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The Complexities, Cost of Midwest Biotech Drug Development

CHICAGO In trying to explain the complexities of the biotech industry to investors, academics and start-up biotech companies, most people now understand that it is a long, painstaking and expensive process. What they don't understand is why.

A brief primer in the drug discovery and development process shows us the following pathway:

Logical questions to the above inc......

Full article >>> ese type of diseases by granting orphan drug designation. This designation provides a company with both fast-track review as well as seven years market exclusivity from the time the drug is actually approved by the FDA (independent of the drugs patent status).

Another situation with the FDA exists for drugs for life-threatening disea......

Full article >>> nt to 80 percent of the cost and about 60 percent of the time to develop a drug is in the clinical phase of development (testing in humans), it is critical to ask this question up front before even starting clinical trials.

It has been said that it costs up to $800 to $900 million for Big Pharma to develop a successful drug. That is a higher amount than you are citing. Why?

Full article >>> y.

Happy Thanksgiving! See you next week!


Full article >>>
'"/> By Michael Rosen 11/24/03

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