By Daria Mochly-Rosen, Kevin Grimes
Written via the founders of the SPARK software at Stanford collage, this e-book is a pragmatic consultant designed for professors, scholars and clinicians at educational learn associations who're attracted to studying extra in regards to the drug improvement procedure and the way to assist their discoveries develop into the radical medications of the long run. frequently many almost certainly transformative uncomplicated technology discoveries will not be pursued simply because they're deemed ‘too early’ to draw curiosity. There are basic, particularly low-priced issues that educational researchers can do to enhance their findings to the purpose that they are often established within the health facility or allure extra curiosity. every one bankruptcy greatly discusses a big subject in drug improvement, from preclinical paintings in assay layout via scientific trial layout, regulatory matters and advertising exams. After the sensible evaluate supplied right here, the reader is inspired to refer to extra specified texts on particular issues of interest.
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Extra info for A Practical Guide to Drug Development in Academia: The SPARK Approach
Linberg SE (2006) Expediting drugs and biologics development, 3rd edn. Parexel International Corporation, Waltham, MA, USA Chapter 2 Discovery and Preclinical Work Daria Mochly-Rosen and Kevin Grimes In any drug discovery and development effort, we must accomplish a number of critical steps to arrive at a compound that is safe and efficacious, and also exhibits the complex array of desired drug-like behaviors that warrants advancement to the clinic. These tasks include target identification and validation; screening for active compounds; chemical modification of candidate compounds to achieve optimized pharmacology; formulating the final drug product; and establishing safety in preclinical models.
Academic research provides essential fuel for new drug development, in general, and for orphan indications in particular. In a recent analysis of 252 drugs approved by CDER between 1998 and 2007, only 47% were considered scientifically novel; and academic discoveries contributed to a third of those novel molecules . In addition, of drugs approved for orphan indications during that period, almost 50% were based on academic discoveries. So academic research is an important engine for innovation in drug discovery.
4 Feasibility of Development Our next step is to determine whether it is feasible to develop our new drug. Is there a straightforward clinical development path? What is our target subject (patient) population? What are the primary and secondary endpoint(s)? How long must we follow the subjects to show efficacy for this endpoint? Are there predictive surrogate endpoints that we can follow? How large is our anticipated effect size? How many subjects must be enrolled? Can we afford to conduct this trial?
A Practical Guide to Drug Development in Academia: The SPARK Approach by Daria Mochly-Rosen, Kevin Grimes