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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. It also lowers the regulatory burden too, the paper reported. [In The team examined the European Public Assessment Report (EPAR) for the QbD approach.

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FDA sketches a path for patient-focused drug development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

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NICE talking to you: Trends in early HTA engagement

pharmaphorum

In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA).

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July 2023 Newsletter

Safe Biologics

Drug Developer Discusses Impacts on R&D ​Steven Potts, PhD, MBA; CEO of Anticipate Bioscience is a cancer drug developer. Dr. Potts discussed how the IRA will reduce investment in drug research and development, particularly for small molecule drugs.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

In 2001 and 2007, through 2009, the economy was hit hard. There was a significant slowdown in drug development, clinical trials, and new drugs coming to market. EMA prepares for winter antibiotic shortages That slowdown resulted in 211 drug shortages in 2010—the highest number recorded in a single year at the time.

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NICE methods and process review aims to create fertile ground for innovation

pharmaphorum

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? At the end of the day, medicines are developed for patients, so understanding what they want and what they need remains absolutely crucial,” says Dr Catchpole.

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Lilly’s chief digital officer Aarti Shah announces retirement

pharmaphorum

At the same time, the industry is looking to develop digital medicines that improve patient outcomes. Shah has been at Lilly since 1994, joining the company as a senior statistician, rising to become vice president for biometrics in 2009.