Introduction to
Drug Development and CMC
How are new drugs discovered and developed?
From the Amazon forests to the Class-1 Biopharmaceutical Cleanrooms, humans have been making medicines since the dawn of knowledge- we've come a long way, and here you will get quick glimpse of the big picture of Pharmaceutical Development and CMC.
Course outline
The course is ~2 hours long, and comprises of two parts:
In the first part we start by setting the context of Pharmaceutical Development, in a (very) high-level overview:
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How are new drugs discovered?
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What's the purpose of animal studies and clinical trials?
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How are drugs manufactured to the high standards we are all used to?
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What do the Regulatory Authorities have in mind when approving new drugs
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What are the different career paths in Pharma and in Pharmaceutical Development?
In the second part, we will expand the concepts of making pharmaceutical products, and controlling their quality- this aspect is called CMC: Short for Chemistry, Manufacturing and Controls.
We will learn:
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What is CMC
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What are the main lines of work in CMC Development (Product, Process and Quality)
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How the CMC story unfolds in CTD Module 3- the main regulatory document to describe CMC
Who is this for?
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Young-professionals and Students:
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In the life sciences, chemists, and engineers interested in the field- Come hear what's waiting for you out there, after graduation.
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in the computer and data sciences- The Pharma industry needs you!**
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Seasoned Professionals in other parts of the Pharmaceutical world who need a quick orientation to CMC
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Experienced CMC professionals- I invite you to Peer-review this, and if you find it suitable for training your junior team members- I encourage you to share it with them!
** The Pharma field is stepping quickly into the world of Pharma 4.0 which will harness the power of Machine learning, AI, blockchain, and more. So as it evolves there is an increasing demand for Computer and Data scientists, and Engineers of diverse backgrounds. Come join us!