Addressing Key Challenges in Drug Safety (Strategic Focus)

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