Drug Safety
in a Health Insurance Portability and Accountability Act-compliant manner.4
It will do this by partnering with healthcare insurance and product providers, academic institutions, federal agencies and other owners of electronic health records.
Consequently, the FDA will have access to product safety data that the industry as yet will not. The natural sequella will be that the regulatory agency will detect signals before the industry it regulates. Signal strengthening and signal detection must become a collaboration with all relevant stakeholders (e.g. the Observational Medical Outcomes Partnership) and clearly the industry must equip itself so that it can respond in an informed, data-driven manner.
Conclusion
New Pharma will need to become focused on the advanced analytics of pharmacovigilance and signal detection, rather than its current preoccupation with the ‘handle turning’ of adverse drug event data collection and regulatory reporting. Whether this is best achieved in a timely and cost-effective manner in-house or out-of-house is an important decision that needs to be made. n
1. Fitzmartin R, Wise JCM, Pharma trends: The role of the emerging markets, Screening: Trends in Drug Discovery, 1 San Mateo, CA: Decision Analytics, LLC, February 2009.
2. WHO, Glossary of Terms used in Pharmacovigilance,
WHO, 2010. Available at:
http://www.who-umc.org /graphics/8321.pdf (accessed 27 October 2010).
3. Trinks U, Wise JCM, Implementing and Maintaining a Drug Safety System, Pharmaceutical Technology Executive, Contract Services Europe, December 2004. Available
Ron Fitzmartin is Managing Partner at Decision Analytics, LLC, and has held scientific and technical leadership positions at Daiichi Sankyo, Daiichi Medical Research and Purdue Pharma in biostatistics, data operations and biomedical informatics. He has been a frequent speaker and meeting chair at the Drug Information Association, of which he is a Past President. He received a PhD in statistics from the University of Maryland, an MBA from the University of New Haven and an MS and a BS from Southern Connecticut State University.
John Wise is Executive Director of the Pistoia Alliance, an organisation committed to service and standards-based innovation in Life Sciences, and an Associate of the PRISM Forum, which is focused on the identification of ‘hot topics’ and the sharing of industry best practices. He has held informatics leadership roles at the University of London, Sandoz, Imperial Cancer Research Fund, Roche, Ipsen and Daiichi Sankyo. Mr Wise is committed to encouraging the pharma industry to use expert, third- party, cost-effective, regulatory-compliant, hosted information services.
at:
pharmtech.findpharma.com/pharmtech /article/articleDetail.jsp?id=138061&sk=&date= &pageID=5
4. US Health Insurance Portability and Accountability Act 1996 and its associated Privacy and Security Rules of 2003.
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