tools mean better safety monitoring and reporting
PV technologies to support post-market surveillance are more important now then ever before
Signal detection is becoming increasingly important during clinical trials
Technology evolution
Signal detection and management solutions are essential for proactive pharmacovigilance
Signal detection technologies must be user-friendly and accessible from global sites
Adverse event reporting systems are becoming increasingly important
In this nascent market, there are no clear leaders for PV solutions
Examples of vendors providing total PV solutions
Aris Global develops a data mining and signal detection application to add to its PV suite
Phase Forward acquires Lincoln Technologies to provide a powerful set of drug safety solutions
TCS, Oracle, and DrugLogic collaborate to deliver a comprehensive and integrated PV solution
Go to market
PV technologies must streamline the pharmacovigilance workflow
IT vendors must educate the industry on the usefulness of signal detection technologies
In a highly fragmented market, partnerships are essential
Vendors that openly communicate with their clients and put their needs first will prosper
Changing regulations will require vendors to continuously update their solutions
Ensure that IT solutions meet government standards for electronic records
A close eye should be kept on emerging markets
APPENDIX
Definitions and Abbreviations
Methodology
Further reading
Ask the analyst
Our consulting
Disclaimer
List of Figures
Figure 1: Balance between risks and benefits for drugs to be approved
Figure 2: A typical pharmacovigilance system utilizing technology and strategy
Figure 3: Sources of risk from a drug, leading to an adverse drug reaction
Figure 4: Key drug safety-related events in FDA history
Figure 5: Stock price for Merck on NYSE for 2004, US$
Figure 6: Stock price for GlaxoSmithKline on NYSE for 2007, US$
Figure 7: Drug discovery and development process
Figure 8: Challenges facing the pharmaceutical industry
Figure 9: Adverse event reporting systems in North America and Europe
Figure 10: An example of a complete PV system
Companies Mentioned:
- GlaxoSmithKline Plc
- Medicines Company, The
- Merck & Co., Inc.
- NYSE Euronext
- Oracle Corporation
- Safety Insurance Group, Inc.
- Tata Consultancy Services Limited
- Wyeth
For more information visit http://www.researchandmarkets.com/reports/c89887
Source: Datamonitor
Contacts:
Laura Wood, Senior Manager
Fax: +353 1
4100 980
press@researchandmarkets.com
