For a man who has penned more than 500 medical articles, moves easily in the microscopic world of cell function, and has led the drug-discovery programs of two large pharmaceutical companies, Jan Lundberg was surprisingly candid about the challenges of developing new medicines.
"It's probably much easier to send a man to the moon than create a successful medicine for Alzheimer's,"Eli Lilly and Co.'s chief scientist confessed to a gathering last week of medical journalists in a Lilly conference room, hung with photos of patients with diseases Lilly hopes it can cure.
Lundberg's comments about the daunting nature of his job help to explain why Lilly and the rest of Big Pharma are struggling on the drug-development front, where truly breakthrough drugs have remained elusive.
Consider that the number of applications to the Food and Drug Administration for new-drug approvals declined from the late 1990s to 2010, before surging a bit to 39 and 41 in the past two years. Similarly, FDA approvals of new drugs limped along at between 18 and 26 a year from 2006-10, before ticking up to 30 in 2011 and 39 last year.
Hardly impressive, considering the $30 billion invested each year in U.S. drug development.
Lilly has agonized along with its peers in getting new drugs to market.
The Indianapolis drug maker has an aging drug portfolio, with only one of its top 10 drugs younger than nine years old. And Lilly has seen a score of promising pipeline drugs fare poorly in clinical trials in the past two years, the latest being the experimental cancer drug ramucirumab. The treatment failed to show efficacy against breast cancer, a major market Lilly was hoping the drug would serve.
Such challenges gave Lilly a public relations reason Thursday to show off its Indianapolis drug research labs. The invitation aimed to spread the word that its drug R&D program remains robust, recent failures notwithstanding.
Ron DeMattos, a research fellow and self-described drug-hunter, led the visitors single-file in and out of cramped labs, piled with instruments, electronic gear and chemicals, where Alzheimer's is under scientific siege.
Few afflictions are as dreaded as Alzheimer's, a degenerative disease which robs brain function and which is the focus of work by many of Lilly's 7,700 R&D workers. Lilly has one drug in late-stage tests for Alzheimer's and others coming behind it.
At one lab bench, a worker sliced sections of an Alzheimer's-afflicted mouse's brain and laid the thinner-than-hair strips on microscope slides for scientists to peer at.
In another area, DeMattos pointed to a proprietary Lilly-developed tool that measures different forms of a peptide that occurs in the brains of Alzheimer's patients and may give insight into the working of Alzheimer's. "The competition can't measure (the peptide)," DeMattos said. "We can."
Lilly showed off another machine it's using to get a step up on its rivals: an automated chemical synthesis lab, cost undisclosed, that lets chemists do their work remotely. The lab averages about 200 chemical reactions a week, serving as a reliable lab assistant to about 50 chemists who regularly use it.
"A chemist can sit at a computer anywhere in the world and tap into this lab," said Alexander Godfrey, a research adviser. "Nothing like this has ever been built."
The new lab technologies have quickly been embraced by Lilly scientists, said Bill Heath, a senior vice president for product and clinical programs. He estimates that more than half of Lilly's current drug-development projects have made use of the automated lab.
With its new research approaches, Lilly also is trying to reduce the cost of drug development, from the current $1 billion to put a major new drug on the market to $750 million or less. Lilly President and Chief Executive John Lechleiter has been pushing the necessity of lower drug development costs for several years.
Are costs coming down at Lilly?
The man who plans Lilly's drug-discovery strategy, Alan Palkowitz, vice president of discovery chemistry research and technologies, doesn't give any quick assurances that it is. "It's hard to measure that," he said. "The trend ... is taking us in the right direction."
Heath can't say for sure, either, but he's hopeful Lilly is squeezing costs from the drug-development process. "From a bang for the buck perspective, I think we're making progress. Time will tell."
For Lundberg, who heads R&D as president of Lilly Research Laboratories, perseverance must be built into Lilly's R&D strategy as well -- especially as it struggles to find winners from its pipeline of 39 molecules in late- or mid-stage testing.
For the Swedish-born scientist, drug research is like cross-country skiing: It requires maximum exertion over a long winding course. He also likes to quote Winston Churchill, who defined success at a difficult time as "going from one failure to another with enthusiasm."
"I am a person who never gives up," Lundberg said. ___