Positioning Biomedical Companies for Strategic Competitive Advantage
Biotechnology today has become an integral part of the national and international economy and thus a critical component of economic competitiveness. Among the various fields that make use of biotechnology processes, medical biotechnology has been one of the most beneficial and controversial. It has already generated superlative discoveries to improve the lifespan and quality of human life. Although this is a high-growth sector, moving a promising research discovery to market is a complex and costly undertaking. Despite the sector's growth, most of the 1,500 U.S. biotech firms do not make money.
Challenges
One of the major challenges facing this industry is the rising costs of new drug development. Most experts agree that the cost of R&D in the drug industry - the cost of clinical trials in particular - is rising significantly. According to an FDA report (FDA critical path initiative-link), "The investment required for one successful commercial launch of a medicinal product increased more than 55% in less than a decade, due in large part to the monies required to take a drug from the laboratory and carry it through the standard phases (1-3) of clinical study". A key part of the problem is the rising costs of clinical trials. It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, which require a strategic design of the clinical trials.
Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. For more than a decade, there has been a steady downturn in the submission of major drug and biologic product applications to the FDA. It is therefore crucial to ensure that the clinical trials attrition rates are reduced.
The Future
To address these challenges, big-picture thinkers, both within and outside the industry, are re-examining every stage of drug development in an effort to foster faster innovation. MIT's New Drug Development Paradigms and Children's Hospital Informatics Program's new forecasting models to reduce drug costs are some of the latest developments towards that goal. Biomarkers and Exploratory Investigational New Drug studies are other two landmark developments in this field.
With high costs associated with the later phases of development, developing Clinical Proof of Concept in early stages is becoming extremely important. Obtaining this evidence allows companies to focus effort and expense on the most promising compounds and to abandon drug candidates before such investment is wasted. However, in the pharmaceutical industry, achieving the clinical proof of concept milestone typically takes 3-4 years and $15M to $40M. BBCR's focus is to create experimental design and reach proof of concept in timeframes of about 2.5 years and significantly reduce the costs.
The economic crisis of 2008 has amplified the importance of managing expenses closely and making decisions when the time is right. However, cutting research costs across the board in a recession is not smart. Instead, companies that are developing new technologies should use R&D as an opportunity to become more competitive globally. Such companies must rely on a network of relationships and services around the world to develop their innovative products. Bilateral service partnerships with service providers in other regions -especially the innovation hubs in U.S. - are critical accelerators of economic development.
Based in Massachusetts, BBCR, LLC was founded to address the need for innovation in clinical development to emerging companies who do not yet have the infrastructure to run such programs themselves. BBCR operates on the fundamental principle that the customization of clinical strategies and study designs are keys for the success of innovative drugs and devices.
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