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Generalizing fastest drug development strategies and practices.
Drug development companies face one of the toughest operating environments: Clinical research costs continue to rise steadily at a rate of 12%–14% annually; average development and regulatory cycle times are worsening; the volume and scope of clinical research activity is increasing while the volume of approved new drug applications and drug development success rates remain low.
Kenneth A. Getz
Development resources in the current climate will be further constrained by market conditions for prescription pharmaceuticals: Public trust in industry integrity has eroded sharply; drug detailing and advertising practices face increasing scrutiny; charges against FDA effectiveness loom as potential openings to overhaul the agency; and the changing of the guard in both houses of Congress threatens to intensify branded drug pricing practices and the use of generic drugs.
Today's operating realities underscore the importance of speed and efficiency as central to all viable drug development strategies. In doing so, companies optimize product revenue while minimizing development costs. The rewards for speed and efficiency can be great with an average of $30 million in out-of-pocket development costs saved and $1.1 billion in incremental prescription revenue gained for each product. A company's aggressive and ongoing pursuit of speed and efficiency also delivers other benefits, including streamlined and continuously improved development operations and coordinated organizational support.
A select group of companies stand apart as the fastest drug developers—"Speed Demons"—during 2000 to 2005. Bayer, Astra-Zeneca, Allergan, Boehringer-Ingelheim, and Merck are the five fastest, and they appear resistant to some of the challenges that plague most biopharmaceutical companies at this time. Speed Demon companies are almost always the fastest among those with which they compete. They exhibit far less cycle-time variability while maintaining levels of development spending comparable to industry benchmarks.
Speed Study Methodology
Whereas most biopharmaceutical companies saw their development and regulatory cycle times increase between 2000 and 2005, for example, Speed Demons defied convention and shortened their development and regulatory timelines. During that six-year period, the fastest 10 companies reduced their median development speed by 20% (from 66.5 to 53 months) and held regulatory cycle times flat. Between 2000 and 2005, the typical company saw median development cycle times increase by 3% and regulatory cycle times increase by nearly 11%.
In each therapeutic area where they compete, the fastest development companies beat median development and regulatory cycle times more than 83% of the time, demonstrating that speed and efficiency are not chance or haphazard events. In addition, the fastest drug developers managed to minimize development and regulatory cycle-time variability, suggesting that they are implementing speed and efficiency strategies across their portfolios.
In comparison, the slowest companies display high levels of variability, suggesting that examples of efficient drug development practices may be found and applied within their own organizations.
Between 2000 and 2005 the fastest development companies delivered as much as a 17-month development speed advantage over average performers and as much as a three-month regulatory speed advantage. So what are the fastest companies doing? Interviews with executives from the fastest companies suggest a number of common practices centered around leveraging resources and collaborations:
Fastest companies, for example, terminate 56% of their discontinued projects in Phase I, whereas slowest companies terminate only one-third of discontinued projects in that time frame. And drug companies that have higher relative CRO usage report completing their projects closer to projected time frames and submitting their projects more than one month closer to projected submission dates.
Faster submissions in the absence of faster approvals are a hollow achievement. But this is not the case with Speed Demons. They tend to have shorter regulatory approval times. The industry median regulatory review time (i.e., NDA submission to NDA approval) was 15.7 months during 2000 to 2005. In that same period, the fastest companies received approval in a median of 13 months.
Speed Demon practices are not rooted in leading-edge and proprietary technologies, nor are they the result of radical approaches to managing and conducting clinical studies. The fastest drug developers attribute their success to superior and consistent implementation of concepts supported across the organization.
It is difficult for companies to sustain a speed advantage for extended periods due in part to the uncertainties of major portfolio changes, significant financial and operating challenges, and merger and acquisition disruptions. Only two of the current fastest companies—Merck and Astra-Zeneca—were ranked among the five fastest during the previous six-year period.
Between 1995 and 2000 the fastest drug developers were Zeneca (now AstraZeneca), GlaxoWellcome (now GlaxoSmithKline), Merck, Pfizer, and Abbott. Key practices cited by Speed Demon companies during this earlier time period appear more insular, focusing on project team empowerment, project planning effectiveness, and data management effectiveness. In the more recent period evaluated, Speed Demon practices focus to a large extent on managing the effectiveness of external collaborations.
Several practices are frequently cited by today's Speed Demons as areas that may yield speed advantages in the future. In interviews, the fastest companies revealed that they are focusing on improving study conduct efficiency. They cite reducing protocol design complexity, applying new approaches to recruiting and retaining patients, and implementing better investigative site management practices as essential new improvement opportunities.
Development and regulatory cycle time reductions are not single occurrences. They are based on identifiable practices best employed by Speed Demon companies that can be learned, imitated, and implemented by all sponsor companies. By shortening overall cycle times, the fastest drug developers are lowering their direct development costs and extending product sales within an intensely competitive and challenging operating environment.
Kenneth A. Getz MS, MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: firstname.lastname@example.org