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Manufacture Standards & Regulation

How to Standardize Advanced Therapy Manufacture

Introductions

“My name is Angela Myers and I lead a new business initiative in gene editing and cell and gene therapy (CGT) manufacturing at Merck. In this role, I am responsible for R&D, commercial, marketing, strategy functions for the viral vector CDMO business, and the CGT manufacturing technologies such as cell lines and acoustic cell therapy manufacturing.”

“Hello, I’m Michael Lehmicke, the Director of Science and Industry Affairs at the Alliance for Regenerative Medicine. ARM is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines – cell, gene, and tissue-based therapies. My role at ARM is to work with our members to identify best practices for establishing robust manufacturing processes. We also work collaboratively to identify CMC guidance gaps. We have a good working relationship with the FDA and EMA and engage with both regulators regularly to address these gaps.”

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About the Author

James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.

From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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