Pharma Reform

While it is hard to argue that you don’t need money to discover innovative new treatments for all the complex diseases that continue to cause illness, disability, and even threaten life.  At the same time, Big Pharma has shown that merely throwing money at discovery research won’t necessarily deliver the results you might expect.

As evidenced by many academic researchers and their teams, it is possible to discovered relevant disease targets and disease altering compounds with far fewer research dollars than Big Pharma has been spending over the past three decades.  Big Pharma R & D budgets, however,  are a misleading indicator of investment in innovation.   In other words, when Pharma holds out the total amount they are spending on R & D ($68 billion), you have to know that only about 30% of that is for discovery and preclinical research.  Still billions of dollars for a disappointing drug discovery return on investment.

Here is another way to look at pharmaceutical innovation productivity.  Let’s say the average Big Pharma has a $1 billion per year to spend on drug discovery and preclinical research.  How do you think that compares to what academic labs (or start up biotechs for that matter) have to spend on discovery research?  Maybe a couple million dollars they have secured in government grants?  Yet, dollar for dollar, who’s delivering the innovation? And why?  An increasing number and percentage of innovative new drugs are being discovered in government or government funded public laboratories.

While they may have less money to work with, academic labs have three essential ingredients that increase the probability for innovative drug discoveries;  expertise, time, and a passionate focus for a comprehensive understanding of the science behind their work (e.g., disease, pathophysiology, biochemistry, and molecular biology).

This is not to say that all Big Pharma researchers lack these essential ingredients.  But even if they do have them, these attributes are mitigated by the distractions of organizational expectations, bureaucracy,  and time pressures to deliver compounds rather than understanding the science.  Perhaps most importantly, expertise in Big Pharma is often rewarded with more work (projects, administrative duties, or increased management responsibilities) that removes (mitigates) the expertise, or at least the focus of the expertise, from the day to day work of discovery research.

Sure, more money can facilitates innovative drug discovery but without expertise, time, and a passionate focus on the science, don’t expect to fill your pipeline.    mike@pharmareform.com

Biotech has proven to be a viable source for innovative new drug products.  The healthcare market’s increasing demand for innovation and the need to fill gaps in Big Pharma’s research pipelines in the face of blockbuster product patent expirations have driven Big Pharma to get a lot more aggressive in seeking innovation outside their own research teams than they have been for decades.

There are five critical success factors that could help the relationship between Big Pharma and biotechs remain a productive source of innovative new products for the healthcare market:

1. Pharma must respect the scientific expertise of the small biotech companies and  resist the temptation to impose its bureaucracy and corporate expectations on the research teams of the smaller biotech companies
2. As much pressure as there is to get products and technologies to market, it is important to make sure the science of these biotech innovations is allowed to be fully vetted before they are advanced to clinical trials.  Pushing technologies into and through development only to be disappointed by the clinical results in Phase 3 trials  may prematurely, inappropriately, and misleadingly dismiss perfectly good products that are not given a valid scientific chance to succeed.  Small modifications or adjustments in chemistry or better defined or better chosen clinical endpoints might lead to success where failure lurks.
3. While there is a robust diversity of innovation being worked on at universities and in small biotech companies, the number of projects that will result in commercially viable innovative products is still finite at any point in time. And because innovation often starts in the university lab, Pharma should be looking for ways to finance and collaborate much earlier with basic science programs at universities to make certain the flow of innovation continues.
4. Technologies and innovative products directed at a particular therapeutic target or disease are frequently dispersed across multiple companies, across different universities, and even across multiple departments within a university.  Pharma should develop programs to help facilitate collaboration amongst these disparate programs and projects to exploit the expertise and increase the probability of finding the best solutions for treating and possibly curing diseases.
5. Universities and small biotech companies must better understand and appreciate the financial risks Big Pharma is taking in providing support at early stages of development and manage their financial expectations accordingly.

mike@pharmareform.com