Speaking at last week's Drug Discovery and Development of Innovative Therapeutics (DDT) conference in Boston, US, Dr Thomas Hofstaetter told delegates he believes that although the industry did have a problem, it is now solved - we just have to be patient to see the results. "The mistake that people often make when they look at this so called productivity issue in the industry is [they forget] the long time lines we are dealing with," he said. "It takes 15 years to get an idea to market and so the dearth of new products making it onto the market that we see now is the result of changes in drug discovery approaches made 15 years ago. "The pipelines are more diverse and better quality than ever before."
The stats do seem to at least partly back up this last statement. In an earlier talk Dr Mervyn Turner, senior vice president of worldwide licensing and external research at Merck Research Laboratories, aggregated the pipelines of seven large healthcare firms. This showed that, in the world of big pharma at least, the late-stage pipeline may have essentially flattened out over the previous few years, but the number of molecules in early stage development is increasing rapidly. "Over the last five years, we've seen close to a doubling of Phase I and Phase II molecules. That represents a big shift in the discovery model and it seems to be getting easier to bring small molecules forward for clinical development," said Turner. "On the other hand, that is not translating into late stage pipeline for big pharma companies. You can take the optimistic view and say that this tsunami is about to break and we are going to have a tidal wave of new products. Or, you could say it's just going to be another white cap and lap up on the shore again." Hofstaetter believes these huge pipelines will translate into interesting and innovative new products, if not a tsunami of new drugs, then certainly more than a trickle, he said, borrowing Turner's analogy. However, he doesn't believe the pharma industry is out of the woods just yet.
"[One area] the industry still has to deal with, is the willingness and ability of the payers to afford all of the innovation that is possible and that is something we have to deal with jointly [pharma and biotech] and we simply have to become much more efficient in everything we do from drug discovery to delivery," he said. By becoming more efficient, Hofstaetter clearly hopes to eventually reduce the time it takes to bring a drug to market and to reduce the number of costly drug failures, especially at a late stage. This, in turn, will mean that those drugs that do make it past the regulators will have been, on average, cheaper to develop. The issues don't stop there, however. Hofstaetter explained that if a biotech or smaller pharma company does get a product to market on its own, it is often a waste for the companies to develop large in-house sales teams. Instead, the biotech industry has to re-think how it does business and share big pharma's commercial resources, according to Hofstaetter. For example, in oncology: "Believe me, there are enough oncology sales forces in the market and the last thing oncology specialists need is additional reps knocking at their door; they need new molecules.
"We [big pharma] are already in the commercial space, not all of you need to be there," he concluded.
Hofstaetter was perhaps playing devil's advocate but, if the cost of drug development can be driven down through increased efficiency, undoubtedly everyone will benefit. Payers will get access to cheaper drugs and the industry will have lower costs; something that could enable them to invest in more projects - including those will small patient populations - while still maintaining profits.