Stretching the Clinical Dollar

It seems that we are being bombarded with messages lamenting the economic downturn and the corresponding needs of virtually every industry to “trim costs” or “preserve capital.” As the access to funding has become increasingly difficult, the intensity of Clinical Operations and Board Room discussions of “stretching” the research and development budget has intensified.

The facts and challenges are staggering – developing a drug from bench to market can cost upwards of a billion dollars; hospitals, physicians and patients rely on the research dollars provided by pharmaceutical companies, in terms of direct payment and “free” patient care to make budget ends meet; regulatory hurdles continue to rise with each new “Vioxx” as the FDA seeks more safety data generated over longer periods of time; the cost to send clinical staff to more remote clinical sites rises astronomically.

With this backdrop, is it even feasible to discuss “stretching” the clinical dollar?

It seems a daunting task – and there is no Sunday circular from which to clip coupons to help save an extra 15% on data management costs. So what can our industry do?

With all challenges come huge opportunities. A greater level of scrutiny on spending in clinical trials is an excellent reason to take steps to ensure we are doing the right study. A few cost saving steps that come to mind are: ensuring the data collection process is streamlined to maximize monitoring visits thereby limiting travel and personnel costs; or ensuring that contracts are negotiated with providers (CROs, labs, etc) with enough detail to limit out of scope charges and changes. As an industry we like to think that more data is better, but more data usually equates to greater cost. Perhaps we should consider building mechanisms for more thorough analysis of data we collect in the clinic so that additional studies are not necessary. (As more studies = more money spent).

Bottom line: we need more disciplined practices in clinical development and decision making to stretch the clinical dollars further.

Thinking Big

My name is Greg Dombal and I am Vice President of Regulatory and Clinical Affairs for Halloran Consulting Group. Our firm works with life science companies developing drugs, biologics and medical devices with the intention of helping our clients get to market quicker and with greater efficiency. As the total expenditures on health care in the United States continue to spiral seemingly out of control, pressure has grown on our industry to deliver better medicines with fewer side effects for less. I am sure that I’m not alone in my struggle to come up with ways to effectively progress brilliant scientific ideas from bench to pharmacy in a commercially viable way.

We all know the numbers – the Tufts Report on Drug Development captures it and throws it in our faces - $1.2 billion to carry an idea from our CSO’s head to the physicians writing prescriptions. $1.2 billion per drug – if we added up the money currently being spent in development, the biotech industry could likely bail out several ailing financial firms. Faced with the odds (that I am grossly generalizing) that most of our promising ideas will not make it to market – why should we, as an industry, continue developing anything?

I think in our hearts, we are optimists and are filled with an incredible sense of purpose. Those from academia and research institutes toil for years exploring and identifying underlying mechanisms of disease entrust not only their ideas to us but also their hopes of bringing life saving drugs to people in need. Likewise, the promise of eradicating cancer, easing diabetic suffering or countless other pharmaceutical applications makes us wake early, work tirelessly and keep a pad by the bedside to capture just one more thought.

We have unprecedented access to data and information through electronic data systems, yet we lament over data that was there all along. The tools for identifying genetic signals and protein expression levels have given us the ability to look in so many places in the human body that were longer hidden from our eyes and imagination, yet in seems that the wealth of knowledge we have on certain diseases has not yet translated to an ability to cure them. For example, virtually everyone wants to have a biomarker for their drug, however, there are relatively few examples of biomarkers guiding and driving development of a drug rather vice versa.

At the end of the day, we have better medicines than generations past and I am confident that our children will have significantly better ones than we have today. Why? The optimism, the ingenuity and the creative genius in our research colleagues combined with tireless effort of development teams have produced breathtaking success.

To that end, I have started this blog as a forum to share thoughts, comments and insights on the challenges faced in drug development from the ever changing mood of FDA to methods for stretching the research and clinical dollar to ways to reach the inflection points in the perceived value of clinical programs. I don’t profess to know the answers to many of the questions facing us, but hope this blog will host a stimulating and engaging discussion. I welcome your comments and look forward to an engaging conversation.