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European Pharmaceutical Contractor

The Right Source

It is no secret that healthcare costs are high, and that keen public attention is being given to the general welfare of the human population. The pharmaceutical and biotechnology industries are being challenged and encouraged to evaluate the impact of different options that are available for treating given medical conditions for patients. In addition, the industry is being asked to compare similar treatments and best-in-class competing pharmaceuticals, as well as to analyse different approaches in drug therapy and surgery. These requests all stem from the government and public insisting on a thorough analysis of pharmaceutical benefits, risks and costs. As a result, our leaders have been actively pursuing the establishment and enhancement of comparative effectiveness programmes worldwide.

COMPARATIVE EFFECTIVENESS

International comparative effectiveness programmes exist and serve a purpose to help ensure the safety and efficacy of pharmaceuticals while proposing to manage not only the cost of the drugs but the overall cost of healthcare. Due to the current focus on comparative effectiveness and the elevated profile of the use of comparators and their ancillary materials, there is an expectation for the industry to justify not only the superiority or non-inferiority of their drug, but also to confirm the value of the new drug product or the new indication that is being introduced to the market. As such, all clinical trials require evidence of clinical effectiveness so that the industry can deliver on the common goal of providing a high quality, safe, effective and affordable product to market.

Comparators are commercial products or placebos used as references in clinical trials. They are also referred to as investigational medicinal products when the drugs are intended to be further manufactured, repackaged or used outside of their registered indication. Traditionally, pharmaceutical and biotech companies have incorporated comparators within their clinical trials to demonstrate the safety, effectiveness and worth of their new drug product or an existing drug productís new indication. That said, although proof of clinical effectiveness is required, there is currently no obligation to use comparators except when a sponsor company is claiming superiority or when placebo comparison is not considered ethical.


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Lekishia White is Vice President of Multipharma, Inc, and manages the US, Canadian and Latin American operations. She obtained her BS degree in Biology from Spelman College in Atlanta, US, and her MBA from Pepperdine University in Malibu, US. For 10 years, she worked in many capacities in several departments for Amgen, Inc, and became a subject matter expert in the areas of good manufacturing practices and operations, cell culture manufacturing, warehouse logistics, quality and regulatory compliance, clinical and commercial supply chain management, procurement and strategic sourcing, and personnel and project management.

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