Pharmaceutical Technologist - July 2008 - (Page 18)

Drug safety The hurdles Personnel must be recruited who can work effectively with the senior doctors running clinical development. They must also be capable of leading the change to a proactive stance, which requires a new skill set in tomorrow’s world, and a major shift in the relationship between drug safety and clinical trials. The status of drug safety must be redefined and a career path should be built that allows scientists/clinicians to move between partner departments. These activities must result in a more consistent view of the safety profile of a development product, and ensure that safety risk is consistently well-managed. Beyond cultural hurdles, technology is also a huge mountain that must be moved. To use clinical data as part of early drug safety signal detection, it must be collated, formatted and analysed differently. Clinical trials are powered to detect efficacy, not safety, and analyses must make use of all available data to identify safety trends throughout the clinical trial process. This creates challenges both within the company, which must manage its clinical and safety databases, and in the relationship between the company and its CRO suppliers, which will need to provide their sponsors with an end of study report and a consistently formatted dataset for further analysis. These activities must result in a more consistent view of the safety profile of a development product, and ensure that safety risk is consistently well-managed. many cases, these mechanisms are independent of one another and can lead to inconsistencies. Bringing the core of these together into a development safety risk management plan — with clear relationships to all key safety risk management mechanisms — will mean there is one clearly identified source of guidance. This ‘living’ document will be updated regularly (at least at major development milestones) to provide transparency of the risk management approach and to ease communication across all participating departments. Ultimately, it will evolve into the submission risk management plan. Submission and beyond With regulators now demanding justification for the risk management approach, and risk minimization activities being implemented and monitored for every new product, it is necessary to ensure that safety risk management activities are effective and feasible. The definition and implementation of these activities requires highly cross-functional teams that operate at a level where they can mobilize resources across R&D and commercial divisions. These levels of organizational coordination and interdependence are rarely called for in normal operations, and require clarity of focus and leadership to be successful. Where there is a need to make commitments to postmarketing risk minimization activities, or ‘enhanced pharmacovigilance’, there is a necessity for careful design of approach; the need to obtain additional safety information and the practicalities of data collection in a postmarketing environment must be considered. The approaches taken may include specific studies to monitor certain safety aspects, the development of patient registries to track product usage, restrictions in supply, and communication plans to support messages of appropriate product usage. Whatever the approach taken, the development of the plan and its implementation must be a cross-functional activity that incorporates multiple central and affiliate functions for greatest effectiveness. Implementation must be measured to assure regulators that actions committed to are being implemented, and, more importantly, that the effectiveness of the actions is being monitored. If the plan is ineffective at managing risk, it becomes a risk itself. The most obvious candidate to lead this activity is the drug safety and pharmacovigilance department, which is accountable for ensuring that potential safety issues are reported to the company and the regulatory bodies. In addition, the appropriate skills will need to be developed to conduct this new leadership role. This is a challenge that supports the push for more proactivity within the industry. While many companies have the corporate will, they do not possess the skill set to follow such plans through. The established relationships and profiles of the affected functions mean that ‘the way we have always done it’ and a lack of new skills will slow progress. The will to do this from the top must permeate down, encouraging massive cultural and technological change. PT References 1. FDA, FDA Amendments Act of 2007. www.fda.gov Mark Perrott is a Managing Consultant at WCI Consulting Ltd (UK). Chris Holmes is a Principal Consultant at WCI Consulting Ltd (UK). www.wcigroup.com Making a plan Safety risk management in development is accomplished through multiple mechanisms such as an investigators’ brochure, inclusion and exclusion criteria in clinical trials, and serious adverse events (SAEs) reporting guidelines. In 18 JULY 2008 PHARMACEUTICAL TECHNOLOGIST http://www.fda.gov http://www.wcigroup.com

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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