Katherine Giacoletti

Merck & Co Inc
Principal Scientist
Katherine Giacoletti is a statistician in the Center for Mathematical Sciences, part of Merck & Co., Inc. Katherine has worked as a statistician in the pharmaceutical industry for over 22 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics degree from North Carolina State University, with a focus in biostatistics, and before starting in Pharma she worked in survey research at the Research Triangle Institute. Katherine lives in Philadelphia, and in her spare time is a dancer and a teacher of Scottish dancing.

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Continuous Manufacturing as a Tool for Accelerated Development
Features
Continuous Manufacturing as a Tool for Accelerated Development

Continuous manufacturing (CM) offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of continuous manufacturing in enhancing accelerated development, as evidenced by experience in solid oral products.