JPM23: After rock climbing in biotech, Novartis' CMO is back to support hopeful hike to US summit

Novartis' chief medical officer and global drug development president Shreeram Aradhye, M.D., is back after a muscle-building stint in biotech, jumping into 2023 laser-focused on five therapeutic areas and driven by the company’s goal of becoming a top U.S. drugmaker.

“I've come back to Novartis—and with great optimism,” Aradhye told Fierce Biotech at the sidelines of the J.P. Morgan Healthcare Conference.

Aradhye has clocked in nearly 20 years with the Swiss pharma, serving as the company’s CMO and global head of medical affairs before departing in 2019. After spending time as Dicerna Pharmaceuticals’ CMO and Axcella’s chief development officer, Aradhye rejoined Novartis last May.

The leader described his move from Big Pharma to biotech as “leaving a well-funded expedition to go rock climbing,” continuing the metaphor by explaining the career jump requires “losing a little bit of fat” and gaining new muscles.

“It's been great to come back,” the CMO said, noting that he’s returned with principles from the biotech world such as intense focus. “What I'm excited about is the fact that I joined back at a time when we position ourselves now as a pure play innovative medicines company.”

Novartis is shaking things up with a “U.S.-first” approach in hopes of positioning itself as one of the country’s top five drugmakers by 2027. Despite ranking as the fifth largest biopharma company by worldwide revenue in 2021, Novartis came in 10th in the U.S. for the same time period.

Part of the approach includes prioritizing five therapeutic areas—cardiovascular, immunology, neuroscience, solid tumors and hematology—though Novartis doesn’t currently plan to cut loose its respiratory and eye meds anytime soon, CEO Vas Narasimhan, M.D., said at JPM earlier this week.  

Novartis also recently implemented a new organizational model in a restructuring that showed several executives and about 8,000 employees the door. The reshuffle included dividing Novartis’ innovative medicines department by U.S. and international markets instead of by therapeutic areas.

“The key word is focus,” Victor Bulto, president of the newly created U.S. business unit, told Fierce. “There are so many exciting ideas … it's pretty much against our traditional DNA in the company, as a conglomerate wanting to do many things that lead in many spaces. It's time for us to demonstrate that we can focus and do things really, really well in the areas where we concentrate.”

For Aradhye, this shift in mindset means moving “from measuring our success in numbers of things to the value of things and impact.” 

“My mandate to the team has been that the only reason that something should not actually work out as planned is if biology truly behaves in unexpected ways,” the CMO explained. “I need to ensure that there is no unintended attrition and that we deliver the value that people expect.”

High on the docket is remibrutinib, a BTK inhibitor being studied across several autoimmune indications, including separate phase 3 trials for chronic spontaneous urticaria and multiple sclerosis. The company is also interested in a biomarker called prostate-specific membrane antigen (PSMA), with plans to expand the reach of its approved drug Pluvicto. The PSMA-targeted radioligand therapy is currently used to treat metastatic castration-resistant prostate cancer but is being assessed in clinical trials for earlier stages of hormone-sensitive prostate cancer.  

Novartis’ new strategy continues to put significant investment towards gene therapy. After launching Zolgensma, the first commercially successful gene therapy, in 2019, Novartis has significant manufacturing, regulatory and development capabilities to lean on. The company is advancing more than 15 in-house programs, with its most advanced candidate a macular degeneration disease geographic atrophy asset picked up in its December 2021 acquisition of British biotech Gyroscope Therapeutics.

As a whole, Novartis considers gene therapy as a potentially curative modality with little risk of other players impeding its space, according to Aradhye.

In terms of seeking out further pipeline expansion and additions, the Big Pharma is being disciplined, which Aradhye describes as “low, single-digit billion-dollar type deals.”

Novartis’ strategy will include looking for additional opportunities that fall within the five therapeutic areas of interest and meet thresholds for a certain value proposition, he explained.

“One is always looking,” Aradhye added, though the CMO did say the assumption that there are plenty of great assets to be picked up amid a troubled biotech market is inaccurate.

“When it actually comes time to look for real good opportunities, they are not as plentiful as people imagined them to be,” he said. “We take pride in the fact that we will not make the deals just for the sake of counting numbers of things done.”

As for newer opportunities that may crop up, Aradhye says it’s the responsibility of leaders to make sure they leverage what works well without becoming complacent, while also paying attention to emerging sciences and tech that holds disruptive potential. Getting those disrupters on the radar is where a meeting like JPM becomes incredibly important, he said.