PharmaWeek: What is the current state of the pharmaceutical industry? 

Dr. Dolsten: The pharmaceutical industry has been accused of being an inefficient and expensive industry. However, in many areas, we have seen substantial therapeutic advances in the last decades (i.e., virology, cancer, cardiovascular and inflammatory diseases). I believe there are ample opportunities ahead of us to more critically address the bottlenecks we face and to explore the bounty of great scientific advances that will help us better understand human disease. These should allow us to proceed with optimism over the next several years, competently exploiting our capability to design novel compounds and provide important drugs for suffering patients. Currently, I see a very promising trend toward increasing the output of better compounds from drug discovery organizations across the entire industry.  

PharmaWeek: What are some of the key bottlenecks? 

Dr. Dolsten: One major bottleneck for many Pharmas is the extent of attrition due to insufficient efficacy in Phase II and III trials. Key lessons we have learned from the research organization is the need to explore more efficient ways of selecting medically relevant targets, by clearly defining the target product's profile, and using animal models early on that use biomarkers to improve the translation from animal data to early clinical signals.  

A second bottleneck stems from the way that we currently prioritize our pipelines. We need to manage our research portfolios more strategically.  The urgency and eagerness for novelty has led to the issue of low success rates. One avenue toward addressing this is to explore pathways that have been clinically proven, but perhaps by using a new entry point to the mechanism, selecting a new subset of patients or trying to carefully assess the compounds in obvious as well as in unexpected indications.  

We also need to increase the diversity in our lead generation capability to better tackle difficult targets that regulate important disease processes and increase our ability to select high-quality lead compounds. Simultaneously, we must increase efficiency and speed in the research phase without sacrificing the quality. 

So on the one hand it is critical to work on the drug discovery value chain, keeping a very strong technical focus on trying to address the bottlenecks. On the other hand, we must improve our ability to select innovative targets in the interest of exploring novelty. However, since complexity is always present in uncharted biological territory, in parallel, we also need to balance our eagerness to break through into immature areas by exploring the emerging and existing ones. I believe there will still be good opportunities for clever follow-on projects to deliver valuable compounds. It all comes back to the goal of providing a better benefit-risk ratio for the patient with a new therapy vis-à-vis an existing one.  

PharmaWeek: Is pharma up to the challenge? 

Dr. Dolsten: All of us in pharma believe that we have highly talented and committed scientists covering many areas of drug discovery. Further, we have access to state-of-the-art technology and leading approaches for selection of projects and development of new drug candidates. On a more general basis, we have to embrace the opportunity to work with multiple partners to tap into the entrepreneurial, external world. This can be despite the fact that you already have a very talented organization. Then, you must strategically select those areas where you feel that external development is moving at a particularly fast clip. When you see a technique maturing to the point that it can be quickly integrated into your own drug discovery engine, you must act. If you can flexibly integrate such opportunities into your internal technological capabilities, then a network of internal and external expertise exists from which you can draw. 

There is of course also the opportunity to partner with skilled biotech companies that have chosen to specialize in discovering compounds with particular mechanisms of action. I think it is usually quite beneficial to seek early collaboration before such compounds progress too far into clinical studies. An early partnering experience lends itself to development of compounds using the pharmaceutical R&D experience in a company, such as Boehringer Ingelheim, combined with the technical expertise of a small biotech working in a specialized area.  

PharmaWeek: What are Boehringer Ingelheim's strengths? 

Dr. Dolsten: I believe that Boehringer Ingelheim is a "right-sized" Pharma company, with an appropriate focus on continuity, consistency and persistency to be a highly successful Discovery organization. I believe that we have the critical resources and capabilities to access both the technique and the knowledge base for the disease areas we pursue. At the same time, we force ourselves to avoid the so-called "nice to have but may not be necessary" in order to focus on critical needs. This is necessary for us since we do not have excessive resources, which may be the case for some very large organizations. We believe we can work efficiently as an integrated, nimble and well-oiled organization drawing upon our global presence. But at the same time, despite our sheer size, it is possible for us to create innovation domains, or "clusters," around therapeutic areas. Our openness and frank curiosity to collaborate with external partners, combined with our internal capability for developing small molecule and protein therapeutics all the way through from lead generation to marketing the product, allows for very strong partnership opportunities.  Pharma and Biotechs will ultimately make those calls for productivity leaps and bounds through collaborations—not only competition.

Note: Mikael Dolsten will be giving a Keynote Presentation at Cambridge Healthtech Institute's World Pharmaceutical Congress, May 23–24, in Philadelphia, PA.

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