Has new technology hampered R&D productivity?
R&D capabilities of pharmaceutical companies, drug research and
development is facing a major problem as R&D productivity in
the last decade is at a historical low despite recent innovations.
That was the verdict from Dr Jan Hoflack, Vice-President of Medicinal Chemistry and ADME-Tox at Johnson and Johnson, who was speaking at the >Drug Discovery Technology Europe conference in London last week.
His concerns stemmed from concerns that pharmaceutical companies are not fully benefiting from the technological advances, suggesting that innovations are taking away from the essential elements of research that have produced the blockbuster drugs of old.
Hoflack cited the emergence of molecular biology and combinatorial chemistry that has seen a focus shift in genetics technology and especially the rational design of new drugs.
Genetic technology is a term that can be applied to the methods used during genetic testing. This can involve both chromosome analysis and the molecular analysis of DNA and RNA, on specimens such as blood, amniotic fluid, bone marrow, skin or products of conception.
Hoflack told DrugResearcher.com: "Have we sufficiently validated these HT methods to base our whole R&D methods on them? We need to build on what we know in chemistry and biology. That is not to say we can't explore the less known off the critical path but we need to give it more time."
His words echo the feeling within the pharmaceutical industry, which suggests that his sentiments are spot on and that an ever-demanding public has unfairly put the industry under pressure.
Hoflack outlined a list of factors that have made the R&D process increasingly difficult - an issue that arguably new technologies have contributed to.
More data has been generated between 1999 and 2002 than that generated in all of the pharmaceutical industry's history. The sheer influx of data generated has understandably slowed down productivity, stretching allocated research budgets.
"What we have to consider is the disease physiology is still poorly understood," he said. "Most disease treatments still target the symptoms, not the cause."
Predictably, the problem stems from the jump from animal to human physiology for many therapeutic areas. Events such as The Northwick incident, which involved a Phase I trial by TeGenero AG of Germany for a drug to treat leukaemia, rheumatoid arthritis and multiple sclerosis.
The test resulted in extreme swelling in human subjects' organs and body parts, despite previous animal experiments in which the subjects successfully passed.
What has changed within the last twenty years remains varied depending on who you talk to but the fact remains that pharma (and to an extent biotech) has struggled to adapt to the changing landscape and crucially the demands of the people who rely on such treatments.
"The size of companies has been a big factor, with corporations becoming so big that it is impossible to oversee it all," said Hoflack.
"Added to the dilution of decision-making, increased bureaucracy and difficulties at the interfaces, the focus of drug-making has become very short-term."
Hoflack suggested areas that he thought could be improved, recommending the construction of organisational structures that foster integration from all disciplines from early discovery to clinical application.
He also said the complexity of human medicine had to be accepted with a switch in strategy that concentrates on the pathway from observation to molecular medicine and not the other way round.
"New technologies will be a major driver for improved diagnosis, early detection, disease prevention and personalised medicine," he said.
"But this will only happen when we link them to 'observation methods,' where there can be an assurance of a translational link from clinic to research and back."
