Table of Contents

Addressing Key Challenges in Drug Safety (Strategic Focus) - An in-depth analysis of the pharmacovigilance technology market including market conditions, adoption strategies, and technology trends.

Product Code: dmtc2185

Publication Date: 26-Mar-2008

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Overview

Introduction

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

Report Highlights

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.

Reasons to Purchase

· 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

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Overview	1
Catalyst	1
Summary	1
Key Messages	2
Pressures to adhere to government regulations are driving the adoption of PV solutions	2
The pharma industry turns to drug safety solutions to ease financial woes	2
Signal detection in clinical research is a necessity to increase efficiency and reduce costs	2
In its nascent stages, companies have been reluctant to adopt PV technologies	3
There are no leading providers of PV solutions, and partnerships are essential	3
Table of Contents	4
Table of figures	5
Market Opportunity	6
Growing drug safety issues are leading to enhanced pharmacovigilance activities	7
Technology is crucial in developing a comprehensive pharmacovigilance strategy	7
Post-market surveillance capabilities is essential for a robust PV system	8
Government regulations are driving the adoption of PV solutions	9
The FDA has a long standing history of drug safety regulations...and shortage of funds	9
The FDA becomes more proactive and enhances drug safety and its IT systems with PDUFA IV	11
FDA will demand more safety data and proactive pharmacovigilance from the industry	11
New reforms standardize the European PV system	11
The EMEA pharmacovigilance system is still developing	12
The pharma industry turns to drug safety solutions to ease financial woes	12
Safety warnings and drug withdrawals hurt companies' business portfolios	13
Unexpected litigation costs lower the overall bottom line of a company	15
Pharma companies will save millions of dollars with early detection of an unsafe drug	16
In its nascent stages, companies have been reluctant to adopt PV technologies	17
The pharma industry's conservative nature impedes the adoption of PV systems	17
Companies relate new PV technologies with older, more cumbersome statistical tools	17
Implementation of PV solutions requires an overhaul of existing IT systems	18
Customer Impact: Using PV Technologies to promote public health	19
Signal detection in clinical research is a necessity to increase efficiency and reduce costs	20
Clinical trials signal detection must provide an intuitive interface	20
A simple example of how clinical trials signal detection is used for proactive pharmacovigilance	20
Detection of safety signals during clinical trials can save pharma companies millions of dollars	21
Consumer knowledge and participation significantly affect pharmacovigilance activities	21
Consumers require more transparency into the pharmacovigilance process	21
Pressures to adhere to global regulations increases the uptake of PV solutions	23
More data and advanced IT tools mean better safety monitoring and reporting	23
PV technologies to support post-market surveillance are more important now then ever before	23
Signal detection is becoming increasingly important during clinical trials	23
Technology evolution	25
Signal detection and management solutions are essential for proactive pharmacovigilance	25
Signal detection technologies must be user-friendly and accessible from global sites	26
Adverse event reporting systems are becoming increasingly important	26
In this nascent market, there are no clear leaders for PV solutions	27
Examples of vendors providing total PV solutions	27
Aris Global develops a data mining and signal detection application to add to its PV suite	28
Phase Forward acquires Lincoln Technologies to provide a powerful set of drug safety solutions	28
TCS, Oracle, and DrugLogic collaborate to deliver a comprehensive and integrated PV solution	28
Go to market	29
PV technologies must streamline the pharmacovigilance workflow	29
IT vendors must educate the industry on the usefulness of signal detection technologies	29
In a highly fragmented market, partnerships are essential	30
Vendors that openly communicate with their clients and put their needs first will prosper	30
Changing regulations will require vendors to continuously update their solutions	30
Ensure that IT solutions meet government standards for electronic records	31
A close eye should be kept on emerging markets	31
APPENDIX	32
Definitions and Abbreviations	32
Methodology	33
Further reading	33
Ask the analyst	33
Datamonitor consulting	33
Disclaimer	33
List of Figures
Figure 1: Balance between risks and benefits for drugs to be approved	6
Figure 2: A typical pharmacovigilance system utilizing technology and strategy	8
Figure 3: Sources of risk from a drug, leading to an adverse drug reaction	9
Figure 4: Key drug safety-related events in FDA history	10
Figure 5: Stock price for Merck on NYSE for 2004, US$	14
Figure 6: Stock price for GlaxoSmithKline on NYSE for 2007, US$	15
Figure 7: Drug discovery and development process	16
Figure 8: Challenges facing the pharmaceutical industry	19
Figure 9: Adverse event reporting systems in North America and Europe	22
Figure 10: An example of a complete PV system	25

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