Pharmaceutical Technologist - July 2008 - (Page 17)

Drug safety development of safety signal monitoring processes by FDA, and describes the tightening of enforcement actions if companies do not follow their own risk management plans. Where there are outstanding questions from the drug development phase regarding defined patient populations, the drug’s developer must describe the actions taken to close these knowledge gaps. Actions range from typical postmarketing safety monitoring to the initiation of targeted clinical or epidemiological studies of safety. Before these actions, there may be restrictions on the use of the product. Where such activities are committed to at submission, the company must ensure that appropriate mechanisms are in place across clinical, safety, regulatory, marketing and sales organizations to guarantee that actions are taken and that these are effective in controlling risk. coupled with monitoring mechanisms and governance processes to ensure they are effective. and expertise should be a prerequisite. The perspective that drug safety happens after launch needs to change. Safety risk management All stakeholders are concerned with identifying ADRs earlier in the product life cycle, allowing better decisions on their mitigation before a product reaches the marketplace. To achieve this, safety monitoring must be more proactive during development, and clinical and drug safety should work in tandem rather than as two distant functions responsible separately for product development and marketplace monitoring. It is not enough to report development safety events in a timely manner; you must anticipate and mitigate safety risk, otherwise you risk warning letters threatening the global reputation of the company, regulators levying huge fines, and product withdrawals that cost millions and put jobs at risk. The problem is that clinicians and drug safety work independently, almost as two separate business units, and even during clinical trials product safety is reviewed in silos. With different groups looking at risk at various stages of the product life cycle, and a limited consistency of approach, ADRs can be missed in the early stages. Clinical and drug safety experts bring two very different, but equally valuable, perspectives, and must work together as peers to describe the benefit/risk balance for a product ahead of marketplace release. Formal accountabilities should be separated, but the sharing of knowledge, data you must anticipate and mitigate safety risk, otherwise you risk warning letters threatening the global reputation of the company, regulators levying huge fines and product withdrawals that cost millions and put jobs at risk. A new look Many companies are establishing the necessary mechanisms to achieve this new outlook. Cross-functional safety management teams are being created to work alongside clinical development teams to focus on understanding the emerging safety profiles of products in development. These teams make use of all data including preclinical studies, external databases of patient information and information on similar products already on the market. Whatever the source of information, the teams are responsible for evaluating the product’s likely safety profile. Proactively testing models during the development process ensures that the emerging safety profile is continually refined, and this information is then fed into the broader development process, allowing clinical/preclinical studies to address the need for information regarding product safety. A growing issue Traditionally, the industry’s answer to drug safety was pharmacovigilance — particularly with monitoring and reacting to adverse drug reactions (ADRs) — but this often only covered the postmarketing phase of drug development. It is a step in the right direction, but also a sticking plaster over a rapidly expanding issue. As the public and regulatory focus on safety grows, pharmaceutical companies must ensure that the benefit and risk profiles of their products are understood throughout development, and are transmitted effectively to customers as products reach the marketplace. The pressures on the industry are two-fold. First, companies must reduce complex and expensive postmarketing commitments and product usage restrictions. This can be achieved by understanding the safety profile of drugs in development as accurately as possible and answering key regulatory areas of concern prior to submission. Second, companies must develop cross-functional mechanisms to generate appropriate and ‘implementable’ risk management/minimization plans, On the go ● ● ● ● Highly public drug failures during the last few years mean that pharmaceutical companies are under greater scrutiny from regulators and the media. EU regulators require new drug submissions to be accompanied by a formal statement regarding the need or lack of need for a risk management plan. Pharmacovigilance often only covers the postmarketing phase, but safety monitoring must be more proactive during drug development. Companies are beginning to establish mechanisms to change the way drug safety is implemented by forming cross-functional safety teams to work alongside clinical development teams. www.ptemagazine.com 17 http://www.ptemagazine.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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