By Ernie Bush
September 15, 2009 | Bush Doctrine | When asked if I wanted to write a regular column for Bio•IT World, it took maybe a microsecond for me to accept the offer. For a person that loves to pontificate, such an opportunity is like offering an overnight stay in a candy store to a chocoholic. Unfortunately, the second question was much more difficult: What should we name it? A few initial thoughts such as: Eye on Drug Safety, Drug Safety Insights, Pre-Clinical & Drug Safety Watch, Pre-Clinical & Drug Safety Trends, Pre-Clinical & Drug Safety Breakthroughs, etc. seemed a little too ‘predictable’ and more importantly, none really addressed the objectives I had in mind. In fact, they demonstrate a fundamental issue with how we name the whole space around early evaluation of compounds intended for human medicines.
Several years ago, many in the pre-clinical drug development community realized that their systems and management practices were heavily fragmented; too often delivering disconnected and difficult to assimilate results. One solution to this problem was to combine all of the preclinical development activities into one operational unit such that their management, objectives and deliverables would be better aligned and more integrated. Accordingly, they combined the traditional Toxicology, Drug Metabolism, Pathology, Pharmacokinetics, Bioanalytical, and Safety Pharmacology groups into one entity. Among the multitude of issues that resulted from trying to integrate such an array of people, philosophies and business practices was again the problem of what do you call this group. Some of the names adopted were: Non-Clinical Drug Safety, Pre-Clinical Sciences, and Early Development. Unfortunately these names also fall short of communicating the real intend and objects of the integrated departments.
So what are these new departments about? In fact, the central goal and objective of these new departments is to predict whether a candidate molecule will make a value added human medicine, i.e. are the properties of this new molecule adequate for it to be a good drug? In other words, is the new molecule drug-like? Or, my personal favorite, what is its “drugness”? So this drugness property is really our primary objective therefore it should be part of the name of these new integrated departments and, by extension, part of the name of this column.
Given this is an informatics oriented publication and given that informatics has traditionally been a very weak area of safety (drugness) evaluation, it would seem clear that IT-sounding words should be part of the column’s name as well. In addition, during my 27 years in this industry I would say the number one frustration and shortcoming of our discipline has been access to our history. Since GLP was adopted in the late 1970s there are literally millions of toxicology, drug metabolism and pharmacokinetic reports locked away, collecting dust, and hard to access, in company archives. Pharma has invested billions of dollars in collecting this data and it is absolutely shocking to realize how poorly we can leverage this investment, especially in terms of being able to utilize it for generation of new knowledge in the form of SAR analysis, modeling, or data mining. While words like “data warehouse”, “knowledge management” or “safety informatics” all have a familiar ring to them, they again seem to be either too narrow or too tech-oriented for this column.
Decisions & Doctrines
For me, the real key to value creation in this space is “easy access”, i.e. once you define a system, infrastructure, and process for making the test results easy to access, then all the other opportunities such as data sharing, data mining, etc. become straight forward extensions to this access engine. As such, I would like to see easy access to our drugness history as part of, or else implied in the column’s name.
One last element is critical to capture in this column. In the end, the hoped for result of generating, collecting, and analyzing all this drugness data is to make good decisions. What is the best molecule to move forward, what is the best design of the clinical development program, how should this project be prioritized against the rest of the portfolio? These are the types of fundamental decisions being made daily, based in large part on this drugness data, and of course the existing pharma R&D attrition rates suggest we are not very good at making these decisions.
Putting this all together suggests a name like: Better Pharma R&D Decision-Making Through Easy Access to Our Drugness History. Hmm… doesn’t exactly roll off the tongue, does it? To simplify this decision and to avoid having to make up new words, my editor has suggested the name The Bush Doctrine. It does have a certain ring to it. But before finally deciding on what to call this new column, I would like to hear your thoughts and feedback.
Ernie Bush is Vice President and Scientific Director of Cambridge Health Associates, the leading organizer and facilitator of biopharmaceutical collaborations in the safety evaluation space. CHA plans collaborative projects, roundtable summits, virtual meetings & seminars, and the Drug Safety Executive Council (an online community of industry leaders in safety assessment). Ernie can be reached at email@example.com