- The business of developing new drugs faces two "existential challenges," Amgen's research chief David Reese told Business Insider in a recent interview.
- Those are: How long it takes to take a drug from idea to approval, and the high failure rates for therapies that start human trials, said Reese. He took charge of the $130 billion biotech's research strategy in 2018.
- "It has to change, therefore it will," Reese said on the low success rate of drugs, where about 8% that enter clinical testing are eventually approved. "Because, realistically, the only alternative is extinction."
- In light of these problems, Amgen has recently narrowed its research focus, backing away from the areas of neuroscience, kidney disease, and bone health.
- Instead, Amgen is investing in genetics, with a "triple threat" approach to understand disease and craft better treatments. "We want to load the dice," Reese said, on boosting success rates with this approach.
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The drug industry is facing two existential challenges in developing new treatments, according to Amgen's top research exec: the process takes too long and the drugs fail too often.
Roughly one in 10 drugs that enter clinical testing eventually make it to market, and those that do typically take 12 to 14 years to go from idea to approved drug.
"We can't go on like that," David Reese, Amgen's executive vice president of research & development, said in a recent interview with Business Insider.
Reese is far from alone - these are well-recognized problems facing the industry. The biggest pharmas have seen returns on their research and development spending plummet over the past decade, from 10% in 2010 to 2% in 2019, according to Deloitte research. The consultancy said it costs about $2 billion to bring a single drug to market.
"It has to change and therefore it will," Reese added on the low success rate of drug development. "Because realistically the only alternative is extinction."
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In response, the world's largest biotech has narrowed its research strategy under Reese, focusing in on three areas: cancer, heart disease, and inflammation.
The California biotech is still selling some treatments for kidney disease, bone health, and brain disorders, and may also make deals to acquire new treatments in those areas. But it won't focus on finding new treatments in those areas in its own labs, Reese said. He said the company just doesn't have a strong enough understanding of the biology underlying those disease areas to make it worthwhile.
'Loading the dice' with genetics
To tackle the big R&D challenges facing the drug industry, Amgen has been building up its expertise in genetics.
"The use of genetic and allied technologies is really meant in many ways to address the success rate," Reese said. "We want to load the dice."
The R&D head called it a "triple threat" approach: building a foundation of genetic data, using biology to turn that data into targets for treatments and a better understanding of how diseases work, and then crafting drugs to target those areas using molecular engineering.
While several large drugmakers are taking similar steps in genetics, Amgen's partnerships make it unique, Reese said.
To build its genetic database, Amgen agreed to acquire deCODE Genetics in 2012. Back then, the Icelandic company had sequenced about 3,000 whole genomes in total. Now, the subsidiary is sequencing more than 10,000 each month and has built a database of 1.5 million participants, Reese said.
Amgen is using deals and partnerships to get access to more genetic data
Two new partnerships inked in 2019 will add one million more genomes over the next few years: Amgen is one of four companies working with the UK government to sequence 500,000 participants. And the biotech also struck a deal with the Utah health system Intermountain Health to provide another half a million genomes.
"At that point, we will largely have the scale we're interested in," Reese said.
The next step is adding depth beyond genetics: large-scale studies of proteins and RNA molecules. deCODE is working with a Colorado-based protein specialist called SomaLogic to run experiments collecting massive amounts of protein measurements.
One ongoing experiment, for instance, is collecting 5,000 protein measurements from 40,000 people, Reese said, totaling 200 million data points from that one effort.
Traditional analytic tools won't be sufficient for this massive data effort, Reese said, inevitablly putting AI and machine learning in Amgen's future.
While the big biotech has stayed out of gene therapy so far, Reese called it "inevitable" that Amgen will eventually enter the burgeoning space. He said he is waiting for when these one-time treatments show the ability to go beyond treating rare diseases.
"Gene therapy now tends to be very focused," he said. "Eventually, it will develop into platforms that are more widely applicable. For me, that's where I am probably going to likely make a move."
Speeding up success
While the moutain of genetic data accumulates and theoretically boosts Amgen's chances of success in drug development, Reese is also attempting to speed up the process.
A few years ago, he led an effort at Amgen to map out in fine detail all the steps in taking a drug from an idea to a marketed product. The goal was to answer the question: what is the speed of drug R&D?
The end result was a playbook to shave as much time as possible off of the drug development process. Now, Reese said the California biotech has begun to do that. An Amgen spokesperson confirmed this is in place for one of its most valuable experimental drugs, AMG 510, which targets a mutation to a gene called KRAS that causes cancer.
"In a number of our programs, we think we're probably on track to take up to three years out of that process," he said. "That's a lot. I think we can do better. So we're continuing to strive for, and iteratively learn, how we can reduce that cycle time going forward."
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