GlaxoSmithKline didn’t have much in the way of R&D news during their last quarterly update, but the company told analysts to watch that space during the second quarter, as some big research news was in the offing.
Many of the details of these previously under-wrap plans were previewed in an interview with Forbes Tuesday, when GSK CEO Emma Walmsley and new chief scientific officer, former Genentech and Calico executive Hal Barron, outlined much of their R&D plans.
In the official reveal within its second-quarter results today, Barron says: “At the core of this new approach is identifying new medicines by focusing on ways to modulate the immune system, leveraging the vast amounts of human genetic data now being generated, analyzing this complex data with machine learning and creating an accountable culture where smart risk-taking is rewarded.”
The British Big Pharma says its research unit will “have an even greater focus on the basic biology of the immune system as well as targets that have a high degree of validation based on human genetics.” It points to its vaccine business as already being involved in this space.
Critics are quick to point out, however, that GSK is quite far behind in developing drugs with the immune system in mind: Checkpoint inhibitors from the likes of Bristol-Myers Squibb, Merck, AstraZeneca and Roche have been around for years, while many startup biotechs have also been harnessing the power of the immune system for their targets for a while now.
As with fellow European Big Pharmas Novartis and Sanofi, GSK is also investing more heavily in digital health, including machine learning and a new pact with 23andMe, to “support interpretation of genetics data [as] an important part of enabling the new R&D approach.”
“In addition, the group will be investing in functional genomics to validate potential targets, applying techniques for gene modification such as CRISPR technology. GSK will also invest in computational design, automation and new capabilities to assess the indication potential, selection, sequencing and management of evidence generation for new assets over the lifecycle. These investments will supplement GSK’s existing strengths in other technologies, including a leading position in Cell and Gene Therapy,” the company notes in its update.
In this area, Barron has said he is particularly excited about its BCMA asset, an experimental antibody drug conjugate, in early trials for multiple myeloma.
It’s targeting a 2020 launch and a pivotal program this year, with combo tests also on the cards, which Barron hopes could see it gain the more lucrative first-line therapy approval down the line, which GSK is “aggressively pursuing.”
But again, gene and cell therapies and CRISPR are pretty well catered for across biopharma, and little is new here in terms of focus for the industry as a whole.
As the Forbes interview made clear, Barron is not a committee man, and he will take much of the responsibility for its R&D future in his hands. As the Forbes piece notes: “He [Barron] believes a single person should be fully accountable for every decision. This is both faster and, he believes, more effective.”
“This individual-centric approach has shaped Barron’s entire way of interacting with others. He starts meetings by making clear who is making the final decision. Then he takes the role either of being the decider—and expecting others to challenge his assumptions—or of challenging the person who will make the final call.”
Today, the company said there will be a different approach in research culture that leverages this philosophy. “A critical element of this will be through effective collaboration with external partners, investment in new talent and development of people.”
“GSK also intends to promote a culture of increased accountability and smart risk-taking. This will include redefining success and fostering a culture of truth-seeking versus progression-seeking, and optimized portfolio decision-making, alongside implementation of a new robust governance model. Targeted business development to strengthen the group’s pipeline and technology capabilities will also be part of the new R&D approach.”
There won’t be, however, any major structural changes across R&D, as the company’s top executives appear to have little appetite for that right now.
Barron will be doing a lot of this from the West Coast or over FaceTime (as this was predominately how he was interviewed by Walmsley for the job, he tells Forbes), as he won’t be moving to GSK’s R&D centers in either southern England or Pennsylvania.
There will be, that interview notes, a lot of traveling for face-to-face meetings. The hope is that his being in San Francisco will help generate more sparks of cutting-edge research for GSK.
This all remains to be seen from both a logistics point of view, and if these ideas can translate into a better, more productive R&D engine that can produce blockbusters.
Last year, Walmsley came into GlaxoSmithKline with a mission to change up its R&D, and she’s wasted little time in looking to enliven a largely stagnant pipeline.
Little has changed so far on the money side. GSK’s R&D budget last year was £3.86 billion ($5.42 billion), down slightly from 2016, but she has been busy on making some big changes, sweeping out programs here and buying up other programs there. Early on in her tenure, Walmsley said she was scrapping more than 30 drug development programs.
The major cull of pipeline prospects has seen GSK focus 80% of its R&D budget on the top candidates in four therapeutic areas, while also exiting rare disease programs it had in the past made so much of in the press.
Other aspects of the revised strategy include a focus on improving connections between the R&D and commercial teams and “governance around pipeline decision-making.” The focus appears to acknowledge previous weaknesses in how GSK has made pipeline decisions and transitioned drugs from the clinic to the market.
Walmsley unveiled the overhaul of GSK’s R&D priorities at the end of her first full quarter as CEO last year and is focusing GSK’s attention on two therapeutic areas in which it already has a sizable presence—respiratory and HIV/infectious diseases—and two in which it aspires to grow—oncology and immuno-inflammation, areas where Kevin Sin, another ex-Genentech executive, may be put to work to boost.
The cancer focus is somewhat of a turnaround for GSK, which in 2014 under former CEO Sir Andrew Witty traded away most of its oncology assets in exchange for the Novartis vaccines stable in a multibillion-dollar deal.
Sin started work at GSK this month as SVP and head of worldwide business development for pharmaceuticals R&D. Translation: Sin will be on the hunt for pipeline deals, with it seems a focus on immunotherapies across diseases. He reports to Barron and will also be based in San Francisco.
Walmsley has the personnel in place. Now, they’ll have to deliver.