Lost in translation

Lost in translation. 

Pharma is broken.  This statement is very true – on so many levels -but blanket statements like this don’t really inform on the structure of a relief plan.  Yet, a blanket statement solution characterizes the new drug discovery and development and clinical trials initiative from on high.  For one, the Clinical Translational Science Award Centers.  The original notions initiating a call for reform were the high cost of medicine and low novelty of NCE’s coming from Pharma.  The notion was to stop depending on Pharma to come up with the new ideas for targets and to more quickly move compounds into
clinical trials.  There is no doubt that basic target and drug discovery is too risky, too expensive for Pharma to
do.  New, seemingly crazy, ideas may best be carried out in universities and medical centers.  Wow, so a conclave of scientists with pharmaceutical experience and those with academic/medical center experience could really turn this into a golden reality! 

And there’s the rub – where are the pharmaceutical scientists in all this?  Pointedly ignored and left out!  It seems we are
destined to rediscover the light bulb, going through the 1,000 failures to find a useful filament.  It is appalling and galling

to watch NIH and various academic centers once again throw money, rather than expertise, at a critical need.  The solution pointedly, if not explicitly, says that the whole R&D enterprise within Pharma is broken.   So, to replace that we will have a wholly new set of translators, ones that don’t know the syntax of the language they need to be speaking, ones who will develop a new language from scratch. 

One can certainly fault some pharmaceutical people and practices for not getting it right, but it's not broken because they are deaf, dumb, and blind.  It’s broken because the timelines to making a profitable pharmaceutical product force foolish
reprioritizations into the discovery and development process.  Development of drugs takes many years – that’s a fact of the processes and needed regulations.   But, financial considerations – read salaries, resources, and shareholders – require the process to complete in, at most, a couple of years.  The answer is to separate drug discovery and early development from the costs and resources of clinical development, manufacturing, marketing and sales. 

It should be a mandate that pharmaceutically-trained scientists and drug development managers be front and center in this new roadmap.  They are the only ones who have ever had to talk the talk and walk the walk.  Maybe Pharma needs to take a more active role here, forming their own independent discovery and training center(s), if nothing else, to embarrass
this high-foolishness being touted as the answer to the high cost of medicines.  A place where academic and medical scientists can work with experienced drug developers to work very hard at bringing new ideas to fruition, at least to decision points, without the financial deadlines so critical to paying employees and stockholders.

This new initiative must fail, in part because there’s no requirement to make it work.  We’ll get a lot of great publications, that the authors can walk away from at the end if they don’t really work out.  I’m sure the FDA will happy to approve the new medicines created by those who don’t have to take responsibility.