Steven Paul Talks About Improving R&D Productivity
Fast Breaking Papers Commentary, February 2011
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Article: How to improve R&D productivity: the pharmaceutical industry's grand challenge
Authors: Paul, SM;Mytelka, DS;Dunwiddie,
CT;Persinger, CC;Munos, BH;Lindborg, SR;Schacht, AL |
Steven Paul talks with ScienceWatch.com and answers a few questions about this month's Fast Breaking Paper paper in the field of Pharmacology & Toxicology.
Why do you think your paper is highly
cited?
Our paper addresses arguably the most important challenge facing the biopharmaceutical industry today—namely rapidly declining R&D productivity. The latter manifests itself in ever-increasing costs to discover and develop new medicines.
We analyze R&D productivity in a highly quantitative manner and provide an explanation for this declining R&D productivity based on real-life data from a recent industry-wide benchmarking study of 13 top pharmaceutical companies. We also identify the key rate-limiting steps in the R&D drug discovery and development process and elaborate specific ways that R&D productivity can be substantially if not dramatically improved.
Does it describe a new discovery, methodology, or
synthesis of knowledge?
"We hope that our research will help improve R&D productivity industry-wide and that extensions of our work by others will identify and elaborate other potentially more effective interventions to help solve the R&D productivity conundrum plaguing the biopharmaceutical industry."
Really a synthesis of knowledge (and data) from most of the largest pharmaceutical companies.
Would you summarize the significance of your paper
in layman's terms?
It now costs about $1.8 billion and takes about 14 years to discover and develop a new medicine and these costs have become prohibitively expensive, reducing the number of innovative new medicines reaching patients on an annual basis to a small handful and making the current business model of the industry almost unsustainable.
Our paper helps explain why R&D productivity is so low and what needs to change (and by how much) for productivity to substantially improve. Without such improvements in R&D productivity it will be impossible to deliver on the great promise of biomedical research and the incredible advances that have (and will continue to) be made in disease biology over the past decade or two.
How did you become involved in this research, and
how would you describe the particular challenges, setbacks, and
successes that you've encountered along the way?
I have led various aspects of R&D at one of the larger and more successful pharmaceutical companies over the past 17 years (including head of R&D) and faced first-hand the many challenges discussed in our paper. Moreover, many of the interventions and improvements we made in the R&D process (a number outlined in our paper) have already had a tangible beneficial impact on our early and mid-stage pipeline.
We hope these changes and their positive impact on the pipeline will result in a near-term number of new medicines (beginning in 2-3 years) reaching patients. Thus, the experiment described in our paper is still in progress.
Where do you see your research leading in the
future?
We hope that our research will help improve R&D productivity industry-wide and that extensions of our work by others will identify and elaborate other potentially more effective interventions to help solve the R&D productivity conundrum plaguing the biopharmaceutical industry.
Do you foresee any social or political
implications for your research?
Absolutely. Our work has implications for the entire biomedical research
enterprise—but especially for the ability of this "enterprise" to
provide a steady flow of life-saving/life-enhancing new medicines for a
whole host of diseases (unmet medical needs like cancer and Alzheimer's
disease) and at affordable costs/prices—something that is critical
for providing cost-effective healthcare to society at
large.
Steven Paul, M.D.
Director, Appel Alzheimer's Disease Research Institute
Professor of Neurology (Neuroscience) and Psychiatry, Weill College of
Medicine of Cornell University
New York, NY, USA
formerly President, Lilly Research Laboratories
Executive Vice President for Science and Technology, Eli Lilly and
Company
Indianapolis, IN, USA
KEYWORDS: CORONARY-HEART-DISEASE; DRUG DEVELOPMENT; CHOLESTEROL; PCSK9; LDL; OPPORTUNITIES; INNOVATION; MUTATIONS; DISCOVERY; ATTRITION.