title: From pharmacovigilance to pharmacoperformance.
abstract: The pharmaceutical industry is going through a period of enormous upheaval, as new sciences, technologies and commercial pressures reshape the way in which it performs research and development. PwC Consulting estimates that the top 20 companies will each need to launch between four and six times the number of drugs they currently produce, as well as improving the quality of those drugs, merely to maintain shareholder returns. This has huge implications for pharmacovigilance departments. More drugs means more trials, more patients and -- of course -- more safety reports for evaluation. The pharmacovigilance teams in most big companies are ill prepared for this transition being already stretched to the limit. But as demand for patients to participate in clinical trials increases -- with shorter development times, higher success rates in discovery and greater productivity -- so companies with a poor reputation for safety will suffer. What is it then that companies should be doing to remain compliant and be seen to be safe in the eyes of the consumer? Can pharmacoepidemiology support both molecules in the marketplace as well as those in research and development and what is really needed to enable this? Key to success will be the ability to capture, analyse and evaluate data (from disparate sources) in real time and to make rapid decisions on the appropriate course of action. Putting better structures, processes and technological platforms in place to cope with a big increase in throughput is only a short-term solution yet is it enough to fulfil the objective in the long-term of ensuring compliance and patient safety?
authors.affiliation: PwC Consulting, Pharmaceutical Consulting Practice, London, United Kingdom. jonathan.c.peachey@uk.pwcglobal.com
authors.forename: Jonathan
authors.initials: J
authors.lastname: Peachey
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000639:trends; D003199:Computer Systems / Q000592:standards / Q000639:trends; D004341:Drug Evaluation / Q000592:standards* / Q000639:trends; D004353:Drug Evaluation, Preclinical / Q000592:standards* / Q000639:trends; D004345:Drug Industry / Q000592:standards* / Q000639:trends; D016903:Drug Monitoring / Q000592:standards / Q000639:trends; D006801:Humans; D017891:Pharmacoepidemiology / Q000592:standards / Q000639:trends; D011358:Product Surveillance, Postmarketing / Q000592:standards* / Q000639:trends; D012015:Reference Standards; D014481:United States; D014486:United States Food and Drug Administration