Pharmaceutical firms must innovate faster
that despite the decline in R&D productivity, scientists are
working harder and completing more projects.
The survey, which questioned more than 60 scientists representing seventeen of the top twenty global pharmaceutical and biotech firms, revealed that R&D isn't producing a sufficient number of commercially successful drugs quickly enough.
"While they've proven they can churn out a great number of products, creating the right products to fit strategies and market potential has become their biggest challenge," said Dr. Steve Chen, industry manager of Kline's Healthcare Practice, the authors of the study.
"In an increasingly difficult market with exceptionally high expectations, they admit they need help to enhance productivity."
Industry data confirms the study's findings. While there have been more products entering the pipeline, fewer are getting through development. The largest problem is in Phase II, which accounts for 17 per cent of the pipeline, and where projects are getting tied up and are taking longer to pass through to subsequent stages.
The emphasis in getting increasingly more out of funding and investment is seen as the stumbling block towards a more streamlined approach to drug R&D. Spending has not resulted in proportionate innovation as the number of new molecule entities (NME's) has declined.
"Scientists are being challenged to discover and develop novel drugs, faster and at less cost, in a more difficult environment," said Dr Chen.
According to Kline's survey, the scientists feel it's much harder to innovate today for several reasons.
One reason that may seem obvious is that the "easy" products have already been discovered. No one can deny that the scientist's job has gotten increasingly difficult over the years with viable drug targets becoming a premium. This has been compounded by events such as the prevalence of antibiotic-resistant drugs, which has increased the demand for new kinds of drugs.
One other reason may be the distinct lack of high returns from new technologies. In order to maximise throughput and productivity, essentially gaining an advantage in the fiercely competitive market, companies will risk a great deal in innovative new discovery technologies even if returns won't be seen until much later. Particular examples include the increase in antisense technology use, which has proven successful, though not to the high standards expected of the industry.
The industry is also suffering from the tightening of legislation, which has made it harder to develop drugs and receive the crucial seals of approval. The approval of Aventis' ketolide antibiotic Ketek (telithromycin) was held up by the US Food and Drug Administration for several months by requests for additional data on resistant strains. Indeed, the fallout resulting from the cox-2 inhibitor fiasco and the subsequent scrutiny of the FDA will ensure standards will be raised to prevent a similar episode.
A recognised trend was the emergence of companies trying to boost productivity primarily by spending more on R&D and looking outside for help, particularly via strategic alliances. While scientists recognise the importance of such partnerships, seventy five per cent of the scientists surveyed still believe companies should focus more attention on internal R&D to enhance innovation and productivity.
There were numerous challenges facing drug R&D, Only 30 per cent of scientists believed metrics to measure productivity were effective, whilst 20 per cent thought work process enhancements worked. A majority (70 per cent) ranked risk identification/management as the greatest challenge facing R&D.
"R&D groups seem to be doing a poor job of identifying and managing risk, a key factor affecting productivity," commented Dr. Chen.
"Bad projects don't end soon enough, driving up costs and wasting resources that could be used on more promising projects. Generally, R&D either overlooks or underestimates risk and must find better ways to identify unpromising projects earlier in the development cycle."
