Leah Kleylein
Leah’s function is Life Sciences and Regulatory Intelligence within Accenture’s Life Sciences practice, with over 20 years of experience.
Leah monitors the Life Sciences regulatory environment for regulations, innovations and trends. Previously Leah worked for global pharmaceutical companies in Regulatory and has deep technical experience in electronic submission standards.
EditorialAdapting, transforming and innovating
For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...
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US FDA CDER and CBER guidance of interest
The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...
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A review of Project Orbis: An initiative enabling faster patient access to cancer therapies
Project Orbis was initiated on 17 September 2019 by the US FDA to provide a framework for the concurrent submission and review of innovative oncology products among international regulatory authorities. The focus of the initiative is on high impact cancer treatments targeting unmet needs or providing significant benefit over existing ...
