Amgen: ‘We’ve shaved 3 years off development but can do better’

Amgen says it hopes to rapidly develop new medicines from a collaboration with Intermountain Health as its EVP of R&D discusses changing timelines.

Wholly-owned Amgen subsidiary deCODE genetics will have access to the genomes of 500,000 Utah-based participants from a study carried out by not-for-profit healthcare provider Intermountain Healthcare. Amgen hopes to use this data to uncover new insights into specific diseases and develop new medicines that reach the right disease targets.

Speaking at the Goldman Sachs 40th Annual Global Healthcare Conference yesterday, Amgen’s EVP of R&D David Reese said such a collaboration formed part of his company’s strategy to push down development timelines.

Image: iStock/Totojang

“This will be the largest single project, focused project of its kind in the United States and I think is a tremendous collaboration of the leadership that Intermountain was visionary and one thing to be able to, both on an individual patient level begin using genetics to guide how they deliver healthcare to learn across their populations,” he told stakeholders.

“That genetics piece is critical,” he said in making new medicines. “Genetics gives you ultimately link to a target or a pathway. There is a lot unique to figure out. I think that’s Amgen’s historic strength and we continue to buttress that.”

Speeding up development

The collaboration falls into two “core existential problems” that industry needs to solve, Reese added.

The first is improving the success rates – “currently they still run around 8% and it’s been that way for some time that varies by therapeutic areas, but we must do better” – while the second is reducing cycle times and drug development.

“[It still takes] 12 to 14 years on average from idea in the laboratory to achieving marketing authorizations for a drug,” he continued.

“We strongly believe that genetics will be foundational for drug development going forward, particularly outside of oncology. We are not talking tumor genomics here, but everything else and we’ve made through the acquisition of deCODE Genetics [in 2012] and then enhancement of their work in the last several years, huge investments in genetics.”

Amgen has managed to accelerate its development timeline from early preclinical work through clinical development with several of its molecules, including AMG 510, its KRASG12C inhibitor currently in a Phase I study.

“KRAS program is an example of where we applied what we’ve learned and again in an integrated fashion across the spectrum of drug development,” Reese said.

“I think we’ve probably taken on average three years off our development timelines right now and I think we can do better than that going forward.”

One thought on “Amgen: ‘We’ve shaved 3 years off development but can do better’

  1. Interesting article. If you can shave a more time off of process development and validation along with rapid manufacturing, it is likely possible to get new products to patients in < 5years. Amgen commercialized Epogen in less that 4 years from start to patient delivery. Today’s development path is more difficult, but the tools exist to speed things up dramatically.

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