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Increasing patient engagement with UK clinical trials

pharmaphorum

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. In 2014 Keith was fortunate to become a full-time salaried patient research ambassador at Liverpool Heart and Chest Hospital Trust.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

As per the US Department of Justice, Biogen paid remuneration in the form of training and consulting fees and speaker honoraria, to induce physicians to prescribe the company’s drugs, in violation of the Anti-Kickback Statute. Ferry describes a popular solution among pharmaceutical companies.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103
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ESG considerations in Europe and Asia: social inclusion – the new diversity frontier in life sciences

European Pharmaceutical Review

Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG. For pharmaceutical companies, ensuring that human rights are protected by offering transparency and performing due diligence in global supply chains is key.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.

FDA 52
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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

176 (September 2014):54517–49. link] The SRM risk assessment process is only as strong as the underlying risk culture and governance practices of the company. One of the most important components of SRM is the company’s risk appetite statement. This document catalogs and summarizes the various risks to the company.