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The Art of Translation Part 2: Drug Development

Once the Center for Clinical and Translational Sciences has helped researchers through several stages, it may be time to start looking at developing a method for delivering the proposed treatment. It is time to bring in the pharmacologists.

The Drug Discovery and Development Core is part of the CCTS and helps researchers work with the College of Pharmacy to find the best method to get treatments into the clinical setting. Whether they are approaching drug development from the clinical perspective (wanting to solve a particular problem) or the chemical (let’s see what this formula can do), researchers will need help. From having the idea to designing a compound to the multiple levels of testing – and this is all before you even satisfy FDA requirements and apply for an IND (Investigational New Drug) – it’s a long and complicated process. Little wonder that it takes an average of 15 years to develop a new drug. Luckily, the CCTS has people experienced in each individual component who can help the investigator in their work.

Dr. Linda Dwoskin is an Endowed Professor in Pharmaceutical Education at the University of Kentucky. She is also Associate Dean for Research and Director of the Drug Discovery Core at CCTS. Given the amount of time to develop a drug, and the length of the CCTS grant from the National Institutes of Health (5 years), she says that while they won’t be able to necessarily see a project from beginning to end, they can at least “get along the pathway” in what is a long, drawn-out process. That pathway will more than likely be a somewhat circular one, as compounds are tested, tweaked, tested again, and so on.

After animal testing, a series of toxicity studies need to be carried out before human testing can begin. Computer programs can analyze the data, predicting whether a formula might be toxic in a certain set of circumstances, which must then be investigated. If it is toxic, then the formula goes back to the chemist to be modified and subjected to a new round of predictive studies.

Dwoskin describes the CCTS as “a kind of conduit that brings people together.” A group known as the Therapeutic Advisory Panel brings together people with expertise in each step of the research and drug development process. The TAP vets applications for CCTS pilot funding in drug development, each expert being able to explore potential problems and ways to overcome them. In this way, applicant projects are reviewed thoroughly before funding is approved. The applicant is then assigned a mentor to assist with each step. The result is a collaboration of expertise that allows an investigator to get much further in their project that they would if they were doing it alone.

Once a formula is found, the next step is equally complicated. Some investigators may conduct clinical trials through the university and the CCTS. Others may form companies to license the formula and patent from the university and attempt to market it to pharmaceutical companies. This is something that Dr. Dwoskin is learning more about in her own research, funded by the National Institute on Drug Abuse. She has been working on finding a compound that might successfully treat meth-amphetamine abuse. With her partner, Dwoskin licensed the patent, and the first round of clinical trials has recently been completed in California. Each step requires additional investment, and another level of translation, this time business-focused.

From a scientist with an idea to a drug on the pharmacy shelf – a very lengthy process that requires input from multiple areas, but ultimately, very worthwhile.

By Fiona Young-Brown, Editor, KY Doc Magazine

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