Streamlined research
pharmafile | January 19, 2004 | Feature | |Â Â Â
For many years the pharmaceutical industry has been promising that they were on the verge of a boom in the number of new chemical entities (NCEs) and drug registrations. R&D announcements from the top 10 drug companies, most recently, GSK and Novartis, indicate that the long wait for proof of these investments made in discovery and pre-clinical could soon be over.
Traditionally, only 10% of NCEs entering development have made it to market and it is estimated that 60% of the active substances currently in discovery will not progress to the more advanced stages of development. These high attrition rates are a major challenge for the industry in the face of demands for increased productivity. Furthermore, such attrition rates mean that companies must strive to achieve a balanced portfolio of NCEs in each phase of development to maximise the likelihood of achieving a steady output of products.
Heavy investment in new discovery and pre-clinical technologies, such as genomics, combinatorial synthesis and proteomics have gathered momentum throughout the industry and are expected to continue. In the short term this will increase R&D costs, but in the long term greater efficiencies will be expected as firms gain greater knowledge of the new targets generated .
Recovering pipelines
In November 2003, Novartis announced a total of 78 development projects of which 63 are in phase II and III/registration. This was followed at the beginning of December when GSK announced a further 30 new chemical entities in their pipeline of 147 projects compared to 2001, with 98 projects in clinical phase II and III/registration.
These reported increased numbers flowing into the later phases of clinical development naturally lead to major questions being asked about how this will be delivered:
- How will the industry cope with the added resources they will need?
- Is there enough skilled scientific staff to handle the industry ramp-up?
The traditional answer has been to outsource to a CRO yet despite the industry reliance on outsourcing it has never really grown from more than a tactical necessity to a strategic imperative. The reason being that the pharmaceutical companies want to maintain some degree of control on what is the lifeblood of the organisation. The answer lies in re-engineering the clinical development process in the same way as has been achieved with discovery and pre-clinical.
Drug development costs
Improving the efficiency of drug development through lower attrition rates or faster development times would have a major impact on the cost of new drug development, according to an analysis completed by the Tufts Center for the Study of Drug Development.
Currently, the average cost to develop and win market approval for a new drug in the US is $802 million. Tufts found that improving clinical approval success rates from one in five to one in three will reduce total costs by approximately 30%.
The early stages of discovery have been revolutionised by the increasing use of lead optimisation and pharmacogenomics. Therefore, pharmaceutical companies should be focusing on technology to enable a streamlined clinical R&D model, which emphasises quality, speed and cost benefits.
Rapidly rising drug R&D spending in the US is helping usher in a new R&D paradigm, shortening development times while improving clinical success rates. Economic pressures in pharmaceutical markets will grow, compelling firms to improve the efficiency of the drug development process.
Increasing the speed and quality of trials
If technology enables the clinical process to become more efficient the industry should be encouraging enterprise-wide adoption. An example of how this can work in practise is demonstrated by Novartis.
Each year the company conducts approximately 200 new trials, at 20,000 active clinical sites with 200,000 patients. These activities encompass around 1.2 million patient visits and generate 60 million clinical data points.
Consequently Novartis has paid particular attention to its development metrics, with the result that its average development speed (pre-clinical to registration) has decreased from 8.3 years in 1997/99 to 6.1 years currently. The main reason attributed to this reduction was through its use of electronic data capture (EDC).
With such high productivity in clinical trials, Novartis has yielded significant benefits in terms of speed and quality. However, the benefits have also proved fiscally beneficial, reducing costs by an estimated $100m annually.
For many years EDC was heralded as the next big thing for the pharma industry, and pilot studies have been well documented. However there has been a general reluctance for broader adoption with many waiting for industry leaders to take up the technology and prove the benefits, in particular the delivery of ROI. The lag between piloting and enterprise adoption has surprised many industry outsiders, who compare the industry to other heavily regulated areas such as finance, a sector that has gained significantly from converting its traditional paper-based systems to an electronic process.
Perhaps what the Novartis data shows most keenly is that one of the key benefits of EDC is the fact that it provides pharmaceutical companies with a greater capacity to handle increased numbers of drug candidates from discovery. It also increases efficiencies in developing new compounds that are eventually approved for marketing; we call this the "fail faster" benefit.
Delayed product termination increases costs, clogs the research pipeline with compounds unlikely to achieve success, and disappoints stakeholders, including company shareholders, project teams, service providers and patients. Real-time information from EDC systems can lead to unsuccessful compounds being terminated earlier, thus allowing resources to be re-deployed faster, to investigate potentially more promising compounds.
Now that pharma companies worldwide are starting to reap the benefits of their investments in discovery, their next big challenge both from an investor and healthcare point of view is delivery. After both the Novartis and GSK R&D days, the media was awash with the same question: "Can they deliver?"
Adopting EDC technology?
The industry is at a crossroads: their stakeholders are demanding results and this will require a revolutionary approach to their clinical groups. If they adopt EDC technology across their worldwide R&D network, estimates suggest that they will require only a 150% increase against the 300% increase in clinical personnel resource predicted using their traditional formula.
The conventional personnel numbers are going to be hard to obtain, and will take significant time and effort to ensure a high level of quality is maintained. Even if companies are able to hire the staff, the soaring cost of resources will put further pressure on their management to produce the profits that the investors expect.
New technology has proved its worth within the pre-clinical arena, so the time is right for the sometimes-conservative pharma industry to harness the power of EDC to allow a better, safer science to be born.
