Monday, January 24, 2011

National Center for Advancing Translational Sciences

National Center for Advancing Translational Sciences
Finally the wraps are off and we can assess how the Federal government intends to address the apparent – real – decline in the number of new medicines.  As presently configured, the pharmaceutical industry cannot support the cost and time required for new drug discovery.  Drug developers and manufacturers need an ally who can evaluate novel potential drug targets and provide enough information for pharmaceutical companies to invest in drug development.  This new Center sounds exactly like the right kind of approach.
In order for National Center the Advancing Translational Sciences (CATS?) to be successful, it must be able to take naked discoveries from academic investigators and fill out their resume enough that pharmaceutical companies can evaluate their feasibility as products.  This should mean taking scientists and managers, and leaders, who are already experienced in this art and putting them into this less financially volatile (hopefully) institute.  Who carries out this role now?   Who has experience?  Well, mainly a large number of un/underemployed pharmaceutical industry scientists and managers.
Will this new Center bring in these experienced professionals?  While this should be a no-brainer, I expect this new and critical part of drug discovery will be staffed by academic-type investigators. The only justification for this that I can imagine would be that the present process of drug discovery and development is wrong, broken.  I don’t believe this!  It is costly, time-consuming, and has a fairly low success rate, but much of that is because the end-products are ethical pharmaceuticals.  These require enormous attention to detail and to safety. As I’ve mentioned earlier, this is not, and I believe should not, be the main charge of academic research. Academic research can be non-generalizable (read, not reproducible) because its function is to stimulate further research, not make a product.  Furthermore, I believe that there are a large number of novel ideas, novel targets that could be worked on.  The bottleneck is providing tools (compounds)
and information (reproducibility, efficacy, safety, among others) in order for drug discovery and development to be objectively triggered.  I don’t believe it is reasonable to ask academic or internal NIH scientists to learn to become pharmaceutical scientists overnight, or even over a 5-10 year period.  Who will teach them?  Are they expected, allowed, to learn from personal experience?! Staffing this new Center with academic investigators and managers will also set the stage for a politically charged battle between this Center, claiming that it has great things for pharma to invest in, and the
industry saying that it doesn’t have the information it needs to start programs.  What will be next, a National Center for the Development, Manufacture, and Sales of Medicines?  Far-fetched?  I sure hope so.
One of the best things about staffing this Translational Sciences Center with a goodly percentage of pharmaceutical research professionals is that so many are currently very available…  They can probably be snatched up for 70-80c on the dollar…   On the other side, Federal stimulus funds have allowed many universities to hire more assistant professors and postdocs so that the academic community doesn’t have as strong a need for new positions.
I call for more pharmaceutical professionals for this important Center for another reason, success. The NIH Genome project was touted to provide a plethora of new medicines.  With the huge, possibly unnecessary, outlay of Federal funds, the medicines are yet to come.  Even at the time of the Genome project it was clear that determination of physiological function would be necessary in order to prioritize gene products as potential drug targets.  This type of effort was going on, slowly, in some academic labs, and, in a much higher throughput manner in some companies.  Belatedly, NIH started
programs like KOMP, the knock-out mouse project.  But, again, the reality is that huge sums of money were spent for KO mice that in many cases already existed, delaying any chances for success stories for years. Sure, there are lots of reasons for why NIH had to reinvent the wheel, but I maintain that those reasons were/are mainly hypothetical as no one –
almost no one – has worked with enough KO mice to understand the real hurdles.  If NIH, and friends, have to reinvent translational sciences, it is likely that a large amount of money will be needlessly spent, and the delay to real successes will be long. [As an aside, KO mice, mice in general could provide a very nice, and presumably less costly, vehicle for most pharmaceutical testing.  However, the industry is built on years of experience with rats.  Let NIH, and industry, work to either solidify KO rats as a general tool, or build up a large amount of disease model and toxicology data on mice!]
I fully believe in and support the need for a Center for Advancing Translational Sciences.  I only hope that it will provide answers and not just a call for a National Center for Developing, Manufacturing, and Selling Medicines in a couple of years.

No comments:

Post a Comment